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

Država: Velika Britanija

Jezik: engleski

Izvor: myHealthbox

Aktivni sastojci:

zoledronic acid

Dostupno od:

Claris Lifesciences UK Limited

ATC koda:

M05BA08

INN (International ime):

zoledronic acid

Doziranje:

4mg/5ml

Farmaceutski oblik:

Concentrate for solution for infusion

Administracija rute:

Oral use

Jedinice u paketu:

Pack of 5 vials

Tip recepta:

POM - Prescription Only Medicine

Proizveden od:

Peckforton Pharmaceuticals Limited

Terapijska grupa:

Drugs for treatment of bone diseases, bisphosphonates

Terapijske indikacije:

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)

Status autorizacije:

Authorised

Datum autorizacije:

2015-05-14

Uputa o lijeku

Package leaflet: Information for the user
ZOLEDRONIC ACID 4MG/5ML CONCENTRATE FOR SOLUTION FOR INFUSION
ZOLEDRONIC ACID
The name of your medicine is Zoledronic acid 4mg/5ml
concentrate for solution for infusion, which will be referred to as
Zoledronic acid throughout this leaflet.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or
pharmacist or nurse.
•
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
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 you will be given Zoledronic acid
4. Possible side effects
5. How to store Zoledronic acid
6. Contents of the pack and other information
The active substance 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:
•
e.g. fractures, in adult patients
with bone metastases (spread of cancer from primary site to the
bone).
•
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).
Your doctor will carry out blood tests before you start treatment
with Zoledronic acid and will check your response to treatment at
regular intervals.
− if you are breast-feeding.
− if you are allergic to Zoledronic acid, another bisphosphonate
(the group of substances
to which Zoledronic acid belongs), or any of the other
ingredients of this medicine (listed in section 6).
− if�

Svojstava lijeka

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 ml concentrate contains 0.8 mg zoledronic acid
corresponding to 0.8523 
mg zoledronic acid monohydrate.  

One vial with 5 ml concentrate solution contains 4 mg zoledronic
acid, 
corresponding to 4.264 mg zoledronic acid monohydrate. 

For the full list of excipients, see section 6.1_. _ 

3 PHARMACEUTICAL 
FORM 
Concentrate for solution for infusion  
Clear and colourless solution.  

pH: 5.7-6.7  

Osmolarity: 240-340 mOsmol/L  

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 _ 
_ _
_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 
≥