Dexamethasone 4mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

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환자 정보 전단 환자 정보 전단 (PIL)
22-07-2022
제품 특성 요약 제품 특성 요약 (SPC)
06-07-2018

유효 성분:

Dexamethasone

제공처:

Krka UK Ltd

ATC 코드:

H02AB02

INN (International Name):

Dexamethasone

복용량:

4mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 06030200; GTIN: 5391512454135

환자 정보 전단

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
Dexamethasone 4 mg tablets
Dexamethasone 8 mg tablets
dexamethasone
What is in this leaflet
1. What Dexamethasone is and what it is used for
2. What you need to know before you take Dexamethasone
3. How to take Dexamethasone
4. Possible side effects
5. How to store Dexamethasone
6. Contents of the pack and other information
1. WHAT DEXAMETHASONE IS AND WHAT IT IS USED FOR
Dexamethasone is a synthetic glucocorticoid. Glucocorticoids are
hormones produced by the cortex of adrenal
glands. The medicine has anti-inflammatory, analgesic and
anti-allergic effects, and suppresses the immune
system.
Dexamethasone is recommended for the treatment of rheumatic and
autoimmune diseases (e.g. systemic lupus
erythematosus, rheumatoid arthritis, juvenile idiopathic arthritis,
polyarthritis nodosa), diseases of respiratory tract
(e.g. bronchial asthma, croup), skin (e.g. erythroderma, pemphigus
vulgaris), tuberculous meningitis only in
conjunction with anti-infective therapy, diseases of blood (e.g.
idiopathic thrombocytopenic purpura in adults),
cerebral oedema, treatment of symptomatic multiple myeloma, acute
lymphoblastic leukemia, Hodgkin’s disease
and non-Hodgkin’s lymphoma in combination with other medicinal
products, palliative treatment of neoplastic
diseases, prophylaxis and treatment of nausea and vomiting caused by
chemotherapy and prevention and
treatment of vomiting after operation, within antiemetic treatment.
Dexamethasone 4 mg tablets
Dexamethasone is used as a treatment of coronavirus disease 2019
(COVID-19) in adult and adolescent patients
(aged 12 years and older with body weight at least 40 kg) with
difficulty breathing and need of oxygen therapy.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEXAMETHASONE
Do not take Dexamethasone
•
if you are allergic to dexamethasone or any of the other ingredients
of this medicine (listed in section 6).
•
if you have an infection that affects the whole body (unless you are
receiving treatment).
•
if you have a stomach or duode
                                
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제품 특성 요약

                                OBJECT 1
DEXAMETHASONE 4 MG TABLETS
Summary of Product Characteristics Updated 26-Apr-2017 | Consilient
Health Ltd
1. Name of the medicinal product
Dexamethasone 4 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 4 mg dexamethasone.
Excipient with known effect:
Each tablet contains 77.9 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
4 mg tablets: White or almost white, round tablets with bevelled edges
and scored on one side (Thickness:
2.5-3.5 mm; Diameter: 5.7-6.3 mm). The tablet can be divided into
equal doses.
4. Clinical particulars
4.1 Therapeutic indications
NEUROLOGY
Cerebral oedema (only with symptoms of intracranial pressure evidenced
by computerised tomography)
caused by a brain tumour, neuro-surgical intervention, cerebral
abscess.
PULMONARY AND RESPIRATORY DISEASES
Acute asthma exacerbations when use of an oral corticosteroid (OCS) is
appropriate, croup.
DERMATOLOGY
Initial treatment of extensive, severe, acute, skin diseases
responding to glucocorticoids, e.g.
erythroderma, pemphigus vulgaris.
AUTOIMMUNE DISORDERS/RHEUMATOLOGY
Initial treatment of autoimmune disorders like systemic lupus
erythematodes.
Active phases of systemic vasculitides like panarteritis nodosa
(treatment duration should be limited to
two weeks in cases of concomitant positive hepatitis B serology).
Severe progressive course of active rheumatoid arthritis, e.g. fast
proceeding destructive forms and/or
extraarticular manifestations.
Severe systemic course of juvenile idiopathic arthritis (Still's
disease).
HAEMATOLOGICAL DISORDER
Idiopathic thrombocytopenic purpura in adults.
INFECTOLOGY
Tuberculous meningitis only in conjunction with anti-infective
therapy.
ONCOLOGY
Palliative treatment of neoplastic diseases.
Prophylaxis and treatment of emesis induced by cytostatics, emetogenic
chemotherapy within antiemetic
treatment.
Treatment of symptomatic multiple myeloma, acute lymphoblastic
leukemia, Hodgkin's disease and non-
Hodgkin's lymp
                                
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