ACLASTA INFUSION (PARENTERAL)

Страна: ПАР

мова: англійська

Джерело: South African Health Products Regulatory Authority (SAHPRA)

Доступна з:

Sandoz South Africa (Pty) Ltd

Дозування:

See ingredients

Фармацевтична форма:

INFUSION (PARENTERAL)

Склад:

EACH 100,0 ml SOLUTION CONTAINS ZOLEDRONATE TRISODIUM 5,0 mg

Статус Авторизація:

Registered

Дата Авторизація:

2009-06-11

інформаційний буклет

Page 1 of 9
PATIENT INFORMATION LEAFLET FOR ACLASTA
SCHEDULING STATUS: S4
PROPRIETARY NAME AND DOSAGE FORM:
ACLASTA 5 mg/100 mℓ solution for infusion
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN ACLASTA:

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.

ACLASTA has been prescribed for you personally and you should not
share your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
1.
WHAT ACLASTA CONTAINS
The _active substance_ of ACLASTA is zoledronic acid.
The _other ingredients_ are mannitol, sodium citrate and water for
injections.
2. WHAT ACLASTA
IS AND WHAT IT IS USED FOR
ACLASTA is given as a single infusion into a vein by a doctor or
nurse. It belongs to a group
of medicines called _bisphosphonates_, and is used to:

treat osteoporosis in post menopausal women.

treat osteoporosis in men.

prevent additional clinical fractures in postmenopausal women who have
recently
had a hip fracture due to low level trauma/injury.

treat osteoporosis in men and women caused by treatment with steroid
medicines
Page 2 of 9
such as prednisone.

treat Paget’s disease of the bone.
For osteoporosis and the prevention of additional fractures, ACLASTA
works for one year
and you will need the next dose after one year. For Paget’s disease,
ACLASTA may work for
longer than one year, and your doctor will let you know if you need to
be treated again.
3.
BEFORE ACLASTA
IS ADMINISTERED TO YOU
Carefully follow all instructions given to you by your doctor. On the
day of treatment with
ACLASTA you should eat and drink normally. Follow you doctor’s
instructions on how much
water to drink; this is important as it will help to prevent you
becoming dehydrated.
YOU SHOULD NOT BE GIVEN ACLASTA:

If you are allergic (hypersensitive) to zoledronic acid or any of the
other ingredients of
ACLASTA.

If you have hypocalcaemia (this means that the levels of

Характеристики продукта

Page 1 of 16
PROFESSIONAL INFORMATION FOR ACLASTA
SCHEDULING STATUS: S4
PROPRIETARY NAME (AND DOSAGE FORM):
ACLASTA 5 mg/100 mℓ (solution for infusion)
COMPOSITION:
One bottle with 100 mℓ solution contains 5 mg zoledronic
corresponding to 5.330 mg zoledronic
acid monohydrate.
_List of excipients: _Mannitol, sodium citrate, water for injections
PHARMACOLOGICAL CLASSIFICATION:
A 34 Other
PHARMACOLOGICAL ACTION:
PHARMACODYNAMIC PROPERTIES:
_MECHANISM OF ACTION:_
Zoledronic acid belongs to the class of nitrogen-containing
bisphosphonates and acts primarily
on bone. It is an inhibitor of osteoclast-mediated bone resorption.
The selective action of
bisphosphonates on bone is based on their high affinity for
mineralised bone. Intravenously
administered zoledronic acid is rapidly distributed to bone and,
localises preferentially at sites of
high bone turnover. The main molecular target of zoledronic acid in
the osteoclast is the enzyme
farnesyl pyrophosphate synthase, but this does not exclude other
mechanisms. The relatively
long duration of action of zoledronic acid is attributable to its high
binding affinity for the active site
of farnesyl pyrophosphate (FPP) synthase and its strong binding
affinity to bone mineral.
Page 2 of 16
_PHARMACODYNAMIC EFFECTS: _
_Osteoporosis:_
Zoledronic acid treatment reduced the rate of bone turnover from
elevated post- menopausal
levels with the nadir for resorption markers observed at 7 days, and
for formation markers at 12
weeks. Thereafter bone markers stabilized within the pre- menopausal
range. There was no
progressive reduction of bone turnover markers with repeated annual
dosing. ln long-term animal
studies, zoledronic acid inhibits bone resorption without adversely
affecting bone formation,
mineralisation or the mechanical properties of bone. Continuing bone
remodelling was observed
in bone samples from all animals treated with clinically relevant
doses of zoledronic acid. There
was no evidence of a mineralising defect, no aberrant accumulation of
osteoid, and no woven
bone