Vepacel

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 



2 

 This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
VEPACEL suspension for injection in multidose container 
Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
1 dose (0.5 ml) contains: 
 
Influenza virus (whole virion, inactivated), containing antigen* of strain: 
A/Vietnam/1203/2004 (H5N1)    7.5 micrograms** 
 
* produced in Vero cells 
** haemagglutinin 
 
This is a multidose container. See section 6.5 for the number of doses per vial. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Suspension for injection.  
Clear to opalescent suspension. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Active immunisation against H5N1 subtype of influenza A virus. 
 
This indication is based on immunogenicity data from subjects from the age of 6 months onwards 
following administration of two doses of vaccine prepared with H5N1 subtype strains (see section 5.1). 
 
The use of this vaccine should be in accordance with official recommendations. 
 
4.2 Posology and method of administration 
 
Posology 
Adults and children from 6 months onwards: 
One dose of 0.5 ml at an elected date. 
A second dose of 0.5 ml should be given after an interval of at least three weeks. 
 
other paediatric Population  
No data is available on the safety and efficacy of VEPACEL in children younger than 6 months of 
age. 
 



3 

Method of administration 
Immunisation should be carried out by intramuscular injection into the deltoid muscle or anterolateral 
thigh, depending on the muscle mass. 
 
See section 6.6 for administration instructions. 
 
4.3 Contraindications 
 
History of anaphylactic reactions to the active substance, or to any of the excipients listed in 
section 6.1, or trace residues (formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein). 
If vaccination is considered necessary, facilities for resuscitation should be immediately available in 
case of need (see section 4.4). 
 
4.4 Special warnings and precautions for use 
 
This vaccine may contain traces of formaldehyde, benzonase, sucrose, trypsin and Vero host cell 
protein, which are used during the manufacturing process. Therefore, hypersensitivity reactions may 
occur. 
 
As with all injectable vaccines, appropriate medical treatment and supervision should always be 
readily available in case of a rare anaphylactic event following the administration of the vaccine. 
 
Hypersensitivity reactions, including anaphylaxis, have been reported following use of a similar 
whole virion, Vero cell derived H1N1 influenza vaccine administered during a pandemic period. 
Such reactions have occurred both in patients with a history of multiple allergies and in patients 
with no known allergy. 
 
Immunisation shall be postponed in patients with severe febrile illness or acute infection. 
 
VEPACEL must not be administered intravascularly. 
 
There are no data with VEPACEL using the subcutaneous route. Therefore, healthcare providers 
need to assess the benefits and potential risks of administering the vaccine in individuals with 
thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection 
unless the potential benefit outweighs the risk of bleeding. 
 
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. 
 
A protective immune response may not be induced in all individuals receiving the vaccine 
(see section 5.1). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
There are no data on co-administration of VEPACEL with other vaccines. However, if co-administration 
with another vaccine is indicated, immunisation should be carried out on separate limbs. It should be 
noted that the adverse reactions may be intensified. 
 
Immunoglobulin is not to be given with VEPACEL unless it is necessary during a medical emergency 
to provide immediate protection. If necessary, VEPACEL may be given at the same time as normal or 
specific immunoglobulin into separate limbs. 
 
The immunological response may be diminished if the patient is undergoing treatment with 
immunosuppressants. 
 
Following influenza vaccination, false positive serology test results may be obtained by the ELISA 
method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus, and especially, 



4 

HTLV-1. In such cases, the western blot method is negative. These transitory false-positive results 
may be due to IgM production in response to the vaccine. 
 
4.6 Fertility, pregnancy and lactation 
 
The safety of VEPACEL in pregnancy and lactation has not been assessed in clinical trials. 
 
Animal studies with H5N1 strain vaccines (A/Vietnam/1203/2004 and A/Indonesia/05/2005) do not 
indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/foetal 
development, parturition or post-natal development (see section 5.3). 
 
Healthcare providers should carefully consider the potential risks and benefits for each specific patient 
before prescribing VEPACEL. 
 
The use of VEPACEL during pregnancy and lactation may be considered in a pre-pandemic situation, 
taking into account official recommendations. 
 
4.7 Effects on ability to drive and use machines 
 
VEPACEL has minor influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
a) Summary of safety profile 
 
• Adults, older people, and special risk groups 
 
Clinical trials were conducted with the H5N1 vaccine (see section 5.1 for more information on the 
H5N1 vaccines) in approximately 3700 subjects (ranging in age groups from 18 to 59 years 
and 60 years and above) and special risk groups of approximately 300 subjects each, consisting of 
immunocompromised subjects and patients with chronic disease conditions. The adverse reactions 
observed are shown in the table below. 
 
The safety profile in immunocompromised subjects and patients with chronic disease conditions is 
similar to the safety profile in healthy adults and older people. 
 
• Infants, children, and adolescents 
 
Children and adolescents aged 3 to 17 years: 
In a clinical trial 300 adolescents aged 9 to 17 years and 153 children aged 3 to 8 years were 
administered the H5N1 vaccine. The incidence and nature of symptoms after the first and second 
vaccination were similar to those observed in the healthy adults and older people. 
 
Infants and children aged 6 to 35 months: 
In a clinical trial the H5N1 vaccine was administered to 36 infants and children aged 6 to 35 months. 
 
The observed adverse reactions from a paediatric clinical trial with the H5N1 vaccine are listed below.  
 



5 

b) Tabulated list of adverse reactions 
 
Adverse reactions are listed according to the following frequency: 
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) 
 

Adverse Reactions (adults and older people) 
System Organ Class (SOC) Preferred MedDRA Term Frequency 

INFECTIONS AND 
INFESTATIONS 

Nasopharyngitis Common 

BLOOD AND LYMPHATIC 
SYSTEM DISORDERS 

Lymphadenopathy Uncommon 

PSYCHIATRIC 
DISORDERS 

Insomnia Uncommon 

NERVOUS SYSTEM 
DISORDERS 

Headache 
Dizziness 
Somnolence 
Sensory disturbance (paresthesia, dysesthesia, 
oral dysesthesia, hypoesthesia, dysgeusia, 
and burning sensation) 
Syncope 

Very common 
Uncommon 
Uncommon 
Common 
 
 
Uncommon 

EYE DISORDERS Conjunctivitis 
Eye irritation 

Uncommon 
Uncommon 

EAR AND LABYRINTH 
DISORDERS 

Vertigo 
Ear pain 
Sudden hearing loss 

Common 
Uncommon 
Uncommon 

VASCULAR DISORDERS Hypotension Uncommon 
RESPIRATORY, 
THORACIC AND 
MEDIASTINAL 
DISORDERS 

Oropharyngeal pain 
Cough 
Dyspnea 
Nasal congestion 
Rhinorrhea 
Dry throat 

Common 
Common 
Uncommon 
Uncommon 
Uncommon 
Uncommon 

GASTROINTESTINAL 
DISORDERS 

Diarrhea 
Vomiting 
Nausea 
Abdominal pain 
Dyspepsia 

Common 
Uncommon 
Uncommon 
Uncommon 
Uncommon 

SKIN AND 
SUBCUTANEOUS TISSUE 
DISORDERS 

Hyperhidrosis 
Pruritis 
Rash 
Urticaria 

Common 
Common 
Uncommon 
Uncommon 

MUSCULOSKELETAL 
AND CONNECTIVE 
TISSUE DISORDERS 

Arthralgia 
Myalgia 

Common 
Common 



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Adverse Reactions (adults and older people) 
System Organ Class (SOC) Preferred MedDRA Term Frequency 

GENERAL DISORDERS 
AND ADMINISTRATION 
SITE CONDITIONS 

Fatigue 
Pyrexia 
Chills 
Malaise 
Influenza-like illness 
Chest discomfort 
Injection Site Reactions 
• Injection site pain 
• Injection site induration 
• Injection site eyrthema 
• Injection site swelling 
• Injection site hemorrhage 
• Injection site irritation 
• Injection site pruritus 
• Injection site movement impairment 

Very Common 
Common 
Common 
Common 
Uncommon 
Uncommon 
 
Very Common 
Common 
Common 
Common 
Common 
Uncommon 
Uncommon 
Uncommon 

 
Adverse Reactions (infants, children and adolescents) 

System Organ Class  
(SOC) 

