País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
norethisterone, Quantity: 5 mg
Bayer Australia Ltd
Norethisterone
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; maize starch; magnesium stearate
Oral
30 tablets, 100 tablets
Medicine Registered
(S4) Prescription Only Medicine
Dysfunctional bleeding, primary and secondary amenorrhoea, premenstrual syndrome, delay of menstrual period, endometriosis, adjunct to estrogen hormone replacement therapy.
Visual Identification: Round and white tablet, quarter scored on one side with the letters "AN" in a regular hexagon on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2007-04-04
1805 PRIMOLUT N ® dCMI 1 PRIMOLUT ® N (PREE·MOE·LOOT) _Norethisterone _ _CONSUMER MEDICINE INFORMATION _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Primolut N. 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 Primolut N against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST FOR MORE ADVICE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PRIMOLUT N IS USED FOR Primolut N contains a hormone, norethisterone. This type of hormone is similar to the natural female hormone progesterone. Some of the information in this leaflet is based on experience with estrogen containing oral contraceptives as some of the active ingredient in Primolut N is converted to estrogen in the body. However, Primolut N is not to be used as a contraceptive Primolut N is used to treat • irregular menstrual periods with heavy and/or persistent bleeding that has no identified cause • lack of menstrual bleeding • premenstrual complaints (premenstrual syndrome) • menopausal complaints in combination with estrogen as part of hormone replacement therapy, • endometriosis (a disease caused by womb-lining tissue growing outside the womb) ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE PRIMOLUT N _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE PRIMOLUT N IF YOU HAVE AN ALLERGY TO: • norethisterone, the active ingredient in Primolut N • any of the ingredients listed at the end of this leaflet. SOME OF THE SYMPTOMS OF AN ALLERGIC REACTION 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 THIS MEDICINE Llegiu el document complet
-1- PRODUCT INFORMATION DECA-DURABOLIN ® _(nandrolone decanoate) _ NAME OF THE MEDICINE _ _ DECA-DURABOLIN ® 50 MG/ML (Solution for injection of nandrolone decanoate) _ _ _ _ _ _ _ _ _ _ _Molecular Formula: C_ _28_ _H_ _44_ _O_ _3 _ _Molecular mass: 428.7 _ _Cas. No: 360-70-3 _ _Chemical Name: 3-oxo-estr-4-en-17_ _-yl decanoate _ Deca-Durabolin is an androgenic oily preparation for intramuscular administration. DESCRIPTION Nandrolone decanoate is a white to creamy white, crystalline powder. It is practically insoluble in water but is freely soluble in chloroform, ethanol, ether, fixed oils and esters. Deca-Durabolin comes in 1 mL pre-filled syringes containing 1 mL of light yellow oily liquid. Each pre-filled syringe contains 1 ml of 50 mg/mL nandrolone decanoate. COMPOSITION Each ml of Deca-Durabolin contains 50 mg of the active ingredient nandrolone decanoate. The product also contains the inactive ingredients benzyl alcohol (0.1 mL) and arachis (peanut) oil making up the volume. PHARMACOLOGY PHARMACODYNAMIC PROPERTIES Deca-Durabolin is an injectable anabolic preparation. The pharmacologically active substance is nandrolone. The decanoate ester gives the preparation a duration of action of about three weeks after injection. Nandrolone is chemically related to the male hormone. Compared to testosterone, it has an enhanced anabolic and a reduced androgenic activity. This has been demonstrated in animal bioassays and explained by receptor binding studies. The low androgenicity of nandrolone is confirmed in clinical use. In the human, Deca-Durabolin has been shown to positively influence calcium metabolism and to increase bone mass in osteoporosis. In women with disseminated mammary carcinoma, Deca- Durabolin has been reported to produce objective regressions for many months. Furthermore, Deca- Durabolin has a nitrogen-saving action. This effect on protein metabolism has been established by -2- metabolic studies and is utilised therapeutically in conditions where a protein deficiency exists such as during chr Llegiu el document complet
1901PRIMOLUT N dPI Page 1 AUSTRALIAN PRODUCT INFORMATION PRIMOLUT ® N (NORETHISTERONE) TABLET 1 NAME OF THE MEDICINE Primolut N 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Primolut N contains 5 mg norethisterone. LIST OF EXCIPIENTS WITH KNOWN EFFECT: LACTOSE MONOHYDRATE For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM TABLET Tablets are round and white, quarter scored on one side, with the letters ‘AN’ in a regular hexagon on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dysfunctional bleeding, primary and secondary amenorrhoea, premenstrual syndrome, delay of menstrual period, endometriosis, adjunct to estrogen hormone replacement therapy. 4.2 DOSE AND METHOD OF ADMINISTRATION The tablets are to be swallowed whole with some liquid. The efficacy of Primolut N could be reduced if the user forgets to take a tablet as directed. The woman should take only the last missed tablet as soon as she remembers and then continue tablet intake at her usual time on the next day. If contraceptive protection is required, additional non-hormonal contraceptive methods should be used. DYSFUNCTIONAL BLEEDING Primolut N 1 tablet is to be taken 3 times daily for 10 days. In the majority of cases this will arrest uterine bleeding that is not associated with organic lesions within 1 to 3 days, nevertheless to ensure treatment success Primolut N must be taken for the full 10 days. About 2 to 4 days after completion of the treatment, 1901PRIMOLUT N dPI Page 2 withdrawal bleeding will occur with the intensity and duration of normal menstruation. Occasionally, slight bleeding may occur after the initial suspension of bleeding. Also in these cases tablet intake should not be interrupted or stopped. If vaginal bleeding does not stop, despite correct tablet intake, an organic cause or an extra-genital factor (e.g. polyps, carcinoma of the cervix uteri or endometrium, myoma, residua of abortion, extra-uterine pregnancy, or coagulation disorders) must be considered Llegiu el document complet