Pofol Injection I.V. emulsion for i/v injection

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Unduh Selebaran informasi (PIL)
09-01-2020
Unduh Karakteristik produk (SPC)
28-11-2016

Bahan aktif:

propofol

Tersedia dari:

Dongkook Pharmaceutical Co.

Kode ATC:

N01AX10

INN (Nama Internasional):

propofol

Dosis:

10mg/ml

Bentuk farmasi:

emulsion for i/v injection

Unit dalam paket:

(1) 50ml glass vial

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2016-11-23

Selebaran informasi

                                INGREDIENTS
Pofol Injection contains Propofol 10.0mg per 1ml.
Pharmacotherapeutic group : Other general anaesthetics (ATC code :
N01AX10)
DOSAGE FORM
Emulsion for Injection
CHARACTERISTICS
White to almost white emulsion
INDICATIONS
Induction and maintenance of general anesthesia, sedation of
ventilated patients receiving intensive care, and sedation for
diagnostic and surgical procedures
DOSAGE AND ADMINISTRATION
1. Induction of general anesthesia
(1) Adults (less than 55 years of age)
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 administ
ration. 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 dose requirement is reduced. The reduction
should take into account of the physical status and age of the
patient. In patients of ASA(American So
ciety Anesthesiologist) grades 3 and 4, especially those with impaired
cardiac function, the dose requirements will be less and the total
dose may be reduced (1 to 1.5 mg/
kg) with a slower administration rate (approximately 20 mg[2 mL] every
10 seconds). Rapid bolus administration (singly or repeated) should
not be used in above mentioned
patients including the elderly as this may lead to cardiopulmonary
depression.
(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 requirements may
be more than 2.5 mg/kg. Lower
dosage is recommended for children of ASA grades 3 and 4.
2. Maintenance of general anesthe
                                
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