INFANRIX HEXA 8 MCG / 0.5 ML — DIN 02253852
PERTACTIN : 8 MCG / 0.5 ML TETANUS TOXOID ADSORBED : 40 MCG / 0.5 ML POLIOVIRUS TYPE 1 MAHONEY (INACTIVATED) : 40 UNIT / 0.5 ML HAEMOPHILUS INFLUENZAE TYPE B-PRP : 10 MCG / 0.5 ML HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 10 MCG / 0.5 ML PERTUSSIS TOXOID : 25 MCG / 0.5 ML TETANUS TOXOID : 10 LF / 0.5 ML FILAMENTOUS HAEMAGGLUTININ : 25 MCG / 0.5 ML POLIOVIRUS TYPE 2 MEF1 (INACTIVATED) : 8 UNIT / 0.5 ML POLIOVIRUS TYPE 3 SAUKETT (INACTIVATED) : 32 UNIT / 0.5 ML DIPHTHERIA TOXOID : 25 LF / 0.5 ML · GLAXOSMITHKLINE INC · SUSPENSION · wholesale supply in Canada
Health Canada status: MARKETED
What is INFANRIX HEXA?
INFANRIX HEXA 8 MCG / 0.5 ML contains PERTACTIN : 8 MCG / 0.5 ML TETANUS TOXOID ADSORBED : 40 MCG / 0.5 ML POLIOVIRUS TYPE 1 MAHONEY (INACTIVATED) : 40 UNIT / 0.5 ML HAEMOPHILUS INFLUENZAE TYPE B-PRP : 10 MCG / 0.5 ML HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 10 MCG / 0.5 ML PERTUSSIS TOXOID : 25 MCG / 0.5 ML TETANUS TOXOID : 10 LF / 0.5 ML FILAMENTOUS HAEMAGGLUTININ : 25 MCG / 0.5 ML POLIOVIRUS TYPE 2 MEF1 (INACTIVATED) : 8 UNIT / 0.5 ML POLIOVIRUS TYPE 3 SAUKETT (INACTIVATED) : 32 UNIT / 0.5 ML DIPHTHERIA TOXOID : 25 LF / 0.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02253852, held by GLAXOSMITHKLINE INC, supplied as SUSPENSION for INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 04-Dec-2008. 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 INFANRIX HEXA used for?
Active primary and booster immunization against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and disease caused by Haemophilus influenzae type b in infants/children 6 weeks to 2 years.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Diphtheria-Pertussis-Poliomyelitis-Tetanus in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
3 holders have a Canadian DIN containing Diphtheria-Pertussis-Poliomyelitis-Tetanus, across 7 DINs, of which 4 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| GLAXOSMITHKLINE INC | 3 | 2 | BOOSTRIX-POLIO, INFANRIX HEXA, INFANRIX-IPV | Sourceable in Canada |
| SANOFI PASTEUR LIMITED | 3 | 2 | ADACEL-POLIO, QUADRACEL | Sourceable in Canada |
| AVENTIS PASTEUR LIMITED | 1 | 0 | DPT POLIO ADSORBED VACCINES | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 8 MCG / 0.5 ML |
|---|---|
| Dosage form | SUSPENSION |
| Route | INTRAMUSCULAR |
| Pack configuration (monograph) | Kit of 10: PEDIARIX (DTaP-HB-IPV) in 0.5 mL pre-filled glass syringes and Hib vaccine as powder in 3.0 mL glass vials. Available with or without needles. |
| Storage | Reconstituted vaccine may be kept for up to 8 hours at room temperature (21°C). (Note: Full storage conditions for unmixed components not in provided text). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation, because this listing covers more than one of them.
Substance and classification
| Active substance | Diphtheria-Pertussis-Poliomyelitis-Tetanus |
|---|---|
| ATC code | J07CA02 |
| AHFS class | 84:12.00 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02253852 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2253852 |
| Brand name | INFANRIX HEXA |
| Generic / active ingredient | PERTACTIN : 8 MCG / 0.5 ML TETANUS TOXOID ADSORBED : 40 MCG / 0.5 ML POLIOVIRUS TYPE 1 MAHONEY (INACTIVATED) : 40 UNIT / 0.5 ML HAEMOPHILUS INFLUENZAE TYPE B-PRP : 10 MCG / 0.5 ML HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 10 MCG / 0.5 ML PERTUSSIS TOXOID : 25 MCG / 0.5 ML TETANUS TOXOID : 10 LF / 0.5 ML FILAMENTOUS HAEMAGGLUTININ : 25 MCG / 0.5 ML POLIOVIRUS TYPE 2 MEF1 (INACTIVATED) : 8 UNIT / 0.5 ML POLIOVIRUS TYPE 3 SAUKETT (INACTIVATED) : 32 UNIT / 0.5 ML DIPHTHERIA TOXOID : 25 LF / 0.5 ML |
| Market authorization holder | GLAXOSMITHKLINE INC |
| Health Canada schedule | Schedule D |
| ATC code | J07CA02 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J07CA |
| Current status | MARKETED |
| Status date | 04-Dec-2008 |
| Original market date | 2005-07-29 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
0.5 mL IM injection. Primary: 2 or 3 doses (min. 1 month interval). Booster: 12-23 months (at least 6 months after last primary dose). Reconstitute Hib powder with PEDIARIX suspension.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to components/previous doses; anaphylaxis after prior DTP, HepB, Polio, or Hib vaccines; encephalopathy within 7 days of pertussis vaccine; not for ages 7+ years.
