Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
PREDNISOLONE
MEGAPHARM LTD
H02AB06
SYRUP
PREDNISOLONE 3 MG / 1 ML
PER OS
Required
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
PREDNISOLONE
PREDNISOLONE
For glucocorticoid respousive inflamination as: Endocrine disorders, rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic diseases, respiratory diseases, hematologic disorders, neoplastic diseases, edematous states and gastrointestinal diseases.
2020-12-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS - 1986 This medicine is dispensed with a physician’s prescription only DANALONE SYRUP Active ingredient and its concentration: Each 1 ml contains: Prednisolone 3 mg Inactive ingredients in this medicine - see section 6 “Additional information”. See also “Important information about some of the medicine’s ingredients” in section 2. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, consult your physician or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Danalone is a glucocorticoid with an anti-inflammatory effect. Danalone is intended to treat inflammations that respond to glucocorticoids, for example: endocrine disorders, rheumatic disorders, hematologic disorders, collagen diseases, ophthalmic diseases, dermatologic diseases, respiratory diseases, neoplastic diseases, gastrointestinal diseases, allergic and edematous conditions. THERAPEUTIC GROUP: Corticosteroids. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive )allergic( to the active ingredient or to any of the additional ingredients contained in the medicine )see section 6(. Symptoms of a severe allergic reaction may include a red and lumpy skin rash, difficulty breathing, swelling of the face, mouth, lips or eyelids, unexplained high temperature, and feeling faint. IF THE SWELLING AFFECTS YOUR THROAT AND MAKES BREATHING AND SWALLOWING DIFFICULT, GO TO A HOSPITAL STRAIGHT AWAY. • You have an infection that affects your entire body )unless you are receiving treatment for the infection(. • You have recently had a “live” vaccination. SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE: BEFORE TREATMENT WITH DANALONE, TELL THE PHYSICIAN IF: • You suffer, or h Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT DANALONE SYRUP 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml of syrup contains 3mg of prednisolone. It also contains 0.86 mg of sodium, 0.36 g sucrose, 36.1 mg ethanol , 0.23 g propylene glycol and 1 mg benzoic acid. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup Colourless to slightly yellowish, clear liquid, with typical vanilla-apricot odour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glucocorticoid with anti-inflammatory activity. This medicine is intended for the treatment of glucocorticoid responsive inflammations, such as: endocrine disorders, rheumatic disorders, hematologic disorders, collagen diseases, ophthalmic diseases, dermatologic diseases, respiratory diseases, neoplastic diseases, gastrointestinal diseases, allergic and edematous conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The lowest dosage that will produce an acceptable result should be used (see section 4.4); when it is possible to reduce the dosage, this must be accomplished by stages. During prolonged therapy any intercurrent illness, trauma or surgical procedure will require a temporary increase in dosage; if corticosteroids have been stopped following prolonged therapy they may need to be temporarily re- introduced. ADULTS: The dose used will depend upon the disease, its severity, and the clinical response obtained. The following regimens are for guidance only. Divided dosage is usually employed. SHORT-TERM TREATMENT: 20mg (6.7ml) to 30mg (10ml) daily for the first few days, subsequently reducing the daily dosage by 2.5mg (0.8ml) or 5mg (1.67ml) every two to five days, depending upon the response. RHEUMATOID ARTHRITIS: 7.5mg (2.5ml) to 10mg (3.3ml) daily. For maintenance therapy the lowest effective dosage is used. MOST OTHER CONDITIONS: 10mg (3.3ml) to 100mg (33.3ml) daily for one to three weeks, then reducing to the minimum effective dosage. CHILDREN: Fractions of the adult dosage may be used (e.g. 75% at 12 years Baca dokumen lengkap