MedPath
HSA Approval

NOREVELL INHALATION ANAESTHETIC LIQUID 100%

SIN16819P

NOREVELL INHALATION ANAESTHETIC LIQUID 100%

NOREVELL INHALATION ANAESTHETIC LIQUID 100%

July 10, 2023

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGOLDPLUS UNIVERSAL PTE LTD
Licence HolderGOLDPLUS UNIVERSAL PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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. ![Norevell Dosage Table 1](https://cdn.medpath.com/drug/dosage/20240520/50dea5721dc1cdfaea3fbe4eb6b8b4e6.png) **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

Sevoflurane

100%

Sevoflurane

Documents

Package Inserts

Norevell Inhalation Anaesthetic Liquid PI.pdf

Approved: October 16, 2023

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NOREVELL INHALATION ANAESTHETIC LIQUID 100% - HSA Approval | MedPath