OPTIMARK 330.9 MG / ML
GADOVERSETAMIDE 330.9 MG · DIN 02393166 · LIEBEL-FLARSHEIM CANADA INC
Health Canada status: CANCELLED PRE MARKET
What is OPTIMARK?
OPTIMARK 330.9 MG / ML contains GADOVERSETAMIDE 330.9 MG. It is listed in the Health Canada Drug Product Database under DIN 02393166, held by LIEBEL-FLARSHEIM CANADA INC, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as cancelled pre market, status dated 23-Mar-2018. 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 OPTIMARK used for?
MRI contrast enhancement for intracranial lesions with abnormal vascularity/blood-brain barrier, lesions of the spine and associated tissues, and lesions in the liver in adults.
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 | 02393166 |
|---|---|
| Brand name | OPTIMARK |
| Generic / active ingredient | GADOVERSETAMIDE 330.9 MG |
| Manufacturer | LIEBEL-FLARSHEIM CANADA INC |
| Strength | 330.9 MG / ML |
| Dosage form | SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Ethical |
| ATC code | V08CA06 GADOVERSETAMIDE |
| Health Canada status | CANCELLED PRE MARKET |
| Status date | 23-Mar-2018 |
How is it administered?
Administer the LOWEST dose possible for adequate imaging. Recommended dose is 0.1 mmol/kg. Allow at least 7 days between repeat scans to ensure clearance.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in the provided text snippet (refers to Part I Summary), but typically 15-30°C for such products.
How is it supplied?
5, 10, 15, 20 mL glass vials; 50 mL pharmacy bulk package vial.
Contraindications
Chronic severe kidney insufficiency (GFR < 30 mL/min/1.73m2); acute kidney injury; neonates up to 4 weeks of age; known hypersensitivity to gadolinium, versetamide, or any ingredients.
Warnings and precautions
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) in renal insufficiency. Risk of gadolinium accumulation in brain. Potential for serious anaphylactoid reactions and QT/QTc prolongation.
What can be used instead?
Other Canadian products sharing ATC code V08CA06 GADOVERSETAMIDE. 0 of 5 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 |
|---|---|---|---|---|---|
| OPTIMARK | 330.9 MG | SOLUTION | LIEBEL-FLARSHEIM CANADA INC | CANCELLED POST MARKET | DIN 02242986 |
| OPTIMARK | 330.9 MG | SOLUTION | LIEBEL-FLARSHEIM CANADA INC | CANCELLED PRE MARKET | DIN 02393158 |
| OPTIMARK | 330.9 MG | SOLUTION | LIEBEL-FLARSHEIM CANADA INC | CANCELLED PRE MARKET | DIN 02393174 |
| OPTIMARK | 330.9 MG | SOLUTION | LIEBEL-FLARSHEIM CANADA INC | CANCELLED PRE MARKET | DIN 02393182 |
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.