CERAZETTE Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Cerazette 75 microgram film-coated tablets.
Qualitative and quantitative composition
Each tablet contains 75 microgram desogestrel. Excipient(s) with known effect: Each tablet contains approximately 55 mg of lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. The tablet is white, round, biconvex and 5 mm in diameter. On one side it is coded KV above 2 and on the reverse side ORGANON*.
Therapeutic indications
Contraception.
Posology and method of administration
Posology To achieve contraceptive effectiveness, Cerazette must be used as directed (see How to take Cerazette and How to start Cerazette). Special populations Renal impairment No clinical studies have ...
Contraindications
Active venous thromboembolic disorder. Presence or history of severe hepatic disease as long as liver function values have not returned to normal. Known or suspected sex-steroid sensitive malignancies. ...
Special warnings and precautions for use
If any of the conditions/risk factors mentioned below is present, the benefits of progestogen use should be weighed against the possible risks for each individual woman and discussed with the woman before ...
Interaction with other medicinal products and other forms of interaction
Interactions Note: The prescribing information of concomitant medications should be consulted to identify potential interactions. Effect of other medicinal products on Cerazette Interactions can occur ...
Fertility, pregnancy and lactation
Pregnancy Cerazette is not indicated during pregnancy. If pregnancy occurs during treatment with Cerazette, further intake should be stopped. Animal studies have shown that very high doses of progestogenic ...
Effects on ability to drive and use machines
Cerazette has no or negligible influence on the ability to drive and use machines.
Undesirable effects
The most commonly reported undesirable effect in the clinical trials is bleeding irregularity. Some kind of bleeding irregularity has been reported in up to 50% of women using Cerazette. Since Cerazette ...
Overdose
There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in this case are nausea, vomiting and, in young girls, slight vaginal bleeding. There are no antidotes and ...
Pharmacodynamic properties
Pharmacotherapeutic group: hormonal contraceptives for systemic use ATC code: G03AC09 Mechanism of action Cerazette is a progestogen-only pill, which contains the progestogen desogestrel. Like other progestogen-only ...
Pharmacokinetic properties
Absorption After oral dosing of Cerazette desogestrel (DSG) is rapidly absorbed and converted into etonogestrel (ENG). Under steady-state conditions, peak serum levels are reached 1.8 hours after tablet-intake ...
Preclinical safety data
Toxicological studies did not reveal any effects other than those, which can be explained from the hormonal properties of desogestrel. h3 .Environmental Risk Assessment (ERA) The active substance etonogestrel ...
List of excipients
Tablet core: Silica, colloidal anhydrous All-rac-α-tocopherol Lactose monohydrate Maize starch Povidone Stearic acid Film coating: Hypromellose Macrogol 400 Talc Titanium dioxide (E171)
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years. Shelf-life after first opening of the sachet: 1 month.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store the blister pack in the original sachet in order to protect from light and moisture. For storage conditions after ...
Nature and contents of container
PVC/Aluminium blister: Each blister contains 28 tablets. Each carton contains 1, 3, 6 or 13 blisters packed separately in an aluminium laminated sachet. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
The active substance etonogestrel shows an environmental risk to fish. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom
Marketing authorization number(s)
PL 00025/0562
Date of first authorization / renewal of the authorization
Date of first authorisation: 09 November 1998 Date of latest renewal: 12 December 2007
Date of revision of the text
12 February 2019
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