Daronrix

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



 
 

  2 

 
1. NAME OF THE MEDICINAL PRODUCT 
 
Daronrix, suspension for injection in pre-filled syringe 
Pandemic influenza vaccine (whole virion, inactivated, adjuvanted) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Whole virion influenza vaccine of pandemic strain, inactivated, containing antigen* equivalent to: 
 
A/Vietnam/1194/2004 (H5N1)*** 15 micrograms**
 
per 0.5 ml dose  
 
* propagated in eggs 
** haemagglutinin 
*** adjuvanted by aluminium phosphate 0.45 milligrams Al3+ 
  and aluminium hydroxide, hydrated  0.05 milligrams Al3+
 
This vaccine complies with the WHO recommendation and EU decision for the pandemic. 
 
Excipients: 
 
Thiomersal 50 micrograms 
 
For a full list of excipients see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Suspension for injection. 
Turbid white 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. (see sections 4.2 and 5.1) 
 
4.2 Posology and method of administration 
 
Daronrix has been evaluated with a haemagglutinin content of 15 µg HA per dose in adults aged 18-60 
years following a 0, 21 day schedule. 
 
Adults from the age of 18 to 60 years will receive two doses of Daronrix, the first administered at an 
elected date, the second at least three weeks after the first dose for maximum efficacy. 
 
No data have been generated with Daronrix below 18 years of age. Therefore health care providers 
need to assess the benefits and potential risks of administering the vaccine in that population. 
 
For pregnant women, see section 4.6. 
 



 
 

  3 

For further information, see section 5.1. 
 
Immunisation should be carried out by intramuscular injection. 
 
4.3 Contraindications 
 
History of an anaphylactic reaction (i.e. life-threatening) to any of the constituents or trace residues 
(e.g. eggs, chicken protein, gentamicin sulphate) 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. 
 
See section 4.4. 
 
4.4 Special warnings and precautions for use 
 
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other 
than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to 
residues e.g. eggs, chicken protein, gentamicin sulphate. 
 
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. 
 
Daronrix should under no circumstances be administered intravascularly. 
 
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. 
 
A protective immune response may not be elicited in all vaccinees (see section 5.1). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Daronrix 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. 
 
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 HIV-1, Hepatitis C and especially HTLV-1 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. 
 
4.6  Pregnancy and lactation 
 
No data have been generated with Daronrix in pregnant women. Therefore health care providers need 
to assess the benefits and potential risks of administering the vaccine to pregnant women taking into 
consideration official recommendations. Data from vaccinations with interpandemic trivalent vaccines 
in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the 
vaccine. 
 
Daronrix may be used during lactation. 
 



 
 

  4 

4.7 Effects on ability to drive and use machines 
 
The vaccine is unlikely to produce an effect on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
• Clinical trials 
 
Adverse reactions from clinical trials with different formulations (H5N1, H2N2 and H9N2) (N=941) 
of the mock-up vaccine are listed here below (see section 5.1 for more information on mock-up 
vaccines). Two hundred and one subjects received the monovalent aluminium-adjuvanted whole virus 
vaccine (A/H5N1). 
 
The incidence of symptoms observed in subjects >60 years of age was lower as compared to the 18-60 
years old population. 
 
Undesirable effects reported are listed according to the following frequency: 
 
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) 
 
Infections and infestations 
Uncommon: nasopharyngitis, rhinitis 
 
Nervous system disorders 
Very common: headache 
 
Skin and subcutaneous tissue disorders 
Common: sweating increase, ecchymosis 
 
Musculoskeletal and connective tissue disorders 
Common: myalgia, arthralgia 
 
General disorders and administration site conditions 
Very common: pain and redness at the site of injection, fatigue  
Common: swelling and induration at the site of injection, shivering, fever 
Uncommon: injection site pruritis 
 
These reactions usually disappear within 1-2 days without treatment. 
 
• Post-marketing surveillance 
 
From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse events 
have been reported: 
 
Uncommon (≥1/1,000 to <1/100):  
Generalised skin reactions including pruritus, urticaria or non-specific rash. 
 
Rare (≥1/10,000 to <1/1,000):  
Neuralgia, paraesthesia, convulsions, transient thrombocytopenia. 
Allergic reactions, in rare cases leading to shock, have been reported. 



 
 

  5 

 
Very rare (<1/10,000): 
Vasculitis with transient renal involvement. 
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome. 
 
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and 
therefore, it is possible that sensitisation reactions may occur (see section 4.4). 
 
4.9 Overdose 
 
No case of overdose has been reported. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01. 
 
This section describes the clinical experience with the mock-up vaccines 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.   
 
A clinical study has evaluated the immunogenicity of the monovalent aluminium-adjuvanted whole 
virus vaccine (A/H5N1) with a haemagglutinin content of 15 µg HA per dose in adults aged 18-60 
years (N=48) following a 0, 21 day schedule. 
 
The seroprotection rate, the seroconversion rate and seroconversion factor for anti-HA antibody were 
as follows: 
 
anti-HA antibody 21 days after 1st dose 

 
21 days after 2nd dose 

Seroprotection rate* 50.0% (95% CI: 35.2;64.8) 70.8% (95% CI: 55.9;83.0) 
Seroconversion rate 47.9% (95% CI: 33.3;62.8) 70.8% (95% CI: 55.9;83.0) 
Seroconversion factor 6 (95% CI: 3.5;10.1) 12.4 (95% CI: 7.1;21.8) 
* anti-HA ≥1:40 
 
In this clinical study, the immunogenicity of the monovalent aluminium-adjuvanted whole virus 
vaccine (A/H5N1) with a haemagglutinin content of 27µg HA per dose in adults aged 18-60 years 
(N=49) was also evaluated following a 0, 21 day schedule. 
 
The seroprotection rate, the seroconversion rate and seroconversion factor for anti-HA antibody were 
as follows 21 days after the first dose: 
 
anti-HA antibody 21 days after 1st dose 

 
Seroprotection rate* 73.5% (95% CI: 58.9;85.0) 
Seroconversion rate 69.4% (95% CI: 54.6;81.7) 
Seroconversion factor 14.5 (95% CI: 8.3;25.4) 



 
 

  6 

* anti-HA ≥1:40 
 
No clinical data have been generated in subjects below 18 years of age.  
 
Although no clinical data have been generated with Daronrix in subjects >60 years of age, the 
immunogenicity of a mock up formulation with different antigen doses of an aluminium-adjuvanted 
whole virus vaccine (A/H9N2) administered at 0, 21 days was evaluated in a clinical trial in this 
population. These results indicated that higher antigen content may be needed in subjects above 60 
years of age as compared to an adult population (18-60 years) in order to ensure optimal protection. 
 
The persistence of antibodies for the mock-up vaccines varies.  With interpandemic trivalent vaccines, 
it is usually 6 - 12 months, but for Daronrix no data are available yet with the H5N1 strain.  
 
In a clinical study where a mock-up formulation of aluminium-adjuvanted whole virus vaccine 
(AH9/N2) containing 3.8 µg HA was evaluated following a 0, 10 day schedule, it has been shown that 
a faster onset of protection could be reached as compared to the recommended 0, 21 day schedule. 
However data suggested that the duration of protection might be shorter. In circumstances when a fast 
onset of protection is needed, a third dose might therefore be necessary to ensure duration of 
protection. 
 
Daronrix 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 (EMEA) will review any new information which may become 
available every year and this SPC will be updated as necessary. 
 
5.2 Pharmacokinetic properties 
 
Not applicable. 
 
