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:

Accord Healthcare 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: 5055565716854

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBANDRONIC ACID ACCORD 3 MG SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
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 use 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 belongs to a group of medicines called
bisphosphonates. It contains the active
substance ibandronic acid.
Ibandronic acid Accord 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 Accord may help lower the chances of breaking bones
(fractures). This reduction in
fractures was shown for the spine but not for the hip.
IBANDRONIC ACID ACCORD IS PRESCRIBED TO YOU TO TREAT POSTMENOPAUSAL
OSTEOPOROSIS BECAUSE YOU
HAVE AN INCREASED RISK OF FRACTURES
. Osteoporosis is a thinning and weakening of the bones, which is
common in women after the menopause. At the menopause, a woman’s
ovaries stop producing the
female hormone, oestrogen, which helps to keep her skeleton healthy.
The earlier a woman reaches the
menopause, the greater her risk of fractures in osteoporosis.
Other things that can increase the risk of fractures include:

not enough calcium and vitamin D in the diet

smoking cigarettes, or drinking too much alcohol

not enough walking or other weight-bearing exercise
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Summary of Product characteristics

OBJECT 1
IBANDRONIC ACID ACCORD 3 MG SOLUTION FOR
INJECTION IN PRE-FILLED SYRINGE
Summary of Product Characteristics Updated 22-Sep-2017 | Accord
Healthcare Limited
1. Name of the medicinal product
Ibandronic acid Accord 3 mg solution for injection in pre-filled
syringe
2. Qualitative and quantitative composition
One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid
(as sodium monohydrate).
Each ml of solution contains 1 mg ibandronic acid.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection (injection)
Clear, colourless solution.
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 should be given the package
leaflet and the 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 vitamin 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 creatinine clearance (measured or
estimated) below 30 ml/min, because
of limited clinical data available from studies includin