Krajina: Singapur
Jazyk: angličtina
Zdroj: HSA (Health Sciences Authority)
IBANDRONIC ACID, monosodium salt, monohydrate eqv. to Ibandronic Acid
DKSH SINGAPORE PTE. LTD.
M05BA06
1mg/ml
INJECTION
IBANDRONIC ACID, monosodium salt, monohydrate eqv. to Ibandronic Acid 1mg/ml
INTRAVENOUS
Prescription Only
Universal Farma, S.L.
ACTIVE
1999-10-29
BONDRONAT Ibandronic acid ______________________________________________________________________________ 1. P HARMACEUTICAL F ORM Concentrate for solution for infusion. 2. Q UALITATIVE AND Q UANTITATIVE C OMPOSITION _Active ingredient_: ibandronic acid. Ampoules with 1 ml of concentrate for infusion. Vials with 2 ml or 6ml of concentrate for solution for infusion. Ampoules of 1 ml contain 1.125 mg ibandronic acid, monosodium salt, monohydrate corresponding to 1 mg ibandronic acid; vials of 2 ml contain 2.25 mg ibandronic acid, monosodium salt, monohydrate corresponding to 2 mg ibandronic acid; vials of 6 ml contain 6.75 mg ibandronic acid, monosodium salt, monohydrate, corresponding to 6 mg ibandronic acid. 3. C LINICAL P ARTICULARS 3.1 THERAPEUTIC INDICATIONS - Prevention of skeletal events associated with metastatic bone disease due to breast cancer. - Treatment of pathologically (abnormally) elevated serum calcium levels (hypercalcemia) as a result of tumours. _ _ _ _ 3.2 DOSAGE AND METHOD OF ADMINISTRATION TREATMENT OF METASTATIC BONE DISEASE The recommended dose for metastatic bone disease is 6 mg IV given every 3-4 weeks. The dose should be infused over at least 15 minutes. For infusion, the contents of the ampoule(s)/vials(s) should be added to 100 ml isotonic sodium chloride solution (or 100 ml 5% dextrose 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 50ml/min. Prescribers should consult the section _Patients with renal impairment_ for recommendations on dosing and administration in this patient group. Prečítajte si celý dokument
5mm 5mm 95 mm 175 mm 45 mm 45 mm 370 mm 66 mm 5mm 679 mm 750 mm ONLY FOR POSITION ONLY FOR POSITION LAETUS CENTERED WITHIN 35 MM ON THE VISIBLE FINAL SIZE AFTER FOLDED Notes Printable Colours Non Printable Colours PAGE 1 OF 2 SG 705-8530 UNI 02 Date 07-12-23 Previous NA BONDRONAT 2MG2ML 6MG6ML 1 VIAL Size 750X370MM Black Guides Guides Barcdes SG 705-8530 UNI 02 BONDRONAT ® Ibandronic acid DOSAGE / INFUSION TIME 1 6 mg / 15 minutes 4 mg / 1 hour 2 mg / 1 hour INFUSION VOLUME 2 100 mL 500 mL 500 mL SMPR per patient Reduction in Rate compared to placebo Treatment 0.29 Treatment Intravenous Infusion (6mg every 3 to 4 weeks SREs Risk Reduction compared to placebo (%) 40 p-value 0.004 p-value 0.003 CREATININE CLEARANCE (ML/MIN) ≥50 CLcr <80 ≥30 CLcr <50 <30 1. PHARMACEUTICAL FORM Concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient:_ ibandronic acid. Ampoules with 1 ml of concentrate for infusion. Vials with 2 ml or 6ml of concentrate for solution for infusion. Ampoules of 1 ml contain 1.125 mg ibandronic acid, monosodium salt, monohydrate corresponding to 1 mg ibandronic acid; vials of 2 ml contain 2.25 mg ibandronic acid, monosodium salt, monohydrate corresponding to 2 mg ibandronic acid; vials of 6 ml contain 6.75 mg ibandronic acid, monosodium salt, monohydrate, corresponding to 6 mg ibandronic acid. 3. CLINICAL PARTICULARS 3.1 THERAPEUTIC INDICATIONS - Prevention of skeletal events associated with metastatic bone disease due to breast cancer. - Treatment of pathologically (abnormally) elevated serum calcium levels (hypercalcemia) as a result of tumours. 3.2 DOSAGE AND METHOD OF ADMINISTRATION TREATMENT OF METASTATIC BONE DISEASE The recommended dose for metastatic bone disease is 6 mg IV given every 3-4 weeks. The dose should be infused over at least 15 minutes. For infusion, the contents of the ampoule(s)/vials(s) should be added to 100 ml isotonic sodium chloride solution (or 100 ml 5% dextrose solution). A shorter (i.e 15 min) infusion time should only be us Prečítajte si celý dokument