5.3  Preclinical safety data 
 
Not applicable. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium chloride 
Disodium phosphate dodecahydrate 
Potassium dihydrogen phosphate 
Potassium chloride 
Magnesium chloride hexahydrate 
Thiomersal  
Water for injections 
 
For adjuvants, see section 2. 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 



 
 

  7 

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 container 
 
0.5 ml in pre-filled syringe (type I glass) with a plunger stopper (butyl) for 1 dose – pack sizes of 1 
and 10 with or without needles. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
The vaccine should be allowed to reach room temperature before use. Shake before use. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
rue de l'Institut 89 
B-1330 Rixensart, Belgium 
 
 
8.  MARKETING AUTHORISATION NUMBER(S) 
 
 
9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
 
10. DATE OF REVISION OF THE TEXT 



 
 

  8 

 
1. NAME OF THE MEDICINAL PRODUCT 
 
Daronrix, suspension for injection. 
Pandemic influenza vaccine (whole virion, inactivated, adjuvanted) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Whole virion influenza vaccine of pandemic strain, inactivated, containing antigen* equivalent to: 
 
A/Vietnam/1194/2004 (H5N1)*** 15 micrograms**
 
per 0.5 ml dose  
 
* propagated in eggs 
** haemagglutinin 
*** adjuvanted by aluminium phosphate 0.45 milligrams Al3+ 
  and aluminium hydroxide, hydrated  0.05 milligrams Al3+
 
This vaccine complies with the WHO recommendation and EU decision for the pandemic. 
 
Excipients: 
 
Thiomersal 50 micrograms 
 
For a full list of excipients see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Suspension for injection. 
Turbid white 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. (see sections 4.2 and 5.1) 
 
4.2 Posology and method of administration 
 
Daronrix has been evaluated with a haemagglutinin content of 15 µg HA per dose in adults aged 18-60 
years following a 0, 21 day schedule. 
 
Adults from the age of 18 to 60 years will receive two doses of Daronrix, the first administered at an 
elected date, the second at least three weeks after the first dose for maximum efficacy. 
 
No data have been generated with Daronrix below 18 years of age. Therefore health care providers 
need to assess the benefits and potential risks of administering the vaccine in that population. 
 
For pregnant women, see section 4.6. 
 



 
 

  9 

For further information, see section 5.1. 
 
Immunisation should be carried out by intramuscular injection. 
 
4.3 Contraindications 
 
History of an anaphylactic reaction (i.e. life-threatening) to any of the constituents or trace residues 
(e.g. eggs, chicken protein, gentamicin sulphate) 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. 
 
See section 4.4. 
 
4.4 Special warnings and precautions for use 
 
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other 
than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to 
residues e.g. eggs, chicken protein, gentamicin sulphate. 
 
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. 
 
Daronrix should under no circumstances be administered intravascularly. 
 
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. 
 
A protective immune response may not be elicited in all vaccinees (see section 5.1). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Daronrix 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. 
 
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 HIV-1, Hepatitis C and especially HTLV-1 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. 
 
4.6  Pregnancy and lactation 
 
No data have been generated with Daronrix in pregnant women. Therefore health care providers need 
to assess the benefits and potential risks of administering the vaccine to pregnant women taking into 
consideration official recommendations. Data from vaccinations with interpandemic trivalent vaccines 
in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the 
vaccine. 
 
Daronrix may be used during lactation. 
 



 
 

  10 

4.7 Effects on ability to drive and use machines 
 
The vaccine is unlikely to produce an effect on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
• Clinical trials 
 
Adverse reactions from clinical trials with different formulations (H5N1, H2N2 and H9N2) (N=941) 
of the mock-up vaccine are listed here below (see section 5.1 for more information on mock-up 
vaccines). Two hundred and one subjects received the monovalent aluminium-adjuvanted whole virus 
vaccine (A/H5N1). 
 
The incidence of symptoms observed in subjects >60 years of age was lower as compared to the 18-60 
years old population. 
 
Undesirable effects reported are listed according to the following frequency: 
 
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) 
 
Infections and infestations 
Uncommon: nasopharyngitis, rhinitis 
 
Nervous system disorders 
Very common: headache 
 
Skin and subcutaneous tissue disorders 
Common: sweating increase, ecchymosis 
 
Musculoskeletal and connective tissue disorders 
Common: myalgia, arthralgia 
 
General disorders and administration site conditions 
Very common: pain and redness at the site of injection, fatigue  
Common: swelling and induration at the site of injection, shivering, fever 
Uncommon: injection site pruritis 
 
These reactions usually disappear within 1-2 days without treatment. 
 
• Post-marketing surveillance 
 
From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse events 
have been reported: 
 
Uncommon (≥1/1,000 to <1/100):  
Generalised skin reactions including pruritus, urticaria or non-specific rash. 
 
Rare (≥1/10,000 to <1/1,000):  
Neuralgia, paraesthesia, convulsions, transient thrombocytopenia. 
Allergic reactions, in rare cases leading to shock, have been reported. 



 
 

  11 

 
Very rare (<1/10,000): 
Vasculitis with transient renal involvement. 
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome. 
 
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and 
therefore, it is possible that sensitisation reactions may occur (see section 4.4). 
 
4.9 Overdose 
 
No case of overdose has been reported. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01. 
 
This section describes the clinical experience with the mock-up vaccines 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.   
 
A clinical study has evaluated the immunogenicity of the monovalent aluminium-adjuvanted whole 
virus vaccine (A/H5N1) with a haemagglutinin content of 15 µg HA per dose in adults aged 18-60 
years (N=48) following a 0, 21 day schedule. 
 
The seroprotection rate, the seroconversion rate and seroconversion factor for anti-HA antibody were 
as follows: 
 
anti-HA antibody 21 days after 1st dose 

 
21 days after 2nd dose 

Seroprotection rate* 50.0% (95% CI: 35.2;64.8) 70.8% (95% CI: 55.9;83.0) 
Seroconversion rate 47.9% (95% CI: 33.3;62.8) 70.8% (95% CI: 55.9;83.0) 
Seroconversion factor 6 (95% CI: 3.5;10.1) 12.4 (95% CI: 7.1;21.8) 
* anti-HA ≥1:40 
 
In this clinical study, the immunogenicity of the monovalent aluminium-adjuvanted whole virus 
vaccine (A/H5N1) with a haemagglutinin content of 27µg HA per dose in adults aged 18-60 years 
(N=49) was also evaluated following a 0, 21 day schedule. 
 
The seroprotection rate, the seroconversion rate and seroconversion factor for anti-HA antibody were 
as follows 21 days after the first dose: 
 
anti-HA antibody 21 days after 1st dose 

 
Seroprotection rate* 73.5% (95% CI: 58.9;85.0) 
Seroconversion rate 69.4% (95% CI: 54.6;81.7) 
Seroconversion factor 14.5 (95% CI: 8.3;25.4) 



 
 

  12 

* anti-HA ≥1:40 
 
No clinical data have been generated in subjects below 18 years of age.  
 
Although no clinical data have been generated with Daronrix in subjects >60 years of age, the 
immunogenicity of a mock up formulation with different antigen doses of an aluminium-adjuvanted 
whole virus vaccine (A/H9N2) administered at 0, 21 days was evaluated in a clinical trial in this 
population. These results indicated that higher antigen content may be needed in subjects above 60 
years of age as compared to an adult population (18-60 years) in order to ensure optimal protection. 
 
The persistence of antibodies for the mock-up vaccines varies.  With interpandemic trivalent vaccines, 
it is usually 6 - 12 months, but for Daronrix no data are available yet with the H5N1 strain.  
 
In a clinical study where a mock-up formulation of aluminium-adjuvanted whole virus vaccine 
(AH9/N2) containing 3.8 µg HA was evaluated following a 0, 10 day schedule, it has been shown that 
a faster onset of protection could be reached as compared to the recommended 0, 21 day schedule. 
However data suggested that the duration of protection might be shorter. In circumstances when a fast 
onset of protection is needed, a third dose might therefore be necessary to ensure duration of 
protection. 
 
Daronrix 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 (EMEA) will review any new information which may become 
available every year and this SPC will be updated as necessary. 
 
5.2 Pharmacokinetic properties 
 
Not applicable. 
 
