Biomed Fentanyl

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Fentanyl citrate 15.71 µg/mL equivalent to fentanyl 10mcg/mL;  

Available from:

Biomed Limited

INN (International Name):

Fentanyl citrate 15.71 mg/L (equivalent to fentanyl 10 mg/L)

Dosage:

10 mcg/mL

Pharmaceutical form:

Solution for infusion

Composition:

Active: Fentanyl citrate 15.71 µg/mL equivalent to fentanyl 10mcg/mL   Excipient: Sodium chloride Water for injection

Units in package:

Bag, plastic, Propyflex with polycarbonate port, 100 mL

Class:

Class B3 Controlled Drug

Prescription type:

Class B1 Controlled Drug

Manufactured by:

Cambrex Charles City Inc

Therapeutic indications:

Fentanyl is indicated for: · analgesic action in the post-operative period as the need arises · use as a narcotic analgesic supplement in general and regional anaesthesia.

Product summary:

Package - Contents - Shelf Life: Bag, plastic, Flexible, non-PVC polypropylene IV bag with foil overwrap - 100 mL - 24 months from date of manufacture stored at or below 25°C protect from light. Do not refrigerate or freeze.

Authorization date:

2010-08-26

Summary of Product characteristics

NEW ZEALAND DATA SHEET
BIOMED FENTANYL 10 MCG/ML, 20 MCG/ML
Page 1 of 16
1.
PRODUCT NAME
Biomed Fentanyl 10 mcg/mL 100 mL bag
Biomed Fentanyl 10 mcg/mL 10 mL syringe
Biomed Fentanyl 20 mcg/mL 100 mL bag
Biomed Fentanyl 20 mcg/mL 50 mL syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 MICROGRAM PER ML
Each 100 mL bag contains fentanyl citrate equivalent to 1000 microgram
fentanyl base
Each 10 mL syringe contains fentanyl citrate equivalent to 100
microgram fentanyl base
20 MICROGRAM PER ML
Each 100 mL bag contains fentanyl citrate equivalent to 2000 microgram
fentanyl base
Each 50 mL syringe contains fentanyl citrate equivalent to 1000
microgram fentanyl base
Excipient(s) with known effect:
Sodium 3.5 mg/mL
For a full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
A clear, colourless isotonic solution. It contains no preservative.
It is formulated with a pH of 4.0 – 7.5.
The following product is a solution for IV injection:
Biomed Fentanyl 10 mcg/mL 10 mL syringe
The following products are solutions for IV infusion:
Biomed Fentanyl 10 mcg/mL 100 mL IV bag
Biomed Fentanyl 20 mcg/mL 100 mL IV bag
Biomed Fentanyl 20 mcg/mL 50 mL syringe
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Biomed Fentanyl is indicated for:
•
analgesic action in the post-operative period as the need arises;
•
use as an opioid analgesic supplement in general and regional
anaesthesia.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Dosage should be individualised. Some of the factors to be considered
in determining the
dose are: age, body weight, physical status, underlying pathological
condition, use of other
medicines, type of anaesthesia to be used, and the surgical procedure
involved.
NEW ZEALAND DATA SHEET
BIOMED FENTANYL 10 MCG/ML, 20 MCG/ML
Page 2 of 16
Biomed Fentanyl contains no antimicrobial agent. It should be used
only once and any
remaining contents discarded. The injectable solution must not be
mixed with other products
(see Section 6.2)
USUAL DOSAGE IN ADULTS
1.
ADJUNCT TO GENERAL ANAESTHESIA
INDUCTION: 50 to