Celvapan

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 

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1. NAME OF THE MEDICINAL PRODUCT 
 
Celvapan suspension for injection 
Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Whole virion influenza vaccine, inactivated containing antigen of strain *: 
 
A/California/07/2009 (H1N1)v 7.5 micrograms** 
per 0.5 ml dose 
 
* propagated in Vero cells (continuous cell line of mammalian origin) 
** expressed in micrograms haemagglutinin. 
 
This is a multidose container. See section 6.5 for the number of doses per vial. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Suspension for injection. 
 
The vaccine is a clear to opalescent, translucent suspension. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Prophylaxis of influenza caused by A(H1N1)v 2009 virus (See section 4.4). 
 
Celvapan should be used in accordance with Official Guidance 
 
4.2 Posology and method of administration 
 
Posology 
 
The dose recommendations take into account available data from clinical studies in healthy subjects 
who received two doses of Celvapan (H1N1)v. 
 
From clinical studies limited immunogenicity and safety data are available for Celvapan (H1N1)v in 
healthy adult and older subjects and in children (see section 4.4, 4.8, and 5.1). 
 
Adults and older people 
One dose of 0.5 ml at an elected date. 
A second dose of vaccine should be given after an interval of at least three weeks. 
 
Children and adolescents aged 3 to 17 years 
One dose of 0.5 ml at an elected date. 
A second dose of vaccine should be given after an interval of at least three weeks. 
 
Children aged 6 to 35 months 
One dose of 0.5 ml at an elected date. 
A second dose of vaccine should be given after an interval of at least three weeks. 

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Children aged less than 6 months 
Vaccination is not currently recommended in this age group. 
 
For further information, see sections 4.8 and 5.1. 
 
It is recommended that subjects who receive a first dose of Celvapan, complete the vaccination course 
with Celvapan (see section 4.4). 
 
Method of administration 
 
Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or 
anterolateral thigh, depending on the muscle mass. 
 
4.3 Contraindications 
 
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues 
(e.g. formaldehyde, benzonase, sucrose) of this vaccine. 
 
See section 4.4 for Special warnings and special precautions for use. 
 
4.4 Special warnings and precautions for use 
 
The vaccine can only be expected to protect against influenza caused by 
A/California/07/2009 (H1N1)v-like strains. 
 
Caution is needed when administrating this vaccine to persons with a known hypersensitivity 
(other than anaphylactic reaction) to the active substance(s), to any of the excipients and to trace 
residues e.g. formaldehyde, benzonase, or sucrose. 
 
Hypersensitivity reactions, including anaphylaxis, have been reported following CELVAPAN 
vaccination (see section 4.8). Such reactions have occurred both in patients with a history of multiple 
allergies and in patients with no known allergy. 
 
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. 
 
Immunisation shall be postponed in patients with severe febrile illness or acute infection. 
 
Celvapan should under no circumstances be administered intravascularly. 
 
There are no data with Celvapan 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 elicited in all vaccinees (see section 5.1). 
 
There are no safety, immunogenicity or efficacy data to support interchangeability of Celvapan with 
other (H1N1)v vaccines. 
 

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4.5 Interaction with other medicinal products and other forms of interaction 
 
There are no data on co-administration of Celvapan with other vaccines. However, if 
co-administration with another vaccine is considered, immunisation should be carried out on 
separate limbs. It should be noted that the adverse reactions may be intensified. 
 
The immunological response may be diminished if the patient is undergoing immunosuppressant 
treatment. 
 
Following influenza vaccination, false positive serology test results may be obtained by the ELISA 
method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus, and especially, 
HTLV-1. In such cases, the Western Blot method is negative. These transitory false-positive results 
may be due to IgM production in response to the vaccine. 
 
4.6 Fertility, pregnancy and lactation 
 
The safety of Celvapan in pregnancy and lactation has been assessed in a limited number of pregnant 
women. 
 
Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do 
not suggest malformations or fetal 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 Celvapan may be considered during pregnancy if this is thought to be necessary, taking into 
account official recommendations. 
 
Celvapan may be used in lactating women. 
 
4.7 Effects on ability to drive and use machines 
 
Some undesirable effects mentioned under section 4.8 “Undesirable effects” may affect the ability to 
drive or use machines. 
 
4.8 Undesirable effects 
 
 Clinical trials with Celvapan (H1N1)v 
 
Adults and Older People 
 
In a clinical study the 7.5 µg dose of Celvapan (H1N1)v was administered to adults 
aged 18 to 59 years (N = 101) and older people over 60 years of age (N = 101). Safety data after the 
first and second vaccination suggest a similar safety profile to that reported for the influenza vaccines 
using a H5N1 strain. 
 

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Adverse reactions from clinical trials with Celvapan (H1N1)v in a healthy adult and older people are 
listed in the table below. 
 

Clinical Adverse Reactions (H1N1)v Studies 
System Organ Class (SOC) Preferred MedDRA Term Frequency1 

INFECTIONS AND INFESTATIONS Nasopharyngitis Common 
PSYCHIATRIC DISORDERS Insomnia Common 
NERVOUS SYSTEM DISORDERS Headache 

Dizziness 
Very Common 
Common 

EYE DISORDERS Eye irritation Common 
RESPIRATORY, THORACIC AND 
MEDIASTINAL DISORDERS 

Pharyngolaryngeal pain Common 

GASTROINTESTINAL DISORDERS Abdominal pain Common 
SKIN AND SUBCUTANEOUS 
TISSUE DISORDERS 

