DIPRIVAN 1 %w/v Emulsion for Inj/Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PROPOFOL

Available from:

AstraZeneca UK Limited

ATC code:

N01AX10

INN (International Name):

PROPOFOL

Dosage:

1 %w/v

Pharmaceutical form:

Emulsion for Inj/Inf

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other general anesthetics

Authorization status:

Authorised

Authorization date:

1995-10-19

Patient Information leaflet

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

Summary of Product characteristics

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