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Tritanrix HepB (diphtheria toxoid/ hepatitis B recombinant...) – Summary of product characteristics - J07CA05

Updated on site: 10-Oct-2017

Medication nameTritanrix HepB
ATC CodeJ07CA05
Substancediphtheria toxoid/ hepatitis B recombinant surface antigen/ Bordetella pertussis (inactivated) /tetanus toxoid
ManufacturerGlaxoSmithKline Biologicals S.A.

1. NAME OF THE MEDICINAL PRODUCT

Tritanrix HepB, suspension for injection
Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 dose (0.5 ml) contains:

 

 

 

 

Diphtheria toxoid1

 

 

not less than 30 IU

Tetanus toxoid1

 

 

not less than 60 IU

Bordetella pertussis (inactivated)2

 

not less than 4 IU

Hepatitis B surface antigen 2,3

 

 

10 micrograms

Adsorbed on aluminium hydroxide, hydrated

 

0.26 milligrams Al3+

Adsorbed on aluminium phosphate

 

0.37 milligrams Al3+

Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology

 

For a full list of excipients, see section 6.1.

 

longer

authorised

 

 

3.

PHARMACEUTICAL FORM

 

 

Suspension for injection.

 

 

 

Turbid white suspension.

 

no

 

4.

CLINICAL PARTICULARS

 

 

 

4.1

Therapeutic indications

 

 

Tritanrix HepB is indicated for active immunisation against diphtheria, tetanus, pertussis and hepatitis B

(HBV) in infants from 6 weeks onwards (see section 4.2).

 

 

4.2 Posology and method of administration

 

 

 

Posology

product

 

 

 

 

 

 

 

 

The recommended dose is 0.5 ml.

 

 

 

Primary vaccination:

 

 

 

 

Medicinal

 

 

 

 

The primary vaccination schedule consists of three doses within the first six months of life. Where HBV vaccine is not given at birth, the combined vaccine can be administered beginning as early as 8 weeks of age. Where there is a high endemicity of HBV, the practice to administer HBV vaccine at birth should be continued. In these circumstances, vaccination with the combined vaccine should start at 6 weeks of age.

Three vaccine doses must be administered at intervals of at least 4 weeks.

When Tritanrix HepB is given according to the 6-10-14 weeks schedule, it is recommended to administer a dose of HBV vaccine at birth to improve protection.

In the case of children born of known HBV carrier mothers the immunoprophylactic measures for hepatitis B should not be modified. This may require separate vaccination with HBV and DTPw vaccines and also include the administration of HBIg at birth.

Hypersensitivity to the active substances or to any of the excipients.
It is recommended that in patients with thrombocytopenia or bleeding disorders subcutaneously (see section 4.4).
Method of administration

Booster vaccination:

A booster dose with Tritanrix HepB will give rise to increased reactogenicity as would be expected for a booster during the second year of life. In consequence, boostering should follow local recommendations.

The administration of a booster dose with trivalent DTP vaccine is recommended before the end of the second year of life. For long-term protection against HBV, a booster dose of HBV vaccine could also be

administered after the first year of life. However, the need for this dose is currently not established. Tritanrix HepB is for deep intramuscular injection, preferably in the anterolateralauthorisedthigh.

the vaccine be administered

4.3 Contraindications

Hypersensitivity after previous administration of diphtheria, tetanus, pertussis or hepatitis B vaccines.

The administration of Tritanrix HepB should be postponed in subjects suffering from acute severe febrile illness.

Tritanrix HepB is contraindicated if the child has experienced an encephalopathy of unknown aetiology,

occurring within 7 days following previous vaccination with pertussis containing vaccine. In these

 

longer

circumstances the vaccination course should be continued with DT and HBV vaccines.

4.4 Special warnings and precautions for use

 

no

 

Vaccination should be precededproductby a review of the medical history (especially with regard to previous vaccination and possible occurrence of adverse reactions) and a clinical examination.

As with all injectable vaccines, appropriate medical treatment should always be readily available in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccinee should remain under medical supervision for 30 minutes after vaccination.

MedicinalIf any of the following events occur in temporal relation to receipt of Tritanrix HepB, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered.

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

Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.

Persistent crying lasting ≥ 3 hours, occurring within 48 hours.

