RIGEVIDON Coated tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Rigevidon coated tablets.
2. Qualitative and quantitative composition
Each tablet contains 150 micrograms levonorgestrel and 30 micrograms ethinylestradiol. <u>Excipients with known effect:</u> Each tablet contains 33 mg of lactose monohydrate and 22.46 mg of sucrose. For ...
3. Pharmaceutical form
Coated tablet. White, biconvex, circular tablets.
4.1. Therapeutic indications
Oral contraception. The decision to prescribe Rigevidon should take into consideration the individual womans current risk factors, particularly those for venous thromboembolism (VTE), and how the risk ...
4.2. Posology and method of administration
Posology How is Rigevidon taken? Tablets must be taken orally in the order directed on the blister package at about the same time every day, with some liquid if necessary. One tablet is to be taken daily ...
4.3. Contraindications
Combined oral contraceptives (COCs) must not be used in the presence of the conditions mentioned below. If such a condition should occur for the first time during use of COCs, the use must be discontinued ...
4.4. Special warnings and precautions for use
Warnings If any of the conditions or risk factors mentioned below is present, the suitability of Rigevidon should be discussed with the woman. In the event of aggravation, or first appearance of any of ...
4.5. Interaction with other medicinal products and other forms of interaction
<u>Note:</u> The prescribing information of concomitant medications should be consulted to identify potential interactions. Pharmacodynamic interactions Concomitant use with medicinal products containing ...
4.6. Fertility, pregnancy and lactation
Pregnancy Rigevidon is not indicated during pregnancy. If pregnancy occurs during medication with ehtinylestradiol/levonorgestrel, treatment should be withdrawn immediately. Extensive epidemiological studies ...
4.7. Effects on ability to drive and use machines
No study on the ability to drive and use machines has been performed. No effects on the ability to drive and use machines in COC users have been observed.
4.8. Undesirable effects
The following adverse effects have been reported during combined oral contraceptive treatment: System Organ Class 17.1 Common (1/100 to <1/10) Uncommon (1/1,000 to <1/100) Rare (1/10,000 to <1/1,000) ...
4.9. Overdose
Symptoms of overdose of oral contraceptive have been reported in adults, adolescents and children aged 12 and under. Symptoms of overdose can manifest by nausea, vomiting, breast pains, dizziness, abdominal ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Hormonal contraceptives for systemic use; Progestogens and estrogens, fixed combinations; <b>ATC code:</b> G03AA07 The contraceptive effect of Rigevidon is based on the ...
5.2. Pharmacokinetic properties
Levonorgestrel Absorption Levonorgestrel is rapidly and completely absorbed after oral administration of Rigevidon. The bioavailability is approximately 100% and levonorgestrel is not subject to first-pass ...
5.3. Preclinical safety data
Acute toxicity of ethinylestradiol and levonorgestrel is low. Because of marked species differences preclinical results possess a limited predictive value for the application of estrogens in humans. In ...
6.1. List of excipients
<u>Core:</u> Silica, colloidal anhydrous Magnesium stearate Talc Maize starch Lactose monohydrate <u>Coating:</u> Sucrose Talc Calcium carbonate Titanium dioxide (E171) Copovidone K90 Macrogol 6000 Silica, ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Store below 25°C.
6.5. Nature and contents of container
Aluminium-PVC/PVDC blister. <u>Pack sizes:</u> 1×21, 3×21, 6×21 and 13×21 coated tablets. Not all pack size may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary
8. Marketing authorization number(s)
PL 04854/0120
9. Date of first authorization / renewal of the authorization
11/09/2007
10. Date of revision of the text
14/05/2020
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