QUADRACEL 20 MCG / 0.5 ML
PERTUSSIS TOXOID : 20 MCG / 0.5 ML DIPHTHERIA TOXOID : 15 LF / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 1 MAHONEY : 40 UNIT / 0.5 ML FIMBRIAE : 5 MCG / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 3 SAUKETT : 32 UNIT / 0.5 ML TETANUS TOXOID : 5 LF / 0.5 ML FILAMENTOUS HAEMAGGLUTININ : 20 MCG / 0.5 ML PERTACTIN : 3 MCG / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 2 MEF1 : 8 UNIT / 0.5 ML · DIN 02230946 · SANOFI PASTEUR LIMITED
Health Canada status: CANCELLED POST MARKET
What is QUADRACEL?
QUADRACEL 20 MCG / 0.5 ML contains PERTUSSIS TOXOID : 20 MCG / 0.5 ML DIPHTHERIA TOXOID : 15 LF / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 1 MAHONEY : 40 UNIT / 0.5 ML FIMBRIAE : 5 MCG / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 3 SAUKETT : 32 UNIT / 0.5 ML TETANUS TOXOID : 5 LF / 0.5 ML FILAMENTOUS HAEMAGGLUTININ : 20 MCG / 0.5 ML PERTACTIN : 3 MCG / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 2 MEF1 : 8 UNIT / 0.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02230946, held by SANOFI PASTEUR LIMITED, supplied as SUSPENSION for INTRAMUSCULAR administration. Health Canada currently lists it as cancelled post market, status dated 12-Nov-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?
QUADRACEL® is indicated for primary immunization of infants, from the age of 2 months and in children up to 6 years of age (prior to their 7th birthday), against diphtheria, tetanus, pertussis and poliomyelitis. When both vaccines are indicated, QUADRACEL® may be used to reconstitute Act-HIB® [Haemophilus b Conjugate Vaccine (Tetanus Protein - Conjugate)] for simultaneous administration of all 5 antigens in a single injection.
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 | 02230946 |
|---|---|
| Brand name | QUADRACEL |
| Generic / active ingredient | PERTUSSIS TOXOID : 20 MCG / 0.5 ML DIPHTHERIA TOXOID : 15 LF / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 1 MAHONEY : 40 UNIT / 0.5 ML FIMBRIAE : 5 MCG / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 3 SAUKETT : 32 UNIT / 0.5 ML TETANUS TOXOID : 5 LF / 0.5 ML FILAMENTOUS HAEMAGGLUTININ : 20 MCG / 0.5 ML PERTACTIN : 3 MCG / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 2 MEF1 : 8 UNIT / 0.5 ML |
| Manufacturer | SANOFI PASTEUR LIMITED |
| Strength | 20 MCG / 0.5 ML |
| Dosage form | SUSPENSION |
| Route of administration | INTRAMUSCULAR |
| Schedule | Schedule D |
| ATC code | J07CA02 DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 12-Nov-2024 |
How is this product identified?
Purchase orders, customs paperwork and tender documents each ask for a different identifier, and a DIN written without its leading zeros is the single most common reason an order line fails to match. Every form Nexara accepts for this product is listed here.
| DIN (8-digit, as used in Nexara ordering) | 02230946 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2230946 |
| Brand name | QUADRACEL |
| Active ingredient / INN | PERTUSSIS TOXOID : 20 MCG / 0.5 ML DIPHTHERIA TOXOID : 15 LF / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 1 MAHONEY : 40 UNIT / 0.5 ML FIMBRIAE : 5 MCG / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 3 SAUKETT : 32 UNIT / 0.5 ML TETANUS TOXOID : 5 LF / 0.5 ML FILAMENTOUS HAEMAGGLUTININ : 20 MCG / 0.5 ML PERTACTIN : 3 MCG / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 2 MEF1 : 8 UNIT / 0.5 ML |
| ATC code | J07CA02 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J07 |
| Health Canada schedule | Schedule D |
| Biosimilar biologic | No |
| Market authorization holder | SANOFI PASTEUR LIMITED |
How is it administered?
Routine 4-dose series: 0.5 mL at 2, 4, 6, and 18 months. If delayed, 3 doses at 2-month intervals, followed by a 4th dose 6-12 months later. May be used to reconstitute Act-HIB.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
null
How is it supplied?
null
Which pack is which?
| Strength on the label | 20 MCG / 0.5 ML |
|---|---|
| Dosage form | SUSPENSION |
| Route | INTRAMUSCULAR |
| Packaging as described in the monograph | null |
| Storage | null |
One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced. 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.
Contraindications
Systemic hypersensitivity to any component; encephalopathy within 7 days of previous pertussis dose; progressive neurologic disorder (e.g., uncontrolled epilepsy, infantile spasms).
Warnings and precautions
Do not administer intravascularly, intradermally, or subcutaneously. Postpone in acute/febrile disease. Caution in patients with bleeding disorders or history of GBS or HHE.
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 |
| 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 |
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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.