Diprivan

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Propofol 20 mg/mL

Fáanlegur frá:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Alþjóðlegt nafn):

Propofol 20 mg/mL

Skammtar:

2% w/v

Lyfjaform:

Emulsion for injection

Samsetning:

Active: Propofol 20 mg/mL Excipient: Disodium edetate Egg lecithin Glycerol Lecithin Nitrogen Sodium hydroxide Soya oil Water for injection

Einingar í pakka:

Syringe, glass, prefilled, 10 mL

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Bachem SA

Ábendingar:

· DIPRIVAN is a short-acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia in adults and children >1 month. · DIPRIVAN may also be used for sedation of ventilated adult and paediatric patients >1 month receiving intensive care. · DIPRIVAN may also be used for monitored anaesthesia care sedation for surgical and diagnostic procedures in adults and children >1 month.

Vörulýsing:

Package - Contents - Shelf Life: Syringe, glass, prefilled - 10 mL - 2 years from date of manufacture stored at or below 25°C - Syringe, glass, prefilled - 50 mL - 2 years from date of manufacture stored at or below 25°C - Vial, glass, - 50 mL - 2 years from date of manufacture stored at or below 25°C

Leyfisdagur:

1999-02-17

Vara einkenni

D
IPRIVAN
Data Sheet
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
D
IPRIVAN
Propofol Injection 10 mg/mL (Diprivan 1%).
Propofol Injection 20 mg/mL (Diprivan 2%).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Diprivan contains 10 mg or 20 mg propofol per 1 mL.
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Diprivan is a white, aqueous and isotonic emulsion for intravenous
injection.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
D
IPRIVAN
is
a
short-acting
intravenous
anaesthetic
agent
suitable
for
induction
and
maintenance of general anaesthesia in adults and children >1 month.
D
IPRIVAN
may also be used for sedation of ventilated adult and paediatric
patients >1 month
receiving intensive care.
D
IPRIVAN
may also be used for monitored anaesthesia care sedation for surgical
and diagnostic
procedures in adults and children >1 month.
4.2
DOSE AND METHOD OF ADMINISTRATION
FOR GENERAL ANAESTHESIA OR MONITORED ANAESTHESIA CARE (MAC) SEDATION,
D
IPRIVAN
SHOULD BE ADMINISTERED ONLY BY PERSONS TRAINED IN THE ADMINISTRATION
OF GENERAL
ANAESTHESIA AND NOT INVOLVED IN THE CONDUCT OF THE SURGICAL/DIAGNOSTIC
PROCEDURE.
PATIENTS SHOULD BE CONTINUOUSLY MONITORED, AND FACILITIES FOR
MAINTENANCE OF A PATENT
AIRWAY, ARTIFICIAL VENTILATION, AND OXYGEN ENRICHMENT AND CIRCULATORY
RESUSCITATION MUST
BE IMMEDIATELY AVAILABLE.
FOR SEDATION OF INTUBATED, MECHANICALLY VENTILATED ADULT PATIENTS IN
THE INTENSIVE CARE
UNIT (ICU), D
IPRIVAN SHOULD BE ADMINISTERED ONLY BY PERSONS SKILLED IN THE MANAGEMENT
OF
CRITICALLY
ILL
PATIENTS
AND
TRAINED
IN
CARDIOVASCULAR
RESUSCITATION
AND
AIRWAY
MANAGEMENT.
D
IPRIVAN
has been used in association with spinal and epidural anaesthesia and
with
commonly used premedicants, neuromuscular blocking medicines,
inhalational agents and
analgesic agents; no pharmacological incompatibility has been
encountered. Lower doses of
D
IPRIVAN
may be required where general anaesthesia is used as an adjunct to
regional
anaesthetic techniques.
D
IPRIVAN
Data Sheet
Copyright
2
For specific guidance relating to