Rapifen

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Alfentanil hydrochloride 0.5435 mg/mL equivalent to 0.5 mg/mL alfentanil

Saadav alates:

Seed Pharma Limited

INN (Rahvusvaheline Nimetus):

Alfentanil hydrochloride 0.5435 mg/mL (equivalent to 0.5 mg/mL alfentanil)

Annus:

0.5 mg/mL

Ravimvorm:

Solution for injection

Koostis:

Active: Alfentanil hydrochloride 0.5435 mg/mL equivalent to 0.5 mg/mL alfentanil Excipient: Sodium chloride Water for injection

Ühikuid pakis:

Ampoule, glass, 2mL, 1 dose unit

Klass:

Class B3 Controlled Drug

Retsepti tüüp:

Class B3 Controlled Drug

Valmistatud:

Janssen Pharmaceutica NV

Näidustused:

RAPIFEN is indicated 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, RAPIFEN 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 RAPIFEN or by adapting its infusion rate.

Toote kokkuvõte:

Package - Contents - Shelf Life: Ampoule, glass, 2mL - 1 dose units -   - Ampoule, glass, 10mL - 1 dose units -   - Ampoule, glass, 10mL - 5 dose units - 60 months from date of manufacture stored at or below 25°C - Ampoule, glass, 2mL - 5 dose units - 60 months from date of manufacture stored at or below 25°C

Loa andmise kuupäev:

1984-11-28

Infovoldik

RAPIFEN
®
CMI NZ
1
RAPIFEN
®
_Alfentanil Hydrochloride Injection (equivalent to 0.5 mg/mL
alfentanil) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
RAPIFEN. It does not contain all the
information that is known about
RAPIFEN.
It does not take the place of talking to
your doctor, anaesthetist or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
RAPIFEN against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR, ANAESTHETIST OR PHARMACIST.
KEEP THIS LEAFLET. YOU MAY NEED TO
READ IT AGAIN.
WHAT RAPIFEN IS FOR
RAPIFEN is a drug used to relieve
pain and produce anaesthesia.
It can be used as a premedication
before an operation, or with a general
anaesthetic during an operation.
RAPIFEN belongs to a group of
medicines called opioid analgesics.
RAPIFEN works by changing the
messages that are sent to the brain
about pain.
Your doctor will have explained why
you are being given RAPIFEN.
Follow all directions given to you by
your doctor carefully. They may
differ from the information contained
in this leaflet.
Your doctor may prescribe this
medicine for another use. Ask your
doctor if you want more information.
RAPIFEN can be addictive, but when
it is used only to relieve or prevent
pain it is unlikely to become habit
forming.
BEFORE YOU ARE GIVEN
RAPIFEN
_WHEN YOU MUST NOT USE IT _
RAPIFEN SHOULD NOT BE USED FOR
PAIN RELIEF AFTER SURGERY HAS TAKEN
PLACE.
RAPIFEN SHOULD NOT BE USED IF
YOU HAVE AN ALLERGY, INTOLERANCE OR
HYPERSENSITIVITY TO:
•
alfentanil
•
any ingredients listed at the end
of this leaflet
•
other opioid analgesics (pain
killers) e.g. morphine or
pethidine.
Symptoms of an allergic or
hypersensitivity reaction may
include:
•
rash, itching or hives on the skin
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body.
RAPIFEN SHOULD NOT B

Toote omadused

1
RAPIFEN

DATA SHEET
1.
NAME OF THE MEDICINE
RAPIFEN® alfentanil 0.5 mg/mL injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of RAPIFEN contains alfentanil hydrochloride 544 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
RAPIFEN 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, RAPIFEN 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
RAPIFEN or by adapting its infusion rate.
4.2.
DOSE AND METHOD OF ADMINISTRATION
RAPIFEN should be administered intravenously. Other routes of
administration have not been evaluated.
The dosage of RAPIFEN 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.
To
avoid
bradycardia,
a
small
intravenous
dose
of
an
anti‐cholinergic
agent
(e.g.
atropine),
be
administered just before induction may be administered. Droperidol may
be given to prevent nausea and
vomiting. However, it is preferable not to administer droperidol to
outpatients since it may lengthen their
recovery period.
2
USE AS AN INDUCTION AGENT
An intravenous bolus dose of

120 micrograms/kg (17 mL/70 kg) of RAPIFEN will induce hypnosis and
analgesia while maintaining good cardiovascular stabi