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Quintanrix (diphtheria toxoid / tetanus toxoid /...) – Summary of product characteristics - J07CA10

Updated on site: 09-Oct-2017

Medication nameQuintanrix
ATC CodeJ07CA10
Substancediphtheria toxoid / tetanus toxoid / inactivated Bordetella pertussis / hepatitis B surface antigen (rDNA) / Haemophilus influenzae type b polysaccharide
ManufacturerGlaxoSmithKline Biologicals S.A.
For excipients, see section 6.1.

1. NAME OF THE MEDICINAL PRODUCT

Quintanrix powder and suspension for suspension for injection

Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

After reconstitution, 1 dose (0.5 ml) contains:

 

 

Diphtheria toxoid1

not less than 30

International Units

Tetanus toxoid1

not less than 60

International Units

Inactivated Bordetella pertussis 2

not less than 4

International Units

Hepatitis B surface antigen (rDNA) 2, 3

 

10 micrograms

Haemophilus influenzae type b polysaccharide

 

 

(polyribosylribitol phosphate) 2

 

2.5 micrograms

conjugated to tetanus toxoid as a carrier

 

5-10 micrograms

 

 

authorised

1 adsorbed on aluminium hydroxide, hydrated

Total: 0.26 milligrams Al3+

2adsorbed on aluminium phosphate

Total: 0.40 milligrams Al3+

 

longer

 

3 produced in Saccharomyces cerevisae cells by recombinant DNA technology

3. PHARMACEUTICAL FORM

Powder and suspension for suspension for injection

The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B (DTPw-HBV) component is a turbid

type b and for booster immunisationProductof young children during the second year of life.

white suspension.

no

The lyophilised Haemophilus influenzae type b (HIB) component is a white powder.

4.

CLINICAL PARTICULARS

 

4.1

Therapeutic indications

 

Quintanrix is indicated for primary immunisation of infants (during the first year of life) against

4.2 Posology and method of administration

diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae The useMedicinalof Quintanrix should be determined on the basis of official recommendations.

Posology

Primary vaccination:

The primary vaccination schedule consists of three doses of 0.5 ml to be administered at intervals of at least 4 weeks within the first six months of life in accordance with local official recommendations. The first dose can be administered at 6 weeks of age. The following schedules have been studied in clinical trials: 2-4-6 months, 3-4-5 months and 6-10-14 weeks. The 3-5-12 month schedule was not evaluated.

Method of administration

Quintanrix can be given to children who have received hepatitis B vaccine at birth.

The immunoprophylactic measures for hepatitis B should not be modified for children born to hepatitis B virus carrying mothers. This may require separate administration of hepatitis B vaccine and should follow official recommendations.

Booster vaccination:

After the completion of the primary series, a booster should be administered preferably before the end of the second year of life. Booster administration should be in accordance with official recommendations.

Quintanrix may be used to boost responses to DTP, HBV and HIB antigens if its composition is in accordance with official recommendations for boosting. The booster dose should preferably be given at least 6 months after the last primary dose.

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

authorised

4.3Contraindications

HIB vaccines.

longer

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

Quintanrix is contra-indicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances the vaccination course should be continued with diphtheria, tetanus, hepatitis B and

As with other vaccines, the administration of Quintanrix should be postponed in subjects suffering

from acute severe febrile illness. The presence of a minor infection, such as a cold, is not a

Product

no

contraindication for vaccination.

4.4 Special warnings and special precautions for use

Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events).

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. For

this reason, the vaccinee should remain under medical supervision for at least 30 minutes.

 

 

decision to give

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

considered:

 

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.

 

 

Medicinal

benefits

 

 

bleeding subjects. A

(without rubbing) for

at least two minutes following administration.

Quintanrix should under no circumstances be administered intravascularly.

The vaccine will not prevent infection caused by other pathogens known to infect the liver such as hepatitis A, hepatitis C and hepatitis E virus.

A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Quintanrix. Vaccinees with a history of febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days post vaccination.