Hyperhidrosis 
Rash 
Urticaria 

Common 
Common 
Common 

MUSCULOSKELETAL AND 
CONNECTIVE TISSUE DISORDERS 

Arthralgia 
Myalgia 

Common 
Common 

GENERAL DISORDERS AND 
ADMINISTRATION SITE 
CONDITIONS 

Fatigue 
Pyrexia 
Chills 
Malaise 
Injection site reactions 
 Injection site pain 
 Injection site induration 
 Injection site erythema 
 Injection site swelling 
 Injection site movement impairment 

Very Common 
Common 
Common 
Common 
 
Common 
Common 
Common 
Common 
Common 

ADR frequency is based upon the following scale: Very Common (≥ 1/10); Common (≥ 1/100 - 
< 1/10), Uncommon (≥ 1/1,000 - < 1/100), Rare (≥ 1/10,000 - < 1/1,000), Very Rare (< 1/10,000) 
 
Children and adolescents 3 to 17 years of age 
 
In a clinical trial 51 children and adolescents aged 9 to 17 years and 51 children aged 3 to 8 years were 
administered the 7.5 µg dose of Celvapan (H1N1)v. The incidence and nature of symptoms after the 
first and second vaccination were similar to that observed in the adult and older population using 
Celvapan. 
 
Children aged 6 to 35 months 
 
In a clinical trial the 7.5 µg dose of Celvapan (H1N1)v was administered to 69 infants and young 
children aged 6 to 35 months. 
 

                                                 
1 represents the highest frequency observed either in the healthy adult or healthy older study population. 

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Adverse reactions from pediatric clinical trials with CELVAPAN (H1N1)v are listed in the table 
below. 
 

Clinical Trial Adverse Reactions H1N1v studies 
System Organ Class 

(SOC) 
Preferred MedDRA 

Term 
Frequency 

9 - 17 years 3 - 8 years 6 – 35 months 
METABOLISM AND 
NUTRITION 
DISORDERS 

Decreased appetite - - Common 

PSYCHIATRIC 
DISORDERS 

Sleep disorder 
Restlessness 

- 
- 

- Very common 
Common 

NERVOUS SYSTEM 
DISORDERS 

Headache 
Crying 
Somnolence 

Common 
- 
- 

Common 
- 
- 

Common 
Common 
Common 

EAR AND LABYRINTH 
DISORDERS 

Vertigo Common - - 

RESPIRATORY, 
THORACIC AND 
MEDIASTINAL 
DISORDERS 

Cough - - Common 

GASTROINTESTINAL 
DISORDERS 

Abdominal pain 
Nausea 
Vomiting 
Diarrhea 

Common 
Common 
Common 
- 

- 
- 
Common 
Common 

Common 
Common 
Common 
Common 

SKIN AND 
SUBCUTANEOUS 
TISSUE DISORDERS 

Hyperhidrosis 
Rash 

- 
- 

- 
- 

Common 
Common 

MUSCULOSKELETAL 
AND CONNECTIVE 
TISSUE DISORDERS 

Myalgia 
Pain in extremity 

Common 
Common 

- 
- 

- 
- 

GENERAL DISORDERS 
AND 
ADMINISTRATION 
SITE CONDITIONS  

Fatigue 
Pyrexia 
Chills 
Irritability 
Malaise 
Injection site reactions 
 Injection site pain 
 Injection site 

induration 
 Injection site 

erythema 
 Injection site 

swelling 

- 
- 
Common 
- 
- 
 
Very common 
Common 
 
Common 
 
Common 

Common 
Common 
Common 
- 
- 
 
Common 
Common 
 
Common 
 
Common 

- 
Very common 
Common 
Common 
Common 
 
Common 
Common 
 
Common 
 
Common 

ADR frequency is based upon the following scale: Very Common (≥ 1/10); Common (≥ 1/100 - 
< 1/10), Uncommon (≥ 1/1,000 - < 1/100), Rare (≥ 1/10,000 - < 1/1,000), Very Rare (< 1/10,000) 
 
 Clinical trials with a version of Celvapan containing a H5N1 vaccine strain 
 
Clinical trials were conducted with a version of Celvapan containing a H5N1 vaccine strain (see 
section 5.1) in approximately 3700 subjects (ranging in age from 18 to 60 years and above), and in 
special risk groups of approximately 300 subjects each, consisting of immune-compromised subjects 
and patients with chronic disease conditions. 
 
Most of the reactions were mild in nature, of short duration and qualitatively similar to those induced 
by influenza vaccines. There were fewer reactions after the second dose of the vaccine compared with 

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the first dose. The safety profile in healthy subjects > 60 years of age, in immune-compromised 
subjects and patients with chronic disease conditions is similar to the safety profile in healthy subjects. 
 
 Post-marketing surveillance 
 
Pandemic Observational Study with Celvapan (H1N1)v 
 
In an observational safety study including 3216 subjects aged 6 months to 60 years and older, the 
nature of adverse events was consistent with those observed in other clinical studies in adults and 
children. The following adverse reactions were reported at a higher frequency category than in the 
other clinical studies: 
 
Adults aged 18 years and older: 
 
Very common: Injection site pain, injection site redness, muscle pain 
Uncommon: influenza like illness 
 
Children and adolescents aged 5 to 17 years: 
 
Very common: fatigue, headache 
Uncommon: cough 
 
Children aged 6 months to 5 years: 
 
Very common: Injection site redness, drowsiness, irritability, loss of appetite, crying 
 
Celvapan (H1N1)v 
 
The following additional adverse reactions have been reported in the post-marketing experience in 
adults and children receiving Celvapan (H1N1)v. 
 
The frequency of these adverse reactions is not known. 
 