5.3  Preclinical safety data 
 
Not applicable. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium chloride 
Disodium phosphate dodecahydrate 
Potassium dihydrogen phosphate 
Potassium chloride 
Magnesium chloride hexahydrate 
Thiomersal  
Water for injections 
 
For adjuvants, see section 2. 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 



 
 

  13 

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 container 
 
0.5 ml in ampoule (type I glass) for 1 dose – pack size of 100 
 
6.6 Special precautions for disposal 
 
The vaccine should be allowed to reach room temperature before use. Shake before use. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
rue de l'Institut 89 
B-1330 Rixensart, Belgium 
 
 
8.  MARKETING AUTHORISATION NUMBER(S) 
 
 
9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE  AUTHORISATION 
 
 
10. DATE OF REVISION OF THE TEXT 



 
 

  14 

 
1. NAME OF THE MEDICINAL PRODUCT 
 
Daronrix, suspension for injection in multidose container 
Pandemic influenza vaccine (whole virion, inactivated, adjuvanted) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Whole virion influenza vaccine of pandemic strain, inactivated, containing antigen* equivalent to: 
 
A/Vietnam/1194/2004 (H5N1)*** 15 micrograms**
 
per 0.5 ml dose  
 
* propagated in eggs 
** haemagglutinin 
*** adjuvanted by aluminium phosphate 0.45 milligrams Al3+ 
 and aluminium hydroxide, hydrated  0.05 milligrams Al3+
 
This vaccine complies with the WHO recommendation and EU decision for the pandemic situation. 
 
This is a multidose container.  See section 6.5 for the number of doses per vial. 
 
Excipients: 
 
Thiomersal 50 micrograms 
 
For a full list of excipients see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Suspension for injection. 
Turbid white 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. (see sections 4.2 and 5.1) 
 
4.2 Posology and method of administration 
 
Daronrix has been evaluated with a haemagglutinin content of 15 µg HA per dose in adults aged 18-60 
years following a 0, 21 day schedule. 
 
Adults from the age of 18 to 60 years will receive two doses of Daronrix, the first administered at an 
elected date, the second at least three weeks after the first dose for maximum efficacy. 
 
No data have been generated with Daronrix below 18 years of age. Therefore health care providers 
need to assess the benefits and potential risks of administering the vaccine in that population. 
 



 
 

  15 

For pregnant women, see section 4.6. 
 
For further information, see section 5.1. 
 
Immunisation should be carried out by intramuscular injection. 
 
4.3 Contraindications 
 
History of an anaphylactic reaction (i.e. life-threatening) to any of the constituents or trace residues 
(e.g. eggs, chicken protein, gentamicin sulphate) 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. 
 
See section 4.4. 
 
4.4 Special warnings and precautions for use 
 
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other 
than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to 
residues e.g. eggs, chicken protein, gentamicin sulphate. 
 
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. 
 
Daronrix should under no circumstances be administered intravascularly. 
 
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. 
 
A protective immune response may not be elicited in all vaccinees (see section 5.1). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Daronrix 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. 
 
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 HIV-1, Hepatitis C and especially HTLV-1 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. 
 
4.6  Pregnancy and lactation 
 
No data have been generated with Daronrix in pregnant women. Therefore health care providers need 
to assess the benefits and potential risks of administering the vaccine to pregnant women taking into 
consideration official recommendations. Data from vaccinations with interpandemic trivalent vaccines 
in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the 
vaccine. 
 



 
 

  16 

Daronrix may be used during lactation. 
 
4.7 Effects on ability to drive and use machines 
 
The vaccine is unlikely to produce an effect on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
• Clinical trials 
 
Adverse reactions from clinical trials with different formulations (H5N1, H2N2 and H9N2) (N=941) 
of the mock-up vaccine are listed here below (see section 5.1 for more information on mock-up 
vaccines). Two hundred and one subjects received the monovalent aluminium-adjuvanted whole virus 
vaccine (A/H5N1). 
 
The incidence of symptoms observed in subjects >60 years of age was lower as compared to the 18-60 
years old population. 
 
Undesirable effects reported are listed according to the following frequency: 
 
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) 
 
Infections and infestations 
Uncommon: nasopharyngitis, rhinitis 
 
Nervous system disorders 
Very common: headache 
 
Skin and subcutaneous tissue disorders 
Common: sweating increase, ecchymosis 
 
Musculoskeletal and connective tissue disorders 
Common: myalgia, arthralgia 
 
General disorders and administration site conditions 
Very common: pain and redness at the site of injection, fatigue  
Common: swelling and induration at the site of injection, shivering, fever 
Uncommon: injection site pruritis 
 
These reactions usually disappear within 1-2 days without treatment. 
 
• Post-marketing surveillance 
 
From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse events 
have been reported: 
 
Uncommon (≥1/1,000 to <1/100):  
Generalised skin reactions including pruritus, urticaria or non-specific rash. 
 
Rare (≥1/10,000 to <1/1,000):  



 
 

  17 

Neuralgia, paraesthesia, convulsions, transient thrombocytopenia. 
Allergic reactions, in rare cases leading to shock, have been reported. 
 
Very rare (<1/10,000): 
Vasculitis with transient renal involvement. 
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome. 
 
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and 
therefore, it is possible that sensitisation reactions may occur (see section 4.4). 
 
4.9 Overdose 
 
No case of overdose has been reported. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01. 
 
This section describes the clinical experience with the mock-up vaccines 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.   
 
A clinical study has evaluated the immunogenicity of the monovalent aluminium-adjuvanted whole 
virus vaccine (A/H5N1) with a haemagglutinin content of 15 µg HA per dose in adults aged 18-60 
years (N=48) following a 0, 21 day schedule. 
 
The seroprotection rate, the seroconversion rate and seroconversion factor for anti-HA antibody were 
as follows: 
 
anti-HA antibody 21 days after 1st dose 

 
21 days after 2nd dose 

Seroprotection rate* 50.0% (95% CI: 35.2;64.8) 70.8% (95% CI: 55.9;83.0) 
Seroconversion rate 47.9% (95% CI: 33.3;62.8) 70.8% (95% CI: 55.9;83.0) 
Seroconversion factor 6 (95% CI: 3.5;10.1) 12.4 (95% CI: 7.1;21.8) 
* anti-HA ≥1:40 
 
In this clinical study, the immunogenicity of the monovalent aluminium-adjuvanted whole virus 
vaccine (A/H5N1) with a haemagglutinin content of 27µg HA per dose in adults aged 18-60 years 
(N=49) was also evaluated following a 0, 21 day schedule. 
 
The seroprotection rate, the seroconversion rate and seroconversion factor for anti-HA antibody were 
as follows 21 days after the first dose: 
 
anti-HA antibody 21 days after 1st dose 

 
Seroprotection rate* 73.5% (95% CI: 58.9;85.0) 



 
 

  18 

Seroconversion rate 69.4% (95% CI: 54.6;81.7) 
Seroconversion factor 14.5 (95% CI: 8.3;25.4) 
* anti-HA ≥1:40 
 
No clinical data have been generated in subjects below 18 years of age.  
 
Although no clinical data have been generated with Daronrix in subjects >60 years of age, the 
immunogenicity of a mock up formulation with different antigen doses of an aluminium-adjuvanted 
whole virus vaccine (A/H9N2) administered at 0, 21 days was evaluated in a clinical trial in this 
population. These results indicated that higher antigen content may be needed in subjects above 60 
years of age as compared to an adult population (18-60 years) in order to ensure optimal protection. 
 
The persistence of antibodies for the mock-up vaccines varies.  With interpandemic trivalent vaccines, 
it is usually 6 - 12 months, but for Daronrix no data are available yet with the H5N1 strain.  
 
In a clinical study where a mock-up formulation of aluminium-adjuvanted whole virus vaccine 
(AH9/N2) containing 3.8 µg HA was evaluated following a 0, 10 day schedule, it has been shown that 
a faster onset of protection could be reached as compared to the recommended 0, 21 day schedule. 
However data suggested that the duration of protection might be shorter. In circumstances when a fast 
onset of protection is needed, a third dose might therefore be necessary to ensure duration of 
protection. 
 
Daronrix 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 (EMEA) will review any new information which may become 
available every year and this SPC will be updated as necessary. 
 
 
5.2 Pharmacokinetic properties 
 
Not applicable. 
 
