AMINOSYN II 450 MG / 100 ML — DIN 02126745
HISTIDINE : 450 MG / 100 ML N-ACETYL-L-TYROSINE : 405 MG / 100 ML L-ASPARTIC ACID : 1050 MG / 100 ML L-ISOLEUCINE : 990 MG / 100 ML METHIONINE : 258 MG / 100 ML TRYPTOPHAN : 300 MG / 100 ML SERINE : 795 MG / 100 ML GLYCINE : 750 MG / 100 ML GLUTAMIC ACID : 1107 MG / 100 ML L-VALINE : 750 MG / 100 ML L-ARGININE : 1527 MG / 100 ML L-PROLINE : 1083 MG / 100 ML L-LEUCINE : 1500 MG / 100 ML L-THREONINE : 600 MG / 100 ML L-ALANINE : 1490 MG / 100 ML L-LYSINE (LYSINE ACETATE) : 1575 MG / 100 ML L-PHENYLALANINE : 447 MG / 100 ML · ICU MEDICAL CANADA INC · SOLUTION · wholesale supply in Canada
Health Canada status: DORMANT
What is AMINOSYN II?
AMINOSYN II 450 MG / 100 ML contains HISTIDINE : 450 MG / 100 ML N-ACETYL-L-TYROSINE : 405 MG / 100 ML L-ASPARTIC ACID : 1050 MG / 100 ML L-ISOLEUCINE : 990 MG / 100 ML METHIONINE : 258 MG / 100 ML TRYPTOPHAN : 300 MG / 100 ML SERINE : 795 MG / 100 ML GLYCINE : 750 MG / 100 ML GLUTAMIC ACID : 1107 MG / 100 ML L-VALINE : 750 MG / 100 ML L-ARGININE : 1527 MG / 100 ML L-PROLINE : 1083 MG / 100 ML L-LEUCINE : 1500 MG / 100 ML L-THREONINE : 600 MG / 100 ML L-ALANINE : 1490 MG / 100 ML L-LYSINE (LYSINE ACETATE) : 1575 MG / 100 ML L-PHENYLALANINE : 447 MG / 100 ML. It is listed in the Health Canada Drug Product Database under DIN 02126745, held by ICU MEDICAL CANADA INC, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as dormant, status dated 01-Sep-2018. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A). This DIN is not currently being marketed in Canada, so it is sourced to order where a compliant route exists rather than held in stock.
What is AMINOSYN II used for?
Prevent nitrogen loss or treat negative nitrogen balance where oral/enteral intake is infeasible, absorption is impaired, or requirements are substantially increased (e.g., extensive burns).
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 Amino Acids 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.
8 holders have a Canadian DIN containing Amino Acids, across 26 DINs, of which 4 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 |
|---|---|---|---|---|
| BAXTER CORPORATION | 8 | 3 | 20% PROSOL, BCAA 4% INJ, PRIMENE 10%, RENAMIN (AMINO ACIDS) INJECTION, TRAVASOL, +2 more | Sourceable in Canada |
| FRESENIUS KABI CANADA LTD | 1 | 1 | ESSEPNA | Sourceable in Canada |
| HOSPIRA HEALTHCARE ULC | 8 | 0 | AMINOSYN 5%, AMINOSYN 7%, AMINOSYN 8.5%, AMINOSYN II 7% INJECTION, AMINOSYN II 8.5% INJECTION, +3 more | No marketed DIN |
| ICU MEDICAL CANADA INC | 3 | 0 | AMINOSYN, AMINOSYN II | No marketed DIN |
| ABBOTT LABORATORIES, LIMITED | 2 | 0 | AMINOSYN II 5% INJ, L CYSTEINE HCL INJ 50MG/ML | No marketed DIN |
| B. BRAUN MEDICAL INC | 2 | 0 | 8.5% FREAMINE III, NEPHRAMINE LIQ IV | No marketed DIN |
| BAXTER CORPORATION CLINTEC NUTRITION DIVISION | 1 | 0 | 4.25% AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 20% DEXTROSE QUICKMIX | No marketed DIN |
| FRESENIUS KABI AB | 1 | 0 | VAMIN 18 ELECTROLYTE-FREE | 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 | 450 MG / 100 ML |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | Not explicitly detailed in text (mentions flexible containers and single containers). |
| Storage | Not explicitly detailed in text (mentions refrigerated storage for mixed solutions limited to <24 hours). |
| 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, because this listing covers more than one of them.
