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CILEST 250/35 microgram TabletsEthinyloestradiolNorgestimate
2014-11-14 11:45:58 来源: 作者: 【 】 浏览:531次 评论:0

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

1. NAME OF THE MEDICINAL PRODUCT

 

 

CILEST® 250/35 microgram Tablets

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 

 

Active ingredients:

Each tablet contains 250 micrograms norgestimate and 35 micrograms ethinyl estradiol.

Excipients: Contains Lactose Anhydrous 89.007mg

For a full list of excipients see section 6.1.

 

3. PHARMACEUTICAL FORM

 

 

Tablet

A dark blue, flat, bevel-edged tablet engraved “C” over “250” on both faces.

 

4. CLINICAL PARTICULARS

 

     

4.1 Therapeutic indications

 

 

Hormonal contraception.

 

4.2 Posology and method of administration

 

 

For oral administration.

 

Adults:

When used perfectly, without missing any pills, the chance of becoming pregnant is less than 1% (i.e. <1 pregnancy per 100 women in their first year of use). Typical failure rates are actually 5% in the first year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle.

Before starting Cilest, a thorough general medical and gynaecological examination (including the breasts and a cytological smear of the cervix) if appropriate should be carried out and the family medical history carefully noted. Disturbances of menstruation, such as oligomenorrhea and amenorrhea should be investigated prior to prescription. Disturbances of the clotting mechanisms should be ruled out if any members of the family have suffered from thrombo-embolic diseases (eg deep vein thrombosis, stroke, myocardial infarction) at a young age.

Pregnancy must be excluded ideally by a pregnancy test.

The woman should be instructed to carefully read the user leaflet and to adhere to the advice given.

As a precaution, thorough medical examinations should be conducted at approximately six month intervals during use of the tablets.

 

Children:

Safety and efficacy of Cilest Tablets have only been established in women of reproductive age.

 

Elderly:

Not indicated in post menopausal women.

- First cycle

Tablet-taking from the first pack of Cilest is started on the 1st day of the menstrual cycle, ie the first day of menstrual bleeding. If menstruation has already begun, Cilest may be commenced up to day 5 of the menstrual period, provided additional contraceptive precautions are taken for the first 7 days of tablet taking.

One tablet is to be taken at around the same time of day on each of 21 consecutive days followed by a tablet-free interval of 7 days, during which a withdrawal bleeding occurs.

- Subsequent cycles

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