Hexavac - patient leaflet, side effects, dosage

6.6 Instructions for use and handling

Before use, the vaccine should be well shaken in order to obtain a homogeneous slightly op suspension.

For needle free syringes, the needle should be pushed firmly on to the end of the rotated through 90 degrees.

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND

MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substances

For Hepatitis B surface antigen:

Merck & Co. Inc.

Sumneytown Pike

West Point

Pennsylvania 19486 USA

F-69280 Marcy L'Etoile

Name and address of the manufacturer responsible for batch release

Sanofi Pasteur SA

Campus Mérieux

1541 Avenue Marcel Mérieux

F-69280 Marcy L'Etoile <

OTHER CONDITIONS

The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.

Official batch release: in accordance with Article 114 Directive 2001/83/EEC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.

HEXAVAC – single dose pre-filled syringe with attached needle – Pack of 1

• 1. NAME OF THE MEDICINAL PRODUCT

HEXAVAC suspension for injection in pre-filled syringe

Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recom Haemophilus influenzae type b conjugate vaccine, adjuvanted.

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 adjuvanted dose (0.5 ml) contains: Purified diphtheria toxoid.......­.............­.............­.........

Purified tetanus toxoid.......­.............­.............­..............

Purified pertussis toxoid.......­.............­.............­...........

Purified pertussis filamentous haemagglutinin­..........

Hepatitis B surface antigen......­.............­.............­........

Inactivated type 1 poliovirus.­.............­.............­..........

Inactivated type 2 poliovirus.­.............­.............­..........

Inactivated type 3 poliovirus.­.............­.............­..........

Haemophilus influenzae type b conjugated to tetanu

buffer solution of disodium phosphate, monopotassium icarbonate, trometamol, sucrose, medium 199 (complex blend s and other ingredients) and water for injections.

4. PHARMAC

FORM AND CONTENTS

1 single dose 0.5 ml pre-filled syringe with attached needle Suspension for injection in pre-filled syringe

^METHOD AND, IF NECESSARY, ROUTE(S) OF ADMINISTRATION

e well before use.

Intramuscular use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE REACH AND SIGHT OF CHILDREN

8. EXPIRY DATE

EXP:

Sanofi Pasteur MSD SNC

8, rue Jonas Salk

F-69007 Lyon

• 12. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS

EU/1/00/147/001

• 13. MANUFACTU­RER’S BATCH NUMBER

Batch

• 14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

• 15. INSTRUCTIONS ON USE

  HEXAVAC – single dose pre-filled syringe without needle – Pack of 1

  
  

  • 1. NAME OF THE MEDICINAL PRODUCT

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 single dose 0.5 ml pre-filled syringe without needle Suspension for injection in pre-filled syringe

HOD AND, IF NECESSARY, ROUTE(S) OF ADMINISTRATION

ke well before use. amuscular 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:

  
  

  9. SPECIAL STORAGE CONDITIONS

  
  

  Store at 2 °C – 8 °C (in a refrigerator) Do not freeze

  
  
  
  

  10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PR OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODU APPROPRIATE

  
  

  TS

  IF

  
  

  11. NAME AND ADDRESS OF THE MARKETING AUTHORISATI

  
  

  Sanofi Pasteur MSD SNC 8, rue Jonas Salk

  F-69007 Lyon

  
  

  DER

  
  

  12. NUMBER(S) IN THE COMMUNITY

  
  

  EU/1/00/147/005

  
  

  13. MANUFACTU­RER’S BATCH N

  
  

  MEDICINAL PRODUCTS

  R

  
  

  Batch

  
  
  
  

  14. GENERAL CLAS

  
  

  ION FOR SUPPLY

  
  

  15. INST

  
  
  
  

  Medicinal product s

  to medical prescription

  
  

  ONS ON USE

  
  

  HEXAVAC – single dose pre-filled syringe with 1 separate needle – Pack of 1

  
  

  1. NAME OF THE MEDICINAL PRODUCT

  
  

  HEXAVAC suspension for injection in pre-filled syringe

  
  

  Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (reco Haemophilus influenzae type b conjugate vaccine, adjuvanted.

  
  

  2. STATEMENT OF ACTIVE SUBSTANCE(S)

  
  

  1 adjuvanted dose (0.5 ml) contains: Purified diphtheria toxoid.......­.............­.............­...

  Purified tetanus toxoid.......­.............­.............­........

  Purified pertussis toxoid.......­.............­.............­.....

  Purified pertussis filamentous haemagglutinin…

  Hepatitis B surface antigen......­.............­.............­..

