Pandemic Influenza Vaccine H5N1 Baxter AG

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
Suspension for injection 
Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Influenza vaccine (whole virion, inactivated) containing antigen * of: 
A/Vietnam/1203/2004 (H5N1) 7.5 micrograms**per 
0.5 ml dose 
 
* produced in Vero cells 
** haemagglutinin 
 
This vaccine complies with the WHO recommendation and EU decision for the pandemic. 
 
The vaccine is available in 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. 
The vaccine is an off-white, opalescent, translucent suspension. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine 
should be used in accordance with official guidance. 
 
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 vaccine should be given after an interval of at least 3 weeks. 
 
Method of administration 
Immunization should be carried out by intramuscular injection into the deltoid muscle or anterolateral 
thigh, depending on the muscle mass. 
 
For further information, see section 5.1. 
 
4.3 Contraindications 
 
History of an anaphylactic (i.e. life-threatening) reaction to the active substance, to any of the 
excipients listed in section 6.1 or to trace residues (e.g. formaldehyde, benzonase, sucrose) of this 
vaccine. However, in a pandemic situation, it may be appropriate to give the vaccine, provided that 
facilities for resuscitation are immediately available in case of need. 
 



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See section 4.4. 
 
4.4 Special warnings and precautions for use 
 

• 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 occurred both in patients with a history of multiple 
allergies and in patients with no known allergy. 

 
• Caution is needed when administering this vaccine to persons with a known 

hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the 
excipients and to trace residues e.g. formaldehyde, benzonase, or sucrose. 

 
• 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. 

 
• If the pandemic situation allows, immunisation shall be postponed in patients with severe 

febrile illness or acute infection. 
 
• PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should under no circumstances 

be administered intravascularly. 
 
• There are no data with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 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 bleedings. 

 
• Antibody response in patients with endogenous or iatrogenic immunosuppression may 

be insufficient. 
 
• A protective response may not be induced in all vaccinees (see section 5.1). 

 
4.5 Interactions with other medicinal products and other forms of interaction 
 

• PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same 
time as 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 PANDEMIC INFLUENZA VACCINE 

H5N1 BAXTER. If it is necessary to provide immediate protection, PANDEMIC 
INFLUENZA VACCINE H5N1 BAXTER may be given at the same time as normal 
or specific immunoglobulin. Injections of PANDEMIC INFLUENZA VACCINE 
H5N1 BAXTER and immunoglobulin should be made into separate limbs. 

 
• The immunological response may be diminished if the patient is undergoing 

immunosuppressant treatment. 
 
• Following influenza vaccination, false positive results in serology tests using the ELISA 

method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been 
observed. The Western Blot technique disproves the results. The transient false positive 
reactions could be due to the IgM response by the vaccine. 

 



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4.6 Fertility, pregnancy and lactation 
 
The safety of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER in pregnancy and lactation has 
not been assessed in clinical trials. Data from pregnant women vaccinated with different inactivated 
non-adjuvanted seasonal vaccines do not suggest malformations or foetal or neonatal toxicity. 
 
Animal reproductive and developmental toxicity 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 female fertility, pregnancy, embryonal/foetal development, parturition or post-natal 
development (see section 5.3). 
 
The use of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may be considered during 
pregnancy if this is thought to be necessary, taking into account official recommendations. 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may be used in lactating women. 
 
Health care providers should carefully consider the potential risks and benefits for each specific 
patient before administering PANDEMIC INFLUENZA VACCINE H5N1 BAXTER. 
 
4.7 Effects on ability to drive and use machines 
 
Some undesirable effects mentioned under section 4.8 such as dizziness and vertigo may affect the 
ability to drive or use machines. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
 
Adults, older people and special risk groups 
 
Clinical trials were conducted with this H5N1 vaccine (see section 5.1 for more information on 
the H5N1 vaccines) in approximately 3500 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 safety profile in immunocompromised subjects and patients with chronic disease conditions is 
similar to the safety profile in healthy adults and older subjects. 
 
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 subjects. 
 
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. 
 
Adverse reactions are listed according to the following frequency below. 
 
Summary of adverse reactions 
 
Very common (≥1/10) 
Common (≥1/100 to <1/10) 
Uncommon (≥1/1,000 to <1/100) 
Rare (≥1/10,000 to <1/1,000) 
Very rare (<1/10,000) 
Not known (cannot be estimated from the available data) 



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Adults and older people: 
 

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 

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 

 



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Infants, children and adolescents: 
 

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 

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 
For PANDEMIC INFLUENZA VACCINE H5N1 BAXTER post-marketing surveillance data are not 
yet available. 
 
Class effects: 
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 
 



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Nervous system disorders: convulsion 
 
Skin and subcutaneous tissue disorders: angioedema 
 
Musculoskeletal 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 
 
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. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER has been authorised under ‘exceptional 
circumstances’. This means that for scientific reasons, it has not been possible to obtain complete 
information on this medicinal product. The European Medicines Agency (EMA) will review any new 
information which may become available every year and this SmPC will be updated as necessary. 
 
This section describes the clinical experience with the mock-up vaccine following a two-dose 
administration. 
 
Mock-up 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 mock-up 
vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical 
immunogenicity, safety and reactogenicity data obtained with mock-up vaccines are relevant for the 
pandemic vaccines. 
 
Adults, older people and special risk groups 
 
Immune response against the vaccine strain contained in PANDEMIC INFLUENZA VACCINE 
H5N1 BAXTER (A/Vietnam/1203/2004) 
 
The immunogenicity of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (strain 
A/Vietnam/1203/2004) has been evaluated in three clinical studies in adults aged 18 – 59 years 
(N=961) and in older subjects aged 60 years and older (N=391) following a 0, 21 day schedule. 

