Zoledronic acid 4mg5ml concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Zoledronic acid monohydrate

Available from:

Intrapharm Laboratories Ltd

ATC code:

M05BA08

INN (International Name):

Zoledronic acid monohydrate

Dosage:

800microgram/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06060200

Patient Information leaflet

_Colours (Printed)_
_Title:_
_Ref:_
_Date:_
_Size (mm):_
_Modified:_
Zoledronic Acid PIL
iP/ZOLE/4mg
09/09/12
110(W) x 454(D)
31/10/17
Pantone 286
Process Black
_Colours (Non printed)_
Cutter
PACKAGE LEAFLET: INFORMATION FOR THE USER
CONCENTRATE FOR SOLUTION FOR INFUSION
ZOLEDRONIC ACID
4 MG/5 ML
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN ZOLEDRONIC
ACID 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, nurse or
pharmacist.
• If you get any side effects, talk to your doctor, nurse or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1. WHAT ZOLEDRONIC ACID IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZOLEDRONIC ACID
3. HOW ZOLEDRONIC ACID IS USED
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ZOLEDRONIC ACID
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ZOLEDRONIC ACID IS AND WHAT IT IS USED FOR
The active substance zoledronic acid 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
(this is when the cancer has spread from the primary cancer 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
• Follow carefully all instructions given to you by your doctor.
• Your doctor will carry out blood tests before you start treatment
with Zoledronic acid and
will check your response to treatment at regular intervals.
YOU SHOULD NOT BE GIVEN ZOLEDRONIC ACID:
• if you are breast-feeding.
•

Summary of Product characteristics

OBJECT 1
ZOLEDRONIC ACID 4 MG / 5 ML CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 19-Nov-2017 | Intrapharm
Laboratories Limited
1. Name of the medicinal product
Zoledronic acid 4 mg/5 ml concentrate for solution for infusion.
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, corresponding to
0.8528 mg zoledronic acid
monohydrate.
For a 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
• 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.
Patients treated with Zoledronic acid
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 older people_
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 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