RotaTeq

1

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

 



2

1. NAME OF THE MEDICINAL PRODUCT

RotaTeq oral solution

Rotavirus vaccine (live)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose (2 ml) contains:

rotavirus type* G1 not less than 2.2 x 106 IU1, 2

rotavirus type* G2 not less than 2.8 x 106 IU1, 2

rotavirus type* G3 not less than 2.2 x 106 IU1, 2

rotavirus type* G4 not less than 2.0 x 106 IU1, 2

rotavirus type* P1A[8] not less than 2.3 x 106 IU1, 2

* human-bovine rotavirus reassortants (live), produced in Vero cells.

1 Infectious Units
2 As lower confidence limit (p = 0.95)

Excipients with known effect
This vaccine contains 1080 milligrams sucrose and 37.6 milligrams sodium (see section 4.4).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral Solution 
Pale yellow clear liquid that may have a pink tint

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

RotaTeq is indicated for the active immunisation of infants from the age of 6 weeks to 32 weeks for 
prevention of gastroenteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1).

RotaTeq is to be used on the basis of official recommendations.

4.2 Posology and method of administration

Posology

From birth to 6 weeks
RotaTeq is not indicated in this subset of paediatric population. 

The safety and efficacy of RotaTeq in individuals from birth to 6 weeks of age have not been 
established.

From 6 weeks to 32 weeks
The vaccination course consists of three doses.
The first dose may be administered from the age of 6 weeks and no later than the age of 12 weeks.

 



3

RotaTeq may be given to infants who were born prematurely provided that the period of gestation was 
at least 25 weeks. These infants should receive the first dose of RotaTeq at least six weeks after birth 
(see sections 4.4 and 5.1).

There should be intervals of at least 4 weeks between doses.

It is preferable that the vaccination course of three doses should be completed by the age of 
20-22 weeks. If necessary, the third (last) dose may be given up to the age of 32 weeks (see section 
5.1).

As no data exist regarding the interchangeability of RotaTeq with another rotavirus vaccine, it is 
recommended that infants who receive RotaTeq for the first immunisation against rotavirus should 
receive this same vaccine for the subsequent doses.

If it is observed or strongly suspected that an incomplete dose has been swallowed (e.g., infant spits or 
regurgitates the vaccine), a single replacement dose may be given at the same vaccination visit, 
however, this has not been studied in clinical trials. If the problem recurs, additional replacement 
doses should not be given.

No further doses are recommended after completion of the 3-dose vaccination course (see sections 4.4 
and 5.1 regarding available information on persistence of protection).

From 33 weeks to 18 years
RotaTeq is not indicated in this subset of paediatric population. 

Method of administration
RotaTeq is for oral administration only.

RotaTeq SHOULD UNDER NO CIRCUMSTANCES BE INJECTED.

RotaTeq may be given without regard to food, liquid, or breast milk.

See section 6.6 for administration instructions.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Hypersensitivity after previous administration of rotavirus vaccines.

Previous history of intussusception.

Subjects with congenital malformation of the gastrointestinal tract that could predispose to 
intussusception.

Infants who have known or suspected immunodeficiency (see sections 4.4 and 4.8).

Administration of RotaTeq should be postponed in infants suffering from acute severe febrile illness. 
The presence of a minor infection is not a contraindication for immunisation.

The administration of RotaTeq should be postponed in subjects suffering from acute diarrhoea or 
vomiting.

4.4 Special warnings and precautions for use

Traceability 

 



4

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

As with all vaccines, appropriate medical treatment should always be readily available in case of an 
anaphylactic event following the administration of the vaccine (see section 4.8).

No safety or efficacy data are available from clinical trials regarding administration of RotaTeq to 
immunocompromised infants, infants infected with HIV or infants who have received a blood 
transfusion or immunoglobulins within 42 days of dosing. Asymptomatic HIV infection is not 
expected to affect the safety or efficacy of RotaTeq. However, in the absence of sufficient data, 
administration of RotaTeq to asymptomatic HIV-infected infants is not recommended.

Cases of gastroenteritis associated with vaccine virus have been reported post marketing in infants 
with severe combined immunodeficiency (SCID, see section 4.3).

