Biopharma Sildenafil 50 sildenafil citrate 50 mg sublingual wafers blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

sildenafil citrate, Quantity: 70.24 mg (Equivalent: sildenafil, Qty 50 mg)

제공처:

iX Biopharma Pty Ltd

약제 형태:

Wafer

구성:

Excipient Ingredients: carmellose sodium; mannitol; lactose monohydrate; potato starch; glycine; macrogol 1500; citric acid; quinoline yellow; microcrystalline cellulose; neotame; Flavour

관리 경로:

Sublingual

패키지 단위:

12, 8, 4

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Biopharma Sildenafil is indicated for the treatment of erectile dysfunction in adult males. Biopharma Sildenafil is not indicated for use by women.

제품 요약:

Visual Identification: Light yellow to yellow oval disc; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Registered

승인 날짜:

2018-06-14

제품 특성 요약

v2.0 260221
1
AUSTRALIAN PRODUCT INFORMATION
BIOPHARMA SILDENAFIL (SILDENAFIL CITRATE) SUBLINGUAL
WAFERS
1
NAME OF THE MEDICINE
Sildenafil (as citrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sublingual wafer contains either 25 or 50mg of sildenafil (as
citrate).
Sildenafil citrate is a white to almost white, crystalline powder. Its
aqueous solubility is equivalent to
2.6 mg sildenafil per mL at 25
°
C.
Excipient with known effect
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Biopharma Sildenafil 25 mg sublingual wafers are light pink to pink
oval discs
Biopharma Sildenafil 50 mg sublingual wafers are light yellow to
yellow oval discs.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Biopharma Sildenafil is indicated for the treatment of erectile
dysfunction in adult males.
Biopharma Sildenafil is not indicated for use by women.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Biopharma Sildenafil wafers are for sublingual administration.
DOSE
_Use in Adults _
The recommended dose is 50 mg taken as needed approximately one hour
before sexual activity.
Based on the efficacy and toleration, the dose may be increased to 100
mg or decreased to 25 mg.
The maximum recommended dose is 100 mg. The maximum recommended dosing
frequency is
once per day.
_Use in Children _
Biopharma Sildenafil is not indicated for use in children.
v2.0 260221
2
METHOD OF ADMINISTRATION
The wafer should only be removed from the blister immediately prior to
administration. The wafer
should be removed from the blister by carefully peeling off the
blister backing and tapping or
pushing the wafer out into dry hands. To prevent crushing, the wafer
must not be removed by
pushing through the blister foil.
To ensure optimal absorption, the mouth should be moist. The patient
should be instructed to rinse
their mouth with a little water prior to administration.
25 mg or 50 mg dose (one wafer): Place the wafer as far back under the
tongue as possible. The
wafer should be kept under the to