Recombivax HB

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Hepatitis B vaccine, rDNA 10 µg/mL
Available from:
Merck Sharp & Dohme (New Zealand) Limited
INN (International Name):
Hepatitis B vaccine, rDNA 10 µg/mL
Dosage:
10 mcg/dose
Pharmaceutical form:
Suspension for injection
Composition:
Active: Hepatitis B vaccine, rDNA 10 µg/mL Excipient: Aluminium as amorphous aluminum hydroxyphosphate sulphate Borax Formaldehyde Potassium thiocyanate Sodium chloride Water for injection
Prescription type:
Prescription
Manufactured by:
Merck Sharp & Dohme Corp
Therapeutic indications:
Indicated for immunisation against infection caused by all known subtypes of hepatitis B virus. Should also prevent hepatitis D (caused by delta virus) since hepatitis D does not occur in the absence of hepatitis B infection.
Product summary:
Package - Contents - Shelf Life: Syringe, glass, Glass syringe with chlorobutyl rubber stopper and tip cap - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
Authorization number:
TT50-10209
Authorization date:
2017-07-27

Read the complete document

NEW ZEALAND DATA SHEET

IPC-HB2-I-122011

Name of Medicine

Recombivax HB

®

hepatitis B vaccine (recombinant) injections

*5 mcg hepatitis B surface antigen per 0.5 mL (without preservative)

10 mcg hepatitis B surface antigen per 1.0 mL (without preservative)

*40 mcg hepatitis B surface antigen per 1.0 mL (This formulation is intended for

predialysis/dialysis patients only (without preservative))

*5 mcg/0.5 mL hepatitis B surface antigen and 40 mcg/1.0 mL hepatitis B surface

antigen vial are currently not supplied in New Zealand.

Presentation

A slightly opaque white sterile suspension (when thoroughly agitated).

The vaccine is available in 1mL prefilled syringes containing 10 mcg/mL of hepatitis

B surface antigen.

Therapeutic Class

Recombivax HB is a vaccine produced in yeast cells by a recombinant DNA

technique which has been shown to produce antibodies to hepatitis B virus.

Indications

All formulations of Recombivax HB are indicated for immunisation against infection

caused by all known subtypes of hepatitis B virus.

Recombivax HB should also prevent hepatitis D (caused by the delta virus) since

hepatitis D does not occur in the absence of hepatitis B infection.

Dosage and Administration

Do not inject intravenously or intradermally.

Recombivax HB (hepatitis B

recombinant

, MSD) (40 mcg/1.0 mL) (without

preservative) is intended only for adult predialysis/dialysis patients.

Recombivax HB (hepatitis B

recombinant

, MSD) (5 mcg/0.5 mL [without

preservative] or 10 mcg/1.0 mL [without preservative]) is not intended for use in

dialysis/predialysis patients.

Recombivax HB (hepatitis B vaccine [recombinant], MSD), (10 mcg/1.0 mL and 5

mcg/0.5 mL [without preservative]) is available for use in individuals for whom a

thimerosal-free vaccine may be desired.

Recombivax HB is for intramuscular injection. The deltoid muscle is the preferred site

for intramuscular injection in adults. The anterolateral thigh is the recommended site

for intramuscular injection in infants and young children. Data suggest that injections

NEW ZEALAND DATA SHEET

IPC-HB2-I-122011

given in the buttocks frequently are given into fatty tissue instead of into muscle.

Such injections have resulted in a lower seroconversion rate than is expected.

Recombivax HB may be administered subcutaneously to persons at risk of

haemorrhage following intramuscular injections. However, when other aluminium-

adsorbed vaccines have been administered subcutaneously, an increased incidence

of local reactions including subcutaneous nodules has been observed. Therefore,

subcutaneous administration should be used only in persons (e.g. haemophiliacs) at

risk of haemorrhage following intramuscular injections.

Shake well before use. Thorough agitation at the time of administration is necessary

to maintain suspension of the vaccine.

