DIANE-35 Coated tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
DIANE-35 0,035 mg/2,0 mg coated tablet.
2. Qualitative and quantitative composition
<u>21 hormone-containing beige coated tablets:</u> Each coated tablet contains ethinylestradiol 0,035 mg and cyproterone acetate 2 mg Contains sugar (19 mg sucrose and 31 mg lactose monohydrate). 7 hormone-free ...
3. Pharmaceutical form
Coated tablets. The hormone-containing tablet is small beige, round with convex faces. The hormone-free tablet is large white, round with convex faces.
4.1. Therapeutic indications
Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism in women of reproductive age. This includes patients with polycystic ovary syndrome requiring ...
4.2. Posology and method of administration
Posology How to take DIANE-35 DIANE-35 is to be taken regularly in order to achieve the therapeutic efficacy and the required contraceptive protection. Previously used hormonal contraception should be ...
4.3. Contraindications
Preparations containing estrogen/progestogen combinations should not be used in the presence of any of the conditions listed below. Should any of these conditions appear for the first time during their ...
4.4. Special warnings and precautions for use
DIANE-35 is composed of the progestogen cyproterone acetate and the estrogen ethinylestradiol and is administered for 21 days of a monthly cycle. It has a similar composition to that of a combined oral ...
4.5. Interaction with other medicinal products and other forms of interaction
Note: The Professional Information on concomitant medications should be consulted to identify potential interactions. Effects of other medicines on DIANE-35 Interactions can occur with medicines that induce ...
4.6. Pregnancy and lactation
Pregnancy Use of DIANE-35 is contraindicated in pregnancy (see section 4.3). If pregnancy occurs during treatment with DIANE-35, further intake must be stopped (see section 5.3). Lactation The administration ...
4.7. Effects on ability to drive and use machines
None.
4.8. Undesirable effects
Summary of safety profile The most commonly reported adverse reactions with DIANE-35 are nausea, abdominal pain, increased weight, headache, depressed mood, altered mood, breast pain, breast tenderness. ...
4.9. Overdose
There have been no reports ofserious deleterious effects from overdose. Symptoms that may occur in case of taking an overdose of hormone-containing beige coated tablets are nausea, vomiting and withdrawal ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> antiandrogens and estrogens <b>ATC code:</b> G03HB The substance cyproterone acetate contained In DIANE-35 blocks the effect of endogenously produced and exogenously administered ...
5.2. Pharmacokinetic properties
Cyproterone acetate Absorption Orally administered cyproterone acetate is rapidly and completely absorbed. Peak serum concentrations of 15 ng/ml are reached at about 1,6 hours after single ingestion. Bioavailability ...
5.3. Preclinical safety data
Administration of cyproterone acetate during the hormone-sensitive differentiation phase of the genital organs (after approximately day 45 of gravidity) could lead to signs of feminisation in male foetuses ...
6.1. List of excipients
Calcium carbonate precipitate Ferric oxide yellow pigment Glycerol 85% Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Montanglycol wax Povidone 25 Povidone 700 000 Sucrose Talc Titanium ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store at or below 30°C. Protect from light.
6.5. Nature and contents of container
PVC/PE.EVOH.PE/PCTFE/aluminium blisters of 28 tablets.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Bayer (Pty) Ltd, Reg. No.: 1968/011192/07, 27 Wrench Road, ISANDO, 1609
8. Marketing authorization number(s)
V/21.8.2/300
9. Date of first authorization / renewal of the authorization
22 September 1988
10. Date of revision of the text
21 July 2022
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