Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Cabergoline 0.5mg
Pfizer New Zealand Limited
Cabergoline 0.5 mg
0.5 mg
Tablet
Active: Cabergoline 0.5mg Excipient: Lactose Leucine
Bottle, glass, 2 tablets
Prescription
Prescription
Olon SpA
Prevention of the onset of lactation in the puerperium only for clearly defined medical reasons: DOSTINEX is indicated for the inhibition of physiological lactation soon after delivery. 1. After parturition, when breast feeding is contraindicated due to medical reasons related to the mother or the new-born. 2.After stillbirth or abortion.
Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle PP child resistant cap (inner cap desiccant) - 2 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE bottle PP child resistant cap (inner cap desiccant) - 8 tablets - 24 months from date of manufacture stored at or below 25°C
1993-03-18
_DOSTINEX_® 1 DOSTINEX ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING DOSTINEX? Dostinex contains the active ingredient cabergoline. Dostinex may be needed if your levels of a hormone known as prolactin are abnormally high (hyperprolactinaemia). Dostinex can also be prescribed to prevent the production of milk in women after birth. For more information, see Section 1. Why am I using Dostinex? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE DOSTINEX? Before starting treatment, your doctor will need to do some tests to detect any underlying heart, lung, or kidney disease. Do not take if you have or have had any scarring or thickening of the lungs with shortness of breath; heart valve disorder; any swelling or inflammation around the heart or lungs; or any abnormal formation of tissue outside the stomach wall. Do not take if you have an allergy to any medicine containing cabergoline, ergot alkaloids or any of the ingredients listed. For more information, see Section 2. What should I know before I use Dostinex? In the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with cabergoline and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? In the full CMI. 4. HOW DO I USE DOSTINEX? To treat hyperprolactinaemia the recommended starting dose is half a tablet taken twice a week. Your doctor will generally start you on a low dose and may gradually increase your dose. To prevent the production of breast milk, the recommended dose is two tablets taken as a single dose, on the first day after delivery of your baby. More instructions can be found in Section 4. How do I use Dostinex? In the full CMI. 5. WHAT SHOULD I KNOW WHILE USING DOSTINEX? THINGS YOU SHOULD DO Follow your doctor's requests for tests and report anything unusual to your doctor such as difficulty in breathing, chest pain or swel Preberite celoten dokument
Version: pfddostt11123 Supersedes: pfddostt10723 Page 1 of 11 NEW ZEALAND DATA SHEET 1. PRODUCT NAME DOSTINEX ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each DOSTINEX tablet contains 0.5 mg cabergoline. EXCIPIENT(S) WITH KNOWN EFFECT Lactose anhydrous For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Cabergoline 0.5 mg tablets are flat, capsule shaped tablets, 4 x 8 mm, scored, white tablets, engraved “PU” on one side and “700” on the reverse side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Prevention of the onset of lactation in the puerperium only for clearly defined medical reasons:_ DOSTINEX is indicated for the inhibition of physiological lactation soon after delivery. 1. After parturition, when breast-feeding is contraindicated due to medical reasons related to the mother or the new-born. 2. After stillbirth or abortion. _Treatment of hyperprolactinaemic disorders_: DOSTINEX is indicated for the treatment of dysfunctions associated with hyperprolactinaemia, including amenorrhoea, oligomenorrhoea, anovulation, and galactorrhoea. DOSTINEX is indicated in patients with prolactin-secreting pituitary adenomas (micro- and macroprolactinomas), idiopathic hyperprolactinaemia, or empty sella syndrome with associated hyperprolactinaemia, which represent the basic underlying pathologies contributing to the above clinical manifestations. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSTINEX is to be administered by the oral route. Since in clinical studies DOSTINEX has been mainly administered with food since the tolerability of this class of compound is improved with food, it is recommended that DOSTINEX be preferably taken with meals. Version: pfddostt11123 Supersedes: pfddostt10723 Page 2 of 11 _Inhibition of physiological lactation_: DOSTINEX should be administered during the first day post-partum. The recommended therapeutic dose is 1 mg (two 0.5 mg tablets) as a single dose. _Treatment of hyperprolactinaemic disorders_: The recommended initial dosage of DOSTINEX i Preberite celoten dokument