Preferred MedDRA 
Term 

Frequency  
6 – 35 months 3 – 8 years 9 – 17 years 

INFECTIONS AND 
INFESTATIONS 

Nasopharyngitis Common  Common  Common  

METABOLISM AND 
NUTRITION DISORDERS 

Decreased appetite Common Uncommon  Uncommon  

PSYCHIATRIC 
DISORDERS 

Insomnia 
Sleep disorder 

- 
Common  

- 
- 

Uncommon  
- 

NERVOUS SYSTEM 
DISORDERS 

Dizziness 
Headache 
Crying 
Somnolence 
Hypoaesthesia 

- 
- 
Common  
Very Common 
- 

- 
Common 
- 
- 
- 

Uncommon  
Very Common  
- 
- 
Uncommon 

EYE DISORDERs Eye irritation - Uncommon - 
EAR AND LABYRINTH 
DISORDERS 

Vertigo - - Uncommon 

RESPIRATORY, 
THORACIC AND 
MEDIASTINAL 
DISORDERS 

Cough 
Oropharyngeal pain 
Rhinorrhoea 

- 
- 
- 

Uncommon 
Common 
Uncommon 

Uncommon 
Common  
Uncommon 

GASTROINTESTINAL 
DISORDERS 

Abdominal pain 
Nausea 
Vomiting 
Diarrhoea 

- 
Common 
Common 
Common 

- 
Common 
Common 
Uncommon 

Common 
Common 
Common 
Uncommon 

SKIN AND 
SUBCUTANEOUS TISSUE 
DISORDERS 

Hyperhidrosis 
Pruritus 

Common 
- 

Uncommon 
- 

Common 
Uncommon 

MUSCULOSKELETAL 
AND CONNECTIVE 
TISSUE DISORDERS 

Arthralgia 
Myalgia 
Pain in extremity 

- 
- 
- 

Common 
Common 
- 

Common 
Common 
Uncommon 



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Adverse Reactions (infants, children and adolescents) 
System Organ Class  

(SOC) 
Preferred MedDRA 

Term 
Frequency  

6 – 35 months 3 – 8 years 9 – 17 years 
GENERAL DISORDERS 
AND ADMINISTRATION 
SITE CONDITIONS  

Injection site pain 
Injection site induration 
Injection site erythema 
Injection site swelling 
Injection site 
hemorrhage 
 
Injection site pruritus 
Axillary pain 
 
Fatigue 
Pyrexia 
Chills 
Irritability 
Malaise 
Feeling Cold 

Very common  
Common  
Common  
Common  
Common  
 
 
- 
- 
 
- 
Very Common  
- 
Very Common  
- 
- 

Very common  
Common  
Common  
Common  
Common  
 
 
Uncommon  
Uncommon 
 
Common 
Common 
- 
- 
Common 
Uncommon 

Very common  
Common  
Common  
Common  
Uncommon  
 
 
Uncommon  
Uncommon 
 
Common 
Uncommon 
Common 
- 
Common 
Uncommon 

 
• Post-marketing surveillance 
 
There are no post-marketing surveillance data available for VEPACEL. 
 
Celvapan (H1N1)v 
From post-marketing surveillance with a whole virion, Vero cell derived, H1N1 vaccine, the following 
adverse reactions have been reported (the frequency of these adverse reactions is not known as it 
cannot be estimated from the available data): 
 
Immune system disorders: anaphylactic reaction, hypersensitivity 
Nervous system disorders: febrile convulsion 
Skin and subcutaneous tissue disorders: angioedema 
Muscoluskeletal and connective tissue disorders: pain in extremity 
 
Trivalent seasonal influenza vaccines 
The following serious adverse reactions have been reported from post-marketing surveillance with 
egg-derived interpandemic trivalent vaccines: 
 
Uncommon: generalised skin reactions 
Rare: neuralgia, transient thrombocytopenia. Allergic reactions, in rare cases leading to shock, have 
been reported. 
 
Very rare: vasculitis with transient renal involvement. Neurological disorders, such as 
encephalomyelitis, neuritis, and Guillain Barré syndrome. 
 
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 for VEPACEL. 
 
 

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


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5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01 
 
This section describes the clinical experience with the H5N1 vaccine. 
 
Pandemic and Pre-pandemic vaccines contain influenza antigens that are different from those in 
the currently circulating influenza viruses. These antigens can be considered as ‘novel’ antigens 
and simulate a situation where the target population for vaccination is immunologically naïve. 
Data obtained with the H5N1 vaccines will support a vaccination strategy that is likely to be used 
for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with 
H5N1 vaccines are relevant for the pandemic and pre-pandemic vaccines. 
 
Adults, older people, and special risk groups 
Immune response against A/Vietnam/1203/2004 (H5N1) 
The immunogenicity of the A/Vietnam/1203/2004 strain vaccine has been evaluated in three clinical 
studies in adults aged 18 – 59 years (N=961) and in two clinical studies in subjects aged 60 years 
and older (N=391) following a 0, 21 day schedule. In addition, the immunogenicity has also been 
evaluated in a Phase 3 study in specified risk groups of immunocompromised subjects (N=122) and 
patients with chronic disease conditions (N=123) following a 0, 21 day schedule. 
 
Immunogenicity in adults aged 18 to 59 years (N=961) and in subjects aged 60 years and 
older (N=391) 
 
After primary vaccination the rate of subjects with neutralising antibody titres > 20, seroconversion 
rate and seroconversion factor as measured by microneutralisation assay (MN) in adults 
aged 18 to 59 years and in older people aged 60 years and above were as follows: 
 

 18 – 59 years 60 years and above 
 21 Days after 21 Days after 
 1st Dose 2nd Dose 1st Dose 2nd Dose 

Seroneutralisation rate* 44.4% 69.7% 51.9% 69.2% 
Seroconversion rate** 32.7% 56.0% 13.3% 23.9% 
Seroconversion factor*** 3.0 4.5 2.0 2.6 

* MN titre ≥ 20 
** ≥ 4-fold increase in MN titre 
*** geometric mean increase 
 
Immunogenicity in immunocompromised subjects (N=122) and patients with chronic disease 
conditions (N=123) 
 
After vaccination the rate of subjects with neutralising antibody titres ≥ 20, seroconversion rate and 
seroconversion factor as measured by MN assay in immunocompromised subjects and patients with 
chronic disease conditions were as follows: 
 

 Immunocompromised subjects Patients with chronic disease conditions 
 21 Days after 21 Days after 
 1st Dose 2nd Dose 1st Dose 2nd Dose 

Seroneutralisation rate* 24.8% 41.5% 44.3% 64.2% 
Seroconversion rate** 9.1% 32.2% 17.2% 35.0% 
Seroconversion factor*** 1.6 2.5 2.3 3.0 

* MN titre ≥ 20 
** ≥ 4-fold increase in MN titre 
*** geometric mean increase 
 



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Cross-reactive immune response against related H5N1 strains 
 
In a clinical study in adults aged 18 to 59 years (N=265) and in older people aged 60 years and above 
(N=270) after vaccination with the A/Vietnam/1203/2004 strain vaccine, the rate of subjects with 
cross-neutralising antibodies as measured by MN (titre ≥ 20) was as follows: 
 

 18 – 59 years 60 years and above 
 Strain A/Indonesia/05/2005 
 21 Days after 2nd Dose 21 Days after 2nd Dose 

Seroneutralisation rate* 35.1% 54.8% 
* MN titre ≥ 20 
 
Heterologous booster vaccinations 
 
A heterologous booster vaccination with a 7.5 µg non-adjuvanted formulation of the 
A/Indonesia/05/2005 strain vaccine has been administered in a time frame of 12 to 24 months after 
priming vaccination with two doses of the A/Vietnam/1203/2004 strain vaccine in three clinical 
studies in adults aged 18 to 59 years and in older people aged 60 years and above. A 12 to 24 months 
heterologous booster has also been administered in a phase 3 study in immunocompromised subjects 
and patients with chronic disease conditions. 
 
Seroneutralisation rates (MN titre ≥ 20) at 21 days after a 12 to 24 months booster vaccination with 
the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and 
heterologous strains were as follows: 
 

Seroneutralisation rate* 18 – 59 years 60 years and above 
Tested against A/Vietnam A/Indonesia A/Vietnam A/Indonesia 

12 – 24 months booster 89.8% 86.9% 82.9% 75.3% 
* MN titre ≥ 20 

 
Seroneutralisation rate* Immunocompromised subjects Patients with chronic disease conditions 

Tested against A/Vietnam A/Indonesia A/Vietnam A/Indonesia 
12 – 24 months booster 71.6% 65.7% 77.5% 70.8% 

* MN titre ≥ 20 
 
A booster with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 strain vaccine 
administered 12 months after a single dose priming vaccination with the A/Vietnam/1203/2004 strain 
vaccine was also evaluated in adults aged 18 to 59 years. 
 
Seroneutralisation rates (MN titre ≥ 20) at 21 days after a 12 months booster vaccination with 
the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and 
heterologous strains were as follows: 
 

Seroneutralisation rate*  
Tested against A/Vietnam A/Indonesia 

12 Month Booster 85.9% 92.9% 
* MN titre ≥ 20 
 
Infants, children, and adolescents 
Immune response against A/Vietnam/1203/2004 (H5N1) 
 
The immunogenicity of the A/Vietnam/1203/2004 strain vaccine has been evaluated in a clinical trial 
in children and adolescents aged 9 to 17 years (N=288), in children aged 3 to 8 years (N=146) and in 
infants and children aged 6 to 35 months (N=33) following a 0, 21 day schedule.  
 