In trials, RotaTeq was shed in the stools of 8.9 % of vaccine recipients almost exclusively in the week 
after dose 1 and in only one vaccine recipient (0.3 %) after dose 3. Peak excretion occurred within 
7 days of dosing. Transmission of vaccine virus strains to non-vaccinated contacts has been observed 
post-marketing. RotaTeq should be administered with caution to individuals with close contacts who 
are immunodeficient (e.g., individuals with malignancies or who are otherwise immunocompromised 
or individuals receiving immunosuppressive therapy). Also, those caring for recent vaccinees should 
observe careful hygiene especially when handling excreta.

In a clinical study, RotaTeq was administered to approximately 1,000 infants who were born at a 
gestational age of 25 to 36 weeks. The first dose was administered from 6 weeks after birth. The safety 
and efficacy of RotaTeq were comparable between this subset of infants and infants born at term. 
However, 19 of the approximately 1,000 infants were born at a gestational age of 25 to 28 weeks, 55 
were born at a gestational age of 29 to 31 weeks and the remainder was born at a gestational age of 
between 32 and 36 weeks. See sections 4.2 and 5.1.

Intussusception

As a precaution, healthcare professionals should follow-up on any symptoms indicative of 
intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or 
high fever) since data from observational studies indicate an increased risk of intussusception, mostly 
within 7 days after rotavirus vaccination (see section 4.8). Parents/guardians should be advised to 
promptly report such symptoms to their healthcare provider.

For subjects with a predisposition for intussusception, see section 4.3.

Safety or efficacy data are not available for infants with active gastrointestinal illnesses (including 
chronic diarrhoea) or growth retardation. Administration of RotaTeq may be considered with caution
in such infants when, in the opinion of the physician, withholding the vaccine entails a greater risk.

The level of protection provided by RotaTeq is based on the completion of all 3 doses. As with any 
vaccine, vaccination with RotaTeq may not result in complete protection in all recipients. RotaTeq 
does not protect against gastroenteritis due to other pathogens than rotavirus.

Clinical trials of efficacy against rotavirus gastroenteritis were performed in Europe, the United States, 
Latin America, and Asia. During these trials, the most common circulating rotavirus genotype was 
G1P[8], while rotavirus genotypes G2P[4], G3P[8], G4P[8], and G9P[8] were identified less often. 
The extent of protection that RotaTeq might provide against other rotavirus types and in other 
populations is unknown.

No clinical data are available on the use of RotaTeq for post-exposure prophylaxis.

 



5

The potential risk of apnoea and the need for respiratory monitoring for 48-72 h should be considered 
when administering the primary immunisation series to very premature infants (born ≤28 weeks of 
gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit 
of vaccination is high in this group of infants, vaccination should not be withheld or delayed.

RotaTeq SHOULD UNDER NO CIRCUMSTANCES BE INJECTED.

Sucrose
RotaTeq contains sucrose. Patients with rare hereditary problems of fructose intolerance, 
glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccine. See 
section 2.

Sodium
This vaccine contains 37.6 mg sodium per dose, equivalent to 1.88% of the WHO recommended 
maximum daily intake of 2 g sodium for an adult. See section 2.

4.5 Interaction with other medicinal products and other forms of interaction

Co-administration of RotaTeq with vaccines containing one or more of the following antigens at 
approximately 2, 4 and 6 months of age demonstrated that the immune responses and the safety 
profiles of the administered vaccines were unaffected:

- Diphtheria-tetanus-acellular pertussis vaccine (DTaP)
- Haemophilus influenzae type b vaccine (Hib)
- Inactivated poliomyelitis vaccine (IPV)
- Hepatitis B vaccine (HBV)
- Pneumococcal conjugate vaccine (PCV)

Co-administration of RotaTeq with DTaP-IPV-HBV-Hib vaccine (Infanrix hexa) at approximately 2, 
3, and 4 months of age demonstrated that the immune responses and the safety profiles of the 
co-administered vaccines were unaffected compared to separate administrations.

