Promedols solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

trimeperidine (trimeperidine hydrochloride)

Available from:

Kalceks JSC

ATC code:

N02AX

INN (International Name):

trimeperidine (trimeperidine hydrochloride)

Dosage:

20mg/ml

Pharmaceutical form:

solution for injection

Units in package:

(10/2x5/) ampoules in plastic liner, (100/20x5/) ampoules in plastic liner

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-08-06

Patient Information leaflet

AGREED BY SAM 01-08-2019
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROMEDOLS 20 MG/ML SOLUTION FOR INJECTION
_Trimeperidini 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 or pharmacist.
–
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 pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Promedols is and what it is used for
2.
What you need to know before you receive Promedols
3.
How to use Promedols
4.
Possible side effects
5.
How to store Promedols
6.
Contents of the pack and other information
1.
WHAT PROMEDOLS IS AND WHAT IT IS USED FOR
Promedols (trimeperidine hydrochloride) is a narcotic analgesic.
It is used:
–
to relieve severe pain in the case of injuries, fractures of bones,
burns, heart attack,
acute inflammation of pancreas (pancreatitis), kidney, liver and
intestinal colic, in the
case of malignant tumour, as well as after surgery;
–
to relieve labour pain and to accelerate labour in the case of
cervical dysfunction,
when epidural anaesthesia is impossible and childbirth is predictable
not earlier than
after two hours;
–
for medicated preparation before surgery (for premedication).
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE PROMEDOLS
YOU SHOULD NOT RECEIVE PROMEDOLS IN FOLLOWING CASES:
–
if you are allergic to trimeperidine hydrochloride;
–
if you have breathing depression;
–
if you have obstructive airway diseases (with blockage), including
bronchial asthma
attacks;
–
if you have bowel obstruction (paralytic ileus) or the risk of its
developing;
–
if you have abdominal pain of unknown origin;
–
if you have increased pressure in your skull or head injury;

Summary of Product characteristics

APPROVED BY SAM 02-11-2017
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Promedols 20 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One
ampoule
(1 ml)
contains
20 mg
of
trimeperidine
hydrochloride
(_Trimeperidini _
_hydrochloridum_).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless or yellowish liquid.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
-
To relieve severe pain in the case of injuries, fractures of bones,
burns, miocardial
infarction,
acute
pancreatitis,
renal,
biliary
and
intestinal
colic,
in
the
case
of
malignant tumour, as well as after surgery.
-
To relieve labour pain and to accelerate labour in the case of
cervical dysfunction,
when epidural anaesthesia is impossible and childbirth is predictable
not earlier than
after two hours.
-
For premedication before surgery.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
The necessity of opioid use should be carefully considered before the
initiation of therapy
and during the therapy. Dose reduction, discontinuation of treatment
or opportunity of
opioid substitution should be regularly evaluated. In order to reduce
opioid characteristic
adverse reactions, it is recommended to avoid
administration of other medicines, if
possible.
Posology
_In _
_adults_
medium
therapeutic
dose
is
10-40 mg
of
trimeperidine
hydrochloride
(corresponds to 0.5-2 ml of Promedols 20 mg/ml solution for
injection). The dose can be
repeated every 4 hours. The maximum adult dose is 40 mg, daily dose
– 160 mg.
_For premedication_ 20-30 mg of trimeperidine hydrochloride
(corresponds to 1-1.5 ml of
Promedols
20 mg/ml
solution
for
injection)
is
administered
subcutaneously
or
APPROVED BY SAM 02-11-2017
intramuscularly with 0.5 mg of atropine 30-45 minutes before surgery._
_In urgent cases the
medicine can be injected into vein.
_Postoperatively _ as_ _ analgesic and anti-shock agent, 20 mg of
trimeperidine hydrochloride
(corresponds
to
1 ml
of
Promedols
20 mg/ml
solution
f