What Bondenza 3 mg solution for injection in pre-filled syringes contains
- The active substance is ibandronic acid. One pre-filled syringe contains 3 mg of ibandronic acid in 3 ml of solution (as 3.375 mg of ibandronic acid, monosodium salt, monohydrate).
- The other ingredients are sodium chloride, acetic acid, sodium acetate trihydrate and water for injections.
What Bondenza 3 mg solution for injection in pre-filled syringes looks like and contents of the pack
Bondenza 3 mg solution for injection in pre-filled syringes is a clear colourless solution. Each pre-filled syringe contains 3 ml of solution. Bondenza is available in packs of 1 pre-filled syringe and 1 injection needle or 4 pre-filled syringes and 4 injection needles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
Manufacturer
Roche Pharma AGEmil-Barell-Strasse 1D-79639 Grenzach-Wyhlen Germany
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
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This leaflet was last approved in {date}
----------------------------------------------------------------------------------------------------------------------------- This information is intended for medical or healthcare professionals only.
INFORMATION FOR THE HEALTHCARE PROFESSIONALS
Please see the Summary of Product Characteristics for more information.
Administration of Bondenza 3 mg solution for injection in pre-filled syringe:
Bondenza 3 mg solution for injection in pre-filled syringe should be injected intravenously over a period of 15 - 30 seconds.
The solution is irritant, therefore strict adherence to the intravenous route of administration is important. If you inadvertently inject into the tissues around the vein, patients may experience local irritation, pain and inflammation at the injection site.
Bondenza 3 mg solution for injection in pre-filled syringe must not be mixed with calcium-containing solutions (such as Ringer-Lactate solution, calcium heparin) or other intravenously administered medicinal products. Where Bondenza is administered via an existing intravenous infusion line, the intravenous infusate should be restricted to either isotonic saline or 50 mg/ml (5 %) glucose solution.
Missed dose:
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.
Overdose:
No specific information is available on the treatment of overdosage with Bondenza.
Based on knowledge of this class of compounds, intravenous overdosage may result in hypocalcaemia, hypophosphataemia, and hypomagnesaemia, which can cause paraesthesia. In severe cases intravenous infusion of appropriate doses of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, may be needed.
General advice:
Bondenza 3 mg solution for injection in pre-filled syringe like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Hypocalcaemia and other disturbances of bone and mineral metabolism should be assessed and effectively treated before starting Bondenza injection therapy. Adequate intake of calcium and vitamin D is important in all patients. All patients must receive supplemental calcium and vitamin D.
Patients with concomitant diseases, or who use medicinal products which have a potential for undesirable effects on the kidney, should be reviewed regularly in line with good medical practice during treatment.
Any unused solution for injection, syringe and injection needle should be disposed of in accordance with local requirements.