5.3  Preclinical safety data 
 
Not applicable. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium chloride 
Disodium phosphate dodecahydrate 
Potassium dihydrogen phosphate 
Potassium chloride 
Magnesium chloride hexahydrate 
Thiomersal  
Water for injections 
 
For adjuvants, see section 2. 
 
6.2 Incompatibilities 
 



 
 

  19 

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
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 container 
 
5 ml in ampoule (type I glass) for 10 doses – pack size of 50 
5 ml in vial (type I glass) for 10 doses – pack size of 50 
10 ml in vial (type I glass) for 20 doses – pack size of 50 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
The vaccine should be allowed to reach room temperature before use. Shake before use. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
rue de l'Institut 89 
B-1330 Rixensart, Belgium 
 
 
8.  MARKETING AUTHORISATION NUMBER(S) 
 
 
9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE  AUTHORISATION 
 
 
10. DATE OF REVISION OF THE TEXT 
 



 
 

  20 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 

SUBSTANCE AND MANUFACTURING AUTHORISATION 
HOLDER RESPONSIBLE FOR BATCH RELEASE 

 
B. CONDITIONS OF THE MARKETING AUTHORISATION 
 
C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE 

MARKETING AUTHORISATION HOLDER 



 
 

  21 

 
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH 
RELEASE 
 
Name and address of the manufacturer of the biological active substance 
 
Sächsisches Serumwerk Dresden (SSW) 
Zirkusstraße 40 
D-01069 Dresden 
Germany 
 
Name and address of the manufacturer responsible for batch release 
 
Sächsisches Serumwerk Dresden (SSW) 
Zirkusstraβe 40 
D-01069 Dresden 
Germany 
 
 
B. CONDITIONS OF THE MARKETING AUTHORISATION 
 
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON 

THE MARKETING AUTHORISATION HOLDER 
 
Medicinal product subject to medical prescription. 
 
Daronrix 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 Daronrix takes due account of 
the officially declared pandemic strain. 
 
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
Not applicable 
 
• OTHER CONDITIONS 
 
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. 
 
Pharmacovigilance system 
 
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the 
product is placed on the market and for as long as the marketed product remains in use. 
 
The MAH commits to performing the studies and pharmacovigilance activities detailed in the 
Pharmacovigilance Plan. 
 
PSUR submission during the influenza pandemic:  

During a pandemic situation, the frequency of submission of periodic safety update reports 
specified in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety 
monitoring of a pandemic vaccine for which high levels of exposure are expected within a 
short period of time.  Such situation requires rapid notification of safety information that may 
have the greatest implications for risk-benefit balance in a pandemic.  Prompt analysis of 



 
 

  22 

cumulative safety information, in light of extent of exposure, will be crucial for regulatory 
decisions and protection of the population to be vaccinated.  In addition, duration a pandemic, 
resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as 
defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may 
not be adequate for a rapid identification of a new safety issue.  
In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza 
preparedness plan) and the pandemic vaccine is used, the MAH shall submit periodic safety 
update reports with periodicity and format defined as follows:  

 
Frequency of submission 

- The clock will start from the first Monday after shipment of the first batch of vaccine. 
- First data-lock point is 14 days later. 
- Report submission is no later than day 22 (i.e. the following Monday). 
- Reporting to be fortnightly for the first 3 months of the pandemic. 
- Periodicity will be reviewed by the MAH and the (Co-)Rapporteur at 3 monthly 

intervals.   
 
Format  
The report shall include the following Tables of aggregate data using the agreed templates: 

1. Fatal and/or life-threatening reactions – for each Preferred Term (PT), including the 
proportion of fatal reports  

2. Adverse Events of Special Interest (PTs)  
3. Serious unexpected reactions (PTs)  
4. All events occurring in the following age groups: 6-23 months, 2-8 years, 8-17 years, 

18-60 years, >60 years  
All events occurring in pregnant women  

5. All events reported by patients that have been entered into the database by data-lock 
point 

6. A cumulative overview of all events reported during the period, stratified according to 
type of reporter (patient or health care professional), seriousness, expectedness, and 
whether spontaneous or solicited. 

 
Presentation of data will take into consideration the following recommendations: 
- Serious expected reactions will be reviewed by the MAH as part of their signal detection 

procedures and will only form part of the report if an issue of concern arises.   
- All tables will be based on number of events (presented on PT level, sorted by System 

Organ Class [SOC]) and not number of cases. 
- Tables 1 to 4 will be based on events reported from healthcare professionals only. 
- In Tables 1 to 5, numbers will be provided for events received during the reporting period 

and cumulatively. 
- All tables will be based on generic and not product-specific data.  Product-specific data 

can be evaluated during signal work-up. 
- A measure of relative reporting rate of signals for each reported PT should be provided if 

possible (e.g. Proportional reporting ratio [PRR], Information Component [IC)] or the 
Empirical Bayesian Geometric Mean [EBMG]; this is not mandatory as all MAHs do not 
yet have this capability. 

- No line listings are required – these can be provided in signal evaluation reports as 
necessary. 

 
A short summary shall also be provided with the periodic safety update reports, in which any 
area of concern should be highlighted, signal work-up prioritised (if the event of multiple 
signals) and appropriate timelines for submission of a full signal evaluation report provided.  
All signal evaluation reports should be provided, including those that were subsequently not 
identified as being signals. 
 



 
 

  23 

A summary of vaccine distribution shall be included and 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 

 
 
Risk Management plan 
 
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk 
Management Systems for medicinal products for human use.  
 
 
C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING 
AUTHORISATION HOLDER 
 
The Marketing Authorisation Holder shall complete the following programme of studies within the 
specified time frame, the results of which shall form the basis of the annual reassessment of the 
benefit/risk profile. 
 
Clinical 
 

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. 

Pharmacovigilance 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. 

 



 
 

  24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



 
 

  25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



 
 

  26 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
MONODOSE PRESENTATION 
PREFILLED SYRINGE X 1  AND X 10 WITH AND WITHOUT NEEDLE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Daronrix, suspension for injection in a prefilled syringe. 
Pandemic influenza vaccine (whole virion, inactivated, adjuvanted) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Whole virion influenza vaccine of pandemic strain, inactivated, containing antigen* equivalent to: 
 
A/Vietnam/1194/2004 (H5N1)*** 15 micrograms**
 
per 0.5 ml dose  
 
* propagated in eggs 
** haemagglutinin 
*** adjuvanted by aluminium phosphate 0.45 milligrams Al3+ 
  and aluminium hydroxide, hydrated  0.05 milligrams Al3+
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride 
Disodium phosphate dodecahydrate 
Potassium dihydrogen phosphate 
Potassium chloride 
Magnesium chloride hexahydrate 
Thiomersal  
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection 
Prefilled syringe 
1 dose 
1 dose (0.5 ml) 
 
Prefilled syringe 
Needle 
10 x 1 dose 
1 dose (0.5 ml) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 



 
 

  27 

Intramuscular use 
Shake before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP: MM/YYYY 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a 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 regulations. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart, Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/0/00/000/000  
 
 
13. BATCH NUMBER 
 
Lot: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 



 
 

  28 

 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 



 
 

  29 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
AMPOULE X 100 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Daronrix, suspension for injection. 
Pandemic influenza vaccine (whole virion, inactivated, adjuvanted) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Whole virion influenza vaccine of pandemic strain, inactivated, containing antigen* equivalent to: 
 
A/Vietnam/1194/2004 (H5N1)*** 15 micrograms**
 
per 0.5 ml dose  
 
* propagated in eggs 
** haemagglutinin 
*** adjuvanted by aluminium phosphate 0.45 milligrams Al3+ 
  and aluminium hydroxide, hydrated  0.05 milligrams Al3+
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride 
Disodium phosphate dodecahydrate 
Potassium dihydrogen phosphate 
Potassium chloride 
Magnesium chloride hexahydrate 
Thiomersal  
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Ampoule 
100 x 1 dose 
1 dose (0.5 ml) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 
Intramuscular use 
Shake before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 



 
 

  30 

Keep out of the reach and sight of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP: MM/YYYY 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a 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 regulations. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart, Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/0/00/000/000  
 
