Ibandronic acid Accord
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
05-01-2023
Charakterystyka produktu
(SPC)
05-01-2023
Sprawozdanie z oceny publicznego
(PAR)
30-10-2017
Składnik aktywny:
ibandronic acid
Dostępny od:
Accord Healthcare S.L.U.
Kod ATC:
M05BA06
INN (International Nazwa):
ibandronic acid
Grupa terapeutyczna:
Drugs for treatment of bone diseases
Dziedzina terapeutyczna:
Wounds and Injuries; Breast Diseases; Neoplastic Processes; Calcium Metabolism Disorders; Water-Electrolyte Imbalance
Wskazania:
Ibandronic acid is indicated in adults forPrevention 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.Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1).A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
Podsumowanie produktu:
Revision: 14
Status autoryzacji:
Authorised
Data autoryzacji:
2012-11-18
Ulotka dla pacjenta
42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBANDRONIC ACID ACCORD 2 MG CONCENTRATE FOR SOLUTION FOR INFUSION
IBANDRONIC ACID ACCORD 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 Accord is and what it is used for
2.
What you need to know before you receive Ibandronic acid Accord
3.
How to receive Ibandronic acid Accord
4.
Possible side effects
5.
How to store Ibandronic acid Accord
6.
Contents of the pack and other information
1.
WHAT IBANDRONIC ACID ACCORD IS AND WHAT IT IS USED FOR
Ibandronic acid Accord contains the active substance ibandronic acid.
This belongs to a group of
medicines called bisphosphonates.
Ibandronic acid Accord 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 Accord can also be prescribed if you have a raised
calcium level in your blood due to a
tumour.
Ibandronic acid Accord 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 ACCORD
_ _
DO NOT RECEIVE IBANDRONIC ACID ACCORD
•
if you are allergic to ibandronic acid or any of the other ingredients
of this medicine (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 apply to you. If you
are not sure, t
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Charakterystyka produktu
1
_ _
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ibandronic acid Accord 2 mg concentrate for solution for infusion
Ibandronic acid Accord 6 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial with 2 ml concentrate for solution for infusion contains 2 mg
ibandronic acid (as sodium
monohydrate).
One vial with 6 ml concentrate for solution for infusion contains 6 mg
ibandronic acid (as sodium
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
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 _
below for recommendations on dosing and administration in this patient
group.
_Treatment of tumour-induced hypercalcaemia_
Prior to treatment with ibandronic acid the p
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