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Nur-Isterate Injection

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Nur-Isterate Injection SELECT THE REQUIRED INFORMATION PROFESSIONAL INFORMATION PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S4 PROPRIETARY NAME AND DOSAGE FORM: NUR-ISTERATE Oily solution for intramuscular injection COMPOSITION: 1 ml contains norethisterone enantate (17-ethinyl-17-heptanoyloxy-4-estrene-3-one) 200 mg. Other ingredients are: benzyl benzoate, castor oil for injection. PHARMACOLOGICAL CLASSIFICATION: A. 21.8.2 Progesterones without estrogens. PHARMACOLOGICAL ACTION: Pharmacodynamic properties: Protection against conception is based primarily upon an alteration of the cervical mucous. This alteration is present for the whole of the duration of action and prevents the ascent of the sperm into the uterine cavity. Radioimmunological studies have shown that, during the first 5 to 7 weeks after injection, ovulation is suppressed as a result of the high plasma level of norethisterone. In addition, NUR- ISTERATE causes morphological changes in the endometrium which have the effect of rendering nidation of a fertilised egg difficult. Pharmacokinetic properties: Norethisterone enantate was completely absorbed after intramuscular injection. The ester was eventually completely hydrolysed to its pharmacologically active compound norethisterone once it was released from the depot. Maximum levels of norethisterone were measured at about 3 to 10 days after IM administration. They amounted on average to 13.4 5.4 ng/ml and 12.2 2.7 ng/ml about 7 days (median) after IM administration of 200 mg norethisterone enantate in 2 ml and 1 ml oily solution, respectively. Plasma levels of norethisterone declined in two disposition phases with half-lives of 4 to 5 days and 15 to 20 days, respectively, which were due to a biphasic release of norethisterone enantate from the depot. Norethisterone enantate is metabolised completely. Norethisterone enantate is split mainly in the liver by enzymatic hydrolysis into norethisterone and heptanoic acid. While the fatty acid is metabolised by means of -oxidation, norethisterone is transformed mainly through the reduction of the C4-C5 double bond and the C3 keto group. The majority of metabolites found in urine were present as conjugates, mainly as sulphates, which are expected to be inactive. Transformation of norethisterone to ethinylestradiol in vivo has been reported for many years but has not been determined quantitatively. Recent investigations have confirmed that norethisterone/-acetate is partly metabolised to ethinylestradiol. Per 1 mg of orally applied norethisterone/-acetate, ethinylestradiol is formed equivalent to an oral dose of approximately 4 g/6 g respectively in humans. Since the estrogenicity of norethisterone has always been assumed and experienced in clinical practice, the discovery of its metabolic characteristics does not change the existing recommendations for use. Up to 85 % of the norethisterone enantate dose was excreted within 30 days in urine (40 %) and faeces (60 %). No unchanged norethisterone enantate was recovered in urine or faeces. In urine and faeces, similar excretion half-lives of 6 to 9 days were estimated for radioactive labelled substances during the observation period of 30 days and – in a further study – an excretion half-life of 20 to 30 days was measured in urine between days 30 and 80 after IM administration of 200 mg 3H-norethisterone enantate. Based on animal studies, retention of the drug in the body is not to be expected. 2376/0307/SA2/0411 1 In plasma of women, 96 % of norethisterone is bound to proteins. The respective percentages bound to sex hormone binding globulin (SHBG) and albumin are approximately 35 % and 61 %, as long as SHBG levels are within the normal range. Due to the half-life of the terminal disposition phase from plasma (about 2.5 weeks) and the initial dose regimen (one injection every 2 months), a slight accumulation of the drug will be expected after multiple administrations. A steady state will already be reached after the second administration. Although there is no direct investigation on bioavailability of norethisterone after IM administration of norethisterone enantate reported, complete availability can be estimated by comparison of norethisterone AUC values determined in different studies after IV injection of norethisterone and after IM injection of norethisterone enantate. INDICATIONS: Hormonal contraception. CONTRA-INDICATIONS: No further injection should be given if, during treatment, migrainous headaches occur for the first time or recurrent, unusually severe headaches develop, if sudden perceptual disorders (e.g. disturbances of vision or hearing) occur, if first signs of thrombophlebitis or