Immune system disorder: 
 
Anaphylactic reaction*, Hypersensitivity* 
 
Nervous system disorders: 
 
Febrile convulsion 
Hypoaesthesia 
 
Skin and subcutaneous tissue disorders: 
 
Angioedema 
 
*Such reactions have been manifested by respiratory distress, hypotension, tachycardia, tachypnea, 
cyanosis, pyrexia, flushing, angioedema, and urticaria 
 
Musculoskeletal and connective tissue disorders: 
 
Pain in extremity (in the majority of cases reported as pain in the injection site arm) 
 
General disorders and administration site conditions: 
 
Influenza-like illness 
 

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Trivalent seasonal influenza vaccines 
 
From post-marketing surveillance with egg-derived trivalent seasonal influenza vaccines, the 
following serious adverse reactions have been reported: 
 
Uncommon: 
 
Generalised skin reactions 
 
Rare: 
 
Neuralgia, paraesthesia, 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 
 
Clinical studies with Celvapan (H1N1)v currently provide: 
 Safety and immunogenicity data obtained three weeks after administration of two doses of 

Celvapan (H1N1)v to healthy adults aged 18 years and older. 
 Safety and immunogenicity data obtained three weeks after administration of two doses of 

Celvapan (H1N1)v to healthy children aged 6 months to 17 years. 
 
Clinical studies in which a version of Celvapan containing HA derived from 
A/Vietnam/1203/2004 (H5N1) was administered at day 0 and at day 21 provide: 
 Safety and immunogenicity data in healthy adults, including older people. 
 Safety and immunogenicity data in special risk groups (immunocompromised and 

chronically ill) 
 
Immune response against A/California/07/2009(H1N1)v 
 
The immunogenicity of the vaccine containing 7.5 μg non-adjuvanted HA derived from strain 
A/California/07/2009 (H1N1)v has been evaluated in clinical studies in adults aged 18 years and older 
(N = 200), in children and adolescents aged 3 to 17 years (N = 102), and in infants and young children 
aged 6 to 35 months (N = 68) following a 0, 21 day schedule. 
 

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Adults aged 18 years and older 
 
After 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 All subjects Seronegative subjects at baseline 

(≤ 4mm2) 
 21 Days After 21 Days After 
 1st Dose 2nd Dose 1st Dose 2nd Dose 
18 to 59 years N = 99 N = 33 
Seroprotection rate* 75.8% 

(66.1; 83.8) 
80.8% 

(71.7; 88.0) 
69.7% 

(51.3; 84.4) 
78.8% 

(61.1; 91.0) 
Seroconversion rate** 64.6% 

(54.4; 74.0) 
70.7% 

(60.7; 79.4) 
69.7% 

(51.3; 84.4) 
78.8% 

(61.1; 91.0) 
Seroconversion factor*** 3.4 

(2.8; 4.3) 
4.1 

(3.3; 5.1) 
7.1 

(4.5; 11.0) 
9.5 

(6.5; 13.8) 
≥ 60 years N = 101 N = 22 
Seroprotection rate* 76.2% 

(66.7; 84.1) 
82.2% 

(73.3; 89.1) 
50.0% 

(28.2; 71.8) 
63.6% 

(40.7; 82.8) 
Seroconversion rate** 28.7% 

(20.1; 38.6) 
35.6% 

(26.4; 45.8) 
50.0% 

(28.2; 71.8) 
63.6% 

(40.7; 82.8) 
Seroconversion factor*** 1.8 

(1.5; 2.1) 
2.0 

(1.7; 2.4) 
3.9 

(2.3; 6.7) 
5.6 

(3.4; 9.2) 
* 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 titres ≥ 40, 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: 
 
MN Assay All subjects Seronegative subjects at baseline 

(< 1:10) 
 21 Days After 21 Days After 
 1st Dose 2nd Dose 1st Dose 2nd Dose 
18 to 59 years N = 100 N = 99 N = 39 N = 38 
Seroneutralization rate* 87.0% 

(78.8; 92.9) 
98.0% 

(92.9; 99.8) 
74.4% 

(57.9; 87.0) 
97.4% 

(86.2; 99.9) 
Seroconversion rate** 80.0% 

(70.8; 87.3) 
86.9% 

(78.6; 92.8) 
84.6% 

(69.5; 94.1) 
97.4% 

(86.2; 99.9) 
Seroconversion factor*** 21.3 

(14.6; 31.2) 
29.0 

(20.5; 41.0) 
28.8 

(15.2; 54.5) 
55.3 

(32.0; 95.6) 
≥ 60 years N = 101 N = 34 N = 38 
Seroneutralization rate* 70.3% 

(60.4; 79.0)
82.2% 

(73.3; 89.1)
55.9% 

(37.9; 72.8) 
76.3% 

(59.8; 88.6)
Seroconversion rate** 55.4% 

(45.2; 65.3) 
71.3% 

(61.4%; 79.9) 
73.5% 

(55.6; 87.1) 
94.7% 

(82.3; 99.4) 
Seroconversion factor*** 5.0 

(3.8; 6.6) 
7.6 

(5.9; 9.9) 
7.1 

(4.4; 11.3) 
15.0 

(10.1; 22.2) 
* MN titre ≥ 1:40 
** > 4-fold increase in MN titre 
*** geometric mean increase 
 

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Persistence of anti-HA antibodies 180 days after the first vaccination as measured by single radial 
haemolysis (SRH) and microneutralisation assay (MN) in adults aged 18 to 59 years and in older 
subjects aged 60 years and above was as follows: 
 
Antibody persistence All subjects Seronegative subjects at baseline 

(< 1:10) 
 Day 181 Day 181 
 SRH MN SRH MN 
18 to 59 years N = 98 N = 98 N = 33 N = 32 
Seroprotection / 
Seroneutralization rate* 

