Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
DIGOXIN
PADAGIS ISRAEL AGENCIES LTD, ISRAEL
C01AA05
ELIXIR
DIGOXIN 0.05 MG / 1 ML
PER OS
Required
ASPEN BAD OLDESLOE GMBH, GERMANY
DIGOXIN
DIGOXIN
Lanoxin is indicated whenever digitalis therapy is required for the treatment of congestive heart failure, atrial fibrilation and/or flutter and supra-ventricular tachycardia.
2023-04-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only Lanoxin ® Elixir 0.05 mg/ml Each 1 ml of Lanoxin Elixir contains digoxin 0.05 mg. Inactive ingredients and allergens in the p re p a ra t i o n : s e e s e c t i o n 2 “ I m p o r t a n t information about some of the ingredients of the medicine” and section 6 “Further information” in the leaflet. Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, ask the doctor or pharmacist. This medicine has been prescribed for your treatment. Do not pass it on to others. It may harm them even if is seems to you that their medical condition is similar. If you experience any side effects, including side effects which are not mentioned in section 4 of this leaflet, inform the doctor or the pharmacist. 1. WHAT IS THE MEDICINE INTENDED FOR? Lanoxin Elixir is indicated whenever digitalis therapy is required for the treatment of congestive heart failure, atrial fibrilation and/or flutter and supra-ventricular tachycardia. Therapeutic group: cardiac glycosides. 2. BEFORE USING THE MEDICINE Do not use Lanoxin Elixir if: • You are sensitive (allergic) to the active ingredient digoxin, to other cardiac glycosides or to any of the additional ingredients this medicine contains (see section 6 “Further information” in the leaflet). • You suffer from serious heart problems, such as problems with the conduction of the electrical impulses in the heart, especially if you have a history of Stokes- Adams attacks )abrupt, short-lived loss of consciousness caused by a sudden change in heart rate or rhythm). • You suffer from an irregular heartbeat caused by cardiac glycoside intoxication or conditions such as Wolff-Parkinson-White syndrome. • You suffer from obstructive cardiomyopathy (enlargement of the heart muscle). Special warnings regarding the use of Lanox Διαβάστε το πλήρες έγγραφο
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 Διαβάστε το πλήρες έγγραφο