10 

After vaccination, the rate of subjects with neutralizing antibody titers ≥ 20, seroconversion rate and 
seroconversion factor, as measured by MN assay, in infants, children, and adolescents aged 6 months 
to 17 years were as follows: 
 

MN assay 
9 – 17 years 3 – 8 years 6 – 35 months 

21 Days after 21 Days after 21 Days after 
1st Dose 2nd Dose 1st Dose 2nd Dose 1st Dose 2nd Dose 

Seroneutralization rate* 52.6% 85.4% 17.1% 72.9% 3.0% 68.8% 
Seroconversion rate** 9.1% 31.8% 16.4% 72.2% 9.1% 65.6% 
Seroconversion 
factor*** 1.6 3.1 2.1 6.3 1.4 6.8 

* MN titer ≥ 20 
** ≥ 4-fold increase in MN titer 
*** geometric mean increase 
 
Heterologous Booster Vaccinations 
 
A heterologous booster vaccination with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 
strain vaccine has been administered 12 months after a priming vaccination with two doses of the 
A/Vietnam/1203/2004 strain vaccine in children and adolescents aged 9 to 17 years (N=196), children aged 
3 to 8 years (N=79) and infants and children aged 6 months to 35 months (N=25).  
 
Seroneutralization rates (MN titer ≥ 20) at 21 days after a booster vaccination with the 7.5 µg dose of 
the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains, 
were as follows: 
 
Seroneutralization 
rate* 

9 – 17 years 3 – 8 years 6 – 35 months 

Tested against A/Vietnam A/Indonesia A/Vietnam A/Indonesia A/Vietnam A/Indonesia 
12 Month Booster 94.1% 93.1% 94.7% 97.2% 100.0% 100.0% 

* MN titer ≥ 20 
 
Information from non-clinical studies 
The protective efficacy of VEPACEL against morbidity and mortality induced by the infection with 
lethal doses of highly pathogenic avian influenza H5N1 virus was assessed non-clinically in a ferret 
challenge model. 
 
Sixteen ferrets were divided into two cohorts and were vaccinated on days 0 and 21 with 7.5 µg of 
the A/Vietnam/1203/2004 vaccine or were sham vaccinated. All ferrets were challenged intranasally 
on day 35 with a high dose of the highly virulent H5N1 virus strain A/Vietnam/1203/2004 and 
monitored for 14 days. Ferrets vaccinated with the 7.5 µg dose of the A/Vietnam/1203/2004 vaccine 
demonstrated a high rate of seroconversion. The A/Vietnam/1203/2004 vaccine afforded protection 
against homologous challenge as evidenced by full survival, reduced weight loss, a less pronounced 
and shorter increase in temperature, a less marked reduction in lymphocyte counts and in reduction of 
inflammation and necrosis in brain and olfactory bulb in the vaccinated cohorts as compared to control 
animals. All control animals succumbed to the infection. 
 
5.2 Pharmacokinetic properties 
 
Not applicable. 
 
5.3 Preclinical safety data 
 
Non-clinical studies demonstrated minor alterations in liver enzymes and calcium levels in a repeat 
dose toxicity study in rats. Clinically significant alterations in liver enzymes and calcium levels have 
not been seen to date in human clinical studies. 
 



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Animal reproductive and developmental toxicology studies do not indicate harmful effects in regard to 
female fertility, embryo-foetal and pre- and post-natal toxicity. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Trometamol 
Sodium chloride 
Water for injections 
Polysorbate 80 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
2 years 
 
After first opening, the vaccine should be used immediately. However, chemical and physical in-use 
stability has been demonstrated for 3 hours at room temperature. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C to 8°C). 
Do not freeze. 
Store in the original package in order to protect from light. 
 
6.5 Nature and contents of the container 
 
One pack of 20 multidose vials (type I glass) of 5 ml suspension (10 x 0.5 ml doses) with a stopper 
(bromobutyl rubber). 
 
6.6 Special precautions for disposal and other handling 
 
The vaccine should be allowed to reach room temperature before use. Shake before use. 
Visually inspect the suspension prior to administration. In case of any particles and/or abnormal 
appearance, the vaccine should be discarded. 
 
The vaccine contains 10 doses of 0.5 ml. 
Each dose of 0.5 ml is withdrawn into a syringe for injection. 
 
Any unused vaccine or waste material should be disposed of in accordance with local requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Ology Bioservices Ireland LTD 
Wilton Park House 
Wilton Place 
Dublin 2 
D02P447 
Ireland 
 



12 

 
8. MARKETING AUTHORISATION NUMBER 
 
EU/1/12/752/001 
 
 
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 17/02/2012 
Date of latest renewal: 04/01/2017 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency (EMA): http://www.ema.europa.eu/ 



13 

 This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
VEPACEL suspension for injection in pre-filled syringe 
Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
1 dose (0.5 ml) contains: 
 
Influenza virus (whole virion, inactivated), containing antigen* of strain: 
A/Vietnam/1203/2004 (H5N1)    7.5 micrograms**  
 
* produced in Vero cells 
** haemagglutinin 
 
The vaccine is available in a single dose pre-filled syringe. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Suspension for injection. 
Clear to opalescent suspension. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Active immunisation against H5N1 subtype of influenza A virus. 
 
This indication is based on immunogenicity data from subjects from the age of 6 months onwards 
following administration of two doses of vaccine prepared with H5N1 subtype strains (see section 5.1). 
 
The use of this vaccine should be in accordance with official recommendations. 
 
4.2 Posology and method of administration 
 
Posology 
Adults and children from 6 months onwards: 
One dose of 0.5 ml at an elected date. 
A second dose of 0.5 ml should be given after an interval of at least three weeks. 
 
other paediatric Population  
No data is available on the safety and efficacy of VEPACEL in children younger than 6 months of 
age. 
 



14 

Method of administration 
Immunisation should be carried out by intramuscular injection into the deltoid muscle or anterolateral 
thigh, depending on the muscle mass. 
 
See section 6.6. for administration instructions. 
 
4.3 Contraindications 
 
History of anaphylactic reactions to the active substance, or to any of the excipients listed in 
section 6.1, or trace residues (formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein). 
If vaccination is considered necessary, facilities for resuscitation should be immediately available in 
case of need (see section 4.4). 
 
4.4 Special warnings and precautions for use 
 
This vaccine may contain traces of formaldehyde, benzonase, sucrose, trypsin and Vero host cell protein, 
which are used during the manufacturing process. Therefore, hypersensitivity reactions may occur. 
 
As with all injectable vaccines, appropriate medical treatment and supervision should always be 
readily available in case of a rare anaphylactic event following the administration of the vaccine. 
 
Hypersensitivity reactions, including anaphylaxis, have been reported following use of a similar 
whole virion, Vero cell derived H1N1 influenza vaccine administered during a pandemic period. 
Such reactions have occurred both in patients with a history of multiple allergies and in patients 
with no known allergy. 
 
Immunisation shall be postponed in patients with severe febrile illness or acute infection. 
 
VEPACEL must not be administered intravascularly. 
 
There are no data with VEPACEL using the subcutaneous route. Therefore, healthcare providers 
need to assess the benefits and potential risks of administering the vaccine in individuals with 
thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection 
unless the potential benefit outweighs the risk of bleeding. 
 
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. 
 
A protective immune response may not be induced in all individuals receiving the vaccine 
(see section 5.1). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
There are no data on co-administration of VEPACEL with other vaccines. However, if co-administration 
with another vaccine is indicated, immunisation should be carried out on separate limbs. It should be 
noted that the adverse reactions may be intensified. 
 
Immunoglobulin is not to be given with VEPACEL unless it is necessary during a medical emergency 
to provide immediate protection. If necessary, VEPACEL may be given at the same time as normal or 
specific immunoglobulin into separate limbs. 
 
The immunological response may be diminished if the patient is undergoing treatment with 
immunosuppressants. 
 
Following influenza vaccination, false positive serology test results may be obtained by the ELISA 
method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus, and especially, 
HTLV-1. In such cases, the western blot method is negative. These transitory false-positive results 
may be due to IgM production in response to the vaccine. 



15 

 
4.6 Fertility, pregnancy and lactation 
 
The safety of VEPACEL in pregnancy and lactation has not been assessed in clinical trials. 
 
Animal studies with H5N1 strain vaccines (A/Vietnam/1203/2004 and A/Indonesia/05/2005) do not 
indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/foetal 
development, parturition or post-natal development (see section 5.3). 
 
Healthcare providers should carefully consider the potential risks and benefits for each specific patient 
before prescribing VEPACEL. 
 
The use of VEPACEL during pregnancy and lactation may be considered in a pre-pandemic situation, 
taking into account official recommendations. 
 
4.7 Effects on ability to drive and use machines 
 
VEPACEL has minor influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
a) Summary of safety profile 
 
• Adults, older people, and special risk groups 
 
Clinical trials were conducted with the H5N1 vaccine (see section 5.1 for more information on the 
H5N1 vaccines) in approximately 3700 subjects (ranging in age groups from 18 to 59 years and 
60 years and above) and special risk groups of approximately 300 subjects each, consisting of 
immunocompromised subjects and patients with chronic disease conditions. The adverse reactions 
observed are shown in the table below. 
 
The safety profile in immunocompromised subjects and patients with chronic disease conditions is 
similar to the safety profile in healthy adults and older people. 
 
