Ibandronic acid 3mg3ml solution for injection pre-filled syringes

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Ibandronic sodium monohydrate

Verfügbar ab:

Sun Pharmaceutical Industries Europe B.V.

ATC-Code:

M05BA06

INN (Internationale Bezeichnung):

Ibandronic sodium monohydrate

Dosierung:

1mg/1ml

Darreichungsform:

Solution for injection

Verabreichungsweg:

Intravenous

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 06060200; GTIN: 8718309129675

Fachinformation

IBANDRONIC ACID 3 MG SOLUTION FOR INJECTION IN
PRE-FILLED SYRINGE
Summary of Product Characteristics Updated 16-May-2017 | Ranbaxy (UK)
Limited a Sun
Pharmaceutical Company
1. Name of the medicinal product
Ibandronic acid SUN 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 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.
Each pre filled syringed contains 0.476 mmol (10.95 mg) of sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection in pre-filled syringe.
Clear, colourless solution with pH between 4.80 and 6.00 and
osmolality between 280 and 320 mOsm/kg.
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_
N