DIPRIVAN 1 % PFS 20 ml INJECTION

Ülke: Güney Afrika

Dil: İngilizce

Kaynak: South African Health Products Regulatory Authority (SAHPRA)

Mevcut itibaren:

Pharmacare Limited û Woodmead

Doz:

See ingredients

Farmasötik formu:

INJECTION

Kompozisyon:

EACH 1 ml INFUSION CONTAINS PROPOFOL 10,0 mg

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

1998-10-10

Ürün özellikleri

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1.3.1.1
PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
S5
PROPRIETARY NAME AND DOSAGE FORM
DIPRIVAN 1 % 20 ML (injection)
DIPRIVAN 1 % 50 ML (infusion [parenteral])
DIPRIVAN 1 % 100 ML (infusion [parenteral])
COMPOSITION
Each ampoule/vial of DIPRIVAN 1 % 20 ml contains 10 mg/ml of propofol.
Each vial of DIPRIVAN 1 % 50 ml vial contains 10 mg/ml of propofol.
Each vial of DIPRIVAN 1 % 100 ml vial contains 10 mg/ml of propofol.
_Excipients: _
Disodium edetate (anhydrous) 0,005 % _m/v_, glycerol, purified egg
phosphatide, soya-bean
oil, water for injection
Sugar free
CATEGORY AND CLASS
A 2.1 Anaesthetics
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PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
DIPRIVAN 1 % (2,6-diisopropylphenol) is a short-acting sedative
hypnotic with a rapid onset
of action of approximately 30 seconds. The mechanism of action is
poorly understood.
Falls in mean arterial blood pressure and changes in heart rate are
observed when
DIPRIVAN 1 % is administered.
Ventilatory depression can occur following administration of DIPRIVAN
1 %.
DIPRIVAN 1 % reduces cerebral blood flow, intracranial pressure and
cerebral metabolism.
Recovery from anaesthesia is usually rapid and clear-headed.
DIPRIVAN 1 % has an anti-emetic effect.
Studies have shown that DIPRIVAN 1 %, at the concentrations likely to
occur clinically, does
not inhibit the synthesis of adrenocortical hormones.
PHARMACOKINETIC PROPERTIES
The decline in propofol concentrations following a bolus dose or
following the termination of
an infusion can be described by a 3-compartment open model. The first
phase is
characterised by a rapid distribution (half-life: 2 to 4 minutes)
followed by rapid elimination
(half-life: 30 to 60 minutes) and a slower final phase, representative
of redistribution of
propofol from poorly perfused tissue.
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Propofol is extensively distributed and r