Co-administration of RotaTeq with a group C meningococcal conjugate vaccine (MenCC, the vaccine 
studied was a tetanus toxoid conjugate) at 3 and 5 months of age (and mostly at the same time as 
DTaP-IPV-Hib vaccine), followed by a third dose of RotaTeq at approximately 6 months of age, 
demonstrated that the immune responses to RotaTeq and MenCC were unaffected. Co-administration 
resulted in an acceptable safety profile.

Concomitant administration of RotaTeq and oral poliomyelitis vaccine (OPV) did not affect the 
immune response to the poliovirus antigens. Although concomitant administration of OPV slightly 
reduced the immune response to rotavirus vaccine, there is currently no evidence that clinical 
protection against severe rotavirus gastroenteritis would be affected. The immune response to RotaTeq 
was unaffected when OPV was administered two weeks after RotaTeq.

Therefore, RotaTeq can be given concomitantly with monovalent or combination infant vaccines 
containing one or more of the following antigens: DTaP, Hib, IPV or OPV, HBV, PCV and MenCC.

4.6 Fertility, pregnancy and lactation

RotaTeq is intended for use in infants only. Thus human data on use during pregnancy or lactation are 
not available and animal fertility or reproduction studies have not been performed.

4.7 Effects on ability to drive and use machines

Not relevant.

 



6

4.8 Undesirable effects 

a. Summary of the safety profile
In a subset of infants from 3 placebo-controlled clinical trials (n=6,130 recipients of RotaTeq and 
5,560 placebo recipients), RotaTeq was evaluated for all adverse events within 42 days of vaccination 
with or without concomitant use of other paediatric vaccines. Overall, 47 % of infants given RotaTeq 
experienced an adverse reaction compared with 45.8 % of infants given placebo. The most commonly 
reported adverse reactions that occurred more frequently with vaccine than with placebo were pyrexia 
(20.9 %), diarrhoea (17.6 %) and vomiting (10.1 %).

Serious adverse reactions were assessed in all participants (36,150 recipients of RotaTeq and 
35,536 placebo recipients) of 3 clinical trials for up to 42 days after each dose. The overall frequency 
of these serious adverse reactions was 0.1 % among recipients of RotaTeq and 0.2 % among placebo 
recipients.

b. Tabulated summary of adverse reactions
Adverse reactions more common in the vaccine group in clinical trials are listed below per system 
organ class and frequency. Based on pooled data from 3 clinical trials in which 6,130 infants received 
RotaTeq and 5,560 received placebo, the adverse reactions listed occurred with excess incidences in 
RotaTeq recipients compared to placebo recipients of between 0.2 % and 2.5 %. 

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

Adverse reactions following administration of RotaTeq in clinical trials and adverse events reported 
post-marketing (in italics)

System Organ Class Frequency Adverse Reaction/Event

Infections and infestations Common Upper respiratory tract infection

Uncommon Nasopharyngitis, otitis media

Immune system disorders Not known Anaphylactic reaction‡

Respiratory, thoracic and 
mediastinal disorders

Rare Bronchospasm

Gastrointestinal disorders Very common Diarrhoea, vomiting

Uncommon Haematochezia†, Abdominal pain upper

Very Rare Intussusception α *

Skin and subcutaneous tissue 
disorders

Uncommon Rash

Rare Urticaria†

Not known Angioedema‡

General disorders and 
administration site conditions

Very common Pyrexia

Not known Irritability‡

† This adverse reaction was identified through post-marketing surveillance. The 
frequency category was estimated based on relevant clinical trials.

α The frequency category was estimated based on observational study data.

 



7

* See section 4.4.
‡ Post-marketing adverse events (frequency cannot be estimated from the available data).

c. Description of selected adverse reactions
Kawasaki disease was reported in 5 of 36,150 vaccine recipients (<0.1 %) and 1 of 35,536 placebo 
recipients (<0.1 %) with a relative risk (RR) of 4.9 [95 % CI, 0.6 – 239.1] (not statistically significant). 
No increased risk of Kawasaki disease was observed among infants receiving RotaTeq in a large post-
marketing observational safety surveillance study (see section 5.1).

