ZOLEDRONIC ACID 5mg/100 Millilitre Solution for Infusion

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

ZOLEDRONIC ACID MONOHYDRATE

থেকে পাওয়া:

Cipla (EU) Limited

এটিসি কোড:

M05BA08

INN (International Name):

ZOLEDRONIC ACID MONOHYDRATE

ডোজ:

5mg/100 Millilitre

ফার্মাসিউটিকাল ফর্ম:

Solution for Infusion

প্রেসক্রিপশন টাইপ:

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

Therapeutic area:

Biphosphonates

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2014-10-17

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLEDRONIC ACID 5 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 is and what it is used for
2. What you need to know before you are given Zoledronic Acid
3. How Zoledronic Acid is given
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
Zoledronic Acid contains the active substance zoledronic acid. It
belongs to a group of medicines
called bisphosphonates and is used to treat Paget’s disease of the
bone in adults.
PAGET’S DISEASE OF THE BONE
It is normal that old bone is removed and is replaced with new bone
material. This process is called
remodelling. In Paget’s disease, bone remodelling is too rapid and
new bone is formed in a disordered
fashion, which makes it weaker than normal. If the disease is not
treated, bones may become
deformed and painful, and may break. Zoledronic Acid works by
returning the bone remodelling
process to normal, securing formation of normal bone, thus restoring
strength to the bone
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZOLEDRONIC ACID
Follow all instructions given to you by your doctor, pharmacist or
nurse carefully before you are
given Zoledronic Acid.
YOU MUST NOT BE GIVEN ZOLEDRONIC ACID
•if you are allergic to zoledronic acid, other bisphosphonates or
any of the other ingredients of this
medicine (listed in section 6)..
• if you have hypocalcaemia (this means that the levels of calcium
in your blood are too low).
• if you have severe kidney problems.
• if you are

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoledronic Acid 5 mg / 100 ml solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as
monohydrate).
Each ml of the solution contains 0.05 mg zoledronic acid anhydrous,
corresponding to 0.0533 mg zoledronic acid
monohydrate.
EXCIPIENTS WITH KNOWN EFFECTS
Each bottle with 100 ml of solution contains 23 mg of sodium (as
sodium citrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear and colourless solution.
pH: 5.50 to 7.50
Osmolarity : 270 milliosmole/kg to 330 milliosmole/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of Paget's disease of the bone in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Patients must be appropriately hydrated prior to administration of
zoledronic acid. This is especially important for the
elderly (
65 years) and for patients receiving diuretic therapy.
Adequate calcium and vitamin D intake are recommended in association
with zoledronic acid administration.
_Paget’s disease_
For the treatment of Paget's disease, Zoledronic Acid should be
prescribed only by physicians with experience in the
treatment of Paget's disease of the bone. The recommended dose is a
single intravenous infusion of 5 mg Zoledronic
Acid. In patients with Paget’s disease, it is strongly advised that
adequate supplemental calcium corresponding to at
least 500 mg elemental calcium twice daily is ensured for at least 10
days following zoledronic acid administration (see
section 4.4).
Re-treatment of Paget's disease: After initial treatment with
Zoledronic Acid in Paget's disease, an extended remission
period is observed in responding patients. Re-treatment consists of an
additional intravenous infusion of 5 mg
Zoledronic Acid after an interval of one year or longer from initial
treatment in patients who have relapsed. Limited
data on re-treatment of Paget's disease are available (see section