Convulsions with or without fever, occurring within 3 days.

There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.

As for any vaccination, the risk-benefit of immunising with Tritanrix HepB or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.

A history of febrile convulsions, a family history of convulsions, a family history of SIDS (Sudden Infant Death Syndrome) and a family history of an adverse reaction following Tritanrix HepB vaccination do not constitute contra-indications.

HIV infection is not considered as a contra-indication for diphtheria, tetanus, pertussis and HBV vaccination. The expected immunological response may not be obtained after vaccination of immunosuppressed patients, e.g. patients on immunosuppressive therapy.

Tritanrix HepB should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.

TRITANRIX HepB SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED

INTRAVENOUSLY.

As the benefit of vaccination is high in this group of infants, vaccination shouldauthorisednot be withheld or delayed.

The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when

administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.

4.5 Interaction with other medicinal products and other forms of interaction

It is current practice in paediatric vaccination to co-administer different vaccines during the same session with injectable vaccines being administered at separate injection sites.

Tritanrix HepB can be administered simultaneously at separate sites or in any temporal relationship with other paediatric vaccines if this fits conveniently in the immunisation scheme.

In clinical studies, Tritanrix HepB has been administered simultaneously with oral polio vaccine (OPV) and Haemophilus influenzae type b (Hib) vaccine. In these studies the immune response to the oral polio vaccine

has not been investigated, however, previous experience with simultaneous administration of DTP, OPV and

HBV vaccines has not shown any interference. In some clinical studies, Tritanrix HepB was used to

 

 

longer

reconstitute the lyophilised Hib vaccine (Hiberix); no interference in the immune response to any of the

antigens was observed as compared to the responses observed following administration of the vaccines at

separate sites (see section 6.2).

no

 

 

 

In patients receiving immunosuppressive therapy or patients with immunodeficiency, an adequate response may not be achieved.

4.6

Pregnancy and lactation

 

 

product

As Tritanrix HepB is not intended for use in adults, information on the safety of the vaccine when used

during pregnancy or lactation is not available.

Medicinal

 

4.7

Effects on ability to drive and use machines

Not relevant.

 

4.8

Undesirable effects

Clinical trials:

 

 

In clinical studies, the most commonly reported adverse events were reactions at the injection site,

 

including redness, swelling and pain.

General reactions that may occur in temporal association with Tritanrix HepB vaccination are listed below.

Frequencies are defined as follows:

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)

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Nervous system disorders:

 

 

very common: drowsiness

 

authorised

Respiratory, thoracic and mediastinal disorders:

 

 

 

common: bronchitis

 

 

uncommon: respiratory disorder

 

 

Gastro-intestinal disorders:

 

 

very common: feeding problems

 

 

common: gastro-intestinal symptoms such as vomiting and diarrhoea

 

Infections and infestations:

 

 

common: otitis media, pharyngitis

longer

 

uncommon: pneumonia

 

 

 

General disorders and administration site conditions: very common: fever, swelling, pain and redness

Immune system disorders:

very rare: allergic reactions including anaphylactic and anaphylactoid reactions and serum sickness

like disease

 

no

 

 

Psychiatric disorders:

 

very common: unusual crying, irritability

 

Medicinal

product

 

 

 

In a prospective comparative study, which compared the administration of the combined DTPw-HBV vaccine with the simultaneous separate administration of DTPw and HBV vaccine, higher incidences of pain, redness, swelling and fever were reported in the group receiving the combined vaccine. The incidences are presented below:

 

 

Group 1

Group 2

 

 

 

DTPw-HBV

DTPw

HBV

 

N° of symptom checklists

(combined)

(separate)

 

 

 

Local symptoms (%)

 

 

 

 

 

Pain

Total

32.0

15.3

 

2.8

 

 

Severe*

0.0

0.0

 

0.0

 

Redness

Total

38.9

27.1

 

5.1

 

 

> 2cm

9.1

3.4

 

0.6

 

Swelling

Total

30.9

21.5

 

4.5

 

 

> 2cm

10.9

3.4

 

0.6

 

 

 

 

 

 

 

General Symptoms (%)

 

 

 

authorised

Fever > 38°C

 

53.1

 

35.0

 

 

 

 

Fever > 39.5° C

1.1

 

0.0

 

 

 

 

 

longer

 

 

* reported by the parents as adversely affecting the child’s daily activities

 

 

no

For both vaccination groups, the majority of the reactions were short lasting.