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 | Amino Acids |
|---|---|
| ATC code | B05BA01 |
| AHFS class | 40:20.00 |
| 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) | 02126745 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2126745 |
| Brand name | AMINOSYN II |
| Generic / active ingredient | HISTIDINE : 450 MG / 100 ML N-ACETYL-L-TYROSINE : 405 MG / 100 ML L-ASPARTIC ACID : 1050 MG / 100 ML L-ISOLEUCINE : 990 MG / 100 ML METHIONINE : 258 MG / 100 ML TRYPTOPHAN : 300 MG / 100 ML SERINE : 795 MG / 100 ML GLYCINE : 750 MG / 100 ML GLUTAMIC ACID : 1107 MG / 100 ML L-VALINE : 750 MG / 100 ML L-ARGININE : 1527 MG / 100 ML L-PROLINE : 1083 MG / 100 ML L-LEUCINE : 1500 MG / 100 ML L-THREONINE : 600 MG / 100 ML L-ALANINE : 1490 MG / 100 ML L-LYSINE (LYSINE ACETATE) : 1575 MG / 100 ML L-PHENYLALANINE : 447 MG / 100 ML |
| Market authorization holder | ICU MEDICAL CANADA INC |
| Health Canada schedule | Ethical |
| ATC code | B05BA01 |
| ATC anatomical main group | B — Blood and blood-forming organs |
| ATC therapeutic subgroup | B05BA |
| Current status | DORMANT |
| Status date | 01-Sep-2018 |
| Original market date | 1995-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Dosage depends on protein requirements, fluid limits, and glucose/nitrogen tolerance. Must be diluted for peripheral use (5% or 7.5%). Central vein infusion requires admixture with dextrose.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to components; hepatic coma; anuria (unless dialysed); metabolic disorders involving impaired nitrogen utilization; azotemia without regard to total nitrogen intake.
Warnings and precautions
Contains aluminum (toxic risk in impaired kidney function/neonates). Risk of fluid/solute overload. May induce rise in BUN or hyperammonemia. Use caution with electrolyte ions in specific states.
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
4 of 26 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| 20% PROSOL | 1.18 G / 100 ML | LIQUID | BAXTER CORPORATION | MARKETED | 02141450 |
| ESSEPNA | 1.1 G / 100 ML | SOLUTION | FRESENIUS KABI CANADA LTD | MARKETED | 02510324 |
| PRIMENE 10% | 189 MG / 100 ML | LIQUID | BAXTER CORPORATION | MARKETED | 02236875 |
| TRAVASOL | 600 MG / 100 ML | SOLUTION | BAXTER CORPORATION | MARKETED | 00872296 |
| 4.25% AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 20% DEXTROSE QUICKMIX | 76 MG / 100 ML | SOLUTION | BAXTER CORPORATION CLINTEC NUTRITION DIVISION | CANCELLED POST MARKET | 02013908 |
| 8.5% FREAMINE III | 770 MG / 100 ML | LIQUID | B. BRAUN MEDICAL INC | CANCELLED POST MARKET | 02158647 |
| AMINOSYN | 440 MG / 100 ML | SOLUTION | ICU MEDICAL CANADA INC | CANCELLED POST MARKET | 00454907 |
| AMINOSYN 5% | 220 MG / 100 ML | SOLUTION | HOSPIRA HEALTHCARE ULC | CANCELLED POST MARKET | 00404160 |
| AMINOSYN 7% | 690 MG / 100 ML | SOLUTION | HOSPIRA HEALTHCARE ULC | CANCELLED POST MARKET | 00523232 |
| AMINOSYN 8.5% | 624 MG / 100 ML | SOLUTION | HOSPIRA HEALTHCARE ULC | CANCELLED POST MARKET | 00613320 |
2 · Same class — other molecules in ATC B05BA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Combinations | 2.5% TRAVASOL AMINO ACID INJECTION WITH ELECTROLYTES IN 10% DEXTROSE · 2.5% TRAVASOL AMINO ACID INJECTION WITH ELECTROLYTES IN 10% DEXTROSE CLINIMIX · 2.5% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 10% DEXTROSE QUICKMIX · 2.5%TRAVASOL AMINO ACID INJ.W.ELEC.W.25%DEX · +51 more | 79 | 22 | Yes |
| Carbohydrates | 10% DEXTROSE INJECTION USP · 10% DEXTROSE INJECTION, USP · 13.3% DEXTROSE INJECTION, USP · 20% DEXTROSE INJECTION USP · +18 more | 32 | 9 | Yes |
| Amino Acids | 20% PROSOL · 4.25% AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 20% DEXTROSE QUICKMIX · 8.5% FREAMINE III · AMINOSYN · +20 more | 26 | 4 | Yes |
| Fat Emulsions | 10% TRAVAMULSION LIQ IV · 20% TRAVAMULSION LIQ IV · CLINOLEIC 20% · COLIP 20% · +9 more | 13 | 3 | 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 B05B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| B05BB | Electrolytes · Electrolytes With Carbohydrates | 90 | 27 |
| B05BC | Carbamide · Carbamide, Combinations · Mannitol | 11 | 5 |
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.
How can I get it?
This DIN is dormant — it holds a Health Canada authorization but is not currently being marketed in Canada, so it cannot simply be ordered from Canadian stock. Where a patient need exists, supply may be possible through exceptional importation or the Special Access Programme, subject to Health Canada's requirements and the prescriber's application. Nexara can advise on the route and on marketed alternatives.
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.