Intussusception
Data from observational safety studies performed in several countries indicate that rotavirus vaccines 
carry an increased risk of intussusception, with up to 6 additional cases per 100,000 infants within 
7 days of vaccination. There is limited evidence of a smaller increased risk following the second dose. 
The background incidence of intussusception in infants less than one year of age in these countries 
ranged from 25 to 101 per 100,000 infants per year. It remains unclear whether rotavirus vaccines 
affect the overall incidence of intussusception based on longer periods of follow up (see section 4.4).

d. Other special populations
Apnoea in very premature infants (born ≤28 weeks of gestation) (see section 4.4)

Gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency 
Disease (SCID) has been reported post-marketing.

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

There have been reports of administration of higher than recommended doses of RotaTeq.

In general, the adverse event profile reported with overdose was comparable to that observed with 
recommended doses of RotaTeq.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Vaccines, Viral Vaccine ATC code: J07BH02.

Efficacy

In clinical trials, efficacy was demonstrated against gastroenteritis due to rotavirus of genotypes 
G1P[8], G2P[4], G3P[8], G4P[8], and G9P[8].

The protective efficacy of RotaTeq was evaluated in two ways in the placebo-controlled Rotavirus 
Efficacy and Safety Trial (REST):

1. In 5,673 vaccinated infants (2,834 in the vaccine group) protective efficacy was measured as a 
reduction in the incidence of rotavirus (RV) gastroenteritis caused by vaccine G genotypes 
(G1-G4) that occurred at least 14 days after the third dose of vaccine through the first full 
rotavirus season after vaccination. 

 

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


8

2. In 68,038 vaccinated infants (34,035 in the vaccine group) protective efficacy was measured as 
a reduction in the rate of hospitalisations and emergency department visits for RV 
gastroenteritis from 14 days after the third dose. 

The results of these analyses are presented in the following tables.

Reduction in incidence of RV gastroenteritis through one full season post-vaccination
(RotaTeq n=2,834) (% [95 % CI])

Efficacy against any severity by rotavirus genotype
Severe* 
disease

(G1-G4)

Any 
severity
(G1-G4)

G1 G2 G3 G4 G9

98.0 %
[88.3, 100.0]†

74.0 %
[66.8, 
79.9]†

74.9 %
[67.3, 80.9]†

63.4 %
[2.6, 88.2]†

82.7 %
[<0, 99.6]

48.1 %
[<0, 91.6]

65.4 %
[<0, 99.3]

* Severe defined as a score >16/24 using a validated clinical scoring system based on the intensity and 
duration of symptoms (fever, vomiting, diarrhoea and behavioural changes)
† Statistically significant

Reduction in hospitalisations and emergency department visits for RV gastroenteritis for up to 2 years 
post-vaccination

(RotaTeq n=34,035) (% [95 % CI])
G1-G4 G1 G2 G3 G4 G9
94.5 %

[91.2, 96.6]†
95.1 %
[91.6, 
97.1]†

87.6 %
[0, 98.5]

93.4 %
[49.4, 99.1]†

89.1 %
[52.0, 
97.5]†

100 % 
[69.6, 100]†

† Statistically significant

The reduction in incidence of RV gastroenteritis caused by genotypes G1-G4 during the second 
rotavirus season after vaccination was 88.0 % [95 % CI 49.4, 98.7] for severe disease and 62.6 % 
[95 % CI 44.3, 75.4] for disease of any severity.

Efficacy against genotypes G2P[4], G3P[8], G4P[8] and G9P[8] rotavirus was based on fewer cases 
than for G1. The efficacy observed against G2P[4] most likely resulted from the G2 component of the 
vaccine.

In a combined post-hoc analysis of REST and another phase III study, the vaccine efficacy against 
G1-, G2-, G3- and G4-serotype RVG cases (any severity) was 61.5 % [95 % CI: 14.2; 84.2] among 
infants who were >26 to ≤32 weeks of age at dose 3.

There was an extension of REST conducted in Finland only. This Finnish Extension Study (FES) 
included a subset of 20,736 subjects that had been enrolled previously in REST. The infants were 
followed for up to 3 years post-vaccination in the FES.

