Dynapar AQ solution for injection

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

diclofenac (diclofenac sodium)

Disponibil de la:

Troikaa Pharmaceuticals Ltd.

Codul ATC:

M01AB05

INN (nume internaţional):

diclofenac (diclofenac sodium)

Dozare:

75mg/ml

Forma farmaceutică:

solution for injection

Unități în pachet:

(5) ampoules 1ml

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2018-02-27

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE
NAME
OF
THE MEDICINAL PRODUCT
Dynapar
AQ
Solution
for
Injections
2.
QUALITY AND QUANTITATIVE COMPOSITION
The active ingredient
is
sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate) (diclofenac
sodium).
Each
1ml
ampoule contains 75mg diclo
fe
nac
sodium
For a
full
list
of
excipients, see section
6.1.
3.
PHARMACEUTICAL FORM:
Solution for
Inj
ect
ion
4.
CLINICAL PARTICULARS
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n.i
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#:
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.
,,
4.1
THERAPEUTIC INDICATIONS:
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.
_' i_
_, _
.
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~/
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.
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C'«':
C::-
INTRAMUSCULAR INJECTION (LNTRAGLUTEAL AND INTRADELTOID) AND
INTRAVENOUS INFUSION :
_,{,y#fl),1~ _
~
,..,_
DYNAPAR
AQ
is
effective
in
acute
forms
of
pain, including renal colic, exacerbations o .
0
_c,? _
osteoarthritis
and
rheumatoid arthritis, acute back pain, acute gout, acute trauma
and
fractures,
:·
.
::
-
and
post-operative pain.
INTRAVENOUS BOLUS INJECTION :
For acute painful conditions
in
post operative pain, renal colic
and
acute exacerbation
of
gouty
arthritis.
4.2. POSOLOGY AND METHOD
OF
ADMINISTRATION:
As
a general recommendation, the dose should
be
individually adjusted and the lowest effective
dose should
be
given for the shortest possible duration. The recommended maximum
daily dose
of
diclofenac
is
150
mg.
DYNAPAR
AQ
injection should not be given for more than
two
days.
INTRAMUSCULAR INJECTION :
For adults, the usual daily dosage
of
DYNAPAR AQ
is
75
mg,
intramuscularly
by
intradeltoid or
deep intragluteal injection into the upper outer quadrant.
It
is
advised that the alternative site
should
be
used
for
the second injection.
INTRAVENOUS USE :
DYNAPAR
AQ
can
be
given
as
an
intravenous bolus injection or intravenous infusion.
By
intravenous bolus :
For moderate
to
severe post-operative p
ai
n,
75
mg
should
be
injected intravenous!)
as
a bolus
injection over 30 to
60
seconds. If necessary, treatment may
be
repeated after 4
to
6 hours,
not
exceeding
15
0
mg
within any period
of24
hours.
Bx
i
nt
ravenous
inn.ision
:
DYNAPAR
AQ
75
mg
must
be
diluted
with
100
-
500
ml