- Approval Id
- 907210fab27aa317
- Drug Name
- ADRENALINE AGUETTANT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.1 MG/ML
- Product Name
- ADRENALINE AGUETTANT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.1 MG/ML
- Approval Number
- SIN16897P
- Approval Date
- 2023-11-07
- Registrant
- INTEGA PTE LTD
- Licence Holder
- INTEGA PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>4.2. Posology and method of administration</strong><br>
Intravenous adrenaline should only be administered by those experienced in the use and titration of vasopressors in their normal clinical practice.</p>
<p><u><strong>Cardiopulmonary resuscitation:</strong></u><br>
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.</p>
<p><u><strong>Acute anaphylaxis</strong></u><br>
Titrate using intravenous boluses of 0.5 ml 0.1 mg/mL solution (0.05 mg) according to response.<br>
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.</p>
<p><u><strong>Paediatric Population:</strong></u><br>
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.</p>
<p><em>Cardiac arrest in children:</em><br>
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/mL solution (1 mg), repeated every 3–5 minutes until return of spontaneous circulation.</p>
- Route Of Administration
- INTRAVENOUS, INTRAMEDULLARY
- Indication Info
- <p><strong>4.1. Therapeutic indications</strong><br>
Cardiopulmonary resuscitation<br>
Acute anaphylaxis in adults</p>
- Contraindications
- <p><strong>4.3. Contraindications</strong><br>
Patients with known hypersensitivity to an excipient, where an alternative presentation of adrenaline or alternative vasopressor is available.</p>
- Atc Code
- C01CA24
- Atc Item Name
- epinephrine
- Pharma Manufacturer Name
- AGUETTANT ASIA PACIFIC PTE. LTD.
