Tramadol Alkaloid solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

tramadol (tramadol hydrochloride)

Available from:

Alkaloid AD Skopje

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:

2017-10-23

Summary of Product characteristics

TRAMADOL ALKALOID 100 mg/2 ml
s
olutioп
for
injection
~
_Summary of _
_Product C_
_IIOI'acteristi_
_cs _
ALKALCIID
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SUМMARY
OF
PRODUCT
CНARACTERISTICS
1.
NАМЕ
OF
ТНЕ
МEDICINAL
PRODUCT
Tramadol Alkaloid
100
mg
/2
ml
solution for injection
2.
QUALITATIVE
AND
QUANTITATIVE COMPOSITION
2 ml solution for injection (1
ampo
ule) contains 100
mg
oftramadoll1ydrocl11oride.
Excipients with
known
effect:
- methylpal'ahydroxybenzoate
(Е
218)
- propylparal1ydroxybenzoate
(Е
216)
2
ml
solution
(1
ampottle) contains 0.064
mg
sodium.
For
а
fulllist
of
excipients,
see
section 6.1.
3.
PHARMACEUTICAL
FORМ
*
Solution for injection
Clear, colourless solution
4.
CLINICAL PARTICULARS
4.1
Therapeutic
indications
Tгamadol
is indicated for
the
maвagcment
of
modera
te to severe
pain
caused
Ьу
variety
of
conditions (postoperati
ve
-pain,
traumatic-paiп,
cancer-pain, colics, neuralgia, as
well
as
myocardial infarction).
4.2
Posology
and
metbod
of
administrat
i
on
As
witl1 all analgesic
dru
gs,
th
e d
ose
oftramadol
slюuld
Ье
adjusted according
to
the
severity
of
the pain
and
the
clinical response
of
tl1e
individнal
pat
ient.
_Ad_
_ul_
_ts _
_alld cblltl_
_reJJ _
_over _
_12 _
_years _
_of _
_age: _
Tramadol injection
may
Ье
adшinistered
in
tramuscu
l
ar
ly,
Ьу
slow
int
t·
avenous
injectioп,
or
diluted
in
solution for
admiпistration
Ьу
iпfusion
or
patient controlled
ana
l
gesia
.
The
usual dose is
50
mg
or 100
mg
4-6
lющ·}у
Ьу
t
l1
e
i
пtr·aveпous
or intramuscular t·oute.
Intravenous
iпjections
шust
Ье
given slowly
over
2-3 minutes.
For
post-operative
pain
admiвister
an
iв
i
t
i
a
l
bolus
of
100 mg. Duriog
the
60
minutes
followiпg
the initial bolus, further doses
of
50
mg
may
Ье
given evet·y 10-20
miвutes,
нр
to
а
total dose
of250
mg
including
the initial bolus. Subsequent doses
shoнld
Ье
50
mg
or
100
mg
tl
;
~/6)
,
_( _
_6}, _
_f,f _
_jf_
_. _
_k_
_-t

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