Страна: Мальта
Язык: английский
Источник: Malta Medicines Authority
DEXAMETHASONE SODIUM, PHOSPHATE
Panpharma Z.I. DU CLAIRAY, 35133 LUITRE, France
H02AB02
DEXAMETHASONE SODIUM PHOSPHATE 6 mg
SOLUTION FOR INJECTION
DEXAMETHASONE SODIUM PHOSPHATE 6 mg
POM
CORTICOSTEROIDS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-05-11
Page 1 of 13 PACKAGE LEAFLET Page 2 of 13 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DEXAMETHASONE PANPHARMA 3.3 MG/ML, SOLUTION FOR INJECTION Dexamethasone (as sodium phosphate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Dexamethasone PANPHARMA is and what it is used for 2. What you need to know before you use Dexamethasone PANPHARMA 3. How to use Dexamethasone PANPHARMA 4. Possible side effects 5. How to store Dexamethasone PANPHARMA 6. Contents of the pack and other information 1. WHAT DEXAMETHASONE PANPHARMA IS AND WHAT IT IS USED FOR Dexamethasone PANPHARMA 3.3 mg/ml, solution for injection contains the active substance dexamethasone (as sodium phosphate), which belongs to a group of medicines called steroids (specifically known as corticosteroids). Dexamethasone is a synthetic glucocorticoid (adrenocortical hormone). Corticosteroids occur naturally in the body and help to maintain health and well-being. Synthetic steroids such as dexamethasone work by mimicking some of their actions to treat disease. Corticosteroids are given to patients for a variety of conditions where their abilities to reduce inflammation and suppress the immune system are valuable. These conditions may include Crohn’s disease, asthma, shock, anaphylaxis, tuberculosis, arthritis, osteoarthritis, and skin disorders including acne. Dexamethasone PANPHARMA 3.3 mg/ml 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 USE DEXAMETHASONE PANPHARMA DO NOT USE DEXAMETHASON Прочитать полный документ
PAGE 1 OF 17 SUMMARY OF PRODUCT CHARACTERISTICS PAGE 2 OF 17 1. NAME OF THE MEDICINAL PRODUCT DEXAMETHASONE PANPHARMA 3.3 mg/ml, solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 3,3 mg dexamethasone (as sodium phosphate) which is equivalent to 4 mg dexamethasone phosphate or 4,37 mg dexamethasone sodium phosphate. Each 1,8 ml contains 6 mg of dexamethasone (as sodium phosphate) which is equivalent to 7,27 mg dexamethasone phosphate or 7,94 mg dexamethasone sodium phosphate. Each 2 ml contains 6,6 mg dexamethasone (as sodium phosphate) which is equivalent to 8 mg dexamethasone phosphate or 8,74 mg dexamethasone sodium phosphate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Corticosteroid. For use in certain endocrine and non-endocrine disorders responsive to corticosteroid therapy. _Systemic administration: _ DEXAMETHASONE PANPHARMA 3.3 mg/ml, solution for injection is recommended for systemic administration by intravenous or intramuscular injection when oral therapy is not feasible or desirable in the following conditions. Dexamethasone PANPHARMA is indicated in the treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged 12 years and older with body weight at least 40 kg) who require supplemental oxygen therapy. _Endocrine disorders _ _Primary or secondary adrenocortical insufficiency _ (hydrocortisone or cortisone is the first choice, but synthetic analogues may be used with mineralocorticoids where applicable and, in infancy, mineralocorticoid supplementation is particularly important). _Non-endocrine disorders _ DEXAMETHASONE PANPHARMA 3.3 mg/ml, solution for injection may be used in the treatment of non-endocrine corticosteroid- responsive conditions, including: _Allergy and anaphylaxis: _ Angioneurotic oedema and anaphylaxis. _Gastro-intestinal: _ Crohn's disease and ulcerative colitis. _Infection (with appropriate chemotherapy) Прочитать полный документ