RAPIFEN 500 Microgram/ML Solution for Inj/Inf

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

ALFENTANIL HYDROCHLORIDE

Disponible depuis:

Janssen-Cilag Ltd

Code ATC:

N01AH02

DCI (Dénomination commune internationale):

ALFENTANIL HYDROCHLORIDE

Dosage:

500 Microgram/ML

forme pharmaceutique:

Solution for Inj/Inf

Type d'ordonnance:

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

Domaine thérapeutique:

Opioid anesthetics

Statut de autorisation:

Authorised

Date de l'autorisation:

1997-06-09

Notice patient

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RAPIFEN
®
500 MICROGRAMS/ML
SOLUTION FOR INJECTION OR INFUSION
Alfentanil
Rapifen is a registered trademark
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again

If you have any further questions, ask your doctor or nurse

This medicine has been prescribed for you. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours

If you get any side effects talk to your doctor or nurse. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1 What Rapifen is and what it is used for
2 What you need to know before you are given Rapifen
3 How Rapifen is given
4 Possible side effects
5 How Rapifen is stored
6 Contents of the pack and other information
1 WHAT RAPIFEN IS AND WHAT IT IS USED FOR
Rapifen contains a medicine called alfentanil hydrochloride. It
belongs to a
group of medicines called ‘opioid analgesics’. Rapifen is a strong
painkiller that
works for a short period of time.
Rapifen is used to prevent or relieve pain during different types of
surgery in
adults and children of all ages, including babies.
In adults it can be:

Used alone for short operations, when you go home on the same day

Used with other medicines (anaesthetics) to put you to sleep for
longer
operations, when you may stay in hospital for a number of days

Used if you are in intensive care and are having your breathing helped
by a
machine called a ventilator.
In children of all ages, including babies it can be:

Used with other medicines (sedatives) for short operations, when you
go
home on the same day

Used with other medicines (general anaesthetics) to put you to sleep
for
longer operations, when you may stay in hospital for a number of days
2 WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN RAPIFEN
DO NOT HAVE RAPIFEN IF:
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
You are allergic to alfenta

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rapifen 500 micrograms/ml solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution contains 500 micrograms of alfentanil (as
hydrochloride).
2ml ampoules contain: 1000 micrograms of alfentanil.
10ml ampoules contain: 5000 micrograms of alfentanil.
Contains sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Ampoules containing a clear, aqueous, sterile solution for injection
or infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults:
As an analgesic supplement for use before and during anaesthesia. It
is indicated:
i)
As an induction agent in general anaesthesia.
ii)
As the sole intravenous anaesthetic agent for short minor surgical
procedures.
iii)
For the induction of anaesthesia, and as an adjunct in the maintenance
of general anaesthesia and analgesia.
iv)
For the provision of analgesia and suppression of respiratory activity
in mechanically ventilated patients
in intensive care and to provide analgesic cover for painful
procedures.
In paediatrics:
Rapifen is indicated for use in neonates, infants, children and
adolescents as:
i)
An opioid analgesic in association with a hypnotic to induce
anaesthesia
ii) An opioid analgesic in association with general anaesthesia and
for both short and long
surgical procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_For intravenous use._
Rapifen should be administered intravenously either by bolus injection
(short procedures) or bolus supplemented by
increments or by infusion (long painful surgical procedures).
The 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 drugs including human cytochrome P450 3A4
inhibitors (see section 4.5), type of anaesthesia to be used and type
and duration of the surgical procedures.
All administrations of Rapifen must be under c