Post marketing surveillance:

 

 

Blood and lymphaticproductsystem disorders:

 

 

Nervous system disorders:

 

 

Collapse or shock-like state (hypotonic-hyporesponsive episode)

 

Respiratory, thoracic and mediastinal disorders:

 

Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)

Experience with hepatitis B vaccine:

 

Medicinal

 

 

Thrombocytopenia

 

Nervous system disorders:

Convulsions

This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.3)

4.9 Overdose

No case of overdose has been reported.

5.PHARMACOLOGICAL PROPERTIES

5.1Pharmacodynamic properties

Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code J07CA05.

Tritanrix HepB contains diphtheria (D), tetanus (T) toxoids, inactivated pertussis bacteria (Pw) and the purified major surface antigen of the hepatitis B virus (HBV), adsorbed on aluminium salts.

The D and T toxoids are prepared from the toxins of cultures of Corynebacterium diphtheriae and Clostridium tetani by formalin inactivation using established technology. The Pw component is obtained by heat inactivation of phase I culture of Bordetella pertussis bacteria.

 

 

 

 

 

authorised

 

For each component of the vaccine, the following immune responses have been documented one month after

 

completion of the primary vaccination schedule.

 

 

 

 

 

Percentage of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with

 

Tritanrix HepB:

 

 

 

 

 

 

 

 

 

 

 

Antibody

6-10-14 weeks

2-4-6 months; 3-4-5 months

 

(cut-off)

 

 

longer

 

 

 

 

and 3-4½-6 months

 

 

 

 

%

no

%

 

 

 

 

 

 

 

 

 

Anti-diphtheria

93.1

 

99.7

 

 

 

(0.1 IU/ml) †

 

 

 

 

 

 

 

 

 

 

 

 

 

Anti-tetanus

 

 

 

 

(0.1 IU/ml) †

 

 

 

 

 

 

Anti-B. Pertussis

97.2

 

97.7

 

 

 

(vaccine response) ††

 

 

 

 

 

 

Anti-HBs

97.7*

 

99.2

 

 

 

(10 mIU/ml) †

product

 

 

 

 

 

* in a subgroup of infants not administered hepatitis B vaccine at birth, 89.9% of subjects had anti-HBs titres

Medicinal

 

 

 

 

 

The surface antigen of the HBV (HBsAg) is produced by culture of genetically-engineered yeast cells (Saccharomyces cerevisiae) which carry the gene coding for the major surface antigen of the HBV. This HBsAg expressed in yeast cells is purified by several physico-chemical steps. The HBsAg assembles spontaneously, in the absence of chemical treatment, into spherical particles of 20 nm in average diameter containing non-glycosylated HBsAg polypeptide and a lipid matrix consisting mainly of phospholipids. Extensive tests have demonstrated that these particles display the characteristic properties of the natural HBsAg.

Four different schedules have been studied (6-10-14 weeks, 2-4-6 months; 3-4-5 months and 3-4½-6 months) according to routine vaccination practices in different countries with three doses administered within the first six months of life.

≥ 10 mIU/ml

cut-off accepted as indicative of protection

†† vaccine response: % of subjects considered to have responded to the Bordetella pertussis antigen

5.2 Pharmacokinetic properties

Evaluation of pharmacokinetic properties is not required for vaccines.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on general safety studies.

6.PHARMACEUTICAL PARTICULARS

0.5 ml of suspension in a vial (type I glass) with a

6.1 List of excipients

Thiomersal Sodium chloride Water for injections
For adjuvants, see section 2.

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf life

 

authorised

3 years.

 

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.

 

 

longer

 

6.5 Nature and contents of container

no Tritanrix HepB can be mixedproductwith the lyophilised Hib vaccine (Hiberix). Upon storage, a white deposit and clear supernatant can be observed.

plunger stopper (rubber butyl) – pack size of 1.

6.6 Special precautions for disposal and other handling

The vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine.

