ProQuad

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

 



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1. NAME OF THE MEDICINAL PRODUCT

ProQuad powder and solvent for suspension for injection
ProQuad powder and solvent for suspension for injection in a pre-filled syringe

Measles, mumps, rubella and varicella vaccine (live).

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

After reconstitution, one dose (0.5 mL) contains:

Measles virus1 Enders’ Edmonston strain (live, attenuated)........not less than 3.00 log10 TCID50*

Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated)...not less than 4.30 log10 TCID50*

Rubella virus2 Wistar RA 27/3 strain (live, attenuated)...............not less than 3.00 log10 TCID50*

Varicella virus3 Oka/Merck strain (live, attenuated) ...................not less than 3.99 log10 PFU**

*50% tissue culture infectious dose
**plaque-forming units

(1) Produced in chick embryo cells.
(2) Produced in human diploid lung (WI-38) fibroblasts.
(3) Produced in human diploid (MRC-5) cells.

The vaccine may contain traces of recombinant human albumin (rHA).
This vaccine contains a trace amount of neomycin. See section 4.3.

Excipient(s) with known effect
The vaccine contains 16 milligrams of sorbitol per dose. See section 4.4.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Powder and solvent for suspension for injection

Before reconstitution, the powder is a white to pale yellow compact crystalline cake and the solvent is 
a clear colourless liquid.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella and varicella in 
individuals from 12 months of age.

ProQuad can be administered to individuals from 9 months of age under special circumstances (e.g., 
to conform with national vaccination schedules, outbreak situations, or travel to a region with high 
prevalence of measles; see sections 4.2, 4.4, and 5.1).

 



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4.2 Posology and method of administration

Posology

ProQuad should be used in accordance to official recommendations.

 Individuals 12 months of age and older
Individuals from 12 months of age should receive two doses of ProQuad or a single dose of
ProQuad followed by a second dose of a monovalent varicella vaccine to ensure optimal 
protection against varicella (see section 5.1). At least one month must elapse between the first 
and second dose of any live viral attenuated vaccine. It is preferred that the second dose be 
administered within three months following the first dose.

 Individuals between 9 and 12 months of age
Immunogenicity and safety data show that ProQuad can be administered to individuals between 
9 and 12 months of age, under special circumstances (e.g., in accordance with official 
recommendations or when early protection is considered necessary). In such cases, individuals 
should receive a second dose of ProQuad, given a minimum of 3 months apart, to ensure
optimal protection against measles and varicella (see sections 4.4 and 5.1). 

 Individuals less than 9 months of age
ProQuad is not indicated in this subset of the paediatric population. The safety and efficacy of 
ProQuad in children under 9 months of age have not been established. 

ProQuad may be used as the second dose in individuals who have previously received measles, 
mumps, and rubella vaccine and varicella vaccine.

Method of administration

The vaccine is to be injected intramuscularly (IM) or subcutaneously (SC).

The preferred injection sites are the anterolateral area of the thigh in younger children and the deltoid 
area in older children, adolescents, and adults.

The vaccine should be administered subcutaneously in patients with thrombocytopenia or any 
coagulation disorder. 

Precautions to be taken before handling or administering the medicinal product: see section 6.6.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

The vaccine should under no circumstances be injected intravascularly.

4.3 Contraindications

Hypersensitivity to any varicella vaccine or measles, mumps, or rubella vaccine or to any of the 
excipients listed in section 6.1, including neomycin (see sections 2 and 4.4).

Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the 
haematopoietic and lymphatic system.

Current immunosuppressive therapy (including high doses of corticosteroids) (see section 4.8). 
ProQuad is not contraindicated in individuals who are receiving topical or low-dose parenteral 
corticosteroids (e.g. for asthma prophylaxis or replacement therapy).

 



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Severe humoral or cellular (primary or acquired) immunodeficiency, e.g., severe combined 
immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific 
CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25%, children between 12-35 
months: CD4+ <20%; children between 36-59 months: CD4+ <15% (see sections 4.4 and 4.8). 

In severely immunocompromised individuals inadvertently vaccinated with measles-containing 
vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence
of disseminated measles vaccine virus infection have been reported.

Family history of congenital or hereditary immunodeficiency, unless the immune competence of the 
potential vaccine recipient is demonstrated.

Active untreated tuberculosis. Children under treatment for tuberculosis have not experienced 
exacerbation of the disease when immunized with live measles virus vaccine. No studies have been 
reported to date on the effect of measles virus vaccines on children with untreated tuberculosis.

Vaccination should be postponed during any illness with fever >38.5C.

Pregnancy. Furthermore, pregnancy should be avoided for 1 month following vaccination (see 
section 4.6).

4.4 Special warnings and precautions for use 

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number
of the administered product should be clearly recorded.

Appropriate medical treatment and supervision should always be readily available in case of a rare 
anaphylactic reaction following the administration of the vaccine.

Additionally, live measles vaccine and live mumps vaccine are produced in chick embryo cell culture. 
Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g. hives, 
swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg 
ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions. The potential 
risk-to-benefit ratio should be carefully evaluated before considering vaccination in such cases.

Due caution should be employed in the administration of ProQuad to persons with individual or 
family history of convulsions, or a history of cerebral injury. The physician should be alert to the 
temperature elevation that may occur following vaccination (see section 4.8).

Individuals less than 12 months of age who are vaccinated with a measles-containing vaccine during 
measles outbreaks or for other reasons may fail to respond to the vaccine due to the presence of 
circulating antibodies of maternal origin and/or immaturity of the immune system (see sections 4.2 
and 5.1).

Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with ProQuad as Reye 
syndrome has been reported following the use of salicylates during wild-type varicella infection.

Vaccination with ProQuad may not result in protection in all vaccine recipients.

Transmission
Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in 
the majority of susceptible individuals 7 to 28 days after vaccination. There is no confirmed evidence 
to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated 
individuals. Consequently, transmission through close personal contact, while accepted as a 
theoretical possibility, is not regarded as a significant risk; however, transmission of the rubella 

 



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vaccine virus to infants via breast milk has been documented without any evidence of clinical disease 
(see section 4.6).

There are no reports of transmission of the more attenuated Enders’ Edmonston strain of measles virus 
or the Jeryl Lynn™ strain of mumps virus from vaccine recipients to susceptible contacts.

Post-marketing experience suggests that transmission of varicella vaccine virus (Oka/Merck strain)
resulting in varicella infection including disseminated disease may rarely occur between vaccine 
recipients (who develop or do not develop a varicella-like rash) and contacts susceptible to varicella
including healthy as well as high-risk individuals (see section 4.8).

High-risk individuals susceptible to varicella include:

• immunocompromised individuals (see section 4.3),
• pregnant women without documented positive history of varicella (chickenpox) or laboratory 

evidence of prior infection,
• newborn infants of mothers without documented positive history of varicella or laboratory 

evidence of prior infection.

Vaccine recipients should attempt to avoid, whenever possible, close association with high-risk 
individuals susceptible to varicella for up to 6 weeks following vaccination. In circumstances where 
contact with high-risk individuals susceptible to varicella is unavoidable, the potential risk of 
transmission of the varicella vaccine virus should be weighed against the risk of acquiring and 
transmitting wild-type varicella virus.

Thrombocytopenia
This vaccine should be given subcutaneously to individuals with thrombocytopenia or any 
coagulation disorder because bleeding may occur following an intramuscular administration in these 
individuals.

In clinical trials, no cases were reported regarding the development or worsening of thrombocytopenia 
in individuals vaccinated with ProQuad. Cases of thrombocytopenia have been reported in post-
marketing experience after primary vaccination with ProQuad. In addition, cases of thrombocytopenia 
have been reported after primary vaccination or revaccination with measles vaccine; measles, mumps, 
and rubella vaccine; and varicella vaccine. Post-marketing experience with live measles, mumps, and 
rubella vaccine indicates that individuals with current thrombocytopenia may develop more severe 
thrombocytopenia following vaccination. In addition, individuals who experienced thrombocytopenia 
following the first dose of a live measles, mumps, and rubella vaccine may develop thrombocytopenia 
with repeat doses. Serologic status may be evaluated to determine whether or not additional doses of 
vaccine are needed. The risk-to-benefit ratio should be carefully evaluated before considering
vaccination with ProQuad in such cases (see section 4.8).

Febrile seizures
In the 5- to 12-day timeframe after the administration of the first dose of quadrivalent measles, 
mumps, rubella and varicella vaccines in children, an increased risk of febrile seizure was observed 
compared to concomitant administration of measles, mumps, rubella and varicella vaccines (see 
sections 4.8 and 5.1).

Other
Vaccination may be considered in patients with selected immune deficiencies where the benefits 
outweigh the risks (asymptomatic HIV patients, IgG subclass deficiencies, congenital neutropenia, 
chronic granulomatous disease, and complement deficiency diseases).

Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may 
not respond as well as immunocompetent patients; therefore, some of these patients may acquire 

 



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measles, mumps, rubella, or varicella in case of contact, despite appropriate vaccine administration. 
These patients should be monitored carefully for signs of measles, parotitis, rubella, and varicella.

Post-exposure prophylaxis
No clinical data are available for ProQuad administered after exposure to measles, mumps, rubella, or 
varicella. However, post-exposure prophylaxis for varicella and measles has been demonstrated with 
Varicella Vaccine live (Oka/Merck) and the measles-containing vaccines manufactured by Merck & 
Co., Inc., respectively.

Sodium
This medicinal product contains less than 1 mmol (23 mg) sodium per dose and is considered to be
essentially sodium-free.

Potassium
This medicinal product contains less than 1 mmol (39 mg) potassium per dose and is considered to be 
essentially potassium-free.

Sorbitol
The additive effect of concomitantly administered products containing sorbitol (or fructose) and 
dietary intake of sorbitol (or fructose) should be taken into account.

Interference with laboratory tests: see section 4.5.

4.5 Interaction with other medicinal products and other forms of interaction

At least 1 month should elapse between receipt of a live virus vaccine and ProQuad.

Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with ProQuad (see 
section 4.4).

Do not give immunoglobulin (IG) or Varicella-Zoster Immune Globulin (VZIG) concomitantly with 
ProQuad.

