PROGYLUTON TABLET

国: シンガポール

言語: 英語

ソース: HSA (Health Sciences Authority)

有効成分:

ESTRADIOL VALERATE (in brown tablet); ESTRADIOL VALERATE (in white tablet); NORGESTREL (in brown tablet)

から入手可能:

BAYER (SOUTH EAST ASIA) PTE LTD

ATCコード:

G03AA06

投薬量:

2 mg

医薬品形態:

TABLET, SUGAR COATED

構図:

ESTRADIOL VALERATE (in brown tablet) 2 mg; ESTRADIOL VALERATE (in white tablet) 2 mg; NORGESTREL (in brown tablet) 0.5 mg

投与経路:

ORAL

処方タイプ:

Prescription Only

製:

BAYER WEIMAR GMBH UND CO. KG

認証ステータス:

ACTIVE

承認日:

1990-06-25

情報リーフレット

 
Progyluton SG _CCDS 13_19 Oct 2013 

1. NAME OF THE MEDICINAL PRODUCT 

 Progyluton 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each white
sugar-coated tablet contains estradiol valerate 2.0 mg.   
Each light brown sugar-coated tablet contains estradiol valerate
2.0 mg and norgestrel 0.5 mg.  

3. PHARMACEUTICAL FORM 

Sugar-coated tablet. 

4. CLINICAL PARTICULARS 

4.1 INDICATIONS  

Hormone replacement therapy (HRT) for the treatment of signs and symptoms of estrogen deficiency 
due  to  menopause  or  hypogonadism,  castration  or  primary  ovarian  failure  in  women  with  an  intact 
uterus.  

Prevention of postmenopausal osteoporosis.  

Control of irregular menstrual cycles.  

Treatment of primary or secondary amenorrhea.  

4.2 DOSAGE AND METHOD OF ADMINISTRATION 

4.2.1 METHOD OF ADMINISTRATION 

Oral use. 

4.2.2 DOSAGE REGIMEN 

•

HOW TO START PROGYLUTON 

If  the  patient  is  still  menstruating,  treatment  should  begin  on  the  5th  day  of  the  cycle  (1st  day  of 
menstrual bleeding = 1st day of the cycle).  

Patients with amenorrhea or very infrequent periods or who are post-menopausal may start at any time, 
provided pregnancy has been excluded (see 
section 4.6, “Pregnancy and lactation”).  

• 
Dosage  
One white tablet is taken daily for the first 11
days, followed by one light brown tablet daily for 10 days. 
Following the 21 days of tablet-taking there will be a
tablet-free interval of 7 days.   

• 
Administration  
Each  pack covers 21 days of treatment. A  new  pack of Progyluton should be started  after the  7-day 
tablet-free interval on the same day of the week as the previous one. The tablets are to be swallowed 
whole with 

製品の特徴

RESTRICTED
1. NAME OF THE MEDICINAL PRODUCT Progyluton
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white coated tablet contains estradiol valerate 2.0 mg.
Each light brown coated tablet contains estradiol valerate 2.0 mg and
norgestrel 0.5 mg.
3. PHARMACEUTICAL FORM
Coated tablet
4. CLINICAL PARTICULARS
4.1 INDICATIONS
Hormone replacement therapy (HRT) for the treatment of signs and
symptoms of estrogen deficiency
due to menopause or hypogonadism, castration or primary ovarian
failure in women with an intact
uterus.
Prevention of postmenopausal osteoporosis.
Control of irregular menstrual cycles.
Treatment of primary or secondary amenorrhea.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
4.2.1 METHOD OF ADMINISTRATION
Oral use.
4.2.2 DOSAGE REGIMEN
Hormonal contraception should be stopped when HRT is started and the
patient should be advised to
take non-hormonal contraceptive precautions, if required.
•
HOW TO START PROGYLUTON
If the patient is still menstruating, treatment should begin on the
5th day of the cycle (1st day of
menstrual bleeding = 1st day of the cycle).
Patients with amenorrhea or very infrequent periods or who are
post-menopausal may start at any time,
provided pregnancy has been excluded (see section 4.6, “Pregnancy
and lactation”).
•
Dosage
One white tablet is taken daily for the first 11 days, followed by one
light brown tablet daily for 10 days.
Following the 21 days of tablet-taking there will be a tablet-free
interval of 7 days.
•
Administration
Each pack covers 21 days of treatment. A new pack of Progyluton should
be started after the 7-day
tablet-free interval on the same day of the week as the previous one.
The tablets are to be swallowed
whole with some liquid. The tablets should preferably be taken at the
same time every day.
Progyluton SG_CCDS 15+16_HSA HRTs Safety Update_Sep 2023
RESTRICTED
Estrogen with or without progestogens should be prescribed at the
lowest effective doses and for the
shortest duration consistent with treatment goals and risks for the
individual women.
T