Atropine sulfate Accord 100 micrograms/ml solution for injection in pre-filled syringe (5 ml)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ATROPINE SULFATE

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

A03BA01

INN (International Name):

ATROPINE SULFATE 0.1 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE

Composition:

ATROPINE SULFATE 0.1 mg/ml

Prescription type:

POM

Therapeutic area:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Withdrawn

Authorization date:

2020-10-13

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATROPINE SULFATE ACCORD 100 MICROGRAMS/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.
WHAT IS IN THIS LEAFLET:
1.
What Atropine sulfate Accord is and what it is used for
2.
What you need to know before you use Atropine sulfate Accord
3.
How to use Atropine sulfate Accord
4.
Possible side effects
5.
How to store Atropine sulfate Accord
6.
Contents of the pack and other information
1.
WHAT ATROPINE SULFATE ACCORD 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 Accord 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 HAVE ATROPINE SULFATE ACCORD
Do not use Atropine sulfate Accord if you:
-
are allergic (hypersensitive) to atropine or any of the other
ingredients of this medicine (listed
in section 6)
-
have urinary difficulties,
-
have elevated pressure in your eye (glaucoma),
-

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Atropine sulfate Accord 100 micrograms/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.
Each 10 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.
Each 10 ml syringe contains 35.4 mg equivalent to 1.54 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 free from visible particles.
pH 3.0 - 4.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atropine sulfate Accord 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 Accord must be administered under medical
supervision.
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Posology
_Pre-anaesthetic medication _
Intravenous
administration
immediately
before
surgery;
if
necessary
an
intramuscular
administration 30-60 minutes bef