RECOMBIVAX HB 40 MCG
HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 40 MCG · DIN 02245977 · MERCK CANADA INC
Health Canada status: MARKETED
What is RECOMBIVAX HB?
RECOMBIVAX HB 40 MCG contains HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 40 MCG. It is listed in the Health Canada Drug Product Database under DIN 02245977, held by MERCK CANADA INC, supplied as SUSPENSION for INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 10-Apr-2006. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is RECOMBIVAX HB used for?
RECOMBIVAX HB® (hepatitis B vaccine [recombinant]) is indicated for immunization against infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB® should prevent hepatitis D (caused by the delta virus), since hepatitis D does not occur in the absence of hepatitis B infection.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02245977 |
|---|---|
| Brand name | RECOMBIVAX HB |
| Generic / active ingredient | HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 40 MCG |
| Manufacturer | MERCK CANADA INC |
| Strength | 40 MCG |
| Dosage form | SUSPENSION |
| Route of administration | INTRAMUSCULAR |
| Schedule | Schedule D |
| ATC code | J07BC01 HEPATITIS B, PURIFIED ANTIGEN |
| AHFS class | 80:12.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 10-Apr-2006 |
| Original market date | 2002-10-24 00:00:00 |
How is it administered?
3-dose regimen (0, 1, 6 months) or accelerated. Adolescents (11-15y) may use a 2-dose regimen (0, 4-6 months). Administer IM (deltoid for adults, anterolateral thigh for infants/children).
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
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How is it supplied?
Pediatric Presentation: available in packages of 1 single-dose vial. Adult Presentation: available in packages of 1 and 10 single-dose vials. Adult Dialysis Presentation: available in packages of 1 single-dose vial. Pediatric Presentation (prefilled syringe): available in packages of 1 single dose pre-filled syringe. Adult Presentation (prefilled syringe): available in packages of 1 and 10 single dose pre-filled syringes.
Contraindications
Hypersensitivity to the drug, any ingredient in the formulation, or component of the container.
Warnings and precautions
Epinephrine must be available for anaphylaxis. Use caution in latex-sensitive individuals (stopper/tip cap contain latex). May not prevent infection if incubation is already present.
What can be used instead?
Other Canadian products sharing ATC code J07BC01 HEPATITIS B, PURIFIED ANTIGEN. 3 of 9 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| ENGERIX-B | 10 MCG / 0.5 ML | SUSPENSION | GLAXOSMITHKLINE INC | MARKETED | DIN 02487020 |
| ENGERIX-B | 20 MCG / 1 ML | SUSPENSION | GLAXOSMITHKLINE INC | MARKETED | DIN 02487039 |
| ENGERIX-B | 10 MCG / 0.5 ML | SUSPENSION | GLAXOSMITHKLINE INC | CANCELLED POST MARKET | DIN 02296454 |
| ENGERIX-B | 20 MCG / 1 ML | SUSPENSION | GLAXOSMITHKLINE INC | CANCELLED POST MARKET | DIN 01919431 |
| PREHEVBRIO | 10 MCG | SUSPENSION | VBI VACCINES INC. | APPROVED | DIN 02533286 |
| RECOMBIVAX HB | 10 MCG | SUSPENSION | MERCK CANADA INC | CANCELLED POST MARKET | DIN 02243676 |
| RECOMBIVAX HB (ADULT DIALYSIS WITH PRESERVATIVE) | 40 MCG | SOLUTION | MERCK CANADA INC | CANCELLED POST MARKET | DIN 01934023 |
| RECOMBIVAX HB (WITH PRESERVATIVE) | 10 MCG | SOLUTION | MERCK CANADA INC | CANCELLED POST MARKET | DIN 00749486 |
Who else supplies HEPATITIS B, PURIFIED ANTIGEN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. HEPATITIS B, PURIFIED ANTIGEN appears in 66 registered pack listings across 8 markets, published on 6 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.