QUADRACEL 5 LF / 0.5 ML
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 · DIN 02534789 · SANOFI PASTEUR LIMITED
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.
Product details and regulatory record
| DIN | 02534789 |
|---|---|
| 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 |
| Manufacturer | SANOFI PASTEUR LIMITED |
| Strength | 5 LF / 0.5 ML |
| Dosage form | SUSPENSION |
| Route of administration | INTRAMUSCULAR |
| Schedule | Schedule D |
| ATC code | J07CA02 DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS |
| AHFS class | 80:12.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 06-May-2024 |
| Original market date | 2024-05-06 00:00:00 |
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.
How is it stored and handled?
Not explicitly detailed in provided text (standard vaccine storage usually 2-8°C, but text only lists section 11 without details).
How is it supplied?
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).
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?
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 |
| INFANRIX HEXA | 8 MCG / 0.5 ML | SUSPENSION | GLAXOSMITHKLINE INC | MARKETED | DIN 02253852 |
| 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.