FENTANYL KALCEKS SOLUTION FOR INJECTION 0.05 MGML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Fentanyl citrate 0.0785mg eqv Fentanyl

Available from:

GOLDPLUS UNIVERSAL PTE LTD

ATC code:

N01AH01

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Fentanyl citrate 0.0785mg eqv Fentanyl 0.05 mg/ml

Administration route:

INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS BOLUS

Prescription type:

Prescription Only

Manufactured by:

HBM Pharma s.r.o.

Authorization status:

ACTIVE

Authorization date:

2019-09-10

Summary of Product characteristics

PACKAGE INSERT
1.
NAME OF THE MEDICINAL
PRODUCT
Fentanyl Kalceks solution for injection 0.05 mg/ml
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
1 ml of solution contains 0.05 mg of fentanyl
(as citrate).
One ampoule (2 ml) contains 0.1 mg of fentanyl
(as citrate).
One ampoule (10 ml) contains 0.5 mg of fentanyl
(as citrate).
Excipient with known effect
Each ampoule of 2 ml contains 7.08 mg
(0.31 mmol) sodium.
Each ampoule of 10 ml contains 35.41 mg
(1.54 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fentanyl Kalceks is an opioid analgesic.
It is used:
-
in low doses to provide analgesia during short
surgical procedures;
-
in high doses as an analgesic/respiratory
depressant in patients requiring assisted
ventilation;
-
in combination with a neuroleptic in the
technique of neuroleptanalgesia
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage of fentanyl should be individualized
according to age, body weight, physical status,
underlying pathological condition, use of other
drugs, and type of surgery and anaesthesia.
To avoid bradycardia, it is recommended to
administer a small intravenous dose of an
anticholinergic just before anaesthetic induction.
A neuroleptic may be given to prevent nausea and
vomiting.
_Adult_
USE AS AN ANALGESIC SUPPLEMENT TO GENERAL
ANAESTHESIA
_LOW DOSE: 2 MCG/KG_
Fentanyl in small doses is most useful for minor
surgery.
_MODERATE DOSE: 2-20 MCG/KG_
Where surgery becomes more complicated,
a larger dose will be required. The duration of
activity is dependent on dosage.
_HIGH DOSE: 20-50 MCG/KG_
During major surgical procedures, in which
surgery is longer, and during which the stress
response would be detrimental to the well-being
of the patient, doses of 20-50 mcg/kg of fentanyl
with nitrous oxide/oxygen have been shown to
have an attenuating effect. When
doses in this
range have been used during surgery,
post-operative ventilation and observation a