HIBERIX

Israel - English - Ministry of Health

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Active ingredient:
HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE 10 MCG / 0.5 ML
Available from:
GLAXO SMITH KLINE (ISRAEL) LTD
ATC code:
J07AG01
Pharmaceutical form:
POWDER FOR SOLUTION FOR INJECTION
Administration route:
I.M
Manufactured by:
GLAXO SMITH KLINE BIOLOGICALS S.A
Therapeutic group:
HEMOPHILUS INFLUENZAE B, PURIFIED ANTIGEN CONJUGATED
Therapeutic indications:
Active immunisation for all infants from the age of two months against disease caused by Hib
Authorization number:
113642953500
Authorization date:
2009-02-01

Hiberix MOH apr 2 2009

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The formatof this leaflet wasdetermined bythe MinistryofHealth and itscontent waschecked and approvedinFebruary2009

1. NAME OF THE MEDICINAL PRODUCT

Hiberix ™

Haemophilus influenzaetype b (Hib)vaccine.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Hiberix ™is a lyophilised vaccine of purified polyribosyl-ribitol-phosphate capsular polysaccharide

(PRP) of Hib, covalently bound to tetanus toxoid.

The Hib polysaccharide is prepared fromHib, strain 20,752 and after activation withcyanogen bromide

and derivatisation withan adipic hydrazidespaceris coupled to tetanus toxoid via carbodiimide

condensation. After purification theconjugate is lyophilised in the presence of lactoseas stabiliser.

Hiberix ™meets the WHO requirements for manufacture ofbiological substancesand of Hib conjugated

vaccines.

Each single dose of vaccine is formulated to contain 10mcg of purified capsular polysaccharide

covalently bound to approximately 30 mcg tetanus toxoid.

3. PHARMACEUTICAL FORM

Powder and solvent for solution for injection.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Hiberix ™isindicatedfor activeimmunisationofall infants fromthe age of 2 months through 5 years

against disease caused byHib.

Hiberix ™does not protect against disease due to other types ofH. influenzaenor against meningitis

caused by other organisms.

4.2 Posology and methodof administration

Posology

The primary vaccinationschedule consists of three dosesin the first 6 months oflife and can start from

the age of 2 months. To ensure along-termprotection, a booster dose isrecommended inthe second year

of life.

Infants between the agesof 6 and 12months previously unvaccinated should receive 2 injections, given

with an interval of one month, followed by a boosterin the second year of life. Previously unvaccinated

children aged 1-5 years shouldbe given one dose of vaccine.

As vaccination schemes vary fromcountry to country, the schedule for each country may be used in

accordance with the different national recommendations.

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Method of administration

The reconstituted vaccine is for intramuscular injection. However, itis good clinical practice that in

patients with thrombocytopenia or bleeding disorders the vaccine should be administered subcutaneously.

Hiberix ™should under no circumstances beadministered intravascularly.

During the course of immunization, injections should not be made morethan one at the samesite.

As with other intramuscular injection, use with caution in patients on anti coagulant therapy.

4.3 Contra-indications

Hiberix ™should not be administered to subjects with knownhypersensitivity to any component of the

vaccine, or to subjects having shown signs of hypersensitivity after previousadministration of Hib

vaccines.

As with other vaccines,the administrationof Hiberix ™should be postponedin subjects sufferingfrom

acute severefebrile illness. The presence of a minor infection, however, is not a contra-indication for

vaccination.

4.4 Special warnings andspecial precautions for use

As with all injectable vaccines, appropriate medical treatment and supervision should alwaysbe readily

available in case of a rare anaphylactic event following the administration of the vaccine.

Human Immunodeficiency Virus (HIV)infection is not considered asa contra-indication for Hiberix ™.

Although limited immune response tothe tetanus toxoid component may occur, vaccination with

Hiberix ™alone does not substitute for routine tetanus vaccination.

As reportedwith Haemophilus bpollysaccharide vaccines,casesof HInfluenzae type b disease may

occur subsequent to vaccination and prior to the onset of protective effects of the vaccine.

Excretion of capsular polysaccharide antigen in theurine has been describedfollowing receipt of Hib

vaccines, and therefore antigen detection maynot have a diagnostic value in suspectedHibdiseasewithin

1-2 weeks ofvaccination.

Special care should be taken to ensure that the vaccine is notinjected into a blood vessel.

Hiberix ™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 immunizationseries to very premature infants (born≤28 weeks of

gestation) and particularlyfor those with a previoushistory of respiratory immaturity. As the benefit of

vaccination is high in this group of infants, vaccination shouldnot be withheld or delayed.

4.5 Interaction with other medicinal productsand other forms of interaction

Hiberix ™can be administered eithersimultaneously or at any time beforeor after adifferent inactivated

or live vaccine.

Hiberix ™can be mixed in the samesyringe with SmithKline Beechamvaccines Infanrix™(DTPa

vaccine), Tritanrix ™(DTPw vaccine) or Tritanrix™-HB (DTPw-HB vaccine). Other injectable vaccines

should always be administeredat different injection sites.

