Pofol Injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

propofol

Available from:

DongKook Pharmaceutical Co.

INN (International Name):

propofol

Dosage:

10mg/ml

Pharmaceutical form:

emulsion for i/v injection

Prescription type:

Prescription

Summary of Product characteristics

Dongkook
I
P H A R M A C E U T I
C A L
DONGKOOK PHARMACEUTICAL CO., LTD
(P.O.365-834) 488-5 Jukhyeon-ri,
Gwanghyewon-myeon, Jincheon-gun,
Choongcheongbuk-do, Korea.
Tel. [phone] Fax. [phone]
www.dkpharm.co.kr
SMPC FOR POFOL 1% INJECTION
1. Name of the medicinal product
Pofol 10 mg/ml (1%) emulsion for injection
2. Qualitative and quantitative composition EACH ML CONTAINS
_*Active ingredients _
Propofol………………………10,0mg
_*Inactive ingredients _
Soy-bean oil, refined………...100mg
Purified egg phosphatide……..12mg
Glycerol………………………22,5mg
Sodium hydroxide…………...0,08mg
Water for injection………………....q.s.
3. Pharmaceutical form
White to almost white emulsion for injection
4. Clinical particulars
4.1 Therapeutic indications
Induction and maintenance of general anesthesia, sedation of
ventilated patients receiving intensive care.
4.2 Posology and method of administration
_1. INDUCTION OF GENERAL ANESTHESIA_
(1) Adults
It is recommended that Pofol should be titrated (approximately
40mg[4ml] every 10 seconds in an average
healthy adult) against the response of the patient until the clinical
signs show the onset of anesthesia.
Most adult patients aged less than 55 years are likely to require 1.5
to 2.5 mg/kg of Pofol, reduce rates of
administration (20-50mg/min) to decrease total amount of
administration. The total dose required can be
reduced by lower rates of administration [20 -50 mg/min (2 - 5
ml/min)]. Over 55 years of age, the
requirement will generally be less. In patients of ASA(American
Society Anesthesiologist) grades 3 and 4,
lower rates of administration should be used (approximately 20mg[2ml]
every 10 seconds).
(2) Children over 3 years of age.
It is recommended that Pofol should be given slowly until the clinical
signs show the onset of anesthesia. The
dose should be adjusted for age and/or weight. Most patients over 8
years of age are likely to require
approximately 2.5 mg/kg of Pofol for induction of anesthesia. Under
this age the requi