The vaccine should be used as supplied; no dilution or reconstitution is necessary.

The full recommended dose of the vaccine should be used.

For single-dose prefilled syringes only: Securely attach a needle by twisting in a

clockwise direction and administer the full recommended dose of RECOMBIVAX HB

intramuscularly.

Parenteral medicine products should be inspected visually for particulate matter and

discolouration prior to administration. After thorough agitation, Recombivax HB is a

slightly opaque, white suspension.

Three-Dose Regimen

The vaccination regimen consists of three doses of vaccine given according to the

following schedule:

First injection: at elected date

Second injection: ≥ 1 month after first injection

Third injection: ≥ 1 month after second injection

Within limits, the timing of successive injections may be adjusted to accommodate a

variety of needs, such as co-administration with other EPI vaccines.

For infants born of mothers who are HBsAg positive or mothers of unknown HBsAg

status, treatment recommendations are described in the subsections titled: 'Dosage

Regimen for Infants Born to HBsAg Positive Mothers' and 'Dosage Regimen for

Infants of Mothers of Unknown HBsAg Status'.

A minimum of one month should separate successive injections of vaccine.

Accelerated three dose regimens (e.g. 0, 1, 2 months; 0, 2, 4 months) may induce

protective antibody earlier in a slightly larger proportion of vaccinees. However,

regimens that extend the time interval between the second and third injections (e.g.

0, 1, 6 months; 0, 1, 12 months) will ultimately seroconvert a similar proportion of

vaccinees while inducing substantially higher antibody titres than accelerated

regimens.

NEW ZEALAND DATA SHEET

IPC-HB2-I-122011

Two-Dose Regimen – Adolescents (11-15 years of age)

An alternate two-dose regimen is available for routine vaccination of adolescents (11

to 15 years of age). The regimen consists of two doses of vaccine (10 mcg) given

according to the following schedule:

First injection: at elected date

Second injection: 4-6 months later

The dosing regimens of Recombivax HB for specific populations other than

predialysis/dialysis patients, regardless of the risk of infection with hepatitis B virus,

are as follows:

GROUP

REGIMEN

Infants**/Children/Adolescents

0-19 years

3 X 5 mcg

Adolescents

11-15 years of age

2 X 10 mcg

Adults

≥ 20 years

3 X 10 mcg

** Infants born of HBsAg negative mothers.

The appropriate dosage can be achieved from another formulation provided that the total volume of

vaccine administered does not exceed 1.0 mL. (See text above regarding the use of the formulations

without preservative).

However the 40 mcg/1.0 mL formulation can be used only for adult predialysis/dialysis patients.

Adolescents (11 to 15 years of age) may receive either the 3 X 5 mcg or the 2 X 10 mcg regimen.

Dosage Regimen for Infants Born To HBsAg Positive Mothers

Infants born to HBsAg positive mothers are at high risk of becoming chronic carriers

of hepatitis B virus and of developing the chronic sequelae of hepatitis B virus

infection. Well-controlled studies have shown that administration of three 0.5 mL

doses of hepatitis B immune globulin starting at birth is 75% effective in preventing

establishment of the chronic carrier state in these infants during the first year of life.

Protection is transient under these circumstances and the effectiveness of the

passively administered hepatitis B immune globulin declines thereafter. Results from

clinical studies indicate that administration of one 0.5 mL dose of hepatitis B immune

globulin at birth and three 5 mcg (0.5 mL) doses of Recombivax HB, the first dose

given within one week after birth, was 96% effective in preventing establishment of

the chronic carrier state in infants born to HBsAg and HBeAg positive mothers.

Testing for HBsAg and anti-HBs is recommended at 12-15 months to monitor the

final success or failure of therapy. If HBsAg is not detectable, and anti-HBs is

present, the child has been protected.

