Flosteron suspension for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

betamethasone (betamethasone dipropionate), betamethasone (betamethasone sodium phosphate)

Available from:

KRKA d.d.

ATC code:

H02AB01

INN (International Name):

betamethasone (betamethasone dipropionate), betamethasone (betamethasone sodium phosphate)

Dosage:

5mg/ml+ 2mg/ml

Pharmaceutical form:

suspension for injection

Units in package:

(5) ampoules 1ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-03-17

Patient Information leaflet

75/359
1.3.1
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Summary of Product characteristics

PI_Text005621_1
– Updated:
Page 1 of 8
1.
NAME OF THE MEDICINAL PRODUCT
Flosteron suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of suspension for injection (1 ampoule) contains 2 mg
betamethasone as disodium
phosphate and 5 mg betamethasone as dipropionate.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection: white suspension, free from particles.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
_LOCAL THERAPY:_
_-_
_Intra-articular and periarticular administration_ in cases of
inflammatory rheumatic
diseases, such as rheumatoid arthritis; seronegative
spondylarthritides; arthritis in
systemic diseases of the connective tissue; post-traumatic arthritis,
in psoriatic arthritis
with oligoarticular involvement and tendosynovitis, in other
crystal-induced arthritis;
_-_
_Intra-articular administration _in cases of degenerative rheumatic
diseases, especially
if synovitis is present (should not be administered in arthrosis of
the hip);
_-_
Inflammatory
disorders
of
periarticular
tissue
(bursitis,
tendinitis,
tendosynovitis,
epicondylitis, plantar fasciitis);
_-_
_Local administration of intra-articular injections_ for the treatment
of skin diseases in
rare cases (if there are no reactions to other methods of local
therapy): sclerosing
folliculitis,
keloids,
granuloma
annulare,
sarcoidosis
of
the
skin;
diabetic
lipodystrophy (liponecrosis), psoriasis, alopecia areata, lichen
planus, neurodermitis,
nummular eczema, discoid lupus erythematosus.
_SYSTEMIC THERAPY:_
Systemic treatment of Flosteron is used in cases of expressed allergic
diseases: allergic
rhinitis, asthmatic status, giant urticaria, hypersensitive reactions
to medicines and serums,
insect bites.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage should be determined individually according to the size of the
joint, disease condition
and response of the patient.
_Intra-articular/periarticular/intrasynovial injections_:
Dosage varies with the degree of inflammation and the size and
location of the affected a