LOETTE Tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
LOETTE 20 µg and 100 µg tablets.
2. Qualitative and quantitative composition
Each tablet contains 20 µg Ethinylestradiol and 100 µg Levonorgestrel. <u>Excipients with known effects:</u> Lactose monohydrate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Each LOETTE calendar blister pack contains 21 pink active tablets and 7 white inactive tablets.
4.1. Therapeutic indications
LOETTE is indicated for the prevention of pregnancy.
4.2. Posology and method of administration
How to Take LOETTE To achieve maximum contraceptive effectiveness, LOETTE must be administered as directed and at the same time every day, at intervals not exceeding 24 hours. How to Start LOETTE Each ...
4.3. Contraindications
LOETTE is contraindicated in patients with: A history of, or current deep vein thrombosis, thrombophlebitis or thromboembolic disorders; thrombogenic valvulopathies or thrombogenic rhythm disorders. Hereditary ...
4.4. Special warnings and precautions for use
The information contained in this document is principally based on studies carried out in women who used oral contraceptives with higher formulations of estrogens and progestogens than those in common ...
4.5. Interaction with other medicinal products and other forms of interaction
Interactions between ethinylestradiol and other substances may lead to decreased or increased ethinylestradiol concentrations, respectively. Concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir ...
4.6. Pregnancy and lactation
Pregnancy Category B3. Pregnancy must be excluded before starting LOETTE. If pregnancy occurs during use of LOETTE, the preparation must be withdrawn immediately. Extensive epidemiological studies have ...
4.7. Effects on ability to drive and use machines
LOETTE is presumed to be safe or unlikely to produce an effect on the ability to drive or use machines.
4.8. Undesirable effects
Use of combined oral contraceptives has been associated with increased risk of the following: Arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, venous thrombosis, ...
4.9. Overdose
Symptoms Symptoms of oral contraceptive overdose in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in ...
5.1. Pharmacodynamic properties
LOETTE is a combined oral contraceptive tablet containing the synthetic progestogen, levonorgestrel, and the synthetic estrogen, ethinylestradiol. The hormonal components of LOETTE suppress gonadotropins ...
5.2. Pharmacokinetic properties
Absorption No specific investigation of the absolute bioavailability of LOETTE in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral ...
5.3. Preclinical safety data
No effects that might indicate an unexpected risk to humans were observed during systemic tolerance studies after repeated administration of combined oral contraceptives. Carcinogenesis Long-term repeated ...
6.1. List of excipients
Each pink active tablet contains 100 µg levonorgestrel and 20 µg ethinylestradiol and the excipients: microcrystalline cellulose, lactose monohydrate, polacrilin potassium, magnesium stearate, macrogol ...
6.2. Incompatibilities
None stated.
6.3. Shelf life
24 months.
6.4. Special precautions for storage
Store below 25ºC.
6.5. Nature and contents of container
One-month pack containing one blister tray or a three-month pack containing 3 blister trays. Each blister tray contains 21 pink active tablets, each containing levonorgestrel 100 µg and ethinylestradiol ...
6.6. Special precautions for disposal and other handling
None stated.
7. Marketing authorization holder
Pfizer New Zealand Limited, P O Box 3998, Auckland, New Zealand, 1140, Toll Free Number: 0800 736 363
9. Date of first authorization / renewal of the authorization
13 August 1998
10. Date of revision of the text
19 November 2018
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