Ketamine Mylan

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ketamine hydrochloride 115.3 mg/mL equivalent to Ketamine 100 mg/mL

Available from:

Viatris Limited

INN (International Name):

Ketamine hydrochloride 115.3 mg/mL (equivalent to Ketamine 100 mg/mL)

Dosage:

200 mg/2mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Ketamine hydrochloride 115.3 mg/mL equivalent to Ketamine 100 mg/mL Excipient: Benzethonium chloride Nitrogen Water for injection

Prescription type:

Class C4 Controlled Drug

Manufactured by:

CU Chemie Uetikon GmbH

Therapeutic indications:

Ketamine is indicated: · as the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine is best suited for short procedures and it can be used with additional doses' for longer procedures · for the induction of anaesthesia prior to the administration of other general anaesthetic agents · to supplement low-potency agents' such as nitrous oxide.

Product summary:

Package - Contents - Shelf Life: Vial, glass, 2 mL Type 1 (USP) closed with bromobutyl rubber stopper and aluminium cap - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. in 5% dextrose, 0.9% sodium chloride, or water for injection - Vial, glass, 2 mL Type 1 (USP) closed with bromobutyl rubber stopper and aluminium cap - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. in 5% dextrose, 0.9% sodium chloride, or water for injection

Authorization date:

2014-12-10