Kenalog 40 suspension for injection

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Download Productkenmerken (SPC)
28-04-2021

Werkstoffen:

triamcinolone (triamcinolone acetonide)

Beschikbaar vanaf:

KRKA d.d.

ATC-code:

H02AB08

INN (Algemene Internationale Benaming):

triamcinolone (triamcinolone acetonide)

Dosering:

40mg/ml

farmaceutische vorm:

suspension for injection

Eenheden in pakket:

(5) ampoules 1ml

Prescription-type:

Prescription

Autorisatie-status:

Registered

Autorisatie datum:

2016-08-23

Productkenmerken

                                1.3.1
Triamcinolone acetonide
SPC, Labeling and Package Leaflet
SmPCPIL162794_1
20.01.2021 – Updated: 20.01.2021
Page 1 of 11
1.
NAME OF THE MEDICINAL PRODUCT
Kenalog 40 40 mg/1 ml suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of suspension for injection (1 ampoule) contains 40 mg
triamcinolone acetonide.
Excipients: benzyl alcohol (9.9 mg/ml), sodium (0.1307–0.1425
mmol/ml).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
White suspension with a slight odour of benzyl alcohol, practically
free from particles and
agglomerates.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Triamcinolone acetonide is recommended for the treatment of:
-_ Allergic states, _including seasonal and perennial allergic
rhinitis, asthma, atopic and contact
dermatitis, reactions to drugs, serum sickness and acute noninfectious
laryngeal oedema. In
anaphylactic reactions, corticosteroids are not useful for treating
the acute phase; however, they are
helpful in preventing the late phase of the reaction.
-_ Rheumatic diseases_
Corticosteroids are mainly used in patients with severe rheumatoid
arthritis while awaiting beneficial
effects of slow-acting anti-rheumatic drugs. They are indicated for
short-term treatment of acute gout,
acute non-specific ankylosing spondylitis, bursitis, epicondylitis,
post-traumatic osteoarthritis,
psoriatic arthritis and synovitis in osteoarthritis.
-_ Dermatological diseases_
Corticosteroids are recommended for bullous dermatitis herpetiformis,
exfoliative dermatitis, severe
erythema multiforme, severe psoriasis, severe seborrheic dermatitis,
eczema, atopic dermatitis, discoid
lupus, contact dermatitis, alopecia areata, pemphigus and various
acute and chronic dermatoses.
-_ Ophthalmic diseases_
Corticosteroids are recommended for severe acute and chronic allergic
and inflammatory conditions
including allergic conjunctivitis, for allergic marginal corneal
ulcers, anterior segment inflammation,
chorioretinitis, diffuse posteri
                                
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