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


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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 seroprotection rate, seroconversion rate and seroconversion factor for 
anti-HA antibody as measured by single radial haemolysis (SRH) in adults aged 18 to 59 years and in 
older subjects aged 60 years and above were as follows: 
 

SRH Assay 18 – 59 years 60 years and above 
 21 Days After 21 Days After 
 1st Dose 2nd Dose 1st Dose 2nd Dose 
Seroprotection rate* 53.2%  66.8% 47.7% 59.0% 
Seroconversion rate** 39.8% 53.7% 41.9% 52.2% 
Seroconversion factor*** 2.5 3.4 2.7 3.5 
* SRH area ≥ 25 mm² 
** either SRH area ≥ 25 mm2 if baseline sample negative or 50% increase in SRH area if baseline 

sample > 4 mm² 
*** geometric mean increase 
 
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 subjects aged 60 years and above were as follows: 
 

Microneutralisation assay 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 in 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: 
 

Microneutralisation Assay 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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Antibody persistence 
Antibody persistence after vaccination with the 7.5 µg non-adjuvanted formulation of 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (strain A/Vietnam/1203/2004) has been 
evaluated in a clinical study in adults aged 18 – 59 years and subjects aged 60 years and above 
at 6 months, 12 - 15 months and 24 months after the start of the primary vaccination series. 
The results indicate an overall decline in antibody levels over time. 
 

Seroprotection*/ 18 – 59 years 60 years and above 
Seroneutralisation rate** SRH Assay MN Assay SRH Assay MN Assay 

Month 6 23.9% 35.0% 26.7% 40.5% 
Month 12-15 20.7% 34.2% 18.9% 36.2% 
Month 24 22.4% 18.4% 12.3% 22.8% 
* SRH area ≥ 25 mm² 
** MN titre ≥ 20 
 
Cross-reactive immune response against related H5N1 strains 
In a phase 3 study in adults (N=270) and older subjects (N=272) 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 
 Day 42 a Day 180 Day 42 a Day 180 

Tested against Strain A/Indonesia/05/2005 
Seroneutralisation rate* 35.1% 14.4% 54.8% 28.0% 
* MN titre ≥ 20 
a 21 days after 2nd dose 
 
Heterologous booster vaccinations 
A booster vaccination with a 7.5 µg heterologous A/Indonesia/05/2005 vaccine strain has been 
administered in a time window 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 
 
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. 
 



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After vaccination, the seroprotection rate, seroconversion rate, and seroconversion factor for anti-HA 
antibody, as measured by SRH, in, infants, children, and adolescents aged 6 months to 17 years were 
as follows: 
 

SRH 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 
Seroprotection rate* 63.8% 75.1% 46.1% 75.4% 13.8% 63.0% 
Seroconversion rate** 48.4% 63.5% 43.3% 78.3% 13.8% 77.8% 
Seroconversion factor*** 3.3 4.7 2.9 5.9 1.4 4.6 
* SRH area ≥ 25 mm2 

** either SRH area ≥ 25 mm2 if baseline sample negative or 50% increase in SRH area if baseline 
sample >4 mm² 

*** geometric mean increase 
 
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). 
 
Seroprotection rates (SRH area ≥ 25 mm²) at 21 days after a 12 months booster vaccination with 
the 7.5 mcg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and 
heterologous strains, were as follows: 
 
Seroprotection 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 81.6% 86.2% 87.5% 86.1% 96.0% 96.0% 
* SRH area ≥ 25 mm² 
 
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 PANDEMIC INFLUENZA VACCINE H5N1 BAXTER against morbidity 
and mortality induced by the infection with lethal doses of highly pathogenic avian Influenza 



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H5N1 virus was assessed non-clinically in a ferret challenge model. Two studies have been 
performed using either the H5N1 A/Vietnam/1203/2004 or the A/Indonesia/05/2005 vaccine. 
 
In one study, 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 survivorship, 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. 
 
In a second study, sixty-six ferrets were divided into 6 cohorts of 11 ferrets and were immunized on 
days 0 and 21 with 3.75 µg or 7.5 µg of the Indonesia vaccine or were sham vaccinated. The ferrets 
were challenged intranasally on day 35 with a high dose of either the clade 2 H5N1 virus 
A/Indonesia/05/2005 or the clade 1 H5N1 virus A/Vietnam/1203/2004 and monitored for 14 days. 
The A/lndonesia/05/2005 vaccine was shown to be efficacious with 100% survival, reduced incidence 
of fever, reduced weight loss, reduced virus burden, and reduced haematological (leukopenia and 
lymphopenia) changes in the vaccinated cohorts following homologous challenge. Similarly, the 
A/lndonesia/05/2005 vaccine was efficacious against a heterologous challenge, showing a vaccine 
dose-dependent survivorship in the vaccinated cohorts as compared to the control cohort. Similar to 
the homologous challenge, vaccination against a heterologous challenge reduced virus burden, and 
reduced haematological (leukopenia) changes associated with highly pathogenic avian influenza 
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. 
 
Animal reproductive and developmental toxicity studies do not indicate direct or indirect harmful 
effects with respect to female fertility, pregnancy, embryonal/ foetal development parturition or post 
natal development. Male fertility was not investigated in the reproductive and developmental toxicity 
studies, however there were no findings in the repeat-dose toxicity studies to indicate any 
vaccine-related changes to the tissues of the male reproductive tract. 
 
 
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. 



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6.3 Shelf life 
 
1 year 
 
After first opening, the medicinal product 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 - 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. 
After shaking, the vaccine is an off-white, opalescent, translucent 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. 
 
Each vaccine 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 AUTHORIZATION HOLDER 
 
Ology Bioservices Ireland LTD 
Wilton Park House 
Wilton Place 
Dublin 2 
D02P447 
Ireland 
 
 
8. MARKETING AUTHORISATION NUMBER 
 
EU/1/09/571/001 
 
 
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 16 October 2009 
 
 



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10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this product is available on the website of the European Medicines Agency 
(EMA): http://www.ema.europa.eu/ 
 
DD/MM/YYYY 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
Suspension for injection 
Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Influenza vaccine (whole virion, inactivated) containing antigen* of: 
A/Vietnam/1203/2004 (H5N1) 7.5 micrograms**per 
0.5 ml dose 
 
* produced in Vero cells 
** haemagglutinin 
 
This vaccine complies with the WHO recommendation and EU decision for the pandemic. 
 
