INFANRIX HEXA 8 MCG / 0.5 ML
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 · DIN 02253852 · GLAXOSMITHKLINE INC
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.
Product details and regulatory record
| DIN | 02253852 |
|---|---|
| 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 |
| Manufacturer | GLAXOSMITHKLINE INC |
| Strength | 8 MCG / 0.5 ML |
| Dosage form | SUSPENSION |
| Route of administration | INTRAMUSCULAR |
| Schedule | Schedule D |
| ATC code | J07CA02 DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS |
| AHFS class | 84:12.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 04-Dec-2008 |
| Original market date | 2005-07-29 00:00:00 |
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.
How is it stored and handled?
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).
How is it supplied?
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.
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?
Other Canadian products sharing ATC code J07CA02 DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS. 4 of 7 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 |
|---|---|---|---|---|---|
| ADACEL-POLIO | 29 UNIT / 0.5 ML | SUSPENSION | SANOFI PASTEUR LIMITED | MARKETED | DIN 02352044 |
| BOOSTRIX-POLIO | 2.5 LF / 0.5 ML | SUSPENSION | GLAXOSMITHKLINE INC | MARKETED | DIN 02312557 |
| QUADRACEL | 5 LF / 0.5 ML | SUSPENSION | SANOFI PASTEUR LIMITED | MARKETED | DIN 02534789 |
| DPT POLIO ADSORBED VACCINES | 25 LF / 0.5 ML | LIQUID | AVENTIS PASTEUR LIMITED | CANCELLED POST MARKET | DIN 00605050 |
| INFANRIX-IPV | 40 UNIT / 0.5 ML | SUSPENSION | GLAXOSMITHKLINE INC | CANCELLED POST MARKET | DIN 02241284 |
| QUADRACEL | 20 MCG / 0.5 ML | SUSPENSION | SANOFI PASTEUR LIMITED | CANCELLED POST MARKET | DIN 02230946 |
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.