Alfentanil 500 micrograms/ml

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Alfentanil hydrochloride monohydrate 0.5438 mg/mL equivalent to alfentanil 0.5 mg/ml;  

Disponibil de la:

Max Health Limited

INN (nume internaţional):

Alfentanil hydrochloride 0.5438 mg/mL (= alfentanil 0.5 mg/ml)

Dozare:

0.5 mg/mL

Forma farmaceutică:

Solution for injection

Compoziție:

Active: Alfentanil hydrochloride monohydrate 0.5438 mg/mL equivalent to alfentanil 0.5 mg/ml   Excipient: Hydrochloric acid Nitrogen Sodium chloride Water for injection

Tip de prescriptie medicala:

Class B3 Controlled Drug

Produs de:

Hameln rds a.s

Indicații terapeutice:

An anaesthetic induction agent.

Rezumat produs:

Package - Contents - Shelf Life: Ampoule, glass, type 1 clear 10 ml fill in cardboard carton - 5 dose units - 36 months from date of manufacture stored at or below 25°C 48 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, glass, type 1 clear 2 ml fill in cardboard carton - 10 dose units - 36 months from date of manufacture stored at or below 25°C 48 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze)

Data de autorizare:

2013-03-26

Caracteristicilor produsului

NEW ZEALAND DATA SHEET
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1. NAME OF THE MEDICINE
Alfentanil 500 micrograms/mL
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1mL contains alfentanil hydrochloride
hydrate 543.8 micrograms, equivalent to 500 micrograms
alfentanil base.
Excipient(s) with known effect: Sodium chloride 9 mg/mL
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Alfentanil is indicated in adults and children aged above one year for
use as:
•
an opioid analgesic in general or regional anaesthesia for both short
(bolus injections) and long
(bolus, supplemented by increments or by continuous infusion) surgical
procedures.
•
an anaesthetic induction agent.
Due to its rapid and short lasting action, alfentanil is particularly
suited as an opioid analgesic for short
procedures and outpatient surgery. It is also useful as an analgesic
supplement for procedures of medium
and long duration, since periods of very painful stimuli can easily be
overcome by small increments of
alfentanil or by adapting its infusion rate.
4.2. DOSE AND METHOD OF ADMINISTRATION
Alfentanil should be administered intravenously. Other routes of
administration have not been evaluated.
The dosage of alfentanil should be individualised according to age,
body weight, physical status, underlying
pathological condition, use of other medicines, type of anaesthesia
and type and duration of the surgical
procedure. As a general principle, the lowest effective dose should be
used.
The initial dose should be appropriately reduced in the elderly and in
debilitated patients. The effect of the
initial dose should be taken into account in determining supplemental
doses.
To avoid bradycardia, it is recommended that a small intravenous dose
of an anti-cholinergic agent (e.g.
atropine), be administered just before induction. Droperidol may be
given to prevent nausea and vomiting.
However, it is preferable not to administer droperidol to outpatients
since it may lengthen their r