 
13. BATCH NUMBER 
 
Lot: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 



 
 

  31 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
MULTIDOSE PRESENTATION 
VIAL (10 DOSES) X 50 
VIAL (20 DOSES) X 50 
AMPOULE (10 DOSES) X 50 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Daronrix, suspension for injection. 
Pandemic influenza vaccine (whole virion, inactivated, adjuvanted) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Whole virion influenza vaccine of pandemic strain, inactivated, containing antigen* equivalent to: 
 
A/Vietnam/1194/2004 (H5N1)*** 15 micrograms**
 
per 0.5 ml dose  
 
* propagated in eggs 
** haemagglutinin 
*** adjuvanted by aluminium phosphate 0.45 milligrams Al3+ 
  and aluminium hydroxide, hydrated  0.05 milligrams Al3+
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride 
Disodium phosphate dodecahydrate 
Potassium dihydrogen phosphate 
Potassium chloride 
Magnesium chloride hexahydrate 
Thiomersal  
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection 
Vial 
50 x 10 doses 
1 dose (0.5 ml) 
 
Vial 
50 x 20 doses 
1 dose (0.5 ml) 
 
Ampoule 
50 x 10 doses 
1 dose (0.5 ml) 



 
 

  32 

 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 
Intramuscular use 
Shake before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP: MM/YYYY 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a 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 regulations. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart, Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/0/00/000/000  
 
 
13. BATCH NUMBER 
 
Lot: 
 



 
 

  33 

 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 



 
 

  34 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
MONODOSE PRESENTATION 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Daronrix, suspension for injection. 
Pandemic influenza vaccine (whole virion, inactivated, adjuvanted) 
I.M. 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 dose (0.5 ml) 
 
 
6. OTHER 
 



 
 

  35 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
MULTIDOSE (10 DOSES) PRESENTATION 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Daronrix, suspension for injection. 
Pandemic influenza vaccine (whole virion, inactivated, adjuvanted) 
I.M. 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
10 doses (5 ml) 
 
 
6. OTHER 
 
 



 
 

  36 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
MULTIDOSE (20 DOSES) PRESENTATION 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Daronrix, suspension for injection. 
Pandemic influenza vaccine (whole virion, inactivated, adjuvanted) 
I.M. 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
20 doses (10 ml) 
 
 
6. OTHER 

 



 
 

  37 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



 
 

  38 

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

 
Daronrix, suspension for injection in pre-filled syringe 

Pandemic influenza vaccine (whole virion, inactivated, adjuvanted) 
 

Read all of this leaflet carefully before you start receiving this vaccine. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This vaccine has been prescribed for you. Do not pass it on to others.  
- If  any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, 

please tell your doctor or pharmacist. 
 
In this leaflet:  
1. What Daronrix is and what it is used for 
2. Before you receive Daronrix 
3. How Daronrix is given 
4. Possible side effects 
5. How to store Daronrix 
6. Further information 
 
 
1. WHAT DARONRIX IS AND WHAT IT IS USED FOR 
 
Daronrix is a vaccine used in adults aged 18 to 60 years to prevent influenza (flu) in an officially 
declared pandemic. The vaccine works by causing the body to produce its own protection (antibodies) 
against the disease. 
 
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 of pandemic flu are similar to those of 
“ordinary” flu but are usually more severe.   
 
 
2. BEFORE YOU RECEIVE DARONRIX  
 
Daronrix should not be given: 
 
• if you have previously had any allergic reaction to Daronrix, or any ingredient (including eggs, 

chicken protein, gentamicin sulphate (antibiotic)) contained in this vaccine.  The active 
substances and other ingredients in Daronrix are listed 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, it may be appropriate to give the vaccine, provided 
that facilities for resuscitation are immediately available in case of need. 

 
Take special care with Daronrix: 
 
• if you have a severe infection with a high temperature (over 38°C).  A minor infection such as a 

cold should not be a problem, but talk to your doctor first. 
 
Using other medicines  
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. 
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, Daronrix can still be given but your response to the 
vaccine may be poor. 



 
 

  39 

 
Pregnancy and breast-feeding 
There is no information on the use of Daronrix in pregnant women.  Your doctor needs to assess the 
benefits and potential risks of giving you the vaccine if you are pregnant. Please tell your doctor if you 
are pregnant. 
 
Daronrix may be used during lactation. 
 
Driving and using machines 
After administration of Daronrix, it is unlikely that side effects would unable you to drive or use 
machines. 
 
Important information about some of the ingredients of Daronrix 
Thiomersal (preservative) is present in this product, and it is possible that you may experience an 
allergic reaction. 
 
 
3. HOW IS DARONRIX GIVEN 
 
Adults from the age of 18 to 60 years will receive two injections of Daronrix, the first injection will be 
administered at an elected date, the second at least three weeks after the first injection. 
 
There is no information on the use of Daronrix below 18 years of age.  Your doctor needs to assess the 
benefits and potential risks of giving you the vaccine if you are below the age of 18 years. 
 
The doctor will give Daronrix as an injection into your upper arm muscle.   
 
The vaccine should never be given into a vein. 
 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. POSSIBLE SIDE EFFECTS 
 
Like all medicines, Daronrix can cause side effects, although not everybody gets them. 
 
♦ Very common (more than 1 per 10 doses of vaccine): 

• Headache 
• Fatigue 
• Pain and redness at the injection site 

 
♦ Common (less than 1 per 10 but more than 1 per 100 doses of vaccine): 

• Increased sweating, bruising 
• Aching muscles, joint pain 
• Swelling at the injection site, hard lump 
• Shivering, fever 

 
♦ Uncommon (less than 1 per 100 but more than 1 per 1000 doses of vaccine): 

• Sore nose and throat and discomfort when swallowing, runny nose 
• Itching at the injection site 

 
These reactions usually disappear within 1-2 days without treatment. 
 



 
 

  40 

Other side effects which have occurred in the days or weeks after vaccination with ordinary flu 
vaccines include: 
 
♦ Uncommon (less than 1 per 100 but more than 1 per 1000 doses of vaccine): 

• Generalised skin reactions such as itching, hives or rash 
 
♦ Rare (less than 1 per 1000 but more than 1 per 10,000 doses of vaccine): 

• Severe stabbing or throbbing pain along one or more nerves 
• Pins and needles 
• Fits 
• Low blood platelet count 
• Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, 

may lead to collapse, coma and death 
 
♦ Very rare (less than 1 per 10,000 doses of vaccine): 

• Narrowing or blockage of blood vessels with kidney problems 
• Inflammation of the brain and spinal column 
• Painful swelling in the arms or legs 
• Temporary inflammation of the nerves, causing pain, weakness and paralysis in the 

extremities and often progressing to the chest and face. 
 
Do not be alarmed by this list of possible side effects.  It is possible that you have no side effects from 
vaccination. 
 
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please 
tell your doctor or pharmacist. 
 
 
5. HOW TO STORE DARONRIX 
 
Keep out of the reach and sight of children. 
 
Do not use Daronrix 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.   
 
Medicines should not be disposed of via wastewater or household waste.  Ask your pharmacist how to 
dispose of medicines no longer required.  These measures will help to protect the environment. 
 
