INTRAROSA prasterone 6.5 mg pessary blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

prasterone, Quantity: 6.5 mg

제공처:

Theramex Australia Pty Ltd

약제 형태:

Pessary

구성:

Excipient Ingredients: Hard fat

관리 경로:

Vaginal

패키지 단위:

28 pessaries, 7 pessaries (starter pack)

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

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

제품 요약:

Visual Identification: Intrarosa is a white to off-white, bullet-shaped pessary, approximately 28 mm long and 9 mm in diameter at its widest end. The product is supplied with six applicators.; Container Type: Blister Pack; Container Material: PVC/PE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

승인 상태:

Registered

승인 날짜:

2023-06-16

제품 특성 요약

INTRAROSA
®
prasterone 6.5 mg pessary
Theramex Australia Pty Ltd
Version 2 – SEP 2023
Page
1
of
16
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
INTRAROSA
® PRASTERONE 6.5 MG PESSARY
1
NAME OF THE MEDICINE
Prasterone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pessary contains 6.5 mg of prasterone in hard fat.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
INTRAROSA is a white to off-white, bullet-shaped pessary,
approximately 28 mm long and 9 mm
in diameter at its widest end.
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
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
INTRAROSA is administered intravaginally with the use of the provided
applicator or with fingers.
One pessary is administered once a day 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 (or as
clinically appropriate) 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 woman
remembers. However, if the next
dose is due in less than 8 hours, the woman should skip the missed
pessary. Do not use two
pessaries to make up for a forgotten dose.
METHOD OF ADMINISTRATION
If INTRAROSA is placed in the vagina using the provided applicator:
1.
Activate the applicator (by pulling back the plunger) before use.
2.
Place the flat end of the pessary into the open end of the activated
applicator.
INTRAROSA
®
prasterone 6.5 mg pessary
Theramex Australia Pty Ltd
Version 2 