PROLIA 60 MG

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Bahan aktif:

DENOSUMAB

Boleh didapati daripada:

AMGEN EUROPE B.V.

Kod ATC:

M05BX04

Borang farmaseutikal:

SOLUTION FOR INJECTION

Komposisi:

DENOSUMAB 60 MG / 1 ML

Laluan pentadbiran:

S.C

Jenis preskripsi:

Required

Dikeluarkan oleh:

AMGEN EUROPE B.V., NETHERLANDS

Kumpulan terapeutik:

DENOSUMAB

Kawasan terapeutik:

DENOSUMAB

Tanda-tanda terapeutik:

Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly reduces the risk of vertebral, non vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy of a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 3 months, in adult patients at high risk of fracture.

Tarikh kebenaran:

2016-05-31

Risalah maklumat

Page 1 of 12
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed according to a doctor's prescription only
PROLIA
®
60 MG, SOLUTION FOR SUBCUTANEOUS INJECTION
EACH PRE-FILLED SYRINGE CONTAINS 60 MG OF DENOSUMAB IN 1 ML OF
SOLUTION.
List of the additional ingredients detailed in section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information
about the medicine. If you have any other questions, refer to the
doctor or the pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them even if it seems to
you that their medical condition is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Prolia is not indicated to be used by children and adolescents under
18 years old.
Prolia is used to treat:
•
osteoporosis in women after the menopause (postmenopausal) and men who
have an increased risk of
fracture (broken bones), reducing the risk of spinal, non-spinal and
hip fractures.
•
bone loss that results from a reduction in hormone (testosterone)
level caused by surgery or treatment
with medicines in patients with prostate cancer.
•
bone loss associated with long-term systemic glucocorticoids therapy
of a daily dosage equivalent to
7.5 mg or greater of prednisone and expected to remain on
glucocorticoids for at least 3 months, in
adult patients at high risk of fracture.
THERAPEUTIC GROUP:
Drugs for the treatment of bone disease - other drugs affecting bone
structure and mineralization.
Prolia contains denosumab, a protein (monoclonal antibody) that
interferes with the action of another
protein, in order to treat bone loss and osteoporosis. Treatment with
Prolia makes bone stronger and less
likely to break.
Bone is a living tissue and is renewed all the time. Estrogen helps
keep bones healthy. After the menopause,
estrogen level drops which may cause bones to become thin and fragile.
This can eventually lead to a
condition called osteoporosis. Osteoporosis can also occur i

Ciri produk

Page 1 of 21
PROLIA
® 60 MG
1.
NAME OF THE MEDICINAL PRODUCT
Prolia 60 mg
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 injection (injection).
Clear, colorless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of osteoporosis in postmenopausal women and in men at
increased risk of fractures. In
postmenopausal women Prolia significantly reduces the risk of
vertebral, non-vertebral and hip
fractures.
Treatment of bone loss associated with hormone ablation in men with
prostate cancer at increased risk
of fractures (see section 5.1). In men with prostate cancer receiving
hormone ablation, Prolia
significantly reduces the risk of vertebral fractures.
Treatment of bone loss associated with long-term systemic
glucocorticoid therapy of a daily dosage
equivalent to 7.5 mg or greater of prednisone and expected to remain
on glucocorticoids for at least
3 months
, in adult patients at high risk of fracture.
PATIENT SAFETY INFORMATION CARD
The marketing of Prolia is subject to a risk management plan (RMP)
including a 'Patient
safety information card'. The 'Patient safety information card',
emphasizes important safety
information that the patient should be aware of before and during
treatment. Please explain
to the patient the need to review the card before starting treatment.
Page 2 of 21
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 60 mg denosumab administered as a single
subcutaneous injection once
every 6 months into the thigh, abdomen or upper arm.
Patients must be adequately supplemented with calcium and vitamin D
(see section 4.4).
Patients treated with Pro