Propofol-Lipuro 2% (20mg/ml)

B. Braun Melsungen AG (GERMANY)🇸🇬 Health Sciences Authority

Approval Date: Mar 23, 2009
Approval ID: 4db1bf71639b461b
Company: B. Braun Melsungen AG (GERMANY)
Type: Therapeutic

Approval Details

Approval Id: 4db1bf71639b461b
Drug Name: Propofol-Lipuro 2% (20mg/ml)
Product Name: Propofol-Lipuro 2% (20mg/ml)
Approval Number: SIN13622P
Approval Date: 2009-03-23
Registrant: B. BRAUN SINGAPORE PTE LTD
Licence Holder: B. BRAUN SINGAPORE PTE LTD
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: EMULSION
Dosage: Dosage General instructions Propofol-Lipuro 2 % (20 mg/ml) must only be given in hospitals or adequately equipped day therapy units by physicians trained in anaesthesia or in the care of patients in intensive care. Circulatory and respiratory functions should be constantly monitored (e.g. ECG, pulse-oxymeter) and facilities for maintenance of patent airways, artificial ventilation, and other resuscitation facilities should always be immediately available. For sedation during surgical or diagnostic procedures Propofol-Lipuro 2 % (20 mg/ml) should not be given by the same person that carries out the surgical or diagnostic procedure. Supplementary analgesic medicinal products are generally required in addition to Propofol-Lipuro 2 % (20 mg/ml). Propofol-Lipuro 2 % (20 mg/ml) is given intravenously. The dosage is adjusted individually according to the patient’s response. General anaesthesia in adults Induction of anaesthesia For induction of anaesthesia Propofol-Lipuro 2 % (20 mg/ml) should be titrated (20 – 40 mg of propofol every 10 seconds) against the patient’s response until the clinical signs show the onset of anaesthesia. Most adult patients younger than 55 years are likely to require 1.5 to 2.5 mg of propofol/kg BW. In older patients and in patients of ASA grades III and IV, especially those with impaired cardiac function, the dosage requirements will be less and the total dose of Propofol-Lipuro 2 % (20 mg/ml) may be reduced to a minimum of 1 mg of propofol/kg BW. In these patients lower rates of administration should be applied (approximately 1 ml, corresponding to 20 mg, every 10 seconds). Maintenance of anaesthesia Anaesthesia is maintained by administering Propofol-Lipuro 2 % (20 mg/ml) by continuous infusion. The dosage requirements usually are in the range of 4 – 12 mg of propofol/kg BW/h. In the elderly, in patients of poor general condition, in patients of ASA grades III and IV and in hypovolaemic patients the dosage may be reduced further depending on the severity of the patient’s condition and on the performed anaesthetic technique. General anaesthesia in children over 3 years of age Induction of anaesthesia For induction of anaesthesia Propofol-Lipuro 2 % (20 mg/ml) should be titrated slowly against the patient’s response until the clinical signs show the onset of anaesthesia. The dosage should be adjusted according to age and/ or BW. Most patients over 8 years are likely to require approximately 2.5 mg of propofol/kg BW for induction of anaesthesia. Below this age the dose requirement may be higher (2.5 – 4 mg of propofol/kg BW). Due to the lack of clinical experience, lower dosages are recommended for young patients at increased risk (ASA grades III and IV). Propofol-Lipuro 2 % (20 mg/ml) is contraindicated for induction of anaesthesia in children below 3 years of age. Maintenance of general anaesthesia: For maintenance of general anaesthesia, a satisfactory level of anaesthesia is usually achieved by continuous infusion with a dosage regimen in the range of 9 – 15 mg of propofol/kg BW/h. Dosage should be adjusted individually and particular attention paid to the need for adequate analgesia (see also “General instructions” above). Propofol-Lipuro 2 % (20 mg/ml) is contraindicated for maintenance of anaesthesia in children below 3 years of age. Sedation of ventilated patients in the intensive care unit When used to provide sedation for ventilated patients under intensive care conditions, it is recommended that Propofol-Lipuro 2 % (20 mg/ml) be given by continuous infusion. The infusion rate should be adjusted according to the required depth of sedation. Usually satisfactory sedation is achieved with administration rates in the range of 0.3 – 4.0 mg of propofol/kg BW/h. (See also “Special warnings and precautions for use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Propofol is not indicated for sedation in the intensive care unit of patients of 16 years of age or younger (see “Contraindications”). Sedation for diagnostic and surgical procedures in adult patients To provide sedation during surgical and diagnostic procedures, doses and administration rates should be adjusted according to the clinical response. Most patients will require 0.5 – 1 mg of propofol/kg BW over 1 to 5 minutes for onset of sedation. Maintenance of sedation may be accomplished by titrating Propofol-Lipuro 2 % (20 mg/ml) infusion to the desired level of sedation. Most patients will require 1.5 – 4.5 mg of propofol/kg BW/h. The infusion may be supplemented by bolus administration of 10 – 20 mg of propofol (0.5 – 1 ml Propofol-Lipuro 2 % (20 mg/ml)) if a rapid increase of the depth of sedation is required. In patients older than 55 years and in patients of ASA grade III and IV lower doses of Propofol-Lipuro 2 % (20 mg/ml) may be required and the rate of administration may need to be reduced. Propofol-Lipuro 2 % (20 mg/ml) must not be used for sedation for diagnostic and surgical procedures in patients of 16 years or younger. Duration of use Propofol-Lipuro 2 % (20 mg/ml) can be administered for a maximum period of 7 days.
Route Of Administration: INTRAVENOUS
Indication Info: Indications Propofol-Lipuro 2 % (20 mg/ml) is a short-acting intravenous general anaesthetic for <ul> <li>induction and maintenance of general anaesthesia in adults and for use in children above 3 years of age</li> <li>sedation of ventilated adult patients (above 16 years of age) in the intensive care unit</li> <li>sedation of adult patients (above 16 years of age) for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia.</li> </ul>
Contraindications: Contraindications Propofol-Lipuro 2 % (20 mg/ml) must not be used: <ul> <li>in patients with known hypersensitivity to propofol or to any of the constituents of the emulsion,</li> <li>in patients who are allergic to soya or peanut,</li> <li>in children younger than 3 years for induction and maintenance of anaesthesia,</li> <li>in patients of 16 years of age or younger for sedation in intensive care.</li> <li>in high doses during pregnancy, and obstetric anaesthesia with the exception of termination of pregnancy</li> </ul>
Atc Code: N01AX10
Atc Item Name: propofol
Pharma Manufacturer Name: B. Braun Singapore Pte Ltd.
Company Detail Path: /organization/b-braun-singapore-pte-ltd

Active Ingredients

Propofol

20.0mg/ml

PROPOFOL

20 MG/ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Mar 23, 2009

Approval ID

4db1bf71639b461b

Type

Therapeutic

Back to HSA Approvals