• Infants, children, and adolescents  
 
Children and adolescents aged 3 to 17 years: 
In a clinical trial 300 adolescents aged 9 to 17 years and 153 children aged 3 to 8 years were 
administered the H5N1 vaccine. The incidence and nature of symptoms after the first and second 
vaccination were similar to those observed in the healthy adults and older people.  
 
Infants and children aged 6 to 35 months: 
In a clinical trial the H5N1 vaccine was administered to 36 infants and children aged 6 to 35 months. 
 
The observed adverse reactions from a paediatric clinical trial with the H5N1 vaccine are listed below.  
 



16 

b) Tabulated list of adverse reactions 
 
Adverse reactions are listed according to the following frequency: 
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) 
 

Adverse Reactions (adults and older people) 
System Organ Class (SOC) Preferred MedDRA Term Frequency 

INFECTIONS AND 
INFESTATIONS 

Nasopharyngitis Common 

BLOOD AND LYMPHATIC 
SYSTEM DISORDERS 

Lymphadenopathy Uncommon 

PSYCHIATRIC 
DISORDERS 

Insomnia Uncommon 

NERVOUS SYSTEM 
DISORDERS 

Headache 
Dizziness 
Somnolence 
Sensory disturbance (paresthesia, dysesthesia, 
oral dysesthesia, hypoesthesia, dysgeusia, 
and burning sensation) 
Syncope 

Very common 
Uncommon 
Uncommon 
Common 
 
 
Uncommon 

EYE DISORDERS Conjunctivitis 
Eye irritation 

Uncommon 
Uncommon 

EAR AND LABYRINTH 
DISORDERS 

Vertigo 
Ear pain 
Sudden hearing loss 

Common 
Uncommon 
Uncommon 

VASCULAR DISORDERS Hypotension Uncommon 
RESPIRATORY, 
THORACIC AND 
MEDIASTINAL 
DISORDERS 

Oropharyngeal pain 
Cough 
Dyspnea 
Nasal congestion 
Rhinorrhea 
Dry throat 

Common 
Common 
Uncommon 
Uncommon 
Uncommon 
Uncommon 

GASTROINTESTINAL 
DISORDERS 

Diarrhea 
Vomiting 
Nausea 
Abdominal pain 
Dyspepsia 

Common 
Uncommon 
Uncommon 
Uncommon 
Uncommon 

SKIN AND 
SUBCUTANEOUS TISSUE 
DISORDERS 

Hyperhidrosis 
Pruritis 
Rash 
Urticaria 

Common 
Common 
Uncommon 
Uncommon 

MUSCULOSKELETAL 
AND CONNECTIVE 
TISSUE DISORDERS 

Arthralgia 
Myalgia 

Common 
Common 



17 

Adverse Reactions (adults and older people) 
System Organ Class (SOC) Preferred MedDRA Term Frequency 

GENERAL DISORDERS 
AND ADMINISTRATION 
SITE CONDITIONS 

Fatigue 
Pyrexia 
Chills 
Malaise 
Influenza-like illness 
Chest discomfort 
Injection Site Reactions 
• Injection site pain 
• Injection site induration 
• Injection site eyrthema 
• Injection site swelling 
• Injection site hemorrhage 
• Injection site irritation 
• Injection site pruritus 
• Injection site movement impairment 

Very Common 
Common 
Common 
Common 
Uncommon 
Uncommon 
 
Very Common 
Common 
Common 
Common 
Common 
Uncommon 
Uncommon 
Uncommon 

 
Adverse Reactions (Infants, children and adolescents) 

System Organ Class  
(SOC) 

Preferred MedDRA 
Term 

Frequency  
6 – 35 months 3 – 8 years 9 – 17 years 

INFECTIONS AND 
INFESTATIONS 

Nasopharyngitis Common  Common  Common  

METABOLISM AND 
NUTRITION DISORDERS 

Decreased appetite Common Uncommon  Uncommon  

PSYCHIATRIC 
DISORDERS 

Insomnia 
Sleep disorder 

- 
Common  

- 
- 

Uncommon  
- 

NERVOUS SYSTEM 
DISORDERS 

Dizziness 
Headache 
Crying 
Somnolence 
Hypoaesthesia 

- 
- 
Common  
Very Common 
- 

- 
Common 
- 
- 
- 

Uncommon  
Very Common  
- 
- 
Uncommon 

EYE DISORDERs Eye irritation - Uncommon - 
EAR AND LABYRINTH 
DISORDERS 

Vertigo - - Uncommon 

RESPIRATORY, 
THORACIC AND 
MEDIASTINAL 
DISORDERS 

Cough 
Oropharyngeal pain 
Rhinorrhoea 

- 
- 
- 

Uncommon 
Common 
Uncommon 

Uncommon 
Common  
Uncommon 

GASTROINTESTINAL 
DISORDERS 

Abdominal pain 
Nausea 
Vomiting 
Diarrhoea 

- 
Common 
Common 
Common 

- 
Common 
Common 
Uncommon 

Common 
Common 
Common 
Uncommon 

SKIN AND 
SUBCUTANEOUS TISSUE 
DISORDERS 

Hyperhidrosis 
Pruritus 

Common 
- 

Uncommon 
- 

Common 
Uncommon 

MUSCULOSKELETAL 
AND CONNECTIVE 
TISSUE DISORDERS 

Arthralgia 
Myalgia 
Pain in extremity 

- 
- 
- 

Common 
Common 
- 

Common 
Common 
Uncommon 



18 

Adverse Reactions (Infants, children and adolescents) 
System Organ Class  

(SOC) 
Preferred MedDRA 

Term 
Frequency  

6 – 35 months 3 – 8 years 9 – 17 years 
GENERAL DISORDERS 
AND ADMINISTRATION 
SITE CONDITIONS  

Injection site pain 
Injection site induration 
Injection site erythema 
Injection site swelling 
Injection site 
hemorrhage 
 
Injection site pruritus 
Axillary pain  
 
Fatigue 
Pyrexia 
Chills 
Irritability 
Malaise 
Feeling Cold 

Very common  
Common  
Common  
Common  
Common  
 
 
- 
- 
 
- 
Very Common  
- 
Very Common  
- 
- 

Very common  
Common  
Common  
Common  
Common  
 
 
Uncommon  
Uncommon 
 
Common 
Common 
- 
- 
Common 
Uncommon 

Very common  
Common  
Common  
Common  
Uncommon  
 
 
Uncommon  
Uncommon 
 
Common 
Uncommon 
Common 
- 
Common 
Uncommon 

 
• Post-marketing surveillance 
 
There are no post-marketing surveillance data available for VEPACEL. 
 
Celvapan (H1N1)v 
From post-marketing surveillance with a whole virion, Vero cell derived, H1N1 vaccine, the following 
adverse reactions have been reported (the frequency of these adverse reactions is not known as it 
cannot be estimated from the available data): 
 
Immune system disorders: anaphylactic reaction, hypersensitivity 
Nervous system disorders: febrile convulsion 
Skin and subcutaneous tissue disorders: angioedema 
Muscoluskeletal and connective tissue disorders: pain in extremity 
 
Trivalent seasonal influenza vaccines 
The following serious adverse reactions have been reported from post-marketing surveillance with 
egg-derived interpandemic trivalent vaccines: 
 
Uncommon: generalised skin reactions 
Rare: neuralgia, transient thrombocytopenia. Allergic reactions, in rare cases leading to shock, have 
been reported. 
 
Very rare: vasculitis with transient renal involvement. Neurological disorders, such as 
encephalomyelitis, neuritis, and Guillain Barré syndrome. 
 
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 for VEPACEL. 
 
 

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


19 

5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01 
 
This section describes the clinical experience with the H5N1 vaccine. 
 
Pandemic and Pre-pandemic vaccines contain influenza antigens that are different from those in 
the currently circulating influenza viruses. These antigens can be considered as ‘novel’ antigens 
and simulate a situation where the target population for vaccination is immunologically naïve. 
Data obtained with the H5N1 vaccines will support a vaccination strategy that is likely to be used 
for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with 
H5N1 vaccines are relevant for the pandemic and pre-pandemic vaccines. 
 
Adults, older people, and special risk groups 
Immune response against A/Vietnam/1203/2004 (H5N1) 
The immunogenicity of the A/Vietnam/1203/2004 strain vaccine has been evaluated in three clinical 
studies in adults aged 18 – 59 years (N=961) and in two clinical studies in subjects aged 60 years 
and older (N=391) following a 0, 21 day schedule. In addition, the immunogenicity has also been 
evaluated in a Phase 3 study in specified risk groups of immunocompromised subjects (N=122) and 
patients with chronic disease conditions (N=123) following a 0, 21 day schedule. 
 
