Ibandronic acid 3mg3ml solution for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ibandronic sodium monohydrate

Available from:

Actavis UK Ltd

ATC code:

M05BA06

INN (International Name):

Ibandronic sodium monohydrate

Dosage:

1mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06060200; GTIN: 5012617022653

Patient Information leaflet

Ibandronic acid 1mg/ml (3mg in 3ml) Solution for injection PIL UK
item no: AAAJ1344
print proof no: 03
origination date: 29-06-2016
originated by: MH
revision date: 23-08-2016
revised by: MD
dimensions: 250 x 680
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: 29-06-2016
supplier: Synthon Spain
technically app. date: 22-08-2016
min pt size: 7pt
TECHNICAL APPROVAL
* Please note that only Actavis Global Artwork Studios are permitted
to make
changes to the above artwork. No changes are permitted by any 3rd
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other than added notes and mark ups for required changes.
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_Continued over page_
IBANDRONIC ACID 3MG SOLUTION FOR INJECTION
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.
• The full name of this medicine is Ibandronic acid
3mg Solution for Injection but within the leaflet it
will be referred to as Ibandronic acid.
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 belongs to a group of medicines
called BISPHOSPHONATES. It contains the active
substance ibandronic acid.
Ibandronic acid may reverse bone loss by stopping
more loss of bone and increasing bone mass in most
women who take it, even though they won’t be able
to see or feel a difference. Ibandronic acid may help
lower the chances of breaking bones (fractures). This
reduction in fractures was shown for the spine but not
for the hip.
IBANDRONIC A

Summary of Product characteristics

OBJECT 1
IBANDRONIC ACID 3MG SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 14-Sep-2016 | Accord-UK Ltd
1. Name of the medicinal product
Ibandronic acid Actavis 3mg Solution for Injection
2. Qualitative and quantitative composition
One pre-filled syringe of 3 ml solution for injection contains 3 mg
ibandronic acid (as 3.375 mg
ibandronic acid, monosodium salt, monohydrate).
The concentration of ibandronic acid in the solution for injection is
1 mg per ml.
Excipients with known effect: sodium (less than 1 mmol per dose)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear, colourless solution.
The pH of the solution is 4.9 – 5.5.
4. Clinical particulars
4.1 Therapeutic indications
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.
4.2 Posology and method of administration
Patients treated with ibandronic acid injections should be given the
package leaflet and patient reminder
card.
Posology:
The recommended dose of ibandronic acid is 3 mg, administered as an
intravenous injection over 15 - 30
seconds, every three months.
Patients must receive supplemental calcium and vitamins D (see section
4.4 and section 4.5)
If a dose is missed, the injection should be administered as soon as
convenient. Thereafter, injections
should be scheduled every 3 months from the date of the last
injection.
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established. The need for
continued treatment should be re-evaluated periodically based on the
benefits and potential risks of
ibandronic acid on an individual patient basis, particularly after 5
or more years of use.
_Special Populations _
_Patients with renal impairment _
Ibandronic acid injection is not recommended for use in patients who
have a serum creatinine above 200
μmol/l (2.3 mg/dl) or who have a crea