Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
DEXAMETHASONE PHOSPHATE ( AS SODIUM PHOSPHATE )
MBI PHARMA LTD., ISRAEL
H02AB02
SOLUTION FOR INJECTION / INFUSION
DEXAMETHASONE PHOSPHATE ( AS SODIUM PHOSPHATE ) 4 MG/ML
I.V, I.M
Required
KERN PHARMA S.L, SPAIN
DEXAMETHASONE
Dexamethasone Kern Pharma is indicated in the treatment of:• Endocrine diseases such as nonsuppurative thyroiditis, hypercalcaemia associated with cancer and congenital adrenal hyperplasia.• Allergy: Severe or disabling allergic conditions resistant to conventional treatments, as in: bronchial asthma, contact or atopical dermatitis, seasonal or perennial allergic rhinitis, hypersensitivity reactions to drugs.• Ophtalmic: Serious inflammatory and allergic processes, acute and chronic, affecting the eyes, such as: iritis and iridocyclitis, chorioretinitis, choroiditis and diffuse posterior uveitis, optical neuritis, allergic conjunctivitis, allergic marginal corneal ulcers.• Inflammatory Bowel dis.: Systemic treatment in exacerbations of ulcerative colitis and regional enteritis.• Dermatological diseases (pemphigus, Stevens Johnson syndrome, exfoliative dermatitis, severe psoriasis and mycosis fungoides) • Respiratory diseases (symptomatic sarcoidosis, berylliosis, Loeffler's syndrome)• Haematological: acquired )autoimmune( haemolytic anaemia, idiopathic thrombocytopenic purpura in adult, pure red cell aplasia• Nephrotic syndrome of the idioplathic type or that due to lupus erythematosus• Cerebral edema caused by brain tumor, neurosurgery, brain abscess, bacterial meningitis• Collagen diseases: Active rheumatoid arthritis with severe progressive course, fast destructive remitting forms and / or extra-articular manifestations, Juvenile idiopathic arthritis with severe systemic-onset form (Still's disease) or locally with no control, rheumatic fever with carditis, dermatomyositis, polymyositis, SLE, temporal arteritis.• Infectious Diseases: Bacterial meningitis – adjunct to antibiotics in suspected Pneumococcal meningitis and TB meningitis. Severe infectious diseases with toxic states (eg tuberculosis, typhoid, brucellosis;. Only with simultaneous anti-infective therapy)• Fetal lung maturation• Chemotherapy – associated nausea and vomiting• Multiple Myeloma – part of chemotherapy protocols (eg VAD)• Prevention and treatment of acute mountain sickness/HACE
2021-02-28
_ _ MBI PHARMA LTD, REHOV HAOREG 4, HASHARON INDUSTRIAL PARK, PO BOX 5061, KADIMA 6092000 ISRAEL TEL: +972 -9-7719003 FAX: +972-9-7719990 EMAIL INFO@MBIPHARMA.CO.IL COMPANY REGISTRATION NO: 514500248 _ _ _ _ ה/אפור ה/דבכנ , ה/דבכנ ת/חקור , תרבח MBI Pharma ןודנבש רישכתב םייוניש לע עידוהל תשקבמ EXAMETHASONE KERN PHARMA D ןתמ תרוצ : Solution for injection I.V :ליעפ ביכרמ Dexamethasone (as sodium phosphate) 4mg/ml :םייונישה תוהמ 1 . הלומרופה רופיש - הלומרופה ךותמ םירמשמה תאצוה 2 . ל רישכתה לש ףדמה ייח רוציק - 30 .םישדוח לבקל ןתינו ,תואירבה דרשמ רתאבש תופורתה רגאמב םסרופמ אפורל ןולעה ו לעבל הינפ ידי לע ספדומ םושירה , תרבח המרפ ייא.יב.םא .ד.ת , 5061 ןופלטב וא ,המידק 7719903 - 09 . ,הכרבב רוד רנבא הנוממ חקור _ _ _BI _ Прочитайте повний документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dexamethasone Kern Pharma 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml ampoule of Dexamethasone Kern Pharma contains dexamethasone phosphate 4 mg (as dexamethasone sodium phosphate, 4.37 mg), which is equivalent to 3.33 mg dexamethasone base. Each 5 ml ampoule of Dexamethasone Kern Pharma contains dexamethasone phosphate 20 mg (as dexamethasone sodium phosphate, 21.85 mg) which is equivalent to 16.65 mg dexamethasone base. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion Clear and colourless solution. pH: 7-8.5 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS By intramuscular or intravenous route Dexamethasone Kern Pharma is indicated in the treatment of: • Endocrine diseases such as nonsuppurative thyroiditis, hypercalcaemia associated with cancer and congenital adrenal hyperplasia. • Allergy: Severe or disabling allergic conditions resistant to conventional treatments, as in bronchial asthma, contact or atopic dermatitis, seasonal or perennial allergic rhinitis, hypersensitivity reactions to drugs. • Ophthalmic: Serious inflammatory and allergic processes, acute and chronic, affecting the eyes, such as: iritis and iridocyclitis, chorioretinitis, choroiditis and diffuse posterior uveitis, optical neuritis, allergic conjunctivitis, allergic marginal corneal ulcers. • Inflammatory Bowel dis.: Systemic treatment in exacerbations of ulcerative colitis and regional enteritis. • Dermatological diseases (pemphigus, Stevens Johnson syndrome, exfoliative dermatitis, severe psoriasis and mycosis fungoides). • Respiratory diseases (symptomatic sarcoidosis, berylliosis, Loeffler's syndrome). • Hematological: acquired (autoimmune) hemolytic anemia, idiopathic thrombocytopenic purpura in adult, pure red cell aplasia. • Nephrotic syndrome of the idiopathic type or that due to lupus erythematosus. • Cerebral edema caused by brain tumor, neurosurgery, brain abscess, bacteria Прочитайте повний документ