Immunogenicity in adults aged 18 to 59 years (N=961) and in subjects aged 60 years and 
older (N=391) 
 
After primary vaccination the rate of subjects with neutralising antibody titres > 20, seroconversion 
rate and seroconversion factor as measured by microneutralisation assay (MN) in adults 
aged 18 to 59 years and in older people aged 60 years and above were as follows: 
 

 18 – 59 years 60 years and above 
 21 Days after 21 Days after 
 1st Dose 2nd Dose 1st Dose 2nd Dose 

Seroneutralisation rate* 44.4% 69.7% 51.9% 69.2% 
Seroconversion rate** 32.7% 56.0% 13.3% 23.9% 
Seroconversion factor*** 3.0 4.5 2.0 2.6 

* MN titre ≥ 20 
** ≥ 4-fold increase in MN titre 
*** geometric mean increase 
 
Immunogenicity in immunocompromised subjects (N=122) and patients with chronic disease 
conditions (N=123) 
 
After vaccination the rate of subjects with neutralising antibody titres ≥ 20, seroconversion rate and 
seroconversion factor as measured by MN assay in immunocompromised subjects and patients with 
chronic disease conditions were as follows: 
 

 Immunocompromised subjects Patients with chronic disease conditions 
 21 Days after 21 Days after 
 1st Dose 2nd Dose 1st Dose 2nd Dose 

Seroneutralisation rate* 24.8% 41.5% 44.3% 64.2% 
Seroconversion rate** 9.1% 32.2% 17.2% 35.0% 
Seroconversion factor*** 1.6 2.5 2.3 3.0 

* MN titre ≥ 20 
** ≥ 4-fold increase in MN titre 
*** geometric mean increase 
 



20 

Cross-reactive immune response against related H5N1 strains 
 
In a clinical study in adults aged 18 to 59 years (N=265) and in older people aged 60 years and above 
(N=270) after vaccination with the A/Vietnam/1203/2004 strain vaccine, the rate of subjects with 
cross-neutralising antibodies as measured by MN (titre ≥ 20) was as follows: 
 

 18 – 59 years 60 years and above 
 Strain A/Indonesia/05/2005 
 21 Days after 2nd Dose 21 Days after 2nd Dose 

Seroneutralisation rate* 35.1% 54.8% 
* MN titre ≥ 20 
 
Heterologous booster vaccinations 
 
A heterologous booster vaccination with a 7.5 µg non-adjuvanted formulation of the 
A/Indonesia/05/2005 strain vaccine has been administered in a time frame of 12 to 24 months after 
priming vaccination with two doses of the A/Vietnam/1203/2004 strain vaccine in three clinical 
studies in adults aged 18 to 59 years and in older people aged 60 years and above. A 12 to 24 months 
heterologous booster has also been administered in a phase 3 study in immunocompromised subjects 
and patients with chronic disease conditions. 
 
Seroneutralisation rates (MN titre ≥ 20) at 21 days after a 12 to 24 months booster vaccination with 
the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and 
heterologous strains were as follows: 
 

Seroneutralisation rate* 18 – 59 years 60 years and above 
Tested against A/Vietnam A/Indonesia A/Vietnam A/Indonesia 

12 – 24 months booster 89.8% 86.9% 82.9% 75.3% 
* MN titre ≥ 20 
 
Seroneutralisation rate* Immunocompromised subjects Patients with chronic disease conditions 

Tested against A/Vietnam A/Indonesia A/Vietnam A/Indonesia 
12 – 24 months booster 71.6% 65.7% 77.5% 70.8% 

* MN titre ≥ 20 
 
A booster with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 strain vaccine 
administered 12 months after a single dose priming vaccination with the A/Vietnam/1203/2004 strain 
vaccine was also evaluated in adults aged 18 to 59 years. 
 
Seroneutralisation rates (MN titre ≥ 20) at 21 days after a 12 months booster vaccination with 
the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and 
heterologous strains were as follows: 
 

Seroneutralisation rate*  
Tested against A/Vietnam A/Indonesia 

12 Month Booster 85.9% 92.9% 
* MN titre ≥ 20 
 
Infants, children, and adolescents 
Immune response against A/Vietnam/1203/2004 (H5N1) 
 
The immunogenicity of the A/Vietnam/1203/2004 strain vaccine has been evaluated in a clinical trial 
in children and adolescents aged 9 to 17 years (N=288), in children aged 3 to 8 years (N=146) and in 
infants and children aged 6 to 35 months (N=33) following a 0, 21 day schedule.  
 



21 

After vaccination, the rate of subjects with neutralizing antibody titers ≥ 20, seroconversion rate and 
seroconversion factor, as measured by MN assay, in infants, children, and adolescents aged 6 months 
to 17 years were as follows: 
 

MN assay 
9 – 17 years 3 – 8 years 6 – 35 months 

21 Days after 21 Days after 21 Days after 
1st Dose 2nd Dose 1st Dose 2nd Dose 1st Dose 2nd Dose 

Seroneutralization rate* 52.6% 85.4% 17.1% 72.9% 3.0% 68.8% 
Seroconversion rate** 9.1% 31.8% 16.4% 72.2% 9.1% 65.6% 
Seroconversion 
factor*** 1.6 3.1 2.1 6.3 1.4 6.8 

* MN titer ≥ 20 
** ≥ 4-fold increase in MN titer 
*** geometric mean increase 
 
Heterologous Booster Vaccinations 
 
A heterologous booster vaccination with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 
strain vaccine has been administered 12 months after a priming vaccination with two doses of the 
A/Vietnam/1203/2004 strain vaccine in children and adolescents aged 9 to 17 years (N=196), children aged 
3 to 8 years (N=79) and infants and children aged 6 months to 35 months (N=25).  
 
Seroneutralization rates (MN titer ≥ 20) at 21 days after a booster vaccination with the 7.5 µg dose of 
the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains, 
were as follows: 
 
Seroneutralization 
rate* 

9 – 17 years 3 – 8 years 6 – 35 months 

Tested against A/Vietnam A/Indonesia A/Vietnam A/Indonesia A/Vietnam A/Indonesia 
12 Month Booster 94.1% 93.1% 94.7% 97.2% 100.0% 100.0% 

* MN titer ≥ 20 
 
Information from non-clinical studies 
The protective efficacy of VEPACEL against morbidity and mortality induced by the infection with 
lethal doses of highly pathogenic avian influenza H5N1 virus was assessed non-clinically in a ferret 
challenge model. 
 
Sixteen ferrets were divided into two cohorts and were vaccinated on days 0 and 21 with 7.5 µg of 
the A/Vietnam/1203/2004 vaccine or were sham vaccinated. All ferrets were challenged intranasally 
on day 35 with a high dose of the highly virulent H5N1 virus strain A/Vietnam/1203/2004 and 
monitored for 14 days. Ferrets vaccinated with the 7.5 µg dose of the A/Vietnam/1203/2004 vaccine 
demonstrated a high rate of seroconversion. The A/Vietnam/1203/2004 vaccine afforded protection 
against homologous challenge as evidenced by full survival, reduced weight loss, a less pronounced 
and shorter increase in temperature, a less marked reduction in lymphocyte counts and in reduction of 
inflammation and necrosis in brain and olfactory bulb in the vaccinated cohorts as compared to control 
animals. All control animals succumbed to the infection. 
 
5.2 Pharmacokinetic properties 
 
Not applicable. 
 
5.3 Preclinical safety data 
 
Non-clinical studies demonstrated minor alterations in liver enzymes and calcium levels in a repeat 
dose toxicity study in rats. Clinically significant alterations in liver enzymes and calcium levels have 
not been seen to date in human clinical studies. 
 



22 

Animal reproductive and developmental toxicology studies do not indicate harmful effects in regard to 
female fertility, embryo-foetal and pre- and post-natal toxicity. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Trometamol 
Sodium chloride 
Water for injections 
Polysorbate 80 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
2 years 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C to 8°C). 
Do not freeze. 
Store in the original package in order to protect from light. 
 
6.5 Nature and contents of the container 
 
One pack of 1 single dose pre-filled syringe (type I glass) containing 0.5 ml suspension for injection, 
with a latex-free plunger stopper (halogeno-butyl rubber) without needles. 
 
6.6 Special precautions for disposal and other handling 
 
The vaccine should be allowed to reach room temperature before use. Shake before use. 
Visually inspect the suspension prior to administration. In case of any particles and/or abnormal 
appearance, the vaccine should be discarded. 
 
After removing the syringe cap, attach the needle immediately and remove the needle shield prior to 
administration. 
 
Once the needle is attached, the vaccine must be administered immediately. 
 
Any unused vaccine or waste material should be disposed of in accordance with local requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Ology Bioservices Ireland LTD 
Wilton Park House 
Wilton Place 
Dublin 2 
D02P447 
Ireland 
 
 



23 

8. MARKETING AUTHORISATION NUMBER 
 
EU/1/12/752/002 
 
 
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 17/02/2012 
Date of latest renewal: 04/01/2017 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency (EMA): http://www.ema.europa.eu/ 



24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 
 
 



25 

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) 
 
Baxter BioScience s.r.o. 
Jevany Bohumil 138 
CZ-281 63 Kostelec nad Cernymi lesy 
Czech Republic 
 
Baxter AG 
Uferstrasse 15 
A-2304 Orth/Donau 
Austria 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Baxter AG 
Uferstrasse 15 
A-2304 Orth/Donau 
Austria 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription (see Annex I: Summary of Product Characteristics, 
section 4.2). 
 
