Diprospan suspension for injection

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

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

Διαθέσιμο από:

Schering-Plough Labo N.V.

Φαρμακολογική κατηγορία (ATC):

H02AB01

INN (Διεθνής Όνομα):

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

Δοσολογία:

5mg/ml+ 2mg/ml

Φαρμακοτεχνική μορφή:

suspension for injection

Μονάδες σε πακέτο:

(5) ampoules 1ml

Τρόπος διάθεσης:

Prescription

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2020-06-10

Αρχείο Π.Χ.Π.

_ _
_ _
SUMMARY OF PRODUCT CHARACTERISTICS FOR ARMENIA
1.
NAME OF THE MEDICINAL PRODUCT
DIPROSPAN
®
,
suspension for injection
2.
COMPOSITION
_Active ingredient: _betamethasone;
1
ml
of
suspension
contains
6.43
mg
betamethasone
dipropionate
(equivalent
to
5
mg
betamethasone) and 2.63 mg betamethasone sodium phosphate (equivalent
to 2 mg betamethasone);
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Transparent, colorless, slightly viscous liquid containing easily
suspending white to off-white
particles, free of foreign matter.
4. CLINICAL PARTICULARS
_4.1 INDICATIONS. _
Corticosteroid hormone therapy is an adjunct to, and not a replacement
for, conventional therapy.
_Intramuscular administration _
Diprospan
®
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 b