ADRENALINE AGUETTANT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.1 MGML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Adrenaline tartrate equivalent to adrenaline

Available from:

AGUETTANT ASIA PACIFIC PTE. LTD.

ATC code:

C01CA24

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Adrenaline tartrate equivalent to adrenaline 0.1 mg/ml

Administration route:

INTRAVENOUS, INTRAMEDULLARY

Prescription type:

Prescription Only

Manufactured by:

Laboratoire AGUETTANT

Authorization status:

ACTIVE

Authorization date:

2023-11-07

Summary of Product characteristics

106697
ADRENALINE AGUETTANT
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.1 MG/ML
1. NAME OF THE MEDICINAL PRODUCT
ADRENALINE AGUETTANT solution for injection in pre-filled
syringe 0.1 mg/mL
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each ml of solution for injection contains 0.1 mg of adrenaline
(as adrenaline tartrate)
Each 10 ml pre-filled syringe contains 1 mg adrenaline (as adrenaline
tartrate)
Excipient with known effect: sodium
Each ml of solution for injection contains 3.54 mg equivalent to
0.154 mmol of sodium.
Each 10 ml pre-filled syringe contains 35.4 mg equivalent to
1.54 mmol of sodium.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe
Clear and colourless solution in a 10ml pre-filled syringe
pH = 3.0 to 3.4
Osmolarity: 270 – 300 mOsm/l
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Cardiopulmonary resuscitation
Acute anaphylaxis in adults
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Intravenous adrenaline should only be administered by those
experienced in the use and titration of vasopressors in their normal
clinical practice.
CARDIOPULMONARY RESUSCITATION:
10 ml of the 0.1 mg/mL solution (1 mg) by the intravenous or
intraosseous route, repeated every 3-5 minutes until return of
spontaneous circulation.
ACUTE ANAPHYLAXIS
Titrate using intravenous boluses of 0.5 ml 0.1 mg/mL solution
(0.05 mg) according to response.
ADRENALINE AGUETTANT solution for injection in pre-filled
syringe 0.1 mg/mL is not recommended for intramuscular use in
acute anaphylaxis. For intramuscular administration, a 1mg/ml
solution should be used.
PAEDIATRIC POPULATION:
This medicinal product is not appropriate to deliver a dose of less
than 0.5 ml and should therefore not be used by the intravenous or
intraosseous route, in neonates and infants with body weight less
than 5 kg.
_Cardiac arrest in children:_
Intravenous or intraosseous route (above 5 kg only): 0.1 ml/kg of
0.1 mg/mL solution (10 micrograms/kg) to a maximum single dose
of 10 ml of 0.1 mg/