  Inactivated type 1 poliovirus.­.............­.............­....

  Inactivated type 2 poliovirus.­.............­.............­....

  Inactivated type 3 poliovirus.­.............­.............­....

  Haemophilus influenzae type b conjugated to tet

  
  

  oid

  
  

  3. LIST OF EXCIPIENTS

  
  
  
  
  
  

  • > 20 IU

  • > 40 IU

1 single dose 0.5 ml pre-filled syringe with 1 separate needle Suspension for injection in pre-filled syringe

THOD AND, IF NECESSARY, ROUTE(S) OF ADMINISTRATION

Shake well before use.

Intramuscular use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

• 8. EXPIRY DATE

EXP:

• 9. SPECIAL STORAGE CONDITIONS

Store at 2 °C – 8 °C (in a refrigerator) Do not freeze

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

  ATION HOLDER

  
  

• 11. NAME AND ADDRESS OF THE MARKETING AUT

Sanofi Pasteur MSD SNC

8, rue Jonas Salk F-69007 Lyon

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

10 single doses 0.5 ml pre-filled syringes with attached needle. Suspen or injection in pre-filled syringe

Shake well before use.

Intramuscular use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

• 8. EXPIRY DATE

EXP:

• 9. SPECIAL STORAGE CONDITIONS

Store at 2 °C – 8 °C (in a refrigerator) Do not freeze

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

  ATION HOLDER

  
  

• 11. NAME AND ADDRESS OF THE MARKETING AUT

Sanofi Pasteur MSD SNC

8, rue Jonas Salk F-69007 Lyon

HEXAVAC – single dose pre-filled syringe without needle – Pack of 10

• 1. NAME OF THE MEDICINAL PRODUCT

  
  

HEXAVAC suspension for injection in pre-filled syringe

Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (reco Haemophilus influenzae type b conjugate vaccine, adjuvanted.

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

• 1 adjuvanted dose (0.5 ml) contains: Purified diphtheria toxoid.......­.............­.............­...

  oid

  
  

  • > 20 IU

  • > 40 IU

Purified tetanus toxoid.......­.............­.............­........

Purified pertussis toxoid.......­.............­.............­.....

Purified pertussis filamentous haemagglutinin…

Hepatitis B surface antigen......­.............­.............­..

Inactivated type 1 poliovirus.­.............­.............­....

Inactivated type 2 poliovirus.­.............­.............­....

Inactivated type 3 poliovirus.­.............­.............­....

Haemophilus influenzae type b conjugated to tet

Excipients: aluminium hydroxide a buffer solution of disodium phosphate, monopotassium phosphate, sodium carbonate, sodium bicarbonate, trometamol, sucrose, medium 199 (complex blend of amino acids, mineral salts, vitamins and other ingredients) and water for injections.

.5 ml pre-filled syringes without needle jection in pre-filled syringe

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE REACH AND SIGHT OF CHILDREN

• 8. EXPIRY DATE

EXP:

• 9. SPECIAL STORAGE CONDITIONS

Store at 2 °C – 8 °C (in a refrigerator) Do not freeze

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

  ATION HOLDER

  
  

• 11. NAME AND ADDRESS OF THE MARKETING AUT

Sanofi Pasteur MSD SNC

8, rue Jonas Salk F-69007 Lyon

10 single doses 0.5 ml pre-filled syringes with 1 separate needle (for each syringe). Suspension for injection in pre-filled syringe

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

• 8. EXPIRY DATE

EXP:

• 9. SPECIAL STORAGE CONDITIONS

Store at 2 °C – 8 °C (in a refrigerator) Do not freeze

10.	SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICNA OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL P APPROPRIATE		^.PRODUCTS PRODUCTS, IF
11.	NAME AND ADDRESS OF THE MARKETING AUTHO	RISATION HOLDER

Sanofi Pasteur MSD SNC 8, rue Jonas Salk

F-69007 Lyon

• 12. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS

EU/1/00/147/011

• 13. MANUFACTU­RER’S BATCH NUMBER

Batch

• 14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

l^T^NSTRUCTIONS ON USE

10 single doses 0.5 ml pre-filled syringes with 2 separate needles (for each syringe) Suspension for injection in pre-filled syringe

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

HEXAVAC – single dose pre-filled syringe with attached needle – Pack of 25

• 1. NAME OF THE MEDICINAL PRODUCT

HEXAVAC suspension for injection in pre-filled syringe

Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recom Haemophilus influenzae type b conjugate vaccine, adjuvanted.