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. 
The vaccine is an off-white, opalescent, translucent suspension. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine 
should be used in accordance with official guidance. 
 
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. 
 
Method of administration 
Immunization should be carried out by intramuscular injection into the deltoid muscle or anterolateral 
thigh, depending on the muscle mass. 
 
For further information, see section 5.1. 
 
4.3 Contraindications 
 
History of an anaphylactic (i.e. life-threatening) reaction to the active substance, to any of the 
excipients listed in section 6.1 or to trace residues (e.g. formaldehyde, benzonase, sucrose) of this 
vaccine. However, in a pandemic situation, it may be appropriate to give the vaccine, provided that 
facilities for resuscitation are immediately available in case of need. 
 



15 

See section 4.4. 
 
4.4 Special warnings and precautions for use 
 

• 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 occurred both in patients with a history of multiple 
allergies and in patients with no known allergy. 

 
• Caution is needed when administering this vaccine to persons with a known 

hypersensitivity (other than anaphylactic reaction) to the active substance, to any 
of the excipients and to trace residues e.g. formaldehyde, benzonase, or sucrose. 

 
• 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. 

 
• If the pandemic situation allows, immunisation shall be postponed in patients with severe 

febrile illness or acute infection. 
 
• PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should under no circumstances 

be administered intravascularly. 
 
• There are no data with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 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 bleedings. 

 
• Antibody response in patients with endogenous or iatrogenic immunosuppression may be 

insufficient. 
 
• A protective response may not be induced in all vaccinees (see section 5.1). 

 
4.5 Interactions with other medicinal products and other forms of interaction 
 

• PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same 
time as 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 PANDEMIC INFLUENZA VACCINE 

H5N1 BAXTER. If it is necessary to provide immediate protection, PANDEMIC 
INFLUENZA VACCINE H5N1 BAXTER may be given at the same time as normal or 
specific immunoglobulin. Injections of PANDEMIC INFLUENZA VACCINE 
H5N1 BAXTER and immunoglobulin should be made into separate limbs. 

 
• The immunological response may be diminished if the patient is undergoing 

immunosuppressant treatment. 
 
• Following influenza vaccination, false positive results in serology tests using the ELISA 

method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been 
observed. The Western Blot technique disproves the results. The transient false positive 
reactions could be due to the IgM response by the vaccine. 

 



16 

4.6 Fertility, pregnancy and lactation 
 
The safety of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER in pregnancy and lactation has 
not been assessed in clinical trials. Data from pregnant women vaccinated with different inactivated 
non-adjuvanted seasonal vaccines do not suggest malformations or foetal or neonatal toxicity. 
 
Animal reproductive and developmental toxicity 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 female fertility, pregnancy, embryonal/foetal development, parturition or post-natal 
development (see section 5.3). 
 
The use of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may be considered during 
pregnancy if this is thought to be necessary, taking into account official recommendations. 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may be used in lactating women. 
 
Health care providers should carefully consider the potential risks and benefits for each specific 
patient before administering PANDEMIC INFLUENZA VACCINE H5N1 BAXTER. 
 
4.7 Effects on ability to drive and use machines 
 
Some undesirable effects mentioned under section 4.8 such as dizziness and vertigo may affect the 
ability to drive or use machines. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
 
Adults, older people and special risk groups 
 
Clinical trials were conducted with this H5N1 vaccine (see section 5.1 for more information on 
the H5N1 vaccines) in approximately 3500 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 safety profile in immunocompromised subjects and patients with chronic disease conditions 
is similar to the safety profile in healthy adults and older people subjects. 
 
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 subjects. 
 
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. 
 
Adverse reactions are listed according to the following frequency below. 
 
Summary of adverse reactions 
 
Very common (≥1/10) 
Common (≥1/100 to <1/10) 
Uncommon (≥1/1,000 to <1/100) 
Rare (≥1/10,000 to <1/1,000) 
Very rare (<1/10,000) 
Not known (cannot be estimated from the available data) 



17 

 
Adults and older people: 
 

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 

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 

 



18 

Infants, children and adolescents: 
 

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 

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 
For PANDEMIC INFLUENZA VACCINE H5N1 BAXTER post-marketing surveillance data are not 
yet available. 
 
Class effects: 
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 
 



19 

Nervous system disorders: convulsion 
 
Skin and subcutaneous tissue disorders: angioedema 
 
Musculoskeletal 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 
 
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. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER has been authorised under ‘exceptional 
circumstances’. This means that for scientific reasons, it has not been possible to obtain complete 
information on this medicinal product. The European Medicines Agency (EMA) will review any new 
information which may become available every year and this SmPC will be updated as necessary. 
 
This section describes the clinical experience with the mock-up vaccine following a two-dose 
administration. 
 
Mock-up 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 mock-up 
vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical 
immunogenicity, safety and reactogenicity data obtained with mock-up vaccines are relevant for the 
pandemic vaccines. 
 
Adults, older people and special risk groups 
 
Immune response against the vaccine strain contained in PANDEMIC INFLUENZA VACCINE 
H5N1 BAXTER (A/Vietnam/1203/2004) 
 
The immunogenicity of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (strain 
A/Vietnam/1203/2004) has been evaluated in three clinical studies in adults aged 18 – 59 years 
(N=961) and in older subjects aged 60 years and older (N=391) following a 0, 21 day schedule. 

