Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INHALANT
**DOSAGE AND ADMINISTRATION** Vaporizer specially calibrated for use with Sevoflurane should be used so that the concentration delivered can be accurately controlled. MAC (minimum alveolar concentration) values for Sevoflurane decrease with age and with the addition of nitrous oxide. The table below indicates average MAC values for different age groups.  **Premedication:** Premedication should be selected according to the need of the individual patient, and at the direction of the anesthetist. The use of anticholinergic drugs is a matter of choice. **Induction:** Anaesthesia can be induced in adults and children with Sevoflurane. Dosage should be individualized and titrated to the desired effect according to the patient’s age and clinical status. A short acting Barbiturate or other intravenous induction agent may be administered followed by inhalation of Sevoflurane. Induction with Sevoflurane may be achieved in oxygen or in combination with oxygen-nitrous oxide mixtures. In adults inspired concentrations of up to 5% Sevoflurane usually produce surgical anaesthesia in less than 2 minutes. In children, inspired concentrations of up to 7 % Sevoflurane usually produce surgical anaesthesia in less than 2 minutes. **Maintenance:** Surgical levels of anesthesia can usually be achieve concentrations of 0.5 – 3% Sevoflurane with or without the concomitant use nitrous oxide. **Elderly:** As with other inhalation agents, lesser concentrations of Sevoflurane are normally required to maintain surgical anesthesia (see MAC values). **Emergence:** Emergence times are generally short following Sevoflurane anesthesia. Therefore, patients may require early post-operative pain relief.
RESPIRATORY (INHALATION)
Medical Information
**INDICATIONS** Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery.
**CONTRAINDICATIONS** Sevoflurane should be used in patients with known or suspected sensitivity to Sevoflurane or to other halogenated inhalational anaesthetics (e.g. history of hepatotoxicity, usually including elevated liver enzymes, fever, leukocytosis and/or eosinophilia temporally related to anaesthesia with one of these agents). Sevoflurane is also contraindicated in patients with known or suspected genetic susceptibility to malignant hypherthermia.
N01AB08
sevoflurane
Manufacturer Information
GOLDPLUS UNIVERSAL PTE LTD
PT. Novell Pharmaceutical Laboratories
Active Ingredients
Documents
Package Inserts
Norevell Inhalation Anaesthetic Liquid PI.pdf
Approved: October 16, 2023