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

• 1 adjuvanted dose (0.5 ml) contains: Purified diphtheria toxoid.......­.............­.............­.......

  > 20 n > 40 n 25 ^g 25 ^g 5.0 ^g 40 D units 8 D units 32 D units 12 ^g

  
  

Purified tetanus toxoid.......­.............­.............­............

Purified pertussis toxoid.......­.............­.............­.........

Purified pertussis filamentous haemagglutinin­.......

Hepatitis B surface antigen......­.............­.............­.....

Inactivated type 1 poliovirus.­.............­.............­.......

Inactivated type 2 poliovirus.­.............­.............­.......

Inactivated type 3 poliovirus.­.............­.............­.......

Haemophilus influenzae type b conjugated to tetan

Excipients: aluminium hydroxide phosphate, sodium carbonate, sodi of amino acids, mineral salts, vi

4. PHARMAC

FORM AND CONTENTS

25 single doses 0.5 ml pre-filled syringes with attached needle. Suspension for injection in pre-filled syringe

^METHOD AND, IF NECESSARY, ROUTE(S) OF ADMINISTRATION

ake well before use.

Intramuscular use.

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

• 8. EXPIRY DATE

EXP:

• 9. SPECIAL STORAGE CONDITIONS

Store at 2 °C – 8 °C (in a refrigerator) Do not freeze

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

  ATION HOLDER

  
  

• 11. NAME AND ADDRESS OF THE MARKETING AUT

Sanofi Pasteur MSD SNC

8, rue Jonas Salk F-69007 Lyon

HEXAVAC – single dose pre-filled syringe without needle – Pack of 25

• 1. NAME OF THE MEDICINAL PRODUCT

  
  

HEXAVAC suspension for injection in pre-filled syringe

Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (reco Haemophilus influenzae type b conjugate vaccine, adjuvanted.

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

• 1 adjuvanted dose (0.5 ml) contains: Purified diphtheria toxoid.......­.............­.............­...

  oid

  
  

  • > 20 IU

  • > 40 IU

Purified tetanus toxoid.......­.............­.............­........

Purified pertussis toxoid.......­.............­.............­.....

Purified pertussis filamentous haemagglutinin…

Hepatitis B surface antigen......­.............­.............­..

Inactivated type 1 poliovirus.­.............­.............­....

Inactivated type 2 poliovirus.­.............­.............­....

Inactivated type 3 poliovirus.­.............­.............­....

Haemophilus influenzae type b conjugated to tet

Excipients: aluminium hydroxide a buffer solution of disodium phosphate, monopotassium phosphate, sodium carbonate, sodium bicarbonate, trometamol, sucrose, medium 199 (complex blend of amino acids, mineral salts, vitamins and other ingredients) and water for injections.

.5 ml pre-filled syringes without needle jection in pre-filled syringe

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

• 8. EXPIRY DATE

EXP:

• 9. SPECIAL STORAGE CONDITIONS

Store at 2 °C – 8 °C (in a refrigerator) Do not freeze

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

  ATION HOLDER

  
  

• 11. NAME AND ADDRESS OF THE MARKETING AUT

Sanofi Pasteur MSD SNC

8, rue Jonas Salk F-69007 Lyon

HEXAVAC – single dose pre-filled syringe with attached needle – Pack of 50

• 1. NAME OF THE MEDICINAL PRODUCT

  
  

HEXAVAC suspension for injection in pre-filled syringe

Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (reco Haemophilus influenzae type b conjugate vaccine, adjuvanted.

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

• 1 adjuvanted dose (0.5 ml) contains: Purified diphtheria toxoid.......­.............­.............­...

  oid

  
  

  • > 20 IU

  • > 40 IU

Purified tetanus toxoid.......­.............­.............­........

Purified pertussis toxoid.......­.............­.............­.....

Purified pertussis filamentous haemagglutinin…

Hepatitis B surface antigen......­.............­.............­..

Inactivated type 1 poliovirus.­.............­.............­....

Inactivated type 2 poliovirus.­.............­.............­....

Inactivated type 3 poliovirus.­.............­.............­....

Haemophilus influenzae type b conjugated to tet

Excipients: aluminium hydroxide a buffer solution of disodium phosphate, monopotassium phosphate, sodium carbonate, sodium bicarbonate, trometamol, sucrose, medium 199 (complex blend of amino acids, mineral salts, vitamins and other ingredients) and water for injections.

