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:

2022-05-12

Summary of Product characteristics

PI_Text027149_1
– Updated:
Page 1 of 10
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.
Excipients with known effect:
Benzyl alcohol, propyl parahydroxybenzoate, methyl
parahydroxybenzoate, sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection: white suspension, free from particles.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Corticosteroid hormone therapy is an adjunct to, and not a replacement
for, conventional therapy.
_Intramuscular administration_
Flosteron is indicated for the treatment
of
various rheumatic, dermatological, allergic
diseases,
disorders of the collagen and other tissues, known for their response
to treatment with corticosteroids.
_Musculoskeletal _
_administration _
_(intra-articular _
_and _
_periarticular _
_administration _
_and _
_direct _
_administration into the soft tissues)_
As adjunctive therapy for short-term administration (to tide the
patient over an acute episode or
exacerbation) in osteoarthritis, rheumatoid polyarthritis.
_Intralesional administration_
In various dermatologic conditions.
_Local administration in the tissue of the foot_
As adjunctive therapy for short-term administration (to tide the
patient over an acute episode or
exacerbation) in bursitis under heloma durum, bursitis under plantar
callosity, bursitis under calcaneal
spur,
bursitis
over
hallux
rigidus
or
digiti
quinti
varus,
synovial
cyst,
Morton’s
neuralgia
(metatarsalgia), tenosynovitis, periostitis of cuboid.
Typical situations
_Allergic conditions_
Status asthmaticus, chronic bronchial asthma, seasonal or perennial
allergic rhinitis, severe allergic
bronchitis, contact dermatitis, atopic dermatitis, hay fever,
angioneurotic edema, serum sickness,
hypersensitivity reactions to medications or insect bites.
_Rheumatic diseases_
Osteoarthritis, rheuma