מדינה: ניו זילנד
שפה: אנגלית
מקור: Medsafe (Medicines Safety Authority)
Levothyroxine sodium, hydrate 111.26ug (pentahydrate equivalent to 100 mcg of anhydrous substance); Levothyroxine sodium, hydrate 111.26ug (pentahydrate equivalent to 100 mcg of anhydrous substance)
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Levothyroxine sodium, hydrate 111.26 µg (pentahydrate equivalent to 100 mcg of anhydrous substance)
100 mcg
Tablet
Active: Levothyroxine sodium, hydrate 111.26ug (pentahydrate equivalent to 100 mcg of anhydrous substance) Excipient: Colloidal silicon dioxide Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch Purified talc Active: Levothyroxine sodium, hydrate 111.26ug (pentahydrate equivalent to 100 mcg of anhydrous substance) Excipient: Colloidal silicon dioxide Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch Purified talc
Bottle, plastic, Polypropylene bottles; LDPE closures, 1000 tablets
Prescription
Prescription
Sandoz GmbH
Levothyroxine is indicated for the treatment of hypothyroidism.
Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP cap - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE with PP cap - 200 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, Polypropylene bottles with LDPE closures - 1000 tablets - 24 months from date of manufacture stored at or below 25°C protect from light
2004-03-23
ELTROXIN® NZ – Consumer Medicine Information Page 2 of 5 ELTROXIN ® _LEVOTHYROXINE SODIUM 50 MICROGRAMS AND 100 MICROGRAMS TABLETS _ _ _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ELTROXIN tablets. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the expected benefits of you taking ELTROXIN against the risks this medicine could have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT ELTROXIN IS USED FOR ELTROXIN contains the active ingredient levothyroxine sodium. It belongs to a small group of medicines called thyroid hormones, which work by replacing the body’s low levels of thyroxine. ELTROXIN is used to treat hypothyroidism, a disease in which the thyroid gland is underactive and does not produce enough thyroxine, a hormone, which is important for controlling your metabolism. Symptoms of hypothyroidism include tiredness, muscle weakness, cramps, feeling the cold, a slow heart rate, dry and flaky skin, hair loss, a deep husky voice and weight gain. ELTROXIN is also used to treat children born with hypothyroidism (congenital), those who develop hypothyroidism in the first year of life (neonatal) and children who have hypothyroidism as part of juvenile myxoedema, a condition in which the amount of thyroxine produced by the body is low. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ELTROXIN HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed ELTROXIN for another purpose. ELTROXIN is available only with a doctor’s prescription. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE ELTROXIN IF: • you have or have had an allergic reaction to any of the ingredients in ELTROXIN listed at the end of this leaflet. • the packaging is torn or shows signs of interference, or קרא את המסמך השלם
NEW ZEALAND DATA SHEET 1 PRODUCT NAME ELTROXIN ® (50 mcg, 100 mcg tablets) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets containing 50 micrograms (0.05 mg) or 100 micrograms (0.1 mg) anhydrous levothyroxine sodium, which is the monosodium salt of the levorotary isomer of thyroxine. 100 mcg levothyroxine is equivalent in activity to 20 to 30 mcg liothyronine or 60 mg thyroid BP. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Eltroxin 50 microgram (0.05 mg) tablets are white to off-white, round, biconvex tablets, imprinted with GS 11E on one face and 50 on the other. Eltroxin 100 microgram (0.1 mg) tablets are white to off-white, round, biconvex tablets, imprinted with GS 21C on one face and 100 on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levothyroxine is indicated for the treatment of hypothyroidism. 4.2 DOSE AND METHOD OF ADMINISTRATION Dose Thyroxine has a narrow therapeutic index. Appropriate thyroxine dosage is based upon clinical assessment and laboratory monitoring of thyroid function tests. During the initial titration period, careful dosage titration and monitoring is necessary to avoid the consequences of under- or over-treatment. The symptoms of excessive thyroxine dosage are the same as many features of endogenous thyrotoxicosis. If the dose of thyroxine is increased too rapidly, symptoms such as diarrhoea, nervousness, rapid pulse, insomnia, tremors and sometimes anginal pain where there is latent myocardial ischaemia may occur, and the dosage must be reduced or withheld for a day or two, then restarted at a lower level. A pre-therapy ECG is valuable, as changes induced by hypothyroidism may be confused with ECG evidence of ischaemia. Thyroxine tablets should preferably be taken on an empty stomach. Missed dosage – If a scheduled daily dose is missed, the dose should be taken as soon as the patient remembers, unless it is almost time for the patient’s next dose. Two doses should not be taken together. In patients whose medications include levothyro קרא את המסמך השלם