NEW ZEALAND DATA SHEET

IPC-HB2-I-122011

The recommended dosage for infants born to HBsAg positive mothers is as follows:

TREATMENT

BIRTH

1 MONTH

6 MONTHS

Recombivax HB

5 mcg***

5 mcg

5 mcg

Hepatitis B immune

globulin

0.5 mL

--

--

The first dose of Recombivax HB may be given at birth at the same time as hepatitis B immune

globulin but it should be administered in the opposite anterolateral thigh.

Dosage Regimen for Infants of Mothers of Unknown HBsAg Status

In the event that a mother's HBsAg status is unknown, vaccination should be initiated

as soon as possible with a 5 mcg dose of vaccine. If within 7 days of delivery, the

mother is determined to be HBsAg-positive, the infant also should be given a dose of

hepatitis B immune globulin immediately; the vaccination series should then be

completed with 5 mcg dosages. If the mother's HBsAg antigen test is negative, then

complete the vaccination series with 5 mcg dosages.

Predialysis/Dialysis Regimen

The recommended three dose vaccination regimen for predialysis/dialysis patients is

as follows:

GROUP

INITIAL

1 MONTH

6 MONTHS

Adult Predialysis and Dialysis Patients***

40 mcg

40 mcg

40 mcg

***Including dialysis and predialysis immunocompromised patients.

Note: There is no data available as yet on immunocompromised patients who are not

also dialysis or predialysis patients.

A booster dose or revaccination with Recombivax HB may be considered in

predialysis/dialysis patients if the anti-HB level is less than 10 mIU/mL 1 to 2 months

after the third dose.

The need for booster doses of vaccine should be assessed by annual antibody

testing, and a booster dose given when antibody levels decline to less than 10

mIU/mL.

Use With Other Vaccines

Results from clinical studies indicate that Recombivax HB can be administered

concomitantly with DTP (Diphtheria, Tetanus and whole cell Pertussis), OPV (Oral

Poliomyelitis Vaccine), M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live),

Liquid PedvaxHIB (Haemophilus b Conjugate Vaccine (Meningococcal Protein

Conjugate)) or a booster dose of DTaP (Diphtheria, Tetanus, acellular Pertussis),

using separate sites and syringes for injectable vaccines. No impairment of immune

response to individually tested vaccine antigens was demonstrated.

NEW ZEALAND DATA SHEET

IPC-HB2-I-122011

In addition, an HBsAg-containing product, COMVAX (Haemophilus b Conjugate

(Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine), was

given concomitantly with eIPV (enhanced Inactivated Poliovirus Vaccine) or

VARIVAX (Varicella Virus Vaccine Live (Oka/Merck)), using separate sites and

syringes for injectable vaccines. No impairment of immune response to these

individually tested vaccine antigens was demonstrated.

Revaccination of Nonresponders

When persons who do not respond (anti-HBs < 10 IU/l) to the primary vaccine series

are revaccinated, 15-25% produce an adequate antibody response after one

additional dose and 30-50% after three additional doses. However, because data are

insufficient concerning the safety of hepatitis B vaccine when additional doses in

excess of the recommended two or three-dose series are administered,

revaccination following completion of the primary series is not routinely

recommended. Revaccination should only be considered for high-risk individuals,

after weighing the benefits of vaccination against the potential risk of experiencing

increased local or systemic adverse reactions.

Known or Presumed Exposure to HBsAg

There are no prospective studies directly testing the efficacy of a combination of

hepatitis B immune globulin and Recombivax HB in preventing clinical hepatitis B

following percutaneous, ocular or mucous membrane exposure to hepatitis B virus.

Since most persons with such exposures (e.g. health care workers) are candidates

for the hepatitis B vaccine and since combined hepatitis B immune globulin plus

vaccine is more efficacious than hepatitis B immune globulin alone in perinatal

exposures, the following guidelines are recommended for persons who have been

exposed to hepatitis B virus such as through (1) percutaneous (needlestick), ocular,

mucous membrane exposure to blood known or presumed to contain HBsAg, (2)

human bites by known or presumed HBsAg carriers, that penetrate the skin, or (3)

following intimate sexual contact with known or presumed HBsAg carriers:

Hepatitis B immune globulin (0.06 mL/kg) should be given as soon as possible after

exposure and within 24 hours if possible. Hepatitis B vaccine with the age

appropriate dose (10 mcg for adults) should be given intramuscularly within 7 days of

exposure and second and third doses given one and six months, respectively, after

the first dose.

