Neostigmine Methylsulfate Injection

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Neostigmine metilsulfate 2.5 mg/mL

제공처:

Max Health Limited

INN (International Name):

Neostigmine metilsulfate 2.5 mg/mL

복용량:

2.5 mg/mL

약제 형태:

Solution for injection

구성:

Active: Neostigmine metilsulfate 2.5 mg/mL Excipient: Nitrogen Sodium chloride Water for injection

처방전 유형:

Prescription

Manufactured by:

DPx Fine Chemicals Austria GmbH & Co KG

치료 징후:

· Propylaxis and treatment of post-operative intestinal atony and urinary retention.

제품 요약:

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

승인 날짜:

2013-11-12

제품 특성 요약

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