thromboembolic disease (e.g. unusual pain in the legs or swelling of the legs, stabbing pains on breathing, or coughing for no apparent reason) are noted, or if a feeling of pain and tightness in the chest, a significant rise in blood pressure, recurrence of earlier depression or pathological changes of liver function and hormone levels are experienced. NUR-ISTERATE should not be used in the presence of any of the conditions listed below. Should any of the conditions appear during the use of NUR-ISTERATE, no further injections should be given. • Known or suspected pregnancy. • Venous thromboembolic disorders or history thereof. • Arterial and cardiovascular disease present or in history (e.g. myocardial infarction, cerebrovascular accident, ischaemic heart disease). • Uncontrolled hypertension. • Acute hepatic disease or history of severe hepatic disease as long as liver function values have not returned to normal. • Primary biliary cirrhosis, Dubin-Johnson syndrome, Rotor syndrome. • Presence or history of liver tumours (benign or malignant). • History of idiopathic jaundice of pregnancy or severe pruritus of pregnancy. • Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breast). • Diabetes mellitus with vascular involvement. • Disturbances of lipometabolism. • Hypersensitivity to the active substance or to any of the excipients. • Undiagnosed vaginal bleeding. In porphyria NUR-ISTERATE should be used only after careful consideration of the benefits and risks. WARNINGS: If any of the conditions/risk factors mentioned below are present or deteriorate, an individual risk/benefit analysis should be done before NUR-ISTERATE is started or continued. Circulatory disorders: According to the present state of knowledge, an association between the use of hormonal contraceptives and an increased risk of venous and arterial thromboembolic diseases cannot be ruled out. The relative risk of arterial thromboses (e.g. stroke, myocardial infarction) appears to increase further when heavy smoking, increasing age and the use of hormonal contraceptives coincide. In women with hypertension the risk of stroke may be slightly enhanced by NUR-ISTERATE. There may be an increased risk of venous thromboembolism (deep venous thrombosis, pulmonary 2376/0307/SA2/0411 2 embolism) associated with the use of NUR-ISTERATE. In case of prolonged immobilisation it is advisable to discontinue the use of NUR-ISTERATE (in the case of elective surgery, 12 weeks in advance) and not to resume until two weeks after complete remobilisation. No further injection should be given • if first signs of thrombophlebitis or thromboembolic disease (e.g. unusual pain in the legs or swelling of the legs, stabbing pains on breathing, or coughing for no apparent reason) are noted, or if a feeling of pain and tightness in the chest are experienced, • in case of symptoms of an arterial or venous thrombotic event or suspicion thereof, • if migrainous headaches occur for the first time, • if recurrent, unusually severe headaches or headaches with a new pattern develop, • if sudden perceptual disorders (e.g. disturbances of vision or hearing) occur. Tumours: Cases of benign liver tumours, and malignant liver tumours have been reported in users of hormonal contraceptives. In isolated cases, these tumours have led to life-threatening intra-abdominal haemorrhages. A hepatic tumour should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal haemorrhage occur in women using NUR- ISTERATE. Other conditions: Progestogen-only contraceptives such as NUR-ISTERATE generally do not appear to affect blood pressure in normotensive women. Small increases in blood pressure have been reported in one study using injectable contraceptives, however, clinically relevant increases are rare. If a sustained clinically significant hypertension develops, then it is prudent for the physician to stop using NUR-ISTERATE and treat the hypertension. Where considered appropriate, the use of NUR-ISTERATE may be resumed if normotensive values can be achieved with antihypertensive therapy. The following conditions have been reported to occur or deteriorate, but the evidence of an association is inconclusive: jaundice and/or pruritus related to cholestasis; gallstone formation; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham’s chorea. Recurrence of cholestatic jaundice and/or pruritus which occurred first during pregnancy or previous use of sex steroids necessitates the discontinuation of NUR-ISTERATE. Chloasma may occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should not use NUR-ISTERATE. If there is a history of extrauterine pregnancy or one tube is missing, the use of NUR-ISTERATE should be decided on only after carefully weighing the benefits against the
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