Administration of immune globulins concomitantly with ProQuad may interfere with the expected 
immune response. Vaccination should be deferred for at least 3 months following blood or plasma 
transfusions, or administration of immune globulins (IG). However, the appropriate suggested interval 
between transfusion or IG administration and vaccination will vary with the type of transfusion or 
indication for, and dose of, IG (e.g. 5 months for VZIG).

Administration of varicella zoster virus antibody-containing blood products, including VZIG or other 
immune globulin preparations, within 1 month following a dose of ProQuad may reduce the immune 
response to the vaccine and hence reduce its protective efficacy. Therefore, administration of any of 
these products should be avoided within 1 month after a dose of ProQuad unless considered to be 
essential.

It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually 
may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin test is to
be done, it should be administered either any time before, simultaneously with, or at least 4 to 6 weeks 
after immunization with ProQuad.

Concomitant use with other vaccines:
Clinical studies have demonstrated that ProQuad can be given simultaneously (but at separate 
injection sites) with Prevenar and/or hepatitis A vaccine, or with monovalent or combination vaccines 
comprised of diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated 
poliomyelitis, or hepatitis B antigen. In these clinical studies, it was demonstrated that the immune

 



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responses were unaffected. The safety profiles of the administered vaccines were comparable (see
section 4.8).

There are insufficient data to support the use of ProQuad with any other vaccines.

4.6 Fertility, pregnancy and lactation

Pregnancy
Pregnant women should not be vaccinated with ProQuad.

Studies have not been conducted with ProQuad in pregnant women. It is not known whether ProQuad 
can cause foetal harm when administered to a pregnant woman or affect reproduction capacity.

Pregnancy should be avoided for 1 month following vaccination. Women who intend to become 
pregnant should be advised to delay.

Breast-feeding
Studies have shown that breast-feeding postpartum women vaccinated with live attenuated rubella 
vaccine may secrete the virus in breast milk and transmit it to breast-fed infants. In the infants with 
serological evidence of rubella infection, none had symptomatic disease. There is no evidence that 
varicella vaccine virus is excreted in breast milk. It is not known whether measles or mumps vaccine 
virus is secreted in human milk. Therefore, caution should be exercised when considering whether to 
administer ProQuad to a breast-feeding woman.

Fertility
Animal reproduction studies have not been conducted with ProQuad. ProQuad has not been evaluated 
for potential to impair fertility.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive or use machinery have been performed. ProQuad is 
expected to have no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects 

a. Summary of the safety profile

In 5 clinical trials, ProQuad was administered without concomitant vaccines to 6038 children 12 
through 23 months of age. The children in these studies received either the current refrigerator-stable 
formulation or an earlier formulation of ProQuad. Children in these studies were monitored for six 
weeks post vaccination. The safety profiles were comparable for the two different formulations after a 
single dose. The only vaccine-related systemic adverse reactions reported at a significantly greater 
rate in individuals who received the earlier formulation of ProQuad compared to individuals who 
received the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. and Varicella 
Vaccine live (Oka/Merck) were fever (≥39.4°C rectal equivalent or abnormal) and measles-like rash. 
Both fever and measles-like rash usually occurred within 5 to 12 days following the vaccination, were 
of short duration and resolved with no long-term sequelae. Pain/tenderness/soreness at the injection 
site was reported at a statistically lower rate in individuals who received ProQuad.

The only vaccine related injection-site adverse reaction that was more frequent among recipients of 
ProQuad than among recipients of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and 
rubella vaccine manufactured by Merck & Co. Inc. was rash at the injection site.

Following ProQuad given alone in 7 clinical trials, the observed rates of fever (≥39.4°C rectal 
equivalent) ranged from 10.1% to 39.4%. In comparison, following ProQuad given concomitantly 

 



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with Prevenar and/or hepatitis A vaccine in 3 clinical trials, the observed rates of reported fever 
(≥39.4°C rectal equivalent) ranged from 15.2% to 27.2%. 

In a clinical trial of ProQuad administered concomitantly with Infanrix Hexa, the rates of fever 
(≥38.0°C rectal equivalent) were 69.3% following concomitant administration, 61.1% following 
ProQuad alone, and 57.3% following Infanrix Hexa alone; the rates of fever (≥39.4°C rectal 
equivalent) were 22.6% following concomitant administration, 20.5% following ProQuad alone, and 
15.9% following Infanrix Hexa alone.

The overall safety profile of ProQuad was comparable whether it was administered concomitantly or 
alone.

Children who received a second dose of ProQuad
In eight clinical studies, the overall rates of adverse reactions after a second dose of ProQuad were 
generally similar to, or lower than, those seen with the first dose. In three of these studies, the rates of 
injection-site erythema and swelling were statistically significantly higher after the second dose than 
after the first dose; however, in the remaining five studies, the rates of each of these reactions were 
similar after the first and second dose. The fever rate in all eight studies was lower after the second 
dose than after the first dose.

Children who received ProQuad intramuscularly
The general safety profiles of the IM and SC administration routes were comparable; however, fewer 
subjects experienced injection-site adverse reactions in the IM group after each dose (see section 5.1 
for study description).

Children who received ProQuad at 4 through 6 years of age after primary immunization with 
Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by 
Merck & Co., Inc.
The rates and types of adverse reactions seen in the study group that received ProQuad were generally 
similar to those seen in the groups that received Varicella Vaccine live (Oka/Merck) and the measles, 
mumps, and rubella vaccine manufactured by Merck & Co., Inc. (see section 5.1 for study 
description).

No specific studies have been conducted in individuals from 2 years of age who had not previously 
received measles, mumps, rubella, and varicella vaccines.

The most common adverse events reported with the use of ProQuad were: injection-site reactions 
including pain/tenderness/soreness, redness, swelling or bruising; fever (≥39.4°C rectal equivalent); 
irritability; rash (including measles-like rash, varicella-like rash, and injection-site rash); upper 
respiratory infection; vomiting and diarrhoea.

b. Tabulated list of adverse reactions

The following adverse reactions were reported as vaccine related by the investigator in individuals 
after a single dose of ProQuad. Several adverse events were solicited in the clinical studies and are 
designated with the symbol (‡). Additionally, other adverse events have been reported with post-
marketing use of ProQuad and/or in clinical studies and post-marketing use of either the measles, 
mumps, and rubella vaccine manufactured by Merck & Co., Inc., the monovalent component vaccines 
of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., or Varicella Vaccine 
live (Oka/Merck). The frequency of these adverse events is qualified as "not known" when it cannot 
be estimated based on the available data.

Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, 
<1/1,000); Not known (cannot be estimated from the available data)

Adverse reactions Frequency

 



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Adverse reactions Frequency
Infections and infestations
Upper respiratory infection Common
Ear infection, Gastroenteritis, Nasopharyngitis, Otitis 
media, Pharyngitis, Roseola, Viral infection, Viral 
rash

Uncommon

Bronchiolitis, Candida nappy rash, Candidiasis, 
Cellulitis, Infectious croup, Viral gastroenteritis, 
Hand-foot-mouth disease, Influenza, Pseudocroup, 
Respiratory infection, Skin infection, Tonsillitis, 
Varicella+ ‡, Viral conjunctivitis

Rare

Aseptic meningitis*,
Atypical measles, Encephalitis*, Epididymitis, 
Herpes zoster*, Infection, Measles, Orchitis, Parotitis

Not known

Blood and the lymphatic system disorders
Leukocytosis, Lymphadenopathy Rare
Lymphadenitis, Regional lymphadenopathy, 
Thrombocytopenia

Not known

Immune system disorders
Hypersensitivity Rare
Anaphylactoid reaction, Anaphylaxis and related 
phenomenon such as Angioneurotic oedema, Facial 
oedema, and Peripheral oedema, Anaphylaxis in 
individuals with or without an allergic history

Not known

Metabolism and nutrition disorders
Anorexia, Decreased appetite Uncommon
Dehydration Rare
Psychiatric disorders
Irritability Common
Crying, Insomnia, Sleep disorder Uncommon
Agitation, Apathy, Clinging, Emotional changes, 
Nervousness, Restlessness

Rare

Nervous system disorders
Febrile seizure*, Somnolence Uncommon
Ataxia, Convulsion, Headache, High-pitched crying, 
Hyperkinesia, Hypersomnia, Lethargy, Tremor

Rare

Afebrile convulsions or seizures, Bell’s palsy, 
Cerebrovascular accident, Dizziness, Dream 
abnormality, Encephalopathy*, Guillain-Barré 
syndrome, Measles inclusion body encephalitis (see 
section 4.3), Ocular palsies, Paraesthesia, 
Polyneuritis, Polyneuropathy, Subacute sclerosing 
panencephalitis*, Syncope, Transverse myelitis, 
Tremor

Not known

Eye disorders
Conjunctivitis, Eye discharge, Eyelid inflammation, 
Eye irritation, Eye swelling, Ocular hyperaemia, 
Tearing, Visual discomfort

Rare

Oedema of the eyelid, Irritation, Optic neuritis, 
Retinitis, Retrobulbar neuritis

Not known

Ear and labyrinth disorders
Ear pain Rare
Nerve deafness Not known
Vascular disorders
Flushing, Pallor Rare

 



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Adverse reactions Frequency
Extravasation Not known
Respiratory, thoracic, and mediastinal disorders
Cough, Nasal congestion, Respiratory congestion, 
Rhinorrhoea

Uncommon

Asthma, Pulmonary congestion, Sinus disorder, 
Sneezing, Wheezing

Rare

Bronchial spasm, Bronchitis, Epistaxis, Pneumonitis 
(see section 4.3), Pneumonia, Pulmonary congestion, 
Rhinitis, Sinusitis, Sore throat

Not known

Gastrointestinal disorders
Diarrhoea, Vomiting Common
Abdominal pain upper, Abnormal faeces, 
Constipation, Flatulence, Nausea, Salivation increase, 
Stomatitis, Teething

Rare

Abdominal pain, Haematochezia, Mouth ulcer Not known
Skin and subcutaneous tissue disorders
Measles-like rash‡, Rash, Varicella-like rash‡ Common
Dermatitis (including contact, atopic, and diaper 
rash), Heat rash, Rubella-like rash‡, Urticaria, Viral 
exanthema, Eczema, Erythema