The HIB component of the vaccine does not protect against diseases due to capsular serotypes other than type b of Haemophilus influenzae or against meningitis caused by otherauthorisedorganisms.

HIV infection is not considered as a contraindication. The expected immunological response may not be obtained after vaccination of immunosuppressed patients.

Since the capsular polysaccharide antigen is excreted in the urine a positive urine antigen test can be observed within 1-2 weeks following vaccination. Other tests should be performed in order to confirm HIB infection during this period.

Antipyretic treatment should be initiated according to locallongertreatment guidelines.

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

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

4.5 Interaction with other medicinal products and other forms of interaction

In paediatric vaccination it is often practice to co-administer different injectable vaccines at separate

Product

no

injection sites, during the same session.

Limited data show that there is no interference with the response to Measles-Mumps-Rubella (MMR) and OPV antigens. Although no data are available on the immune response to the Bacille-Calmette- Guérin (BCG) antigen, no interference is expected.

As with other vaccines it may be expected that an adequate response may not be achieved in patients receiving immunosuppressive therapy or patients with immunodeficiency.

4.6

Pregnancy and lactation

 

Medicinal

As Quintanrix 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

Quintanrix was administered to approximately 1,340 healthy infants from 6 weeks of age as a primary vaccination course in several clinical trials.

In these trials, the most common reactions occurring after vaccine administration were pain at the site of injection, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) and irritability, which were associated with about 50% of the doses administered.

Nervous system disorders: very common: drowsiness
Psychiatric disorders very common: irritability

Adverse reactions are listed below.

 

Frequencies are reported as:

authorised

Very common:

(>1/10)

Common:

(>1/100, <1/10)

 

Uncommon:

(>1/1,000, <1/100)

 

Rare:

(>1/10,000, <1/1,000)

 

Very rare:

(<1/10,000) including isolated reports

 

Psychiatric disorders:

 

 

very common: irritability

Nervous system disorders: very common: drowsiness

rare: collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions

Respiratory, thoracic and mediastinal disorders rare: bronchitis, coughing

Gastrointestinal disorders: very common: loss of appetite rare: vomiting

General disorders and administration site conditions:

very common: pain, redness and swelling, fever (axillary 37.5°C; rectal 38°C) common: induration, fever (axillary > 39°C; rectal > 39.5°C)

longer

Quintanrix was administered as a booster to 435 infantsno in the second year of life. As shown with

other vaccines, the booster dose is potentially associated with an increased incidence of minor adverse

events such as fever and localProductreactions.

Adverse reactions reported after booster vaccination are listed below.

Gastrointestinal disorders: very Medicinalcommon: loss of appetite

General disorders and administration site conditions:

very common: pain, redness and swelling, fever (axillary 37.5°C; rectal 38°C) common: fever (axillary > 39°C; rectal > 39.5°C)

uncommon: induration

Allergic reactions, including anaphylactoid reactions and urticaria, have been reported very rarely following vaccination with DTP, hepatitis B and HIB containing vaccines.

During post marketing surveillance studies with other hepatitis B containing vaccines, serum sickness like disease and thrombocytopenia have been reported very rarely.

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).

Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
4.9 Overdose
No case of overdose has been reported.

5. PHARMACOLOGICAL PROPERTIES

Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code JO7CA10

5.1 Pharmacodynamic properties

of infants with anti-PRP titres ≥ 0.15 µg/ml was > 99% and the percentageauthorisedwith anti-HBs titres ≥ 10 mIU/ml was 97.3%. More than 99% of subjects were considered to have responded to the pertussis

The immune response after a three-dose primary vaccination course was evaluated in five trials: 297

infants were evaluated after vaccination at 6, 10 and 14 weeks of age, 685 after vaccination at 2, 4,

and 6 months of age and 107 after vaccination at 3, 4 and 5 months of age. Results from different

studies show that, overall, 95.5% and 99.9% of subjects had anti-diphtheria and anti-tetanus titres ≥

