OVA-MIT Tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Ova-mit 50 mg tablets.
2. Qualitative and quantitative composition
Each tablet contains clomifene citrate 50 mg. <u>Excipient(s) with known effect:</u> This product contains 143.7 mg lactose and ponceau 4R, cochineal Red A aluminium lake E124. For the full list of excipients, ...
3. Pharmaceutical form
Tablet. Light orange, round, flat scored tablets with Remedicas logo on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4.1. Therapeutic indications
Ova-mit is indicated for the treatment of ovulatory failure in women desiring pregnancy. Good levels of endogenous oestrogen provide a favourable prognosis for ovulatory response induced by Ova-mit, Ova-mit ...
4.2. Posology and method of administration
Adults only The recommended dose for the first course of Ova-mit is 50 mg (1 tablet) daily for 5 days. Therapy may be started at any time in the patient who has had no recent uterine bleeding. If progestin-induced ...
4.3. Contraindications
Pregnancy Ova-mit is not indicated during pregnancy. Although there is no evidence that clomifene citrate tablets have a harmful effect on the human foetus, there is evidence that clomifene citrate tablets ...
4.4. Special warnings and precautions for use
Warnings The purpose and risks of Ova-mit therapy should be presented to the patient before starting treatment. It should be emphasized that the goal of Ova-mit therapy is ovulation for subsequent pregnancy. ...
4.5. Interaction with other medicinal products and other forms of interaction
None stated.
4.6. Pregnancy and lactation
Pregnancy Ova-mit is not indicated during pregnancy. See contraindications (See section 4.3, Contraindications). Lactation It is not known whether Clomifene Citrate is excreted in human milk. Clomifene ...
4.7. Effects on ability to drive and use machines
Patients should be warned that visual symptoms may render such activities as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting. (See section ...
4.8. Undesirable effects
The following CIOMS frequency rating is used, when applicable: 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 ...
4.9. Overdose
Toxic effects of acute overdosage of clomifene citrate have not been reported but the number of overdose cases recorded is small. In the event of overdose, appropriate supportive measures should be employed. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Sex hormones and modulators of the genital system; Gonadotropins and other ovulation stimulants <b>ATC code:</b> G03GB02 Mechanism of action The ovulatory response to ...
5.2. Pharmacokinetic properties
Orally administered <sup>14</sup>C labelled clomifene citrate was readily absorbed when administered to humans. Cumulative excretion of the <sup>14</sup>C label by way of urine and faeces averaged about ...
5.3. Preclinical safety data
Long term carcinogenicity studies have not been performed to evaluate the carcinogenic potential clomifene citrate tablets. Clomifene citrate did not induce gene mutations in bacteria (Ames test) or chromosome ...
6.1. List of excipients
Povidone Cellulose, microcrystalline Lactose monohydrate Maize starch Starch, pregelatinised Silica, colloidal anhydrous Magnesium stearate Talc Quinoline yellow aluminium lake E104 Ponceau 4R, cochineal ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C. Protected from light and moisture.
6.5. Nature and contents of container
PVC/Aluminium blisters. Pack-size of 10 tablets. PP containers with PE closure. Pack-sizes of 100 and 1000 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Remedica Ltd Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
7874
9. Date of first authorization / renewal of the authorization
Date of first authorization: 02 April 1981 Date of latest renewal: 05 June 2013
10. Date of revision of the text
17/11/2021
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