RAPIFEN INJECTION 0.5 mgml

Ülke: Singapur

Dil: İngilizce

Kaynak: HSA (Health Sciences Authority)

Aktif bileşen:

ALFENTANIL HCl EQV ALFENTANIL

Mevcut itibaren:

ALLIANCE PHARM PTE. LTD.

ATC kodu:

N01AH02

Doz:

0.5 mg/ml

Farmasötik formu:

INJECTION

Kompozisyon:

ALFENTANIL HCl EQV ALFENTANIL 0.5 mg/ml

Uygulama yolu:

INTRAVENOUS

Reçete türü:

Prescription Only

Tarafından üretildi:

GlaxoSmithKline (GSK) Manufacturing S.p.A.

Yetkilendirme durumu:

ACTIVE

Yetkilendirme tarihi:

1990-05-03

Bilgilendirme broşürü

[RAPIFEN] (15 July 2008) 
1
NAME OF THE MEDICINAL PRODUCT 
TRADE NAME 
RAPIFEN 
NONPROPRIETARY NAMES 
Alfentanil Hydrochloride 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
RAPIFEN is a sterile preservative-free, isotonic, aqueous solution
containing 
alfentanil hydrochloride equivalent to 0.5 mg alfentanil per ml.
The other ingredients 
are sodium chloride and water for injection. RAPIFEN (alfentanil)
is supplied in 2 ml 
ampoules. 

PHARMACEUTICAL FORM 
RAPIFEN is a very short-acting potent narcotic analgesic for
intravenous (I.V.) use. 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
RAPIFEN is indicated for use as: 
- 
an anaesthetic induction agent. 
- 
a narcotic analgesic in general as well as adjuvant to regional
anaesthesia and 
for both short (bolus injections) and long (bolus, supplemented by
increments or by 
infusion) surgical procedures. 
Because of its rapid and short-lasting action, RAPIFEN is
particularly suited as a 
narcotic analgesic for short procedures and outpatient surgery,
but also 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. 
POSOLOGY AND METHOD OF ADMINISTRATION 
The dosage of RAPIFEN should be individualized according to
age, body weight, 
physical status, underlying pathological condition,
use of other drugs and type of 
surgery and anaesthesia. 
The initial dose should be reduced in the elderly and in
debilitated patients. In 
children it should be increased. The effect of the initial dose
should be taken into 
account in determining supplemental doses. 
To avoid bradycardia, it is recommended to administer a
small intravenous dose of an 
anti-cholinergic agent just before induction.
Droperidol may be given to prevent 
nausea and vomiting. 
1. 
For use as an induction agent 
An intravenous bolus dose of

Ürün özellikleri

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PRODUCT NAME
RAPIFEN
®
(alfentanil hydrochloride)
DOSAGE FORMS AND STRENGTHS
Sterile, preservative-free, isotonic aqueous solution containing
alfentanil hydrochloride
equivalent to 0.5mg alfentanil per mL.
For excipients, see _List of Excipients_.
CLINICAL INFORMATION
INDICATIONS
RAPIFEN is indicated for use as:
- an anesthetic induction agent.
- an opioid analgesic in general as well as an adjuvant to regional
anesthesia and
for both short (bolus injections) and long (bolus, supplemented by
increments or
by infusion) surgical procedures.
Because of its rapid and short-lasting action, RAPIFEN is particularly
suited as an
opioid analgesic for short procedures and outpatient surgery, but also
as an analgesic
supplement for procedures of medium and long duration, since periods
of very
painful stimuli can usually be overcome by small increments of RAPIFEN
or by
adapting its infusion rate.
DOSAGE AND ADMINISTRATION
The dosage of RAPIFEN should be individualized according to age, body
weight,
physical status, underlying pathological condition, use of other drugs
and type of
surgery and anesthesia.
The initial dose should be reduced in the elderly (> 65 years of age)
and in debilitated
patients. In children it should be increased. The effect of the
initial dose should be
taken into account in determining supplemental doses.
To avoid bradycardia, a small intravenous (I.V.) dose of an
anti-cholinergic agent
just before anesthetic induction may be administered.
DOSAGE
_ADULTS_
_FOR USE AS AN ANESTHETIC INDUCTION AGENT_
An I.V. bolus dose of ≥120 mcg/kg (17 mL/70 kg) RAPIFEN will induce
unconsciousness
and
analgesia
while
maintaining
good
cardiovascular
stability
in
patients
with
adequate muscle relaxation.
_FOR SHORT PROCEDURES AND USE IN OUTPATIENTS_
Small doses of RAPIFEN are most useful for minor, short surgical
procedures and
for outpatients, provided cardiopulmonary monitoring equipment is
available.
An I.V. bolus dose of 7 to 15 mcg/kg (1 to 2 mL/70 kg) is usually
adequate for
procedures lasting less than 10