PROGYNOVA TABLET 2 mg

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

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资料单张 资料单张 (PIL)
21-12-2011
产品特点 产品特点 (SPC)
10-11-2023

有效成分:

ESTRADIOL VALERATE

可用日期:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC代码:

G03CA03

剂量:

2 mg

药物剂型:

TABLET, SUGAR COATED

组成:

ESTRADIOL VALERATE 2 mg

给药途径:

ORAL

处方类型:

Prescription Only

厂商:

Bayer Weimar GmbH und Co. KG

授权状态:

ACTIVE

授权日期:

1990-05-23

资料单张

                                Progynova 1& 2 mg PI_SG_CCDS 11_20 Dec 2011 
1. NAME OF THE MEDICINAL PRODUCT 
 
Progynova 1mg 
Progynova 2mg 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each beige sugar-coated tablet contains estradiol valerate 1.0
mg.   
Each blue sugar-coated tablet contains estradiol valerate 2.0
mg   
 
3. PHARMACEUTICAL FORM 
 
Sugar-coated tablets 
 
4. CLINICAL PARTICULARS 
 
4.1 INDICATIONS   
Hormone replacement therapy (HRT) for the treatment of signs and
symptoms of estrogen deficiency due to 
natural menopause or castration.   
   
Prevention of postmenopausal osteoporosis.   
   
4.2  DOSAGE AND METHOD OF ADMINISTRATION 
 
4.2.1 METHOD 
OF 
ADMINISTRATION 
 
Oral use   
 
4.2.2 DOSAGE 
REGIMEN 
 
HOW TO START PROGYNOVA 
 
If the patient has an intact uterus and is still menstruating, a
combination regimen with Progynova and a 
progestogen (see below, “Combination regimen”) should begin
within the first 5 days of menstruation.   
 
Patients with amenorrhea or very infrequent periods or who are
post-menopausal, may start a combination 
regimen (see below, “Combination regimen”) at any time, provided
pregnancy has been excluded.   
 
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.     
_ _
CHANGE FROM OTHER HRT (CYCLIC, SEQUENTIAL OR CONTINUOUS COMBINED) 
 
Women changing from other HRT should complete the current cycle of
therapy before initiating Progynova 
therapy.  
 
DOSAGE  
 
One beige tablet Progynova 1.0mg tablet (or one
blue tablet Progynova 2.0mg tablet ) is taken daily.   
 
ADMINISTRATION  
 
Each pack covers 28 days of treatment. Treatment is continuous,
which means that the next pack follows 
immediately without a break. 
Progynova 1& 2 mg PI_SG_CCDS 11_20 Dec 2011 
 
The tablets are to be swallowed whole with some liquid.   
 
The ta
                                
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产品特点

                                Progynova 2 mg PI_SG_CCDS 12_04 HSA HRTs Safety Updates_Sep 2023
RESTRICTED
1. NAME OF THE MEDICINAL PRODUCT
Progynova 1mg
Progynova 2mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each beige sugar-coated tablet contains estradiol valerate 1.0 mg.
Each white sugar-coated tablet contains estradiol valerate 2.0 mg
3. PHARMACEUTICAL FORM
Sugar-coated tablets
4. CLINICAL PARTICULARS
4.1 INDICATIONS
Hormone replacement therapy (HRT) for the treatment of signs and
symptoms of estrogen deficiency due to
natural menopause or castration.
Prevention of postmenopausal osteoporosis.
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.
4.2.3
HOW TO START PROGYNOVA
If the patient has an intact uterus and is still menstruating, a
combination regimen with Progynova and a
progestogen (see section “Combination regimen”) should begin
within the first 5 days of menstruation.
Patients with amenorrhea or very infrequent periods or who are
post-menopausal, may start a combination
regimen (see section “Combination regimen”) at any time, provided
pregnancy has been excluded.
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.
_ _
CHANGE FROM OTHER HRT (CYCLIC, SEQUENTIAL OR CONTINUOUS COMBINED)
Women changing from other HRT should complete the current cycle of
therapy before initiating Progynova
therapy.
DOSAGE
One beige tablet Progynova 1.0mg tablet (or one white tablet Progynova
2.0mg tablet ) is taken daily.
Progynova 2 mg PI_SG_CCDS 12_04 HSA HRTs Safety Updates_Sep 2023
RESTRICTED
ADMINISTRATION
Each pack covers 28 days of treatment. Treatment is continuous, which
means that the next pack follows
immediately without a break.
The tablets are to be swallowed whole with some liquid.
The tablets 
                                
                                阅读完整的文件
                                
                            

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