LUTIGEST

Posology Adults The dose of Lutigest is 100 mg administered vaginally three times daily starting at oocyte retrieval. The administration of Lutigest should be continued for 30 days, if pregnancy has been confirmed. Paediatric population There is no relevant use of Lutinus in the paediatric population.

Elderly No clinical data have been collected in patients over age 65. Use in special populations There is no experience with use of Lutigest in patients with impaired liver or renal function. Method of Administration Lutigest is to be placed directly into the vagina by the applicator provided.

4% subjects, respectively. The table below displays the main adverse drug reactions in women treated with Lutigest in the clinical trial distributed by system organ classes (SOCs) and frequency. 5%. 4%. ***Cases seen during post marketing experience.

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. uk/yellowcard.

Lutigest should be discontinued if any of the following conditions are suspected: myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis, or retinal thrombosis.

Cautious use in patients with mild to moderate hepatic dysfunction. Patients with a history of depression need to be closely observed. Consider discontinuation if symptoms worsen. g. epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation.

A decrease in insulin sensitivity and thereby in glucose tolerance has been observed in a small number of patients on oestrogen-progestogen combination drugs. The mechanism of this decrease is not known. For this reason, diabetic patients should be carefully observed while receiving progesterone therapy.

Sex steroid use may also increase the risk of retinal vascular lesions. To prevent these latter complications, caution is to be taken in users >35 years, in smokers, and in those with risk factors for atherosclerosis. Use should be terminated in case of transient ischemic events, appearance of sudden severe headaches, or vision impairments related to papillary edema or retinal hemorrhage.

Abrupt discontinuation of progesterone dosing may cause increased anxiety, moodiness, and increased sensibility to seizures. Before starting treatment with Lutigest, the patient and her partner should be assessed by a doctor for causes of infertility.

1 • Undiagnosed vaginal bleeding • Known missed abortion or ectopic pregnancy • Severe hepatic dysfunction or disease • Known or suspected breast or genital tract cancer • Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events • Porphyria