What Iasibon contains
- One ampoule with 1 ml concentrate for solution for infusion contains 1 mg ibandronic acid (as 1.125 mg ibandronic acid, monosodium salt, monohydrate).
- The other ingredients are sodium chloride, glacial acetic acid, sodium acetate trihydrate and water for injections.
What Iasibon looks like and contents of the pack
Iasibon is a colourless, clear solution.
Iasibon 1 mg is supplied as pack containing 1 ampoule (2 ml type I glass ampoule).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pharmathen S.A.
Dervenakion 6
Pallini 15351
Attiki
Greece
Manufacturer
Pharmathen S.A.
Dervenakion 6
Pallini 15351
Attiki
Greece
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
BelgiëBelgiqueBelgien Pharmathen S.A. TélTel 30 210 66 65 067 LuxembourgLuxemburg Portfarma ehf.. TélTel 354 534 4030
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Danmark Pharmathen S.A. Tlf 30 210 66 65 067 Nederland Pharmathen S.A. Tel 30 210 66 65 067
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Eesti Estonia Portfarma ehf. Tel 354 534 4030 Österreich Pharmathen S.A. Tel 30 210 66 65 067
Pharmathen S.A. 30 210 66 65 067 Polska Pharmathen S.A. Tel. 30 210 66 65 067
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Ireland Aspire Pharma Ltd Tel 44 1730 234527 Slovenija Pharmathen S.A. Tel 30 210 66 65 067
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Italia Pharmathen S.A. Tel 30 210 66 65 067 SuomiFinland Pharmathen S.A. PuhTel 30 210 66 65 067
P.T. Hagjigeorgiou Co Ltd 357 25372425 Sverige Pharmathen S.A. Tel 30 210 66 65 067
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Lietuva
Portfarma ehf.
Tel: +354 534 4030
This leaflet was last approved in
--------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only
Prevention of skeletal events in patients with breast cancer and bone metastases The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenously given every 3-4 weeks. The dose should be infused over at least 15 minutes. For infusion, the contents of the vial(s) should only be added to 100 ml isotonic sodium chloride solution or 100 ml 5% glucose solution.
A shorter (i.e. 15 min) infusion time should only be used for patients with normal renal function or mild renal impairment. There are no data available characterizing the use of a shorter infusion time in patients with creatinine clearance below 50 ml/min. Prescribers should consult the section Patients with Renal Impairment (see section 4.2) for recommendations on dosing and administration in this patient group.
Treatment of tumour-induced hypercalcemia
Prior to treatment with Iasibon the patient should be adequately rehydrated with 9 mg/ml (0.9%) sodium chloride. Consideration should be given to the severity of the hypercalcaemia as well as the tumour type. In general patients with osteolytic bone metastases require lower doses than patients with the humoral type of hypercalcaemia. In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ?3 mmol/l or ?12 mg/dl) 4 mg is an adequate single dosage. In patients with moderate hypercalcaemia (albumin-corrected serum calcium <3 mmol/l or <12 mg/dl) 2 mg is an effective dose. The highest dose used in clinical trials was 6 mg but this dose does not add any further benefit in terms of efficacy.
* Note albumin-corrected serum calcium concentrations are calculated as follows:
Albumin-corrected Serum calcium (mmol/l) = Serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8 Or
Albumin-corrected Serum calcium (mg/dl) = Serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)]
To convert the albumin-corrected serum calcium in mmol/l value to mg/dl, multiply by 4.
In most cases a raised serum calcium level can be reduced to the normal range within 7 days. The median time to relapse (return of serum albumin-corrected serum calcium above 3 mmol/l) was 18-19 days for the 2 mg and 4 mg doses. The median time to relapse was 26 days with a dose of 6 mg.
Method and route of administration
Iasibon therapy should only be initiated by physicians experienced in the treatment of cancer. For intravenous administration.
For single use only. Only clear solution without particles should be used.
Iasibon concentrate for solution for infusion should be administered as an intravenous infusion. For this purpose, the contents of the vials are to be added to 500 ml isotonic sodium chloride solution (or 500 ml 5% dextrose solution) and infused over two hours.
As the inadvertent intra-arterial administration of preparations not expressly recommended for this purpose as well as paravenous administration can lead to tissue damage, care must be taken to ensure that Iasibon concentrate for solution for infusion is administered intravenously.
Note:
To avoid potential incompatibilities Iasibon concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% glucose solution.
Iasibon should not be mixed with calcium containing solutions.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2 - 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.
(see point 5 of this leaflet ?HOW TO STORE IASIBON?).
Frequency of administration
The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenous injection given every 3-4 weeks. The dose should be infused over at least 15 minutes.
In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ?3 mmol/l or ?12 mg/dl) 4 mg is an adequate single dosage.
Duration of treatment
A limited number of patients (50 patients) have received a second infusion for hypercalcaemia. Repeated treatment may be considered in case of recurrent hypercalcaemia or insufficient efficacy.
Overdose
Up to now there is no experience of acute poisoning with Iasibon concentrate for solution for infusion. Since both the kidney and the liver were found to be target organs for toxicity in preclinical studies with high doses, kidney and liver function should be monitored.
Clinically relevant hypocalcaemia (very low serum calcium levels) should be corrected by intravenous administration of calcium gluconate.