Warnings and precautions
Do not give IV/intradermally. Risk of syncope. Caution in bleeding disorders. Potential for febrile convulsions. Monitor for 30 mins post-vaccination for anaphylaxis.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
4 of 7 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ADACEL-POLIO | 29 UNIT / 0.5 ML | SUSPENSION | SANOFI PASTEUR LIMITED | MARKETED | 02352044 |
| BOOSTRIX-POLIO | 2.5 LF / 0.5 ML | SUSPENSION | GLAXOSMITHKLINE INC | MARKETED | 02312557 |
| QUADRACEL | 5 LF / 0.5 ML | SUSPENSION | SANOFI PASTEUR LIMITED | MARKETED | 02534789 |
| DPT POLIO ADSORBED VACCINES | 25 LF / 0.5 ML | LIQUID | AVENTIS PASTEUR LIMITED | CANCELLED POST MARKET | 00605050 |
| INFANRIX-IPV | 40 UNIT / 0.5 ML | SUSPENSION | GLAXOSMITHKLINE INC | CANCELLED POST MARKET | 02241284 |
| QUADRACEL | 20 MCG / 0.5 ML | SUSPENSION | SANOFI PASTEUR LIMITED | CANCELLED POST MARKET | 02230946 |
2 · Same class — other molecules in ATC J07CA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Diphtheria-Pertussis-Poliomyelitis-Tetanus | ADACEL-POLIO · BOOSTRIX-POLIO · DPT POLIO ADSORBED VACCINES · INFANRIX HEXA · +2 more | 7 | 4 | Yes |
| Dipht-Hemoph Influen B-Pertuss-Polio-Tetanus | INFANRIX-IPV/HIB · PEDIACEL · PENTACEL | 4 | 2 | Yes |
| Diphtheria-Poliomyelitis-Tetanus | DT POLIO ADSORBED - SUS IM · TD POLIO ADSORBED | 2 | 0 | Not in Canada |
| Bacterial And Viral Vaccines, Combined | T POLIO ADSORBED | 1 | 0 | Not in Canada |
| Typhoid-Hepatitis A | VIVAXIM | 1 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
4 · Fixed-dose combinations with Canadian supply
| Product | Active ingredients | Holder | Status | DIN |
|---|---|---|---|---|
| ADACEL-POLIO | POLIOVIRUS TYPE 1 MAHONEY (INACTIVATED) : 29 UNIT / 0.5 ML FILAMENTOUS HAEMAGGLUTININ : 5 MCG / 0.5 ML DIPHTHERIA TOXOID : 2 LF / 0.5 ML PERTUSSIS TOXOID : 2.5 MCG / 0.5 ML TETANUS TOXOID : 5 LF / 0.5 ML POLIOVIRUS TYPE 2 MEF1 (INACTIVATED) : 7 UNIT / 0.5 ML POLIOVIRUS TYPE 3 SAUKETT (INACTIVATED) : 26 UNIT / 0.5 ML FIMBRIAE TYPES 2 AND 3 (FIM) : 5 MCG / 0.5 ML PERTACTIN : 3 MCG / 0.5 ML | SANOFI PASTEUR LIMITED | MARKETED | 02352044 |
| INFANRIX-IPV/HIB | FILAMENTOUS HAEMAGGLUTININ : 25 MCG / 0.5 ML HAEMOPHILUS INFLUENZAE TYPE B-PRP AND TETANUS TOXOID CONJUGATE (PRP-T) : 10 MCG / 0.5 ML INACTIVATED POLIOVIRUS TYPE II : 8 UNIT / 0.5 ML PERTUSSIS TOXOID : 25 MCG / 0.5 ML DIPHTHERIA TOXOID : 30 UNIT / 0.5 ML INACTIVATED POLIOVIRUS TYPE III : 32 UNIT / 0.5 ML TETANUS TOXOID : 40 UNIT / 0.5 ML PERTACTIN : 8 MCG / 0.5 ML INACTIVATED POLIOVIRUS TYPE I : 40 UNIT / 0.5 ML | GLAXOSMITHKLINE INC | MARKETED | 02257122 |
| QUADRACEL | TETANUS TOXOID : 5 LF / 0.5 ML FIMBRIAE TYPES 2 AND 3 (FIM) : 5 MCG / 0.5 ML POLIOVIRUS TYPE 1 MAHONEY (INACTIVATED) : 29 UNIT / 0.5 ML PERTACTIN : 3 MCG / 0.5 ML DIPHTHERIA TOXOID : 15 LF / 0.5 ML POLIOVIRUS TYPE 2 MEF1 (INACTIVATED) : 7 UNIT / 0.5 ML POLIOVIRUS TYPE 3 SAUKETT (INACTIVATED) : 26 UNIT / 0.5 ML PERTUSSIS TOXOID : 20 MCG / 0.5 ML FILAMENTOUS HAEMAGGLUTININ : 20 MCG / 0.5 ML | SANOFI PASTEUR LIMITED | MARKETED | 02534789 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
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. Patients and unlicensed buyers are routed to a partner pharmacy.
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.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
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.