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HSA Approval

EPHEDRINE AGUETTANT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 30 MG/ 10 ML

SIN16846P

EPHEDRINE AGUETTANT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 30 MG/ 10 ML

EPHEDRINE AGUETTANT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 30 MG/ 10 ML

August 25, 2023

AGUETTANT ASIA PACIFIC PTE. LTD.

AGUETTANT ASIA PACIFIC PTE. LTD.

Regulatory Information

AGUETTANT ASIA PACIFIC PTE. LTD.

AGUETTANT ASIA PACIFIC PTE. LTD.

Therapeutic

Prescription Only

Formulation Information

INJECTION, SOLUTION

**4.2. Dosage and method of administration** _Adults and the elderly_ Up to 30 mg in increments of 3 – 7.5 mg. After the development of hypotension, by slow intravenous administration. _Paediatric Population_ 0.5 – 0.75 mg/kg body weight or 17 – 25 mg/m2 body surface. After the development of hypotension, by slow intravenous administration. **Compatibilities** Ephedrine is reported to be compatible with 0.9% sodium chloride.

INTRAVENOUS

Medical Information

**4.1. Therapeutic indications** Reversal of anaesthesia induced hypotension during spinal and epidural anaesthesia

**4.3. Contraindications** This medicinal product must never be used in the following cases: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - in combination with other indirect sympathomimetic agents such as pseudoephedrine, methylphenidate, bupropion, cafedrine, and theodrenaline. - in combination with alpha sympathomimetic agents. - in combination with irreversible monoamine oxidase inhibitors (MAOI).

C01CA26

ephedrine

Manufacturer Information

AGUETTANT ASIA PACIFIC PTE. LTD.

Laboratoire Aguettant

Laboratoire AGUETTANT

Active Ingredients

Ephedrine hydrochloride

30 mg/ 10 ml

Ephedrine

Documents

Package Inserts

Ephedrine Aguettant PFS (30mg in 10ml) PI.pdf

Approved: August 25, 2023

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