FLUZONE HIGH-DOSE 60 MCG / 0.5 ML
HAEMAGGLUTININ-STRAIN A (H3N2) : 60 MCG / 0.5 ML HAEMAGGLUTININ-STRAIN B : 60 MCG / 0.5 ML HAEMAGGLUTININ-STRAIN A (H1N1) : 60 MCG / 0.5 ML · DIN 02445646 · SANOFI PASTEUR LIMITED
Health Canada status: MARKETED
What is FLUZONE HIGH-DOSE?
FLUZONE HIGH-DOSE 60 MCG / 0.5 ML contains HAEMAGGLUTININ-STRAIN A (H3N2) : 60 MCG / 0.5 ML HAEMAGGLUTININ-STRAIN B : 60 MCG / 0.5 ML HAEMAGGLUTININ-STRAIN A (H1N1) : 60 MCG / 0.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02445646, held by SANOFI PASTEUR LIMITED, supplied as SUSPENSION for INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 10-Sep-2025. 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 FLUZONE HIGH-DOSE used for?
Active immunization against influenza caused by specific strains in the vaccine for adults 65 years of age and older.
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 | 02445646 |
|---|---|
| Brand name | FLUZONE HIGH-DOSE |
| Generic / active ingredient | HAEMAGGLUTININ-STRAIN A (H3N2) : 60 MCG / 0.5 ML HAEMAGGLUTININ-STRAIN B : 60 MCG / 0.5 ML HAEMAGGLUTININ-STRAIN A (H1N1) : 60 MCG / 0.5 ML |
| Manufacturer | SANOFI PASTEUR LIMITED |
| Strength | 60 MCG / 0.5 ML |
| Dosage form | SUSPENSION |
| Route of administration | INTRAMUSCULAR |
| Schedule | Schedule D |
| ATC code | J07BB02 INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN |
| AHFS class | 80:12.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 10-Sep-2025 |
How is it administered?
Single 0.5 mL intramuscular injection. Fractional doses should not be given. Shake well before use. Preferred site is the deltoid muscle.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not specified in the provided text (Section 11 heading present but content truncated).
How is it supplied?
Single dose prefilled Type 1 glass syringes. Available in packages of 5 x 0.5 mL syringes without attached needle. Latex-free.
Contraindications
History of severe allergic reaction to egg protein or any component of the vaccine or after previous administration of the vaccine or a vaccine containing the same components.
Warnings and precautions
Not 100% protective. Caution in persons with egg/formaldehyde/Triton X-100 hypersensitivity. Risk of GBS within 6 weeks of prior vaccine. Avoid in acute febrile illness. Risk of syncope.
What can be used instead?
Other Canadian products sharing ATC code J07BB02 INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN. 8 of 36 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 |
|---|---|---|---|---|---|
| AREPANRIX H5N1 | 3.75 MCG / 0.5 ML | EMULSION | ID BIOMEDICAL CORPORATION OF QUEBEC | MARKETED | DIN 02401886 |
| FLUAD | 15 MCG / 0.5 ML | SUSPENSION | SEQIRUS UK LIMITED | MARKETED | DIN 02362384 |
| FLUCELVAX | 15 MCG / 0.5 ML | SUSPENSION | SEQIRUS UK LIMITED | MARKETED | DIN 02553708 |
| FLUVIRAL | 15 MCG / 0.5 ML | SUSPENSION | ID BIOMEDICAL CORPORATION OF QUEBEC | MARKETED | DIN 02420686 |
| FLUZONE | 15 MCG / 0.5 ML | SUSPENSION | SANOFI PASTEUR LIMITED | MARKETED | DIN 02365936 |
| FLUZONE | 15 MCG / 0.5 ML | SUSPENSION | SANOFI PASTEUR LIMITED | MARKETED | DIN 02365707 |
| INFLUVAC TETRA | 15 MCG / 0.5 ML | SUSPENSION | BGP PHARMA ULC | MARKETED | DIN 02484854 |
| AFLURIA TETRA | 15 MCG / 0.5 ML | SUSPENSION | SEQIRUS PTY LTD | CANCELLED POST MARKET | DIN 02473283 |
| AFLURIA TETRA | 15 MCG / 0.5 ML | SUSPENSION | SEQIRUS PTY LTD | CANCELLED POST MARKET | DIN 02473313 |
| AGRIFLU | 15 MCG / 0.5 ML | SUSPENSION | SEQIRUS UK LIMITED | CANCELLED PRE MARKET | DIN 02346850 |
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.