Revaccination

The duration of protective effect of Recombivax HB in healthy vaccinees is unknown

at present and the need for booster doses is not yet defined.

Contraindications

Hypersensitivity to yeast or any other component of the vaccine.

NEW ZEALAND DATA SHEET

IPC-HB2-I-122011

Warnings and Precautions

General

Persons with immunodeficiency or those receiving immunosuppressive therapy

require larger vaccine doses and respond less well than healthy individuals.

Because of the long incubation period for hepatitis B, it is possible for unrecognised

infection to be present at the time Recombivax HB is given. Recombivax HB may not

prevent hepatitis B in such patients.

Patients who develop symptoms suggestive of hypersensitivity after an injection

should not receive further injections of Recombivax HB (see 'Contraindications').

Use caution when vaccinating latex-sensitive individuals since the syringe plunger

stopper and tip cap contains dry natural latex rubber that may cause allergic

reactions.

As with any parenteral vaccine, epinephrine (adrenaline) should be available for

immediate use should an anaphylactoid reaction occur.

Any serious active infection is reason for delaying use of Recombivax HB, except

when, in the opinion of the physician, withholding the vaccine entails a greater risk.

Caution and appropriate care should be exercised in administering Recombivax HB

to individuals with severely compromised cardiopulmonary status or to others in

whom a febrile or systemic reaction could pose a significant risk.

All formulations of the vaccine are preservative-free.

Pregnancy

There are no well-controlled studies in pregnant women. Recombivax HB should be

used during pregnancy only if the potential benefit justifies the potential risk to the

foetus. Animal reproduction studies have not been conducted with Recombivax HB.

Nursing Mothers

It is not known whether Recombivax HB is excreted in human milk. Because many

medicines are excreted in human milk, caution should be exercised when the

vaccine is administered to nursing mothers. However, studies with hepatitis B

vaccine [recombinant], MSD in 12 lactating women have failed to reveal evidence of

this vaccine being excreted.

Paediatrics

Hepatitis B vaccine [recombinant], MSD has been shown to be usually well-tolerated

and highly immunogenic in infants and children of all ages. Newborns have

responded well; maternally transferred antibodies did not interfere with the active

immune response to the vaccine. (See 'Dosage and Administration' for

recommended paediatric dosage and recommended dosage for infants born to

HBsAg positive mothers). The safety profile and effectiveness of the dialysis

formulation in children have not been established.

NEW ZEALAND DATA SHEET

IPC-HB2-I-122011

Geriatric Use

Clinical studies of H-B-VAX II used for licensure did not include sufficient numbers of

subjects 65 years and older to determine whether they respond differently from

younger subjects. However, in later studies of hepatitis B vaccines, it has been

shown that a diminished antibody response and seroprotective levels can be

expected in persons older than 60 years of age.

Adverse Effects

Hepatitis B vaccine [recombinant], MSD is generally well tolerated. No adverse

experiences were reported during clinical trials which could be related to the titres of

antibodies to yeast.

As with any vaccine, there is the possibility that broad use of the vaccine could reveal

rare adverse reactions not observed in clinical trials.

In a group of studies worldwide, 3,258 doses of 10 mcg of hepatitis B vaccine

[recombinant], MSD were administered to 1,252 healthy adults. Vaccine recipients

were monitored for five days after each dose and the following adverse effects were

reported: (similar adverse effects can be expected with 2.5 mcg and 5 mcg doses):

Incidence Equal or Greater Than 1% of Injection

Local Reactions At Injection Site: Injection site reactions, consisting principally of

local pain, soreness and tenderness and including pruritus, erythema, ecchymoses,

swelling, warmth and nodule formation.