0.1 IU/ml one month after completion of the primary vaccination course. At this time, the percentage

seronegative subjects (i.e. subjects with pre-vaccination longertitres < 15 ELU/ml) or a post-vaccination titre at least equal to pre-vaccination levels in subjects initially seropositive due to maternally- derived antibodies.

component of the vaccine, which was defined as the appearance of antibodies in initially

Seroprotection and vaccine response rates were similar for the three schedules used, with the exception of anti-HBs. The seroprotection rates for anti-HBs (≥10 mlU/ml) observed with the 6, 10, 14 week schedule was lower as shown in the table below, but is unlikely to be clinically relevant due to the small sample size:

2, 4, 6 months schedule

3, 4, 5 months schedule

6, 10, 14 weeks schedule

N = 672

no

N = 97

N = 107

98.9%

95.3%

92.8%

in the second year of life, inducesProducta greater than 10-fold increase in mean antibody titre with respect

Limited information exists on the persistence of the immune response after primary vaccination with Quintanrix as well as on the immunogenicity of booster doses. Results from one pilot study showed that, for 63 infants primed according to a 6, 10, 14 week schedule, > 80% still had antibodies to diphtheria, tetanus, HBs and PRP at levels considered to be protective. Forty-one percent had

antibodiesMedicinalto pertussis. Data from clinical trials show that Quintanrix, when given as a booster dose

to prebooster levels for all vaccine components.

It can be expected that hepatitis D will also be prevented by immunisation with Quintanrix as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

No preclinical safety testing with the vaccine has been conducted.

6. PHARMACEUTICAL PARTICULARS

6.1

List of excipients

 

Lyophilised HIB component:

authorised

Lactose

 

Liquid DTPw-HBV component:

 

Thiomersal

 

Sodium chloride

 

Water for injections.

 

For adjuvants, see section 2.

 

6.2

Incompatibilities

 

In the absence of compatibility studies, the reconstituted Quintanrix vaccine must not be mixed with other medicinal products.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

longer

no

Store in a refrigerator (2°C – 8°C)

Do not freeze.

 

 

 

Store in the original package in order to protect from light.

 

Product

 

After reconstitution, it is recommended to inject the vaccine promptly. However the stability has been demonstrated for 8 hours at 25°C after reconstitution.

6.5 Nature and contents of container

Powder in a vial (type I glass) for 1 dose with a stopper (rubber butyl).

0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl) in the following pack sizes:

- pack size of 1 vial of powder plus 1 vial of suspension

6.6 Instructions for use and handling

- pack size of 100 vials of powder plus 100 vials of suspension Not allMedicinalpack sizes may be marketed.

Upon storage, a white deposit and clear supernatant may be observed for the DTPw-HBV component. This does not constitute a sign of deterioration.

The DTPw-HBV component should be well shaken in order to obtain a homogeneous turbid white suspension and should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. Any unused vaccine or waste material should be disposed of in accordance with local requirements.

The vaccine is reconstituted by withdrawing the contents of the vial containing the DTPw-HBV component by means of a syringe and by adding it to the vial containing the HIB powder. After the addition of the DTPw-HBV component to the HIB powder, the mixture should be well shaken until

the powder is completely dissolved. The reconstituted vaccine is a homogeneous turbid white suspension.

Remove and discard the needle used for reconstitution and replace it with a second needle to administer the vaccine. After reconstitution, the vaccine should be injected promptly.

7.

MARKETING AUTHORISATION HOLDER

authorised

EU/1/04/301/002

GlaxoSmithKline Biologicals s.a.

 

Rue de l'Institut 89

 

B-1330 Rixensart, Belgium

 

8.

MARKETING AUTHORISATION NUMBER(S)

 

EU/1/04/301/001

9.DATE OF FIRST AUTHORISATION/RENEWALlongerOF THE AUTHORISATION

 

Product

no

Medicinal

 

 

 

For excipients, see section 6.1.

1. NAME OF THE MEDICINAL PRODUCT

Quintanrix powder and suspension for suspension for injection, multidose

Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

3 produced in Saccharomyces cerevisae cells by recombinant DNA technology This is a multidose container. See section 6.5 for the number of doses per vial.

