Neostigmine Metilsulfate 2.5mg/ml Solution for Injection

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

NEOSTIGMINE METILSULFATE

Pieejams no:

Mercury Pharmaceuticals (Ireland) Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland

ATĶ kods:

N07AA01

SNN (starptautisko nepatentēto nosaukumu):

NEOSTIGMINE METILSULFATE 2.5 mg/ml

Zāļu forma:

SOLUTION FOR INJECTION

Kompozīcija:

NEOSTIGMINE METILSULFATE 2.5 mg/ml

Receptes veids:

POM

Ārstniecības joma:

OTHER NERVOUS SYSTEM DRUGS

Autorizācija statuss:

Withdrawn

Autorizācija datums:

2006-11-28

Lietošanas instrukcija

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
If you get any of the side effects, talk to your doctor or nurse. This
includes any
possible side effects not listed in this leaflet. See section 4.
This product will be referred to as Neostigmine Injection from here
on.
WHAT IS IN THIS LEAFLET
1. What Neostigmine Injection is and what it is used for
2. What you need to know before you are given Neostigmine Injection
3. How Neostigmine Injection is given to you
4. Possible side effects
5. How to store Neostigmine Injection
6. Contents of the pack and other information
1. WHAT NEOSTIGMINE INJECTION IS AND WHAT IT IS USED FOR
Neostigmine Injection belongs to a group of medicines called
cholinesterase
inhibitors.
Neostigmine Injection is used:
• to reverse the effects of some muscle relaxants
• in a condition where muscles become abnormally tired and weak
(myasthenia
gravis) and it is not suitable to give the treatment by mouth
• to improve the movement in the small intestine
• to reduce the inability to pass water or to relieve the feeling of
being bloated after
an operation.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN NEOSTIGMINE INJECTION
YOU SHOULD NOT BE GIVEN NEOSTIGMINE INJECTION:
• if you are allergic to neostigmine metilsulfate or any of the
other ingredients of
this medicine (listed in section 6)
• if you have an obstruction in your stomach, intestine or cannot
urinate
• if you have stomach pain, inflammation or infection of the outer
layer of your
stomach or intestines (peritonitis)
• if you are receiving suxamethonium, a muscle relaxant usually
given during
operations.
Tell your doctor if any of these apply to you before you are given
this medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before Neostigmine Injection is given to
you if
• you suffer from asthma
• you have a very slow heart be

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS 

1 NAME OF THE MEDICINAL PRODUCT 
Neostigmine Metilsulfate 2.5mg/ml Solution for Injection. 

2 QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each 1 ml contains 2.5mg Neostigmine Metilsulfate. 
For a full list of excipients, see section 6.1. 

3 PHARMACEUTICAL FORM 
Solution for Injection. 
Clear colourless sterile solution. 

4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS 
The symptomatic treatment of myasthenia gravis where oral
therapy is impractical. Reversal of 
the effects of non-depolarising neuromuscular blocking agents.  
The management of post-operative distension, paralytic ileus and
urinary retention, where 
mechanical obstruction has been out-ruled. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 
Neostigmine Injection BP may be administered intramuscularly,
subcutaneously or 
intravenously. Where the intravenous route is used, administration
must be by very slow 
injection. 

TREATMENT OF MYASTHENIA GRAVIS 
Adults: Doses 1 to 2.5 mg may be given by I.M. or S.C. injection
at intervals during the day 
when strength is most needed. The total daily dose is usually in
the range of 5 to 20 mg but 
higher doses may be required by some patients. 

CHILDREN: Neonatal myasthenia can be treated with an initial
dose of 0.1mg intramuscularly. 
Thereafter, the dosage should be titrated individually and
is usually in the range of 0.05 to 
0.25mg by injection. Treatment is rarely needed beyond eight weeks
of age. 

Reversal of non-depolarising neuromuscular blocking agents. 
ADULTS AND CHILDREN: The usual dose is 0.05 to
0.07mg per kg body weight, given concomitantly 
with or after atropine sulphate, by slow intravenous injection over
a period of 60 seconds. 
Additional neostigmine may be required to restore normal
muscle power but a total of 5mg for 
adults and 2.5mg for children should not be exceeded. If preferred,
the atropine sulph