Pergoveris · 4.6 Fertility, pregnancy and lactation · 1

HOS-094514 · has-adverse-reaction-information · PDF-Seite 36

Summary of the safety profile The most commonly reported adverse reactions are headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection). Mild or moderate OHSS has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. Severe OHSS is uncommon (see section 4.4). Thromboembolism may occur very rarely, usually associated with severe OHSS (see section 4.4). 36 Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA system organ class and by frequency. The frequency categories used are: 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 anaphylactic reactions and shock Nervous system disorders Very common: Headache Vascular disorders Very rare: Thromboembolism, usually associated with severe OHSS Respiratory, thoracic and mediastinal disorders Very rare: Exacerbation or aggravation of asthma Gastrointestinal disorders Common: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea Reproductive system and breast disorders Very common: Ovarian cysts Common: Breast pain, pelvic pain, mild or moderate OHSS (including associated symptomatology) Uncommon: Severe OHSS (including associated symptomatology) (see section 4.4) Rare: Complication of severe OHSS General disorders and administration site conditions Very common: Mild to severe injection site reactions (e.g. pain, erythema, haematoma, bruising, swelling and/or irritation at the site of injection) 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.

HOS-094502 · has-adverse-reaction-information · PDF-Seite 16

Summary of the safety profile The most commonly reported adverse reactions are headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection). Mild or moderate OHSS has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. Severe OHSS is uncommon (see section 4.4). Thromboembolism may occur very rarely, usually associated with severe OHSS (see section 4.4). 16 Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA system organ class and by frequency. The frequency categories used are: 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 anaphylactic reactions and shock Nervous system disorders Very common: Headache Vascular disorders Very rare: Thromboembolism, usually associated with severe OHSS Respiratory, thoracic and mediastinal disorders Very rare: Exacerbation or aggravation of asthma Gastrointestinal disorders Common: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea Reproductive system and breast disorders Very common: Ovarian cysts Common: Breast pain, pelvic pain, mild or moderate OHSS (including associated symptomatology) Uncommon: Severe OHSS (including associated symptomatology) (see section 4.4) Rare: Complication of severe OHSS General disorders and administration site conditions Very common: Mild to severe injection site reactions (e.g. pain, erythema, haematoma, bruising, swelling and/or irritation at the site of injection) 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.

HOS-094496 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The most commonly reported adverse reactions are headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection). Mild or moderate OHSS has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. Severe OHSS is uncommon (see section 4.4). Thromboembolism may occur very rarely, usually associated with severe OHSS (see section 4.4). 6 Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA system organ class and by frequency. The frequency categories used are: 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 anaphylactic reactions and shock Nervous system disorders Very common: Headache Vascular disorders Very rare: Thromboembolism, usually associated with severe OHSS Respiratory, thoracic and mediastinal disorders Very rare: Exacerbation or aggravation of asthma Gastrointestinal disorders Common: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea Reproductive system and breast disorders Very common: Ovarian cysts Common: Breast pain, pelvic pain, mild or moderate OHSS (including associated symptomatology) Uncommon: Severe OHSS (including associated symptomatology) (see section 4.4) Rare: Complication of severe OHSS General disorders and administration site conditions Very common: Mild to severe injection site reactions (e.g. pain, erythema, haematoma, bruising, swelling and/or irritation at the site of injection) 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.

HOS-094508 · has-adverse-reaction-information · PDF-Seite 26

Summary of the safety profile The most commonly reported adverse reactions are headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection). Mild or moderate OHSS has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. Severe OHSS is uncommon (see section 4.4). Thromboembolism may occur very rarely, usually associated with severe OHSS (see section 4.4). 26 Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA system organ class and by frequency. The frequency categories used are: 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 anaphylactic reactions and shock Nervous system disorders Very common: Headache Vascular disorders Very rare: Thromboembolism, usually associated with severe OHSS Respiratory, thoracic and mediastinal disorders Very rare: Exacerbation or aggravation of asthma Gastrointestinal disorders Common: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea Reproductive system and breast disorders Very common: Ovarian cysts Common: Breast pain, pelvic pain, mild or moderate OHSS (including associated symptomatology) Uncommon: Severe OHSS (including associated symptomatology) (see section 4.4) Rare: Complication of severe OHSS General disorders and administration site conditions Very common: Mild to severe injection site reactions (e.g. pain, erythema, haematoma, bruising, swelling and/or irritation at the site of injection) 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.