After reconstitution, 1 dose (0.5 ml) contains:

 

 

Diphtheria toxoid1

not less than 30

International Units

Tetanus toxoid1

not less than 60

International Units

Inactivated Bordetella pertussis 2

not less than 4

International Units

Hepatitis B surface antigen (rDNA) 2, 3

 

10 micrograms

Haemophilus influenzae type b polysaccharide

 

 

(polyribosylribitol phosphate) 2

 

2.5 micrograms

conjugated to tetanus toxoid as a carrier

 

5-10 micrograms

 

 

authorised

1 adsorbed on aluminium hydroxide, hydrated

Total: 0.26 milligrams Al3+

2adsorbed on aluminium phosphate

Total: 0.40 milligrams Al3+

 

longer

 

3.PHARMACEUTICAL FORM

Powder and suspension for suspension for injectionno

Quintanrix is indicated for primaryProductimmunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae type b and for booster immunisation of young children during the second year of life.

The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B (DTPw-HBV) component is a turbid white suspension.

The lyophilised Haemophilus influenzae type b (HIB) component is a white powder.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

 

Medicinal

The use of Quintanrix should be determined on the basis of official recommendations.

4.2 Posology and method of administration

Posology

Primary vaccination:

The primary vaccination schedule consists of three doses of 0.5 ml to be administered at intervals of at least 4 weeks within the first six months of life in accordance with local official recommendations. The first dose can be administered at 6 weeks of age. The following schedules have been studied in

Method of administration
Booster vaccination:

clinical trials: 2-4-6 months, 3-4-5 months and 6-10-14 weeks. The 3-5-12 month schedule was not evaluated.

Quintanrix can be given to children who have received hepatitis B vaccine at birth.

The immunoprophylactic measures for hepatitis B should not be modifiedauthorisedfor children born to

hepatitis B virus carrying mothers. This may require separate administration of hepatitis B vaccine and should follow official recommendations.

After the completion of the primary series, a booster should be administered preferably before the end of the second year of life. Booster administration should be in accordance with official recommendations.

Quintanrix may be used to boost responses to DTP, HBV and HIB antigens if its composition is in accordance with official recommendations for boosting. The booster dose should preferably be given at least 6 months after the last primary dose.

Quintanrix is for deep intramuscular injection, preferablylongerin the anterolateral thigh.

4.3 Contraindications

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

occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances the vaccination course should be continued with diphtheria, tetanus, hepatitis B and HIB vaccines.

Quintanrix is contra-indicated if the child has experiencedno an encephalopathy of unknown aetiology,

As with other vaccines, the administrationProductof Quintanrix should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, such as a cold, is not a contraindication for vaccination.

4.4 Special warnings and special precautions for use

Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events).

 

Medicinal

always be

 

 

 

 

vaccine.

 

 

minutes.

 

 

decision to give

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

considered:

 

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.

benefits

 

 

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

fine needle can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least two minutes following administration.

Quintanrix should under no circumstances be administered intravascularly.

The vaccine will not prevent infection caused by other pathogens known to infect the liver such as hepatitis A, hepatitis C and hepatitis E virus.

The HIB component of the vaccine does not protect against diseases due to capsular serotypes other than type b of Haemophilus influenzae or against meningitis caused by other organisms.

A history of febrile convulsions,a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Quintanrix. Vaccinees with a history of

febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days post vaccination.

HIV infection is not considered as a contraindication. The expected immunological response may not be obtained after vaccination of immunosuppressed patients.

authorised

when administering immunisation series to very prematurelongerinfants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratoryno immaturity.

Since the capsular polysaccharide antigen is excreted in the urine a positive urine antigen test can be

observed within 1-2 weeks following vaccination. Other tests should be performed in order to confirm HIB infection during this period.

Antipyretic treatment should be initiated according to local treatment guidelines.

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

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

delayed.