• 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 
 
The marketing authorisation holder shall submit periodic safety update reports for this product in 
accordance with the requirements set out in the list of Union reference dates (EURD list) provided for 
under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
 
PSUR submission when VEPACEL is used during an influenza pandemic: 
During a pandemic situation, the frequency of submission of periodic safety update reports specified 
in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of 
a pandemic vaccine for which high levels of exposure are expected within a short period of time. Such 
situation requires rapid notification of safety information that may have the greatest implications for 
risk-benefit balance in a pandemic. Prompt analysis of cumulative safety information, in light of extent 
of exposure, will be crucial for regulatory decisions and protection of the population to be vaccinated. 
In addition, during a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update 
Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the 
European Union may not be adequate for a rapid identification of a new safety issue. 
 



26 

In consequence, as soon as the pandemic is declared and the prepandemic vaccine is used, the MAH 
shall submit more frequent simplified periodic safety update reports with a format and a periodicity 
defined in the "CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines 
prepared from viruses with the potential to cause a pandemic and intended for use outside of the core 
dossier context" (EMEA/49993/2008), and any subsequent update. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
The 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. 

 
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the 
same time. 
 



27 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



29 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON – 10 DOSE VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
VEPACEL suspension for injection in multidose container 
Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 dose (0.5 ml) contains: 
 
Influenza virus (whole virion, inactivated) containing antigen of strain : 
A/Vietnam/1203/2004 (H5N1)    7.5 micrograms  
 
 
3. LIST OF EXCIPIENTS 
 
Trometamol 
Sodium Chloride 
Water for injections 
Polysorbate 80 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection  
20 multidose vials 
(10 doses of 0.5 ml per vial) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use. 
The vaccine should be allowed to reach room temperature before use. 
Shake before use. 
After first opening, the vaccine should be used immediately (within 3 hours maximum). 
 
 
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 



30 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in refrigerator. 
Do not freeze. 
Store in the original package 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 

 
Dispose of in accordance with local requirements. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Ology Bioservices Ireland LTD 
Wilton Park House 
Wilton Place 
Dublin 2 
D02P447 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/12/752/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 



31 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON – PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
VEPACEL suspension for injection in a pre-filled syringe 
Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 dose (0.5 ml) contains: 
 
Influenza virus (whole virion, inactivated) containing antigen of strain: 
A/Vietnam/1203/2004 (H5N1)   7.5 micrograms 
 
 
3. LIST OF EXCIPIENTS 
 
Trometamol 
Sodium Chloride 
Water for injections 
Polysorbate 80 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection 
1 pre-filled syringe (0.5 ml) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use. 
The vaccine should be allowed to reach room temperature before use. 
Shake 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 
 
 



32 

9. SPECIAL STORAGE CONDITIONS 
 
Store in refrigerator. 
Do not freeze. 
Store in the original package 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 

 
Dispose of in accordance with local requirements. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Ology Bioservices Ireland LTD 
Wilton Park House 
Wilton Place 
Dublin 2 
D02P447 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/12/752/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 



33 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL FOR 10-DOSE VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
VEPACEL suspension for injection 
Prepandemic influenza vaccine (H5N1) 
I.M. 
 
 
2. METHOD OF ADMINISTRATION 
 
Shake before use 
 
 
3. EXPIRY DATE 
 
EXP 
After first opening, use immediately (within 3 hours max) 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
Multidose vial (10 doses of 0.5 ml) 
 
 
6. OTHER 
 



34 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL - SINGLE DOSE PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
VEPACEL suspension for injection 
Prepandemic influenza vaccine (H5N1) 
I.M. 
 
 
2. METHOD OF ADMINISTRATION 
 
Shake before use 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
Pre-filled  syringe (0.5ml) 
 
 
6. OTHER 
 



35 

MINIMUM PARTICULARS ATTACHED TO THE OUTER CARTON OF MULTIDOSE 
CONTAINER AND PRE-FILLED SYRINGE 
 
PEEL OFF´S (1 PEEL OFF PER DOSIS) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
VEPACEL 
 
 
2. ACTIVE SUBSTANCE 
 
A/Vietnam/1203/2004 (H5N1) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Ology Bioservices Ireland Ltd Logo 
 



36 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



37 

Package leaflet: Information for the user 
VEPACEL suspension for injection 

Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) 
 

 This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 

 
Read all of this leaflet carefully before you receive this vaccine 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 nurse. 
- If you get any of the side effects, talk to your doctor or nurse. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet: 
 
1. What VEPACEL is and what it is used for 
2. What you need to know before you receive VEPACEL 
3. How VEPACEL is given 
4. Possible side effects 
5. How to store VEPACEL 
6. Contents of the pack and other information 
 
 
1. What VEPACEL is and what it is used for 
 
VEPACEL is a vaccine for use in individuals aged 6 months and older. It is intended to be given 
before the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus. 
 
Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly around 
the world. The symptoms of pandemic flu are similar to those of an ordinary flu but are usually more 
severe. 
 
When a person is given the vaccine, the immune system (the body’s natural defence system) will 
produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can 
cause flu. 
 
As with all vaccines, VEPACEL may not fully protect all persons who are vaccinated. 
 
 
2. What you need to know before you receive VEPACEL 
 
You should not receive VEPACEL 
 
- if you have previously had a severe allergic reaction to any ingredient of VEPACEL (these are 

listed at the end of the leaflet – section 6) or to any substances that may be present in trace (very 
low) amounts: formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein. 
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the 
face or tongue. However, in a pandemic situation, it may be appropriate for you to have the 
vaccine, provided that appropriate medical treatment is immediately available in case of an 
allergic reaction. 

 
If you are not sure, talk to your doctor or nurse before having this vaccine. 
 



38 

Warnings and precautions 
 
You should tell your doctor before vaccination: 
- if you have a severe infection with a high temperature (over 38°C). If this applies to you then 

your vaccination will usually be postponed until you are feeling better. A minor infection such 
as a cold should not be problem, but your doctor should advise whether you could still be 
vaccinated with VEPACEL. 

- if you have had any allergic reaction to any ingredient of the vaccine (see section 6 at the end of 
the leaflet) or trace residues (formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein). 
Allergic reactions, including sudden life-threatening allergic reactions (anaphylaxis) have been 
reported following use of a similar vaccine for H1N1 influenza during a pandemic period. Such 
reactions have occurred both in patients with a history of multiple allergies and in patients with 
no known allergy. 

- if you have a weakened immune system as for example because of immunosuppressive therapy, 
e.g. taking of corticosteroids or treatment for cancer. 

- if you have a bleeding problem or bruise easily. 
 
If you need a blood test to look for evidence of infection with certain viruses in the first few weeks 
after vaccination with VEPACEL, the result of the test may not be correct. Tell the doctor requesting 
the test that you have recently received VEPACEL. 
 
The vaccine should never be given into a blood vessel. 
 
In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, 
or may need to be delayed. 
 
Other medicines and VEPACEL 
 
Please tell your doctor or nurse if you are taking, have recently taken or might take any other 
medicines, including medicines obtained without a prescription, or if you have recently received any 
other vaccine. 
 
There is no information on administration of VEPACEL with other vaccines. However, if this cannot 
be avoided, the other vaccine should not be injected into the same arm used for VEPACEL. 
You should be aware that side effects may be intensified. 
 
If you take any medicines that reduce immunity to infections or have any other type of treatment that 
affects the immune system (such as radiotherapy), VEPACEL can still be given but your response to 
the vaccine may be poor. 
 
VEPACEL should not be given at the same time as immunoglobulins. However, if this cannot be 
avoided, the immunoglobulins should not be injected into the same arm used for VEPACEL. 
 
Pregnancy, breast-feeding  
 
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your 
doctor for advice if you should receive VEPACEL. 
 
Driving and using machines 
 
VEPACEL may affect your ability to drive and use machines. 
 
 



39 

3. How VEPACEL is given 
 
Your doctor or nurse will administer the vaccine in accordance with official recommendations. 
The vaccine will be injected into the muscle of the upper arm (deltoid muscle) or upper thigh, 
depending on the muscle mass. The vaccine should never be given into a vein. 
 
Infants, children and adolescents from the age of 6 months to 17 years and adults from the age 
of 18 years: 
One dose of 0.5 ml will be given. A second dose of 0.5 ml should be given after an interval of at least 
three weeks. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
In the clinical studies conducted in adults and older people most side effects were mild in nature and 
short term. The side effects are generally similar to those related to the flu vaccine. There were fewer 
side effects after the second vaccination compared with the first. The most frequently occurring side 
effect was injection- site pain, which was usually mild. 
 
The following side effects have been reported in clinical studies in adults and older people. 
 