 
6. FURTHER INFORMATION 
 
What Daronrix contains 
 
- The active substances are: 

Whole virion influenza vaccine of pandemic strain, inactivated, containing antigen* equivalent 
to: 
 

 A/Vietnam/1194/2004 (H5N1)*** 15 micrograms**
 
per 0.5 ml dose  



 
 

  41 

 
* propagated in eggs 
** haemagglutinin 
*** adjuvanted by aluminium phosphate 0.45 milligrams Al3+ 
  and aluminium hydroxide, hydrated  0.05 milligrams Al3+

 
- The other ingredients are: sodium chloride, disodium phosphate dodecahydrate, potassium 

dihydrogen phosphate, potassium chloride, magnesium chloride hexahydrate, thiomersal, water 
for injections 

 
What Daronrix looks like and contents of the pack 
 
Daronrix is a white, slightly milky liquid and is presented in a pre-filled syringe (0.5 ml) for 1 dose in 
pack sizes of 1 and 10 with or without needles 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart 
Belgium 
 
Manufacturer 
Sächsisches Serumwerk Dresden (SSW) 
Zirkusstraße 40 
D-01069 Dresden 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
GlaxoSmithKline s.a./n.v. 
Tél/Tel: + 32 2 656 21 11 
 

Luxembourg/Luxemburg 
GlaxoSmithKline s.a./n.v. 
Tél/Tel: + 32 2 656 21 11 

България 
ГлаксоСмитКлайн ЕООД 
Тел.: + 359 2 953 10 34 

Magyarország 
GlaxoSmithKline Kft. 
Tel.: + 36-1-2255300 
 

Česká republika 
GlaxoSmithKline s.r.o. 
Tel: + 420 2 22 00 11 11 
gsk.czmail@gsk.com 
 

Malta 
GlaxoSmithKline Malta 
Tel: + 356 21 238131 
 

Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
info@glaxosmithkline.dk 
 

Nederland 
GlaxoSmithKline BV 
Tel: + 31 (0)30 69 38 100 
nlinfo@gsk.com 

Deutschland 
GlaxoSmithKline GmbH & Co. KG 
Tel: + 49 (0)89 360448701 
produkt.info@gsk.com 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
firmapost@gsk.no 



 
 

  42 

  
Eesti 
GlaxoSmithKline Eesti OÜ  
Tel: +372 667 6900 
estonia@gsk.com 
 

Österreich 
GlaxoSmithKline Pharma GmbH. 
Tel: + 43 1 970 75-0 
at.info@gsk.com  
 

Ελλάδα 
GlaxoSmithKline A.E.B.E 
Tηλ: + 30 210 68 82 100 
 

Polska 
GSK Commercial Sp. z o.o. 
Tel.: + 48 (22) 576 9000 
 

España 
GlaxoSmithKline, S.A. 
Tel: + 34 902 202 700 
es-ci@gsk.com  
 

Portugal 
Smith Kline & French Portuguesa, Produtos 
Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com
 

France 
Laboratoire GlaxoSmithKline 
Tél: + 33 (0) 1 39 17 84 44 
diam@gsk.com 
 

România 
GlaxoSmithKline (GSK) SRL  
Tel: + 40 (0)21 3028 208 
www.gsk.ro
 

Ireland 
GlaxoSmithKline (Ireland) Ltd 
Tel: + 353 (0)1 4955000 
 

Slovenija 
GlaxoSmithKline d.o.o. 
Tel: + 386 (0) 1 280 25 00 
medical.x.si@gsk.com 
 

Ísland 
GlaxoSmithKline ehf. 
Sími: +354-530 3700 
 

Slovenská republika 
GlaxoSmithKline Slovakia s.r.o. 
Tel: + 421 (0)2 49 10 33 11 
recepcia.sk@gsk.com 
 

Italia 
GlaxoSmithKline S.p.A. 
Tel:+ 39 04 59 21 81 11 
 

Suomi/Finland 
GlaxoSmithKline Oy 
Puh/Tel: + 358 10 30 30 30 
Finland.tuoteinfo@gsk.com  
 

Κύπρος 
GlaxoSmithKline Cyprus Ltd 
Τηλ: + 357 22 89 95 01 
 

Sverige 
GlaxoSmithKline AB 
Tel: + 46 (0)8 638 93 00 
info.produkt@gsk.com
 

Latvija 
GlaxoSmithKline Latvia SIA 
Tel: + 371 7312687 
lv-epasts@gsk.com 
 

United Kingdom 
GlaxoSmithKline UK 
Tel: + 44 (0)808 100 9997 
customercontactuk@gsk.com 
 

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel. +370 5 264 90 00 
info.lt@gsk.com 
 

 

This leaflet was last approved in {MM/YYYY}. 
 

mailto:FI.PT@gsk.com
http://www.gsk.ro/
mailto:info.produkt@gsk.com


 
 

  43 

Daronrix 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 (EMEA) will review any new information on the medicine every 
year and this leaflet will be updated as necessary. 
 
 
 
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web 
site: http://www.emea.europa.eu/

http://www.emea.eu.int/


 
 

  44 

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

 
Daronrix, suspension for injection. 

Pandemic influenza vaccine (whole virion, inactivated, adjuvanted) 
 

Read all of this leaflet carefully before you start receiving this vaccine. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This vaccine has been prescribed for you. Do not pass it on to others.  
- If  any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, 

please tell your doctor or pharmacist. 
 
In this leaflet:  
1. What Daronrix is and what it is used for 
2. Before you receive Daronrix 
3. How Daronrix is given 
4. Possible side effects 
6. How to store Daronrix 
6. Further information 
 
 
1. WHAT DARONRIX IS AND WHAT IT IS USED FOR 
 
Daronrix is a vaccine used in adults aged 18 to 60 years to prevent influenza (flu) in an officially 
declared pandemic. The vaccine works by causing the body to produce its own protection (antibodies) 
against the disease. 
 
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 of pandemic flu are similar to those of 
“ordinary” flu but are usually more severe.   
 
 
2. BEFORE YOU RECEIVE DARONRIX  
 
Daronrix should not be given: 
 
• if you have previously had any allergic reaction to Daronrix, or any ingredient (including eggs, 

chicken protein, gentamicin sulphate (antibiotic)) contained in this vaccine.  The active 
substances and other ingredients in Daronrix are listed 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, it may be appropriate to give the vaccine, provided 
that facilities for resuscitation are immediately available in case of need. 

 
Take special care with Daronrix: 
 
• if you have a severe infection with a high temperature (over 38°C).  A minor infection such as a 

cold should not be a problem, but talk to your doctor first. 
 
Using other medicines  
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. 
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, Daronrix can still be given but your response to the 
vaccine may be poor. 



 
 

  45 

 
Pregnancy and breast-feeding 
There is no information on the use of Daronrix in pregnant women.  Your doctor needs to assess the 
benefits and potential risks of giving you the vaccine if you are pregnant. Please tell your doctor if you 
are pregnant. 
 
Daronrix may be used during lactation. 
 
Driving and using machines 
After administration of Daronrix, it is unlikely that side effects would unable you to drive or use 
machines. 
 
Important information about some of the ingredients of Daronrix 
Thiomersal (preservative) is present in this product, and it is possible that you may experience an 
allergic reaction. 
 
 
3. HOW IS DARONRIX GIVEN 
 
Adults from the age of 18 to 60 years will receive two injections of Daronrix, the first injection will be 
administered at an elected date, the second at least three weeks after the first injection. 
 
There is no information on the use of Daronrix below 18 years of age.  Your doctor needs to assess the 
benefits and potential risks of giving you the vaccine if you are below the age of 18 years. 
 
The doctor will give Daronrix as an injection into your upper arm muscle.   
 
The vaccine should never be given into a vein. 
 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. POSSIBLE SIDE EFFECTS 
 
Like all medicines, Daronrix can cause side effects, although not everybody gets them. 
 
♦ Very common (more than 1 per 10 doses of vaccine): 

• Headache 
• Fatigue 
• Pain and redness at the injection site 

 
♦ Common (less than 1 per 10 but more than 1 per 100 doses of vaccine): 

• Increased sweating, bruising 
• Aching muscles, joint pain 
• Swelling at the injection site, hard lump 
• Shivering, fever 

 
♦ Uncommon (less than 1 per 100 but more than 1 per 1000 doses of vaccine): 

• Sore nose and throat and discomfort when swallowing, runny nose 
• Itching at the injection site 

 
These reactions usually disappear within 1-2 days without treatment. 
 