Body As A Whole: Fatigue/asthenia, malaise, fever (> 100ºF)

Digestive System: Nausea, diarrhoea

Nervous System: Headache

Respiratory System: Pharyngitis, upper respiratory infection (NOS)

Incidence Less Than 1% of Injections

Body As A Whole: Sweating, chills, flushing, aching, sensation of warmth

Integumentary System: Pruritus, rash, urticaria, angioedema

Digestive System: Vomiting, abdominal pains/cramps, dyspepsia, diminished

appetite

Musculoskeletal System: Myalgia, arthralgia, back pain, neck pain, shoulder pain,

neck stiffness

Nervous System: Light headedness, vertigo/dizziness, paresthesia

Respiratory System: Rhinitis, cough, influenza

NEW ZEALAND DATA SHEET

IPC-HB2-I-122011

Special Senses: Earache

Haemic/lymphatic System: Lymphadenopathy

Psychiatric/behavioural: Insomnia/disturbed sleep

Urogenital System: Dysuria

Cardiovascular System: Hypotension

In a study that compared the three-dose regimen (5 mcg) with the two-dose regimen

(10 mcg) of H-B-VAX II in adolescents, the overall frequency of adverse reactions

was generally similar.

In a group of studies, 1636 doses of hepatitis B vaccine [recombinant], MSD were

administered to 653 healthy infants and children (up to 10 years of age) who were

monitored for 5 days after each dose. Injection site reactions (including erythema

and swelling) and systemic complaints were reported following 8% and 17% of the

injections, respectively. The most frequently reported systemic adverse reactions (>

1% injections), in decreasing order of frequency, were irritability, tiredness, fever (>

101°F or > 38°C oral equivalent), crying, diarrhoea, vomiting, diminished appetite,

and insomnia.

Additional Adverse Effects

The following additional adverse effects have been reported with use of the

marketed vaccine; however, in many instances a causal relationship to the vaccine

has not been established.

Hypersensitivity: Anaphylaxis and symptoms of immediate hypersensitivity reactions

including oedema, dyspnoea, chest discomfort, bronchial spasm, or palpitation have

been reported within the first few hours after vaccination. An apparent

hypersensitivity syndrome (serum-sickness-like) of delayed onset has been reported

days to weeks after vaccination, including: arthritis (usually transient), and

dermatologic reactions such as erythema multiforme, ecchymoses and erythema

nodosum (see 'Warnings and Precautions').

Immune System: Vasculitis, polyarteritis nodosa

Integumentary System: Alopecia, eczema

Musculoskeletal System: Arthritis, pain in extremity

Nervous System: Peripheral neuropathy including Bell's Palsy; Guillain-Barré

syndrome, exacerbation of multiple sclerosis, multiple sclerosis, optic neuritis,

seizure, febrile seizure, encephalitis, vasovagal syncope

NEW ZEALAND DATA SHEET

IPC-HB2-I-122011

Special Senses: Tinnitus, uveitis

Haematologic: Increased erythrocyte sedimentation rate, thrombocytopenia.

Actions

Clinical studies have established that hepatitis B vaccine [recombinant], MSD, when

injected into the deltoid muscle, induced protective levels of antibody in 96% of 1213

healthy adults who received the recommended three dose regimen. Antibody

responses varied with age; a protective level of antibody was induced in 98% of 787

young adults 20-29 years of age, in 94% of 249 adults 30-39 years of age, and in

89% of 177 adults > 40 years of age. Studies with hepatitis B vaccine derived from

plasma have shown that a lower response rate (81%) to vaccine may be obtained if

the vaccine is administered as a buttock injection.

Seroconversion rates and geometric mean antibody titres were measured 1 to 2

months after the third dose. A protective antibody (anti-HBs) level has been defined

as 10 or more sample ratio units (SRU) as determined by radioimmunoassay or

positive by enzyme immunoassay.

Note: 10 SRU is comparable to 10 mIU/mL of antibody.