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


20 

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 seroprotection rate, seroconversion rate and seroconversion factor for 
anti-HA antibody as measured by single radial haemolysis (SRH) in adults aged 18 to 59 years and in 
older subjects aged 60 years and above were as follows: 
 

SRH Assay 18 – 59 years 60 years and above 
 21 Days After 21 Days After 
 1st Dose 2nd Dose 1st Dose 2nd Dose 
Seroprotection rate* 53.2%  66.8% 47.7% 59.0% 
Seroconversion rate** 39.8% 53.7% 41.9% 52.2% 
Seroconversion factor*** 2.5 3.4 2.7 3.5 
* SRH area ≥ 25 mm² 
** either SRH area ≥ 25 mm2 if baseline sample negative or 50% increase in SRH area if baseline 

sample > 4 mm² 
*** geometric mean increase 
 
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 subjects aged 60 years and above were as follows: 
 

Microneutralisation assay 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 in 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: 
 

Microneutralisation Assay 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 
 



21 

Antibody persistence 
Antibody persistence after vaccination with the 7.5 µg non-adjuvanted formulation of 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (strain A/Vietnam/1203/2004) has been 
evaluated in a clinical study in adults aged 18 – 59 years and subjects aged 60 years and above 
at 6 months, 12 - 15 months and 24 months after the start of the primary vaccination series. 
The results indicate an overall decline in antibody levels over time. 
 

Seroprotection*/ 18 – 59 years 60 years and above 
Seroneutralisation rate** SRH Assay MN Assay SRH Assay MN Assay 

Month 6 23.9% 35.0% 26.7% 40.5% 
Month 12-15 20.7% 34.2% 18.9% 36.2% 
Month 24 22.4% 18.4% 12.3% 22.8% 
* SRH area ≥ 25 mm² 
** MN titre ≥ 20 
 
Cross-reactive immune response against related H5N1 strains 
In a phase 3 study in adults (N=270) and older subjects (N=272) 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 
 Day 42 a Day 180 Day 42 a Day 180 

Tested against Strain A/Indonesia/05/2005 
Seroneutralisation rate* 35.1% 14.4% 54.8% 28.0% 
* MN titre ≥ 20 
a 21 days after 2nd dose 
 
Heterologous booster vaccinations 
A booster vaccination with a 7.5 µg heterologous A/Indonesia/05/2005 vaccine strain has been 
administered in a time window 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 
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 
 
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. 
 



22 

After vaccination, the seroprotection rate, seroconversion rate, and seroconversion factor for anti-HA 
antibody, as measured by SRH, in, infants, children, and adolescents aged 6 months to 17 years were 
as follows: 
 

SRH 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 
Seroprotection rate* 63.8% 75.1% 46.1% 75.4% 13.8% 63.0% 
Seroconversion rate** 48.4% 63.5% 43.3% 78.3% 13.8% 77.8% 
Seroconversion factor*** 3.3 4.7 2.9 5.9 1.4 4.6 
* SRH area ≥ 25 mm2 

** either SRH area ≥ 25 mm2 if baseline sample negative or 50% increase in SRH area if baseline sample 
>4 mm² 

*** geometric mean increase 
 
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). 
 
Seroprotection rates (SRH area ≥ 25 mm²) 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: 
 

Seroprotection 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 81.6% 86.2% 87.5% 86.1% 96.0% 96.0% 
* SRH area ≥ 25 mm² 
 
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 PANDEMIC INFLUENZA VACCINE H5N1 BAXTER against 
morbidity and mortality induced by the infection with lethal doses of highly pathogenic avian 



23 

Influenza H5N1 virus was assessed non-clinically in a ferret challenge model. Two studies have 
been performed using either the H5N1 A/Vietnam/1203/2004 or the A/Indonesia/05/2005 vaccine. 
 
In one study, 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 survivorship, 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. 
 
In a second study, sixty-six ferrets were divided into 6 cohorts of 11 ferrets and were immunized on 
days 0 and 21 with 3.75 µg or 7.5 µg of the Indonesia vaccine or were sham vaccinated. The ferrets 
were challenged intranasally on day 35 with a high dose of either the clade 2 H5N1 virus 
A/Indonesia/05/2005 or the clade 1 H5N1 virus A/Vietnam/1203/2004 and monitored for 14 days. 
The A/lndonesia/05/2005 vaccine was shown to be efficacious with 100% survival, reduced incidence 
of fever, reduced weight loss, reduced virus burden, and reduced haematological (leukopenia and 
lymphopenia) changes in the vaccinated cohorts following homologous challenge. Similarly, the 
A/lndonesia/05/2005 vaccine was efficacious against a heterologous challenge, showing a vaccine 
dose-dependent survivorship in the vaccinated cohorts as compared to the control cohort. Similar to 
the homologous challenge, vaccination against a heterologous challenge reduced virus burden, and 
reduced haematological (leukopenia) changes associated with highly pathogenic avian influenza 
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. 
 
Animal reproductive and developmental toxicity studies do not indicate direct or indirect harmful 
effects with respect to female fertility, pregnancy, embryonal/ foetal development parturition or post 
natal development. Male fertility was not investigated in the reproductive and developmental toxicity 
studies, however there were no findings in the repeat-dose toxicity studies to indicate any 
vaccine-related changes to the tissues of the male reproductive tract. 
 
 
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. 



24 

 
6.3 Shelf life 
 
1 year 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C - 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) with or 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. 
After shaking, the vaccine is an off-white, opalescent, translucent 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. 
 
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 AUTHORIZATION HOLDER 
 
Ology Bioservices Ireland LTD 
Wilton Park House 
Wilton Place 
Dublin 2 
D02P447 
Ireland 
 
 
8. MARKETING AUTHORISATION NUMBER 
 
EU/1/09/571/002 
 
 
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 16 October 2009 
 
 



25 

10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this product is available on the website of the European Medicines Agency 
(EMA): http://www.ema.europa.eu/ 
 
DD/MM/YYYY 



26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE 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 

 
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION 

MEASURES FOR THE MARKETING AUTHORISATION UNDER 
EXCEPTIONAL CIRCUMSTANCES 

 
 



27 

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

 
Name and address of the manufacturers of the biological active substance 
 
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 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. 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER can only be marketed when there is 
an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing 
Authorisation Holder for PANDEMIC INFLUENZA VACCINE H5N1 BAXTER takes due account 
of the officially declared pandemic strain. 
 
• Official batch release 
 
In accordance with Article 114 Directive 2001/83/EC as amended, 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. 
 
Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with 
a specific review of AESI. This should include data from ongoing studies, or actual use if applicable, 
of the ‘mock-up’ strains. 
 
