Država: Novi Zeland
Jezik: engleski
Izvor: Medsafe (Medicines Safety Authority)
Neostigmine metilsulfate 0.5 mg/mL
AstraZeneca Limited
Neostigmine metilsulfate 0.5 mg/mL
0.5 mg/mL
Solution for injection
Active: Neostigmine metilsulfate 0.5 mg/mL Excipient: Dibasic sodium phosphate dodecahydrate Monobasic sodium phosphate dihydrate Sodium chloride Water for injection
Polyamp, foil wrapped, 1 mL
Prescription
Prescription
Takeda Austria GmbH
Package - Contents - Shelf Life: Polyamp, foil wrapped - 1 mL - 30 months from date of manufacture stored at or below 25°C - Polyamp, - 1 mL - 18 months from date of manufacture stored at or below 25°C
1990-06-29
Neostigmine Data Sheet 070918 NEW ZEALAND DATA SHEET 1. PRODUCT NAME N EOSTIGMINE M ETHYLSULFATE I NJECTION B.P. Solution for injection 2.5 mg/mL. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL sterile solution of pH 4.5 – 6.5 containing 2.5 mg of neostigmine methylsulfate. Excipients with known effect: sodium chloride, monobasic sodium phosphate, dibasic sodium phosphate dodecahydrate. For the full list of excipients, see Section 6.1 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless, particle-free solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Reversal of the effects of nondepolarising neuromuscular blocking agents (e.g. tubocurarine, pancuronium, etc.) • Prophylaxis and treatment of post-operative intestinal atony and urinary retention. • Treatment of myasthenia gravis during acute exacerbations, when the condition is severe or in neonates. 4.2 DOSE AND METHOD OF ADMINISTRATION Neostigmine can be given as an intramuscular (IM), intravenous (IV) or subcutaneous (SC) injection. When Neostigmine is given, a syringe of atropine sulfate should be available to counteract severe cholinergic reactions, if they occur. Do not mix atropine with other medicines in the same syringe as compatibility data are not available. The presentations of N EOSTIGMINE Injection BP solution contain no antimicrobial agents. They are intended for single use only and any solution remaining from an opened container should be discarded. ANTAGONIST TO NONDEPOLARISING NEUROMUSCULAR BLOCKADE Usually, reversal of neuromuscular blockade with Neostigmine should not be attempted until spontaneous recovery from paralysis is evident. It is recommended that the patient be well ventilated and patent airway maintained until complete recovery of normal respiration is affirmed. Neostigmine Data Sheet 070918 2 ADULT A single dose of Neostigmine 0.5 to 2.5 mg (0.05 – 0.07 mg/kg) to be administered simultaneously (in separate syringes) with atropine sulfate 0.6-1.2 mg (0.02 to 0.03) mg/kg) by slow IV injection over Pročitajte cijeli dokument