In REST there were 403 healthcare encounters (20 in the vaccine group and 383 in the placebo group) 
associated with G1-G4 and G9 RV gastroenteritis in the per protocol population. The additional data 
from the FES increased the number by 136 encounters in total, including 9 in the vaccine group and 
127 in the placebo group. Overall, 31 % and 25 % of the encounters in the respective groups occurred 
during the FES.

Based upon combined data from REST and the FES, the reduction up to 3 years post-vaccination in 
the rate of hospitalisations and emergency department visits for RV gastroenteritis was 94.4 % 
(95 % CI: 91.6, 96.2) for genotypes G1-G4, 95.5 % (95 % CI: 92.8, 97.2) for genotype G1, 81.9 % 
(95 % CI: 16.1, 98.0) for genotype G2, 89.0 % (95 % CI: 53.3, 98.7) for genotype G3, 83.4 % 
(95 % CI: 51.2, 95.8) for genotype G4, and 94.2 % (95 % CI: 62.2, 99.9) for genotype G9. During 
year 3, there were no health care contacts for RV gastroenteritis in the vaccine group (n=3,112) and 
one (non-typeable) in the placebo group (n=3,126).

 



9

A complete 3-dose vaccination series of RotaTeq should be administered (see section 4.2) to provide 
the level and duration of protection against rotavirus gastroenteritis that was observed in the clinical 
studies. However, post hoc analyses indicated that RotaTeq achieved some reduction in the numbers 
of cases of rotavirus gastroenteritis of sufficient severity to require hospitalisation or an emergency 
department visit before completion of all three doses (i.e. from approximately 14 days after 
administration of the first dose onwards).

Efficacy in premature infants
In REST, RotaTeq was administered to approximately 1,000 infants who were born at a gestational 
age of 25 to 36 weeks. The efficacy of RotaTeq was comparable between this subset of infants and 
infants born at term.

Post-marketing observational safety surveillance study 
In a large prospective post-marketing observational study in the US, the risk of Kawasaki disease was
analysed among 85,150 infants receiving one or more doses of RotaTeq (17,433 person-years of 
follow-up).

During the 0-30 day follow-up period after vaccination, there were no statistically significant 
difference in the rate of Kawasaki disease compared with the expected background rate. In addition, 
there was no statistically significant increased risk of this adverse event during the 0-30 day follow-up 
period compared with a concurrent control group of infants who received DTaP, but not RotaTeq 
(n=62,617, 12,339 person-years of follow-up). One chart-confirmed case was recorded among infants 
vaccinated with RotaTeq compared with one chart-confirmed case among concurrent DTaP controls 
(relative risk = 0.7, 95 % CI: 0.01-55.56). In the general safety analyses, no specific safety concerns 
were identified.

 



10

Effectiveness study data
Post marketing studies demonstrating effectiveness to prevent RV gastroenteritis (RVGE) 

Study design
(Region)

Study population Endpoints Effectiveness
% [95%CI]

RV seasons

Claims 
database 
analysis (US)

33,140 vaccinated 
26,167 unvaccinated
Aged ≥7 months
Received 3 doses

Hospitalization and Emergency 
Department (ED) visits due to 
RVGE

Outpatients due to RVGE

Hospitalization and ED visits 
due to all cause gastroenteritis

100% [87,100]

96% [76,100]

59% [47,68]

2007-2008

Cohort study
(France)

1,895 vaccinated with 3 
doses
2,102 unvaccinated
Aged <2 years

Hospitalization due to RVGE 98% [83,100] 2007-2008
2008-2009

Case-control 
study (US)

402 cases
2,559 controls*
Aged <8 years
Received 3 doses

Hospitalization and ED visits 
due to RVGE

Strain-specific
- G1P[8]
- G2P[4]
- G3P[8]
- G12P[8]
Age-specific
- 1st year of life
- 2nd year of life
- 3rd year of life
- 4th year of life
- 5th year of life
- 6th-7th year of life

80% [74,84]

89% [55,97]
87% [65,95]
80% [64,89]
78% [71,84]

91% [78,96]
82% [69,89]
88% [78,93]
76% [51,88]
60% [16,81]
69% [43,84]

2011-2012
2012-2013

*RV-negative acute gastroenteritis controls

Immunogenicity
The immunological mechanism by which RotaTeq protects against rotavirus gastroenteritis is not 
completely understood. No immunological correlate of protection has currently been identified for 
rotavirus vaccines. In phase III studies between 92.5 % and 100 % of recipients of RotaTeq achieved a 
significant rise in serum anti-rotavirus IgA after a three-dose regimen. The vaccine induces an immune 
response (i.e., appearance of serum neutralising antibody) to the five human-rotavirus proteins 
expressed on the reassortants (G1, G2, G3, G4 and P[8]).

