AMBISOME 50 MG — DIN 02241630
AMPHOTERICIN B : 50 MG · ASTELLAS PHARMA CANADA INC · POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is AMBISOME?
AMBISOME 50 MG contains AMPHOTERICIN B : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02241630, held by ASTELLAS PHARMA CANADA INC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 24-Jul-2012. 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 AMBISOME used for?
AmBisome (liposomal amphotericin B for injection) is indicated for empirical therapy for presumed fungal infection in febrile, neutropenic patients and for treatment of cryptococcal meningitis in HIV-infected patients. AmBisome is also indicated for the treatment of systemic or disseminated infections due to Candida, Aspergillus or Cryptococcus in patients who are refractory to or intolerant to conventional amphotericin B therapy or renally impaired patients.
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 Amphotericin B 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.
6 holders have a Canadian DIN containing Amphotericin B, across 7 DINs, of which 2 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 |
|---|---|---|---|---|
| ASTELLAS PHARMA CANADA INC | 1 | 1 | AMBISOME | Sourceable in Canada |
| CHEPLAPHARM ARZNEIMITTEL GMBH | 1 | 1 | FUNGIZONE | Sourceable in Canada |
| THREE RIVERS PHARMACEUTICALS LLC | 2 | 0 | AMPHOTEC 100 MG, AMPHOTEC 50 MG | No marketed DIN |
| LEADIANT BIOSCIENCES, INC | 1 | 0 | ABELCET | No marketed DIN |
| STERIMAX INC | 1 | 0 | AMPHOTERICIN B FOR INJECTION, USP | No marketed DIN |
| TARO PHARMACEUTICALS INC | 1 | 0 | TARO-AMPHOTERICIN B LIPOSOMAL | 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 | 50 MG |
|---|---|
| Dosage form | POWDER FOR SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | AmBisome is supplied as a lyophilized powder in either 20 mL or 30 mL vials. Each vial of AmBisome contains 50 mg of amphotericin B. AmBisome is available as single unit vials in a pack of ten vials in individual cartons. Each carton contains one pre-packaged, disposable sterile 5 micron filter. |
| Storage | Unopened vials of lyophilized material are to be stored between temperatures of 2 to 25°C (36 - 77°F). The reconstituted product concentrate may be stored for up to 24 hours at 2-8°C (36-46°F) following reconstitution with Sterile Water for Injection, USP. Do not freeze. Do not freeze. Injection of AmBisome should commence within 6 hours of dilution with 5% Dextrose. CAUTION: DISCARD partially-used vials. |
| 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.
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 | Amphotericin B |
|---|---|
| ATC code | J02AA01 |
| AHFS class | 08:14.28 |
| 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) | 02241630 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2241630 |
| Brand name | AMBISOME |
| Generic / active ingredient | AMPHOTERICIN B : 50 MG |
| Market authorization holder | ASTELLAS PHARMA CANADA INC |
| Health Canada schedule | Prescription |
| ATC code | J02AA01 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J02AA |
| Current status | MARKETED |
| Status date | 24-Jul-2012 |
| Original market date | 2000-05-29 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
AmBisome (liposomal amphotericin B for injection) should be administered by intravenous infusion over a period of approximately 120 minutes. Infusion time may be reduced to approximately 60 minutes in patients in whom the treatment is well tolerated. If the patient experiences discomfort during infusion, the duration of infusion may be increased. The recommended concentration for intravenous infusion is 0.5 mg/mL to 2.0 mg/mL of AmBisome. The daily dose and duration of therapy of AmBisome should be based on the infecting organism, the patient's condition and the response to therapy. Treatment should be continued until clinical parameters and laboratory tests indicate that an active fungal infection has been cured or subsided. An inadequate period of treatment may lead to recurrence of active infection. Dose, rate of infusion and duration of treatment may have to be individualized for the needs of specific patients. The recommended initial dosage of AmBisome for each indication for adult, pediatric and special population groups is outlined below and reported in the “Pharmacology” section. Systemic Mycoses: Patients with a proven systemic infection with Aspergillus, Candida and/or Cryptococcus species who are refractory to or intolerant to conventional amphotericin B therapy or are renally impaired usually have therapy instituted at 3.0 mg/kg/day, which is increased up to 5.0 mg/kg/day, as required. Cryptococcal Meningitis in HIV-Infected Patients: HIV-infected patients with cryptococcal meningitis were treated with a dose of 3.0 mg/kg/day or 6.0 mg/kg/day for an average of 14 days. Due to an increased incidence of adverse events with the 6.0 mg/kg/day dose, it is recommended patients be started with a dose of 3.0 mg/kg/day and increase to 6.0 mg/kg/day as required. Because of the high frequency of relapses, chronic suppressive therapy with another agent may be necessary after completion of a treatment course with AmBisome. Empirical Treatment: For empirical therapy, AmBisome was administered at an initial dose of 3.0 mg/kg/day, and increased or decreased as needed (dose range of 1.5-6.0 mg/kg/day) for 1-53 days at a cumulative dose of 33.4 ± 30.8 mg/kg.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
AmBisome (liposomal amphotericin B for injection) is contraindicated in those patients who have demonstrated or have known hypersensitivity to conventional amphotericin B or any other constituents of AmBisome unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk.
