Zoledronic acid 4mg/5ml concentrate for solution for infusion

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Zoledronic acid monohydrate

Предлага се от:

Intrapharm Laboratories Limited

АТС код:

M05BA; M05BA08

INN (Международно Name):

Zoledronic acid monohydrate

дозиране:

4 mg/5ml

Лекарствена форма:

Concentrate for solution for infusion

Вид предписание :

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

Терапевтична област:

Bisphosphonates; zoledronic acid

Статус Оторизация:

Not marketed

Дата Оторизация:

2013-07-04

Листовка

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLEDRONIC ACID 4 MG/5 ML CONCENTRATE FOR SOLUTION FOR INFUSION
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).
3
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.
-
if you are allergic (hypersensitive) to zoledronic acid, another
bisphosphonate (the
group of substances to which Zoledronic acid belongs), or any of the
other ingredients
of Zoledronic acid

Данни за продукта

Health Products Regulatory Authority
19 October 2018
CRN008L6K
Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoledronic acid 4mg/5ml 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_
Health Products Regulatory Authority
19 October 2018
CRN008L6K
Page 2 of 23
_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