ZOLEDRONIC ACID MCM PHARMA 4 MG/5ml Concentrate for Soln for Inf
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-05-2024
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Active ingredient:
ZOLEDRONIC ACID MONOHYDRATE
Available from:
MCM Pharma GmbH
INN (International Name):
ZOLEDRONIC ACID MONOHYDRATE
Dosage:
4 MG/5ml
Pharmaceutical form:
Concentrate for Soln for Inf
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization date:
0000-00-00
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoledronic acid MCM PHARMA 4mg/5ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate, corresponding to 4.264 mg zoledronic
acid monohydrate).
One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
This medicinal product contains 5.63 mg sodium per vial.
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear and colourless solution.
Average values for pH = 6.0 and for osmolarity 300 mOsm/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
–
Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone,
or tumour-induced hypercalcaemia) in
adult
patients with advanced malignancies involving bone.
–
Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Zoledronic acid must only be prescribed and administered to patients by healthcare professionals experienced in the
administration of intravenous bisphosphonates.
Posology
_Prevention of skeletal related events in patients with advanced malignancies involving bone_
_Adults and elderly_
The recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving
bone 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 TIH
_Adults and elderly_
The recommended dose in hypercalcaemia (albumin-
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