Atropine Sulfate Aguettant 0.1 mg/ml solution for injection in pre-filled syringe

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atropine Sulfate Monohydrate

Available from:

Laboratoire AGUETTANT

ATC code:

A03BA; A03BA01

INN (International Name):

Atropine Sulfate Monohydrate

Dosage:

0.1 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection in pre-filled syringe

Administration route:

Intravenous use

Units in package:

box of 1, 5, 10, 12 or 20.

Prescription type:

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

Manufactured by:

Laboratoire AGUETTANT

Therapeutic group:

Belladonna alkaloids, tertiary amines

Therapeutic area:

Belladonna alkaloids, tertiary amines; atropine

Therapeutic indications:

Atropine sulfate Aguettant 0.1 mg/ml, solution for injection in pre-filled syringe is indicated in adults and in paediatric population from birth, but with a body weight superior to 3 kg - 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 relaxants - 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

Authorization status:

Marketed

Authorization date:

2015-10-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ATROPINE SULFATE AGUETTANT 0.1 MG/ML SOLUTION FOR INJECTION IN
PRE-FILLED SYRINGE
ATROPINE SULFATE
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 0.1
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 a 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 0.1 mg/ml solution for injection in
pre-filled syringe is used to treat adults
and children from birth with a body weight superior to 3 kg.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE

Summary of Product characteristics

Health Products Regulatory Authority
12 April 2019
CRN008HJ0
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atropine Sulfate Aguettant 0.1 mg/ml solution for injection in
pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection contains 0.1 mg atropine sulfate
monohydrate, equivalent to 0.083 mg atropine.
Each 5 ml syringe contains 0.5 mg atropine sulfate monohydrate,
equivalent to 0.415 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 0.1 mg/ml, solution for injection in
pre-filled syringe is indicated in adults and in paediatric
population from birth, but with a body weight superior to 3 kg (see
section 4.2).
- 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 relaxants
- 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 0.1 mg/mlsolution 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 befo