ZOLEDRONIC ACID FRESENIUS 4 MG5 ML

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

ZOLEDRONIC ACID AS MONOHYDRATE

Tillgänglig från:

NEOPHARM (ISRAEL) 1996 LTD

ATC-kod:

M05BA08

Läkemedelsform:

CONCENTRATE FOR SOLUTION FOR INFUSION

Sammansättning:

ZOLEDRONIC ACID AS MONOHYDRATE 4 MG

Administreringssätt:

I.V

Receptbelagda typ:

Required

Tillverkad av:

FRESENIUS KABI AUSTRIA GmbH

Terapiområde:

ZOLEDRONIC ACID

Terapeutiska indikationer:

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.

Tillstånd datum:

2021-07-31

Bipacksedel

1986
-
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)
This medicine is dispensed with a doctor’s prescription only
ZOLEDRONIC ACID FRESENIUS 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,
consult 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 Fresenius 4 mg/5 ml 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 Fresenius 4 mg/5 ml 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:
-
you are sensitive (allergic) to zoledronic acid, to 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 breastfeeding.
SPECIAL WARNINGS ABOUT USING THIS MEDICI

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
ZOLEDRONIC ACID FRESENIUS 4 MG/ 5 ML
1.
NAME OF THE MEDICINAL PRODUCT
Zoledronic Acid Fresenius 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
) sterile concentrate)
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
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Zoledronic Acid Fresenius must only be prescribed and administered to
patients by healthcare
professionals experienced in the administration of intravenous
bisphosphonates. Patients treated
with Zoledronic Acid Fresenius 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.
Patients must be maintained well hydrated prior to and following
administration of
Zoledronic
Acid Fresenius.
_Renal impairment _
_Patients with hypercalcemia of malignancy (HCM): _
Zoledronic Acid Fresenius treatment in