Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Neostigmine metilsulfate 2.5 mg/mL
Max Health Limited
Neostigmine metilsulfate 2.5 mg/mL
2.5 mg/mL
Solution for injection
Active: Neostigmine metilsulfate 2.5 mg/mL Excipient: Nitrogen Sodium chloride Water for injection
Prescription
DPx Fine Chemicals Austria GmbH & Co KG
· Propylaxis and treatment of post-operative intestinal atony and urinary retention.
Package - Contents - Shelf Life: Ampoule, glass, type 1, 5 x 1 mL ampoules - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, type 1, 10 x 1 mL ampoules - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light
2013-11-12
NEW ZEALAND DATA SHEET 1. PRODUCT NAME Neostigmine Methylsulfate Injection, solution for injection, 2.5 mg/mL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains 2.5 mg neostigmine methylsulfate. Excipient with known effect This medicinal product contains approximately 3.54 mg sodium per each 1 mL ampoule – see section 4.4. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection. A clear, colourless, sterile solution at pH 4.5 to 6.5. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Reversal of the effects of non-depolarising 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 sulphate 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. ANTAGONIST TO NON-DEPOLARISING 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. 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 sulphate 0.6-1.2 mg (0.02 to 0.03 mg/kg) by slow IV injection over 1 minute is generally adequate for complete reversible of non-depolarising muscle relaxants within 5 to 15 minutes. The maximum recommended dose of neostigmine in adults is 5 mg. CHILDREN The suggested dose in children is 0.05 mg/kg/dose and atropine sulphate 0.02 mg/kg/dos Olvassa el a teljes dokumentumot