Fentanyl Kalceks 0.05mg/ml solution for injection (10ml ampoule)

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

FENTANYL CITRATE

Dostupné z:

AS KALCEKS Krustpils iela 71E, Riga, LV-1057,, Latvia

ATC kód:

N01AH01

INN (Medzinárodný Name):

FENTANYL CITRATE 0.05 mg/ml

Forma lieku:

SOLUTION FOR INJECTION

Zloženie:

FENTANYL CITRATE 0.05 mg/ml

Typ predpisu:

POM

Terapeutické oblasti:

ANESTHETICS

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2017-08-30

Príbalový leták

_Package leaflet: Information for the user _
FENTANYL KALCEKS 0.05 MG/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.
-
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 is and what it is used for
2.
What you need to know before you receive Fentanyl Kalceks
3.
How Fentanyl Kalceks is given to you
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 solution for injection contains the active substance
fentanyl (as citrate). It belongs to
a group of medicines known as opioid analgesics. These medicines
prevent and relieve pain.
Fentanyl Kalceks is used:
-
as a narcotic analgesic supplement in general or regional anaesthesia;
-
in combination with a neuroleptic (e.g. droperidol) in the technique
of neuroleptanalgesia;
-
for the induction of anaesthesia, and as an adjuvant in the
maintenance of general and regional
anaesthesia;
-
as an anaesthetic agent with oxygen in high-risk patients undergoing
surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE FENTANYL KALCEKS
DO NOT USE FENTANYL KALCEKS:
-
if you are allergic to fentanyl or any of the ingredients of this
medicine (listed in section 6),
-
if you are allergic to medicines called morphinomimetics.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Fentanyl Kalceks:
-
if you or anyone in your family have ever abused or been dependent on
alcohol, prescription
medicines or illegal drugs (“addiction”).
-
if you are a smoker.
-
if you have ever had problems with your mood (depression, anxiety or a
personality disorder) or
have been treated by a psychiatrist for other ment

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fentanyl Kalceks 0.05 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 0.0785 mg of fentanyl citrate corresponding
to 0.05 mg of fentanyl.
One ampoule (2 ml) contains 0.157 mg of fentanyl citrate corresponding
to 0.1 mg of fentanyl.
One ampoule (10 ml) contains 0.785 mg of fentanyl citrate
corresponding to 0.5 mg of fentanyl.
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 liquid. pH of solution 4.0 - 7.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fentanyl citrate is used:
-
as a narcotic analgesic supplement in general or regional anaesthesia;
-
in combination with a neuroleptic (e.g. droperidol) in the technique
of neuroleptanalgesia;
-
for the induction of anaesthesia, and as an adjuvant in the
maintenance of general and regional
anaesthesia;
-
as an anaesthetic agent with oxygen in high-risk patients undergoing
surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicine should be given only in an environment where the airway
can be controlled and by
personnel who can control the airway (see section 4.4).
Posology
The dose of medicine should be individualised according to age, body
weight, physical condition,
underlying
pathological
condition,
concomitant
use
of
other
drugs,
and
type
of
surgery
and
anaesthesia.
_Adults _
_ _
-
As an analgesic supplement in general anaesthesia
In low doses for minor surgical procedures: 2 mcg/kg of fentanyl.
Moderate dose: 2-20 mcg/kg of fentanyl.
In high doses during major surgery: 20-50 mcg/kg of fentanyl. The
duration of the effect depends on
the
dose.
During
major
surgery
the
administration
of
20-50 mcg/kg
of
fentanyl
with
nitrous
oxide/oxygen has been shown to have an attenuating effect.
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When these doses were used during s