<>>>/Subtype/Form/BBox[0 0 595 842]>>stream Doseringsforslag. 0.5 mL of solution in a pre-filled syringe (type I glass) with a plunger stopper (halobutyl rubber) and plunger (plastic), and with a needle for injection (stainless) – pack of 1. Studies on reproduction were not performed in animals. Adherence to recommended Ovitrelle dosage and regimen of administration can minimise the risk of ovarian hyperstimulation. Preparat jest choriogonadotropiną alfa otrzymywaną metodą rekombinacji DNA. In women, chorionic gonadotropin acts as a surrogate luteinising hormone surge that triggers ovulation. Reporting suspected adverse reactions after authorisation of the medicinal product is important. How has Ovitrelle been studied? Ovitrelle is indicated for use in infertility (see section 4.1). Ovitrelle 250 Mikrogramm/0,5 ml enthält den Wirkstoff Choriongonadotropin. x�S�*�2T0 B �ghnfn d'�r����f`Idvr��~D���K�B W � � (Orifarm) Kr. endstream Pharmacotherapeutic group: Sex hormones and modulators of the genital system, gonadotropins, ATC code: G03GA08. x�+� � | In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. • Anovulatory or oligo-ovulatory adult women: Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory women after stimulation of follicular growth. x�� endstream The effects of an overdose of Ovitrelle are unknown. <>stream Date of first authorisation/renewal of the authorisation. %PDF-1.4 - Ponechte si příbalovou informaci pro případ, že si ji budete potřebovat přečíst znovu. <>stream 6500 ie waren es und das bei 65 kg. The patient is recommended to have coitus on the day of, and the day after, Ovitrelle injection. OVITRELLE 250 mcg/0.5 ml 1 kullanıma hazır şırınga Aktif 2021 Yılı yılı ilaç fiyatları listesi ve diğer yıllara ait satış fiyat grafikleri, eşdeğer ilaçlarının fiyatları, Türk İlaç Rehberi İlaç Fiyatları Sayfasında. endobj x�+�r Može biti potrebno da ga ponovo pročitate. After opening, the medicinal product should be used immediately. endobj Léčivý přípravek Ovitrelle je buď prášková forma léku k přípravě injekčního roztoku s rozpouštědlem a nebo již hotová naplněná injekční stříkačka roztokem, či předplněné pero, které se používá ke spuštění ovulace. Generally… x��X_��6?���¥��81����L���B?��W(ܕ���-K��?��pǒM&��_?��v�+���/�o��r�_y�e�Ҙ�0C����Ͽ����ϧ��ia���2ĥ|t���>�Կ�1�w�,������݇!������d.S]����s.�:��# A��RX|*�T�T����{)W����]��D4�r��������q,�n��W��w��� Merck Serono Ltd, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK. One pre-filled syringe of Ovitrelle (250 micrograms) is administered 24 to 48 hours after optimal stimulation of follicular growth is achieved. Ovitrelle 250 microgramas solução injectável pode ser conservado à temperatura ambiente (a ou abaixo de 25ºC) durante 30 dias sem voltar a ser colocado no frigorífico durante este período. it is essentially “sodium-free”. There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple treatment regimens for infertility. endobj �*T0T0 B�����f����� �6 � 8 0 obj Clinical investigation in women for the indication of ART and anovulation was limited to one treatment cycle. -�"���-���6��62��.�'�x=�tvr=R��b��� �v�f@��=�2�H�B��`q��t��C�Ż��c�nVʚ��pp��u=8�����p� ��������wNT�35�F�����yL����{.