Uncommon

Acne, Clammy skin, Exfoliative dermatitis, Drug 
eruption, Exanthema, Henoch-Schönlein purpura, 
Livedo reticularis, Papular rash, Pruritus, Skin 
discolouration, Skin lesion, Zosteriform rash

Rare

Erythema multiforme, Herpes simplex, Impetigo, 
Panniculitis, Purpura, Skin induration, Stevens-
Johnson syndrome, Sunburn

Not known

Musculoskeletal, connective tissue and bone disorders
Arm pain, Musculoskeletal stiffness Rare
Arthritis and/or arthralgia (usually transient and 
rarely chronic)* , Musculoskeletal pain, Myalgia, 
Pain of the hip, leg, or neck, Swelling

Not known

General disorders and administration site conditions
Fever‡, Erythema‡ or Pain/Tenderness/Soreness‡ at 
the injection site

Very common

Ecchymosis or Swelling‡ at the injection site, 
injection-site rash‡

Common

Asthenia/fatigue, Injection-site haemorrhage, 
Injection-site induration or warmth, Injection-site 
mass, Malaise

Uncommon

Influenza-like illness, Injection-site desquamation, 
Injection-site discolouration, Injection-site pruritus, 
Injection-site rash non-specific, Injection-site 
reaction, Injection-site scar, Hyperthermia, Pain 

Rare

Injection site complaints (Burning and/or Stinging of 
short duration, Eczema, Oedema/Swelling, Hive-like 
rash, Hematoma, Induration, Lump, Vesicles, Wheal
and Flare), Inflammation, Lip abnormality, Papillitis, 
Roughness/Dryness, Stiffness, Trauma, Varicella-like 
rash, Venipuncture site haemorrhage, Warm 
sensation, Warm to touch

Not known

Investigations
Weight loss Rare
Injury and poisoning, and procedural complications

 



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Adverse reactions Frequency
Contusion, Non-venomous bite/sting Rare
Social circumstances
Activities of daily living impaired Rare
+ Varicella caused by vaccine strain was observed in post-marketing use with Varicella Vaccine live 
(Oka/Merck).
* See section c

c. Description of selected adverse reactions

Aseptic meningitis
Cases of aseptic meningitis have been reported following measles, mumps, and rubella vaccination. 
Although a causal relationship between other strains of mumps vaccine and aseptic meningitis has
been shown, there is no evidence to link Jeryl Lynn™ mumps vaccine to aseptic meningitis.

Complications associated with varicella
Complications of varicella from vaccine strain including herpes zoster and disseminated disease such 
as aseptic meningitis and encephalitis have been reported in immunocompromised or 
immunocompetent individuals.

Febrile seizures
Febrile seizures have been reported in children receiving ProQuad. Consistent with clinical study data 
on the timing of fever and measles-like rash, a post-marketing observational study in children 12 to 60 
months of age revealed an approximate two-fold increase (0.70 per 1000 vs. 0.32 per 1000 children) 
in the risk of febrile seizures in the 5- to 12-day timeframe after a first dose of ProQuad (N=31,298) 
compared with concomitant administration of the measles, mumps, and rubella vaccine manufactured 
by Merck & Co., Inc., and the Varicella Vaccine live (Oka/Merck) (N=31,298).These data suggest 
one additional case of febrile seizure per 2600 children vaccinated with ProQuad compared with 
separate administration of the measles, mumps, and rubella vaccine manufactured by Merck & Co., 
Inc., and the Varicella Vaccine live (Oka/Merck). These data were confirmed by a post-marketing 
observational study sponsored by the U.S. Centers for Disease Control and Prevention. In the 30-day 
timeframe following vaccination, no increased risk of febrile seizures was observed (see section 5.1).

Encephalitis and encephalopathy
In severely immunocompromised individuals inadvertently vaccinated with measles-containing 
vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence 
of disseminated measles vaccine virus infection have been reported (see section 4.3); disseminated 
mumps and rubella vaccine virus infection has also been reported.

SSPE
There is no evidence that measles vaccine can cause SSPE. There have been reports of SSPE in 
children who did not have a history of infection with wild-type measles but did receive measles 
vaccine. Some of these cases may have resulted from unrecognized measles in the first year of life or 
possibly from the measles vaccination. The results of a retrospective case-controlled study conducted 
by the US Centers for Disease Control and Prevention show that the overall effect of measles vaccine 
has been to protect against SSPE by preventing measles with its inherent risk of SSPE. 

Arthralgia and/or arthritis
Arthralgia and/or arthritis (usually transient and rarely chronic), and polyneuritis are features of 
infection with wild-type rubella and vary in frequency and severity with age and gender, being 
greatest in adult females and least in prepubertal children. Following vaccination in children, 
reactions in joints are generally uncommon (0 to 3%) and of brief duration. In women, incidence rates 
for arthritis and arthralgia are generally higher than those seen in children (12 to 20%), and the 
reactions tend to be more marked and of longer duration. Symptoms may persist for a matter of 
months or on rare occasions for years. In adolescent girls, the reactions appear to be intermediate in 

 



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incidence between those seen in children and adult women. Even in older women (35 to 45 years), 
these reactions are generally well tolerated and rarely interfere with normal activities.

Chronic arthritis
Chronic arthritis has been associated with wild-type rubella infection and has been related to 
persistent virus and/or viral antigen isolated from body tissues. Only rarely have vaccine recipients 
developed chronic joint symptoms.

Cases of herpes zoster in clinical studies
In a clinical trial, 2 cases of herpes zoster were reported in 2108 healthy subjects 12 through 
23 months of age who were vaccinated with one dose of ProQuad and followed for 1 year. Both cases 
were unremarkable and no sequelae were reported. 

Active surveillance data in children vaccinated with Varicella Vaccine live (Oka/Merck) and 
followed for 14 years after vaccination showed no increase in the frequency of herpes zoster 
compared to children with prior wild-type varicella during the pre-vaccine era. These surveillance 
data actually suggest that varicella-vaccinated children may have a lower risk of herpes zoster. 
However, the long term effect of varicella vaccination on the incidence of herpes zoster is unknown at 
present. There are no long-term data currently available with ProQuad (see section 5.1).

Transmission
Based on post-marketing surveillance, the possibility exists that varicella vaccine virus (Oka/Merck
strain) may rarely be transmitted to contacts of recipients of ProQuad who develop or do not develop 
a varicella-like rash (see section 4.4). 

d. Other special populations

Immunocompromised individuals (see section 4.3)
Necrotizing retinitis has been reported post-marketing in immunocompromised individuals. 

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V.

4.9 Overdose

No case of overdose has been reported.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Vaccines, Viral Vaccine; ATC code: J07BD54.

Efficacy
Formal studies to evaluate the efficacy of ProQuad have not been performed. However, the efficacy 
of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by 
Merck & Co., Inc. has been demonstrated in numerous studies. 

Efficacy of the measles, mumps, and rubella components of ProQuad was previously established in a 
series of double-blind controlled field trials with the monovalent vaccines manufactured by Merck & 
Co., Inc., which demonstrated a high degree of protective efficacy. In these studies seroconversion in
response to vaccination against measles, mumps, and rubella paralleled protection from these 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


13

diseases. ProQuad elicits rates of antibody responses against measles, mumps, and rubella similar to 
those observed after vaccination with the measles, mumps, and rubella vaccine manufactured by 
Merck & Co., Inc.

More than 518 million doses of the measles, mumps, and rubella vaccine manufactured by Merck & 
Co., Inc. have been distributed worldwide (1978 to 2007). Widespread use of a 2-dose vaccination 
schedule in the United States and countries such as Finland and Sweden has led to a >99% reduction 
in the incidence of each of the 3 targeted diseases. 

In combined clinical trials of a single dose of Varicella Vaccine live (Oka/Merck) in healthy children, 
the protective efficacy of the vaccine against all severities of varicella disease ranged from 81% to 
100%. In a large case-control study, the vaccine was estimated to be 85% effective against all forms 
of varicella and 97% effective against moderately severe and severe disease. 

In a study comparing 1 dose (N=1114) to 2 doses (N=1102) of Varicella Vaccine live (Oka/Merck), 
the estimated vaccine efficacy against all severities of varicella disease for the 10-year observation 
period was 94% for 1 dose and 98% for 2 doses (p<0.001). Over the 10-year observation period, the 
cumulative rate of varicella was 7.5% after 1 dose and 2.2% after 2 doses. Most cases of varicella 
reported in recipients of 1 dose or 2 doses of vaccine were mild.

Antibody responses against varicella virus ≥5 gpELISA Units/mL in the glycoprotein enzyme-linked 
immunosorbent assay (gpELISA, a highly sensitive assay which is not commercially available) have 
been shown to be highly correlated with long-term protection. Clinical studies have shown that 
immunization with ProQuad elicits rates of antibody responses against varicella virus ≥5 gpELISA 
Units/mL similar to those observed after vaccination with Varicella Vaccine live (Oka/Merck). 

Immunogenicity 
Immunogenicity was studied in children 12 through 23 months of age with a negative clinical history 
of measles, mumps, rubella, and varicella who participated in 5 randomized clinical trials. The 
immunogenicity of the current refrigerator-stable formulation was shown to be similar to the 
immunogenicity of the earlier formulation of ProQuad six weeks after a single dose of the vaccine.
The immunogenicity of a single dose of an earlier formulation of ProQuad was comparable to the 
immunogenicity of a single dose of its individual component vaccines (Varicella Vaccine live 
(Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.), 
currently used in routine vaccination in some countries.

Clinical trials involving 6987 subjects who received ProQuad demonstrated detectable immune 
responses to measles, mumps, rubella, and varicella in a high proportion of individuals. The presence 
of detectable antibody was assessed by an appropriately sensitive enzyme-linked immunosorbent 
assay (ELISA) for measles, mumps (wild-type and vaccine-type strains), and rubella, and by gpELISA 
for varicella. Following a single dose of ProQuad, the vaccine response rates were 97.7% for measles, 
96.3% to 98.8% for mumps, and 98.8% for rubella. While the seroconversion rate for varicella was 
uniformly high (97.9% to 99.8% across all studies), seroconversion has not been shown to correlate 
well with protection. The vaccine response rate was 90.9% (range 80.8% to 94.5%) for varicella 
based on a post-vaccination antibody titre ≥5 gpELISA units/mL (an antibody titre that has been 
shown to be highly correlated with long-term protection). These results were similar to the immune 
response rates induced by concomitant administration of a single dose of Varicella Vaccine live 
(Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. at 
separate injection sites.