HOS-094498 · has-contraindication-information · PDF-Seite 13

Pergoveris is contraindicated in patients with: • hypersensitivity to the active substances or to any of the excipients listed in section 6.1 • tumours of the hypothalamus and pituitary gland • ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin • gynaecological haemorrhages of unknown origin • ovarian, uterine or mammary carcinoma Pergoveris must not be used 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

HOS-094492 · has-contraindication-information · PDF-Seite 3

Pergoveris is contraindicated in patients with: • hypersensitivity to the active substances or to any of the excipients listed in section 6.1 • tumours of the hypothalamus and pituitary gland • ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin • gynaecological haemorrhages of unknown origin • ovarian, uterine or mammary carcinoma Pergoveris must not be used 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

HOS-094510 · has-contraindication-information · PDF-Seite 33

Pergoveris is contraindicated in patients with: • hypersensitivity to the active substances or to any of the excipients listed in section 6.1 • tumours of the hypothalamus and pituitary gland • ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin • gynaecological haemorrhages of unknown origin • ovarian, uterine or mammary carcinoma Pergoveris must not be used 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

HOS-094504 · has-contraindication-information · PDF-Seite 23

Pergoveris is contraindicated in patients with: • hypersensitivity to the active substances or to any of the excipients listed in section 6.1 • tumours of the hypothalamus and pituitary gland • ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin • gynaecological haemorrhages of unknown origin • ovarian, uterine or mammary carcinoma Pergoveris must not be used 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

HOS-094509 · has-indication-information · PDF-Seite 32

Pergoveris is indicated for the stimulation of follicular development in adult women with severe LH and FSH deficiency.

HOS-094491 · has-indication-information · PDF-Seite 2

Pergoveris is indicated for the stimulation of follicular development in adult women with severe LH and FSH deficiency.

HOS-094497 · has-indication-information · PDF-Seite 12

Pergoveris is indicated for the stimulation of follicular development in adult women with severe LH and FSH deficiency.

HOS-094503 · has-indication-information · PDF-Seite 22

Pergoveris is indicated for the stimulation of follicular development in adult women with severe LH and FSH deficiency.

HOS-094494 · has-interaction-information · PDF-Seite 6

Pergoveris should not be administered as a mixture with other medicinal products, in the same injection, except follitropin alfa for which studies have shown that co-administration does not significantly alter the activity, stability, pharmacokinetic nor pharmacodynamic properties of the active substances.

HOS-094506 · has-interaction-information · PDF-Seite 26

Pergoveris solution for injection in pre-filled pen must not be administered as a mixture with other medicinal products in the same injection. Pergoveris solution for injection in pre-filled pen may be administered concomitantly with a licensed follitropin alfa preparation as separate injections.

HOS-094512 · has-interaction-information · PDF-Seite 36

Pergoveris solution for injection in pre-filled pen must not be administered as a mixture with other medicinal products in the same injection. Pergoveris solution for injection in pre-filled pen may be administered concomitantly with a licensed follitropin alfa preparation as separate injections.

HOS-094500 · has-interaction-information · PDF-Seite 16

Pergoveris solution for injection in pre-filled pen must not be administered as a mixture with other medicinal products in the same injection. Pergoveris solution for injection in pre-filled pen may be administered concomitantly with a licensed follitropin alfa preparation as separate injections.

HOS-094495 · has-pregnancy-information · PDF-Seite 6

Pregnancy There is no indication for the use of Pergoveris during pregnancy. Data on a limited number of exposed pregnancies indicate no adverse reactions of follitropin alfa and lutropin alfa on pregnancy, embryonal or foetal development, parturition or postnatal development following controlled ovarian stimulation. No teratogenic effect of such gonadotropins has been reported in animal studies. In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of Pergoveris. Breast-feeding Pergoveris is not indicated during breast-feeding. Fertility Pergoveris is indicated for use in infertility (see section 4.1).

HOS-094507 · has-pregnancy-information · PDF-Seite 26

Pregnancy There is no indication for the use of Pergoveris during pregnancy. Data on a limited number of exposed pregnancies indicate no adverse reactions of follitropin alfa and lutropin alfa on pregnancy, embryonal or foetal development, parturition or postnatal development following controlled ovarian stimulation. No teratogenic effect of such gonadotropins has been reported in animal studies. In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of Pergoveris. Breast-feeding Pergoveris is not indicated during breast-feeding. Fertility Pergoveris is indicated for use in infertility (see section 4.1).