Very common (affects more than 1 user in 10): 
• pain at the injection site 
• fatigue (feeling tired) 
• headache 
 
Common (affects 1 to 10 users in 100): 
• runny nose and sore throat 
• vertigo (a spinning sensation) 
• pain in mouth and throat 
• cough 
• diarrhoea 
• increased sweating 
• itching 
• pain in joint or muscle 
• fever 
• chills 
• malaise (generally feeling unwell) 
• hardness, redness, swelling or bruising at the injection site 
• abnormal, reduced sensation 
 
Uncommon (affects 1 to 10 users in 1,000): 
• swollen glands 
• insomnia (difficulty sleeping) 
• dizziness 
• sleepiness 
• conjunctivitis (an inflammation of the eye), eye irritation 
• ear pain 
• reduced blood pressure, feeling faint (syncope) 
• shortness of breath  
• stuffy or runny nose 
• dry throat 
• vomiting 



40 

• feeling sick  
• stomach pain, upset stomach 
• rash, hives 
• chest discomfort 
• flu-like illness 
• injection-site reaction such as irritation, itching, bruising or stiff arm 
• sudden hearing loss 
 
In the clinical studies conducted in infants, children and adolescents, the incidence and nature of 
symptoms after the first and second vaccination were similar to those occurred in adults and older 
people. 
 
a) The following side effects have been reported in a clinical study in infants aged 6 to 35 months. 
 
Very common (affects more than 1 user in 10): 
• sleepiness 
• pain at the injection site 
• fever 
• irritability 
 
Common (affects 1 to 10 users in 100): 
• runny nose and sore throat 
• decreased appetite 
• sleep disorder 
• crying 
• feeling sick 
• vomiting 
• diarrhoea 
• increased sweating 
• hardness, redness, swelling or bruising at the injection site 
 
b) The following side effects have been reported in clinical studies in children aged 3 to 8 years. 
 
Very common (affects more than 1 user in 10): 
• pain at the injection site 
 
Common (affects 1 to 10 users in 100): 
• runny nose and sore throat 
• headache 
• pain in mouth and throat 
• feeling sick 
• vomiting 
• pain in joint or muscle 
• hardness, redness, swelling or bruising at the injection site 
• fatigue (feeling tired) 
• fever 
• malaise 
 
Uncommon (affects 1 to 10 users in 1,000): 
• decreased appetite 
• eye irritation 
• cough 
• runny nose  
• diarrhoea 
• increased sweating 



41 

• itching where the injection was given 
• pain in the armpit  
• feeling cold 

 
c) The following side effects have been reported in clinical studies in adolescents aged 9 to 17 years. 

 
Very common (affects more than 1 user in 10): 
• headache 
• pain at the injection site 

 
Common (affects 1 to 10 users in 100): 
• runny nose and sore throat 
• pain in mouth and throat 
• stomach pain 
• feeling sick 
• vomiting 
• increased sweating 
• pain in joint or muscle 
• hardness, redness or swelling at the injection site 
• fatigue (feeling tired) 
• chills 
• malaise 
 
Uncommon (affects 1 to 10 users in 1,000): 
• decreased appetite 
• insomnia (difficulty sleeping) 
• dizziness 
• abnormal, reduced sensation  
• vertigo (a spinning sensation) 
• cough 
• runny nose  
• diarrhoea 
• itching 
• pain in extremity 
• bruising at the injection site 
• itching where the injection was given 
• pain in the armpit  
• fever 
• feeling cold 
 
There are no post-marketing data available for VEPACEL. 
 
Side effects observed with a similar influenza vaccine (Celvapan) 
The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and 
children during the H1N1 pandemic flu vaccination programme: 
• allergic reactions, including anaphylactic reactions leading to a dangerous decrease in blood 

pressure which, if untreated, may lead to shock 
• fits due to fever 
• pain in arms and/or legs (in the majority of cases reported as pain in the vaccination arm) 
• swelling of tissue just below the skin 
 
Side effects observed with flu vaccines given routinely every year 
In the days or weeks after vaccination with vaccines given routinely every year to prevent flu, the side 
effects listed below have occurred. These side effects may occur with VEPACEL. 
 



42 

Uncommon (affects 1 to 10 users in 1,000): 
• generalised skin reactions including urticaria (hives) 
 
Rare (affects 1 to 10 users in 10,000): 
• allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, 

may lead to shock. Doctors are aware of this possibility and have emergency treatment available 
for use in such cases. 

• severe stabbing or throbbing pain along one or more nerves 
• low blood platelet count which can result in bleeding or bruising 
 
Very rare (affects less than 1 user in 10,000): 
• vasculitis (inflammation of blood vessels which can cause skin rashes, joint pain and kidney 

problems) 
• neurological disorders such as encephalomyelitis (inflammation of the central nervous system), 

neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome 
 
Reporting of side effects 
If you get any side effects talk to your doctor or nurse. 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 VEPACEL 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and the label. The expiry 
date refers to the last day of that month. 
 
Store in a refrigerator (2°C - 8°C). 
Store in the original package in order to protect from light. 
Do not freeze. 
 
After first opening, the vaccine should be used immediately (within a maximum period of 3 hours). 
 
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 VEPACEL contains 
 
- The active substance is: 
 1 dose (0.5 ml) contains: 

Influenza virus (whole virion, inactivated), containing antigen of*strain: 
A/Vietnam/1203/2004 (H5N1) 7.5 micrograms**  
* produced in Vero cells  
** haemagglutinin  

 
- The other ingredients are 

Trometamol 
Sodium chloride 
Water for injections 
Polysorbate 80. 

 

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


43 

What VEPACEL looks like and contents of the pack 
 
VEPACEL is presented as a suspension for injection in multidose vial (10 doses of 0.5 ml per vial) in 
pack size of 20 vials. 
 
The suspension is clear to opalescent. 
 
Marketing Authorisation Holder 
 
Ology Bioservices Ireland LTD 
Wilton Park House 
Wilton Place 
Dublin 2 
D02P447 
Ireland 
 
Manufacturer 
 
Baxter AG 
Uferstrasse 15 
A-2304 Orth/Donau 
Austria 
 
 
This leaflet was last revised in  
 
Detailed information on this medicine is available on the European Medicines Agency (EMA) 
web site: http://www.ema.europa.eu/. 
 
--------------------------------------------------------------------------------------------------------------------------- 
 
The following information is intended for healthcare professionals only: 
 
Multidose vial (10 doses of 0.5 ml per vial) 
 
The vaccine should be allowed to reach room temperature before use. Shake before use. 
 
After shaking, the vaccine is a clear to opalescent suspension. 
Prior to administration, visually inspect the suspension for any foreign particulate matter and/or 
abnormal physical appearance. In the event of either being observed, discard the vaccine. 
 
The vaccine should not be administered intravascularly. 
 
Any unused vaccine or waste material should be disposed of in accordance with local requirements. 
 
After first opening, the vial is to be used within a maximum of 3 hours. 
 
Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection. 
 



44 

Package leaflet: Information for the user 
VEPACEL suspension for injection 

Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) 
 

 This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 

 
Read all of this leaflet carefully before you receive this vaccine 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 nurse. 
- If you get any of the side effects, talk to your doctor or nurse. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet: 
 
1. What VEPACEL is and what it is used for 
2. What you need to know before you receive VEPACEL 
3. How VEPACEL is given 
4. Possible side effects 
5. How to store VEPACEL 
6. Contents of the pack and other information 
 
 
1. What VEPACEL is and what it is used for 
 
VEPACEL is a vaccine for use in individuals aged 6 months and older. It is intended to be given 
before the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus. 
 
Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly around 
the world. The symptoms of pandemic flu are similar to those of an ordinary flu but are usually more 
severe. 
 
When a person is given the vaccine, the immune system (the body’s natural defence system) will 
produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can 
cause flu. 
 
As with all vaccines, VEPACEL may not fully protect all persons who are vaccinated. 
 
 
2. What you need to know before you receive VEPACEL 
 
You should not receive VEPACEL 
 
- if you have previously had a severe allergic reaction to any ingredient of VEPACEL (these are 

listed at the end of the leaflet – section 6) or to any substances that may be present in trace (very 
low) amounts: formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein. 
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the 
face or tongue. However, in a pandemic situation, it may be appropriate for you to have the 
vaccine, provided that appropriate medical treatment is immediately available in case of an 
allergic reaction. 

 
If you are not sure, talk to your doctor or nurse before having this vaccine. 
 



45 

Warnings and precautions 
 
You should tell your doctor before vaccination: 
- if you have a severe infection with a high temperature (over 38°C). If this applies to you then 

your vaccination will usually be postponed until you are feeling better. A minor infection such 
as a cold should not be problem, but your doctor should advise whether you could still be 
vaccinated with VEPACEL. 

- if you have had any allergic reaction to any ingredient of the vaccine (see section 6 at the end of 
the leaflet) or trace residues (formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein). 
Allergic reactions, including sudden life-threatening allergic reactions (anaphylaxis) have been 
reported following use of a similar vaccine for H1N1 influenza during a pandemic period. Such 
reactions have occurred both in patients with a history of multiple allergies and in patients with 
no known allergy. 

- if you have a weakened immune system as for example because of immunosuppressive therapy, 
e.g. taking of corticosteroids or treatment for cancer. 

- if you have a bleeding problem or bruise easily. 
 