Warnings and precautions
Anaphylaxis has been reported with conventional amphotericin B and other amphotericin B-containing drugs. Anaphylactoid-type reactions have been reported with AmBisome (liposomal amphotericin B for injection). If a severe reaction occurs, the infusion should be immediately discontinued. The patient should not receive further infusions of AmBisome. AmBisome should be administered primarily to patients with progressive, potentially fatal infections. This drug should not be used to treat the common apparent forms of fungal diseases, which show only positive skin or serologic tests.
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
2 of 7 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| FUNGIZONE | 50 MG | POWDER FOR SOLUTION | CHEPLAPHARM ARZNEIMITTEL GMBH | MARKETED | 00029149 |
| ABELCET | 5 MG | SUSPENSION | LEADIANT BIOSCIENCES, INC | CANCELLED POST MARKET | 02231590 |
| AMPHOTEC 100 MG | 100 MG | POWDER FOR SUSPENSION | THREE RIVERS PHARMACEUTICALS LLC | CANCELLED POST MARKET | 02241749 |
| AMPHOTEC 50 MG | 50 MG | POWDER FOR SUSPENSION | THREE RIVERS PHARMACEUTICALS LLC | CANCELLED POST MARKET | 02241750 |
| AMPHOTERICIN B FOR INJECTION, USP | 50 MG | POWDER FOR SOLUTION | STERIMAX INC | APPROVED | 02405032 |
| TARO-AMPHOTERICIN B LIPOSOMAL | 50 MG | POWDER FOR SOLUTION | TARO PHARMACEUTICALS INC | APPROVED | 02554186 |
2 · Same class — other molecules in ATC J02AA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Amphotericin B | ABELCET · AMBISOME · AMPHOTEC 100 MG · AMPHOTEC 50 MG · +3 more | 7 | 2 | Yes |
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.
3 · Adjacent classes in ATC J02A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| J02AC | Fluconazole · Isavuconazole · Itraconazole · Posaconazole · Voriconazole | 115 | 54 |
| J02AX | Anidulafungin · Caspofungin · Micafungin | 25 | 12 |
| J02AB | Ketoconazole | 5 | 2 |
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.
What else is AMBISOME called?
Also recorded in Canada as: amphotericin B liposomal 50 MG Injection [AmBisome] (US), 20 ML amphotericin B lipid complex 5 MG/ML Injection [Abelcet] (US), amphotericin B 30 MG/ML Topical Cream (US), amphotericin B 30 MG/ML Topical Lotion (US), amphotericin B 100 MG/ML Oral Suspension (US), amphotericin B 10 MG Oral Lozenge (US), amphotericin B 50 MG Injection (US), amphotericin B 100 MG Oral Tablet (US), amphotericin B liposomal 5 MG/ML Injectable Solution (US), amphotericin B liposomal 50 MG Injection (US), 20 ML amphotericin B lipid complex 5 MG/ML Injection (US), AMPHOTERICIN B (US), AMPHOTERICIN B LIPOSOME (US), Amphotericin B (GLOBAL), Amphotericin B (UK).
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.