Atropine Sulfate 600 micrograms/ml Solution for Injection

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

ATROPINE SULFATE

Verfügbar ab:

Mercury Pharmaceuticals (Ireland) Ltd

ATC-Code:

A03BA; A03BA01

INN (Internationale Bezeichnung):

ATROPINE SULFATE

Dosierung:

600 microgram(s)/millilitre

Darreichungsform:

Solution for injection

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Belladonna alkaloids, tertiary amines; atropine

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

1979-04-01

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATROPINE SULFATE 600 MICROGRAMS/ML SOLUTION FOR INJECTION
atropine sulfate
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, nurse or
pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, nurse or
pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
The name of your medicine is Atropine Sulfate 600 micrograms/ml
Solution for Injection; it will
be called Atropine Sulfate Injection for ease here after.
WHAT IS IN THIS LEAFLET:
1. What Atropine Sulfate
Injection is and what it is used for
2. What you need to know before you are given Atropine Sulfate
Injection
3. How you are given Atropine Sulfate
Injection
4. Possible side effects
5. How to store Atropine Sulfate
Injection
6. Contents of the pack and other information
1. WHAT ATROPINE SULFATE INJECTION IS AND WHAT IT IS USED FOR
Atropine Sulfate Injection contains the active substance Atropine
Sulfate, which belongs to a group of medicines called anticholinergic
drugs. It has the effect of
reversing the action of certain muscle-relaxing drugs. The effects of
atropine include an increase
in heart rate, a decrease in production of saliva, sweat, bronchial
and intestinal secretions and a
decrease in the movements of the intestine.
Atropine Sulfate Injection is used in the following conditions:
• during anaesthesia to reduce the risk of slowing of the heart and
dry up secretions in the
mouth and chest
• in the treatment of poisoning caused by certain substances like
pesticides
• to reverse the effects of certain drugs given to relax muscles
• to prevent slowing of the heartbeat during the use of emergency
procedure undertaken to
revive the hear

Fachinformation

Health Products Regulatory Authority
31 March 2021
CRN00C7YW
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atropine Sulfate 600 micrograms/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 600 micrograms of atropine sulfate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (Injection).
Clear, colourless, sterile, aqueous solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In anaesthesia, as a parasympatholytic agent.
In the treatment of cholinergic crisis of myasthenia gravis.
In conjunction with neostigmine used to reverse the effects of
non-depolarising muscle relaxants.
In the treatment of poisoning by certain cholinesterase inhibitors
e.g. organo-phosphorous compounds.
During cardiopulmonary resuscitation to counteract excessive vagal
tone on the heart.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Use in anaesthesia
_Adults (including older people):_
The usual dose is 0.3 to 0.6mg intramuscularly or intravenously.
_Paediatric population:_
Premature infants: 65 micrograms
Full-term infants: 100 micrograms
6 - 12 months: 200 micrograms
Over one year: 10 - 20 micrograms/kg bodyweight
Treatment of cholinergic crisis of myasthenia gravis
_Adults: _The usual dose is 0.4 to 2.0 mg intravenously, which may be
increased according to patient's response.
In conjunction with neostigmine used to reverse the effects of
non-depolarising muscle relaxants
_Adults: _The usual dose is 0.6 to 1.2 mg given by slow intravenous
injection. Atropine should be administered before
neostigmine.
Treatment of poisoning by certain cholinesterase inhibitors
_Adults: _From 1.2 mg, increased according to patient's response.
Use during cardiopulmonary resuscitation
_Adults: _A dose of 0.2 to 0.5 mg may be given intravenously and
repeated if necessary. Persistent bradycardia should be
controlled by the insertion of a pacemaker as soon as possible.
Health Products Regulatory Authority
31 March 2021
CRN00C7YW
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