� Within its shelf-life, the solution may be stored at or below 25°C for up to 30 days without being refrigerated again during this period. Bei mir war ein Test schon nach 7 Tagen negativ gewesen. No specific interaction studies with Ovitrelle and other medicinal products have been performed; however, no clinically significant medicinal product interactions have been reported during hCG therapy. endstream By continuing to browse the site you are agreeing to our policy on the use of cookies. �*T0T0 B�����f����� �6 � • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, • Tumours of the hypothalamus or pituitary gland, • Ovarian enlargement or cyst unrelated to polycystic ovarian syndrome, • Gynaecological haemorrhages of unknown aetiology, Ovitrelle must not be used in conditions when an effective response cannot be obtained, such as, • malformations of sexual organs incompatible with pregnancy, • fibroid tumours of the uterus incompatible with pregnancy. To minimise the risk of higher order multiple pregnancy, careful monitoring of ovarian response is recommended. endobj There is no relevant use of Ovitrelle in the paediatric population. The effectiveness of Ovitrelle was measured by looking at how many eggs were released. Ich löse mit Ovitrelle aus und spritze eine Woche später nochmal nach. Anvendes ofte sammen med follikelstimulerende hormon (FSH). Renal or hepatic impairment. It must be discarded if not used after these 30 days. endobj <>stream Ovitrelle is used to trigger final follicular maturation and early luteinisation after use of medicinal products for stimulation of follicular growth. * recombinant human chorionic gonadotropin, r-hCG produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. x� <>stream Special populations. The majority of multiple conceptions are twins. endstream Ovitrelle 250 mikrogram / 1 stk. It is more commonly seen in women with polycystic ovarian syndrome and usually regresses without treatment. dose er 250 μg. <>stream This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. �2P�01RI�r � However, the in-use stability has been demonstrated for 24 hours at + 2°C to 8°C. Therefore, if signs of ovarian hyperstimulation occur, it is recommended that hCG be withheld and the patient be advised to refrain from coitus or use barrier contraceptive methods for at least 4 days. x� endobj https://www.institutobernabeu.com/de/Sein Wirkstoff ist das rekombinante Hormon hCG (Humanes Choriongonadotropin). endstream There is no clinical experience with Ovitrelle in the treatment of other conditions (such as corpus luteum insufficiency or male conditions); therefore, Ovitrelle is not indicated in these conditions. OHSS was observed in approximately 4% of patients treated with Ovitrelle. endstream endobj In comparative clinical trials, administration of a dose of 250 micrograms of Ovitrelle was as effective as 5,000 IU and 10,000 IU of urinary hCG in inducing final follicular maturation and early luteinisation in assisted reproductive technologies, and as effective as 5,000 IU of urinary hCG in ovulation induction. <>stream x�+� � | For subcutaneous use. x�S�*�2T0 B �ghnfn d'�r����f`Idvr��~D���K�B W � � endobj 18 0 obj Interference with serum or urinary testing. Qualitative and quantitative composition, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines, 6.6 Special precautions for disposal and other handling, 9. Ovitrelle syr 250mcg PIL (EMA 100122) ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ : ΠΛΗΡΟΦΟΡΙΕΣ ΓΙΑ ΤΟΝ ΧΡΗΣΤΗ Ovitrelle 250 μικρογραμμάρια/0,5 ml, ενέσιμο διάλυμα σε προγεμισμένη σύριγγα Xοριακή γοναδοτροπίνη άλφα. ��\�j0n$� ����@��_�&�_E�3}¯���-�A��}�کa�����Cw��v�z!�Q��K;.�/�'�z�~����m������4�����3�� �gl��S��=��2H��i�5�pN�w�?�r ����?���A��������e�!n��G!i��k�}�5�:Dg��.��4w�{n�kނ����|I���;��$�)}~���8�}8�_�6��!x\jH�u�_aJ���� ���~ #�`�܇��+���V� ������Qt?��c���smt�ʜ��I���W��xp��`�����I��2�;K�1xZն���~Lb�m���9W��IX��Ĉ�n8B�������� �>F�&!��mR�vNY�'�V!$GuG�o`3�K�9��E�����KH{�8h!�`�J�Q���xe�KJ�!e�͕"[ǹ%���V�#k�w!