Kenalog 40 suspension for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

triamcinolone (triamcinolone acetonide)

Available from:

KRKA d.d.

ATC code:

H02AB08

INN (International Name):

triamcinolone (triamcinolone acetonide)

Dosage:

40mg/ml

Pharmaceutical form:

suspension for injection

Units in package:

(5) ampoules 1ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-08-24

Summary of Product characteristics

PI_Text009171_1
– Updated:
Page 1 of 13
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
Intra-articular use: for alleviating the joint pain, swelling and
stiffness associated with rheumatoid
arthritis and osteoarthrosis, with an inflammatory component; also for
bursitis, epicondylitis, and
tenosynovitis.
Intramuscular use: Where sustained systemic corticosteroid treatment
is required:
_Allergic states_: bronchial asthma. (see section 4.2);
_Endocrine disorders_, e.g. primary or secondary adrenocortical
insufficiency.
_Collagen disorders_, e.g. during an exacerbation of maintenance
therapy of selected cases of SLE or
acute rheumatic carditis;
_Dermatological diseases_, e.g. pemphigus, severe dermatitis and
Stevens Johnson Syndrome;
_Rheumatic, Gastrointestinal or Respiratory disorders_ - as an
adjunctive, short-term therapy;
_Haematological disorders_, e.g. acquired (autoimmune) haemolytic
anaemia;
_Neoplastic diseases_, e.g. palliative management of leukaemia and
lymphomas;
_Renal disease_, such as acute interstitial nephritis, minimal change
nephrotic syndrome or lupus
nephritis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Kenalog is for Intra-articular/Intramuscular injection ONLY. The
safety and efficacy of administration
by other routes has yet to be established (see sections 4.3 and 4.4).
Strict aseptic precautions should be
observed. Since the duration of effect is variable, subsequent doses
should be given when symptoms
recur and not at set intervals.
_Intra-articular administration_
Intra-Articular Injection: For intra-ar