Pabi-Dexamethason tablets

Land: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

dexamethasone

Fáanlegur frá:

Adamed Pharma S.A.

ATC númer:

H02AB02

INN (Alþjóðlegt nafn):

dexamethasone

Skammtar:

500mcg

Lyfjaform:

tablets

Einingar í pakka:

(20/1x20/) in blister

Gerð lyfseðils:

Prescription

Leyfisstaða:

Registered

Leyfisdagur:

2022-12-06

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PABI-DEXAMETHASON 500 MCG TABLETS
Dexamethasone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or
nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Pabi-Dexamethason is and what it is used for
2. What you need to know before you take Pabi-Dexamethason
3. How to take Pabi-Dexamethason
4. Possible side effects
5. How to store Pabi-Dexamethason
6. Contents of the pack and other information
1.
WHAT PABI-DEXAMETHASON IS AND WHAT IT IS USED FOR
Dexamethasone is indicated as a treatment for certain endocrine and
non- endocrine
disorders,
in
certain
cases
of
cerebral
oedema,
and
for
diagnostic
testing
of
adrenocortical hyperfunction.
Endocrine disorders: Primary or secondary adrenocortical
insufficiency, congenital
adrenal hyperplasia.
Non-endocrine disorders: Dexamethasone may be used in the treatment of
non-
endocrine corticosteroid responsive conditions, including:
Allergy and anaphylaxis: Angioneurotic oedema, anaphylaxis.
Arteritis collagenosis: Polymyalgia rheumatica, polyarteritis nodosa.
Blood disorders: Haemolytic anaemia, leukaemia, myeloma.
Cardiovascular disorders: Post-myocardial infarction syndrome.
Gastro-intestinal: Crohn's disease, ulcerative colitis.
Hypercalcaemia: Sarcoidosis.
Infections (with appropriate chemotherapy): Miliary tuberculosis.
Muscular disorders: Polymyositis.
Neurological disorders: Raised intra-cranial pressure secondary to
cerebral tumours.
Ocular disorders: Anterior and posterior uveitis, optic neuritis.
Renal disorders: Lupus nephritis.
Respiratory disease:

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pabi-Dexamethason 500 mcg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mg tablet contains 500 mcg dexamethasone.
Excipient(s) with known effect
Lactose monohydrate 82 mg/ tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White tablets with a slightly yellowish shade, round, flat on both
sides, engraved on both side:
with Dx on one side and with breakline on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dexamethasone is indicated as a treatment for certain endocrine and
non- endocrine disorders,
in
certain
cases
of
cerebral
oedema,
and
for
diagnostic
testing
of
adrenocortical
hyperfunction.
_Endocrine disorders_: Primary or secondary adrenocortical
insufficiency, congenital adrenal
hyperplasia.
_Non-endocrine disorders_: Dexamethasone may be used in the treatment
of non-endocrine
corticosteroid responsive conditions, including:
_Allergy and anaphylaxis_: Angioneurotic oedema, anaphylaxis.
_Arteritis collagenosis_: Polymyalgia rheumatica, polyarteritis
nodosa.
_Blood disorders_: Haemolytic anaemia, leukaemia, myeloma.
_Cardiovascular disorders_: Post-myocardial infarction syndrome.
_Gastro-intestinal_: Crohn's disease, ulcerative colitis.
_Hypercalcaemia_: Sarcoidosis.
_Infections (with appropriate chemotherapy)_: Miliary tuberculosis.
_Muscular disorders_: Polymyositis.
_Neurological disorders_: Raised intra-cranial pressure secondary to
cerebral tumours.
_Ocular disorders_: Anterior and posterior uveitis, optic neuritis.
_Renal disorders_: Lupus nephritis.
_Respiratory disease_: Bronchial asthma, aspiration pneumonitis.
_Rheumatic disorders_: Rheumatoid arthritis.
_Skin disorders_: Pemphigus vulgaris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_General considerations_: Dosage must be individualised on the basis
of the disease and the
response of the patient. In order to minimise side effects, the lowest
possible dosage adequate
to control the disease process should be used (see sect