.5 ml pre-filled syringes with attached needle. jection in pre-filled syringe

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

• 8. EXPIRY DATE

EXP:

• 9. SPECIAL STORAGE CONDITIONS

Store at 2 °C – 8 °C (in a refrigerator) Do not freeze

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

  ATION HOLDER

  
  

• 11. NAME AND ADDRESS OF THE MARKETING AUT

Sanofi Pasteur MSD SNC

8, rue Jonas Salk F-69007 Lyon

HEXAVAC – single dose pre-filled syringe without needle – Pack of 50

• 1. NAME OF THE MEDICINAL PRODUCT

  
  

HEXAVAC suspension for injection in pre-filled syringe

Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (reco Haemophilus influenzae type b conjugate vaccine, adjuvanted.

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

• 1 adjuvanted dose (0.5 ml) contains: Purified diphtheria toxoid.......­.............­.............­...

  oid

  
  

  • > 20 IU

  • > 40 IU

Purified tetanus toxoid.......­.............­.............­........

Purified pertussis toxoid.......­.............­.............­.....

Purified pertussis filamentous haemagglutinin…

Hepatitis B surface antigen......­.............­.............­..

Inactivated type 1 poliovirus.­.............­.............­....

Inactivated type 2 poliovirus.­.............­.............­....

Inactivated type 3 poliovirus.­.............­.............­....

Haemophilus influenzae type b conjugated to tet

Excipients: aluminium hydroxide a buffer solution of disodium phosphate, monopotassium phosphate, sodium carbonate, sodium bicarbonate, trometamol, sucrose, medium 199 (complex blend of amino acids, mineral salts, vitamins and other ingredients) and water for injections.

.5 ml pre-filled syringes without needle jection in pre-filled syringe

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

• 8. EXPIRY DATE

EXP:

• 9. SPECIAL STORAGE CONDITIONS

Store at 2 °C – 8 °C (in a refrigerator) Do not freeze

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

  ATION HOLDER

  
  

• 11. NAME AND ADDRESS OF THE MARKETING AUT

Sanofi Pasteur MSD SNC

8, rue Jonas Salk F-69007 Lyon

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

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

HEXAVAC

PACKAGE LEAFLET

Read all of this leaflet carefully before your child is vaccinated.

• – Keep this leaflet. You may need to read it again.

• – If you have further questions, please ask your doctor or your pharmacist.

• – This vaccine has been prescribed for your child and you should not pass it on to others.

  In this leaflet :

  
  

  • 1.

  • 2.

  • 3.

  • 4.

  • 5.

  • 6.

• .. equal to or greater than 40 IU* (10 Lf)

• .. 25 micrograms

• .. 25 micrograms

• .. 5.0 micrograms

• .. D antigenA: 40 units'

• .. D antigenA: 8 units'

• .. D antigenA: 32 units'

ride (polyribosylribitol phosphate) 12 micrograms

ing Authorisation Holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon actured by: Sanofi Pasteur SA, F-69280 Marcy l’Etoile

1. WHAT IS HEXAVAC AND WHAT IT IS USED FOR

HEXAVAC is an injectable vaccine in a 0.5 ml single dose syringe.

HEXAVAC is indicated to help protect your child against diphtheria, tetanus, pertussis, poliomyelitis, infection of the liver caused by all known subtypes of hepatitis B virus and invasive disease (infection of brain and spinal cord tissues, infection of the blood, etc.) caused by Haemophilus-influenzae type b (Hib) bacterium in children 8 weeks to 18 months of age.

HEXAVAC is available in packs of 1, 10, 25 and 50 with or without neddles.

2. BEFORE YOU USE HEXAVAC

Do not use HEXAVAC:

• – if your child is allergic to any component of the vaccine.

• – in case of newborns, adolescents or adults.

• – if your child has fever or other illness, particularly a cough, cold or flu (vaccination should be

delayed).

• – if your infant has suffered brain damage (encephalopathy) following a previous dose of a whole cell or acellular pertussis vaccine.

Take special care with HEXAVAC:

OCv

• – if your child has an hypersensitivity to neomycin, streptomycin and polymyxin B, due to the use of these substances during production.

• – if your child has a thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.

• – if any of the following events are known to have occurred in temporal relation to receipt of the vaccine (The decision to give further doses of pertussis-containing vaccines to your child should be carefully considered if any of the following events are known to have occurred following the administration of the vaccine) :

  lowing the administration of the vaccine) :

  Temperature of > 40.0 °C within 48 hours, not due to another identifiable cause.

  Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination.

  Persistent, inconsolable crying lasting > 3 hours, occurring within 48 hours of vaccination.