MedicinalAny unused product of waste material should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Biologicals s.a. rue de l'Institut 89

B-1330 Rixensart, Belgium

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/96/014/001

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19 July 1996.

Date of latest renewal: 19 July 2006.

10. DATE OF REVISION OF THE TEXT

 

 

 

longer

authorised

 

 

no

 

 

product

 

 

Medicinal

 

 

 

 

 

 

 

1. NAME OF THE MEDICINAL PRODUCT
Tritanrix HepB, suspension for injection, multidose
Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 dose (0.5 ml) contains:

 

 

Diphtheria toxoid1

not less than 30 IU

Tetanus toxoid1

not less than 60 IU

Bordetella pertussis (inactivated)2

not less than 4 IU

Hepatitis B surface antigen2,3

10 micrograms

Adsorbed on aluminium hydroxide, hydrated

0.26 milligrams Al3+

Adsorbed on aluminium phosphate

0.37 milligrams Al3+

Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology

 

This is a multidose container. See section 6.5 for the number of doses per vial.

authorised

For a full list of excipients, see section 6.1.

longer

 

 

 

 

3. PHARMACEUTICAL FORM

Suspension for injection.

no

Turbid white suspension.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

 

 

product

 

Tritanrix HepB is indicated for active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from 6 weeks onwards (see section 4.2).

4.2 Posology and method of administration

MedicinalPosology

The recommended dose is 0.5 ml.

Primary vaccination:

The primary vaccination schedule consists of three doses within the first six months of life. Where HBV vaccine is not given at birth, the combined vaccine can be administered beginning as early as 8 weeks of age. Where there is a high endemicity of HBV, the practice to administer HBV vaccine at birth should be continued. In these circumstances, vaccination with the combined vaccine should start at 6 weeks of age.

Three vaccine doses must be administered at intervals of at least 4 weeks.

When Tritanrix HepB is given according to the 6-10-14 weeks schedule, it is recommended to administer a dose of HBV vaccine at birth to improve protection.

Method of administration

In the case of children born of known HBV carrier mothers the immunoprophylactic measures for hepatitis B should not be modified. This may require separate vaccination with HBV and DTPw vaccines and also include the administration of HBIg at birth.

Booster vaccination:

A booster dose with Tritanrix HepB will give rise to increased reactogenicity as would be expected for a booster during the second year of life. In consequence, boostering should follow local recommendations.

The administration of a booster dose with trivalent DTP vaccine is recommendedauthorisedbefore the end of the

second year of life. For long-term protection against HBV, a booster dose of HBV vaccine could also be administered after the first year of life. However, the need for this dose is currently not established.

Tritanrix HepB is for deep intramuscular injection, preferably in the anterolateral thigh.

It is recommended that in patients with thrombocytopenia or bleeding disorders the vaccine be administered subcutaneously (see section 4.4.).

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients.longer

Hypersensitivity after previous administration of diphtheria, tetanus, pertussis or hepatitis B vaccines.

The administration of Tritanrix HepB should be postponed in subjects suffering from acute severe febrile illness.

Tritanrix HepB is contraindicated if the child has experiencedno an encephalopathy of unknown aetiology,

4.4 Special warnings and precautions for use

occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances the vaccinationproductcourse should be continued with DT and HBV vaccines.

Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of adverse reactions) and a clinical examination.

As with all injectable vaccines, appropriate medical treatment should always be readily available in case Medicinalof anaphylactic reactions following the administration of the vaccine. For this reason, the vaccinee

should remain under medical supervision for 30 minutes after vaccination.

If any of the following events occur in temporal relation to receipt of Tritanrix HepB, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered.

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

Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.

Persistent crying lasting ≥ 3 hours, occurring within 48 hours.

Convulsions with or without fever, occurring within 3 days.

There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.

As for any vaccination, the risk-benefit of immunising with Tritanrix HepB or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.

A history of febrile convulsions, a family history of convulsions, a family history of SIDS (Sudden Infant Death Syndrome) and a family history of an adverse reaction following Tritanrix HepB vaccination do not constitute contra-indications.

HIV infection is not considered as a contra-indication for diphtheria, tetanus, pertussis and HBV vaccination. The expected immunological response may not be obtained after vaccination of immunosuppressed patients, e.g. patients on immunosuppressive therapy.

