Prolia Solution for Injection 60mgml Pre-filled Syringe

Valsts: Malaizija

Valoda: angļu

Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktīvā sastāvdaļa:

DENOSUMAB

Pieejams no:

Amgen Biopharmaceuticals Malaysia Sdn Bhd

SNN (starptautisko nepatentēto nosaukumu):

DENOSUMAB

Vienības iepakojumā:

1 Pre-Filled Syringes

Ražojis:

Amgen Manufacturing Limited

Lietošanas instrukcija

Not Applicable

Produkta apraksts

1
Confidential Compliance
PROLIA
®
SOLUTION FOR INJECTION 60MG/ML PRE-FILLED SYRINGE
DENOSUMAB
1.
NAME OF THE MEDICINAL PRODUCT
Prolia Solution for Injection 60mg/ml Pre-filled Syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 60 mg of denosumab in 1 mL of
solution (60 mg/mL).
Denosumab is a human monoclonal IgG2 antibody produced in a mammalian
cell line (Chinese hamster
ovary cells) by recombinant DNA technology.
Excipient with known effect
This medicine contains 47 mg sorbitol in each mL of solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for subcutaneous injection.
Clear, colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Postmenopausal osteoporosis _
Prolia is indicated for the treatment of osteoporosis in
postmenopausal women at increased risk of
fracture. In postmenopausal women with osteoporosis, Prolia increases
bone mineral density (BMD) and
reduces the incidence of hip, vertebral and non-vertebral fractures_._
_Bone loss in patients undergoing hormone ablation for cancer _
Prolia is indicated for the treatment of bone loss in patients
undergoing hormone ablation for prostate or
aromatase inhibitor treatment for breast cancer. In patients with
prostate cancer, Prolia reduces the
incidence of vertebral fractures.
_Male osteoporosis _
Prolia is indicated as a treatment to increase bone mass in men with
osteoporosis at increased risk of
fracture.
_Glucocorticoid-induced osteoporosis_
Treatment of glucocorticoid-induced osteoporosis in men and women at
high risk of fracture who are
either initiating or continuing systemic glucocorticoids in a daily
dosage equivalent to 7.5 mg or greater
of prednisone and expected to remain on glucocorticoids for at least 6
months.
2
Confidential Compliance
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADMINISTRATION
For subcutaneous use.
Administration should be performed by an individual who has been
adequately trained in injection
techniques.
The instructio