During a pandemic situation, the resources must be concentrated on a timely and effective monitoring 
of the safety profile of the influenza vaccines used during the pandemic. Moreover, a 6-monthly cycle 
may be too long to allow assessment of the safety of a vaccine for which high levels of exposure are 
expected within a short period of time. Therefore, 6-monthly or annual PSURs falling within the 
pandemic period will be replaced by monthly “simplified PSURs” (S-PSUR) accompanied by 
a summary of vaccine distribution. 



28 

 
Frequency of submission 
 
- The clock should start from the first Monday after shipment of the first batch of vaccine. 
- First data-lock point is 30 days later. 
- S-PSUR submission to the Rapporteur and CHMP members on Day 45. 
- Rapporteur’s assessment report is circulated to CHMP members on Day 50. 
- CHMP report is circulated to the vaccine manufacturer on Day 55. 
- Reporting to be monthly for the first 6 months. 
- Periodicity should be reviewed by the MAH and the (Co-)Rapporteur at 6 monthly intervals. 
 
When it has been agreed by the CHMP that the S-PSUR is no longer necessary, a full PSUR covering 
the period since the data lock point of the last routine PSUR will be submitted within a time frame to 
be agreed with the Rapporteur. 
 
Format of the simplified PSUR 
 
Only spontaneously reported data should be included in the S-PSUR. The report should include the 
following Tables of aggregate data (using the pre-defined templates attached in Annex 2). 
 

1. An overview for all spontaneous cases per country, stratified according to type of report 
(medically confirmed or non-medically confirmed) and seriousness, for the period 
covered by the report and cumulatively. 

 
2. An overview for all spontaneous adverse reactions by SOC, High Level Term (HLT) 

and Preferred Term (PT), stratified according to type of report (medically confirmed 
or non-medically confirmed) and including the number of fatal reports, for the period 
covered by the report and cumulatively. 

 
3. Adverse Events of Special Interest stratified according to type of report (medically 

confirmed or non-medically confirmed). AESIs will be defined as follows: 
 

- Neuritis: PT “Neuritis” 
- Convulsion: narrow SMQ “Convulsions” 
- Anaphylaxis: narrow SMQ “Anaphylactic reaction”

 and narrow SMQ “Angioedema” 
- Encephalitis: narrow SMQ “Non-infectious

 encephalitis” 
- Vasculitis: narrow SMQ “Vasculitis” 
- Guillain-Barré syndrome: narrow SMQ “Guillain-Barré

 syndrome” 
- Demyelination: narrow SMQ “Demyelination”  

 (as GBS is also included in this SMQ,
 there will be an overlap in the number
 of cases for these two categories). 

- Bell’s palsy: PT “Bell’s palsy” 
- Vaccination failure: PT “Vaccination failure”. 

 
4. Serious unlisted adverse reactions (SOC, HLT, PTs) stratified according to type of report 

(medically confirmed or non-medically confirmed), for the period covered by the report 
and cumulatively. 

 
5. All spontaneous adverse reactions by age group, per SOC, HLT and PT, stratified 

according to type of report (medically confirmed or non-medically confirmed), for the 
period covered by the report and cumulatively. The following age groups will be used: 
< 2 years, 2-8 years, ≥ 9 years. 

 



29 

6. All spontaneous adverse reactions (SOC, HLT, PT) occurring in pregnant women, 
stratified according to type of report (medically confirmed or non-medically confirmed), 
for the period covered by the report and cumulatively. 

 
The following principles should be followed when compiling the data: 
 
- Except for Table 1, all tables will be based on number of reactions (presented on PT level, 

sorted by System Organ Class [SOC] and High Level Term [HLT]) and not number of cases. 
- All tables will be based on generic and not product-specific data1. Product-specific data can be 

evaluated during signal work-up. 
- “Cumulatively” means since the use of the vaccine; events not reported during the period of 

interest should not be presented in the tables. 
- All non-medically confirmed events are those that have been entered into the database by the 

data-lock point. Those which have not yet been entered should be reported in the following 
S-PSUR. 

- A line listing of fatal cases will be provided in an Annex. 
 
A short summary should be provided in which validated signals and areas of concern are highlighted, 
taking into account information arising from the prospective cohort study described in 4.5. In the event 
of multiple signals, signal work-up may be prioritised and appropriate timelines for submission of a 
full signal evaluation report should be provided. 
 
Vaccine distribution report 
 
To put the safety report into context, a summary of vaccine distribution should be included and should 
provide details of the number of doses of vaccine distributed in 

i) EU member states for the reporting period by batch number, 
ii) EU member states cumulatively and 
iii) the rest of the world. 

 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

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

                                                      
 
1 Based on the assumption that product name will not be provided in a significant proportion of cases. 



30 

E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES 
FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL 
CIRCUMSTANCES 

 
This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation 
(EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures: 
 
Description Due date 
During the pandemic, the applicant will collect clinical 
safety and effectiveness data of the pandemic vaccine and 
submit this information to the CHMP for evaluation. 

Depending on and after implementation 
of vaccine when first pandemic will 
take place. 

During the pandemic, the applicant will conduct 
a prospective cohort study as identified in the 
Pharmacovigilance plan. 

Depending on and after implementation 
of vaccine when first pandemic will 
take place. 



31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



32 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



33 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON – 10-DOSE VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER, suspension for injection 
Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Influenza vaccine (whole virion, inactivated) containing antigen of*: 
 
A/Vietnam/1203/2004 (H5N1) 7.5 microgram** 
per 0.5 ml dose 
 
* produced in Vero cells 
** haemagglutinin 
 
 
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 per vial – 0.5 ml per dose) 
 
 
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 vial is to be used within a maximum of 3 hours. 
 
 
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 
 
Do not inject intravascularly. 
 