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

A single and repeated dose oral toxicity study in mice suggests no special hazard to humans. The dose 
administered to mice was approximately 2.79 x 108 infectious units per kg (about 14-fold the projected 
infant dose).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose
Sodium citrate

 



11

Sodium dihydrogen phosphate monohydrate
Sodium hydroxide
Polysorbate 80
Culture media (containing inorganic salts, amino acids and vitamins)
Purified water

6.2 Incompatibilities

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

6.3 Shelf life

2 years

RotaTeq should be administered promptly after removal from refrigeration.

6.4 Special precautions for storage

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

Keep the dosing tube in the outer carton in order to protect from light.

6.5 Nature and contents of container

2 ml solution in a pre-filled squeezable tube (LDPE), with a twist-off cap (HDPE) in a protective bag, 
pack size of 1 or 10 pre-filled squeezable tube(s).

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

The vaccine is to be administered orally without mixing with any other vaccines or solutions. Do not 
dilute.

 



12

To administer the vaccine:

Tear open the protective bag and remove the dosing tube.

Clear the fluid from the dispensing tip by holding tube vertically and tapping the 
twist-off cap.

Open the dosing tube in 2 easy motions:

1. Puncture the dispensing tip by screwing cap clockwise until it becomes 
tight.

2. Remove cap by turning it counterclockwise. 

Administer dose by gently squeezing liquid into infant's mouth toward the inner 
cheek until dosing tube is empty. (A residual drop may remain in the tip of the 
tube.) 

Discard the empty tube and cap in approved biological waste containers 
according to local regulations.

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 NUMBERS

EU/1/06/348/001
EU/1/06/348/002

 



13

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 27 June 2006 

Date of latest renewal: 18 May 2011

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/


14

ANNEX II

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

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION

D. CONDITION OR RESTRICTION WITH REGARD TO THE 
SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT

 



15

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

Name and address of the manufacturer of the biological active substance 

Merck Sharp & Dohme Corp.
Sumneytown Pike
West Point
Pennsylvania 19486
United States of America

Name and address of the manufacturer responsible for batch release

Merck Sharp and Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch.

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 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 

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.

 



16

ANNEX III

LABELLING AND PACKAGE LEAFLET

 



17

A. LABELLING

 



18

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

RotaTeq – Pack size of 1 single-dose (2 ml) Tube
RotaTeq – Pack size of 10 single-dose (2 ml) Tubes

1. NAME OF THE MEDICINAL PRODUCT

RotaTeq oral solution
Rotavirus vaccine (live)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One dose (2 ml) contains rotavirus type*:
G1  2.2 x 106 IU1

G2  2.8 x 106 IU1

G3  2.2 x 106 IU1

G4  2.0 x 106 IU1

P1A[8]  2.3 x 106 IU1

* human-bovine rotavirus reassortants (live), produced in Vero cell.

1Infectious Units

3. LIST OF EXCIPIENTS

Sucrose, sodium

4. PHARMACEUTICAL FORM AND CONTENTS

2 ml oral solution in a tube
pack size of 1 tube
pack size of 10 tubes

5. METHOD AND ROUTE(S) OF ADMINISTRATION

FOR ORAL USE ONLY
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

 



19

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store and transport refrigerated.
Keep the dosing tube in the outer carton in order to protect from light.

