STEROCORT 4 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

TRIAMCINOLONE

Tilgjengelig fra:

TARO PHARMACEUTICAL INDUSTRIES LTD

ATC-kode:

H02AB08

Legemiddelform:

TABLETS

Sammensetning:

TRIAMCINOLONE 4 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

TARO PHARMACEUTICAL INDUSTRIES LTD

Terapeutisk gruppe:

TRIAMCINOLONE

Terapeutisk område:

TRIAMCINOLONE

Indikasjoner:

Rheumatology: - Active phases of systemic vasculitis: Panarteritis nodosa (in patients with concomitant positive hepatitis B serology, the duration of treatment should be restricted to two weeks), polymyalgia rheumatica (PMR), PMR with giant cell arteritis, arteritis temporalis with acute visual loss;- Active phases of systemic rheumatic disease: systemic lupus erythematosus, mixed connective tissue disease;- Severe progressive forms of active rheumatoid arthritis, e.g. rapidly destructive forms and/or with extra-articular manifestations;- Other forms of inflammatory rheumatic arthritis, provided that the severity of symptoms requires it and non-steroidal anti-inflammatory drugs (NSAIDs) cannot be used:Spondylarthritis (ankylosing spondylitis with involvement of peripheral joints, psoriatic arthritis, enteropathic arthropathy with high inflammatory activity);- Reactive forms of arthritis;- Arthritis in sarcoidosis;- Severe systemic form of juvenile idiopathic arthritis (Still’s disease) or with iridocyclitis refractory to topical treatment.Pulmonary and respiratory tract disorders: - Bronchial asthma:For the long-term treatment of severe chronic asthma (category 4) and for treatment of exacerbations in adults and children.- Chronic obstructive pulmonary disease (COPD):For short-term treatment (max. 14 days) of exacerbations;- Upper respiratory tract disorders:For short-term treatment of severe forms of allergic rhinitis in adults after failure of all other treatment alternatives, including topical glucocorticoids.Dermatology: - Oral initial treatment of extensive, severe, acute skin conditions responsive to glucocorticoids, such as: Allergic skin disease (e.g. acute urticaria, contact dermatitis, drug eruption), atopic eczema (acute exacerbations or extensive weeping eczema), pemphigus vulgaris.Nephrology: - Minimal change glomerulonephritis;- Extracapillary proliferative glomerulonephritis (rapidly progressive glomerulonephritis), generally in combination with cytostatics, tapering and ending treatment in Goodpasture’s syndrome; for all other forms, long-term continuation of treatment;- Idiopathic retroperitoneal fibrosis.

Autorisasjon dato:

2022-10-31

Informasjon til brukeren

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
STEROCORT 4 MG
Tablets
ACTIVE INGREDIENT - Each tablet contains:
triamcinolone 4 mg
Inactive ingredients and allergens: see section 2 under 'Important
information about some of
this medicine's ingredients' and section 6 ‘Additional
Information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, refer to your doctor
or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if it seems to you that their illness is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Sterocort 4 mg contains a corticosteroid with an anti-inflammatory and
anti-rheumatic effect.
This corticosteroid provides relief to inflamed areas of the body,
reduces swelling, redness,
itching and allergic reactions.
THERAPEUTIC GROUP: anti-inflammatory corticosteroid.
Corticosteroids affect metabolism, electrolyte balance and tissue
function.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE USING STEROCORT 4 MG, TALK TO YOUR DOCTOR OR PHARMACIST.
Treatment with glucocorticoids can lead to an underactive adrenal
cortex (insufficient production
of glucocorticoids by the body) which, depending on the dose and
duration of treatment, may
persist for several months and, in isolated cases, for more than one
year after discontinuation of
glucocorticoids. If marked physical stress occurs during treatment
with Sterocort 4 mg, such as
feverish illness, accidents or surgery, your doctor must be informed
or an emergency room
doctor be told about the ongoing treatment with Sterocort 4 mg. It may
become necessary to
temporarily increase the daily dose of Sterocort 4 mg.
Glucocorticoid administration may also become necessary in physically
stressful situations if
underactivity of t

Preparatomtale

_Prescribing Information (Summary of Product Characteristics) -
Sterocort 4 mg _
Page 1 of 11
STEROCORT 4 MG
1.
NAME OF THE MEDICINAL PRODUCTS
STEROCORT 4 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Sterocort 4 mg tablet contains 4 mg triamcinolone.
Excipient with known effect: 90 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_ _
STEROCORT 4 MG:_ _
white, round, bi-convex tablets. One side scored.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatology
-
Active phases of systemic vasculitis:
Polyarteritis
nodosa
(in
patients
with
concomitant
positive
hepatitis
B
serology,
the
duration of treatment should be restricted to two weeks), polymyalgia
rheumatica (PMR),
PMR with giant cell arteritis, temporal arteritis with acute vision
loss;
-
Active
phases
of
systemic
rheumatic
disease:
systemic
lupus
erythematosus,
mixed
connective tissue disease;
-
Severe progressive forms of active rheumatoid arthritis, e.g. rapidly
destructive forms
and/or with extra-articular manifestations;
-
Other forms of inflammatory rheumatic arthritis, provided that the
severity of symptoms
requires it and non-steroidal anti-inflammatory drugs (NSAIDs) cannot
be used:
Spondylarthritis (ankylosing spondylitis with involvement of
peripheral joints, psoriatic
arthritis, enteropathic arthropathy with high inflammatory activity);
-
Reactive forms of arthritis;
-
Arthritis in sarcoidosis;
-
Severe systemic form of juvenile idiopathic arthritis (Still’s
disease) or with iridocyclitis
refractory to topical treatment.
Pulmonary and respiratory tract disorders
-
Bronchial asthma:
For the long-term treatment of severe chronic asthma (category 4) and
for treatment of
exacerbations in adults and children.
-
Chronic obstructive pulmonary disease (COPD):
For short-term treatment (max. 14 days) of exacerbations;
-
Upper respiratory tract disorders:
_Prescribing Information (Summary of Product Characteristics) -
Sterocort 4 mg _
Page 2 of 11
For short-term treatment of severe forms of aller