Land: Nya Zeeland
Språk: engelska
Källa: Medsafe (Medicines Safety Authority)
Levothyroxine sodium 150ug (plus a 9% manufacturing overage); Levothyroxine sodium 150ug (plus a 2% manufacturing overage)
Viatris Limited
Levothyroxine sodium 150 µg (plus a 9% manufacturing overage)
150 mcg
Tablet
Active: Levothyroxine sodium 150ug (plus a 9% manufacturing overage) Excipient: Acacia Indigo carmine Lactose monohydrate Magnesium stearate Povidone Purified talc Sucrose Active: Levothyroxine sodium 150ug (plus a 2% manufacturing overage) Excipient: Acacia Indigo carmine Lactose monohydrate Magnesium stearate Povidone Purified talc Sucrose
Bottle, plastic, white HDPE with PP CRC and StabilOX canister 90 tablets, 90 tablets
Prescription
Prescription
AbbVie Inc
SYNTHROID (levothyroxine sodium, USP) is indicated as replacement or supplemental therapy in patients of any age or state (including pregnancy) with hypothyroidism of any etiology except transient hypothyroidism during the recovery phase of subacute thyroiditis; Specific indication include: primary hypothyroidism resulting from thyroid dysfunction, primary atrophy, or partial or total absence of thyroid gland, or from the effects of surgery, radiation or drugs, with or without the presence of goiter, including subclinical hypothyroidism; secondary (pituitary) hypothyroidism; and tertiary (hypothalamic) hypothyroidism.
Package - Contents - Shelf Life: Bottle, plastic, white 40 cc HDPE or HDPE/EVOH/HDPE with PP CRC and StabilOX canister or dessicant - 90 tablets - 15 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, white 175 cc HDPE or HDPE/EVOH/HDPE with PP CRC and StabilOX canister or dessicant - 1000 tablets - 15 months from date of manufacture stored at or below 25°C protect from light and moisture
2008-09-02
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION SYNTHROID ® _LEVOTHYROXINE SODIUM, 25 MCG, 50 MCG AND 100 MCG _ _TABLETS_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking SYNTHROID. This leaflet answers some common questions about SYNTHROID. It does not contain all 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 risks of you taking SYNTHROID against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING SYNTHROID, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT SYNTHROID IS TAKEN FOR SYNTHROID is used to replace a hormone that is normally produced by your thyroid gland. It is also used to help decrease the size of enlarged thyroid glands (known as goiter) and to treat thyroid cancer. The thyroid gland produces and releases two hormones: thyroxine and liothyronine. These hormones are responsible for maintaining a normal rate of metabolism in the body. When the thyroid gland is unable to produce normal amounts of thyroxine, the level of thyroid hormones in the blood decreases (hypothyroidism). This results in a reduced rate of metabolism and interferes with the proper function of many body organs. SYNTHROID contains levothyroxine sodium, the same as the thyroxine hormone, produced by the normally functioning thyroid gland. Generally, replacement therapy is to be taken for life, except in cases of transient (temporary) hypothyroidism, which is usually associated with inflammation of the thyroid gland (thyroiditis). ASK YOUR DOCTOR IF YOU HAVE QUESTIONS ABOUT WHY SYNTHROID HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed SYNTHROID for another reason. BEFORE YOU TAKE SYNTHROID _WHEN YOU MUST NOT TAKE IT_ SYNTHROID SHOULD NOT BE USED IN PATIENTS WITH: • Overactive thyroid gland (thyrotoxicosis) of any cause • Uncorrected/untreated adrenal gland under-activity • A h Läs hela dokumentet
Page 1 of 21 NEW ZEALAND DATA SHEET SYNTHROID ® 1. PRODUCT NAME Synthroid, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, 300 mcg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Synthroid tablet contains 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg or 300 mcg of levothyroxine sodium. Excipients with known effect: Synthroid tablets contain lactose and sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Synthroid tablets are round, colour coded, contain a score line and are debossed with “SYNTHROID” and potency. The score line is not intended for breaking the tablet. The colour code is as follows in table 1: TABLE 1: SYNTHROID TABLET VISUAL CHARACTERISTICS STRENGTH (MCG) TABLET COLOUR 25 Orange 50 White 75* Violet 88* Olive 100 Yellow 112* Rose 125* Brown 137* Dark blue 150* Blue 175* Lilac 200* Pink 300* Green *not currently marketed. Page 2 of 21 4. CLINICAL PARTICULARS _4.1_ _THERAPEUTIC INDICATIONS_ Synthroid is indicated as replacement or supplemental therapy in patients of any age or state (including pregnancy) with hypothyroidism of any etiology except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary hypothyroidism resulting from thyroid dysfunction, primary atrophy, or partial or total absence of thyroid gland, or from the effects of surgery, radiation or drugs, with or without the presence of goiter, including subclinical hypothyroidism; secondary (pituitary) hypothyroidism; and tertiary (hypothalamic) hypothyroidism. Synthroid is also indicated as a pituitary TSH suppressant in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in conjunction with surgery and radioactive iodine therapy in the management of thyrotropin-dependent well-differentiated papillary or follicular carc Läs hela dokumentet