Ibandronic Acid 6 mg Concentrate for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibandronate sodium monohydrate

Available from:

Noridem Enterprises Limited

ATC code:

M05BA; M05BA06

INN (International Name):

Ibandronate sodium monohydrate

Dosage:

6 milligram(s)

Pharmaceutical form:

Concentrate for solution for infusion

Prescription type:

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

Therapeutic area:

Bisphosphonates; ibandronic acid

Authorization status:

Not marketed

Authorization date:

2013-05-03

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBANDRONIC ACID 6 MG CONCENTRATE FOR SOLUTION FOR INFUSION
ibandronic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Ibandronic Acid is and what it is
used for
2. What you need to know before you receive Ibandronic Acid
3. How to receive Ibandronic Acid
4. Possible side effects
5.
How to store Ibandronic Acid
6.
Contents of the pack and other information
1. WHAT IBANDRONIC ACID IS AND WHAT IT IS USED FOR
Ibandronic Acid contains the active substance ibandronic acid. This
belongs to a group of medicines called
bisphosphonates.
Ibandronic Acid is used in adults and prescribed to you if you have
breast cancer that has spread to your bones
(called ‘bone metastases’).
• It helps to prevent your bones from breaking (fractures)
• It helps to prevent other bone problems that may need surgery or
radiotherapy
Ibandronic Acid can also be prescribed if you have a raised calcium
level in your blood due to a tumour.
Ibandronic Acid works by reducing the amount of calcium that is lost
from your bones. This helps to stop your
bones from getting weaker.
2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE IBANDRONIC ACID
DO NOT RECEIVE IBANDRONIC ACID:

if you
are allergic to ibandronic acid or any of the other ingredients of
this medicine that are listed in
section 6

if you have, or have ever had low levels of calcium in your blood
_ _
Do not receive
this medicine if any of the above applies to you. If you are not sure,
talk to your doctor or
pharmacist before having Ibandronic Acid.
WARNINGS AND PRECAUTIONS
A side effect called osteonecrosis of the jaw (ONJ) (bone da

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibandronic Acid 6 mg Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial with 6 mL concentrate for solution for infusion contains 6 mg
ibandronic acid, (as 6.75 mg ibandronic acid,
monosodium salt, monohydrate).
Excipients with known effect: Sodium (less than 1 mmol per dose).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ibandronic Acid is indicated in adults for:
- Prevention of skeletal events (pathological fractures, bone
complications requiring radiotherapy or surgery) in patients
with breast cancer and bone metastases
- Treatment of tumour-induced hypercalcaemia with or without
metastases.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Patients treated with Ibandronic Acid should be given the package
leaflet and the patient reminder card.
Ibandronic Acid therapy should only be initiated by physicians
experienced in the treatment of cancer.
Posology
_Prevention of skeletal events in patients with breast cancer and bone
metastases_
The recommended dose for prevention of skeletal events in patients
with breast cancer and bone metastases is 6 mg
intravenous injection given every 3-4 weeks. The dose should be
infused over at least 15 minutes.
A shorter (i.e. 15 min) infusion time should only be used for patients
with normal renal function or mild renal
impairment. There are no data available characterising the use of a
shorter infusion time in patients with creatinine
clearance below 50 mL/min. Prescribers should consult the section_
Patients with Renal Impairment_ (see section 4.2) for
recommendations on dosing and administration in this patient group.
_Treatment of tumour-induced hypercalcaemia_
Prior to treatment with Ibandronic Acid the patient should be
adequately rehydrated with 9 mg/mL (0.9%) sodium
chloride solution. Consideration should be given to the severity of