ZOLEDRONIC ACID

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

ZOLEDRONIC ACID

Доступна з:

Accord Healthcare Limited

Код атс:

M05BA08

ІПН (Міжнародна Ім'я):

ZOLEDRONIC ACID

Дозування:

4/100 Mg/Ml

Фармацевтична форма:

Solution for Infusion

Тип рецепту:

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

Терапевтична области:

zoledronic acid

Статус Авторизація:

Not Marketed

Дата Авторизація:

2018-06-22

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLEDRONIC ACID 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 solution for infusion is and what it is used
for
2. What you need to know before you are given Zoledronic Acid
solution for infusion
3. How to use Zoledronic Acid solution for infusion
4. Possible side effects
5. How to store Zoledronic Acid solution for infusion
6. Contents of the pack and other information 1. WHAT ZOLEDRONIC ACID SOLUTION FOR INFUSION IS
AND WHAT IT IS USED FOR
The active substance in Zoledronic Acid solution for infusion 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 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 SOLUTION FOR INFUSION
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
Zoledronic Acid solution for infusion and will check your response to
treatment at regular intervals.
YOU SHOULD NOT BE GIVEN ZOLEDRONIC ACID SOLUTION FOR INFUSION:
−
if you are breast-f

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoledronic Acid 4 mg/100 ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bag with 100 ml solution contains 4 mg zoledronic acid,
corresponding to 4.264 mg zoledronic acid monohydrate.
One ml solution contains 0.04 mg zoledronic acid, corresponding to
0.042 mg zoledronic acid monohydrate.
Each bag with 100 ml solution contains 342.9 mg (14.9 mmol) of sodium
(see Section 4.4)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
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 Solution for infusion must only be prescribed and
administered to patients by healthcare professionals
experienced in the administration of intravenous bisphosphonates.
Patients treated with Zoledronic Acid Solution for
infusion 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 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.
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