- Approval Id
- 5dc5c1070b2113b3
- Drug Name
- HEAREM SEVOFLURANE INHALATION ANAESTHETIC LIQUID 100%
- Product Name
- HEAREM SEVOFLURANE INHALATION ANAESTHETIC LIQUID 100%
- Approval Number
- SIN17305P
- Approval Date
- 2025-08-08
- Registrant
- HENGRUI SG PTE. LTD.
- Licence Holder
- HENGRUI SG PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INHALANT
- Dosage
- <p><strong><u>Dosage and Administration</u></strong><br>
Vaporisers specifically 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.</p>
<img src="/TGIF/Hearem-Table1.png" alt="Hearem Dosage Table 1" /><br><br>
<p><strong>Premedication:</strong> Premedication should be selected according to the need of the individual patient, and at the discretion of the anaesthetist. The use of anticholinergic drugs is a matter of choice.</p>
<p><strong>Induction:</strong> Anaesthesia can be induced in adults and children with Sevoflurane. Dosage should be individualised 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. (See also “Interactions” – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). 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. Alternatively, for induction of anaesthesia in unpremedicated patients, inspired concentrations of up to 8% Sevoflurane may be used.</p>
<p><strong>Maintenance:</strong> Surgical levels of anaesthesia may be sustained with concentrations of 0.5 –3% Sevoflurane with or without the concomitant use of nitrous oxide (see also “Drug Interactions” – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Elderly:</strong> As with other inhalation agents, lesser concentrations of Sevoflurane are normally required to maintain surgical anaesthesia. See above for MAC values.</p>
<p><strong>Emergence:</strong> Emergence times are generally short following Sevoflurane anaesthesia. Therefore, patients may require early post-operative pain relief.</p>
- Route Of Administration
- RESPIRATORY (INHALATION)
- Indication Info
- <p><strong><u>Indications</u></strong><br>
For induction and maintenance of general anaesthesia for in-patient and out-patient surgery in both adults and children.</p>
<p><strong>Actions:</strong> The depth of anaesthesia changes rapidly following changes in the inspired concentration of Sevoflurane. Emergence and recovery are particularly rapid. Therefore, patients may require early postoperative pain relief.</p>
<p>As with all other inhalation agents Sevoflurane depresses cardiovascular function in a dose related fashion. In one volunteer study, increases in Sevoflurane concentration resulted in decrease in mean arterial pressure, but there was no change in heart rate. Sevoflurane did not alter plasma noradrenaline concentrations in this study.</p>
<p>No evidence of seizure was observed during the clinical development programme.</p>
- Contraindications
- <p><strong><u>Contraindications</u></strong><br>
Sevoflurane should not 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).</p>
<p>Sevoflurane is also contraindicated in patients with known or suspected genetic susceptibility to malignant hyperthermia.</p>
