Zoledronic acid 4mg5ml solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Zoledronic acid monohydrate

Available from:

Actavis UK 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; GTIN: 5690528402056

Patient Information leaflet

Zoledronic Acid 4mg in 5ml (0.08mg/ml) PIL Central Procedure Group -
UK
item no:
print proof no:
origination date:
originated by:
revision date:
revised by:
dimensions: 124 x 480
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
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date sent: 20.08.13
supplier:
technically app. date: 15.10.13
min pt size: 8pt, 9 Leading
TECHNICAL APPROVAL
Black
AAAF8107
6
20.08.13
R.Paul
23.10.13
R.Paul
Nerviano
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 Actavis is and what it is
used for
2.
What you need to know before you are given
Zoledronic acid Actavis
3.
How Zoledronic acid Actavis is used
4.
Possible side effects
5.
How to store Zoledronic acid Actavis
6.
Contents of the pack and other information
1. WHAT ZOLEDRONIC ACID ACTAVIS IS AND WHAT IT IS
USED FOR
The active substance in Zoledronic acid Actavis
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 ACTAVIS
Follow carefully all instructions given to you by your
doctor.
Your doctor will carry ou

Summary of Product characteristics

OBJECT 1
ZOLEDRONIC ACID ACTAVIS 4 MG/5 ML CONCENTRATE
FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 24-Jan-2014 | Accord-UK Ltd
1. Name of the medicinal product
Zoledronic acid Actavis 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 (as
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 concentrate for solution for infusion.
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 Actavis 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 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 4 mg zoledronic acid.
_Renal impairment_
_TIH:_
Zoledronic acid Actavis treatment in TIH patients who also have severe
renal impairm