HOS-094501 · has-pregnancy-information · PDF-Seite 16

Pregnancy There is no indication for the use of Pergoveris during pregnancy. Data on a limited number of exposed pregnancies indicate no adverse reactions of follitropin alfa and lutropin alfa on pregnancy, embryonal or foetal development, parturition or postnatal development following controlled ovarian stimulation. No teratogenic effect of such gonadotropins has been reported in animal studies. In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of Pergoveris. Breast-feeding Pergoveris is not indicated during breast-feeding. Fertility Pergoveris is indicated for use in infertility (see section 4.1).

HOS-094513 · has-pregnancy-information · PDF-Seite 36

Pregnancy There is no indication for the use of Pergoveris during pregnancy. Data on a limited number of exposed pregnancies indicate no adverse reactions of follitropin alfa and lutropin alfa on pregnancy, embryonal or foetal development, parturition or postnatal development following controlled ovarian stimulation. No teratogenic effect of such gonadotropins has been reported in animal studies. In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of Pergoveris. Breast-feeding Pergoveris is not indicated during breast-feeding. Fertility Pergoveris is indicated for use in infertility (see section 4.1).

HOS-094499 · has-warning-information · PDF-Seite 13

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. 13 General recommendations Pergoveris contains potent gonadotropic substances capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management. 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 appropriate specific treatment should be given. Gonadotropin therapy requires a certain time commitment by physicians and supportive health care professionals, as well as the availability of appropriate monitoring facilities. In women, safe and effective use of Pergoveris calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis. There may be a degree of interpatient variability in response to FSH/LH administration, with a poor response to FSH/LH in some patients. The lowest effective dose in relation to the treatment objective should be used in women. Porphyria Patients with porphyria or a family history of porphyria should be closely monitored during treatment with Pergoveris. In these patients, Pergoveris may increase the risk of an acute attack. Deterioration or a first appearance of this condition may require cessation of treatment. 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. The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nau

Auszug; vollständigen Abschnitt im Original lesen.

HOS-094493 · 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. 3 General recommendations Pergoveris contains potent gonadotropic substances capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management. 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 appropriate specific treatment should be given. Gonadotropin therapy requires a certain time commitment by physicians and supportive health care professionals, as well as the availability of appropriate monitoring facilities. In women, safe and effective use of Pergoveris calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis. There may be a degree of interpatient variability in response to FSH/LH administration, with a poor response to FSH/LH in some patients. The lowest effective dose in relation to the treatment objective should be used in women. Porphyria Patients with porphyria or a family history of porphyria should be closely monitored during treatment with Pergoveris. In these patients, Pergoveris may increase the risk of an acute attack. Deterioration or a first appearance of this condition may require cessation of treatment. 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. The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea

Auszug; vollständigen Abschnitt im Original lesen.

HOS-094511 · has-warning-information · PDF-Seite 33

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. 33 General recommendations Pergoveris contains potent gonadotropic substances capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management. 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 appropriate specific treatment should be given. Gonadotropin therapy requires a certain time commitment by physicians and supportive health care professionals, as well as the availability of appropriate monitoring facilities. In women, safe and effective use of Pergoveris calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis. There may be a degree of interpatient variability in response to FSH/LH administration, with a poor response to FSH/LH in some patients. The lowest effective dose in relation to the treatment objective should be used in women. Porphyria Patients with porphyria or a family history of porphyria should be closely monitored during treatment with Pergoveris. In these patients, Pergoveris may increase the risk of an acute attack. Deterioration or a first appearance of this condition may require cessation of treatment. 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. The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nau

Auszug; vollständigen Abschnitt im Original lesen.

HOS-094505 · has-warning-information · PDF-Seite 23

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. 23 General recommendations Pergoveris contains potent gonadotropic substances capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management. 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 appropriate specific treatment should be given. Gonadotropin therapy requires a certain time commitment by physicians and supportive health care professionals, as well as the availability of appropriate monitoring facilities. In women, safe and effective use of Pergoveris calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis. There may be a degree of interpatient variability in response to FSH/LH administration, with a poor response to FSH/LH in some patients. The lowest effective dose in relation to the treatment objective should be used in women. Porphyria Patients with porphyria or a family history of porphyria should be closely monitored during treatment with Pergoveris. In these patients, Pergoveris may increase the risk of an acute attack. Deterioration or a first appearance of this condition may require cessation of treatment. 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. The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nau

Auszug; vollständigen Abschnitt im Original lesen.