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

Please read the package leaflet for disposal of medicines no longer required

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/06/348/001 pack of 1 tube 
EU/1/06/348/002 pack of 10 tubes

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.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN

 



20

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Text for the protective bag

1. NAME OF THE MEDICINAL PRODUCT

RotaTeq oral solution
Rotavirus vaccine (live)

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

1 dose

 



21

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Tube label 

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

RotaTeq
Oral solution
Oral use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 dose (2 ml)

6. OTHER

MSD VACCINS

 



22

B. PACKAGE LEAFLET

 



23

Package Leaflet: Information for the user
RotaTeq oral solution
Rotavirus vaccine (live)

Read all of this leaflet carefully before 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 pharmacist.
- If your child gets any 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 RotaTeq is and what it is used for
2. What you need to know before your child receives RotaTeq
3. How to use RotaTeq 
4. Possible side effects
5. How to store RotaTeq
6. Contents of the pack and other information

1. What RotaTeq is and what it is used for

RotaTeq is an oral vaccine that helps protect infants and young children against gastroenteritis 
(diarrhoea and vomiting) caused by rotavirus infection and may be given to infants from the age of 
6 weeks to 32 weeks (see section 3). The vaccine contains five types of live rotavirus strains. When an 
infant is given the vaccine, the immune system (the body’s natural defences) will make antibodies 
against the most commonly occurring types of rotavirus. These antibodies help protect against 
gastroenteritis caused by these types of rotavirus.

2. What you need to know before your child receives RotaTeq

Do not use RotaTeq if

- your child is allergic to any of the components of this vaccine (see section 6 Contents of the 
pack and other information).

- your child developed an allergic reaction after receiving a dose of RotaTeq or other rotavirus 
vaccine.

- your child has previously had intussusception (a bowel obstruction in which one segment of 
bowel becomes enfolded within another segment).

- your child was born with a malformation of the gastrointestinal system that might predispose for 
intussusception.

- your child has any disease which reduces his/her resistance to infection.
- your child has a severe infection with a high temperature. It might be necessary to postpone the 

vaccination until recovery. A minor infection such as a cold should not be a problem, but talk to
your doctor first.

- your child has diarrhoea or is vomiting. It might be necessary to postpone the vaccination until
recovery.

 



24

Warnings and precautions

Talk to your doctor or pharmacist before using RotaTeq if your child:
- has received a blood transfusion or immunoglobulins within the last 6 weeks.
- has a close contact such as a household member who has a weakened immune system, e.g., a 

person with cancer or who is taking medicines that may weaken the immune system.
- has any disorder of the gastrointestinal system.
- has not been gaining weight and growing as expected.

After your child has received RotaTeq, contact a doctor/health care professional right away if your 

child experiences severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or 

high fever (see also section 4 “Possible side effects”).

As always, please take care to wash your hands thoroughly after changing soiled nappies.  

As with other vaccines, RotaTeq may not completely protect all children who are vaccinated even 
after all three doses have been given.  

If your child has already been infected with rotavirus but is not yet ill when vaccinated, RotaTeq may 
not be able to prevent the illness. 

RotaTeq does not protect against diarrhoea and vomiting due to causes other than rotavirus. 

Other medicines and RotaTeq

RotaTeq may be given at the same time as your child receives other normally recommended 
vaccinations, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, 
inactivated or oral poliomyelitis, hepatitis B, pneumococcal conjugate and meningococcus group C 
conjugate vaccines.

Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other 
medicines (or other vaccines).

RotaTeq with food and drink

There are no restrictions on taking food or liquid, including breast milk, either before or after 
vaccination with RotaTeq. 

RotaTeq contains sucrose

If you have been told that your child has an intolerance to some sugars, inform your doctor/health care 
professional before the vaccine is administered.  

RotaTeq contains sodium

This vaccine contains 37.6 mg sodium (main component of cooking/table salt) in each dose. This is 
equivalent to 1.88% of the recommended maximum daily dietary intake of sodium for an adult.

3. How to use RotaTeq

RotaTeq IS FOR ORAL USE ONLY.

A doctor or nurse will administer the recommended doses of RotaTeq to your child. The vaccine will 
be given by gently squeezing the tube and delivering the vaccine into your child’s mouth. 

 



25

The vaccine can be given without regard to food, liquid, or breast milk. 
In case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be 
given at the same vaccination visit. 

Under no circumstance should this vaccine be administered by injection. 