34 

 
8. EXPIRY DATE 
 
EXP 
 
 
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/1/09/571/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 



35 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON – PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER, suspension for injection 
Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Influenza vaccine (whole virion, inactivated) containing antigen* 
 
A/Vietnam/1203/2004 (H5N1) 7.5 microgram** 
per 0.5 ml dose 
 
* produced in Vero cells 
** haemagglutinin 
 
 
3. LIST OF EXCIPIENTS 
 
Trometamol, 
sodium chloride, 
water for injections, 
polysorbate 80 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection. 
One single dose pre-filled syringe (containing 0.5ml suspension) 
 
 
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 
 
Do not inject intravascularly. 
 
 



36 

8. EXPIRY DATE 
 
EXP 
 
 
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/1/09/571/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 



37 

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 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER suspension for injection 
Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) 
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 
 
Multidose vial (10 doses of 0.5 ml per vial) 
 
 
6. OTHER 
 
After first opening, the vial is to be used within a maximum of 3 hours. 
 
Ology Bioservices Ireland LTD 
Wilton Park House 
Wilton Place 
Dublin 2 
D02P447 
Ireland 
 
 



38 

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 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER suspension for injection 
Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) 
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 
 
Single dose syringe (0.5ml) 
 
 
6. OTHER 
 
Ology Bioservices Ireland LTD 
Wilton Park House 
Wilton Place 
Dublin 2 
D02P447 
Ireland 
 
 



39 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



40 

Package leaflet: Information for the user 
 

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
suspension for injection 

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

Read all of this leaflet carefully, before you are 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 you get 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 PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is and what it is used for 
2. What you need to know before you are vaccinated with PANDEMIC INFLUENZA VACCINE 

H5N1 BAXTER 
3. How PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is given 
4. Possible side effects 
5. How to store PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
6. Contents of the pack and other information 
 
 
1. What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is and what it is used for 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is a vaccine used in individuals 
aged 6 months adults and older. It is used to prevent influenza (flu) in an officially declared pandemic. 
 
Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly to affect 
most countries and regions around the world. The symptoms (signs) of pandemic flu are similar to 
those of an ‘ordinary’ flu but are usually more severe. 
 
The vaccine works by helping the body to produce its own protection (antibodies) against the disease. 
 
 
2. What you need to know before your are vaccinated with PANDEMIC INFLUENZA 

VACCINE H5N1 BAXTER 
 
Do not use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
 
• if you previously had a serious allergic reaction (i.e. life-threatening) to PANDEMIC 

INFLUENZA VACCINE H5N1 BAXTER. 
• if you are allergic to any of the ingredients or trace residues (formaldehyde, benzonase, sucrose) 

contained in the vaccine. The active substance and other ingredients in PANDEMIC 
INFLUENZA VACCINE H5N1 BAXTER are listed in section 6 at the end of the leaflet. 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, your doctor may recommend to give the vaccine. 

 
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 a problem, but your doctor should advise whether you could still be 
vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER; 



41 

• if you have had any allergic reaction, to any ingredient contained in the vaccine (see section 6 at 
the end of the leaflet) or to formaldehyde, benzonase or sucrose. Allergic reactions, including 
sudden and life-threatening allergic reactions (anaphylaxis), have been reported with a similar 
H1N1 influenza vaccine (swine flu vaccine) given during a pandemic period. Such reactions 
have happened both in people who have allergies and in those who do not; 

• if you have a poor immune response (for example because of immunosuppressive therapy, 
e.g. corticosteroid treatments or chemotherapy for cancer); 

• if you are having a blood test to look for evidence of infection with certain viruses. In the first 
few weeks after vaccination with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER the 
results of these tests may not be correct. Tell the doctor requesting these tests that you have 
recently received PANDEMIC INFLUENZA VACCINE H5N1 BAXTER; 

• if you have a bleeding problem or bruise easily. 
 
The vaccine should never be given into a blood vessel. 
There is no information on the use of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER under 
the skin. 
 
Other medicines and PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
 
Please tell your doctor if you are taking or have recently taken any other medicines, including 
medicines obtained without a prescription or have recently received any other vaccine. 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as other 
vaccines. However, if this cannot be avoided, the other vaccine should be injected into the other limb. 
You should be aware that the side effects may be intensified. 
 
If you take any medicines that reduce immunity to infections or have any other type of treatment 
(such as radiotherapy) that affects the immune system, PANDEMIC INFLUENZA VACCINE 
H5N1 BAXTER can still be given but your response to the vaccine may be poor. 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as 
immunoglobulins. However, if this cannot be avoided, the immunoglobulins should be injected into 
the other limb. 
 
Pregnancy, breast-feeding and fertility 
 
If your 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 PANDEMIC INFLUENZA VACCINE H5N1 BAXTER. 
 
Driving and using machines 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may make you feel dizzy or sick which may 
affect your ability to drive or use machines. 
 
 
3. How to use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
 
Infants, children and adolescents from the age of 6 months to 17 years and adults from the age 
of 18 years and older: 
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. 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is given as an injection into the muscle 
(usually in the upper arm or upper thigh, depending on the muscle mass). 
 
The vaccine should never be given into a vein. 
 



42 

If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER can cause side effects, 
although not everybody gets them. 
 
In the clinical studies conducted in adults and older people with PANDEMIC INFLUENZA 
VACCINE H5N1 BAXTER, most side effects were mild in nature and short term. The side-effects are 
generally similar to those related to the influenza 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 (may affect more than 1 in 10 vaccinees): 
• pain at the injection site 
• fatigue (feeling tired) 
• headache 
 
Common (may affect up to 1 in 10 vaccinees): 
• runny nose and sore throat 
• vertigo (motion sickness) 
• pain in mouth and throat 
• cough 
• diarrhoea 
• increased sweating 
• itching 
• joint or muscle pain 
• fever 
• chills 
• malaise (generally feeling unwell), 
• hardness, redness, swelling or minor bleeding at the injection site 
• abnormal, reduced sensation 
 
Uncommon (may affect more than 1 in 100 vaccinees): 
• swollen glands 
• insomnia (difficulty sleeping) 
• dizziness 
• sleepiness 
• conjunctivitis (an inflammation of the eye), eye irritation 
• sudden hearing loss, ear pain 
• reduced blood pressure, feeling faint (syncope) 
• shortness of breath 
• dry throat 
• stuffy or runny nose 
• feeling sick 
• vomiting 
• stomach pain, indigestion 
• rash, hives 
• irritation or itching at the injection site, bruising or stiff arm 
• chest discomfort 
• flu-like illness 
 



43 

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. 
 
