Diclofenac-Asteria solution for injection

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

diclofenac (diclofenac sodium)

Διαθέσιμο από:

Hankook Korus Pharm Co.

Φαρμακολογική κατηγορία (ATC):

M01AB05

INN (Διεθνής Όνομα):

diclofenac (diclofenac sodium)

Δοσολογία:

75mg/3ml

Φαρμακοτεχνική μορφή:

solution for injection

Μονάδες σε πακέτο:

(5) ampoules 3ml

Τρόπος διάθεσης:

Prescription

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2020-09-08

Φύλλο οδηγιών χρήσης

2/25/2021
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To be prescribed
ATC Code: M01AB05
DICLOFENAC-ASTERIA
INJ. 75MG/3ML
SOLUTION FOR INJECTION (Diclofenac sodium)
COMPOSITION
Each ampoule contains
Active ingredient:
Diclofenac
sodium………………………………………………………………………….75
mg/3ml
EXCIPIENTS: Benzyl alcohol, propylene glycol, sodium pyrosulfate,
D-mannitol,
water for injection
INDICATIONS &USAGE
_Ampoules for im use_:
The ampoules are effective in acute forms of pain, including renal
colic, exacerbations of osteo- and
rheumatoid arthritis, acute back pain, acute gout, acute trauma and
fractures, and post-operative pain.
_Ampoules used in intravenous infusion_:
For treatment or prevention of post-operative pain in the hospital
setting.
CONTRAINDICATIONS
•
Hypersensitivity to the active substance, sodium metabisulphite or any
of the excipients.
•
Active, gastric or intestinal ulcer, bleeding or perforation
•
History of gastrointestinal bleeding or perforation, relating to
previous NSAID therapy
•
Active, or history of recurrent peptic ulcer/haemorrhage (two or more
distinct episodes of proven
ulceration or bleeding)
•
Last trimester of pregnancy (see section Pregnancy and lactation)
•
Hepatic failure
•
Renal failure
•
Established congestive heart failure (NYHA II-IV), ischemic heart
disease, peripheral
arterial disease and/or cerebrovascular disease
•
Like
other
non-steroidal
anti-inflammatory
drugs
(NSAIDs),
diclofenac
is
also
contraindicated in patients in whom attacks of asthma, angioedema,
urticaria or acute rhinitis
are precipitated by ibuprofen, acetylsalicylic acid or other
nonsteroidal anti-inflammatory
drugs.
_SPECIFICALLY FOR IV USE_
.
•
Concomitant NSAID or anticoagulant use (including low dose heparin).
•
History of haemorrhagic diathesis, a history of confirmed or suspected
cerebrovascular bleeding.
•
Operations associated with a high risk of haemorrhage.
•
A history of asthma.
•
Moderate or severe renal impairment (serum creatinine >160μmol/l).
2/25/2021
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•

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
Diclofenac-Asteria Inj. 75mg/3ml
2/25/2021
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1.
NAMEOFTHE MEDICINAL PRODUCT
Diclofenac-Asteria, Inj. 75mg/3ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
No.
Chemical Name
Quantity/mL
Use
1
Diclofenac sodium
25.0 mg
Active ingredient
Excipient(s)
No.
Chemical Name
Quantity/mL
Use
1
Benzyl alcohol
40.0 mg
Pain relieving agent
2
Propylene glycol
200.0 mg
Solubilizer
3
Sodium pyrosulfate
1.0 mg
Antioxidant
4
D-mannitol
6.0 mg
Stabilizer
5
Water For Injection
q.s
Solvent
3.
PHARMACEUTICAL
FORM
Solution for injection in ampoules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Ampoules for im use_:
The ampoules are effective in acute forms of pain, including renal
colic, exacerbations of osteo-
and rheumatoid arthritis, acute back pain, acute gout, acute trauma
and fractures, and post-
operative pain.
_Ampoules used in intravenous infusion_:
For treatment or prevention of post-operative pain in the hospital
setting.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for the shortest
duration necessary to control symptoms (see section 4.4 Special
warnings and precautions for
use).
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_ADULTS_
_ _
Diclofenac-Asteria, Inj. 75mg/3ml
(given im or iv) should not be given for more than two days; if
necessary, treatment can be continued with
Diclofenac-Asteria
tablets or suppositories.
Intramuscular injection: The following directions for intramuscular
injection must be adhered
to in order to avoid damage to a nerve or other tissue at the
injection site.
One ampoule once (or in severe cases twice) daily intramuscularly by
deep intragluteal
injection into the upper outer quadrant. If two injections daily are
required it is advised that
the alternative buttock be used for the second injection.
Alternatively, one ampoule of 75mg can be combined with other dosage
forms of (tablets or
suppositories) up to the maximum daily dosage of 150mg.
Renal colic: One 75mg ampoule intramuscularly. A further a