The first dose (2 ml) of RotaTeq may be given from the age of 6 weeks and should be given before 
12 weeks of age (about 3 months). RotaTeq may be given to infants who were born early provided that 
the pregnancy had lasted at least 25 weeks. These infants should receive the first dose of vaccine 
between 6 and 12 weeks after birth.

Your child will receive 3 doses of RotaTeq given at least four weeks apart. It is important that your 
child receives all 3 doses of the vaccine for protection against rotavirus. It is preferred that all three 
doses should be given by the age of 20-22 weeks and at latest all three doses should be given by the 
age of 32 weeks.

When RotaTeq is given to your child for the first dose, it is recommended that your child also receives 
RotaTeq (and not another rotavirus vaccine) to complete the vaccination course. 

If you forget an appointment for RotaTeq

It is important that you follow the instructions of your doctor/health care professional regarding your 
child’s return visits for the follow-up doses. If you forget or are not able to go back to your 
doctor/health care professional at the scheduled time, ask him or her for advice. 

4. Possible side effects

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

Contact a doctor/health care professional right away if your child experiences one of the following 
symptoms:

 Allergic reactions (frequency cannot be estimated from the available data), which may be severe
(anaphylaxis), and may include: allergic swelling that may affect the face, lips, tongue or throat.

 Bronchospasm (rare, may affect up to 1 in 1000 infants). This may present as wheezing, 
coughing or difficulty breathing.

 Severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever. 
These could be symptoms of a very rare (may affect up to 1 in 10,000 infants), but serious, side 
effect called intussusception (a bowel obstruction in which one segment of bowel becomes 
enfolded within another segment).

The following other side effects reported with the use of RotaTeq were:

 Very common (may affect more than 1 in 10 infants): fever, diarrhoea, vomiting

 Common (may affect up to 1 in 10 infants): infections of the upper respiratory system

 Uncommon (may affect up to 1 in 100 infants): stomach pains (see also above for signs of a 
very rare side effect of intussusception), runny nose and sore throat, ear infection, rash, blood 
in stool

 Rare (may affect up to 1 in 1000 infants): hives

 



26

 Not known (frequency cannot be estimated from the available data): irritability

In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between 
breaths may occur for 2-3 days after vaccination.

Ask your doctor/health care professional if you want more information about side effects for RotaTeq.  

Reporting of side effects
If your child 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 RotaTeq

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

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

Store and transport refrigerated (2 °C to 8 °C). Keep the dosing tube 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 to protect the environment.  

6. Contents of the pack and other information

What RotaTeq contains

The active substances in RotaTeq are 5 human-bovine reassortant rotavirus strains:
G1 2.2 x 106 Infectious Units
G2 2.8 x 106 Infectious Units
G3 2.2 x 106 Infectious Units
G4 2.0 x 106 Infectious Units
P1A[8] 2.3 x 106 Infectious Units

The other ingredients in RotaTeq are: sucrose, sodium citrate, sodium dihydrogen phosphate 
monohydrate, sodium hydroxide, polysorbate 80, culture media (containing inorganic salts, amino 
acids and vitamins), and purified water.  

What RotaTeq looks like and contents of the pack

Oral solution

This vaccine is contained in a single-dose tube and is a pale yellow clear liquid that may have a pink 
tint.

RotaTeq is available in pack size of 1, 10 dosing tubes. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

 

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


27

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

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
Tél: +33 (0)1 80 46 40 40
information.medicale@msd.com

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

 

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


28

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

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 health care professionals only:

Instructions

To administer the vaccine:

Tear open the protective bag and remove the dosing tube.

 

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


29

Clear the fluid from the dispensing tip by holding tube vertically and 
tapping the twist-off cap.

Open the dosing tube in 2 easy motions:

1. Puncture the dispensing tip by screwing cap clockwise until it
becomes tight.

2. Remove cap by turning it counterclockwise.  

Administer dose by gently squeezing liquid into infant's mouth toward 
the inner cheek until dosing tube is empty. (A residual drop may remain
in the tip of the tube.)  

Discard the empty tube and cap in approved biological waste containers 
according to local regulations.

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

See also section 3. How to use RotaTeq.

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER 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