Tramadol solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

tramadol (tramadol hydrochloride)

Available from:

KRKA d.d.

ATC code:

N02AX02

INN (International Name):

tramadol (tramadol hydrochloride)

Dosage:

100mg/2ml

Pharmaceutical form:

solution for injection

Units in package:

(5) ampoules 2ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-04-25

Patient Information leaflet

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Tramadol
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SPC, Labeling and Package Leaflet
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Read the complete document

Summary of Product characteristics

1.3.1
Tramadol
hydrochloride
SPC.
Labelin
and Package
Leaflet
1.
NAME OF THE MEDICINAL
PRODUCT
Tramadol
100 mg/2 ml
solution for injection
2.
QUALITATIVE
AND QUANTITATIVE
COMPOSITION
2 ml of solution for injection (I
ampoule) contains
100 mg tramadol
hydrochloride.
Excipient:
sodium (0.701
_mglml)_
For a full
list of excipients,
see section 6.1.
3.
PHARMACEUTICAL
FORM
Solution for injection.
Clear,
colourless solution,
practically free from particles.
4.
CLINICAL PARTICULARS
4.1
Therapeutic
indications
Pain of various aetiologies
(including elderly):
pain due to injuries (wounds,
fractures),
severe neuralgias,
pain due to malignant
tumours
pain due to myocardial
infarction,
pain during diagnostic
and therapeutic procedures,
pain during postoperative
period.
4.2
Posology and method
of administration
Dosage should be individualised
and adjusted according to the severity of pain.
The lowest
effective
dose for analgesia should generally be selected.
Dosage guidelines:
_Adults and children over_
12
_years of age:_
50 mg to 100 mg (I
ml to 2 ml of solution) intravenously or intramuscularly.
If after
a single
application
of 50-100 mg tramadol
(equivalent
to 0.5-1 ampoules
ofTramadol
_100 mg/2_
ml)
were
not
satisfactory
analgesia
occurred,
then 30-60 min a single
dose of
50 mg
can be readministered.
Intravenolls injections should be administered very slowly or they
should be diluted in an infusion
solution.
Doses may be repeated at 4- to 6-hour intervals.
Daily doses over 400 mg are not recommended in adults,
except
for pain relief
in cancer
patients and
those with severe postoperative
pain,
in whom daily doses can be increased to up to 600 mg.
_Geriatric patients_
SmPCPIL081765
9
01.09.2016
-
U dated:
29.03.2017
1.3.1
Tramadol
hydrochloride
SPC, Labelin
and Package Leaflet
A dose adjustment
is not usually necessary in patients up to 75 years without
clinically manifest
hepatic or renal
insufficiency.
In elderly patients over 75 years elimination may be prolonged.
Therefore,
if necessary the dosage interval
is to be exte