1. Name of the medicinal product
Atropine sulfate 0.5 mg/5 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 0.085 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 0.5 mg/5 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 0.5 mg/5 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 (3 – 6 ml)

Paediatric population:

The usual dose in children is between 0.01-0.02 mg/kg body weight (maximum 0.6 mg per dose), dosage should be adjusted according to the patient's response and tolerance.

In combination with neostigmine to limit its muscarinic effects:

Adults:

0.6-1.2 mg IV (6 to 12 ml)

Paediatric population

0.02 mg/kg IV

Treatment of hemodynamically compromising bradycardia, atrioventricular block, cardiopulmonary resuscitation:

Adults:

- Sinus bradycardia: 0.5 mg IV (5ml), every 2-5 minutes until the desired heart rate is achieved.

- AV block: 0.5 mg IV (5ml), every 3-5 minutes (maximum 3 mg)

Paediatric population

0.02 mg/kg IV in a single dose (maximum dose 0.6 mg).

As an antidote to organophosphates (pesticides, nerve gases), to cholinesterase inhibitors and in muscarinic mushroom poisoning:

Intravenous use.

Adults:

0.5 - 2 mg atropine sulfate (5 - 20 ml), can be repeated after 5 minutes and subsequently every 10-15 minutes as required, until signs and symptoms disappear (this dose may be exceeded many times).

Paediatric population:

0.02 mg atropine sulfate/kg body weight possibly repea