Fentanyl Kalceks solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

fentanyl (fentanyl citrate)

Available from:

Kalceks JSC

ATC code:

N01AH01

INN (International Name):

fentanyl (fentanyl citrate)

Dosage:

0,05mg/ml

Pharmaceutical form:

solution for injection

Units in package:

(10/2x5/) ampoules 2ml in plastic liner

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-04-21

Patient Information leaflet

OGYÉI/63649/2020
PACKAGE LEAFLET: INFORMATION FOR THE USER
FENTANYL KALCEKS 50 MICROGRAMS/ML SOLUTION FOR INJECTION
fentanyl
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 only. 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 Fentanyl Kalceks 50 micrograms/ml solution for injection
(Fentanyl Kalceks) is and what
it is used for
2.
What you need to know before you are given Fentanyl Kalceks
3.
How Fentanyl Kalceks is given
4.
Possible side effects
5.
How to store Fentanyl Kalceks
6.
Contents of the pack and other information
1.
WHAT FENTANYL KALCEKS
IS AND WHAT IT IS USED FOR
Fentanyl Kalceks 50 micrograms/ml solution for injection is a fluid
that is injected. Fentanyl is a
substance that reduces pain and is responsible for the action of this
medicine. Fentanyl belongs to a
group of strong, narcotic painkillers, which are also called opioid
painkillers.
You will be given this medicine during surgery to ensure that you feel
no pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FENTANYL KALCEKS
YOU SHOULD NOT BE GIVEN FENTANYL KALCEKS
-
if you are allergic to fentanyl or any of the other ingredients of
this medicine (listed in
section 6). Also, if you are hypersensitive to other strong (narcotic)
painkillers, you must not be
given this medicine.
-
your lungs are not working properly (without mechanical ventilation of
the lungs).
WARNINGS AND PRECAUTIONS
After administration of this medicine, your breathing may become
abnormally slow or weak. It is
important that you tell your doctor about this immediately. As this
may also occur some time after
surgery, yo

Summary of Product characteristics

OGYÉI/63649/2020
1.
NAME OF THE MEDICINAL PRODUCT
Fentanyl Kalceks 50 micrograms/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 50 micrograms of fentanyl (as fentanyl
citrate).
Each ampoule of 2 ml contains 100 micrograms of fentanyl (as fentanyl
citrate).
Each ampoule of 10 ml contains 500 micrograms of fentanyl (as fentanyl
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 for injection, free from visible particles.
pH: 4.0 to 7.0
Osmolality: 285 mOsmol/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fentanyl Kalceks 50 micrograms/ml solution for injection is an
anaesthesia analgesic:
­
for use as an opioid analgesic supplement in general or local
anaesthesia;
­
for administration with a neuroleptic.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Fentanyl Kalceks 50 micrograms/ml solution for injection may only be
administered in an
environment where the airways can be monitored and by personnel able
to monitor the airways (see
section 4.4).
Posology
The dosage of Fentanyl Kalceks 50 micrograms/ml solution for injection
must be determined
individually based on age, body weight, physical status, underlying
pathological condition, medication
use and type of surgery and anaesthesia.
_Adults _
At induction, 200 to 600 micrograms (2.8 to 8.5 micrograms/kg)
corresponding to 4-12 ml is usually
injected intravenously. Doses above 200 micrograms should only be
administered together with
ventilation. For maintenance of analgesia, additional intravenous
doses of 50 to 200 micrograms
(0.7 to 2.8 micrograms/kg) corresponding to 1-4 ml can be administered
after 30 to 45 minutes.
_Paediatric population_
_Adolescents 12 to 18 years of age _
Follow adult dosage.
OGYÉI/63649/2020
_Children 2 to 12 years of age _
A dose of 1.25-2.5 micrograms/kg o