If you need a blood test to look for evidence of infection with certain viruses in the first few weeks 
after vaccination with VEPACEL, the result of the test may not be correct. Tell the doctor requesting 
the test that you have recently received VEPACEL. 
 
The vaccine should never be given into a blood vessel. 
There is no information on the use of VEPACEL under the skin. 
 
In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, 
or may need to be delayed. 
 
Other medicines and VEPACEL 
 
Please tell your doctor or nurse if you are taking, have recently taken or might take any other 
medicines, including medicines obtained without a prescription, or if you have recently received any 
other vaccine. 
 
There is no information on administration of VEPACEL with other vaccines. However, if this cannot 
be avoided, the other vaccine should not be injected into the same arm used for VEPACEL. 
You should be aware that side effects may be intensified. 
 
If you take any medicines that reduce immunity to infections or have any other type of treatment that 
affects the immune system (such as radiotherapy), VEPACEL can still be given but your response to 
the vaccine may be poor. 
 
VEPACEL should not be given at the same time as immunoglobulins. However, if this cannot be 
avoided, the immunoglobulins should not be injected into the same arm used for VEPACEL. 
 
Pregnancy, breast-feeding and fertility 
 
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your 
doctor for advice  if you should receive VEPACEL. 
 
Driving and using machines 
 
VEPACEL may affect your ability to drive and use machines. 
 
 



46 

3. How VEPACEL is given 
 
Your doctor or nurse will administer the vaccine in accordance with official recommendations. 
The vaccine will be injected into the muscle of the upper arm (deltoid muscle) or upper thigh, 
depending on the muscle mass. The vaccine should never be given into a vein. 
 
Infants, children and adolescents from the age of 6 months to 17 years and adults from the age 
of 18 years: 
One dose of 0.5 ml will be given. A second dose of 0.5 ml should be given after an interval of at least 
three weeks. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
In the clinical studies conducted in adults and older people most side effects were mild in nature and 
short term. The side effects are generally similar to those related to the flu vaccine. There were fewer 
side effects after the second vaccination compared with the first. The most frequently occurring side 
effect was injection- site pain, which was usually mild. 
 
The following side effects have been reported in clinical studies in adults and older people 
 
Very common (affects more than 1 user in 10): 
• pain at the injection site 
• fatigue (feeling tired) 
• headache 
 
Common (affects 1 to 10 users in 100): 
• runny nose and sore throat 
• vertigo (a spinning sensation) 
• pain in mouth and throat 
• cough 
• diarrhoea 
• increased sweating 
• itching 
• pain in joint or muscle 
• fever 
• chills 
• malaise (generally feeling unwell) 
• hardness, redness, swelling or bruising at the injection site 
• abnormal, reduced sensation 
 
Uncommon (affects 1 to 10 users in 1,000): 
• swollen glands 
• insomnia (difficulty sleeping) 
• dizziness 
• sleepiness 
• conjunctivitis (an inflammation of the eye), eye irritation 
• ear pain 
• reduced blood pressure, feeling faint (syncope) 
• shortness of breath 
• stuffy nose 
• dry throat 
• vomiting 



47 

• feeling sick 
• stomach pain, upset stomach 
• rash, hives 
• chest discomfort 
• flu-like illness 
• injection-site reaction such as irritation, itching, bruising or stiff arm 
• sudden hearing loss 
 
In the clinical studies conducted in infants, children and adolescents, the incidence and nature of 
symptoms after the first and second vaccination were similar to those occurred in adults or older 
people. 
 
a) The following side effects have been reported in a clinical study in infants aged 6 to 35 months. 
 
Very common (affects more than 1 user in 10): 
• sleepiness 
• pain at the injection site 
• fever 
• irritability 
 
Common (affects 1 to 10 users in 100): 
• runny nose and sore throat 
• decreased appetite 
• sleep disorder 
• crying 
• feeling sick 
• vomiting 
• diarrhoea 
• increased sweating 
• hardness, redness, swelling or bruising at the injection site 
 
b) The following side effects have been reported in clinical studies in children aged 3 to 8 years. 
 
Very common (affects more than 1 user in 10): 
• pain at the injection site 
 
Common (affects 1 to 10 users in 100): 
• runny nose and sore throat 
• headache 
• pain in mouth and throat 
• feeling sick 
• vomiting  
• pain in joint or muscle 
• hardness, redness, swelling or bruising at the injection site 
• fever 
• malaise 
• fatigue (feeling tired) 
 
Uncommon (affects 1 to 10 users in 1,000): 
• decreased appetite 
• eye irritation 
• cough 
• runny nose  
• diarrhoea 
• increased sweating 



48 

• itching where the injection was given 
• pain in the armpit  
• feeling cold 

 
c) The following side effects have been reported in clinical studies in adolescents aged 9 to 17 years. 

 
Very common (affects more than 1 user in 10): 
• headache 
• pain at the injection site 

 
Common (affects 1 to 10 users in 100): 
• runny nose and sore throat 
• pain in mouth and throat 
• stomach pain 
• feeling sick 
• vomiting  
• increased sweating 
• pain in joint or muscle 
• hardness, redness or swelling at the injection site 
• fatigue (feeling tired) 
• chills 
• malaise 
 
Uncommon (affects 1 to 10 users in 1,000): 
• decreased appetite 
• insomnia (difficulty sleeping) 
• dizziness 
• abnormal, reduced sensation  
• vertigo (a spinning sensation) 
• cough 
• runny nose  
• diarrhoea 
• itching 
• pain in extremity 
• bruising at the injection site 
• itching where the injection was given 
• pain in the armpit  
• fever 
• feeling cold 
 
There are no post-marketing data available for VEPACEL. 
 
Side effects observed with a similar influenza vaccine (Celvapan) 
The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and 
children during the H1N1 pandemic flu vaccination programme: 
• allergic reactions, including anaphylactic reactions leading to a dangerous decrease in blood 

pressure which, if untreated, may lead to shock 
• fits due to fever 
• pain in arms and/or legs (in the majority of cases reported as pain in the vaccination arm) 
• swelling of tissue just below the skin 
 
Side effects observed with flu vaccines given routinely every year 
In the days or weeks after vaccination with vaccines given routinely every year to prevent flu, the side 
effects listed below have occurred. These side effects may occur with VEPACEL. 
 



49 

Uncommon (affects 1 to 10 users in 1,000): 
• generalised skin reactions including urticaria (hives) 
 
Rare (affects 1 to 10 users in 10,000): 
• allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, 

may lead to shock. Doctors are aware of this possibility and have emergency treatment available 
for use in such cases. 

• severe stabbing or throbbing pain along one or more nerves 
• low blood platelet count which can result in bleeding or bruising 
 
Very rare (affects less than 1 user in 10,000): 
• vasculitis (inflammation of blood vessels which can cause skin rashes, joint pain and kidney 

problems) 
• neurological disorders such as encephalomyelitis (inflammation of the central nervous system), 

neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome 
 
Reporting of side effects 
If you get any side effects talk to your doctor or nurse. 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 VEPACEL 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and the label. The expiry 
date refers to the last day of that month. 
 
Store in a refrigerator (2°C - 8°C). 
Store in the original package in order to protect from light. 
Do not freeze. 
 
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 VEPACEL contains 
 
- The active substance is: 
 1 dose (0.5 ml) contains: 

Influenza virus (whole virion, inactivated), containing antigen of*strain : 
A/Vietnam/1203/2004 (H5N1) 7.5 micrograms**  
* produced in Vero cells  
** haemagglutinin  

 
- The other ingredients are 

Trometamol 
Sodium chloride 
Water for injections 
Polysorbate 80. 

 

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


50 

What VEPACEL looks like and contents of the pack 
 
VEPACEL is presented as a suspension for injection in a pre-filled syringe. 
 
1 pack of a pre-filled syringe containing a single dose of 0.5 ml suspension for injection with 
a latex-free plunger (halogeno-butyl-rubber) without needles. 
 
The suspension is clear to opalescent. 
 
Marketing Authorisation Holder 
 
Ology Bioservices Ireland LTD 
Wilton Park House 
Wilton Place 
Dublin 2 
D02P447 
Ireland 
 
Manufacturer 
 
Baxter AG 
Uferstrasse 15 
A-2304 Orth/Donau 
Austria 
 
 
This leaflet was last revised in May 2015 
 
Detailed information on this medicine is available on the European Medicines Agency (EMA) 
web site: http://www.ema.europa.eu/. 
 
--------------------------------------------------------------------------------------------------------------------------- 
 
The following information is intended for healthcare professionals only: 
 
The vaccine should be allowed to reach room temperature before use. Shake before use. 
 
After shaking, the vaccine is a clear to opalescent suspension. 
 
Prior to administration, visually inspect the suspension for any foreign particulate matter and/or 
abnormal physical appearance. In the event of either being observed, discard the vaccine. 
 
The vaccine should not be administered intravascularly. 
 
Any unused vaccine or waste material should be disposed of in accordance with local requirements. 
 
After removing the syringe cap, attach the needle immediately and remove the needle shield prior to 
administration. 
 
Once the needle is attached, the vaccine must be administered immediately. 
 


	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