Evaluation of immunogenicity in children from 9 to 12 months of age at the time of first dose
A clinical study was conducted with ProQuad administered with a 2-dose schedule, the doses being 
given 3 months apart in 1,620 healthy subjects from 9 to 12 months of age at the time of first dose. 
The safety profile post-dose 1 and 2 was generally comparable for all age cohorts.

 



14

In the Full Analysis Set (vaccinated subjects regardless of their antibody titre at baseline), high 
seroprotection rates of >99% were elicited to mumps, rubella, and varicella post-dose 2, regardless of 
the age of the vaccinees at the first dose. After 2 doses, the seroprotection rates against measles were 
98.1% when the first dose was given at 11 months, compared to 98.9% when the first dose was given 
at 12 months (non-inferiority study objective met). After two doses, the seroprotection rates against 
measles were 94.6% when the first dose was given at 9 months, compared to 98.9% when the first 
dose was given at 12 months (non-inferiority study objective not met). 

The seroprotection rates to measles, mumps, rubella, and varicella 6 weeks post-dose 1 and 6 weeks 
post-dose 2, for the Full Analysis Set are given in the following table.

Valence 
(seropro
tection 
level)

Time 
point

Dose 1 at 9 months / 
Dose 2 at 12 months

N = 527

Dose 1 at 11 months / 
Dose 2 at 14 months

N = 480

Dose 1 at 12 months / 
Dose 2 at 15 months

N = 466
Seroprotection rates

[95% CI]
Seroprotection rates

[95% CI]
Seroprotection rates

[95% CI]

Measles 
(titre ≥255 
mIU/mL)

Post-
dose 1

72.3% 
[68.2; 76.1]

87.6% 
[84.2; 90.4]

90.6% 
[87.6; 93.1]

Post-
dose 2

94.6% 
[92.3; 96.4]

98.1% 
[96.4; 99.1]

98.9% 
[97.5; 99.6]

Mumps 
(titre ≥10 
ELISA Ab 
units/mL)

Post-
dose 1

96.4% 
[94.4; 97.8]

98.7% 
[97.3; 99.5]

98.5% 
[96.9; 99.4]

Post-
dose 2

99.2% 
[98.0; 99.8]

99.6% 
[98.5; 99.9]

99.3% 
[98.1; 99.9]

Rubella
(titre ≥10 
IU/mL)

Post-
dose 1

97.3% 
[95.5; 98.5]

98.7% 
[97.3; 99.5]

97.8% 
[96.0; 98.9]

Post-
dose 2

99.4% 
[98.3; 99.9]

99.4% 
[98.1; 99.9]

99.6% 
[98.4; 99.9]

Varicella
(titre 
≥5 gp 
ELISA 
units/mL)

Post-
dose 1

93.1% 
[90.6; 95.1]

97.0% 
[95.1; 98.4]

96.5% 
[94.4; 98.0]

Post-
dose 2

100% 
[99.3; 100]

100% 
[99.2; 100]

100% 
[99.2; 100]

The post-dose 2 geometric mean titres (GMTs) against mumps, rubella, and varicella were 
comparable across all age categories, while the GMTs against measles were lower in subjects who 
received the first dose at 9 months of age as compared to subjects who received the first dose at 11 or 
12 months of age.

Children who received a second dose of ProQuad
In 2 clinical trials, 1035 subjects were administered a second dose of ProQuad approximately 
3 months after the first dose. The vaccine response rates were 99.4% for measles, 99.9% for mumps, 
98.3% for rubella, and 99.4% for varicella (≥5 gpELISA Units/mL). The geometric mean titres 
(GMTs) following the second dose of ProQuad increased approximately 2 fold each for measles, 
mumps, and rubella, and approximately 41 fold for varicella (for safety information, see section 4.8).

Children who received 2 doses of ProQuad intramuscularly or subcutaneously
In a clinical trial, 405 children received 2 doses of ProQuad, either by the intramuscular or 
subcutaneous route of administration. Two doses of ProQuad administered by the IM route of 
administration were as immunogenic as two doses administered by the SC route in terms of antibody 
response rates and antibody titres to measles, mumps, rubella, and varicella.

 



15

Children who received ProQuad at 4 through 6 years of age after primary vaccination with Varicella 
Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & 
Co., Inc.
The immunogenicity and safety of ProQuad were evaluated in a clinical trial involving 799 subjects 4 
through 6 years of age who had received Varicella Vaccine live (Oka/Merck) and the measles, 
mumps, and rubella vaccine manufactured by Merck & Co., Inc. at least 1 month prior to study entry. 
Following the dose of ProQuad, GMTs for measles, mumps, rubella, and varicella were similar to 
those following a second dose of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and 
rubella vaccine manufactured by Merck & Co., Inc. administered concomitantly at separate injection 
sites. Additionally, GMTs for measles, mumps, and rubella were similar to those following a second 
dose of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. given 
concomitantly with placebo (for safety information, see section 4.8).

Persistence of immune response
The persistence of antibody at 1 year after vaccination was evaluated in a subset of 2108 subjects who 
were involved in 1 clinical trial. The antibody persistence rates 1 year postvaccination in recipients of 
a single dose of ProQuad were 98.9% (1722/1741) for measles, 96.7% (1676/1733) for mumps, 
99.6% (1796/1804) for rubella, and 97.5% (1512/1550) for varicella (≥5 gpELISA Units/mL).

Experience with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. 
demonstrates that antibodies to measles, mumps, and rubella viruses are still detectable in most 
individuals 11 to 13 years after primary vaccination. In clinical studies involving healthy subjects 
who received 1 dose of Varicella Vaccine live (Oka/Merck), detectable varicella antibodies were 
present in most individuals tested for up to 10 years postvaccination.

Observational studies of long-term effectiveness of varicella vaccine
Surveillance data from two U.S. observational effectiveness studies confirmed that widespread 
varicella vaccination reduces the risk of varicella by approximately 90% and that protection is 
maintained over at least 15 years both in vaccinated and unvaccinated individuals. These data also 
suggest that varicella vaccination may reduce the risk of herpes zoster in vaccinated individuals.

In the first study, a long-term prospective cohort study, approximately 7,600 children vaccinated in 
1995 with varicella vaccine in their second year of life were actively followed for 14 years in order to 
estimate the occurrence of varicella and herpes zoster. Over the entire follow-up, the incidence of 
varicella was approximately 10-fold lower among vaccinees than among children of the same age in 
the pre-vaccine era (estimated vaccine effectiveness over the study period was between 73% and 
90%). Regarding herpes zoster, there were fewer herpes zoster cases among varicella vaccinees 
during the follow-up period than expected from rates in children of the same age with prior wild-type 
varicella during the pre-vaccine era (relative risk = 0.61, 95% CI 0.43 - 0.89). Breakthrough varicella 
and zoster cases were usually mild.

In a second long-term surveillance study, five cross-sectional surveys on varicella incidence, each 
from a random sample of approximately 8,000 children and adolescents 5 to 19 years of age, were 
conducted over 15 years, from 1995 (pre-vaccine) through 2009. Results showed a gradual decline of 
varicella rates by an overall 90% to 95% (approximately 10- to 20-fold) from 1995 to 2009 in all age 
groups, both in vaccinated and unvaccinated children and adolescents. In addition, a decrease by 
approximately 90% (approximately 10-fold) in varicella hospitalization rates was observed in all age 
groups.

Post-marketing observational safety surveillance study
Safety was evaluated in an observational study that included 69,237 children vaccinated with 
ProQuad 12 months to 12 years old and 69,237 matched children in a historical comparison group 
who were vaccinated concomitantly with the measles, mumps, and rubella vaccine manufactured by 
Merck & Co., Inc., and the Varicella Vaccine live (Oka/Merck). In addition to assessing the incidence 
of febrile seizures occurring within 30 days after the first dose (see section 4.8), the study also 
assessed the general safety of ProQuad in the 30-day period after the first or second dose. Other than 

 



16

the increase in febrile seizure after the first dose, no safety concerns after the first or second dose 
were identified.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Traditional non-clinical studies were not performed, but there are no non-clinical concerns considered 
relevant to clinical safety beyond data included in other sections of the Summary of Product 
Characteristics (SmPC).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Powder
Sucrose
Hydrolysed gelatin
Sodium chloride
Sorbitol (E 420)
Monosodium glutamate
Sodium phosphate
Sodium bicarbonate
Potassium phosphate
Potassium chloride
Medium 199 with Hanks’ Salts
Minimum Essential Medium, Eagle (MEM)
Neomycin
Phenol red
Hydrochloric acid (to adjust pH)
Sodium hydroxide (to adjust pH)
Urea

Solvent
Water for injections.

6.2 Incompatibilities

In the absence of compatibility studies, the vaccine must not be mixed with other medicinal products.

6.3 Shelf life

18 months.
After reconstitution, the vaccine should be used immediately. However, in-use stability has been 
demonstrated for 30 minutes when stored between 20C and 25C.

6.4 Special precautions for storage

Store and transport refrigerated (2°C-8°C).

Do not freeze.

Store in the original package in order to protect from light.

 



17

For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5 Nature and contents of container

ProQuad with solvent for reconstitution supplied in a vial:

Powder in a vial (Type I glass) with a stopper (butyl rubber) and solvent in a vial (Type I glass) with 
stopper (chlorobutyl rubber) in a pack size of 1 and 10.

ProQuad with solvent for reconstitution supplied in a pre-filled syringe:

Powder in a vial (Type I glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (Type I 
glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), without 
needle, in a pack size of 1, 10 and 20.

Powder in a vial (Type I glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (Type I 
glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), with one or 
two unattached needles, in a pack size of 1, 10 and 20.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Before mixing with the solvent, the powder vaccine is a white to pale yellow compact crystalline 
cake. The solvent is a clear colourless liquid. When completely reconstituted, the vaccine is a clear 
pale yellow to light pink liquid.

To reconstitute the vaccine, use only the solvent supplied, because it is free of preservatives or other 
antiviral substances, which might inactivate the vaccine.

