CLIMARA 25 PATCH

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Beli Sekarang

Unduh Karakteristik produk (SPC)
02-06-2020

Bahan aktif:

ESTRADIOL (ESTRADIOL HEMIHYDRATE)

Tersedia dari:

BAYER INC

Kode ATC:

G03CA03

INN (Nama Internasional):

ESTRADIOL

Dosis:

25MCG

Bentuk farmasi:

PATCH

Komposisi:

ESTRADIOL (ESTRADIOL HEMIHYDRATE) 25MCG

Rute administrasi :

TRANSDERMAL

Unit dalam paket:

4

Jenis Resep:

Prescription

Area terapi:

ESTROGENS

Ringkasan produk:

Active ingredient group (AIG) number: 0106457033; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2007-03-08

Karakteristik produk

                                17β)
·
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John’s wort.
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·
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17β. Upon application to
17β, the major estrogenic hormone secreted by the human ovary.
17β is the predominant estrogen produced by the ovaries in
premenopausal women.
17β), and provides controlled delivery of estradiol
17β,
17β), and provides controlled delivery of estradiol
17β, 0.05
17β), and provides controlled delivery of estradiol
17β,
17β)
PART II: SCIENTIFIC INFORMATION
β
2 •
–
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–
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17β per day) is not approved for
completed the study. Both CLIMARA 50 and CLIMARA 100 were
significantly (p ≤ 0.05) more
efficacy parameters. Statistically significant (p ≤ 0.05) treatment
effects with both doses were
–
change from baseline significantly (p≤0.05) less for placebo group
than for the CLIMARA 50 and CLIMARA 100
Mean score significantly (p≤0.05) less for the placebo group than
for the CLIMARA 50 and CLIMARA 100
CLIMARA 50 and CLIMARA 100 statistically significant at p ≤ 0.05.
–
Mean score significantly (p ≤ 0.05) less for the for the CLIMARA 50
group than for the CLIMARA 100
Mean score significantly (p ≤ 0.05) less for the for the CLIMARA 50
group than for the CLIMARA 100 group, and, mean score
significantly (p ≤ 10.05) less for the
–
–
–
–
–
–
Patient’s Assessment
Investigator’s Assessment
Patient’s Assessment
Investigator’s Assessment
–
–
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<0.0001‡
<0.0001 ‡
0.0001 ‡
<0.0001‡
<0.0001 ‡
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‡ p < 0.05
17β per day) is not approved for sale in Canada.
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0.0141 ‡
<0.0001 ‡
0.0001 ‡
<0.0001 ‡
<0.0001 ‡
†
‡ p < 0.05
17β per day) is not approved for sale in Canada.
–
crease in bone mineral density at the hip (trochanteric region,
Ward’s triangle, femoral neck) and spine
Ward’s Triang
                                
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