Morfina hidrohlorids-Kalceks solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

morphine (morphine hydrochloride)

Available from:

Kalceks JSC

ATC code:

N02AA01

INN (International Name):

morphine (morphine hydrochloride)

Dosage:

10mg/ml

Pharmaceutical form:

solution for injection

Units in package:

(10/2x5/) ampoules 1ml in plastic liner

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-12-27

Patient Information leaflet

AGREED BY SAM 27-08-2020
PACKAGE LEAFLET: INFORMATION FOR THE USER
MORFĪNA HIDROHLORĪDS-KALCEKS 10 MG/ML SOLUTION FOR INJECTION
_Morphini hydrochloridum _
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, pharmacist 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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Morfīna hidrohlorīds-Kalceks is and what it is used for
2.
What you need to know before you use Morfīna hidrohlorīds-Kalceks
3.
How to use Morfīna hidrohlorīds-Kalceks
4.
Possible side effects
5
How to store Morfīna hidrohlorīds-Kalceks
6.
Contents of the pack and other information
1.
WHAT MORFĪNA HIDROHLORĪDS-KALCEKS IS AND WHAT IT IS USED FOR
The medicine Morfīna hidrohlorīds-Kalceks contains morphine
hydrochloride (hereafter –
morphine). It belongs to a group of medicines called narcotics or
opioid analgesics. Morphine
is a naturally occurring substance with very potent analgesic effect.
It is used in following cases:
-
to relieve severe, acute pain after severe injuries, fractures of
bones, burns, surgery;
-
to prevent acute and chronic pain in the case of myocardial
infarction, as well as in the case
of acute pancreatitis;
-
to relieve severe chronic pain in the case of malignant tumour and to
relieve colic pain
arising from movements of renal and gall stones;
-
as cough suppressant in the case of chest injury and pulmonary
bleeding, when cough
attacks become life-threatening, and at end-stage of lung cancer if it
is difficult to stop
cough;
-
breathing disorders associated with left ventricular damage and
pulmonary oedema;
-
for premedication (medical p

Summary of Product characteristics

AGREED BY SAM 27-08-2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Morfīna hidrohlorīds-Kalceks 10 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One
ampoule
(1 ml)
contains
10 mg
of
morphine
hydrochloride
(_Morphini _
_hydrochloridum_).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless or yellowish solution without visible particles.
pH of solution 3.0-5.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Morphine hydrochloride is prescribed:
-
to reverse severe, acute pain after severe injuries, fractures of
bones, burns, surgery;
-
to prevent acute and chronic pain in the case of myocardial
infarction, as well as in
the case of acute pancreatitis;
-
to relieve severe chronic pain in the case of malignant tumour and to
relive colicky
pain arising from movements of renal and gall stones;
-
as cough suppressant in the case of chest injury and pulmonary
bleeding, when
cough attacks become life-threatening and at end-stage of lung cancer
if it is difficult
to stop cough;
-
in the case of dyspnoea associated with left ventricular damage and
pulmonary
oedema;
-
for premedication before anaesthesia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology

_For intravenous, subcutaneous or intramuscular administration _
When
administered
as
slow
intravenous
injection,
¼
-
½
from
the
corresponding
intramuscular dose is used. For dilution 0.9 % sodium chloride or 5 %
glucose solution is
used.
_ _
AGREED BY SAM 27-08-2020
_ADULTS _
_In _
_the _
_case _
_of _
_acute _
_pain_,_ _
subcutaneously
or
intramuscularly:
10 mg
of
morphine
hydrochloride is usually given. The injection can be repeated after
4-6 hours if necessary.
_To reverse postoperative pain_, subcutaneously or intramuscularly:_ _
10 mg of morphine
hydrochloride is given every 2-4 hours (as necessary).
_ _
_In the case of chronic pain_, subcutaneously or intramuscularly: 5-20
mg is injected every
4 hours.
_In the case of myocardial infarction _