Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
HYDROCORTISONE AS SODIUM SUCCINATE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
H02AB09
POWDER FOR SOLUTION FOR INJ/INF
HYDROCORTISONE AS SODIUM SUCCINATE 100 MG
I.V, I.M
Required
PFIZER MANUFACTURING BELGIUM NV/SA
HYDROCORTISONE
HYDROCORTISONE
Solu-Cortef is indicated to treat any condition in which IM or IV corticosteroid treatment is required such as: - allergic states, - dermatologic diseases, - endocrine disorders, - gastrointestinal diseases,- hematologic disorders, - neoplastic diseases, - nervous system disorders, - ophthalmic diseases, - renal diseases, - respiratory diseases, - rheumatic disorders,- certain medical emergencies.
2023-11-30
1 ,ה/דבכנ ת/חקור ,ה/אפור ינוי 2019 ןוכדע לע ךעידוהל וננוצרב אפורל םינולעב לש SOLU CORTEF 100 MG ו - SOLU CORTEF 500 .הרמחה העמשמ השגדה ,טסקט תקיחמ ועמשמ הצוח וק ,טסקט תפסות ועמשמ יתחת וק :קזוחו בכרה Hydrocortisone (as sodium succinate) 100mg or 500mg :היוותה Solu-Cortef is indicated to treat any condition in which IM or IV corticosteroid treatment is required such as: allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic disorders, neoplastic diseases, nervous system disorders, ophthalmic diseases, renal diseases, respiratory diseases, rheumatic disorders, certain medical emergencies. :אפורל ןולעב םיירקיעה םינוכדעה ןלהל PRECAUTIONS OTHER: Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. In patients with suspected pheochromocytoma, consider the risk of pheochromocytoma crisis prior to administering corticosteroids. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients. Corticosteroids have been shown to impair fertility in male rats. ADVERSE REACTIONS The following adverse reactions have been reported with SOLU-CORTEF or other corticosteroids: … Blood and lymphatic system disorders: Leukocytosis. Neurologic/Psychiatric: …epidural lipomatosis. Ophthalmic: Central serous chorioretinopathy… םייונישה מה םישגדו עקרב בוהצ םיווהמ רמחה ה . ומכ ןכ , ועצוב םייוניש םיפסונ םיללוכה תפסות עדימ , תטמשה עדימ ינוכדעו חסונ םניאש םיווהמ הרמחה . םינולעה אפורל םינונימהמ דחא לכ רובע דרשמל וחלשנ םינ Citiți documentul complet
Solu Cortef 100 mg LPD CC 13 June 2021 1 2019-0050135 SOLU CORTEF ® 100 MG NAME OF THE MEDICINAL PRODUCT SOLU CORTEF ® 100 MG QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient in SOLU CORTEF ® is hydrocortisone sodium succinate equivalent to 100 mg hydrocortisone. For the full list of excipients, see section " DESCRIPTION " below. PHARMACEUTICAL FORM Powder for solution for injection or infusion. FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION DESCRIPTION SOLU CORTEF ® Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU CORTEF ® is available in several packages for intravenous or intramuscular administration. 100 MG PLAIN VIAL Each vial contains Hydrocortisone sodium succinate equivalent to 100 mg hydrocortisone. Monobasic sodium phosphate monohydrate 0.9 mg Dibasic sodium phosphate dried 8.8mg Sodium Hydroxide Water for injections SOLU CORTEF 100 mg plain does not contain diluent (see DOSAGE AND ADMINISTRATION , PREPARATION OF SOLUTIONS ). When necessary, the pH was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8. The chemical name for hydrocortisone sodium succinate is pregn-4-ene-3,20-dione,21- (3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11β)- and its molecular weight is 484.52. The structural formula is represented below: Solu Cortef 100 mg LPD CC 13 June 2021 2 2019-0050135 Hydrocortisone sodium succinate is a white or nearly white, odorless, hygroscopic amorphous solid. It is very soluble in water and in alcohol, very slightly soluble in acetone, and insoluble in chloroform. CLINICAL PHARMACOLOGY Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt- retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthet Citiți documentul complet