It is important to use a separate sterile syringe and needle for each individual to prevent transmission 
of infectious agents from one individual to another.

One needle should be used for reconstitution and a separate, new needle for injection.

ProQuad must not be mixed in a syringe with other vaccines.

Reconstitution instructions

ProQuad with solvent for reconstitution supplied in a vial:

Withdraw the entire content of the solvent vial into a syringe. Inject the entire content of the syringe 
into the vial containing the powder. Gently agitate to dissolve completely.

The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or 
abnormal physical appearance prior to administration. In the event of either being observed, discard 
the vaccine.

It is recommended that the vaccine be administered immediately after reconstitution, to
minimize loss of potency. Discard if reconstituted vaccine is not used within 30 minutes.

Do not freeze the reconstituted vaccine.

Withdraw the entire content of the reconstituted vaccine from the vial into a syringe, change the 
needle, and inject the entire volume by subcutaneous or intramuscular route.

 



18

ProQuad with solvent for reconstitution supplied in a pre-filled syringe:

To attach the needle, it should be firmly placed on the tip of the syringe and secured by rotating a 
quarter of a turn (90°).

Inject the entire content of the solvent syringe into the vial containing the powder. Gently agitate to 
dissolve completely. 

The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or 
abnormal physical appearance prior to administration. In the event of either being observed, discard 
the vaccine.

It is recommended that the vaccine be administered immediately after reconstitution, to 
minimize loss of potency. Discard if reconstituted vaccine is not used within 30 minutes.

Do not freeze the reconstituted vaccine.

Withdraw the entire content of the reconstituted vaccine from the vial into a syringe, change the 
needle, and inject the entire volume by subcutaneous or intramuscular route.

Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.

7. MARKETING AUTHORISATION HOLDER

MSD VACCINS
162 avenue Jean Jaurès
69007 Lyon
France

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/05/323/001 
EU/1/05/323/002 
EU/1/05/323/005
EU/1/05/323/006
EU/1/05/323/007
EU/1/05/323/008
EU/1/05/323/009
EU/1/05/323/010
EU/1/05/323/011
EU/1/05/323/012
EU/1/05/323/013

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 06 April 2006
Date of latest renewal: 16 December 2015

 



19

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.

 

http://www.ema.europa.eu./


20

ANNEX II

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 
SUBSTANCE(S) AND MANUFACTURER(S)
RESPONSIBLE FOR BATCH RELEASE

B. CONDITIONS OR RESTRICTIONS REGARDING 
SUPPLY AND USE

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT

 



21

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 
SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR 
BATCH RELEASE

Name and address of the manufacturer(s) of the biological active substance(s)

Merck Sharp & Dohme Corp.
Sumneytown Pike 
West Point
Pennsylvania 19486
U.S.A.

Merck Sharp & Dohme Corp.
5325 Old Oxford Road
Durham
North Carolina 27712
U.S.A.

Name and address of the manufacturer(s) responsible for batch release

Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem
P.O. BOX 581, 2003 PC Haarlem
The Netherlands

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

 Official batch release

In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be 
undertaken by a state laboratory or a laboratory designated for that purpose.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION

 Periodic safety update reports (PSURs)

The requirements for submission of PSURs reports for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and 
any subsequent updates published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE 
AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

 Risk management plan (RMP)

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing 
authorisation and any agreed subsequent updates of the RMP.

 



22

An updated RMP should be submitted:
 At the request of the European Medicines Agency;
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached.

 



23

ANNEX III

LABELLING AND PACKAGE LEAFLET

 



24

A. LABELLING

 



25

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

ProQuad - Powder in vial and solvent in vial - Pack of 1, 10

1. NAME OF THE MEDICINAL PRODUCT

ProQuad powder and solvent for suspension for injection
Measles, mumps, rubella and varicella vaccine (live)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

After reconstitution, 1 dose (0.5 ml) contains (live, attenuated):

Measles virus Enders’ Edmonston strain .....................................≥ 3.00 log10 TCID50
Mumps virus Jeryl Lynn™ (Level B) strain ................................≥ 4.30 log10 TCID50
Rubella virus Wistar RA 27/3 strain ............................................≥ 3.00 log10 TCID50
Varicella virus Oka/Merck strain.................................................≥ 3.99 log10 PFU

3. LIST OF EXCIPIENTS

Sucrose, hydrolysed gelatin, sodium chloride, E 420, monosodium glutamate, sodium phosphate,
sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks’ Salts, MEM, 
neomycin, phenol red, HCl, NaOH, urea, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for suspension for injection
1 vial (powder) + 1 vial (solvent)
10 vials (powder) + 10 vials (solvent)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular or subcutaneous use.
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

 



26

9. SPECIAL STORAGE CONDITIONS

Store and transport refrigerated. Do not freeze. Keep the vial of powder in the outer carton to protect 
from light.

After reconstitution, use immediately or within 30 minutes if stored between 20°C and 25°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS
162 avenue Jean Jaurès
69007 Lyon
France

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/05/323/001 - pack of 1 
EU/1/05/323/002 - pack of 10

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

 



27

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC
SN
NN

 



28

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL OF SOLVENT

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Solvent for ProQuad

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 dose

6. OTHER

 



29

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

ProQuad - Powder in vial and solvent in pre-filled syringe without needle - Pack of 1, 10, 20

1. NAME OF THE MEDICINAL PRODUCT

ProQuad powder and solvent for suspension for injection in a pre-filled syringe
Measles, mumps, rubella and varicella vaccine (live)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

After reconstitution, 1dose (0.5 ml) contains (live, attenuated):

Measles virus Enders’ Edmonston strain .....................................≥ 3.00 log10 TCID50
Mumps virus Jeryl Lynn™ (Level B) strain ................................≥ 4.30 log10 TCID50
Rubella virus Wistar RA 27/3 strain ............................................≥ 3.00 log10 TCID50
Varicella virus Oka/Merck strain.................................................≥ 3.99 log10 PFU

3. LIST OF EXCIPIENTS

Sucrose, hydrolysed gelatin, sodium chloride, E 420, monosodium glutamate, sodium phosphate, 
sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks’ Salts, MEM, 
neomycin, phenol red, HCl, NaOH, urea, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for suspension for injection
1 vial (powder) + 1 pre-filled syringe without needle (solvent)
10 vials (powder) + 10 pre-filled syringes without needle (solvent)
20 vials (powder) + 20 pre-filled syringes without needle (solvent)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular or subcutaneous use.
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

 



30

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store and transport refrigerated. Do not freeze. Keep the vial of powder in the outer carton to protect 
from light.

After reconstitution, use immediately or within 30 minutes if stored between 20°C and 25°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS
162 avenue Jean Jaurès
69007 Lyon
France

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/05/323/005 – pack of 1
EU/1/05/323/006 – pack of 10
EU/1/05/323/007 – pack of 20

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

 



31

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC
SN
NN

 



32

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

ProQuad - Powder in vial and solvent in pre-filled syringe with 1 unattached needle - Pack of 1, 
10, 20

1. NAME OF THE MEDICINAL PRODUCT

ProQuad powder and solvent for suspension for injection in a pre-filled syringe
Measles, mumps, rubella and varicella vaccine (live)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

After reconstitution, 1 dose (0.5 ml) contains (live, attenuated):

Measles virus Enders’ Edmonston strain .....................................≥ 3.00 log10 TCID50
Mumps virus Jeryl Lynn™ (Level B) strain ................................≥ 4.30 log10 TCID50
Rubella virus Wistar RA 27/3 strain ............................................≥ 3.00 log10 TCID50
Varicella virus Oka/Merck strain.................................................≥ 3.99 log10 PFU

3. LIST OF EXCIPIENTS

Sucrose, hydrolysed gelatin, sodium chloride, E 420, monosodium glutamate, sodium phosphate, 
sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks’ Salts, MEM, 
neomycin, phenol red, HCl, NaOH, urea, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for suspension for injection
1 vial (powder) + 1 pre-filled syringe (solvent)+ 1 needle
10 vials (powder) + 10 pre-filled syringes (solvent)+ 10 needles
20 vials (powder) + 20 pre-filled syringes (solvent)+ 20 needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular or subcutaneous use.
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

 



33

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store and transport refrigerated. Do not freeze. Keep the vial of powder in the outer carton to protect 
from light.

After reconstitution, use immediately or within 30 minutes if stored between 20°C and 25°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS
162 avenue Jean Jaurès
69007 Lyon
France

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/05/323/008 – pack of 1
EU/1/05/323/009 – pack of 10
EU/1/05/323/012 – pack of 20

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

 



34

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC
SN
NN

 



35

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

ProQuad - Powder in vial and solvent in pre-filled syringe with 2 unattached needles - Pack of 
1, 10, 20

1. NAME OF THE MEDICINAL PRODUCT

ProQuad powder and solvent for suspension for injection in a pre-filled syringe
Measles, mumps, rubella and varicella vaccine (live)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

After reconstitution, 1 dose (0.5 ml) contains (live, attenuated):

Measles virus Enders’ Edmonston strain .....................................≥ 3.00 log10 TCID50
Mumps virus Jeryl Lynn™ (Level B) strain ................................≥ 4.30 log10 TCID50
Rubella virus Wistar RA 27/3 strain ............................................≥ 3.00 log10 TCID50
Varicella virus Oka/Merck strain.................................................≥ 3.99 log10 PFU

3. LIST OF EXCIPIENTS

Sucrose, hydrolysed gelatin, sodium chloride, E 420, monosodium glutamate, sodium phosphate, 
sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks’ Salts, MEM, 
neomycin, phenol red, HCl, NaOH, urea, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for suspension for injection
1 vial (powder) + 1 pre-filled syringe (solvent)+ 2 needles
10 vials (powder) + 10 pre-filled syringes (solvent)+ 20 needles
20 vials (powder) + 20 pre-filled syringes (solvent)+ 40 needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular or subcutaneous use.
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

 



36

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store and transport refrigerated. Do not freeze. Keep the vial of powder in the outer carton to protect 
from light.

