Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Puregon

Puregon 300 IU/0.36 mL solution for injection Puregon 600 IU/0.72 mL solution for injection Puregon 900 IU/1.08 mL solution for injection · Abschnitt 4.3 · PDF-Seite 4

HOS-085457 · Präparat HOS-083121

For males and females • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus. • Primary gonadal failure.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Puregon

Puregon 300 IU/0.36 mL solution for injection Puregon 600 IU/0.72 mL solution for injection Puregon 900 IU/1.08 mL solution for injection · Abschnitt 4.3 · PDF-Seite 4–5

HOS-085458 · Präparat HOS-083121

4 Additionally for females • Undiagnosed vaginal bleeding. • Ovarian cysts or enlarged ovaries, not related to polycystic ovarian syndrome (PCOS). • Malformations of the reproductive organs incompatible with pregnancy. • Fibroid tumours of the uterus incompatible with pregnancy.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Puregon

Puregon 300 IU/0.36 mL solution for injection Puregon 600 IU/0.72 mL solution for injection Puregon 900 IU/1.08 mL solution for injection · Abschnitt 4.5 · PDF-Seite 7

HOS-085459 · Präparat HOS-083121

Concomitant use of Puregon and clomifene citrate may enhance the follicular response. After pituitary desensitisation induced by a GnRH agonist, a higher dose of Puregon may be necessary to achieve an adequate follicular response.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): citrate (HOS-085460)

Nebenwirkungen · Puregon

Puregon 300 IU/0.36 mL solution for injection Puregon 600 IU/0.72 mL solution for injection Puregon 900 IU/1.08 mL solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-085461 · Präparat HOS-083121

Clinical use of Puregon by the intramuscular or subcutaneous routes may lead to local reactions at the site of injection (3% of all patients treated). The majority of these local reactions are mild and transient in nature. Generalised hypersensitivity reactions have been observed uncommonly (approximately 0.2% of all patients treated with follitropin beta). Cases of anaphylactic reactions (including those requiring hospitalisation) have been reported in the post-marketing setting.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Puregon

Puregon 300 IU/0.36 mL solution for injection Puregon 600 IU/0.72 mL solution for injection Puregon 900 IU/1.08 mL solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-085462 · Präparat HOS-083121

Treatment of females: In approximately 4% of the women treated with follitropin beta in clinical trials, signs and symptoms related to ovarian hyperstimulation syndrome (OHSS) have been reported (see section 4.4). Adverse

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Puregon

Puregon 300 IU/0.36 mL solution for injection Puregon 600 IU/0.72 mL solution for injection Puregon 900 IU/1.08 mL solution for injection · Abschnitt 4.8 · PDF-Seite 7–8

HOS-085463 · Präparat HOS-083121

7 reactions related to this syndrome include pelvic pain and/or congestion, abdominal pain and/or distension, breast complaints and ovarian enlargement.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Puregon

Puregon 300 IU/0.36 mL solution for injection Puregon 600 IU/0.72 mL solution for injection Puregon 900 IU/1.08 mL solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-085464 · Präparat HOS-083121

The table below lists the adverse reactions with follitropin beta reported in clinical trials and post- marketing surveillance in females, according to system organ class and frequency; common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (cannot be estimated from available data). SOC Frequency Adverse reaction Immune system disorders Not known Anaphylactic reactions Nervous system disorders Common Headache Gastrointestinal disorders Common Abdominal distension Abdominal pain Uncommon Abdominal discomfort Constipation Diarrhoea Nausea Reproductive system and breast Common OHSS disorders Pelvic pain Uncommon Breast complaints1 Metrorrhagia Ovarian cyst Ovarian enlargement Ovarian torsion Uterine enlargement Vaginal haemorrhage General disorders and Common Injection site reaction2 administration site conditions Uncommon Generalised hypersensitivity reaction3 1. Breast complaints include tenderness, pain and/or engorgement and nipple pain. 2. Local reactions at the site of injection include: bruising, pain, redness, swelling and itching. 3. Generalised hypersensitivity reaction include erythema, urticaria, rash and pruritus.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Puregon

Puregon 300 IU/0.36 mL solution for injection Puregon 600 IU/0.72 mL solution for injection Puregon 900 IU/1.08 mL solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-085465 · Präparat HOS-083121

In addition, ectopic pregnancy, miscarriage and multiple gestations have been reported. These are considered to be related to ART or subsequent pregnancy.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Puregon

Puregon 300 IU/0.36 mL solution for injection Puregon 600 IU/0.72 mL solution for injection Puregon 900 IU/1.08 mL solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-085466 · Präparat HOS-083121

In rare instances, thromboembolism has been associated with follitropin beta /hCG therapy as with other gonadotrophins.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Puregon

Puregon 300 IU/0.36 mL solution for injection Puregon 600 IU/0.72 mL solution for injection Puregon 900 IU/1.08 mL solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-085467 · Präparat HOS-083121

Treatment of males: The table below lists the adverse reactions with follitropin beta reported in a clinical trial in males (30 patients dosed) and post-marketing surveillance, according to system organ class and frequency; common (≥ 1/100 to < 1/10) and not known (cannot be estimated from available data). SOC Frequency1 Adverse reaction Immune system disorders Not known Anaphylactic reactions Nervous system disorders Common Headache Skin and subcutaneous tissue Common Acne disorders Rash Reproductive system and breast Common Epididymal cyst disorders Gynaecomastia General disorders and Common Injection site reaction2 administration site conditions 1. Adverse reactions that are reported only once are listed as common because a single report raises the frequency above 1%. 2. Local reactions at the site of injection include induration and pain.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Puregon

Puregon 300 IU/0.36 mL solution for injection Puregon 600 IU/0.72 mL solution for injection Puregon 900 IU/1.08 mL solution for injection · Abschnitt 4.8 · PDF-Seite 8–9

HOS-085468 · Präparat HOS-083121

8 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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.