ZOLEDRONIC ACID SANDOZ 0.05 Mg/Ml Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ZOLEDRONIC ACID MONOHYDRATE

Available from:

Rowex Ltd

ATC code:

M05BA08

INN (International Name):

ZOLEDRONIC ACID MONOHYDRATE

Dosage:

0.05 Mg/Ml

Pharmaceutical form:

Solution for Infusion

Prescription type:

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

Therapeutic area:

Biphosphonates

Authorization status:

Authorised

Authorization date:

2012-09-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

ZOLEDRONIC ACID SANDOZ 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. 

  This medicine has been prescribed for you only. Do not pass
it on to others. It may harm  them, 
even if their signs of illness are the same as yours. 

  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 Sandoz is and what it is used for 
2. 
What you need to know before you are given Zoledronic acid
Sandoz  
3. 
How Zoledronic acid Sandoz is given 
4. 
Possible side effects 
5. 
How to store Zoledronic acid Sandoz  
6. 
Contents of the pack and other information 

1. 
WHAT ZOLEDRONIC ACID SANDOZ IS AND WHAT IT IS USED FOR 

Zoledronic acid Sandoz contains the active substance zoledronic acid.
It belongs to a group of 
medicines called bisphosphonates and is used to
treat post-menopausal women and adult men with 
osteoporosis or osteoporosis caused
by treatment with corticosteroids used to treat inflammation,
and 
Paget’s disease of the bone in adults. 

OSTEOPOROSIS 
Osteoporosis is a disease that involves the thinning and
weakening of the bones and is common in 
women after the menopause, but can also occur in men. At the
menopause, a woman’s ovaries stop 
producing the female hormone oestrogen, which helps keep
bones healthy. Following the menopause 
bone loss occurs, bones become weaker and break more easily.
Osteoporosis could also occur in men 
and women because of the long term use of ste

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoledronic acid Sandoz 5mg/100ml Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle of 100 ml solution for infusion contains 5 mg zoledronic acid.
Each ml of the solution contains 0.05 mg zoledronic acid anhydrous, corresponding to 0.0533 mg zoledronic acid
monohydrate.
Excipient with known effect: This medicinal product contains 0.306 mmol (or 7.04 mg) sodium per dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear and colourless solution (isotonic, pH between 6.0 – 7.0).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of osteoporosis
•
in post-menopausal women
•
in adult men
at increased risk of fracture, including those with a recent low-trauma hip fracture.
Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy
•
in post-menopausal women
•
in adult men
at increased risk of fracture.
Treatment of Paget’s disease of the bone in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Patients treated with Zoledronic acid Sandoz should be given the package leaflet and the patient reminder card.
Posology
Patients must be appropriately hydrated prior to administration of Zoledronic acid Sandoz. 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 Sandoz administration.
_Osteoporosis_
For the treatment of post-menopausal osteoporosis, osteoporosis in men and the treatment of osteoporosis associated
with long-term systemic glucocorticoid therapy, the recommended dose is a single intravenous infusion of 5 mg
zoledronic acid administered once a year.
The optimal duration