Prolia Solution for Injection 60 mgml (Prefilled Syringe)

देश: सिंगापुर

भाषा: अंग्रेज़ी

स्रोत: HSA (Health Sciences Authority)

सक्रिय संघटक:

Denosumab

थमां उपलब्ध:

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

ए.टी.सी कोड:

M05BX04

डोज़:

60 mg/ml

फार्मास्यूटिकल फॉर्म:

INJECTION, SOLUTION

रचना:

Denosumab 60 mg/ml

प्रशासन का मार्ग:

SUBCUTANEOUS

प्रिस्क्रिप्शन प्रकार:

Prescription Only

द्वारा बनाया गया:

Amgen Manufacturing Limited

प्राधिकरण का दर्जा:

ACTIVE

प्राधिकरण की तारीख:

2011-09-27

सूचना पत्रक

Page 1 of 15
PROLIA
TM
DENOSUMAB
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 60 mg of denosumab in 1.0
mL solution (60 mg/mL).
PHARMACEUTICAL FORM
Solution for subcutaneous injection.
Clear, colourless to slightly yellow solution, pH 5.2 and
may contain trace amounts of translucent to 
white proteinaceous particles.
CLINICAL PARTICULARS
INDICATIONS
_TREATMENT OF POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR
FRACTURE_
_PROLIA _is indicated for the treatment of postmenopausal women
with osteoporosis at high risk of 
fracture, defined as
a history of osteoporotic fracture, or multiple risk factors for fracture;
or patients 
who have failed
or are intolerant to other osteoporosis therapy. 
In postmenopausal women with 
osteoporosis, _PROLIA _reduces the incidence
of vertebral, nonvertebral, and hip fractures.
_TREATMENT OF MEN WITH OSTEOPOROSIS AT HIGH RISK OF FRACTURE_
_PROLIA _is indicated for the treatment of men
with osteoporosis at high risk of fracture, defined as a 
history of osteoporotic fracture,
or multiple risk factors for fracture; or patients who
have failed or are 
intolerant to other osteoporosis therapy.
DOSAGE AND ADMINISTRATION
ADMINISTRATION
Administration should be performed by an individual who has been
adequately trained in injection 
techniques. 
2B
DOSAGE
The recommended dose of _PROLIA _is 60 mg administered as
a single subcutaneous injection once 
every 6 months. 
All patients should receive calcium 1000 mg daily and
at least 400 IU vitamin D daily whilst 
undergoing treatment. 
If a dose of _PROLIA _is missed, administer the injection as
soon as the patient is available. Thereafter, 
schedule injections every 6 months from the
date of the last injection.
Page 2 of 15
POPULATIONS
CHILDREN
_PROLIA _is not recommended in paediatric patients as the
safety and effectivene

उत्पाद विशेषताएं

1
PROLIA
®
DENOSUMAB
NAME OF THE MEDICINAL PRODUCT
Prolia 60 mg solution for injection in pre-filled syringe
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 60 mg of denosumab in 1.0 mL solution
(60 mg/mL).
Denosumab has an approximate molecular weight of 147 kDa. Denosumab is
produced in genetically
engineered mammalian (Chinese hamster ovary) cells.
PHARMACEUTICAL FORM
Solution for subcutaneous injection.
Clear, colourless to slightly yellow solution, pH 5.2 and may contain
trace amounts of translucent to
white proteinaceous particles.
CLINICAL PARTICULARS
INDICATIONS
_TREATMENT OF POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR
FRACTURE _
Prolia is indicated for the treatment of postmenopausal women with
osteoporosis at high risk of fracture,
defined as a history of osteoporotic fracture, or multiple risk
factors for fracture; or patients who have
failed or are intolerant to other osteoporosis therapy. In
postmenopausal women with osteoporosis, Prolia
reduces the incidence of vertebral, nonvertebral, and hip fractures.
_TREATMENT OF MEN WITH OSTEOPOROSIS AT HIGH RISK OF FRACTURE _
Prolia_ _is indicated for the treatment of men with osteoporosis at
high risk of fracture, defined as a history
of osteoporotic fracture, or multiple risk factors for fracture; or
patients who have failed or are intolerant
to other osteoporosis therapy.
_TREATMENT OF BONE LOSS IN MEN RECEIVING ANDROGEN DEPRIVATION THERAPY
FOR PROSTATE CANCER _
Prolia is indicated as a treatment to increase bone mass in men at
high risk for fracture receiving androgen
deprivation therapy for nonmetastatic prostate cancer. In these
patients Prolia also reduced the incidence
of vertebral fractures.
_TREATMENT OF BONE LOSS IN WOMEN RECEIVING ADJUVANT AROMATASE
INHIBITOR THERAPY FOR BREAST CANCER _
Prolia is indicated as a treatment to increase bone mass in women at
high risk for fracture receiving
adjuvant aromatase inhibitor therapy for nonmetastatic breast cancer.
2
_TREATMENT OF BONE LOSS ASSOCIATED WITH LONG-TERM SY