TRITANRIX HepB SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED

INTRAVENOUSLY.

The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.

As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.

Tritanrix HepB should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration toauthorisedthese subjects.

4.5 Interaction with other medicinal products and otherlongerforms of interaction

It is current practice in paediatric vaccination to co-administer different vaccines during the same session with injectable vaccines being administered at separate injection sites.

Tritanrix HepB can be administered simultaneously at separate sites or in any temporal relationship with other paediatric vaccines if this fits conveniently in the immunisation scheme.

and Haemophilus influenzae type b (Hib) vaccine.noIn these studies the immune response to the oral polio vaccine has not been investigated,producthowever, previous experience with simultaneous administration of

In clinical studies, Tritanrix HepB has been administered simultaneously with oral polio vaccine (OPV)

DTP, OPV and HBV vaccines has not shown any interference. In some clinical studies, Tritanrix HepB

was used to reconstitute the lyophilised Hib vaccine (Hiberix); no interference in the immune response

to any of the antigens was observed as compared to the responses observed following administration of the vaccines at separate sites. (see section 6.2.).

In patients receiving immunosuppressive therapy or patients with immunodeficiency, an adequate

response may not be achieved.

Medicinal4.6 Pregnancy and lactation

As Tritanrix HepB is not intended for use in adults, information on the safety of the vaccine when used during pregnancy or lactation is not available.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

Clinical trials:

In clinical studies, the most commonly reported adverse events were reactions at the injection site, including redness, swelling and pain.

General reactions that may occur in temporal association with Tritanrix HepB vaccination are listed below.

Frequencies are defined as follows:

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)

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Nervous system disorders: very common: drowsiness

Respiratory, thoracic and mediastinal disorders: common: bronchitis

uncommon: respiratory disorder

Gastro-intestinal disorders:

 

 

authorised

very common: feeding problems

 

 

 

 

 

common: gastro-intestinal symptoms such as vomiting and diarrhoea

 

Infections and infestations:

 

longer

 

common: otitis media, pharyngitis

 

 

uncommon: pneumonia

 

 

General disorders and administration site conditions:

 

 

 

very common: fever, swelling, pain and redness

 

 

Immune system disorders:

no

 

 

 

 

 

very rare: allergic reactions including anaphylactic and anaphylactoid reactions and serum sickness

like disease

 

 

 

 

Psychiatric disorders:

 

 

 

very common: unusual crying, irritability

 

 

 

Medicinal

product

 

 

 

 

 

 

 

In a prospective comparative study, which compared the administration of the combined DTPw-HBV vaccine with the simultaneous separate administration of DTPw and HBV vaccine, higher incidences of pain, redness, swelling and fever were reported in the group receiving the combined vaccine. The incidences are presented below:

 

 

Group 1

 

Group 2

 

 

 

DTPw-HBV

DTPw

 

HBV

 

N° of symptom checklists

(combined)

 

(separate)

 

 

 

Local symptoms (%)

 

 

 

 

 

Pain

Total

32.0

15.3

 

2.8

 

 

Severe*

0.0

0.0

 

0.0

 

Redness

Total

38.9

27.1

 

5.1

 

 

> 2cm

9.1

3.4

 

0.6

 

Swelling

Total

30.9

21.5

 

4.5

 

 

> 2cm

10.9

3.4

 

0.6

 

 

 

 

 

 

 

General Symptoms (%)

 

 

 

authorised

Fever > 38°C

53.1

 

35.0

 

 

 

Fever > 39.5° C

1.1

 

0.0

 

 

 

 

 

longer

 

 

* reported by the parents as adversely affecting the child’s daily activities

 

 

no

For both vaccination groups, the majority of the reactions were short lasting.

Post marketing surveillance:

 

 

Blood and lymphaticproductsystem disorders:

 

 

Nervous system disorders:

 

 

Collapse or shock-like state (hypotonic-hyporesponsive episode).

 

Respiratory, thoracic and mediastinal disorders:

 

Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)

Experience with hepatitis B vaccine:

 

Medicinal

 

 

Thrombocytopenia

 

Nervous system disorders:

Convulsions

This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.3)

4.9 Overdose

No case of overdose has been reported.