The following side effects have been reported in a clinical study in infants aged 6 to 35 months. 
 
Very common (affects more than 1 in 10 vaccinees): 
• sleepiness 
• fever 
• irritability 
• pain at the injection site 
 
Common (affects 1 to 10 in 100 vaccinees): 
• runny nose and sore throat 
• decreased appetite 
• sleep disorder 
• crying 
• vomiting 
• feeling sick 
• diarrhoea 
• increased sweating 
• hardness, redness, swelling or bruising at the injection site 
 
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 in 100 vaccinees): 
• runny nose and sore throat 
• headache 
• pain in mouth and throat 
• vomiting 
• feeling sick 
• pain in joint or muscle 
• hardness, redness, swelling or bruising at the injection site 
• fatigue (feeling tired) 
• fever 
• malaise 
 
Uncommon (affects 1 to 10 in 1,000 vaccinees): 
• decreased appetite 
• eye irritation 
• cough 
• runny nose 
• diarrhoea 
• increased sweating 
• pain in the armpit 
• itching where the injection was given 
• feeling cold 

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



44 

Very common (affects more than 1 in 10 vaccinees): 
• headache 
• pain at the injection site 
 
Common (affects 1 to 10 in 100 vaccinees): 
• 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 in 1,000 vaccinees): 
• decreased appetite 
• insomnia (difficulty sleeping) 
• dizziness 
• abnormal, reduced sensation 
• vertigo (a spinning sensation) 
• cough 
• runny nose 
• diarrhoea 
• itching 
• pain in extremity 
• pain in the armpit 
• bruising at the injection site 
• itching where the injection was given 
• fever 
• feeling cold 
 
The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and 
children during the H1N1 pandemic flu vaccination programme. The frequency cannot be estimated 
from the available data. 
 
• allergic reactions, including severe reactions leading to a dangerous decrease in blood pressure 

which, if untreated, may lead to shock. 
• fits 
• 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 
 
Reporting of side effects 
If you get 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. 
 
 

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


45 

5. How to store PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER after the expiry date which is 
stated on the carton. 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 protect the environment. 
 
 
6. Contents of the pack and other information 
 
What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER contains 
 
Active substance: 
Whole virion H5N1 influenza vaccine, inactivated, containing antigen of*: 
 
A/Vietnam/1203/2004 (H5N1) 7.5 micrograms** 
per 0.5 ml dose 
 
* produced in Vero cells 
** haemagglutinin 
 
The other ingredients are: trometamol, sodium chloride, water for injections, polysorbate 80. 
 
What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER looks like and contents of 
the pack 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is an off-white, opalescent, translucent 
liquid. 
The vaccine is available as 1 pack containing 20 multidose vials (type I glass) of 5 ml suspension 
(10 doses). 
 
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 {MM/YYYY}. 
 



46 

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER has been authorised under “exceptional 
circumstances”. This means that for scientific reasons, it has been impossible to get complete 
information on this medicine. The European Agency (EMA) will review any new information on 
the medicine every year and this leaflet will be updated as necessary. 
 
Other sources of information 
 
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 health care professionals only: 
 
The vaccine should be allowed to reach room temperature before use. Shake before use. 
 
After shaking, the vaccine is an off-white, opalescent, translucent 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. 
 



47 

Package leaflet: Information for the user 
 

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
suspension for injection 

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

Read all of this leaflet carefully, before you are 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 you get 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 PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is and what it is used for 
2. What you need to know before you are vaccinated with PANDEMIC INFLUENZA VACCINE 

H5N1 BAXTER 
3. How PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is given 
4. Possible side effects 
5. How to store PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
6. Contents of the pack and other information 
 
 
1. What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is and what it is used for 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is a vaccine used in individuals 
aged 6 months and older. It is used to prevent influenza (flu) in an officially declared pandemic. 
 
Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly to affect 
most countries and regions around the world. The symptoms (signs) of pandemic flu are similar to 
those of an ‘ordinary’ flu but are usually more severe. 
 
The vaccine works by helping the body to produce its own protection (antibodies) against the disease. 
 
 
2. What you need to know before you are vaccinated with PANDEMIC INFLUENZA 

VACCINE H5N1 BAXTER 
 
Do not use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
 
• if you previously had a serious allergic reaction (i.e. life-threatening) to PANDEMIC 

INFLUENZA VACCINE H5N1 BAXTER. 
• if you are allergic to any of the ingredients or trace residues (formaldehyde, benzonase, sucrose) 

contained in the vaccine. The active substance and other ingredients in PANDEMIC 
INFLUENZA VACCINE H5N1 BAXTER are listed in section 6 at the end of the leaflet. 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, your doctor may recommend to give the vaccine. 

 
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 a problem, but your doctor should advise whether you could still be 
vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER; 



48 

• if you have had any allergic reaction, to any ingredient contained in the vaccine (see section 6 at 
the end of the leaflet) or to formaldehyde, benzonase or sucrose. Allergic reactions, including 
sudden and life-threatening allergic reactions (anaphylaxis), have been reported with a similar 
H1N1 influenza vaccine (swine flu vaccine) given during a pandemic period. Such reactions 
have happened both in people who have allergies and in those who do not; 

• if you have a poor immune response (for example because of immunosuppressive therapy, 
e.g. corticosteroid treatments or chemotherapy for cancer); 

• if you are having a blood test to look for evidence of infection with certain viruses. In the first 
few weeks after vaccination with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER the 
results of these tests may not be correct. Tell the doctor requesting these tests that you have 
recently received PANDEMIC INFLUENZA VACCINE H5N1 BAXTER; 

• if you have a bleeding problem or bruise easily. 
 
The vaccine should never be given into a blood vessel. 
There is no information on the use of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER under 
the skin. 
 
