ZOLEDRONIC ACID TARO 4 MG 5 ML

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ZOLEDRONIC ACID

متاح من:

TARO INTERNATIONAL LTD, ISRAEL

ATC رمز:

M05BA08

الشكل الصيدلاني:

CONCENTRATE FOR SOLUTION FOR INFUSION

تركيب:

ZOLEDRONIC ACID 4 MG / 5 ML

طريقة التعاطي:

I.V

نوع الوصفة الطبية :

Required

المصنعة من قبل:

SUN PHARMACEUTICAL INDUSTRIES LTD., INDIA

المجال العلاجي:

ZOLEDRONIC ACID

الخصائص العلاجية:

Treatment of hypercalcaemia of malignancy.Treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.Prostate cancer should have progressed after treatment with at least one hormonal therapy.

تاريخ الترخيص:

2020-10-31

نشرة المعلومات

Page 1 of 5
Zoledronic Acid Taro_PIL_ HEB_ 2021-09

you are sensitive (allergic) to zoledronic acid, another
bisphosphonate (the
group of substances to which zoledronic acid belongs) or to any of the
other
ingredients that this medicine contains (listed in section 6, in the
list of inactive
ingredients).

you are breast-feeding.
1986
-
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations)
The dispensing of this medicine requires a doctor’s prescription
Zoledronic Acid Taro 4 mg/5 ml
Concentrate for solution for infusion
Active ingredient:
One 5 ml vial contains 4 mg zoledronic acid
Inactive ingredients and allergens: see section 2 under 'Important
information about some of this medicine's
ingredients', and section 6 'Additional Information'.
Read the entire leaflet carefully before using this medicine. This
leaflet contains concise information about this
medicine. If you have further questions, refer to your doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them, even if it seems
to you that their illness is similar to yours.
1. What is this medicine intended for?
Zoledronic Acid Taro is used to:

treat patients with multiple myeloma and patients with documented bone
metastases from solid tumours (where
cancer spreads from the primary site to the bone), together with
standard anticancer therapy.

For prostate cancer, treatment is given if there is progression after
at least one hormonal treatment.

reduce the amount of calcium in the blood in patients where the level
is too high due to presence of a tumour.
Therapeutic group:
Bisphosphonates
The active substance in Zoledronic Acid Taro is zoledronic acid, which
belongs to a group of substances called
bisphosphonates. Zoledronic acid works by attaching itself to the bone
and slowing down the rate of bone change.
2. Before using this medicine
Carefully follow all the instructions given to you by the doctor.
Do not use this medicine if:
Special warnings ab

خصائص المنتج

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ZOL CON SEP 21 SPC
SUMMARY OF PRODUCT CHARACTERISTICS
ZOLEDRONIC ACID TARO 4 MG/ 5 ML
1.
NAME OF THE MEDICINAL PRODUCT
Zoledronic Acid Taro 4 mg/5 ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial with 5 ml concentrate contains 4 mg zoledronic acid,
corresponding to 4.264 mg zoledronic acid
monohydrate.
One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
-
Treatment of patients with multiple myeloma and patients with
documented bone metastases
from solid tumors, in conjunction with standard antineoplastic
therapy.
-
Prostate cancer should have progressed after treatment with at least
one hormonal therapy.
-
Treatment of hypercalcaemia of malignancy (HCM).
4.2
Posology and method of administration
Zoledronic Acid Taro must
only
be prescribed
and
administered to patients by
healthcare professionals
experienced in the administration of intravenous bisphosphonates.
Patients treated with Zoledronic Acid Taro
should be given the package leaflet.
Posology
Multiple Myeloma and bone metastases from solid tumors
Adults and older people
The recommended dose is 4 mg zoledronic acid every 3 to 4 weeks.
Patients should also be administered an oral calcium supplement of 500
mg and 400 IU vitamin D daily.
The decision to treat patients with bone metastases for the prevention
of skeletal related events should consider
that the onset of treatment effect is 2-3 months.
Treatment of hypercalcemia of malignancy (HCM)
Adults and older people
The recommended dose in hypercalcaemia (albumin-corrected serum
calcium  12.0 mg/dl or 3.0 mmol/l) is a
single dose of 4 mg zoledronic acid.
Page 2 of 18
ZOL CON SEP 21 SPC
Patients must be maintained well hydrated prior to and following
administration of
Zoledronic Acid Taro.
Renal impairment
Patients with hypercalcemia of malignancy (HCM):
Zoledronic Acid Taro treatm