Predialysis and haemodialysis patients responded less well to Recombivax HB than

do healthy individuals, however, vaccination of adult patients early in the course of

their renal disease produces higher seroconversion rates than revaccination after

dialysis has been initiated. In two studies, where 40 mcg doses of vaccine were

administered in the deltoid muscle, 89% of 28 participants developed anti-HBs with

86% achieving levels > 10 mIU/mL. However, in two other studies, in which vaccine

was inappropriately administered either in the buttock or a combination of buttock

and deltoid, 62% of 47 participants developed anti-HBs with 55% achieving levels of

> 10 mIU/mL.

Recombivax HB is highly immunogenic in younger individuals. In clinical studies,

99% of 94 infants under 1 year of age born of non-carrier mothers, 96% of 46

children 1-10 years of age, and 99% of 112 adolescents 11-19 years of age

developed a protective level of antibody following the recommended 3-dose regimen

of vaccine.

The protective efficacy of three 5 mcg doses hepatitis B vaccine [recombinant], MSD

has been demonstrated in neonates born of mothers positive for both HBsAg and

HBeAg (a core-associated antigenic complex which correlates with high infectivity).

In a clinical study of infants who received one dose of hepatitis B immune globulin at

birth followed by the recommended 3-dose regimen of hepatitis B vaccine

[recombinant], MSD, chronic infection had not occurred in 96% of 130 infants after 9

months of follow-up. The estimated efficacy in prevention of chronic hepatitis B

infection was 95% as compared to the infection rate in untreated historical controls.

NEW ZEALAND DATA SHEET

IPC-HB2-I-122011

Significantly fewer neonates became chronically infected when given one dose of

hepatitis B immune globulin at birth followed by the recommended three dose

regimen of hepatitis B vaccine [recombinant], MSD when compared to historical

controls who received only a single dose of hepatitis B immune globulin. Testing for

HBsAg and anti-HBs is recommended at 12-15 months of age. If HBsAg is not

detectable, and anti-HBs is present, the child has been protected.

As demonstrated in the above study hepatitis B immune globulin, when administered

simultaneously with hepatitis B vaccine [recombinant], MSD at separate body sites,

did not interfere with the induction of protective antibodies against hepatitis B virus

elicited by the three dose vaccine.

The duration of the protective effect of hepatitis B vaccine [recombinant], MSD in

healthy vaccinees is unknown at present, and the need for booster doses is not yet

defined. However, long-term follow-up (5 to 9 years) of approximately 3000 high-risk

vaccinees (infants of carrier mothers, male homosexuals, Alaskan Natives) who

developed an anti-HBs titre of ≥ 10 mIU/mL when given a similar plasma-derived

vaccine at intervals of 0, 1, and 6 months showed that no subjects developed

clinically apparent hepatitis B infection and that 5 subjects developed antigenaemia,

even though up to half of the subjects failed to maintain a titre at this level.

Persistence of vaccine-induced immunologic memory among healthy vaccinees who

responded to a primary course of plasma-derived or recombinant hepatitis B vaccine

has been demonstrated by an anamnestic antibody response to a booster dose of

hepatitis B vaccine [recombinant], MSD given 5-12 years later. Data from a follow-up

study showed that a group of adolescents and adults immunised 13 years earlier

with a primary series of hepatitis B vaccine [recombinant], MSD, including several

individuals whose antibody level had subsequently fallen below 10 mIU/mL, retained

immunologic memory and were able to mount a vigorous secondary antibody

response to a booster dose of hepatitis B vaccine [recombinant], MSD. A booster

dose or revaccination with the dialysis formulation may be considered in

predialysis/dialysis patients if the anti-HBs level is less than 10 mIU/mL 1 to 2

months after the third dose.

Reports in the literature describe a more virulent form of hepatitis B associated with

superinfections or co-infections by delta virus, an incomplete RNA virus. Delta virus

can only infect and cause illness in persons infected with hepatitis B virus since the

delta agent requires a coat of HBsAg in order to become infectious. Therefore,

persons immune to hepatitis B virus infection should also be immune to delta virus

infection.

