Atropine Sulfate Aguettant 0.2mg/ml Solution for Injection in Pre-Filled Syringe

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Atropine sulfate

Commercializzato da:

Laboratoire AGUETTANT

Codice ATC:

A03BA; A03BA01

INN (Nome Internazionale):

Atropine sulfate

Dosaggio:

0.2 milligram(s)/millilitre

Forma farmaceutica:

Solution for injection in pre-filled syringe

Tipo di ricetta:

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

Area terapeutica:

Belladonna alkaloids, tertiary amines; atropine

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

2015-07-24

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
ATROPINE SULFATE AGUETTANT 0.2 MG/ML
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
The name of this medicinal product is ATROPINE SULFATE AGUETTANT 0.2
mg/ml solution for
injection
in
pre-filled
syringe,
but
will
be
referred
as
ATROPINE
SULFATE
AGUETTANT
throughout the whole leaflet.
WHAT IS IN THIS LEAFLET:
1. What ATROPINE SULFATE AGUETTANT is and what it is used for
2. What you need to know before you use ATROPINE SULFATE AGUETTANT
3. How to use ATROPINE SULFATE AGUETTANT
4. Possible side effects
5. How to store ATROPINE SULFATE AGUETTANT
6. Contents of the pack and other information
1.
WHAT ATROPINE SULFATE AGUETTANT IS AND WHAT IT IS USED FOR
Atropine belongs to a group of medicines known as anticholinergics. An
anticholinergic is a substance
that blocks the neurotransmitter acetylcholine in the central and
peripheral nervous system. It is used
in
emergency
situations
when
the
heart
beats
too
slowly,
as
an
antidote
to
for
example
organophosphate insecticide or nerve gas poisoning and in mushroom
poisoning.
It can be used as part of the premedication before general
anaesthesia. It can also be used to prevent
side effects of other drugs which are used to reverse the effects of
muscle relaxants after surgery.
ATROPINE SULFATE AGUETTANT 0.2 mg/ml solution for injection in
pre-filled syringe is used to
treat adults only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ATROPINE SULFATE AGUETTANT
DO NOT USE ATROPINE SULFATE AGUETTANT IF YOU:

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atropine Sulfate Aguettant 0.2mg/ml Solution for Injection in
Pre-Filled Syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection contains 0.2 mg atropine sulfate
monohydrate, equivalent to 0.17 mg atropine.
Each 5 ml syringe contains 1 mg atropine sulfate monohydrate,
equivalent to 0.83 mg atropine.
Excipient with known effect: sodium
Each ml of solution for injection contains 3.5 mg equivalent to 0.154
mmol of sodium.
Each 5 ml syringe contains 17.7 mg equivalent to 0.770 mmol of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
Clear and colourless solution.
pH 3.2 – 4.0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atropine sulfate Aguettant 0.2 mg/ml, solution for injection in
pre-filled syringe is indicated in adults only.
As a pre-anaesthetic medication to prevent
vagal
reactions associated with tracheal
intubation and surgical
manipulation
To limit the muscarinic effects of neostigmine, when given
postsurgically to counteract non-depolarising muscle
relaxant
Treatment of hemodynamically compromising bradycardia and/or
atrioventricular block due to excessive vagal
tone in emergency situation
Cardiopulmonary resuscitation: to treat symptomatic bradycardia and AV
block
As
antidote following overdosage or
poisoning with acetylcholinesterase-inhibitors
e.g.
anticholinesterases,
organophosphorus, carbamates and muscarinic mushrooms
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Atropine Sulfate Aguettant 0.2 mg/ml solution for injection in
pre-filled syringe must be administered under medical
supervision.
Posology:
_Pre-anaesthetic medication_
Intravenous administration immediately before surgery; if necessary an
intramuscular administration 30-60 minutes
before surgery is possible.
_Adults:_
0.3 – 0.6 mg IV or IM (1.5 - 3 ml)
_In combination with neostigmine to limit its muscarinic effects:_
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