Երկիր: Նոր Զելանդիա
Լեզու: անգլերեն
Աղբյուրը: Medsafe (Medicines Safety Authority)
Fludrocortisone acetate 0.1mg (+5% manufacturing overage)
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Fludrocortisone acetate 0.1 mg (+5% manufacturing overage)
0.1 mg
Tablet
Active: Fludrocortisone acetate 0.1mg (+5% manufacturing overage) Excipient: Calcium hydrogen phosphate dihydrate Lactose monohydrate Magnesium stearate Maize starch Purified talc Sodium benzoate
Bottle, Glass, 30 tablets
Prescription
Prescription
Farmabios SpA
Partial replacement therapy for primary adrenocortical insufficiency in Addison's disease and for the treatment of salt losing adrenogenital syndrome.
Package - Contents - Shelf Life: Bottle, glass, - 30 tablets - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 months opened stored at or below 25°C - Bottle, glass, - 100 tablets - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 months opened stored at or below 25°C
1969-12-31
FLORINEF tablets – Consumer Medicine Information - NZ Page 1 of 2 FLORINEF _fludrocortisone acetate _ CONSUMER PRODUCT INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Florinef. It does not contain all of the available information. It does not take the place of talking with your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Florinef against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FLORINEF IS USED FOR Florinef contains fludrocortisone acetate as the active ingredient. It is a type of medicine known as a corticosteroid. Florinef is used in combination with other medicines when there is an inadequate production of one type of natural steroid hormone produced by the adrenal glands (Addison’s disease). It is also used to treat a disorder (called salt-losing adrenogenital syndrome) which causes too much salt to be lost in the urine. Florinef can help treat this condition by causing the kidneys to retain fluid and salt in the body. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. There is no evidence that it is addictive. BEFORE YOU TAKE IT _ _ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE FLORINEF IF YOU HAVE EVER HAD AN ALLERGY TO FLUDROCORTISONE ACETATE OR ANY INGREDIENT LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction to Florinef may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE FLORINEF IF YOU HAVE A CURRENT SERIOUS OR UNCONTROLLED INFECTION INCLUDING SYSTEMIC FUNGAL INFECTIONS. Your doctor will know if this is the case and you will be receiving Կարդացեք ամբողջական փաստաթուղթը
Florinef tablets – New Zealand Data Sheet Page 1 of 10 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Florinef tablet 0.1 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Florinef tablets contain 0.1 mg of fludrocortisone acetate as the active ingredient. Fludrocortisone acetate is a white to pale yellow, odourless or almost odourless, crystalline powder. Practically insoluble in water; soluble 1 in 50 in alcohol, 1 in 50 in chloroform; slightly soluble in ether. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Florinef is a white, uncoated tablet with a score line on one side and “FT 01" on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Partial replacement therapy for primary adrenocortical insufficiency in Addison's disease and for the treatment of salt losing adrenogenital syndrome. 4.2 DOSE AND METHOD OF ADMINISTRATION ADDISON'S DISEASE The combination of Florinef with a glucocorticoid such as hydrocortisone or cortisone provides substitution therapy approximating normal adrenal activity with minimal risks of unwanted effects. The usual dose is 0.1 mg of Florinef daily, although dosage ranging from 0.1 mg three times a week to 0.2 mg daily has been employed. In the event transient hypertension develops as a consequence of therapy, the dose should be reduced to 0.05 mg daily. Florinef is preferably administered in conjunction with cortisone (10 to 37.5 mg daily in divided doses) or hydrocortisone (10 to 30 mg daily in divided doses). SALT-LOSING ADRENOGENITAL SYNDROME The recommended dosage is 0.1 to 0.2 mg of Florinef daily. 4.3 CONTRAINDICATIONS Patients with systemic fungal infections. Florinef tablets – New Zealand Data Sheet Page 2 of 10 Patients with suspected or known hypersensitivity to fludrocortisone or any on the inactive ingredients. Patients on high dose Florinef should not be administered live vaccines as the antibody response will be reduced (see section 4.4 Special warnings and precautions for use). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Because of Կարդացեք ամբողջական փաստաթուղթը