Neostigmine Methylsulfate Injection

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Neostigmine metilsulfate 2.5 mg/mL

थमां उपलब्ध:

Max Health Limited

INN (इंटरनेशनल नाम):

Neostigmine metilsulfate 2.5 mg/mL

डोज़:

2.5 mg/mL

फार्मास्यूटिकल फॉर्म:

Solution for injection

रचना:

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

प्रिस्क्रिप्शन प्रकार:

Prescription

द्वारा बनाया गया:

DPx Fine Chemicals Austria GmbH & Co KG

चिकित्सीय संकेत:

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

उत्पाद समीक्षा:

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

प्राधिकरण की तारीख:

2013-11-12

उत्पाद विशेषताएं

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