  
  

s, occurring within 48 hours of vaccination.

Convulsions with or without fever, occurring within 3 days of vaccination.

if your child has any present or past medical problems or allergies, including allergic reactions after any dose of HEXAVAC.

if you are a hepatitis B virus surface antigen (HBsAg)-positive mother, your infant should receive Hepatitis B Immune Globulin (HBIG) and hepatitis B vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series. The subsequent administration of HEXAVAC for completion of the hepatitis B vaccination series in infants who were born of HBsAg-positive mothers and received HBIG or infants born of mothers of unknown status has not been studied. HEXAVAC should not be used as the birth dose or subsequent doses during the first year of life for children born to HbsAg-positive mothers.

because as with other similar vaccines, cases of Haemophilus b disease may occur in the week after vaccination prior to the onset of the protective effects of the vaccine.

because hepatitis B infection can go undetected for a long period of time, it is possible that an individual may already be infected at the time the vaccine is given. The vaccine may not prevent hepatitis B in these individuals.

other vaccines

e are currently not sufficient data available regarding immune response of the concomitant administration of HEXAVAC with PREVENAR (pneumococcal polysaccharide conjugated vaccine, adsorbed). However, when HEXAVAC was co-administered in clinical studies the rate of febrile reactions was higher compared to that occurring following administration of hexavalent vaccines alone. These reactions were mostly moderate and transient. If your child is due to be vaccinated with HEXAVAC and other vaccines simultaneously, please ask your doctor for further information.

3. HOW TO USE HEXAVAC

The primary vaccination schedule consists of two or three doses of 0.5 ml administered within the first year of life according to the official recommendations. There should be an interval of at least 1 month between doses : such as 2 , 3, 4 months; 2, 4, 6 months; 3, 5 months.

After a primary vaccination with 2 doses of HEXAVAC (e.g 3, 5 months), a booster dose must be given between 11 and 13 months of age; after a primary vaccination with 3 doses of Hexavac (e.g. 2, 3, 4 months; 2, 4, 6 months), a booster dose must be given between 12 and 18 months of age, according to official recommendations.

HEXAVAC can be used for the booster dose provided the toddler has received a full primary vaccination course of each of the antigens contained in Hexavac regardless of whether they were administered as monovalent or combination vaccines produced by Sanofi Pasteur MSD.

HEXAVAC should be injected into the quadriceps or deltoid muscle preferably at alt subsequent injections.

HEXAVAC should under no circumstances be administered intravascularly subcutaneous routes must not be used either.

HEXAVAC must not be mixed in the same syringe with other administered drugs.

For needle free syringes, the needle should be pushed firmly rotated through 90 degrees.

If you forget to take HEXAVAC:

Your doctor will decide when to give the missed dose.

4. POSSIBLE SIDE EFFECTSAs with other vaccines your child m tolerated in clinical trials. Side effecswelling and pain. Other side ef vomiting, loss of appetite and proy have some side effects. HEXAVAC has been generally well s included injection-site reactions such as tenderness, redness, included irritability, sleepiness, fever, sleeplessness, diarrhoea,ged crying where the child cannot be consoled.Following the widesp Among reactions fou

of HEXAVAC, additional undesirable effects have been reported: injection site, itching and hives have been also reported.

Rarely, the patient may have prolonged or abnormal crying.

Very rarely there may be allergic reaction; chills; fatigue; malaise; oedema; swelling of the entire limb(s); Guillain Barré Syndrome; hypotonic hyporesponsive episode; pallor; convulsions (with or without fever); brain inflammation, acute brain swelling; eyes rolling; decrease in muscle tone; neuritis; nausea; abdominal gas and/or pain; low platelet count; purple or red brown spots visible through the skin; agitation; difficulty sleeping; breathing difficulty ; wheezing ; swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing; rash; skin redness; generalized hives; generalized itching; flushing; temporary swelling of local lymph nodes.

Tell your doctor promptly about these symptoms. If the condition persists or worsens, you may have to bring your child to the doctor.

In addition, tell your doctor if your child experiences any symptoms that suggest an allergic reaction such as rash, redness, itching, pallor or oedema after any dose in the vaccination series.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

• 5. STORING HEXAVAC

Keep out of the reach and sight of children.

Store at 2 °C – 8 °C (in a refrigerator)

Do not freeze

Do not use after the expiry date stated on the label.

• 6. FURTHER INFORMATION

  Luxembourg/Lu­xemburg

  Sanofi Pasteur MSD sa/nv Tél: 32.2.726.95.84

  entative Office