CIPLA ZOLEDRONIC ACID INJECTION

Quốc gia: Nam Phi

Ngôn ngữ: Tiếng Anh

Nguồn: South African Health Products Regulatory Authority (SAHPRA)

Sẵn có từ:

Cipla Medpro (Pty) Ltd

Liều dùng:

See ingredients

Dạng dược phẩm:

INJECTION

Thành phần:

EACH VIAL CONTAINS ZOLEDRONATE TRISODIUM EQUIVALENT TO ZOLEDRONIC ACID 4,0 mg

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2012-02-03

Tờ rơi thông tin

Cipla Medpro (Pty) Ltd
Cipla Zoledronic Acid
1.3.2
Page 1 of 8
Approved PIL
23-04-2015
PATIENT INFORMATION LEAFLET
INFORMATION FOR THE PATIENT ABOUT
CIPLA ZOLEDRONIC ACID INJECTION
SCHEDULING STATUS:
S4
PROPRIETARY NAME (AND DOSAGE FORM):
CIPLA ZOLEDRONIC ACID (Injection)
WHAT CIPLA ZOLEDRONIC ACID CONTAINS:
The active substance in CIPLA ZOLEDRONIC ACID is zoledronic acid.
Zoledronic
acid belongs to a class of medicines known as bisphosphonates, which
primarily
acts on bone. It prevents the breakdown of bone tissue.
Each vial of CIPLA ZOLEDRONIC ACID contains zoledronic acid
monohydrate
equivalent to zoledronic acid anhydrous 4 mg.
The inactive ingredients include mannitol and sodium citrate.
WHAT CIPLA ZOLEDRONIC ACID IS USED FOR:
CIPLA ZOLEDRONIC ACID is indicated for the treatment of:
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU RECEIVE CIPLA ZOLEDRONIC
ACID.
-
KEEP THIS LEAFLET, YOU MAY NEED TO READ IT AGAIN.
-
IF YOU HAVE FURTHER QUESTIONS PLEASE ASK YOUR DOCTOR OR YOUR
PHARMACIST.
Cipla Medpro (Pty) Ltd
Cipla Zoledronic Acid
1.3.2
Page 2 of 8
Approved PIL
23-04-2015

High blood levels of calcium due to cancer.

Bone lesions resulting from multiple myeloma (a cancer that originates
in
bone marrow) in combination with standard therapy for this condition.

Breast cancer that has spread to the bone in combination with
appropriate
anticancer therapy.

Prostate cancer that has spread to the bone in patients who have
increased
levels of prostate specific antigen (PSA) despite hormone treatment.
Your oncologist (doctor specialising in the treatment of cancer) will
decide whether
you qualify for treatment with CIPLA ZOLEDRONIC ACID and what other
therapy
you should be receiving in combination with it.
BEFORE YOU RECEIVE CIPLA ZOLEDRONIC ACID:
DO NOT RECEIVE CIPLA ZOLEDRONIC ACID IF YOU:

Are known to be hypersensitive (allergic) to CIPLA ZOLEDRONIC ACID,
any
other bisphosphonates, or to any components of the formulation.

Suffer from severely impaired kidney function.

Suffer from severely impa

Đặc tính sản phẩm

Cipla Medpro (Pty) Ltd
Cipla Zoledronic Acid
1.3.1.1
Page 1 of 11
Approved PI
23-04-2015
PACKAGE INSERT FOR
CIPLA ZOLEDRONIC ACID
SCHEDULING STATUS:
S4
PROPRIETARY NAME (AND DOSAGE FORM):
CIPLA ZOLEDRONIC ACID (Injection)
COMPOSITION:
Each
vial
contains
zoledronic
acid
monohydrate
equivalent
to
zoledronic
acid
anhydrous 4 mg.
PHARMACOLOGICAL CLASSIFICATION:
A 3.5 Others
PHARMACOLOGICAL ACTION:
Zoledronic acid is a bisphosphonate which primarily acts on the bone
by inhibiting
bone
resorption
without
adversely
affecting
the
formation,
mineralisation
or
mechanical properties of bone. The selective action of zoledronic acid
on bone is
based on the affinity for mineralised bone, but the precise molecular
mechanism
leading to the inhibition of osteoclastic activity is still unclear.
In addition to inhibiting
osteoclastic bone resorption, zoledronic acid exerts direct
anti-tumour effects on
cultured
human
myeloma
and
breast
cancer
cells,
inhibiting
proliferation
and
inducing apoptosis. It also inhibits human endothelial cell
proliferation _in vitro_.
Cipla Medpro (Pty) Ltd
Cipla Zoledronic Acid
1.3.1.1
Page 2 of 11
Approved PI
23-04-2015
Zoledronic
acid
reduces
the
invasion
of
human
breast
cancer
cells
through
extracellular matrix _in vitro_, indicating that it may have
anti-metastatic properties.
INDICATIONS:
CIPLA ZOLEDRONIC ACID is indicated for:

Treatment of tumour-induced hypercalcaemia (HCM).

Osteolytic
lesions
of
multiple
myeloma,
in
conjunction
with
standard
antineoplastic therapy.

Breast
carcinoma
with
metastatic
bone
lesions
in
combination
with
appropriate anticancer therapy.

Prostate carcinoma in patients with bone metastases who have increased
prostate specific antigen (PSA) levels despite hormonal therapy.
CONTRA-INDICATIONS:
CIPLA ZOLEDRONIC ACID is contra-indicated in the following:

Patients with clinically significant hypersensitivity to zoledronic
acid, other
bisphosphonates
or
any
of
the
excipients
in
the
formulation
of
CIPLA
ZOLEDRONIC ACID.

Severe impairment of renal function.