Zoledronic acid Sandoz, Solution for Infusion 4mg/100ml

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

ZOLEDRONIC ACID, MONOHYDRATE

Disponible des:

Sandoz Limited 200 Frimley Business Park, Frimley Camberley, Surrey GU16 7SR, United Kingdom

Codi ATC:

M05BA08

Designació comuna internacional (DCI):

ZOLEDRONIC ACID MONOHYDRATE 4 mg

formulario farmacéutico:

SOLUTION FOR INFUSION

Composición:

ZOLEDRONIC ACID MONOHYDRATE 4 mg

tipo de receta:

POM

Área terapéutica:

DRUGS FOR TREATMENT OF BONE DISEASES

Estat d'Autorització:

Withdrawn

Data d'autorització:

2013-07-15

Informació per a l'usuari

 
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, 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. 

WHAT IS 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 in Zoledronic acid  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  

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 allergic to zoledronic acid, another bisphosphonate
(th

Fitxa tècnica

Page 1 of 21 
 SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Zoledronic acid  4 mg/100 ml solution for infusion 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One bottle of 100 ml solution for infusion contains 4 mg zoledronic
acid, corresponding to 
4.264 mg zoledronic acid monohydrate. 1 ml solution contains 0.04 mg
zoledronic acid 

Excipient with known effect: This medicinal product contains 0.245
mmol (or 5.63 mg) 
sodium per dose.  

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  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 
Page 2 of 21 
_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. 

Treatment of TIH 
_Adults and 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.