Ő�#M!��d ��uH;�t�iң�+wM P��U�R�o���������R��Y�(��7>��z�/)Q�b6����. endstream The prevalence of ectopic pregnancy after ART in this population was reported to be higher than in the general population. 5 0 obj <>stream Start typing to retrieve search suggestions. x�+� � | De werkzaamheid van Ovitrelle werd gemeten aan de hand van het aantal vrijgekomen eicellen. The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ovulation induction or ART than following natural conception. endstream Healthcare professionals are asked to report any suspected adverse reactions via: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store, Website: www.medicinesauthority.gov.mt/adrportal. Az adag beadása 6. gespritzt. endobj 15 0 obj Maks. The pH of the solution is 7.0 ± 0.3, its osmolality 250-400 mOsm/kg. Az Ovitrelle előretöltött injekciós toll előkészítése az injekció beadására 4. For the full list of excipients, see section 6.1. x�S�*�2T0 B �ghnfn d'�r����f`Idvr��~D���K�B W � � Az Ovitrelle 250 mikrogramm oldatos injekció a lejárati időn belül hűtés nélkül, szobahőmérsékleten (legfeljebb 25 °C-on) 30 napig tárolható újrahűtés nélkül, a 30 napon belül fel nem használt injekciót ki … endobj Lekarz prowadzący dokładnie wyjaśni, kiedy należy podawać lek. This information is intended for use by health professionals, Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled syringe. Hey man sagt, dass es nach 10 Tagen raus ist. The following definitions apply to the frequency terminology used hereafter: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). On the contrary, it is synthesized in the laboratory using genetic engineering techniques and its origin is artificial. There are no data on the excretion of choriogonadotropin alfa in milk. 4 0 obj Ovitrelle 250 Mikrogramm/0,5 ml Injektionslösung in einer Fertigspritze 2 008198-E679 – Ovitrelle 250 Mikrogramm/0,5 ml – n. anders metabolisiert oder ausgeschieden wird als endogenes hCG. ��P��o�͘����&ԡ�/C`����TP(8���q��-�J�h� I��gru�����u���Py��i��V��,�K����-�Fg"_�$[;Ց�� wY���u��Ο�@���e:�-rU�n�ׅ�n�;ov����w6�$7N�����RG��ջ������0/uST�f�ڔ�҇[��#��TBd���;�ڞ $����4�㱅L潠�L�;�g4�O��l)�7;̷�\���D���W��v�BS�mHVg��ygS�*?[�W���\o����i�4��;.=�ti�mz/V,�B�;������b��VL7����p��J�}Ȋ�;�U�c5B�����B���\���W�ʦk$�}�A��B��K6U�۟��b:q�F~���}�������B����@�p��L�`�$�Q���tԓ2�����$fE�? 6 0 obj endstream Ob er schon eher negativ gewesen wäre weiß ich nicht, weil ich nie früher getestet habe. <>stream Ovitrelle is not indicated during breastfeeding. <>stream x�+� � | 30 0 obj endstream Přečtěte si pozorně celou příbalovou informaci dříve, než začnete tento přípravek používat, protože obsahuje pro Vás důležité údaje. Self-administration of Ovitrelle should only be performed by patients who are adequately trained and have access to expert advice. Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events, such as pulmonary embolism, ischaemic stroke or myocardial infarction. endobj <> Nach subkutaner Anwendung wird Chorio-gonadotropin alfa mit einer terminalen Halb- <> <>/Subtype/Form/BBox[0 0 1 1]>>stream endstream 3 0 obj endobj Findes som injektionsvæske, der indgives under huden. x�S�*�2T0 B �ghnfn d'�r����f`Idvr��~D���K�B W �� � Ovitrelle is indicated in the treatment of. In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given. x�S�*�2T0 B �ghnfn d'�r����f`Idvr��~D���K�B W �' � <>stream The principal pharmacodynamic activity in women is oocyte meiosis resumption, follicular rupture (ovulation), corpus luteum formation and production of progesterone and estradiol by the corpus luteum.
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