As with other vaccines it may be expectedthat inpatients receivingimmunosuppressivetherapy or

patients with immunodeficiency, an adequate response may not be achieved.

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Immunosopressive therapies, including irradiation, antimetabolites, alkytalin agents, cytotoxic drugs, and

corticosteroids ( used ingreater than physiologicdoses), may reduce the immune response to vaccines.

Short-term( < 2 weeks ) of corticosteroid therapyor intra-articular, bursalor tendon injections with

corticosteroids should not be immunosuppressive. Although no specific studies with pertussis vaccine are

available, if immunosuppressivetherapy will be discontinuedshortly, it isreasonable to defer vaccination

until the patient has beenoff therapy for one month;otherwise, the patient shouldbe vaccinate while still

on therapy.

4.6Use during pregnancy and lactation

Adequate human data on use during pregnancy or lactation and adequateanimal reproduction studies are

not available.

4.7 Effects on ability todrive and use machines

Not applicable.

4.8 Undesirable effects

In controlled clinical studies, signs and symptomswere actively monitored and recorded on diary cards

following the administration of the vaccine.

Of the local solicited symptomsthe most frequently reported within the first 48hours was mild redness at

the injection sitewhich resolved spontaneously. Other localsolicited symptomsreported were mild

swelling andpain at the injection site.

The general symptomswhich have been solicited and reported within the first 48 hours were mild and

resolved spontaneously. These include fever, lossof appetite, restlessness, vomiting, diarrhoea and

unusual crying. As forall Hib vaccines, these general symptomshave been also reported when

administered concomitantly with other vaccines.

Very rarely allergic reactions, including anaphylactoid reactions, have been reported.

4.9 Overdose

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

A titre of>0.15 mcg/mlwas obtained in 95-100% of infants one month after the completion of the

vaccination course. A titre of >0.15 mcg/mlwasobtained in 100% ofinfants one month after the booster

dose (94.7% with a titre of >10 mcg/ml).

5.2 Pharmacokinetic properties

Evaluation ofpharmacokinetic properties is not required for vaccines.

5.3 Preclinical safety data

Not applicable.

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6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Vaccine : lactose

Diluent : sterile saline solution

6.2 Incompatibilities

Hiberix ™can be mixed in the samesyringe with SmithKline Beechamvaccines Infanrix™(DTPa

vaccine), Tritanrix ™(DTPw vaccine) or Tritanrix™-HB (DTPw-HB vaccine). Other injectable vaccines

should always be administeredat different injection sites.

Hiberix ™should not be mixed with other vaccines inthe samesyringe (except for authorised

combinations).

6.3 Shelf-life

The expiry date of the vaccine isindicated on the label and packaging.

When stored under prescribed conditions, the shelf-life is 36 months.

6.4 Special precautions for storage

The lyophilised vaccine has to be stored at +2°Cto+8°C. The lyophilised vaccine is not affected by

freezing.

The diluent can bestoredin therefrigeratoror atambient temperatures (up to25°C) and should not be

frozen.

6.5 Nature and content of container

The lyophilised vaccine is presentedas a white pellet in a glass vial.

The sterile diluent (saline) is clear and colourless and presented ina prefilled syringe.

The vials and syringes are made of neutral glass type I, which conformsto European Pharmacopoeia

Requirements.

6.6 Instructions for us and handling, and disposal (if appropriate)

The diluent and reconstituted vaccine should beinspectedvisually for any foreign particulate matter

and/or variation of physical aspectsprior to administration. In the event of either being observed, discard

the diluent orreconstituted vaccine.

The vaccine must be reconstituted byadding the entire contents of the supplied container of diluent to the

vial containing the pellet. After the additionofthe diluent to the pellet, the mixture should be well shaken

until the pellet is completelydissolvedin the diluent.

After reconstitution, the vaccine should be injected promptly.

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As stated in section 6.2 above, Hiberix ™may be mixed with Infanrix™, Tritanrix™, Tritanrix™HB

monodose vaccines. Inthis case, the diluent supplied in the Hiberix ™package is replaced bythe liquid

vaccine.

Make sure the container of the vaccine intended for mixing with Hiberix ™is a monodose container. From

the Hiberix ™package, discard the vial containingthe diluent.

The combined vaccine must be reconstituted byaddingtheentire contents ofthe other vaccinecontainer

to the vial containing the Hib white pellet.

This extemporaneously combined vaccine shouldbe handled in the sameway as the monocomponent

reconstituted Hiberix ™vaccine.

7. MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89

1330 Rixensart, Belgium

8. LICENSE HOLDER

GlaxoSmithKline (Israel) Ltd.

25 Bazel St.,Petah Tikva , 49002 Israel

9. MARKETING AUTHORISATIONNUMBER

Hiberix 113-64-29535

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