QUADRACEL 5 LF / 0.5 ML — DIN 02534789
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 · SUSPENSION · wholesale supply in Canada
Health Canada status: MARKETED
What is QUADRACEL?
QUADRACEL 5 LF / 0.5 ML contains 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. It is listed in the Health Canada Drug Product Database under DIN 02534789, held by SANOFI PASTEUR LIMITED, supplied as SUSPENSION for INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 06-May-2024. 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 QUADRACEL used for?
Primary immunization of infants from 2 months and children up to 6 years of age against diphtheria, tetanus, pertussis and poliomyelitis.
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 | 5 LF / 0.5 ML |
|---|---|
| Dosage form | SUSPENSION |
| Route | INTRAMUSCULAR |
| Pack configuration (monograph) | 1 dose package (1 x 0.5 mL vial); 5 dose package (5 x 0.5 mL vials). Also supplied as PENTACEL (with Act-HIB). |
| Storage | Not explicitly detailed in provided text (standard vaccine storage usually 2-8°C, but text only lists section 11 without details). |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
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.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Substance and classification
| Active substance | Diphtheria-Pertussis-Poliomyelitis-Tetanus |
|---|---|
| ATC code | J07CA02 |
| AHFS class | 80:12.00 |
| 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) | 02534789 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2534789 |
| Brand name | QUADRACEL |
| Generic / active ingredient | 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 |
| Market authorization holder | SANOFI PASTEUR LIMITED |
| 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 | 06-May-2024 |
| Original market date | 2024-05-06 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
0.5 mL intramuscular (I.M.) injection. Routine series at 2, 4, 6, and 18 months of age. Booster dose at 4 to 6 years of age.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Systemic hypersensitivity to any component; Encephalopathy within 7 days of a previous pertussis vaccine; Progressive neurologic disorder (e.g., uncontrolled epilepsy, infantile spasms).
Warnings and precautions
Postpone in acute/febrile disease. Caution in patients with bleeding disorders, history of GBS within 6 weeks of tetanus vaccine, or history of HHE. Not for intravascular or subcutaneous use.
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 |
| INFANRIX HEXA | 8 MCG / 0.5 ML | SUSPENSION | GLAXOSMITHKLINE INC | MARKETED | 02253852 |
| 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.