Other medicines and PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
 
Please tell your doctor if you are taking or have recently taken any other medicines, including 
medicines obtained without a prescription or have recently received any other vaccine. 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as other 
vaccines. However, if this cannot be avoided, the other vaccine should be injected into the other limb. 
You should be aware that the side effects may be intensified. 
 
If you take any medicines that reduce immunity to infections or have any other type of treatment (such 
as radiotherapy) that affects the immune system, PANDEMIC INFLUENZA VACCINE 
H5N1 BAXTER can still be given but your response to the vaccine may be poor. 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as 
immunoglobulins. However, if this cannot be avoided, the immunoglobulins should be injected into 
the other limb. 
 
Pregnancy, breast-feeding and fertility 
 
If your 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 PANDEMIC INFLUENZA VACCINE H5N1 BAXTER. 
 
Driving and using machines 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may make you feel dizzy or sick which may 
affect your ability to drive or use machines. 
 
 
3. How to use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
 
Infants, children and adolescents from the age of 6 months to 17 years and adults from the age 
of 18 years and older: 
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. 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is given as an injection into the muscle 
(usually in the upper arm or upper thigh, depending on the muscle mass). 
 
The vaccine should never be given into a vein. 
 



49 

If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER can cause side effects, 
although not everybody gets them. 
 
In the clinical studies conducted in adults and older people with PANDEMIC INFLUENZA 
VACCINE H5N1 BAXTER, most side effects were mild in nature and short term. The side-effects 
are generally similar to those related to the influenza 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 (may affect more than 1 in 10 vaccinees): 
• pain at the injection site 
• fatigue (feeling tired) 
• headache 
 
Common (may affect up to 1 in 10 vaccinees): 
• runny nose and sore throat 
• vertigo (motion sickness) 
• pain in mouth and throat 
• cough 
• diarrhoea 
• increased sweating 
• itching 
• joint or muscle pain 
• fever 
• chills 
• malaise (generally feeling unwell) 
• hardness, redness, swelling or minor bleeding at the injection site 
• abnormal, reduced sensation 
 
Uncommon (may affect more than 1 in 100 vaccinees): 
• swollen glands 
• insomnia (difficulty sleeping) 
• dizziness 
• sleepiness 
• conjunctivitis (an inflammation of the eye), eye irritation 
• sudden hearing loss, ear pain 
• reduced blood pressure, feeling faint (syncope) 
• shortness of breath 
• dry throat 
• stuffy or runny nose 
• feeling sick 
• vomiting 
• stomach pain, indigestion 
• rash, hives 
• irritation or itching at the injection site, bruising or stiff arm 
• chest discomfort 
• flu-like illness 
 



50 

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. 
 
The following side effects have been reported in a clinical study in infants aged 6 to 35 months. 
 
Very common (affects more than 1 in 10 vaccinees): 
• sleepiness 
• fever 
• irritability 
• pain at the injection site 
 
Common (affects 1 to 10 in 100 vaccinees): 
• runny nose and sore throat 
• decreased appetite 
• sleep disorder 
• crying 
• vomiting, feeling sick, diarrhoea 
• increased sweating 
• hardness, redness, swelling or bruising at the injection site 
 
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 in 100 vaccinees): 
• runny nose and sore throat 
• headache 
• pain in mouth and throat 
• vomiting 
• feeling sick 
• pain in joint or muscle 
• hardness redness, swelling or bruising at the injection site 
• fatigue (feeling tired) 
• fever 
• malaise, 
 
Uncommon (affects 1 to 10 in 1,000 vaccinees): 
• decreased appetite 
• eye irritation 
• cough 
• runny nose 
• diarrhoea 
• increased sweating 
• pain in the armpit 
• itching where the injection was given 
• feeling cold 
 
The following side effects have been reported in clinical studies in adolescents aged 9 to 17 years. 
 
Very common (affects more than 1 in 10 vaccinees): 
• headache 
• pain at the injection site 
 



51 

Common (affects 1 to 10 in 100 vaccinees): 
• 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 in 1,000 vaccinees): 
• decreased appetite 
• insomnia (difficulty sleeping) 
• dizziness 
• abnormal, reduced sensation 
• vertigo (a spinning sensation) 
• cough 
• runny nose 
• diarrhoea 
• itching 
• pain in extremity 
• pain in the armpit 
• bruising at the injection site 
• itching where the injection was given 
• fever 
• feeling cold 
 
The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and 
children during the H1N1 pandemic flu vaccination programme. The frequency cannot be estimated 
from the available data. 
 
• allergic reactions, including severe reactions leading to a dangerous decrease in blood pressure 

which, if untreated, may lead to shock. 
• fits 
• 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 
 
Reporting of side effects 
If you get 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 PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER after the expiry date which is 
stated on the carton. The expiry date refers to the last day of that month. 
 

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


52 

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 protect the environment. 
 
 
6. Contents of the pack and other information 
 
What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER contains 
 
Active substance: 
Whole virion H5N1 influenza vaccine, inactivated, containing antigen of*: 
 
A/Vietnam/1203/2004 (H5N1) 7.5 micrograms** 
per 0.5 ml dose 
 
* produced in Vero cells 
** haemagglutinin 
 
The other ingredients are: trometamol, sodium chloride, water for injections, polysorbate 80. 
 
What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER looks like and contents of 
the pack 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is an off-white, opalescent, translucent 
liquid. 
The vaccine is available or as 1 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) with or without 
needles. 
 
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 {MM/YYYY}. 
 
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER has been authorised under “exceptional 
circumstances”. This means that for scientific reasons, it has been impossible to get complete 
information on this medicine. The European Agency (EMA) will review any new information on the 
medicine every year and this leaflet will be updated as necessary. 
 



53 

Other sources of information 
 
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 health care professionals only: 
 
The vaccine should be allowed to reach room temperature before use. Shake before use. 
 
After shaking, the vaccine is an off-white, opalescent, translucent 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 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
	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
	A. LABELLING
	B. PACKAGE LEAFLET