4.5 Interaction with otherProductmedicinal products and other forms of interaction

In paediatric vaccination it is often practice to co-administer different injectable vaccines at separate injection sites, during the same session.

Limited data show that there is no interference with the response to Measles-Mumps-Rubella (MMR) and OPV antigens. Although no data are available on the immune response to the Bacille-Calmette- Guérin (BCG) antigen, no interference is expected.

As with other vaccines it may be expected that an adequate response may not be achieved in patients

receivingMedicinalimmunosuppressive therapy or patients with immunodeficiency.

4.6 Pregnancy and lactation

As Quintanrix 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

Quintanrix was administered to approximately 1,340 healthy infants from 6 weeks of age as a primary vaccination course in several clinical trials.

Psychiatric disorders very common: irritability

In these trials, the most common reactions occurring after vaccine administration were pain at the site of injection, fever (axillary 37.5°C; rectal 38°C) and irritability, which were associated with about 50% of the doses administered.

Adverse reactions are listed below.

 

 

authorised

Frequencies are reported as:

 

 

 

Very common:

(>1/10)

 

 

Common:

(>1/100, <1/10)

 

 

Uncommon:

(>1/1,000, <1/100)

 

 

Rare:

(>1/10,000, <1/1,000)

 

 

Very rare:

(<1/10,000) including isolated reports

Psychiatric disorders:

 

 

 

 

very common: irritability

 

 

 

Nervous system disorders:

 

 

 

very common: drowsiness

 

 

 

 

 

 

 

 

rare: collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions

Respiratory, thoracic and mediastinal disorders

 

longer

 

rare: bronchitis, coughing

 

 

 

Gastrointestinal disorders:

 

 

 

very common: loss of appetite

 

 

rare: vomiting

 

 

 

 

General disorders and administration site conditions:

 

very common: pain, redness and swelling, fever (axillary 37.5°C; rectal 38°C)

common: induration, fever (axillary > 39°C; rectal > 39.5°C)

 

 

 

Product

no

 

 

Nervous system disorders:

 

 

 

Quintanrix was administered as a booster to 435 infants in the second year of life. As shown with other vaccines, the booster dose is potentially associated with an increased incidence of minor adverse events such as fever and local reactions.

Adverse reactions reported after booster vaccination are listed below.

very Medicinalcommon: drowsiness Gastrointestinal disorders:

very common: loss of appetite

General disorders and administration site conditions:

very common: pain, redness and swelling, fever (axillary 37.5°C; rectal 38°C) common: fever (axillary > 39°C; rectal > 39.5°C)

uncommon: induration

Allergic reactions, including anaphylactoid reactions and urticaria, have been reported very rarely following vaccination with DTP, hepatitis B and HIB containing vaccines.

During post marketing surveillance studies with other hepatitis B containing vaccines, serum sickness like disease and thrombocytopenia have been reported very rarely.

No case of overdose has been reported.

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).

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

4.9 Overdose

5. PHARMACOLOGICAL PROPERTIES

Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code JO7CA10

5.1 Pharmacodynamic properties

infants were evaluated after vaccination at 6, 10 and 14 weeks of age, 685 after vaccination at 2, 4,

The immune response after a three-dose primary vaccination course wasauthorisedevaluated in five trials: 297

and 6 months of age and 107 after vaccination at 3, 4 and 5 months of age. Results from different

studies show that, overall, 95.5% and 99.9% of subjects had anti-diphtheria and anti-tetanus titres ≥ 0.1 IU/ml one month after completion of the primary vaccination course. At this time, the percentage of infants with anti-PRP titres ≥ 0.15 µg/ml was > 99% and the percentage with anti-HBs titres ≥ 10 mIU/ml was 97.3%. More than 99% of subjects were considered to have responded to the pertussis component of the vaccine , which was defined as the appearance of antibodies in initially

seronegative subjects (i.e. subjects with pre-vaccination titres < 15 ELU/ml) or a post-vaccination

titre at least equal to pre-vaccination levels in subjects initially seropositive due to maternally-

derived antibodies.