80.6% 
(71.4;87.9) 

94.9% 
(88.5;98.3) 

78.8% 
(61.1;91,0) 

90.6% 
(75.0;98.0) 

Seroconversion rate** 68.4% 
(58.2;77.4) 

83.7% 
(74.8;90.4) 

78.8% 
(61.1;91.0) 

96.9% 
(83.8;99.9) 

Seroconversion factor*** 3.6 
(2.9;4.4) 

15.0 
(11.0;20.4) 

8.0 
(5.7;11.4) 

30.0 
(17.7;50.8) 

≥ 60 years N = 101 N = 101 N = 22 N = 24 
Seroprotection / 
Seroneutralization rate* 

80.2% 
(71.1;87.5) 

79.2% 
(68.9;85.8) 

59.1% 
(36.4;79.3) 

66.7% 
(44.7;84.4) 

Seroconversion rate** 30.7% 
(21.9;40,7) 

54.5% 
(44.2;64.4) 

59.1% 
(36.4;79.3) 

83.3% 
(62.6;95.3) 

Seroconversion factor*** 1.8 
(1.5;2,1) 

4.6 
(3.7;5.7) 

4.6 
(2.9;7.3) 

8.9 
(5.6;14.0) 

* SRH area > 25 mm²; MN titre ≥ 1:40; 
** either SRH area > 25 mm² if baseline sample negative or 50% increase in SRH area if baseline 

sample > 4 mm²; > 4-fold increase in MN titre; 
*** geometric mean increase 
 
Children and adolescents (3 – 17 years of age) 
 
The seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as 
measured by single radial haemolysis (SRH) in children and adolescents aged 3 to 17 years were as 
follows: 
 
SRH Assay All subjects Seronegative subjects at baseline 

(≤ 4mm2) 
 21 Days After 21 Days After 
 1st Dose 2nd Dose 1st Dose 2nd Dose 
3 to 8 years N = 51 N = 31 
Seroprotection rate*  51.0% 

(36.6; 65.2) 
88.2% 

(76.1; 95.6) 
58.1% 

(39.1; 75.5) 
93.5% 

(78.6; 99.2) 
Seroconversion rate** 47.1% 

(32.9; 61.5) 
88.2% 

(76.1; 95.6) 
58.1% 

(39.1; 75.5) 
93.5% 

(78.6; 99.2) 
Seroconversion factor*** 3.5 

(2.5; 4.9) 
8.6 

(6.6; 11.3) 
5.8 

(3.9; 8.8) 
15.0 

(12.4; 18.1) 
9 to 17 years N = 50 N = 29 
Seroprotection rate* 80.0% 

(66.3; 90.0)
88.0% 

(75.7; 95.5)
82.8% 

(64.2; 94.2) 
93.1% 

(77.2; 99.2) 
Seroconversion rate** 74.0% 

(59.7; 85.4) 
84.0% 

(70.9; 92.8) 
82.8% 

(64.2; 94.2) 
93.1% 

(77.2; 99.2) 
Seroconversion factor*** 6.8 

(5.0; 9.2) 
8.9 

(6.6; 11.9) 
9.8 

(6.9; 14.0) 
13.8 

(10.3; 18.4) 
* 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 
 

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After vaccination the rate of subjects with neutralizing antibody titres ≥ 40, seroconversion rate and 
seroconversion factor as measured by microneutralisation assay (MN) in children and adolescents 
aged 3 to 17 years were as follows: 
 
MN Assay All subjects Seronegative subjects at baseline 

(< 1:10) 
 21 Days After 21 Days After 
 1st Dose 2nd Dose 1st Dose 2nd Dose 
3 to 8 years N = 51 N = 47 
Seroneutralization rate* 84.3% 

(71.4; 93.0) 
100.0% 

(93.0; 100.0) 
83.0% 

(69.2; 92.4) 
100.0% 

(92.5; 100.0) 
Seroconversion rate** 94.1% 

(83.8; 98.8) 
100.0% 

(93.0; 100.0) 
93.6% 

(82.5; 98.7) 
100.0% 

(92.5; 100.0) 
Seroconversion factor*** 12.9 

(9.5; 17.5) 
156.9 

(119.4; 206.2) 
13.5 

(9.7; 18.8) 
168.2 

(131.1; 215.7) 
9 to 17 years N = 51 N = 34 
Seroneutralization rate* 94.1 % 

(83.8; 98.8) 
100.0% 

(93.0; 100.0) 
91.2% 

(76.3; 98.1) 
100.0% 

(89.7; 100.0) 
Seroconversion rate** 100.0% 

(93.0; 100.0) 
100.0% 

(93.0; 100.0) 
100.0% 

(89.7; 100.0) 
100.0% 

(89.7; 100.0) 
Seroconversion factor*** 33.3 

(22.2; 50.0) 
115.6 

(87.4; 152.8) 
29.2 

(17.9; 47.7) 
137.5 

(99.5; 189.9) 
* MN titre ≥ 1:40 
** ≥ 4-fold increase in MN titre 
*** geometric mean increase 
 
Persistence of anti-HA antibodies 180 days and 360 days after the first vaccination as measured by 
single radial hemolysis (SRH) and microneutralization (MN) assay in children and adolescents 
aged 3 to 17 years was as follows: 
 
Antibody persistence Day 181 Day 361 
 SRH MN SRH MN 
9 to 17 years N=50 N=47 N=29 N=27 
Seroprotection / 
Seroneutralization rate* 

98.0% 
(89.4; 99.9) 

100% 
(92.5; 100.0) 

96.6% 
(82.2; 99.9) 

88.9% 
(70.8; 97.6) 

