Ovitrelle · 4.6 Fertility, pregnancy and lactation · 2

HOS-084334 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile In comparative trials with different doses of Ovitrelle, OHSS was found to be associated with Ovitrelle in a dose-related fashion. OHSS was observed in approximately 4% of patients treated with Ovitrelle. Severe OHSS was reported in less than 0.5% of patients (see section 4.4). List of adverse reactions 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). Immune system disorders Very rare: Mild to severe hypersensitivity reactions including rash, anaphylactic reactions and shock Nervous system disorders Common: Headache Vascular disorders Very rare: Thromboembolism (both in association with and separate from OHSS) Gastrointestinal disorders Common: Abdominal pain, abdominal distension, nausea, vomiting Uncommon: Abdominal discomfort, diarrhoea Reproductive system and breast disorders Common: Mild or moderate OHSS Uncommon: Severe OHSS General disorders and administration site conditions Common: Injection site reactions. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 6

HOS-084340 · has-adverse-reaction-information · PDF-Seite 14

Summary of the safety profile In comparative trials with different doses of Ovitrelle, OHSS was found to be associated with Ovitrelle in a dose-related fashion. OHSS was observed in approximately 4% of patients treated with Ovitrelle. Severe OHSS was reported in less than 0.5% of patients (see section 4.4). List of adverse reactions 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). Immune system disorders Very rare: Mild to severe hypersensitivity reactions including rash, anaphylactic reactions and shock Nervous system disorders Common: Headache Vascular disorders Very rare: Thromboembolism (both in association with and separate from OHSS) Gastrointestinal disorders Common: Abdominal pain, abdominal distension, nausea, vomiting Uncommon: Abdominal discomfort, diarrhoea Reproductive system and breast disorders Common: Mild or moderate OHSS Uncommon: Severe OHSS General disorders and administration site conditions Common: Injection site reactions. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 14

HOS-084336 · has-contraindication-information · PDF-Seite 11

• 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 • Ovarian, uterine or mammary carcinoma • Active thromboembolic disorders Ovitrelle must not be used in conditions when an effective response cannot be obtained, such as • primary ovarian failure • malformations of sexual organs incompatible with pregnancy • fibroid tumours of the uterus incompatible with pregnancy • postmenopausal women

HOS-084330 · has-contraindication-information · PDF-Seite 3

• 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 • Ovarian, uterine or mammary carcinoma • Active thromboembolic disorders Ovitrelle must not be used in conditions when an effective response cannot be obtained, such as • primary ovarian failure • malformations of sexual organs incompatible with pregnancy • fibroid tumours of the uterus incompatible with pregnancy • postmenopausal women

HOS-084335 · has-indication-information · PDF-Seite 10

Ovitrelle is indicated in the treatment of: • Adult women undergoing superovulation prior to assisted reproductive technologies (ART) such as in vitro fertilisation (IVF): Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth, • 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.

HOS-084329 · has-indication-information · PDF-Seite 2

Ovitrelle is indicated in the treatment of • Adult women undergoing superovulation prior to assisted reproductive technologies (ART) such as in vitro fertilisation (IVF): Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth, • 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.

HOS-084332 · has-interaction-information · PDF-Seite 5

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.

HOS-084338 · has-interaction-information · PDF-Seite 13

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.

HOS-084333 · has-pregnancy-information · PDF-Seite 5

Pregnancy There is no indication for the use of Ovitrelle during pregnancy. Data on a limited number of exposed pregnancies indicate no increased risks of malformation or foeto/neonatal toxicity. No reproduction studies with choriogonadotropin alfa in animals were performed (see section 5.3). The potential risk for humans is unknown. 5 Breast-feeding Ovitrelle is not indicated during breastfeeding. There are no data on the excretion of choriogonadotropin alfa in milk. Fertility Ovitrelle is indicated for use in infertility (see section 4.1).

HOS-084339 · has-pregnancy-information · PDF-Seite 13

Pregnancy There is no indication for the use of Ovitrelle during pregnancy. Data on a limited number of exposed pregnancies indicate no increased risks of malformation or foeto/neonatal toxicity. No reproduction studies with choriogonadotropin alfa in animals were performed (see section 5.3). The potential risk for humans is unknown. 13 Breast-feeding Ovitrelle is not indicated during breastfeeding. There are no data on the excretion of choriogonadotropin alfa in milk. Fertility Ovitrelle is indicated for use in infertility (see section 4.1).

HOS-084331 · has-warning-information · PDF-Seite 3

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General recommendations Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated. In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given. 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. 3 Ovarian hyperstimulation syndrome (OHSS) A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation. It is more commonly seen in women with polycystic ovarian syndrome and usually regresses without treatment. In distinction to uncomplicated ovarian enlargement, OHSS is a condition that can manifest itself with increasing degrees of severity. It comprises marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities. Mild manifestations of OHSS may include abdominal pain, abdominal discomfort and distension, and enlarged ovaries. Moderate OHSS may additionally present with nausea, vomiting, ultrasound evidence of ascites and marked ovarian enlargement. Severe OHSS further includes symptoms such as severe ovarian enlargement, weight gain, dyspnoea or oliguria. Clinical evaluation may reveal signs such as hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, pleural effusions, or acute pulmonary distress. Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events, such as pulmonary embolism, ischaemic stroke or myocardial infarction. Independent risk factors for developing OHSS include young age, lean body mass, polycystic ovarian syndrome, higher doses of exogenous gonadotropins, high absolute or rapidly rising serum estradiol levels and previous episodes of OHSS, large number of developing ovarian follicles and large number of oocytes retrieved in ART cycles. Adherence to recommended Ovitrelle dosage and regimen of administration can minimise the risk of ova

Auszug; vollständigen Abschnitt im Original lesen.

HOS-084337 · has-warning-information · PDF-Seite 11

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General precautions Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated. In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given. 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. 11 Ovarian hyperstimulation syndrome (OHSS) A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation. It is more commonly seen in women with polycystic ovarian syndrome and usually regresses without treatment. In distinction to uncomplicated ovarian enlargement, OHSS is a condition that can manifest itself with increasing degrees of severity. It comprises marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities. Mild manifestations of OHSS may include abdominal pain, abdominal discomfort and distension, and enlarged ovaries. Moderate OHSS may additionally present with nausea, vomiting, ultrasound evidence of ascites and marked ovarian enlargement. Severe OHSS further includes symptoms such as severe ovarian enlargement, weight gain, dyspnoea or oliguria. Clinical evaluation may reveal signs such as hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, pleural effusions, or acute pulmonary distress. Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events, such as pulmonary embolism, ischaemic stroke or myocardial infarction. Independent risk factors for developing OHSS include young age, lean body mass, polycystic ovarian syndrome, higher doses of exogenous gonadotropins, high absolute or rapidly rising serum estradiol levels and previous episodes of OHSS, large number of developing ovarian follicles and large number of oocytes retrieved in ART cycles. Adherence to recommended Ovitrelle dosage and regimen of administration can minimise the risk of ovarian

Auszug; vollständigen Abschnitt im Original lesen.