After reconstitution, use immediately or within 30 minutes if stored between 20°C and 25°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS
162 avenue Jean Jaurès
69007 Lyon
France

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/05/323/010 – pack of 1
EU/1/05/323/011 – pack of 10
EU/1/05/323/013 – pack of 20

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

 



37

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC
SN
NN

 



38

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL OF POWDER

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

ProQuad powder for suspension for injection
IM/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 dose

6. OTHER

MSD VACCINS

 



39

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SYRINGE OF SOLVENT

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Solvent for ProQuad

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 dose

6. OTHER

 



40

B. PACKAGE LEAFLET

 



41

Package leaflet: Information for the User

ProQuad
Powder and solvent for suspension for injection

Measles, mumps, rubella and varicella vaccine (live)

Read all of this leaflet carefully before you or your child is vaccinated because it contains 
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your pharmacist.
- This vaccine has been prescribed for you or your child only. Do not pass it on to others.
- If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible 

side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What ProQuad is and what it is used for
2. What you need to know before you receive ProQuad
3. How to use ProQuad
4. Possible side effects
5. How to store ProQuad
6. Contents of the pack and other information

1. What ProQuad is and what it is used for

ProQuad is a vaccine containing measles, mumps, rubella, and chickenpox (varicella) viruses that 
have been weakened. When a person is given the vaccine, the immune system (the body’s natural 
defences) will make antibodies against the measles, mumps, rubella, and varicella viruses. The 
antibodies help protect against diseases caused by these viruses.

ProQuad is given to help protect your child against measles, mumps, rubella, and chickenpox
(varicella). The vaccine may be administered to persons from 12 months of age.

ProQuad may also be administered to infants from 9 months of age under special circumstances (to 
conform with national vaccination schedules, outbreak situations, or travel to a region with high 
prevalence of measles).

Although ProQuad contains live viruses, they are too weak to cause measles, mumps, rubella, or 
chickenpox (varicella) in healthy people.

2. What you need to know before you receive ProQuad

Do not use ProQuad
 If the person to be vaccinated is allergic to any varicella vaccine or measles, mumps, or rubella 

vaccine or to any of the ingredients of this vaccine (listed in section 6) including neomycin.
 If the person to be vaccinated has a blood disorder or any type of cancer that affects the 

immune system.
 If the person to be vaccinated is receiving treatment or taking medications that may weaken the 

immune system (except low-dose corticosteroid therapy for asthma or replacement therapy).
 If the person to be vaccinated has a weakened immune system because of a disease (including 

AIDS).
 If the person to be vaccinated has a family history of congenital or hereditary 

immunodeficiency, unless the immune competence of this person is demonstrated.

 



42

 If the person to be vaccinated has active untreated tuberculosis.
 If the person to be vaccinated has any illness with fever higher than 38.5°C; however, low-

grade fever itself is not a reason to delay vaccination.
 If the person to be vaccinated is pregnant (in addition, pregnancy should be avoided for 1 

month after vaccination, see Pregnancy and breast-feeding).

Warnings and precautions
If the person to be vaccinated has experienced any of the following, talk to the doctor or pharmacist 
before ProQuad is given:
 An allergic reaction to eggs or anything that contained egg.
 A history or family history of allergies or of convulsions (fits).
 A side effect after vaccination with measles, mumps, and/or rubella-containing vaccines that 

involved easy bruising or bleeding for longer than usual.
 An infection with Human Immunodeficiency Virus (HIV) without showing symptoms of HIV 

disease. However, vaccination may be less effective than for uninfected persons (see Do not 
use ProQuad).

If you have a blood clotting disorder or low levels of platelets in your blood, the injection will be 
given under the skin.

In rare circumstances, it is possible to catch chickenpox, including severe chickenpox, from a person 
who has been vaccinated with ProQuad. This may occur in persons who have not previously been 
vaccinated against chickenpox or had chickenpox, as well as persons who fall into one of the 
following categories:
 Individuals with a lowered resistance to diseases.
 Pregnant women who have either not had chickenpox or have not been vaccinated against 

chickenpox.
 Newborn infants of mothers who have either not had chickenpox or have not been vaccinated 

against chickenpox.

Whenever possible, individuals who have been vaccinated with ProQuad should attempt to avoid 
close contact, for up to 6 weeks following the vaccination, with anyone who falls into one of the 
categories above. Tell your doctor if there is anyone who falls into one of the categories above and is 
expected to be in close contact with the person being vaccinated.

As with other vaccines, ProQuad may not completely protect all persons who are vaccinated. Also, if
the person to be vaccinated has already been exposed to the measles, mumps, rubella, or varicella 
virus but is not yet ill, ProQuad may not be able to prevent the illness from appearing.

Other medicines and ProQuad
Tell your doctor or pharmacist if the person to be vaccinated is taking or has recently taken any other 
medicines (or other vaccines).

ProQuad can be given at the same time as other childhood vaccines such as Prevenar, and/or hepatitis 
A vaccine, or with vaccines containing diphtheria, tetanus, acellular pertussis, Haemophilus 
influenzae type b, inactivated poliomyelitis, or hepatitis B. A different place for the injection will be 
used for each vaccine.

The doctor may delay vaccination for at least 3 months following blood or plasma transfusions, or 
administration of immune globulin (IG), or varicella-zoster immune globulin (VZIG). After
vaccination with ProQuad, IG or VZIG should not be given for 1 month, unless your doctor tells you 
otherwise. 

If a tuberculin test is to be performed, it should be done either any time before, simultaneously with, 
or 4 to 6 weeks after vaccination with ProQuad.

 



43

Tell the doctor if the person to be vaccinated has recently received a vaccine or if one is scheduled to 
be given in the near future. The doctor will determine when ProQuad may be given. 

The use of salicylates (for example, acetylsalicylic acid, a substance present in many medicines used 
to relieve pain and lower fever) should be avoided for 6 weeks following vaccination with ProQuad.

Pregnancy and breast-feeding
ProQuad should not be given to pregnant women. Women of child-bearing age should take the 
necessary precautions to avoid pregnancy for 1 month following vaccination.

Persons who are breast-feeding or who intend to breast-feed should tell the doctor. The doctor will 
decide if ProQuad should be given.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this vaccine.

ProQuad contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’.

ProQuad contains potassium
This medicine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially 
‘potassium-free’.

ProQuad contains sorbitol
The additive effect of concomitantly administered products containing sorbitol (or fructose) and 
dietary intake of sorbitol (or fructose) should be taken into account.

3. How to use ProQuad

ProQuad should be injected into the muscle or under the skin either in the area of the outer thigh or of 
the upper arm.

Usually for injections into the muscle the thigh area is preferred in young children, whereas for older 
individuals the upper arm area is the preferred injection site.

If the person to be vaccinated has a blood clotting disorder or low levels of platelets, the vaccine 
should be given under the skin because bleeding may occur following administration into the muscle.

ProQuad is not to be injected directly into any blood vessel. 

ProQuad is given by injection as follows: 
 Infants between 9 and 12 months of age:

ProQuad may be administered from 9 months of age. To ensure optimal protection against 
chickenpox and measles, two doses of ProQuad should be given at least three months apart.

 Individuals 12 months of age and older:
To ensure optimal protection against chickenpox, two doses of ProQuad should be given at 
least one month apart.

The appropriate time and number of injections will be determined by your doctor in accordance with 
official recommendations.

Reconstitution instructions intended for medical and healthcare professionals are included at 
the end of the leaflet

 



44

If you forget to take ProQuad
Your doctor will decide when to give the missed dose.

4. Possible side effects

Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets 
them.

Allergic reactions (hives) may occur. Some of these reactions may be serious and may include 
difficulty in breathing or swallowing. If the vaccinated person has an allergic reaction, call your 
doctor right away.

Other side effects have been reported following administration of ProQuad and some of these were 
serious. These included:
 Uncommon (may affect up to 1 in 100 people): seizures with a fever.
 Rare (may affect up to 1 in 1,000 people): bronchiolitis (difficulty breathing with or without 

cough); unsteadiness with walking.

The following other side effects reported with the use of ProQuad were:
 Very common (may affect more than 1 in 10 people): injection site complaints including 

pain/tenderness/soreness, redness, fever (38.9°C or higher);
 Common (may affect up to 1 in 10 people): injection site complaints including swelling or 

bruising; irritability; rash (including measles-like rash, varicella-like rash, and injection-site 
rash); upper respiratory infection; vomiting and diarrhoea.

Other side effects have been reported with the use of at least one of the following: ProQuad, previous 
formulations of monovalent and of the combined measles, mumps, and rubella vaccines manufactured 
by Merck & Co., Inc., or Varicella Vaccine live (Oka/Merck). These adverse events include: 
 Uncommon (may affect up to 1 in 100 people): cough.
 Rare (may affect up to 1 in 1,000 people): skin infection; chickenpox (varicella).
 Not known (frequency cannot be estimated from the available data): unusual bleeding or 

bruising under the skin, swelling of the testicles; tingling of the skin, herpes zoster (shingles); 
inflammation of the brain (encephalitis); inflammation of the coverings of the brain and spinal 
cord not caused by bacterial infection (aseptic meningitis), severe skin disorders; stroke; 
seizures without a fever; joint pain and/or swelling (which could be transient or chronic); and
inflammation of the lung (pneumonia/pneumonitis).

The doctor has a more complete list of side effects for ProQuad and for the vaccine components for 
ProQuad (the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. and Varicella 
Vaccine live (Oka/Merck)).

Reporting of side effects
If the vaccinated person gets any side effects, talk to your doctor or pharmacist. This includes any 
possible side effects not listed in this leaflet. You can also report side effects directly via the national
reporting system listed in Appendix V. By reporting side effects you can help provide more 
information on the safety of this medicine.

5. How to store ProQuad

Keep this vaccine out of the sight and reach of children.

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


45

Do not use this vaccine after the expiry date which is stated on the outer carton after EXP. The expiry 
date refers to the last day of that month.

Store and transport refrigerated (2°C-8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What ProQuad contains

After reconstitution, one dose (0.5 mL) contains:
The active substances are:

Measles virus1 Enders’ Edmonston strain (live, attenuated)........ not less than 3.00 log10 TCID50*

Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated)... not less than 4.30 log10 TCID50*

Rubella virus2 Wistar RA 27/3 strain (live, attenuated)............... not less than 3.00 log10 TCID50*

Varicella virus3 Oka/Merck strain (live, attenuated) ................... not less than 3.99 log10 PFU**

*50% tissue culture infectious dose
** plaque-forming units

(1) Produced in chick embryo cells. 
(2) Produced in human diploid lung (WI-38) fibroblasts. 
(3) Produced in human diploid cells (MRC-5). 

