País: Singapur
Idioma: anglès
Font: HSA (Health Sciences Authority)
Ibandronic acid ( as monosodium monohydrate 56.25mg)
DKSH SINGAPORE PTE. LTD.
M05BA06
50mg
TABLET, FILM COATED
Ibandronic acid ( as monosodium monohydrate 56.25mg) 50mg
ORAL
Prescription Only
Penn Pharmaceutical Services Ltd
ACTIVE
2008-03-10
BONDRONAT ® Ibandronic acid ______________________________________________________________________________ 1. P HARMACEUTICAL F ORM TABLETS 50MG Film-coated tablets of oblong shape and white to off-white in colour, engraved L2/IT. 2. Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Ibandronic acid, monosodium salt, monohydrate. TABLETS 50MG One film-coated tablet contains 56.25 mg of ibandronic acid, monosodium salt, monohydrate corresponding to 50 mg ibandronic acid. 3. C LINICAL P ARTICULARS 3.1 THERAPEUTIC INDICATIONS Bondronat is indicated for the prevention of skeletal events associated with metastatic bone disease due to breast cancer. 3.2 DOSAGE AND METHOD OF ADMINISTRATION The recommended dose is one 50 mg film-coated tablet daily. Bondronat should be taken after an overnight fast and before the first food or drink of the day. Medications and supplements (including calcium) should similarly be avoided prior to taking Bondronat tablets. Fasting should be continued for at least 60 minutes after taking the tablet. Plain water may be taken at any time during the course of Bondronat treatment. - The tablets should be swallowed whole with a full glass of plain water (180 to 240 ml) while the patient is standing or sitting in an upright position. - Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration. - Plain water is the only drink that should be taken with Bondronat. Please note that some mineral waters may have a higher concentration of calcium and therefore should not be used. - Patients should not lie down for 60 minutes after taking Bondronat. _ _ _Patients with hepatic impairment _ No dosage adjustment is expected to be necessary (see 4.2.5 Pharmacokinetics in Llegiu el document complet
1 BONDRONAT ® Ibandronic acid 1. P HARMACEUTICAL F ORM TABLETS 50MG Film-coated tablets of oblong shape and white to off-white in colour, engraved L2/IT. 2. Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Ibandronic acid, monosodium salt, monohydrate. TABLETS 50MG One film-coated tablet contains 56.25 mg of ibandronic acid, monosodium salt, monohydrate corresponding to 50 mg ibandronic acid. 3. C LINICAL P ARTICULARS 3.1 THERAPEUTIC INDICATIONS Bondronat is indicated for the prevention of skeletal events associated with metastatic bone disease due to breast cancer. 3.2 DOSAGE AND METHOD OF ADMINISTRATION The recommended dose is one 50 mg film-coated tablet daily. Bondronat should be taken after an overnight fast and before the first food or drink of the day. Medications and supplements (including calcium) should similarly be avoided prior to taking Bondronat tablets. Fasting should be continued for at least 60 minutes after taking the tablet. Plain water may be taken at any time during the course of Bondronat treatment. - The tablets should be swallowed whole with a full glass of plain water (180 to 240 ml) while the patient is standing or sitting in an upright position. - Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration. - Plain water is the only drink that should be taken with Bondronat. Please note that some mineral waters may have a higher concentration of calcium and therefore should not be used. - Patients should not lie down for 60 minutes after taking Bondronat. _ _ _Patients with hepatic impairment _ No dosage adjustment is expected to be necessary (see 4.2.5 Pharmacokinetics in Special Populations). _Patients with renal impairment _ For patients with mild renal impairment (CLcr ≥50 and <80 mL/min) no dosage adjustment is necessary. For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) a dosage adjustment to one 50 mg film-coated tablet every second day is recommended. For patients with severe renal impairment (CLcr <30 mL/min) the recommend Llegiu el document complet