Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
PROPOFOL
AstraZeneca UK Limited
N01AX10
PROPOFOL
1 %w/v
Emulsion for Inj/Inf
Product subject to prescription which may not be renewed (A)
Other general anesthetics
Authorised
1995-10-19
453695-A02 10-01-15 P039718 297625L1 1889 RY Diprivan 50ml-1% Leaflet: Combined IE-MT Black Technical Info Profile BODY TEXT SIZE 7.5 pt SMALLEST TEXT SIZE 6.0 pt MEDICAL INFORMATION LEAFLET DIPRIVAN 1% W/V EMULSION FOR INJECTION OR INFUSION, PRE-FILLED SYRINGE propofol 1. NAME OF THE MEDICINAL PRODUCT Diprivan 1% w/v Emulsion for Injection or Infusion, Pre-filled Syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Contains propofol 10 mg/ml. Each 50 ml pre-filled syringe contains 500 mg propofol. Excipient(s) with known effect: Contains sodium 0.0018 mmol/ml. Contains soya-bean oil, refined 100 mg/ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White emulsion for injection or infusion, supplied in pre-filled syringes. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diprivan is a short-acting intravenous general anaesthetic for: • Induction and maintenance of general anaesthesia in adults and children over one month of age. • Sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children over one month of age. • Sedation of ventilated patients over 16 years of age in the intensive care unit. Diprivan may be administered by a Diprifusor TCI system for induction and maintenance of general anaesthesia and conscious sedation for surgical and diagnostic procedures in adults only. Administration of Diprivan by a Diprifusor TCI system is not recommended for any indication in children or adolescents under 16 years old. Administration of Diprivan by a Diprifusor TCI system is not recommended for intensive care sedation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Supplementary analgesic agents are generally required in addition to Diprivan. For specific guidelines relating to the administration of Diprivan using the Diprifusor Target Controlled Infusion (TCI) system, which incorporates Diprifusor TCI software, see section e. Such use is restricted সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diprivan 1% w/v Emulsion for Injection or Infusion, Pre-filled Syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains propofol 10 mg/ml. Each 20 ml pre-filled syringe contains 200 mg propofol. Each 50 ml pre-filled syringe contains 500 mg propofol. Excipient(s) with known effect: Contains sodium 0.0018 mmol/ml. Contains refined soya-bean oil 100 mg/ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Emulsion for injection or infusion. White or almost white emulsion for injection or infusion, supplied in pre-filled syringes. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diprivan is a short-acting intravenous general anaesthetic for: Induction and maintenance of general anaesthesia in adults and children over one month of age. Sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children over one month of age. Sedation of ventilated patients over 16 years of age in the intensive care unit. Diprivan may be administered by a Diprifusor TCI system for induction and maintenance of general anaesthesia and conscious sedation for surgical and diagnostic procedures in adults only. Administration of Diprivan by a Diprifusor TCI system is not recommended for any indication in children or adolescents under 16 years old. Administration of Diprivan by a Diprifusor TCI system is not recommended for intensive care sedation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Supplementary analgesic agents are generally required in addition to Diprivan. For specific guidelines relating to the administration of Diprivan using the Diprifusor target controlled infusion (TCI) system, which incorporates Diprifusor TCI software, see section সম্পূর্ণ নথি পড়ুন