The other ingredients are:
Powder
Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol (E 420), monosodium glutamate, sodium 
phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks’ 
Salts, MEM, neomycin, phenol red, hydrochloric acid and sodium hydroxide.

Solvent
Water for injections.

What ProQuad looks like and contents of the pack
The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be 
mixed with solvent provided with the vial of powder.

The powder is a white to pale yellow compact crystalline cake and the solvent is a clear colourless 
liquid.

ProQuad is available in pack of 1 and pack of 10. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France

Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 
BN Haarlem, The Netherlands

 



46

For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder.

België/Belgique/Belgien
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
dpoc_belux@merck.com

Lietuva
UAB Merck Sharp & Dohme
Tel.: +370.5.2780.247
msd_lietuva@merck.com

България
Мерк Шарп и Доум България ЕООД, 
тел.: + 359 2 819 3737
info-msdbg@merck.com

Luxembourg/Luxemburg
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
dpoc_belux@merck.com

Česká republika
Merck Sharp & Dohme s.r.o. 
Tel.: +420 233 010 111
dpoc_czechslovak@merck.com

Magyarország
MSD Pharma Hungary Kft.
Tel.: + 36.1.888.5300
hungary_msd@merck.com

Danmark
MSD Danmark ApS
Tlf: + 45 4482 4000
dkmail@merck.com

Malta
Merck Sharp & Dohme Cyprus Limited.
Tel: 8007 4433 (+356 99917558)
malta_info@merck.com

Deutschland
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
e-mail@msd.de

Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000 
(+31 23 5153153)
medicalinfo.nl@merck.com

Eesti
Merck Sharp & Dohme OÜ
Tel.: +372 6144 200
msdeesti@merck.com

Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00
msdnorge@msd.no

Ελλάδα
MSD Α.Φ.Β.Ε.Ε.
Τηλ: +30 210 98 97 300
dpoc_greece@merck.com

Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
msd-medizin@merck.com

España
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00
msd_info@merck.com

Polska
MSD Polska Sp. z o.o.
Tel.: +48.22.549.51.00
msdpolska@merck.com

France
MSD VACCINS
Tel:+ 33 (0)1 80 46 40 40
information.medicale@msd.com

Portugal
Merck Sharp & Dohme, Lda
Tel: +351 21 4465700
inform_pt@merck.com

Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: +385 1 66 11 333
croatia_info@merck.com

România
Merck Sharp & Dohme Romania S.R.L
Tel: + 4021 529 29 00
msdromania@merck.com

 

mailto:croatia_info@merck.com
mailto:msdpolska@merck.com
mailto:msd_info@merck.com


47

Ireland
Merck Sharp & Dohme Ireland (Human Health) 
Limited
Tel: +353 (0)1 2998700
medinfo_ireland@merck.com

Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: +386.1.520.4201
msd.slovenia@merck.com

Ísland
Vistor hf.
Sími: + 354 535 7000

Slovenská republika
Merck Sharp & Dohme, s. r. o
Tel: +421 2 58282010
dpoc_czechslovak@merck.com

Italia
MSD Italia S.r.l. 
Tel: +39 06 361911
medicalinformation.it@merck.com

Suomi/Finland
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650
info@msd.fi

Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673 (+357 22866700)
cyprus_info@merck.com

Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488
medicinskinfo@merck.com

Latvija
SIA Merck Sharp & Dohme Latvija
Tel: +371.67364.224
msd_lv@merck.com

United Kingdom
Merck Sharp & Dohme Limited
Tel: +44 (0) 1992 467272
medicalinformationuk@merck.com

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu.

---------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Before mixing with the solvent, the powder vaccine is a white to pale yellow compact crystalline 
cake. The solvent is a clear colourless liquid. When completely reconstituted, the vaccine is a clear 
pale yellow to light pink liquid.

To reconstitute the vaccine, use only the solvent supplied, because it is free of preservatives or other 
antiviral substances, which might inactivate the vaccine.

It is important to use a separate sterile syringe and needle for each individual to prevent transmission 
of infectious agents from one individual to another.

One needle should be used for reconstitution and a separate, new needle for injection.

ProQuad must not be mixed in a syringe with other vaccines.

Reconstitution instructions

 

http://www.ema.europa.eu/
mailto:cyprus_info@merck.com
mailto:medicalinformation.it@merck.com
mailto:msd.slovenia@merck.com


48

Withdraw the entire content of the solvent vial into a syringe. Inject the entire content of the syringe 
into the vial containing the powder. Gently agitate to dissolve completely.

The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or
abnormal physical appearance prior to administration. In the event of either being observed, discard 
the vaccine.

It is recommended that the vaccine be administered immediately after reconstitution to 
minimize loss of potency. Discard if reconstituted vaccine is not used within 30 minutes.

Do not freeze the reconstituted vaccine.

Withdraw the entire content of the reconstituted vaccine from the vial into a syringe, change the 
needle, and inject the entire volume by subcutaneous or intramuscular route.

Any unused product or waste material should be disposed of in accordance with local requirements.

See also section 3 How to use ProQuad.

 



49

Package leaflet: Information for the User

ProQuad
Powder and solvent for suspension for injection in a pre-filled syringe

Measles, mumps, rubella and varicella vaccine (live)

Read all of this leaflet carefully before you or your child is vaccinated because it contains 
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your pharmacist.
- This vaccine has been prescribed for you or your child only. Do not pass it on to others.
- If you get any of the side effects talk to your doctor of pharmacist. This includes any possible 

side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What ProQuad is and what it is used for
2. What you need to know before you receive ProQuad
3. How to use ProQuad
4. Possible side effects
5. How to store ProQuad
6. Contents of the pack and other information

1. What ProQuad is and what it is used for

ProQuad is a vaccine containing measles, mumps, rubella, and chickenpox (varicella) viruses that 
have been weakened. When a person is given the vaccine, the immune system (the body’s natural 
defences) will make antibodies against the measles, mumps, rubella, and varicella viruses. The 
antibodies help protect against diseases caused by these viruses.

ProQuad is given to help protect your child against measles, mumps, rubella, and chickenpox
(varicella). The vaccine may be administered to persons from 12 months of age.

ProQuad may also be administered to infants from 9 months of age under special circumstances (to 
conform with national vaccination schedules, outbreak situations, or travel to a region with high 
prevalence of measles).

Although ProQuad contains live viruses, they are too weak to cause measles, mumps, rubella, or 
chickenpox (varicella) in healthy people.

2. What you need to know before you receive ProQuad

Do not use ProQuad
 If the person to be vaccinated is allergic to any varicella vaccine or measles, mumps, or rubella

vaccine or to any of the ingredients of this vaccine (listed in section 6) including neomycin.
 If the person to be vaccinated has a blood disorder or any type of cancer that affects the 

immune system.
 If the person to be vaccinated is receiving treatment or taking medications that may weaken the 

immune system (except low-dose corticosteroid therapy for asthma or replacement therapy).
 If the person to be vaccinated has a weakened immune system because of a disease (including 

AIDS).
 If the person to be vaccinated has a family history of congenital or hereditary 

immunodeficiency, unless the immune competence of this person is demonstrated.

 



50

 If the person to be vaccinated has active untreated tuberculosis.
 If the person to be vaccinated has any illness with fever higher than 38.5°C; however, low-

grade fever itself is not a reason to delay vaccination.
 If the person to be vaccinated is pregnant (in addition, pregnancy should be avoided for 1 

month after vaccination, see Pregnancy and breast-feeding).

Warnings and precaution
If the person to be vaccinated has experienced any of the following, talk to the doctor or pharmacist 
before ProQuad is given:
 An allergic reaction to eggs or anything that contained egg.
 A history or family history of allergies or of convulsions (fits).
 A side effect after vaccination with measles, mumps, and/or rubella-containing vaccines that 

involved easy bruising or bleeding for longer than usual.
 An infection with Human Immunodeficiency Virus (HIV) without showing symptoms of HIV 

disease. However, vaccination may be less effective than for uninfected persons (see Do not 
use ProQuad).

If you have a blood clotting disorder or low levels of platelets in your blood, the injection will be
given under the skin.

In rare circumstances, it is possible to catch chickenpox, including severe chickenpox, from a person 
who has been vaccinated with ProQuad. This may occur in persons who have not previously been 
vaccinated against chickenpox or had chickenpox, as well as persons who fall into one of the 
following categories:
 Individuals with a lowered resistance to diseases.
 Pregnant women who have either not had chickenpox or have not been vaccinated against 

chickenpox.
 Newborn infants of mothers who have either not had chickenpox or have not been vaccinated 

against chickenpox.

Whenever possible, individuals who have been vaccinated with ProQuad should attempt to avoid 
close contact, for up to 6 weeks following the vaccination, with anyone who falls into one of the 
categories above. Tell your doctor if there is anyone who falls into one of the categories above and is 
expected to be in close contact with the person being vaccinated.

As with other vaccines, ProQuad may not completely protect all persons who are vaccinated. Also, if 
the person to be vaccinated has already been exposed to the measles, mumps, rubella, or varicella 
virus but is not yet ill, ProQuad may not be able to prevent the illness from appearing.

Other medicines and ProQuad
Tell your doctor or pharmacist if the person to be vaccinated is taking or has recently taken any other 
medicines (or other vaccines).

ProQuad can be given at the same time as other childhood vaccines such as Prevenar, and/or hepatitis 
A vaccine, or with vaccines containing diphtheria, tetanus, acellular pertussis, Haemophilus 
influenzae type b, inactivated poliomyelitis, or hepatitis B. A different place for the injection will be 
used for each vaccine.

The doctor may delay vaccination for at least 3 months following blood or plasma transfusions, or
administration of immune globulin (IG), or varicella-zoster immune globulin (VZIG). After 
vaccination with ProQuad, IG or VZIG should not be given for 1 month, unless your doctor tells you 
otherwise. 

If a tuberculin test is to be performed, it should be done either any time before, simultaneously with, 
or 4 to 6 weeks after vaccination with ProQuad.