 
 

  46 

Other side effects which have occurred in the days or weeks after vaccination with ordinary flu 
vaccines include: 
 
♦ Uncommon (less than 1 per 100 but more than 1 per 1000 doses of vaccine): 

• Generalised skin reactions such as itching, hives or rash 
 
♦ Rare (less than 1 per 1000 but more than 1 per 10,000 doses of vaccine): 

• Severe stabbing or throbbing pain along one or more nerves 
• Pins and needles 
• Fits 
• Low blood platelet count 
• Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, 

may lead to collapse, coma and death 
 
♦ Very rare (less than 1 per 10,000 doses of vaccine): 

• Narrowing or blockage of blood vessels with kidney problems 
• Inflammation of the brain and spinal column 
• Painful swelling in the arms or legs 
• Temporary inflammation of the nerves, causing pain, weakness and paralysis in the 

extremities and often progressing to the chest and face. 
 
Do not be alarmed by this list of possible side effects.  It is possible that you have no side effects from 
vaccination. 
 
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please 
tell your doctor or pharmacist. 
 
 
5. HOW TO STORE DARONRIX 
 
Keep out of the reach and sight of children. 
 
Do not use Daronrix 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.   
 
Medicines should not be disposed of via wastewater or household waste.  Ask your pharmacist how to 
dispose of medicines no longer required.  These measures will help to protect the environment. 
 
 
6. FURTHER INFORMATION 
 
What Daronrix contains 
 
- The active substances are: 

Whole virion influenza vaccine of pandemic strain, inactivated, containing antigen* equivalent 
to: 
 

 A/Vietnam/1194/2004 (H5N1)*** 15 micrograms**
 
per 0.5 ml dose  



 
 

  47 

 
* propagated in eggs 
** haemagglutinin 
*** adjuvanted by aluminium phosphate 0.45 milligrams Al3+ 
  and aluminium hydroxide, hydrated  0.05 milligrams Al3+

 
- The other ingredients are: sodium chloride, disodium phosphate dodecahydrate, potassium 

dihydrogen phosphate, potassium chloride, magnesium chloride hexahydrate, thiomersal, water 
for injections 

 
What Daronrix looks like and contents of the pack 
 
Daronrix is a white, slightly milky liquid and is presented as follows in an ampoule (0.5 ml) for 1 dose 
in a pack of 100 
 
Marketing Authorisation Holder 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart 
Belgium 
 
Manufacturer 
Sächsisches Serumwerk Dresden (SSW) 
Zirkusstraße 40 
D-01069 Dresden 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
GlaxoSmithKline s.a./n.v. 
Tél/Tel: + 32 2 656 21 11 
 

Luxembourg/Luxemburg 
GlaxoSmithKline s.a./n.v. 
Tél/Tel: + 32 2 656 21 11 

България 
ГлаксоСмитКлайн ЕООД 
Тел.: + 359 2 953 10 34 

Magyarország 
GlaxoSmithKline Kft. 
Tel.: + 36-1-2255300 
 

Česká republika 
GlaxoSmithKline s.r.o. 
Tel: + 420 2 22 00 11 11 
gsk.czmail@gsk.com 
 

Malta 
GlaxoSmithKline Malta 
Tel: + 356 21 238131 
 

Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
info@glaxosmithkline.dk 
 

Nederland 
GlaxoSmithKline BV 
Tel: + 31 (0)30 69 38 100 
nlinfo@gsk.com 

Deutschland 
GlaxoSmithKline GmbH & Co. KG 
Tel: + 49 (0)89 360448701 
produkt.info@gsk.com 
 
 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
firmapost@gsk.no 
 



 
 

  48 

Eesti 
GlaxoSmithKline Eesti OÜ  
Tel: +372 667 6900 
estonia@gsk.com 
 

Österreich 
GlaxoSmithKline Pharma GmbH. 
Tel: + 43 1 970 75-0 
at.info@gsk.com  
 

Ελλάδα 
GlaxoSmithKline A.E.B.E 
Tηλ: + 30 210 68 82 100 
 

Polska 
GSK Commercial Sp. z o.o. 
Tel.: + 48 (22) 576 9000 
 

España 
GlaxoSmithKline, S.A. 
Tel: + 34 902 202 700 
es-ci@gsk.com  
 

Portugal 
Smith Kline & French Portuguesa, Produtos 
Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com
 

France 
Laboratoire GlaxoSmithKline 
Tél: + 33 (0) 1 39 17 84 44 
diam@gsk.com 
 

România 
GlaxoSmithKline (GSK) SRL  
Tel: + 40 (0)21 3028 208 
www.gsk.ro
 

Ireland 
GlaxoSmithKline (Ireland) Ltd 
Tel: + 353 (0)1 4955000 
 

Slovenija 
GlaxoSmithKline d.o.o. 
Tel: + 386 (0) 1 280 25 00 
medical.x.si@gsk.com 
 

Ísland 
GlaxoSmithKline ehf. 
Sími: +354-530 3700 
 

Slovenská republika 
GlaxoSmithKline Slovakia s.r.o. 
Tel: + 421 (0)2 49 10 33 11 
recepcia.sk@gsk.com 
 

Italia 
GlaxoSmithKline S.p.A. 
Tel:+ 39 04 59 21 81 11 
 

Suomi/Finland 
GlaxoSmithKline Oy 
Puh/Tel: + 358 10 30 30 30 
Finland.tuoteinfo@gsk.com  
 

Κύπρος 
GlaxoSmithKline Cyprus Ltd 
Τηλ: + 357 22 89 95 01 
 

Sverige 
GlaxoSmithKline AB 
Tel: + 46 (0)8 638 93 00 
info.produkt@gsk.com
 

Latvija 
GlaxoSmithKline Latvia SIA 
Tel: + 371 7312687 
lv-epasts@gsk.com 
 

United Kingdom 
GlaxoSmithKline UK 
Tel: + 44 (0)808 100 9997 
customercontactuk@gsk.com 
 

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel. +370 5 264 90 00 
info.lt@gsk.com 
 

 

This leaflet was last approved in {MM/YYYY}. 
 
Daronrix 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. 

mailto:FI.PT@gsk.com
http://www.gsk.ro/
mailto:info.produkt@gsk.com


 
 

  49 

The European Medicines Agency (EMEA) will review any new information on the medicine every 
year and this leaflet will be updated as necessary. 
 
 
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web 
site: http://www.emea.europa.eu/

http://www.emea.europa.eu/


 
 

  50 

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

 
Daronrix, suspension for injection in multidose container 

Pandemic influenza vaccine (whole virion, inactivated, adjuvanted) 
 

Read all of this leaflet carefully before you start receiving this vaccine. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This vaccine has been prescribed for you. Do not pass it on to others.  
- If  any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, 

please tell your doctor or pharmacist. 
 
In this leaflet:  
1. What Daronrix is and what it is used for 
2. Before you receive Daronrix 
3. How Daronrix is given 
4. Possible side effects 
7. How to store Daronrix 
6. Further information 
 
 
1. WHAT DARONRIX IS AND WHAT IT IS USED FOR 
 
Daronrix is a vaccine used in adults aged 18 to 60 years to prevent influenza (flu) in an officially 
declared pandemic. The vaccine works by causing the body to produce its own protection (antibodies) 
against the disease. 
 
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 of pandemic flu are similar to those of 
“ordinary” flu but are usually more severe.   
 
 
2. BEFORE YOU RECEIVE DARONRIX  
 
Daronrix should not be given: 
 
• if you have previously had any allergic reaction to Daronrix, or any ingredient (including eggs, 

chicken protein, gentamicin sulphate (antibiotic)) contained in this vaccine.  The active 
substances and other ingredients in Daronrix are listed 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, it may be appropriate to give the vaccine, provided 
that facilities for resuscitation are immediately available in case of need. 

 
Take special care with Daronrix: 
 
• if you have a severe infection with a high temperature (over 38°C).  A minor infection such as a 

cold should not be a problem, but talk to your doctor first. 
 
Using other medicines  
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. 
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, Daronrix can still be given but your response to the 
vaccine may be poor. 



 
 

  51 

 
Pregnancy and breast-feeding 
There is no information on the use of Daronrix in pregnant women.  Your doctor needs to assess the 
benefits and potential risks of giving you the vaccine if you are pregnant. Please tell your doctor if you 
are pregnant. 
 
Daronrix may be used during lactation. 
 
Driving and using machines 
After administration of Daronrix, it is unlikely that side effects would unable you to drive or use 
machines. 
 