Seroconversion rate** 92.0% 
(80.8; 97.8) 

100% 
(92.5; 100.0) 

93.1% 
(77.2; 99.2) 

96.3% 
(81.0; 99.9) 

Seroconversion factor*** 7.8 
(6.2; 9.9) 

66.4 
(47.4; 93.1) 

6.5 
(4.7; 9.0) 

26.7 
(16.6; 43.1) 

3 to 8 years N=51 N=47 N=33 N=31 
Seroprotection / 
Seroneutralization rate* 

79.6% 
(65.7; 89.8) 

100% 
(92.5; 100.0) 

54.5% 
(36.4; 71.9) 

100% 
(88.8; 100.0) 

Seroconversion rate** 77.6% 
(63.4; 88.2) 

100% 
(92.5; 100.0) 

57.6% 
(39.2; 74.5) 

96.8% 
(83.3; 99.9) 

Seroconversion factor*** 5.6 
(4.5; 7.1) 

59.5 
(45.1; 78.3) 

4.5 
(3.4; 6.1) 

26.5 
(18.5; 37.9) 

* SRH area > 25 mm²; MN titer ≥1:40; 
** either SRH area > 25 mm² if baseline sample negative or 50% increase in SRH area if baseline 

sample > 4 mm²; > 4-fold increase in MN titer; 
*** geometric mean increase 
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Infants and children aged 6–35 months 
 
The seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as 
measured by single radial haemolysis (SRH) in children aged 6 to 35 months were as follows: 
 
SRH Assay All subjects Seronegative subjects at baseline 

(≤ 4mm2) 
 21 Days After 21 Days After 
 1st Dose 2nd Dose 1st Dose 2nd Dose 
6 to 11 months N = 19 N = 15 
Seroprotection rate* 31.6% 

(12.6; 56.6)
78.9% 

(54.4; 93.9)
33.3% 

(11.8; 61.6) 
80.0% 

(51.9; 95.7)
Seroconversion rate** 31.6% 

(12.6; 56.6) 
84.2% 

(60.4; 96.6) 
33.3% 

(11.8; 61.6) 
80.0% 

(51.9; 95.7) 
Seroconversion factor*** 1.9 

(1.2; 3.0) 
7.6 

(4.9; 11.7) 
2.1 

(1.1; 3.7) 
9.0 

(5.6; 14.5) 
12 to 35 months N = 49 N = 40 
Seroprotection rate* 24.5% 

(13.3; 38.9) 
95.9% 

(86.0; 99.5) 
20.0% 

(9.1;35.6) 
95.0% 

(83.1;99.4) 
Seroconversion rate** 22.4% 

(11.8; 36.6)
91.8% 

(80.4; 97.7)
20.0% 

(9.1; 35.6) 
95.0% 

(83.1; 99.4)
Seroconversion factor*** 1.8 

(1.4; 2.5) 
11.2 

(9.3; 13.4) 
1.8 

(1.3; 2.5) 
12.5 

(10.7; 14.5) 
* 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 vaccination the rate of subjects with neutralizing antibody titres ≥ 40, seroconversion rate and 
seroconversion factor as measured by microneutralisation assay (MN) in children aged 6 to 35 months 
were as follows: 
 
MN Assay All subjects Seronegative subjects at baseline 

(< 1:10) 
 21 Days After 21 Days After 
 1st Dose 2nd Dose 1st Dose 2nd Dose 
6 to 11 months N = 17 N = 19 N = 17 N = 19 
Seroneutralization rate* 35.3% 

(14.2; 61.7) 
100% 

(82.4; 100.0) 
35.3% 

(14.2; 61.7) 
100% 

(82.4; 100.0) 
Seroconversion rate** 76.5% 

(50.1; 93.2) 
100% 

(82.4;100.0) 
76.5% 

(50.1; 93.2) 
100% 

(82.4;100.0) 
Seroconversion factor*** 4.5 

(2.7; 7.5)
60.6 

(27.9; 131.7)
4.5 

(2.7; 7.5)
60.6 

(27.9; 131.7)
12 to 35 months N = 49 N = 48 
Seroneutralization rate* 55.1% 

(40.2; 69.3) 
100% 

(92.7; 100.0) 
54.2% 

(39.2; 68.6) 
100.0% 

(92.6; 100.0) 
Seroconversion rate** 75.5% 

(61.1; 86.7) 
100% 

(92.7;100.0) 
75.0% 

(60.4; 86.4) 
100.0% 

(92.6; 100.0) 
Seroconversion factor*** 6.6 

(4.6; 9.4) 
108.0 

(75.5; 154.5) 
6.7 

(4.7; 9.6) 
112.4 

(78.7; 160.5) 
* MN titre ≥ 1:40 
** ≥ 4-fold increase in MN titre 
*** geometric mean increase 
 

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Persistence of anti-HA antibodies 180 days and 360 days after the first vaccination as measured by 
single radial hemolysis (SRH) and microneutralization assay (MN) in infants and young children 
aged 6 to 35 months was as follows: 
 
Antibody persistence Day 181 Day 361 
 SRH MN SRH MN 
12 to 35 months N=47 N=47 N=31 N=31 
Seroprotection / 
Seroneutralization rate* 

68.1% 
(52.9; 80.9) 

100% 
(92.5; 100.0) 

48.8% 
(30.2; 66.9) 

90.3% 
(74.2; 98.0) 

Seroconversion rate** 63.8% 
(48.5; 77.3) 

100% 
(92.5; 100.0) 

45.2% 
(27.3; 64.0) 

93.5% 
(78.6; 99.2) 

Seroconversion factor*** 5.7 
(4.7; 7.0) 

40.2 
(29.2; 55.4) 

4.1 
(3.0; 5.5) 

18.3 
(11.2; 29.8) 

6 to 11 months N=16 N=13 N=13 N=11 
Seroprotection / 
Seroneutralization rate* 

37.5% 
(15.2; 64.6) 

100% 
(75.3; 100.0) 

30.8% 
(9.1; 61.4) 

81.8% 
(48.2; 97.7) 

Seroconversion rate** 37.5% 
(15.2; 64.6) 

100% 
(75.3; 100.0) 

30.8% 
(9.1; 61.4) 

100% 
(71.5; 100.0) 

Seroconversion factor*** 2.9 
(2.0; 4.4) 

19.3 
(13.8; 27.0) 

2.6 
(1.5; 4.5) 

17.6 
(7.1; 43.4) 

* SRH area > 25 mm²; MN titer ≥ 1:40; 
** either SRH area > 25 mm² if baseline sample negative or 50% increase in SRH area if baseline 

sample >4 mm²; > 4-fold increase in MN titer; 
*** geometric mean increase 
 
Following a 12-month booster vaccination with a licensed trivalent virosomal influenza vaccine for 
the 2010/2011 Northern hemisphere influenza season, seroprotection rates, seroconversion rates and 
serconversion factors (compared to pre-booster antibody levels) for the H1N1 component as measured 
by SRH and MN assays were as follows: 
 
21-28 Days Post Booster SRH MN SRH MN 
 9 to 17 years 3 to 8 years 
 N=29 N=27 N=33 N=31 
Seroprotection / 
Seroneutralization rate* 

100% 
(88.1; 100.0) 

100% 
(87.2; 100.0) 

100% 
(89.4; 100.0) 

100% 
(88.8; 100.0) 

Seroconversion rate**  40.0% 
(22.7; 59.4) 

93.1% 
(77.2; 99.2) 

85.3% 
(68.9; 95.0) 

100% 
(89.7; 100.0) 

Seroconversion factor***  1.5 
(1.3; 1.7) 

13.7 
(9.4; 20.0) 

2.7 
(2.2; 3.4) 

29.8 
(20.1; 44.1) 

 12 to 35 months 6 to 11 months 
 N=31 N=29 N=11 N=9 
Seroprotection / 
Seroneutralization rate* 

100% 
(88.8; 100.0) 

100% 
(88.1; 100.0) 

100% 
(71.5; 100.0) 

100% 
(66.4; 100.0) 

Seroconversion rate** 87.1% 
(70.2; 96.4) 

96.6% 
(82.2; 99.9) 

90.9% 
(58.7; 99.8) 

100% 
(71.5; 100.0) 

Seroconversion factor***  3.6 
(2.8; 4.6)

38.7 
(23.9; 62.7)

4.9 
(2.7; 8.9)

29.1 
(11.6; 73.1)

* SRH area > 25 mm²; MN titer ≥1:40; 
** either SRH area > 25 mm² if baseline sample negative or 50% increase in SRH area if baseline 

sample >4 mm²; > 4-fold increase in MN titer; 
*** geometric mean increase 
 
Immune response against a version of Celvapan containing A/H5N1 vaccine strains 
 
The immunogenicity of the vaccine containing 7.5 µg non-adjuvanted HA derived from strain 
A/Vietnam/1203/2004 has been evaluated in two clinical studies in adults aged 18 – 59 years 
(N = 312) and in older subjects aged 60 years and older (N = 272) following a 0, 21 day schedule. 

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The seroprotection rates, seroconversion rates and seroconversion factors reported in adults and older 
subjects were comparable with Celvapan (H1N1)v. 
 
Results from Vaccine Effectiveness Study in Jersey 
 
Pandemic vaccine effectiveness against the medically-attended influenza like illness (ILI) with 
laboratory-confirmation as A(H1N1)v, was assessed for the vaccination campaign in 
Jersey 2009/2010 in a case control study (test-negative design). Younger children 6 months to 9 years 
received Celvapan, while older children from 9 to 18 years of age received an adjuvanted split 
pandemic vaccine. There were no reported vaccine failures in either of these paediatric age groups. 
Crude vaccine effectiveness of one dose of pandemic vaccine among children was 100% (95% 
CI: 70-100%). 
 
5.2 Pharmacokinetic properties 
 
Not applicable. 
 
5.3 Preclinical safety data 
 
Non-Clinical data obtained with Celvapan containing a H5N1 vaccine strain demonstrated alterations 
in liver enzymes and calcium levels in repeat dose toxicity studies in rats. Such alterations in liver 
function have not been seen to date in human clinical studies. Alterations in calcium metabolism have 
not been examined in human clinical studies. 
 
Animal reproductive toxicology studies do not indicate harmful effects in regard to female fertility, 
embryo-foetal and pre- and post-natal toxicity. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Trometamol 
Sodium chloride 
Water for injections 
Polysorbate 80 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf-life 
 
18 months 
After first opening, the 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. 
For storage conditions after first opening of the medicinal product, see section 6.3. 
 

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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. 
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 
 
Nanotherapeutics Bohumil, s.r.o. 
Bohumil 138 
28163 Jevany  
Czech Republic 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/08/506/001 
 
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
 
04/03/2009 
 
 
10. DATE OF REVISION OF THE TEXT 
 
MM/YYYY 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency (EMA): http://www.ema.europa.eu. 
 

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ANNEX II 
 

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 

 
 

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

 
Name and address of the manufacturers of the biological active substance(s) 
 
Baxter BioScience s.r.o. 
Jevany Bohumil 138 
CZ-281 63 Kostelec nad Cernymi lesy 
Czech Republic 
 
Baxter AG 
Uferstrasse 15 
A-2304 Orth/Donau 
Austria 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Baxter AG 
Uferstrasse 15 
A-2304 Orth/Donau 
Austria 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch.  
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 Official batch release 
 
In accordance with Article 114 Directive 2001/83/EC, the official batch release will be undertaken by 
a state laboratory or a laboratory designated for that purpose. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORIZATION 
 
 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. 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
 Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 
 At the request of the European Medicines Agency; 

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 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. 
 
 Additional risk minimisation measures 
 

 The MAH shall agree with Member States to measures facilitating the identification and 
traceability of the A/(H1N1)v vaccine administered to each patient, in order to minimise 
medication errors and aid patients and health care professionals to report adverse 
reactions. This may include the provision by the MAH of stickers with invented name 
and batch number with each pack of the vaccine. 

 
 The MAH shall agree with Member States on mechanisms allowing patients and health 

care professionals to have continuous access to updated information regarding Celvapan. 
 
 The MAH shall agree with Member States on the provision of a targeted communication 

to health care professionals which should address the following: 
 
 The correct way to prepare the vaccine prior to administration. 
 
 Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse 

reactions, unexpected severe adverse reactions, adverse events of special interest 
(AESI). 

 
 The minimal data elements to be transmitted in individual case safety reports in 

order to facilitate the evaluation and the identification of the vaccine administered 
to each subject, including the invented name, the vaccine manufacturer and the 
batch number. 

 
 If a specific notification system has been put in place, how to report adverse 

reactions. 
 

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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 

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A. LABELLING 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Celvapan suspension for injection 
Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Whole virus influenza vaccine, inactivated containing antigen of strain*: 
 
A/California/07/2009 (H1N1)v 7.5 microgram** 
per 0.5 ml dose 
 
* propagated in Vero cells (continuous cell line of mammalian origin) 
** expressed in micrograms 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. 
 

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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 
 
Nanotherapeutics Bohumil, s.r.o. 
Bohumil 138 
28163 Jevany  
Czech Republic 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/08/506/001 
 
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. 
 
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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 
 
Celvapan suspension for injection 
Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated) 
 
Intramuscular use 
 
 
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. 
 
Nanotherapeutics Bohumil, s.r.o. 
Bohumil 138 
28163 Jevany  
Czech Republic 

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B. PACKAGE LEAFLET 

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PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

CELVAPAN suspension for injection 
Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated) 

 
Read all of this leaflet carefully before you receive this vaccine because it contains important 
information for you. 
 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or nurse. 
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects 

not listed in this leaflet. See section 4.  
 
What is in this leaflet 
 
1. What Celvapan is and what it is used for 
2. What you need to know before you receive Celvapan 
3. How Celvapan is given 
4. Possible side effects 
5. How to store Celvapan 
6. Contents of the pack and other information 
 
 
1. What Celvapan is and what it is used for 
 
Celvapan is a vaccine to prevent influenza (flu) caused by A(H1N1)v 2009 virus 
 
When a person is given the vaccine, the immune system (the body’s natural defense system) will 
produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can 
cause flu. 
 
 
2. What you need to know before you receive Celvapan 
 
You should not receive Celvapan: 
 
 if you previously had a sudden life-threatening allergic reaction to any ingredient of Celvapan 

or to any of the substances that may be present in trace amounts as follows: formaldehyde, 
benzonase, sucrose. 
- Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling 

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

 
Take special care with Celvapan: 
 
Check with your doctor or nurse before you are given Celvapan if 
 
 you have had any allergic reaction other than a sudden life-threatening allergic reaction to any 

ingredient contained in the vaccine, to formaldehyde, benzonase, or to sucrose. (see section 6. 
Further information). 

 you have a severe infection with a high temperature (over 38 °C). If this applies to you then 
your vaccination will usually be postponed until you are feeling better. A minor infection such 
as a cold should not be problem, but your doctor or nurse should advise whether you could still 
be vaccinated with Celvapan. 

 you have problems with your immune system, since your response to the vaccine may then 
be poor. 

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 you are having a blood test to look for evidence of infection with certain viruses. In the first few 
weeks after vaccination with Celvapan the results of these tests may not be correct. Tell the 
doctor requesting these tests that you have recently been given Celvapan. 

 you have a bleeding condition or a bleeding problem or you bruise easily. 
 
If any of the above apply to you (or you are not sure), talk to your doctor or nurse before having 
Celvapan. This is because the vaccination may not be recommended, or may need to be delayed. 
 
Other medicines and Celvapan 
 
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including 
medicines obtained without a prescription or have recently been given any other vaccine. 
 
There is no information on administration of the vaccine Celvapan with other vaccines. However, if 
this cannot be avoided, the vaccines should be injected into separate limbs. In such cases, you should 
be aware that the side effects may be more intense. 
 
Pregnancy and breast-feeding 
 
Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. Your 
doctor will discuss with you whether you should be given Celvapan. 
 
The vaccine may be used during breast-feeding. 
 
Driving and using machines 
 
Some effects mentioned under section 4. “Possible side effects” may affect your ability to drive or use 
machines. 
 
 
3. How Celvapan is given 
 
Your doctor or nurse will administer the vaccine in accordance with official recommendations. 
The vaccine will be injected into a muscle (usually in the upper arm). The vaccine should never be 
given into a vein. 
 
Adults and older people: 
 
A dose (0.5 ml) of the vaccine will be given. 
A second dose of the vaccine should be given after an interval of at least three weeks. 
 
Children and adolescents aged 6 months to 17 years of age: 
 
A dose (0.5 ml) of the vaccine will be given. 
A second dose of the vaccine should be given after an interval of at least three weeks. 
 
