FUNGIZONE 50 MG
AMPHOTERICIN B : 50 MG · DIN 00029149 · CHEPLAPHARM ARZNEIMITTEL GMBH
Health Canada status: MARKETED
What is FUNGIZONE?
FUNGIZONE 50 MG contains AMPHOTERICIN B : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 00029149, held by CHEPLAPHARM ARZNEIMITTEL GMBH, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 02-Jan-2020. 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 FUNGIZONE used for?
FUNGIZONE (amphotericin B) is specifically intended for the treatment of disseminated mycotic infections, including coccidioidomycosis; cryptococcosis (torulosis); disseminated candidiasis, histoplasmosis, South American leishmaniasis, North and South American blastomycosis; mucormycosis (phycomycosis) caused by species of the genera Mucor, Rhizopus, Absidia, Entomophthora, and Basidiobolus, sporotrichosis (Sporotrichum schenckii), and aspergillosis (Aspergillus fumigatus). Limited studies have shown that amphotericin B powder for injection may be useful when administered by routes other than intravenous for the treatment of certain types of fungal infections.
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 | 00029149 |
|---|---|
| Brand name | FUNGIZONE |
| Generic / active ingredient | AMPHOTERICIN B : 50 MG |
| Manufacturer | CHEPLAPHARM ARZNEIMITTEL GMBH |
| Strength | 50 MG |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Prescription |
| ATC code | J02AA01 AMPHOTERICIN B |
| AHFS class | 28:16.08.24 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 02-Jan-2020 |
| Original market date | 1968-12-31 00:00:00 |
How is it administered?
Slow IV infusion over 2-6 hours. Recommended concentration 0.1 mg/mL in 5% Dextrose. Dosage must be individualized; do not exceed 1.5 mg/kg/day. Test dose (1 mg) often preferred.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
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How is it supplied?
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Contraindications
Hypersensitivity to amphotericin B or any component unless the condition is life-threatening and amenable only to this therapy.
Warnings and precautions
Specifically for progressive, potentially fatal infections. Exercise caution to prevent inadvertent overdose (fatal cardiac arrest). Avoid rapid infusion (<1 hour). Monitor renal function.
What can be used instead?
Other Canadian products sharing ATC code J02AA01 AMPHOTERICIN B. 2 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 |
|---|---|---|---|---|---|
| AMBISOME | 50 MG | POWDER FOR SOLUTION | ASTELLAS PHARMA CANADA INC | MARKETED | DIN 02241630 |
| ABELCET | 5 MG | SUSPENSION | LEADIANT BIOSCIENCES, INC | CANCELLED POST MARKET | DIN 02231590 |
| AMPHOTEC 100 MG | 100 MG | POWDER FOR SUSPENSION | THREE RIVERS PHARMACEUTICALS LLC | CANCELLED POST MARKET | DIN 02241749 |
| AMPHOTEC 50 MG | 50 MG | POWDER FOR SUSPENSION | THREE RIVERS PHARMACEUTICALS LLC | CANCELLED POST MARKET | DIN 02241750 |
| AMPHOTERICIN B FOR INJECTION, USP | 50 MG | POWDER FOR SOLUTION | STERIMAX INC | APPROVED | DIN 02405032 |
| TARO-AMPHOTERICIN B LIPOSOMAL | 50 MG | POWDER FOR SOLUTION | TARO PHARMACEUTICALS INC | APPROVED | DIN 02554186 |
Who else supplies AMPHOTERICIN B worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. AMPHOTERICIN B appears in 24 registered pack listings across 10 markets, published on 8 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
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.