 



51

Tell the doctor if the person to be vaccinated has recently received a vaccine or if one is scheduled to 
be given in the near future. The doctor will determine when ProQuad may be given. 

The use of salicylates (for example, acetylsalicylic acid, a substance present in many medicines used 
to relieve pain and lower fever) should be avoided for 6 weeks following vaccination with ProQuad.

Pregnancy and breast-feeding
ProQuad should not be given to pregnant women. Women of child-bearing age should take the 
necessary precautions to avoid pregnancy for 1 month following vaccination. 

Persons who are breast-feeding or who intend to breast-feed should tell the doctor. The doctor will 
decide if ProQuad should be given.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this vaccine.

ProQuad contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’.

ProQuad contains potassium
This medicine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially 
‘potassium-free’.

ProQuad contains sorbitol
The additive effect of concomitantly administered products containing sorbitol (or fructose) and 
dietary intake of sorbitol (or fructose) should be taken into account.

3. How to use ProQuad

ProQuad should be injected into the muscle or under the skin either in the area of the outer thigh or of 
the upper arm.

Usually for injections into the muscle the thigh area is preferred in young children, whereas for older 
individuals the upper arm area is the preferred injection site.

If the person to be vaccinated has a blood clotting disorder or low levels of platelets, the vaccine 
should be given under the skin because bleeding may occur following administration into the muscle.

ProQuad is not to be injected directly into any blood vessel. 

ProQuad is given by injection as follows: 
 Infants between 9 and 12 months of age:

ProQuad may be administered from 9 months of age. To ensure optimal protection against 
chickenpox and measles, two doses of ProQuad should be given at least three months apart.

 Individuals 12 months of age and older:
To ensure optimal protection against chickenpox, two doses of ProQuad should be given at 
least one month apart.

The appropriate time and number of injections will be determined by your doctor in accordance with 
official recommendations.

Reconstitution instructions intended for medical and healthcare professionals are included at 
the end of the leaflet

 



52

If you forget to take ProQuad

Your doctor will decide when to give the missed dose.

4. Possible side effects

Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets 
them.

Allergic reactions (hives) may occur. Some of these reactions may be serious and may include
difficulty in breathing or swallowing. If the vaccinated person has an allergic reaction, call your 
doctor right away.

Other side effects have been reported following administration of ProQuad and some of these were 
serious. These included:
 Uncommon (may affect up to 1 in 100 people): seizures with a fever. 
 Rare (may affect up to 1 in 1,000 people): bronchiolitis (difficulty breathing with or without 

cough); unsteadiness with walking.

The following other side effects reported with the use of ProQuad were:
 Very common (may affect more than 1 in 10 people): injection site complaints including 

pain/tenderness/soreness, redness; fever (38.9°C or higher);
 Common (may affect up to 1 in 10 people): injection site complaints including swelling or

bruising; irritability; rash (including measles-like rash, varicella-like rash, and injection-site 
rash); upper respiratory infection; vomiting and diarrhoea.

Other side effects have been reported with the use of at least one of the following: ProQuad, previous 
formulations of monovalent and of the combined measles, mumps, and rubella vaccines manufactured 
by Merck & Co., Inc., or Varicella Vaccine live (Oka/Merck). These adverse events include: 
 Uncommon (may affect up to 1 in 100 people): cough.
 Rare (may affect up to 1 in 1,000 people): skin infection; chickenpox (varicella).
 Not known (frequency cannot be estimated from the available data): unusual bleeding or 

bruising under the skin, swelling of the testicles; tingling of the skin, herpes zoster (shingles); 
inflammation of the brain (encephalitis); inflammation of the coverings of the brain and spinal 
cord not caused by bacterial infection (aseptic meningitis), severe skin disorders; stroke; 
seizures without a fever; joint pain and/or swelling (which could be transient or chronic); and 
inflammation of the lung (pneumonia/pneumonitis).

The doctor has a more complete list of side effects for ProQuad and for the vaccine components for 
ProQuad (the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. and Varicella 
Vaccine live (Oka/Merck)).

Reporting of side effects
If the vaccinated person gets any side effects, talk to your doctor or pharmacist. This includes any 
possible side effects not listed in this leaflet. You can also report side effects directly via the national 
reporting system listed in Appendix V. By reporting side effects you can help provide more 
information on the safety of this medicine.

5. How to store ProQuad

Keep this vaccine out of the sight and reach of children.

 

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53

Do not use this vaccine after the expiry date which is stated on the outer carton after EXP. The expiry 
dates refers to the last day of that month.

Store and transport refrigerated (2°C-8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What ProQuad contains
After reconstitution, one dose (0.5 mL) contains:
The active substances are:

Measles virus1 Enders’ Edmonston strain (live, attenuated)........not less than 3.00 log10 TCID50*

Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated)...not less than 4.30 log10 TCID50*

Rubella virus2 Wistar RA 27/3 strain (live, attenuated)...............not less than 3.00 log10 TCID50*

Varicella virus3 Oka/Merck strain (live, attenuated) ...................not less than 3.99 log10 PFU**

*50% tissue culture infectious dose
**plaque-forming units

(1) Produced in chick embryo cells. 
(2) Produced in human diploid lung (WI-38) fibroblasts. 
(3) Produced in human diploid cells (MRC-5). 

The other ingredients are:
Powder
Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol (E 420), monosodium glutamate, sodium 
phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks’ 
Salts, MEM, neomycin, phenol red, hydrochloric acid and sodium hydroxide.

Solvent
Water for injections.

What ProQuad looks like and contents of the pack
The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be 
mixed with solvent provided with the vial of powder.

The powder is a white to pale yellow compact crystalline cake and the solvent is a clear colourless 
liquid.

ProQuad is available in pack of 1, 10 and 20. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France

Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 
BN Haarlem, The Netherlands

 



54

For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder.

België/Belgique/Belgien
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
dpoc_belux@merck.com

Lietuva
UAB Merck Sharp & Dohme
Tel.: +370.5.2780.247
msd_lietuva@merck.com

България
Мерк Шарп и Доум България ЕООД, 
тел.: + 359 2 819 3737
info-msdbg@merck.com

Luxembourg/Luxemburg
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
dpoc_belux@merck.com

Česká republika
Merck Sharp & Dohme s.r.o. 
Tel.: +420 233 010 111
dpoc_czechslovak@merck.com

Magyarország
MSD Pharma Hungary Kft.
Tel.: + 36.1.888.5300
hungary_msd@merck.com

Danmark
MSD Danmark ApS
Tlf: + 45 4482 4000
dkmail@merck.com

Malta
Merck Sharp & Dohme Cyprus Limited.
Tel: 8007 4433 (+356 99917558)
malta_info@merck.com

Deutschland
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
e-mail@msd.de

Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000 
(+31 23 5153153)
medicalinfo.nl@merck.com

Eesti
Merck Sharp & Dohme OÜ
Tel.: +372 6144 200
msdeesti@merck.com

Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00
msdnorge@msd.no

Ελλάδα
MSD Α.Φ.Β.Ε.Ε.
Τηλ: +30 210 98 97 300
dpoc_greece@merck.com

Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
msd-medizin@merck.com

España
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00
msd_info@merck.com

Polska
MSD Polska Sp. z o.o.
Tel.: +48.22.549.51.00
msdpolska@merck.com

France
MSD VACCINS
Tel:+ 33 (0)1 80 46 40 40
information.medicale@msd.com

Portugal
Merck Sharp & Dohme, Lda
Tel: +351 21 4465700
inform_pt@merck.com

Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: +385 1 66 11 333
croatia_info@merck.com

România
Merck Sharp & Dohme Romania S.R.L
Tel: + 4021 529 29 00
msdromania@merck.com

 

mailto:croatia_info@merck.com
mailto:msdpolska@merck.com
mailto:msd_info@merck.com


55

Ireland
Merck Sharp & Dohme Ireland (Human Health) 
Limited
Tel: +353 (0)1 2998700
medinfo_ireland@merck.com

Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: +386.1.520.4201
msd.slovenia@merck.com

Ísland
Vistor hf.
Sími: + 354 535 7000

Slovenská republika
Merck Sharp & Dohme, s. r. o
Tel: +421 2 58282010
dpoc_czechslovak@merck.com

Italia
MSD Italia S.r.l. 
Tel: +39 06 361911
medicalinformation.it@merck.com

Suomi/Finland
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650
info@msd.fi

Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673 (+357 22866700)
cyprus_info@merck.com

Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488
medicinskinfo@merck.com

Latvija
SIA Merck Sharp & Dohme Latvija
Tel: +371.67364.224
msd_lv@merck.com

United Kingdom
Merck Sharp & Dohme Limited
Tel: +44 (0) 1992 467272
medicalinformationuk@merck.com

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Agency website: 
http://www.ema.europa.eu.

---------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Before mixing with the solvent, the powder vaccine is a white to pale yellow compact crystalline 
cake. The solvent is a clear colourless liquid. When completely reconstituted, the vaccine is a clear 
pale yellow to light pink liquid.

To reconstitute the vaccine, use only the solvent supplied, because it is free of preservatives or other 
antiviral substances, which might inactivate the vaccine.

It is important to use a separate sterile syringe and needle for each individual to prevent transmission 
of infectious agents from one individual to another.

One needle should be used for reconstitution and a separate, new needle for injection.

ProQuad must not be mixed in a syringe with other vaccines.

Reconstitution instructions

 

http://www.ema.europa.eu/
mailto:cyprus_info@merck.com
mailto:medicalinformation.it@merck.com
mailto:msd.slovenia@merck.com


56

To attach the needle, it should be firmly placed on the tip of the syringe and secured by rotating a 
quarter of a turn (90°).

Inject the entire content of the solvent syringe into the vial containing the powder. Gently agitate to 
dissolve completely.

The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or 
abnormal physical appearance prior to administration. In the event of either being observed, discard
the vaccine.

It is recommended that the vaccine be administered immediately after reconstitution to 
minimize loss of potency. Discard if reconstituted vaccine is not used within 30 minutes.

Do not freeze the reconstituted vaccine.

Withdraw the entire content of the reconstituted vaccine from the vial into a syringe, change the 
needle, and inject the entire volume by subcutaneous or intramuscular route.

Any unused product or waste material should be disposed of in accordance with local requirements.

See also section 3 How to use ProQuad.

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET