CRINONE PROGESTERONE VAGINAL

125g 8% gel) every day, starting after documented ovulation or arbitrarily on the 18th – 21st day of the cycle. Use during in-vitro fertilisation Daily application of Crinone 8% gel should be continued for 30 days if there is laboratory evidence of pregnancy.

Paediatric population Not applicable Older people Not applicable Method of Administration Crinone is applied directly from the specially designed sealed applicator into the vagina. The applicator should be removed from the sealed wrapper.

The twist-off cap should not be removed at this time. 1. The applicator should be gripped firmly by the thick end. It should be shaken down like a thermometer to ensure that the contents are at the thin end. 2. The tab should be twisted off and discarded.

3. The applicator may be inserted while patient is in a sitting position or when lying on her back with the knees bent. The thin end of applicator should be gently inserted well into the vagina. 4. The thick end of the applicator should be pressed firmly to deposit gel.

The applicator should be removed and discarded in a waste container.

The adverse reactions reported below are classified according to frequency of occurrence as follows: Very common (³ 1/10) Common (³ 1/100 to < 1/10) Uncommon (³ 1/1,000 to < 1/100) Rare (³ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Crinone is generally well-tolerated.

In clinical studies, the following adverse events have been reported during Crinone therapy. Most adverse events observed in clinical studies cannot be distinguished from the symptoms common in early pregnancy. Common Breast tenderness, itching or burning.

Post Marketing Reports For adverse reactions identified during post-marketing surveillance, the frequency is not known (cannot be estimated from the available data). In addition, intermenstrual bleeding (spotting), vaginal irritation, hypersensitivity reactions usually manifesting as skin rash, and other mild application site reactions have been reported post-marketing.

Rare events of urticaria and pruritis were noted. 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.

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The pre-treatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear. Cautious use in severe hepatic insufficiency. In cases of breakthrough bleeding, as in all cases of irregular vaginal bleeding, non-functional causes should be considered.

In cases of undiagnosed vaginal bleeding, adequate diagnostic measures should be undertaken. Crinone is not indicated in threatened abortion. Treatment should be discontinued in the event of a missed abortion. The physician should be alert to the early manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorder, pulmonary embolism and retinal thrombosis).

Should any of these symptoms occur or be suspected, the drug should be discontinued immediately. Patients who have risk factors for thrombotic disorders should be kept under careful observation. Although risk of thromboembolism has been associated with estrogens, a link with progestins remains questionable.

Therefore, in women with generally recognised risk factors for thrombo-embolic events, such as personal or family history, treatment with Crinone may further increase the risk. In these women, the benefits of Crinone administration need to be weighed against the risks.

It should be noted however, that pregnancy itself carries an increased risk of thrombo-embolic events. g, epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation. Patients who have a history of depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.

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

g. contact dermatitis) or vaginal irritation.

1. 1. 2. Undiagnosed vaginal bleeding 3. Known or suspected progesterone-sensitive malignant tumours 4. Porphyria 5. Thrombophlebitis, thromboembolic disorder, cerebral apoplexy, or patients with an history of these conditions 6. Missed abortion