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HSA Approval

ADRENALINE AGUETTANT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.1 MG/ML

SIN16897P

ADRENALINE AGUETTANT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.1 MG/ML

ADRENALINE AGUETTANT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.1 MG/ML

November 7, 2023

AGUETTANT ASIA PACIFIC PTE. LTD.

AGUETTANT ASIA PACIFIC PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantAGUETTANT ASIA PACIFIC PTE. LTD.
Licence HolderAGUETTANT ASIA PACIFIC PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, SOLUTION

**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/mL solution (1 mg), repeated every 3–5 minutes until return of spontaneous circulation.

INTRAVENOUS, INTRAMEDULLARY

Medical Information

**4.1. Therapeutic indications** Cardiopulmonary resuscitation Acute anaphylaxis in adults

**4.3. Contraindications** Patients with known hypersensitivity to an excipient, where an alternative presentation of adrenaline or alternative vasopressor is available.

C01CA24

epinephrine

Manufacturer Information

AGUETTANT ASIA PACIFIC PTE. LTD.

Laboratoire AGUETTANT

Active Ingredients

Adrenaline tartrate equivalent to adrenaline

0.1 mg/ml

Epinephrine

Documents

Package Inserts

Adrenaline Aguettant PI.pdf

Approved: November 7, 2023

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ADRENALINE AGUETTANT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.1 MG/ML - HSA Approval | MedPath