Important information about some of the ingredients of Daronrix 
Thiomersal (preservative) is present in this product, and it is possible that you may experience an 
allergic reaction. 
 
 
3. HOW IS DARONRIX GIVEN 
 
Adults from the age of 18 to 60 years will receive two injections of Daronrix, the first injection will be 
administered at an elected date, the second at least three weeks after the first injection. 
 
There is no information on the use of Daronrix below 18 years of age.  Your doctor needs to assess the 
benefits and potential risks of giving you the vaccine if you are below the age of 18 years. 
 
The doctor will give Daronrix as an injection into your upper arm muscle.   
 
The vaccine should never be given into a vein. 
 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. POSSIBLE SIDE EFFECTS 
 
Like all medicines, Daronrix can cause side effects, although not everybody gets them. 
 
♦ Very common (more than 1 per 10 doses of vaccine): 

• Headache 
• Fatigue 
• Pain and redness at the injection site 

 
♦ Common (less than 1 per 10 but more than 1 per 100 doses of vaccine): 

• Increased sweating, bruising 
• Aching muscles, joint pain 
• Swelling at the injection site, hard lump 
• Shivering, fever 

 
♦ Uncommon (less than 1 per 100 but more than 1 per 1000 doses of vaccine): 

• Sore nose and throat and discomfort when swallowing, runny nose 
• Itching at the injection site 

 
These reactions usually disappear within 1-2 days without treatment. 
 



 
 

  52 

Other side effects which have occurred in the days or weeks after vaccination with ordinary flu 
vaccines include: 
 
♦ Uncommon (less than 1 per 100 but more than 1 per 1000 doses of vaccine): 

• Generalised skin reactions such as itching, hives or rash 
 
♦ Rare (less than 1 per 1000 but more than 1 per 10,000 doses of vaccine): 

• Severe stabbing or throbbing pain along one or more nerves 
• Pins and needles 
• Fits 
• Low blood platelet count 
• Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, 

may lead to collapse, coma and death 
 
♦ Very rare (less than 1 per 10,000 doses of vaccine): 

• Narrowing or blockage of blood vessels with kidney problems 
• Inflammation of the brain and spinal column 
• Painful swelling in the arms or legs 
• Temporary inflammation of the nerves, causing pain, weakness and paralysis in the 

extremities and often progressing to the chest and face. 
 
Do not be alarmed by this list of possible side effects.  It is possible that you have no side effects from 
vaccination. 
 
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please 
tell your doctor or pharmacist. 
 
 
5. HOW TO STORE DARONRIX 
 
Keep out of the reach and sight of children. 
 
Do not use Daronrix 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.   
 
Medicines should not be disposed of via wastewater or household waste.  Ask your pharmacist how to 
dispose of medicines no longer required.  These measures will help to protect the environment. 
 
 
6. FURTHER INFORMATION 
 
What Daronrix contains 
 
- The active substances are: 

Whole virion influenza vaccine of pandemic strain, inactivated, containing antigen* equivalent 
to: 
 

 A/Vietnam/1194/2004 (H5N1)*** 15 micrograms**
 
per 0.5 ml dose  



 
 

  53 

 
* propagated in eggs 
** haemagglutinin 
*** adjuvanted by aluminium phosphate 0.45 milligrams Al3+ 
  and aluminium hydroxyde, hydrated  0.05 milligrams Al3+

 
- The other ingredients are: sodium chloride, disodium phosphate dodecahydrate, potassium 

dihydrogen phosphate, potassium chloride, magnesium chloride hexahydrate, thiomersal, water 
for injections 

 
What Daronrix looks like and contents of the pack 
 
Daronrix is a white, slightly milky liquid and is presented as follows: 
- in an ampoule (5 ml) for 10 doses in a pack of 50 
- in a vial (5 ml) for 10 doses in a pack of 50 
- in a vial (10 ml) for 20 doses in a pack of 50 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart 
Belgium 
 
Manufacturer 
Sächsisches Serumwerk Dresden (SSW) 
Zirkusstraße 40 
D-01069 Dresden 
Germany 
 
For any information about thismedicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
GlaxoSmithKline s.a./n.v. 
Tél/Tel: + 32 2 656 21 11 
 

Luxembourg/Luxemburg 
GlaxoSmithKline s.a./n.v. 
Tél/Tel: + 32 2 656 21 11 

България 
ГлаксоСмитКлайн ЕООД 
Тел.: + 359 2 953 10 34 

Magyarország 
GlaxoSmithKline Kft. 
Tel.: + 36-1-2255300 
 

Česká republika 
GlaxoSmithKline s.r.o. 
Tel: + 420 2 22 00 11 11 
gsk.czmail@gsk.com 
 

Malta 
GlaxoSmithKline Malta 
Tel: + 356 21 238131 
 

Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
info@glaxosmithkline.dk 
 
 
 

Nederland 
GlaxoSmithKline BV 
Tel: + 31 (0)30 69 38 100 
nlinfo@gsk.com 



 
 

  54 

Deutschland 
GlaxoSmithKline GmbH & Co. KG 
Tel: + 49 (0)89 360448701 
produkt.info@gsk.com 
 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
firmapost@gsk.no 
 

Eesti 
GlaxoSmithKline Eesti OÜ  
Tel: +372 667 6900 
estonia@gsk.com 
 

Österreich 
GlaxoSmithKline Pharma GmbH. 
Tel: + 43 1 970 75-0 
at.info@gsk.com  
 

Ελλάδα 
GlaxoSmithKline A.E.B.E 
Tηλ: + 30 210 68 82 100 
 

Polska 
GSK Commercial Sp. z o.o. 
Tel.: + 48 (22) 576 9000 
 

España 
GlaxoSmithKline, S.A. 
Tel: + 34 902 202 700 
es-ci@gsk.com  
 

Portugal 
Smith Kline & French Portuguesa, Produtos 
Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com
 

France 
Laboratoire GlaxoSmithKline 
Tél: + 33 (0) 1 39 17 84 44 
diam@gsk.com 
 

România 
GlaxoSmithKline (GSK) SRL  
Tel: + 40 (0)21 3028 208 
www.gsk.ro
 

Ireland 
GlaxoSmithKline (Ireland) Ltd 
Tel: + 353 (0)1 4955000 
 

Slovenija 
GlaxoSmithKline d.o.o. 
Tel: + 386 (0) 1 280 25 00 
medical.x.si@gsk.com 
 

Ísland 
GlaxoSmithKline ehf. 
Sími: +354-530 3700 
 

Slovenská republika 
GlaxoSmithKline Slovakia s.r.o. 
Tel: + 421 (0)2 49 10 33 11 
recepcia.sk@gsk.com 
 

Italia 
GlaxoSmithKline S.p.A. 
Tel:+ 39 04 59 21 81 11 
 

Suomi/Finland 
GlaxoSmithKline Oy 
Puh/Tel: + 358 10 30 30 30 
Finland.tuoteinfo@gsk.com  
 

Κύπρος 
GlaxoSmithKline Cyprus Ltd 
Τηλ: + 357 22 89 95 01 
 

Sverige 
GlaxoSmithKline AB 
Tel: + 46 (0)8 638 93 00 
info.produkt@gsk.com
 

Latvija 
GlaxoSmithKline Latvia SIA 
Tel: + 371 7312687 
lv-epasts@gsk.com 
 

United Kingdom 
GlaxoSmithKline UK 
Tel: + 44 (0)808 100 9997 
customercontactuk@gsk.com 
 

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel. +370 5 264 90 00 
info.lt@gsk.com 
 

 

mailto:FI.PT@gsk.com
http://www.gsk.ro/
mailto:info.produkt@gsk.com


 
 

  55 

This leaflet was last approved in {MM/YYYY}. 
 
Daronrix 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 (EMEA) will review any new information on the medicine every 
year and this leaflet will be updated as necessary. 
 
 
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web 
site: http://www.emea.europa.eu/
 

http://www.emea.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
	CONDITIONS OF THE MARKETING AUTHORISATION
	SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
	LABELLING
	PACKAGE LEAFLET