no

longer

 

Seroprotection and vaccine response rates were similar for the three schedules used, with the exception of anti-HBs. The seroprotection rates for anti-HBs (≥10 mlU/ml) observed with the 6, 10, 14 week schedule was lower as shown in the table below, but is unlikely to be clinically relevant due to the small sample size:

2, 4, 6 months schedule

3, 4, 5 months schedule

6, 10, 14 weeks schedule

N = 672

N = 107

N = 97

98.9%

95.3%

92.8%

Limited information exists onProductthe persistence of the immune response after primary vaccination with Quintanrix as well as on the immunogenicity of booster doses. Results from one pilot study showed

that, for 63 infants primed according to a 6, 10, 14 week schedule, > 80% still had antibodies to diphtheria, tetanus, HBs and PRP at levels considered to be protective. Forty-one percent had antibodies to pertussis. Data from clinical trials show that Quintanrix, when given as a booster dose in the second year of life, induces a greater than 10-fold increase in mean antibody titre with respect to prebooster levels for all vaccine components.

It can be expected that hepatitis D will also be prevented by immunisation with Quintanrix as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

5.2

Pharmacokinetic properties

Not applicable.

 

Medicinal

5.3

Preclinical safety data

No preclinical safety testing with the vaccine has been conducted.
6. PHARMACEUTICAL PARTICULARS

6.1

List of excipients

authorised

Lyophilised HIB component:

Lactose

Liquid DTPw-HBV component:

Thiomersal

Sodium chloride

Water for injections.

For adjuvants, see section 2.

6.2

Incompatibilities

 

 

In the absence of compatibility studies, the reconstituted Quintanrix vaccine must not be mixed with other medicinal products.

6.3 Shelf life

3 years.

After reconstitution,it is recommended to inject the vaccine promptly. However the stability has been

demonstrated for 8 hours at 25°C after reconstitution.

longer

6.4 Special precautions for storage

no

 

Store in a refrigerator (2°C – 8°C)

 

Do not freeze.

Store in the original packageProductin order to protect from light. in the following pack sizes:

6.5 Nature and contents of container

Powder in a vial (type I glass) for 2 doses with a stopper (rubber butyl).

1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (rubber butyl)

– packMedicinalsize of 1 vial of powder plus 1 vial of suspension

– pack size of 100 vials of powder plus 100 vials of suspension.

Powder in a vial (type I glass) for 10 doses with a stopper (rubber butyl).

5 ml of suspension in a vial (type I glass) for 10 doses with a stopper (rubber butyl) in a pack size of 50 vials of powder plus 50 vials of suspension.

Not all pack sizes may be marketed.

6.6 Instructions for use and handling

Upon storage, a white deposit and clear supernatant may be observed for the DTPw-HBV component. This does not constitute a sign of deterioration.

The DTPw-HBV component should be well shaken in order to obtain a homogeneous turbid white suspension and should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. Any unused vaccine or waste material should be disposed of in accordance with local requirements.

The vaccine is reconstituted by withdrawing the contents of the vial containingauthorisedthe DTPw-HBV

component by means of a syringe and by adding it to the vial containing the HIB powder. After the addition of the DTPw-HBV component to the HIB powder, the mixture should be well shaken until the powder is completely dissolved. The reconstituted vaccine is a homogeneous turbid white suspension.

Remove and discard the needle used for reconstitution and replace it with a second needle to administer the vaccine. After reconstitution, the vaccine should be injected promptly.

When using a multidose vial, each 0.5 ml dose of the reconstituted suspension 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.

7. MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Biologicals s.a.

 

 

Rue de l'Institut 89

 

 

B-1330 Rixensart, Belgium

 

 

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/301/003

no

longer

 

EU/1/04/301/004

 

 

 

EU/1/04/301/005

9. DATE OF FIRST AUTHORISATION/RENEWAL AUTHORISATIONOF THE

17/02/2005

Product

 

10. DATE OF REVISION OF THE TEXT

Medicinal

 

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