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primolut depot 250 mG BAYER MIDDLE EAST - HCP

BAYER-PRIMOLUT Depot 250 mg - p.2/3 General disorders and complaints at the admministrattion site Complaints at the administration site, reddening, swelling,


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Text of primolut depot 250 mG BAYER MIDDLE EAST - HCP

BAYER-PRIMOLUT Depot 250 mg - Habitual abortionAs soon as pregnancy has been diagnostically con-firmed, one to two ampoules of Primolut Depot 250 mg are to be injected at weekly intervals during the first months of pregnancy, in isolated cases even longer. Threatened abortionTherapy is initiated by injecting 2 ampoules of Primolut Depot 250 mg twice to three times per week until bleeding rest is strongly recommended during this time. After this one ampoule of Primolut Depot 250 mg is to be injected twice a week for several weeks, until such time as the patient demonstrates neither blee-ding nor other complaints despite being mobile Primolut Depot should be given prophy-lactically for an even longer period depends on the individual ContraindicationsHypersensitivity to the active ingredient or any other constituents; a history of herpes gestationis; past or present liver Special warnings and precautions for useA thorough general medical examination (including measurement of blood pressure, testing the urine for sugar, possibly also conducting special liver diag-nostic tests) must be conducted before treatment begins in order to be able to detect any diseases needing treatment as well as any risk caution and monitoring are required in the case of diabetes there is no conclusive evidence that proges-togens are effective in maintaining pregnancy after previous abortions, tentative treatment may be indi-cated, depending on the individual the course of protracted therapy it is neces-sary to ensure that pregnancy is continuing by con-ducting appropriate checkups ( sonography) and immunological tests, because a dead embryo may be retained owing to the relaxing effect that Primolut-Depot has on the caproate1. Name of the mediCiNal produCtPrimolut Depot 250 mg ampoules2. Qualitative aNd QuaNtitative CompoSi-tioNOne 1-ml ampoule contains 250 mg hydroxyproges-terone constituents: mg benzyl benzoate, mg castor oil for injection See section entitled List of other constituents for a full list of the other doSaGe formOily, pale yellow solution for injection, free of CliNiCal indicationsHabitual and threatened abortion due to corpus lute-um dosage, mode and duration of employment Like all oily solutions Primolut Depot 250 mg must be injected via the intramuscular route. Experience has shown that the transient patient reactions that occur in rare cases during or immediately after the injection of oily solutions (urge to cough, coughing bouts, shortness of breath) can be prevented by injecting particularly :In line with the latest scientific knowledge any medicinal therapy in early pregnancy requires an unequivocal indication. This applies similarly to the use of hormonal preparations like Primolut Depot to maintain pregnancy. Consequently, Primolut Depot must only be used if the patient urgently wants to have a baby, especially if there is corpus luteum insufficiency or a history of achieve this goal and to maintain pregnancy Primolut Depot must be injected in sufficiently high doses for a protracted depot 250 mG BAYER MIDDLE EAST08-15BAYER-PRIMOLUT Depot 250 mg - disorders and complaints at the admministrattion siteComplaints at the administration site, reddening, swelling, painrespiratory, thoracic and mediastinal disordersExperience has shown that the transient patient reactions that occur in rare cases during or imme-diately after the injection of oily solutions (urge to cough, coughing bouts, shortness of breath) can be prevented by injecting particularly tract disordersIn rare cases after the use of hormonal active ingre-dients such as those that are contained in Primolut Depot, benign liver tumors, and even more rarely malignant liver tumors have been observed, which in isolated cases led to life-threatening hemorrhages in the abdominal severe upper abdominal complaints, liver enlarge-ment or signs of intraabdominal hemorrhage occur, differential diagnostic considerations should also include the possibility of hepatic tumor, and the drug must be discontinued as the case may overdoseOn the strength of animal experimental studies into acute toxicity the risk of side effects from an over-dose appears to be pharmaColoGiCal pharmacodynamic propertiesPharmacotherapeutic category:Pregnene-4 derivativesATC code: G03DA03Hydroxyprogesterone caproate is a long-acting pro-gestogen which causes secretory transformation of the endometrium at a dose of 250 mg. The effect of hydroxyprogesterone caproate on the endometrium persists for about 10 days if an estrogen is adminis-tered at the same caproate is an ester of the natu-rally occurring hydroxyprogesterone and possesses progesterone-like progestogenic effects such as anti-gonadotropic effects, the secretory transformation of the endometrium and thickening of the cervical mucus. 