Atropine BP

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Atropine sulfate monohydrate 0.4 mg/mL

Disponible depuis:

Juno Pharmaceuticals NZ Limited

DCI (Dénomination commune internationale):

Atropine sulfate monohydrate 0.4 mg/mL

Dosage:

0.4 mg/mL

forme pharmaceutique:

Solution for injection

Composition:

Active: Atropine sulfate monohydrate 0.4 mg/mL Excipient: Hydrochloric acid Sodium chloride Water for injection

Unités en paquet:

Ampoule, glass, 50x1mL (not marketed), 50 mL

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Boehringer Ingelheim Pharma GmbH & Co KG

Descriptif du produit:

Package - Contents - Shelf Life: Ampoule, glass, 50x1mL - 50 mL - 18 months from date of manufacture stored at or below 25°C - Polyamp, 5x1mL Duofit - 5 mL - 18 months from date of manufacture stored at or below 25°C - Polyamp, 50x1mL Duofit - 50 mL - 18 months from date of manufacture stored at or below 25°C

Date de l'autorisation:

1984-11-29

Résumé des caractéristiques du produit

NEW ZEALAND DATA SHEET
Page 1 of 11
1.
NAME OF MEDICINE
Atropine Sulfate Injection, atropine sulfate 600 mcg/mL solution for
injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atropine Sulfate 0.06% w/v
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Surgery
Atropine may be given as a pre-anaesthetic medication to inhibit
excessive salivary and
bronchial secretions and to diminish the risk of vagal inhibition of
the heart. The use of
Atropine as an antisialagogue is rarely necessary since the
introduction of halothane and
similar anaesthetics in place of ether anaesthesia.
Atropine may be administered concurrently with anticholinesterase
agents (e.g. neostigmine,
physostigmine) to block the adverse muscarinic effects when they are
used after surgery to
terminate curarisation.
Cardiopulmonary Resuscitation
It may be used in the management of patients with acute myocardial
infarction and sinus
bradycardia who have associated hypotension and increased ventricular
irritability.
Anticholinesterase Poisoning
It is also used concomitantly with a cholinesterase reactivator (e.g.
pralidoxime) to reverse
muscarinic effects associated with toxic exposure to
anticholinesterase compounds (e.g.
organophosphate pesticides).
Atropine may be used in conjunction with morphine or other agents for
the relief of biliary or
renal colic.
4.2 DOSAGE AND ADMINISTRATION
Atropine
may
be
administered
by
subcutaneous
(SC),
intramuscular
(IM)
or
direct
intravenous (IV) injection. The product contains no antimicrobial
agent. It should be used
only once and any residue discarded. Atropine sulfate should not be
added to any IV
infusion solution.
SURGERY
Adults:
300 to 600 mcg IM or SC, approximately 1 hour before anaesthesia,
usually in conjunction
with a narcotic. Alternatively, 300 to600 mcg may be given IV
immediately prior to induction
Page 2 of 11
of anaesthesia.
To reverse the effects of non depolarising muscle relaxants, 600 mcg
to 1.2