MICROLUT Sugar-coated tablet (2017)
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Περιεχόμενα
1. Name of the medicinal product
Microlut 30 micrograms tablets.
2. Qualitative and quantitative composition
One tablet contains 30 micrograms levonorgestrel. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Sugar-coated tablets. The tablets are white, biconvex, round and 5.7 mm in diameter.
4.1. Therapeutic indications
Oral contraception.
4.2. Posology and method of administration
The pregnancy rate of progestogen-only pills is slightly higher than that of combined oral progestogen-oestrogen combinations. Combined oral contraceptives, when taken correctly, have a failure rate of ...
4.3. Contraindications
MICROLUT should not be used in the presence of any of the conditions listed below. Should any of the conditions appear during the use of Microlut, the use of the preparation must be discontinued immediately. ...
4.4. Special warnings and precautions for use
If any of the conditions/risk factors mentioned below is present, the benefits of using Microlut should be weighed against the possible risks for each individual woman and discussed with the woman before ...
4.5. Interaction with other medicinal products and other forms of interaction
Note: The data sheet of concomitant medications should be consulted to identify potential interactions. Effects of other medicinal products on Microlut Interactions can occur with drugs that induce microsomal ...
4.6. Pregnancy and lactation
Use in Pregnancy (Category B3) Microlut is not indicated during pregnancy. If pregnancy occurs during treatment with Microlut, further intake must be stopped. However, extensive extensive epidemiological ...
4.7. Effects on ability to drive and use machines
There are no observed effects.
4.8. Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions with progestogen-only pills including Microlut are uterine/vaginal bleeding including spotting, menorrhagia and/ or metrorrhagia ...
4.9. Overdose
There have been no reports of serious deleterious effects from overdose. For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766). Symptoms Symptoms ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Progestogens, levonorgestrel <b>ATC Code:</b> G03AC03 MICROLUT contains the oral progestogen levonorgestrel in a very low dose. The continuous daily ingestion of 0.03mg ...
5.2. Pharmacokinetic properties
Absorption Orally administered levonorgestrel is rapidly and completely absorbed. Peak serum concentrations of 0.8 ng/ml are reached about 1 hour after single ingestion of MICROLUT. The absolute bioavailability ...
5.3. Preclinical safety data
Acute toxicity studies did not indicate a risk of acute adverse effects in case of inadvertent intake of a multiple of the daily contraceptive dose. In animal studies on systemic tolerance with repeated ...
6.1. List of excipients
Calcium carbonate, glycol montanate, lactose monohydrate, macrogol 6000, magnesium stearate, maize starch, povidone, purified talc, sucrose. Microlut is gluten free.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C.
6.5. Nature and contents of container
PVC/Aluminium blisters. Pack sizes of 1 28 or 3 28 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Any unused medicine or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Bayer New Zealand Limited, 3 Argus Place, Hillcrest, North Shore, AUCKLAND 0627 Free Phone: 0800 233 988
9. Date of first authorization / renewal of the authorization
Date of first approval: 08 February 1973
10. Date of revision of the text
21 March 2017
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