8 to 14 days after unsuccessful treatment of threat-ened abortion and the subsequent necessary curet-tage, withdrawal bleeding may sometimes occur owing to the continuing effect of Primolut-Depot which subsides only gradually. No further measures are necessary, injection must be avoided at all interactions with other medications and other interactionsThe need for oral antidiabetics or insulin may pregnancy and lactationHydroxyprogesterone caproate must only be used if the patient urgently wants to have a baby, if there is corpus luteum insufficiency or a history of is no tangible evidence from clinical studies or postmarketing experience that the administration of Primolut during pregnancy is minute amounts of the hormone dose pass into the mother s milk the risk-benefit ratio should be weighed up very carefully before using during effects on ability to drive and use machinesnot Side effectsMost of the serious adverse effects - in connection with the use of medicinal products containing pro-gestogens only - are listed in section Warnings and special precautions for use . Moreover, the fol-lowing undesired effects have been reported in users of Primolut Depot, although a causal link could not always be table below lists the side effects arranged according to the MedDRA body system categories. Incidence figures are based on reports from post-marketing studies and literature common 1/10Common 1/100 and <1/10Uncommon ( 1/1000, <1/100)Rare ( 1/10000 and <1/1000)Very rare(<1/10000)Body system (meddra )immune system diseasesAllergic skin reac-tions allergic rash, allergic urticar-ia, allergic edemaAnaphy-lactoid reactionsBAYER-PRIMOLUT Depot 250 mg - with Primolut Depot or its active sub-stance hydroxyprogesterone caproate because this was not considered necessary for determining risk in caproate is an ester of the hydroxyprogesterone occurring naturally in inter-mediary metabolism. For this reason - provided it is used in humans as prescribed - no symptoms of systemic intolerance or tumorigenic effects are to be expected. No mutagenic potential can be expected on account of its the other hand it must be remembered that sex steroids can trigger the growth of hormone-depen-dent tissue and toxicology studies gave no indication that Primolut Depot has any teratogenic potential or any deleterious effects on reproductive capacity in the subsequent F1 pharmaCeutiCal list of other constituentsBenzyl benzoateCastor oil for incompatibilitiesNot Special precautions for storageLight protection neededStore below 30 Nature and contents of containerOne 1-ml amber glass Special precautions for disposal and other notes on handlingNo special requirements7. maNufaCturerBayer Schering Pharma AGBerlin, iNformatioN StatuSJuly 2007prescription status / pharmacy-only?Rp, pharmacy-onlyThe transformation of the endometrium facilitates the implantation of a fertilized ovum and creates favorable conditions for the maintenance of any the case of parenteral administration the trans-formation dose of hydroxyprogesterone caproate is 250 mg. The progestogen possesses only a minor inhibitory effect on LH secretion and no effect on the placental production of hormones like caproate has no estrogenic, androgenic, antiandrogenic or corticoid the short-lived effect of progesterone, hydroxy-progesterone caproate possesses a distinct depot effect. For this reason, if a single intramuscular injec-tion is performed when an estrogen is being adminis-tered at the same time, an effect on the endometrium lasting 10 days can be observed. The thermogenic effect of hydroxyprogesterone caproate is retardant effect that all sexual hormones have on the anterior pituitary-hypothalamus system is relatively weak in the case of hydroxyprogesterone caproate: It inhibits neither the progesterone produc-tion in the corpus luteum phase nor hormone pro-duction in the thermogenic effect is small. Only doses of 500 mg and more increase basal pharmacokinetic propertiesHydroxyprogesterone caproate is not cleaved into the free steroid alcohol and the fatty acid residue. The active ingredient hydroxyprogesterone capro-ate is thus bioavailable to 100%. In vitro, 95% of the active ingredient is bound to plasma proteins (human plasma).On the second day after intramuscular injection the level of active ingredient plus metabolites in the entire blood pool amounted to approx. 1% of the is exclusively in the form of conjugates, with approx. 80% being excreted via the bile and approx. 20% via the speed of release can be deduced from the elim-ination half-life of 6 days. The depot is exhausted after 3 - 4 preclinical safety dataConventional animal studies into repeated dose tox-icity, carcinogenicity or mutagenicity have not been

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