Bonviva 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:

Atnahs Pharma 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: 5000471006674

Patient Information leaflet

1
uk-ie-mt-pil-bonviva-clean-160421-3mg-inj
PACKAGE LEAFLET: INFORMATION FOR THE USER
BONVIVA 3 MG SOLUTION FOR INJECTION
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 Bonviva is and what it is used for
2.
What you need to know before you receive Bonviva
3.
How to receive Bonviva
4.
Possible side effects
5.
How to store Bonviva
6.
Content of the pack and other information
1.
WHAT BONVIVA IS AND WHAT IT IS USED FOR
Bonviva belongs to a group of medicines called bisphosphonates. It
contains the active substance
ibandronic acid.
Bonviva 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. Bonviva may help
lower the chances of breaking bones (fractures). This reduction in
fractures was shown for the spine
but not for the hip.
BONVIVA 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
•
a family history of osteoporosis
A HEALTHY LIFESTYLE
will also help you to get the most benefit from your treatment. This
includ

Summary of Product characteristics

BONVIVA 3MG/3ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 05-May-2016 | Roche
Products Limited
1. Name of the medicinal product
Bonviva 3 mg solution for injection
2. Qualitative and quantitative composition
One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid
(as sodium monohydrate).
The concentration of ibandronic acid in the solution for injection is
1mg per ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for 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 Bonviva 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
Bonviva on an individual patient basis, particularly after 5 or more
years of use.
_Special populations_
_Patients with renal impairment_
Bonviva 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 including such patients
(see section 4.4 and section 5.2).
No dose adjustment is necessary fo