Children aged less than 6 months: 
 
Vaccination is not currently recommended in this age group. 
 
When Celvapan is given for the first dose, it is recommended that Celvapan (and not another vaccine 
against (H1N1)v) be given for the complete vaccination course. 
 
 
4. Possible side effects 
 
Like all medicines, Celvapan can cause side effects, although not everybody gets them. 

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Allergic reactions may occur following vaccination, in rare cases leading to shock. Doctors are aware 
of this possibility and have emergency treatment available for use in such cases. 
 
Side effects from clinical studies in adults and older people 
 
The side effects listed below have occurred with Celvapan (H1N1)v in clinical studies in adults, 
including older people. In the clinical studies, most side effects were mild in nature and short term. 
 
Very common: 
 
 Headache 
 Feeling tired 
 
Common: 
 
 Runny nose and sore throat 
 Insomnia (difficulty sleeping) 
 Dizziness 
 Eye irritation 
 Stomach pain 
 Increased sweating 
 Rash, hives 
 Joint and muscle pain 
 Fever, shivering, generally feeling unwell 
 Pain, redness, swelling or a hard lump where the injection was given, reduced movement in the 

arm injected 
 
Side effects from clinical studies in children 
 
Children and adolescents 6 months to 17 years of age 
 
In a clinical study the frequency and type of side effects after the first and second injection were 
basically similar to that seen in the adult and older population using Celvapan. However, some 
differences in frequency and type of side effects were observed. Specifically, headache, vertigo 
(spinning feeling), cough, feeling sick, vomiting, diarrhoea, pain in the arms or legs and tiredness were 
observed commonly in children and adolescents. 
 
Additionally, in the case of the 9 to 17 year olds pain at the injection site was very common. 
 
In children aged 6 to 35 months disturbed sleep and fever were very common, and decreased appetite, 
restlessness, irritability, crying and drowsiness were common. 
 
Side effects from the Pandemic Observational Study with CELVAPAN (H1N1)v 
 
Results from a clinical study done on marketed vaccine confirmed the safety profile as observed in the 
clinical studies. The following adverse reactions were reported at a higher frequency category than in 
the other clinical studies: 
 
Adults aged 18 years and older: 
 
Very common: Pain and redness where the injection was given, aching muscles 
Uncommon: Influenza like illness 
 

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Children and adolescents aged 5 to 17 years: 
 
Very common: Feeling tired, headache 
Uncommon: Cough 
 
Children aged 6 months to 5 years: 
 
Very common: Redness where the injection was given, drowsiness, irritability, loss of appetite, crying 
 
 Clinical trials with a similar vaccine 
 
In a study with a similar influenza vaccine (containing a H5N1 vaccine strain) that included healthy 
adults and older people, subjects with a weakened immune system and patients with long-term 
conditions, the safety profile was similar to that in healthy adults. 
 
 Side effects observed during post-marketing surveillance 
 
The side effects listed below have occurred with Celvapan (H1N1)v in adults and children during the 
pandemic flu vaccination program. 
 
- Allergic reactions, including anaphylactic reactions leading to a dangerous decrease in blood 

pressure which, if untreated, may lead to shock. Your doctors know that this might happen and 
will have emergency treatment ready to use. 

- Fits due to fever 
- Reduced skin sensitivity 
- Pain in arms and or legs (in the majority of cases reported as pain in the vaccination arm) 
- Flu-like illness 
- Swelling of tissue just below the skin. 
 
 Side effects observed with flu vaccines given routinely every year 
 
The side effects listed below have occurred in the days or weeks after vaccination with vaccines given 
routinely every year to prevent flu. They may also happen with Celvapan. 
 
Uncommon: 
 
 generalized skin reactions including urticaria (hives) 
 
Rare: 
 
 severe stabbing or throbbing pain along one or more nerves 
 low blood platelet count which can result in bleeding or bruising 
 
Very rare: 
 
 vasculitis (inflammation of blood vessels which can cause skin rashes, joint pain and kidney 

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

neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome 
 
If any of these side effects occur, please tell your doctor or nurse immediately. 
 
Reporting of side effects 
If you get any of the side effects talk to your doctor. 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. 

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5. How to store Celvapan 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use Celvapan 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. 
 
After first opening the vial is to be used within a maximum of 3 hours. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist what to do 
with medicines you no longer use. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Celvapan contains 
 
Active substance: 
 
Whole virion influenza vaccine, inactivated, containing antigen of strain*: 
 
A/California/07/2009 (H1N1)v 7.5 micrograms** 
per 0.5 ml dose 
 
* propagated in Vero cells (continuous cell line of mammalian origin) 
** haemagglutinin 
 
Other ingredients: 
 
The other ingredients are: trometamol, sodium chloride, water for injections, polysorbate 80. 
 
What Celvapan looks like and contents of the pack 
 
Celvapan is a clear to opalescent, translucent liquid. 
One pack of Celvapan contains 20 multidose vials of 5 ml suspension for injection for 10 doses. 
 
Marketing Authorization Holder: 
 
Nanotherapeutics Bohumil, s.r.o. 
Bohumil 138 
28163 Jevany  
Czech Republic 
Manufacturer: 
 
Baxter AG 
Uferstrasse 15 
A-2304 Orth/Donau 
Austria 
 
 
 

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This leaflet was last revised in {month/YYYY} 
 
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 medical or health care professionals only: 
 
Prior to administration, the vaccine should be allowed to reach room temperature and the vial should 
be shaken well. 
 
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. 
 
The vaccine should not be administered intravascularly. 
 
Any unused vaccine or waste material should be disposed of in accordance with local requirements. 
 

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