Atropine Injection BP Minijet 100 microgram/ml Solution for Injection

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

קנה את זה

הורד עלון מידע (PIL)
07-04-2018
הורד מאפייני מוצר (SPC)
07-04-2018

מרכיב פעיל:

ATROPINE SULFATE

זמין מ:

International Medication Systems (UK) Ltd

קוד ATC:

A03BA; A03BA01

INN (שם בינלאומי):

ATROPINE SULFATE

כמות:

100 microgram(s)/millilitre

טופס פרצבטיות:

Solution for injection

סוג מרשם:

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

איזור תרפויטי:

Belladonna alkaloids, tertiary amines; atropine

מצב אישור:

Not marketed

תאריך אישור:

1977-09-08

עלון מידע

                                Read all of this leaflet carefully
Please note this medicine is mainly used in
emergency situations in which case the doctor will
have decided that you needed it.
It is unlikely, therefore, that you will have read this
leaflet before the medicine was administered to you.
-
Keep this leaflet. You may need to read it again
-
If you have any further questions, ask the doctor
or nurse
-
This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours
-
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell the doctor or nurse.
In this leaflet:
1. What Atropine Injection BP Minijet is and what it
is used for
2. Before or after you are given Atropine
Injection BP Minijet
3. How to use Atropine Injection BP Minijet
4. Possible side effects
5. How to store Atropine Injection BP Minijet
6. Further information.
1. What Atropine Injection BP Minijet is and what it
is used for
Your medicine is called Atropine Injection BP
Minijet.
Atropine is an antimuscarinic. It temporarily blocks
some nerve endings. This stops glands secreting,
makes some muscles (such as in the gut) relax and
speeds up the heart.
This medicine is used for:
•
Pre-medication before an anaesthetic to dry the
mouth and throat before surgery
•
During anaesthetic it is used to prevent a slow heart
rate and restore blood pressure.
•
To treat a very slow heart beat
•
To treat a heart attack
•
To treat poisoning from insecticides, nerve gas or
poisonous mushrooms
•
To control the side effects of neostigmine (a
medicine which increases nerve impulses to the
muscles).
•
As part of an emergency procedure to manually
maintain brain function after a heart attack. It is
used to treat a slow heart beat occurring with low
blood pressure, decreased blood flow or an
irregular heart rate.
2. Before or after you are given Atropine Injection BP
Minijet
You should not be given Atropine if you suffer from
any of the following:
•
Reflux
                                
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מאפייני מוצר

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atropine Injection BP Minijet 100 microgram/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml contains 0.1 mg atropine sulfate. Each 5ml contains 0.5 mg
atropine sulfate; each 10ml contains 1mg
atropine sulfate; each 30 ml contains 3mg atropine sulfate.
Excipients: also includes sodium, not more than 0.22 mmol per 1ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
A clear, colourless solution is contained in a USP Type 1 glass vial
with an elastomeric closure. The container is
specially designed for use with the IMS Minijet injector supplied.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acute myocardial infarction with AV conduction block due to excess
vagal tone (Wenkebach Type I, second-degree
AV block) and sinus bradycardia, with associated hypotension and
increased ventricular irritability.
Atropine can also be used in cardiopulmonary resuscitation for the
treatment of sinus bradycardia accompanied by
hypotension, hypoperfusion or ectopic arrhythmias.
Parenteral atropine is indicated as an antisialogogue in anaesthetic
premedication to prevent or reduce secretions of the
respiratory tract.
During anaesthesia, atropine may be used to prevent reflex bradycardia
and restore cardiac rate and arterial pressure
resulting from increased vagal activity associated with laryngoscopy,
tracheal intubation and intra-abdominal
manipulation. It may also be administered to block muscarinic effects
when neostigmine is used to counteract muscle
relaxants such as tubocurarine.
Parenteral atropine is an antidote for cardiovascular collapse
following overdose of anticholinesterases; in the treatment
of poisoning from organophosphorous insecticides or from chemical
warfare 'nerve'
gases and in the treatment of
mushroom poisoning.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS, CHILDREN OVER 30KG AND THE ELDERLY:
Bradyarrhythmias: intramuscular or intravenous 300 to 600 mcg (0.3 to
0.
                                
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