Pharmacokinetics

Pharmaceutical Precautions

Store unopened and opened prefilled syringes at 2-8°C (35.6-46.4°F). Storage above

or below the recommended temperature may reduce potency.

NEW ZEALAND DATA SHEET

IPC-HB2-I-122011

NOTE: As the formulations available in New Zealand do not contain preservative:

The vaccine should be used promptly, and the prefilled syringe must be discarded

after use.

Do not freeze because freezing destroys potency.

Medicine Classification

Prescription Medicine

Package Quantities

Recombivax HB supplied as:

1 mL single dose prefilled syringe containing 10 mcg/mL hepatitis B surface

(without preservative).

Further Information

Description

Recombivax HB (hepatitis B vaccine (recombinant), MSD) is a non-infectious sub-

unit viral vaccine consisting of surface antigen (HBsAg or Australia antigen) of

hepatitis B virus produced in yeast cells.

A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast and the

vaccine for hepatitis B is produced from cultures of this recombinant yeast strain

according to methods developed in the Merck Research Laboratories.

The antigen is harvested and purified from fermentation cultures of a recombinant

strain of the yeast Saccharomyces cerevisiae containing the gene for the adw

subtype of HBsAg. The HBsAg protein is released from the yeast cells by cell

disruption and purified by a series of physical and chemical methods. The currently

produced vaccine contains no detectable yeast DNA and less than 1% of the protein

content is from yeast. The purified protein is treated in phosphate buffer with

formaldehyde and then coprecipitated with alum (potassium aluminium sulphate) to

form bulk vaccine adjuvanted with amorphous aluminium hydroxyphosphate sulphate

(previously referred to as aluminium hydroxide). The vaccine produced by the Merck

method has been shown to be comparable to the plasma-derived vaccine in terms of

protective efficacy (chimpanzee and human).

The vaccine against hepatitis B, prepared from recombinant yeast cultures, is free of

association with human blood or blood products.

NEW ZEALAND DATA SHEET

IPC-HB2-I-122011

Recombivax HB is a sterile suspension for intramuscular injection; however, it may

be administered subcutaneously to persons at risk of haemorrhage following

intramuscular injections (see 'Dosage and Administration'). Recombivax HB is

supplied in three formulations (see 'Presentation').

The 10 mcg/1.0 mL formulation is only available without preservative. In the

formulation, hepatitis B surface antigen is adsorbed onto approximately 0.5 mg of

aluminium (provided as amorphous aluminium hydroxyphosphate sulphate) per mL

of vaccine. The vaccine is of the adw subtype.

Interchangeability of Plasma-Derived and Recombinant Hepatitis B Vaccines

A clinical study has shown that in healthy neonates a regimen of hepatitis B vaccine

can be initiated with other currently licensed hepatitis B vaccine and completed with

Recombivax HB.

Both the recombinant and plasma-derived vaccines are of antigen subtype ad. The

known amino acid sequence of the recombinant derived vaccine cannot be

compared precisely to that of the plasma derived vaccine, since the latter represents

a pool of antigen from several different plasma donors and has not been sequenced.

The yeast derived recombinant vaccine contains less than 1% normal yeast protein

as an impurity.

Inactive Ingredients

Each 1 mL dose contains approximately 0.5 mg of aluminum provided as amorphous

aluminum hydroxyphosphate sulfate, and 70 mcg of sodium borate, 9.0 mg sodium

chloride, and water for injection.

Each 0.5 mL dose contains approximately 0.25 mg of aluminum provided as

amorphous aluminum hydroxyphosphate sulfate, and 35 mcg of sodium borate, 4.5

mg sodium chloride, and water for injection.

Name and Address

Merck Sharp & Dohme (New Zealand) Limited

P O Box 99 851

Newmarket

Auckland

NEW ZEALAND

Tel: 0800 500 673

Date of Preparation

17 August 2017

DP-HB2-2012 (201211)

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