Properties
What is it?
Ovvestin Cream Vaginal 1mg/1g 15g Tube Composition: 1g of the preparation contains: Active substance: Estriol (micronized estriol) 1.0 mg Excipients: Octyldodecanol 50.0 mg, Cetyl palmitate 15.0 mg, Glycerol 120.0 mg, Cetyl alcohol 36.7 mg, Stearyl alcohol 88.4 mg, Polysorbate 60 32.4 mg, Sorbitan stearate 7.6 mg, Lactic acid 4.0 mg, Chlorhexidine dihydrochloride 0.1 mg, Sodium hydroxide to pH 4.0, Purified water up to 1000.0 mg. Indications for use: Hormone Replacement Therapy (HRT): Treatment of atrophic vaginitis and urethritis in postmenopausal women due to estrogen deficiency. Pre- and postoperative therapy in postmenopausal women undergoing surgery with vaginal approach. As an aid in diagnostic procedures in cases of unsatisfactory results of cervical smear cytology (PAP test, class III) in menopausal women with pathological cells on a background of atrophic changes. Contraindications: Hypersensitivity to estriol and/or any of the excipients; Diagnosed, history of or suspected breast cancer (BC); Diagnosed or suspected estrogen-dependent neoplasia (e.g., endometrial cancer); Undiagnosed vaginal bleeding; Untreated endometrial hyperplasia; Current or history of venous thromboembolism (VTE) (deep vein thrombosis, pulmonary embolism); Confirmed thrombophilic disorders (e.g., deficiency of protein C, protein S or antithrombin III, etc.); Current or history of arterial thrombosis or thromboembolism (ATE), including myocardial infarction, stroke, cerebrovascular disorders or prodromal states (including transient ischemic attack, angina pectoris); Acute or history of liver disease with normalization of liver function tests; Porphyria; Pregnancy and lactation. Dosage regimen: 1 application (1 filled applicator) contains 0.5g of cream, which corresponds to 0.5mg of estriol. Hormone Replacement Therapy (HRT): Treatment of atrophic vaginitis and urethritis in postmenopausal women due to estrogen deficiency: 1 application of 0.5mg estriol daily intravaginally for the first 2-3 weeks (maximum 4 weeks), followed by gradual dose reduction based on symptom relief until a maintenance dose is reached (which implies 1 application (0.5mg estriol) twice weekly). As pre- and postoperative therapy in postmenopausal women undergoing surgery with vaginal approach: 1 application (0.5mg estriol) daily for 2 weeks before surgery; 1 application twice weekly for 2 weeks after surgery. As an aid in diagnostic procedures in cases of unsatisfactory results of cervical smear cytology (PAP test, class III) in menopausal women with pathological cells on a background of atrophic changes: 1 application (0.5mg estriol) every other day for 1 week before the next smear. Method of administration: Intravaginally, in the evening, before bedtime. The cream should be inserted deep into the vagina with the help of the applicator, while lying on your back. Method of use and duration of treatment: Ovvestin cream is recommended for use at night before bedtime. The cream should be inserted deep into the vagina with an applicator, or applied externally to damaged skin areas in the genital area. At the beginning or continuation of treatment for menopausal symptoms, the lowest effective dose should be used for the shortest possible duration. Systemic exposure levels of estriol contained in Ovvestin® remain close to normal ranges for the postmenopausal period when dosed twice weekly. Addition of a progestogen to the treatment is not recommended (see section 4.4 "Special warnings"). In women not taking HRT, or women switching from continuous use of combined HRT preparations, treatment with Ovvestin® cream can be started on any day. Women discontinuing cyclical HRT preparations should start treatment with Ovvestin® cream one week after completing the course of HRT preparations. Recommendations for using Ovvestin cream: The cream is inserted into the vagina at night before bedtime. Unscrew the cap from the tube, turn the cap over and use the pointed end to open the tube. Screw the applicator onto the tube. Squeeze the tube to fill the applicator with cream until the plunger stops. Remove the applicator from the tube and close the tube with the cap. In a "lying down" position, insert the tip of the applicator deep into the vagina and slowly press the plunger until it stops. After administering the preparation, remove the plunger from the cylinder and wash the cylinder and plunger with warm soapy water. Do not use detergents. After this, rinse the cylinder and plunger thoroughly with clean water. Do not immerse the applicator in hot or boiling water. Storage conditions: Store the preparation at a temperature not exceeding 25°C. Do not freeze. Keep out of reach of children.