5.PHARMACOLOGICAL PROPERTIES

5.1Pharmacodynamic properties

Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code J07CA05.

Tritanrix HepB contains diphtheria (D), tetanus (T) toxoids, inactivated pertussis bacteria (Pw) and the purified major surface antigen of the hepatitis B virus (HBV), adsorbed on aluminium salts.

The D and T toxoids are prepared from the toxins of cultures of Corynebacterium diphtheriae and Clostridium tetani by formalin inactivation using established technology. The Pw component is obtained by heat inactivation of phase I culture of Bordetella pertussis bacteria.

 

 

 

 

 

authorised

 

For each component of the vaccine, the following immune responses have been documented one

 

month after completion of the primary vaccination schedule.

 

 

 

Percentage of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with

 

Tritanrix HepB:

 

 

 

 

 

 

 

 

 

 

 

Antibody

6-10-14 weeks

2-4-6 months; 3-4-5 months

 

(cut-off)

 

 

longer

 

 

 

 

and 3-4½-6 months

 

 

 

 

%

no

%

 

 

 

 

 

 

 

 

 

Anti-diphtheria

93.1

 

99.7

 

 

 

(0.1 IU/ml) †

 

 

 

 

 

 

 

 

 

 

 

 

 

Anti-tetanus

 

 

 

 

(0.1 IU/ml) †

 

 

 

 

 

 

Anti-B. Pertussis

97.2

 

97.7

 

 

 

(vaccine response) ††

 

 

 

 

 

 

Anti-HBs

97.7*

 

99.2

 

 

 

(10 mIU/ml) †

product

 

 

 

 

 

* in a subgroup of infants not administered hepatitis B vaccine at birth, 89.9% of subjects had anti-HBs titres

Medicinal

 

 

 

 

 

The surface antigen of the HBV (HBsAg) is produced by culture of genetically-engineered yeast cells (Saccharomyces cerevisiae) which carry the gene coding for the major surface antigen of the HBV. This HBsAg expressed in yeast cells is purified by several physico-chemical steps. The HBsAg assembles spontaneously, in the absence of chemical treatment, into spherical particles of 20 nm in average diameter containing non-glycosylated HBsAg polypeptide and a lipid matrix consisting mainly of phospholipids. Extensive tests have demonstrated that these particles display the characteristic properties of the natural HBsAg.

Four different schedules have been studied (6-10-14 weeks, 2-4-6 months; 3-4-5 months and 3-4½-6 months) according to routine vaccination practices in different countries with three doses administered within the first six months of life.

≥ 10 mIU/ml

cut-off accepted as indicative of protection

†† vaccine response: % of subjects considered to have responded to the Bordetella pertussis antigen

5.2 Pharmacokinetic properties

Evaluation of pharmacokinetic properties is not required for vaccines.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on general safety studies.

6.PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Thiomersal Sodium chloride Water for injections
For adjuvants, see section 2.

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf life

 

authorised

3 years.

 

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.

 

 

longer

 

6.5 Nature and contents of container

1.

no

1 ml of suspension in a vial (type I glass) for 2 doses with a plunger stopper (rubber butyl) – pack size of 1.

5 ml of suspension in a vial (type I glass) for 10 doses with a plunger stopper (rubber butyl) – pack size of Not all pack-sizes may be productmarketed

6.6 Special precautions for disposal and other handling

Tritanrix HepB can be mixed with the lyophilised Hib vaccine (Hiberix).

MedicinalUpon storage, a white deposit and clear supernatant can be observed.

The vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine.

When using a multidose vial, each dose should be taken with a sterile needle and syringe. As with other vaccines, a dose of vaccine should be withdrawn under strict aseptic conditions and precautions taken to avoid contamination of the contents.

Any unused product of waste material should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Biologicals s.a. rue de l'Institut 89

B-1330 Rixensart, Belgium

8. MARKETING AUTHORISATION NUMBER

EU/1/96/014/002

EU/1/96/014/003

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19 July 1996.

 

 

authorised

 

 

 

Date of latest renewal: 19 July 2006.

 

 

 

10. DATE OF REVISION OF THE TEXT

 

 

 

 

 

no

longer

 

 

product

 

 

Medicinal

 

 

 

 

 

 

 

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