INTRAROSA

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Bahan aktif:

PRASTERONE

Boleh didapati daripada:

DEXCEL LTD, ISRAEL

Kod ATC:

G03XX01

Borang farmaseutikal:

VAGINAL PESSARIES

Komposisi:

PRASTERONE 6.5 MG

Laluan pentadbiran:

INTRAVAGINAL

Jenis preskripsi:

Required

Dikeluarkan oleh:

ENDOCEUTICS INC., CANADA

Kawasan terapeutik:

PRASTERONE

Tanda-tanda terapeutik:

Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.

Tarikh kebenaran:

2020-03-03

Ciri produk

2
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Intrarosa.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal pessary contains 6.5 mg of prasterone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal pessary
White to off-white, bullet-shaped pessary.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Intrarosa is indicated for the treatment of vulvar and vaginal atrophy
in postmenopausal women
having moderate to severe symptoms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 6.5 mg prasterone (one pessary) administered
once daily, at bedtime.
For the treatment of postmenopausal symptoms, Intrarosa should only be
initiated for symptoms that
adversely affect quality of life. In all cases, a careful appraisal of
the risks and benefits should be
reassessed at least every 6 months and Intrarosa should only be
continued as long as the benefit
outweighs the risk.
If a dose is forgotten, it should be taken as soon as the patient
remembers. However, if the next dose is
due in less than 8 hours, the patient should skip the missed pessary.
Two pessaries should not be used
to make up for a forgotten dose.
_Special populations _
_ _
_Elderly _
No dose adjustment is considered necessary in elderly women.
_Patients with renal and/or hepatic impairment _
Since Intrarosa acts locally in the vagina, no dose adjustment is
needed for postmenopausal women
having renal or hepatic impairment or any other systemic anomaly or
disease.
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_Paediatric population _
There is no relevant use of Intrarosa in female children of any age
group for the indication of vulvar
and vaginal atrophy due to menopause.
Method of administration
Vaginal use
Intrarosa can be inserted in the vagina with the finger or with an
applicator provided within the
identified pack.
The pessary should be inserted in the vagina as far as it can
comfortably go without force.
If inserted with an applicator, the following steps should be
followed:
1.
The applicator should be activated (by p