ZOLEDRONIC ACID MYLAN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ZOLEDRONIC ACID MONOHYDRATE

Available from:

Generics (UK) Limited

ATC code:

M05BA08

INN (International Name):

ZOLEDRONIC ACID MONOHYDRATE

Dosage:

4mg/100 Millilitre

Pharmaceutical form:

Solution for Infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

zoledronic acid

Authorization status:

Not Marketed

Authorization date:

2014-07-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLEDRONIC ACID MYLAN 4 MG/100 ML SOLUTION FOR INFUSION
zoledronic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zoledronic acid Mylan is and what it is used for
2.
What you need to know before you are given Zoledronic acid Mylan
3.
How Zoledronic acid Mylan is used
4.
Possible side effects
5.
How to store Zoledronic acid Mylan
6.
Contents of the pack and other information
1.
WHAT ZOLEDRONIC ACID MYLAN IS AND WHAT IT IS USED FOR
The active substance in Zoledronic acid Mylan 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. It is used:
•
TO PREVENT BONE COMPLICATIONS, e.g. fractures, in adult patients with
bone metastases
(spread of cancer from primary site to the bone).
•
TO REDUCE THE AMOUNT OF CALCIUM in the blood in adult patients where
it is too high
due to the presence of a tumour. Tumours can accelerate normal bone
change in such a
way that the release of calcium from bone is increased. This condition
is known as
tumour-induced hypercalcaemia (TIH).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZOLEDRONIC ACID MYLAN
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
Zoledronic acid Mylan
and will check your response to treatment at regular intervals.
YOU MUST NOT BE GIVEN ZOLEDRONIC ACID MYLAN:
− if you are breast-feeding.
− if you are allergic to zoledronic acid, another bisphosphonate
(the group of substances to
which Zoledronic acid Mylan belongs), or any of t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoledronic acid Mylan 4 mg/100 ml Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial with 100 ml solution contains 4 mg zoledronic acid,
corresponding to 4.26 mg zoledronic acid monohydrate.
One ml of solution contains 0.04 mg zoledronic acid (as monohydrate).
Excipient with known effect: Each vial contains 6.4 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear and colourless solution
pH: 5.5-7.0
Osmolality: 0.27-0.33 Osmol/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 Mylan must only be prescribed and administered to
patients by healthcare professionals experienced in
the administration of intravenous bisphosphonates. Patients treated
with Zoledronic acid Mylan should be given the
package leaflet and the patient reminder card.
POSOLOGY
_PREVENTION OF SKELETAL RELATED EVENTS IN PATIENTS WITH ADVANCED
MALIGNANCIES INVOLVING BONE_
_ADULTS AND THE 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 the elderly_
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.
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