מדינה: ישראל
שפה: אנגלית
מקור: Ministry of Health
DIGOXIN
PERRIGO ISRAEL AGENCIES LTD
C01AA05
SOLUTION FOR INJECTION
DIGOXIN 0.5 MG / 2 ML
I.V
Required
CENEXI-FONTENAY SOUS BOIS, FRANCE
DIGOXIN
DIGOXIN
For management of chronic cardiac failure,and certain supraventricular arrhythmias.
2020-07-01
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת 2.7.2013 םש רישכת תילגנאב רפסמו םושירה LANOXIN INJECTION REG. NO. 101-75- 20033-00 םש לעב םושירה : וגירפ לארשי תויונכוס מ"עב ספוט הז דעוימ טורפל תורמחהה דבלב ! תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE For elective direct current cardioversion of a patient who is taking digoxin, the drug should be withheld for 24 hours before cardioversion is performed. In emergencies, such as cardiac arrest, when attempting cardioversion the lowest effective energy should be applied. Direct current cardioversion is inappropriate in the treatment of arrhythmias thought to be caused by cardiac glycosides. . For elective direct current cardioversion of a patient who is taking digoxin, the drug should be withheld for 24 hours before cardioversion is performed. In emergencies, such as cardiac arrest, when attempting cardioversion the lowest effective energy should be applied. Direct current cardioversion is inappropriate in the treatment of arrhythmias thought to be caused by cardiac glycosides. Although many patients with chronic congestive cardiac failure benefit from acute administration of digoxin, there are some in whom it does not lead to constant, marked or lasting haemodynamic improvement. It is therefore important to evaluate the response of each patient individually when Lanoxin is continued long-term. Herbal preparations containing St. John’s wort (Hypericum perfortum) should not be used while taking Lanoxin due to the risk of decreased plasma concentrations and reduced clinical effects of Lanoxin (see 4.5 – Interactions). This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per dose. INTERACTION WITH OTHER ME קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lanoxin ® Elixir 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Digoxin 0.05 mg/1 ml For a full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Oral solution 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Lanoxin Elixir is indicated whenever digitalis therapy is required for the treatment of congestive heart failure, atrial fibrillation and/or flutter and supra-ventricular tachycardia. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology: The dose of digoxin for each patient has to be tailored individually according to age, lean body weight and renal function. Suggested doses are intended only as an initial guide. In cases where cardiac glycosides have been taken in the preceding two weeks the recommendations for initial dosing of a patient should be reconsidered and a reduced dose is advised. The difference in bioavailability between injectable digoxin and oral formulations must be considered when changing from one dosage form to another. For exampleif patients are switched from oral to the I.V. formulation the dosage should be reduced by approximately 33%. Adults and paediatric populations over 10 years _Rapid oral loading: _ If medically appropriate, rapid digitalisation may be achieved in a number of ways, such as 750 to 1500 micrograms (0.75 to 1.5 mg) as a single dose. Where there is less urgency, or greater risk of toxicity e.g. in the elderly, the oral loading dose should be given in divided doses six hours apart, with approximately half the total dose given as the first dose. Clinical response should be assessed before giving each additional dose (see section 4.4). _Slow oral loading: _ In some patients, for example those with mild heart failure, digitalisation may be achieved more slowly with doses of 250 to 750 micrograms (0.25 to 0.75 mg) daily for one week followed by an appropriate maintenance dose. A clinical response should be seen within one week. The choice between slow and rapid oral loading depends on the cl קרא את המסמך השלם