qanastek/EMEA-V3 huggingface dataset:
To avoid potential incompatibilities Bondronat concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% glucose solution.
Biex jiġu evitati inkompatabiltajiet potenzjali l- Bondronat konċentrat għal soluzzjoni għall- infużjoni għandu jiġi dilwit biss ma ’ soluzzjoni ta ’ sodium chloride jew soluzzjoni ta ’ glucose 5%.
24 hours.
24 siegħa
No special precautions for storage prior to reconstitution.
M’ hemm l- ebda prekawzjonijiet speċjali għal ħażna qabel ir- rikostituzzjoni.
Bondronat is supplied as packs containing 1, 5 and 10 vials (6 ml type I glass vial).
Bondronat jiġi f’ pakketti li fihom 1, 5 u 10 kunjetti (kunjetti tal- ħġieġ ta ’ 6 ml tat- tip I).
The vials are closed with rubber stoppers complying with Ph. Eur.
Il- kunjetti jingħalqu b’ tappijiet tal- lastku skond ma tirrikjedi Ph. Eur.
Not all pack sizes may be marketed..
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
6 Falcon Way Shire Park Welwyn Garden City AL7 1TW Ir- Renju Unit
34 ANNEX II
35 ANNESS II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Name and address of the manufacturers responsible for batch release
Isem u indirizz tal- manifatturi responsabbli għall- ħruġ tal- lott.
Concentrate for solution for infusion
Konċentrat għal soluzzjoni għall- infużjoni
Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany
Roche Diagnostics GmbH Sandhofer Strasse 116 D- 68305 Mannheim Ġermanja
Film-coated tablet
Pillola miksija b’ rita
1 D-79639 Grenzach-Wyhlen Germany
1 D- 79639 Grenzach- Wyhlen Ġermanja
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
Fuq il- fuljett ta 'tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli mill- ħruġ tal- lott konċernat
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
Summary of Product Characteristics, section 4.2).
Sommarju tal - Karatteristiċi tal - Prodott, sezzjoni 4. 2).
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
37 A.
37 ANNESS III
LABELLING
TIKKETTA U FULJETT TA ’ TAGĦRIF
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
Outer Carton
Pakkett ta ’ Barra
Bondronat 2 mg concentrate for solution for infusion ibandronic acid
Bondronat 2 mg konċentrat għal soluzzjoni għall- infużjoni ibandronic acid
Each vial contains 2 mg of ibandronic acid (as monosodium salt, monohydrate).
Kull kunjett fih 2. 25 mg ta ’ ibandronic acid (bħala monosodium salt, monohydrate)
Sodium acetate, sodium chloride, acetic acid and water for injections.
Sodium acetate, Sodium chloride, acetic acid u ilma għall- injezzjoni.
1 vial
Kunjett 1
Intravenous use, for infusion after dilution.
Użu għal ġol- vina, għall- infużjoni wara li jiġi dilwit.
Read the package leaflet before use
Aqra il- fuljett ta ’ tagħrif qabel\ l- użu.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN 9.
No special precautions for storage prior to reconstitution.
Ma hemm l- ebda prekawzjonijiet speċjali għal ħażna qabel ir- rikostituzzjoni.
After dilution the infusion solution is stable for 24 hours at 2 °C - 8 °C (in a refrigerator)
Wara li jiġi dilwit is - soluzzjoni għall- infużjoni hija stabbli għal 24 siegħa f’ temperatura ta ’ bejn 2 °C – 8 °C (fil- friġġ)
10.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI 10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
BATCH NUMBER
NUMRU TAL - LOTT
INSTRUCTIONS ON USE
STRUZZJONIJIET DWAR L- UŻU 15.
Justification for not including Braille accepted
Il- Ġustifikazzjoni biex ma ’ jkunx inkluż il- Braille hija aċċettata
40 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
41 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI IŻ- ŻGĦAR EWLENIN
Vial
Kunjett
Bondronat 2 mg concentrate for solution for infusion ibandronic acid I. V. use
Bondronat 2 mg konċentrat għal soluzzjoni għall- infużjoni ibandronic acid Użu I. V.
Read the package leaflet before use
Aqra il- fuljett ta ’ tagħrif qabel l- użu
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI.
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
42 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer Carton
Kaxxa ta ’ barra
Bondronat 50 mg film-coated tablets ibandronic acid
Pilloli miksija b’ rita ta ’ Bondronat 50 mg ibandronic acid
Each film-coated tablet contains 50 mg of ibandronic acid (as ibandronic sodium monohydrate).
Kull pillola miksija b’ rita fiha 50 mg ta ’ ibandronic acid (bħala ibandronic sodium monohydrate)
Lactose monohydrate, Povidone, Cellulose (microcrystalline), Crospovidone, Stearic acid, Silica (anhydrous colloidal), Hypromellose, Titanium dioxide E171, Talc, Macrogol 6000.
Lactose monohydrate, Povidone, Cellulose (microcrystalline), Crospovidone, Stearic acid, Silica (anhydrous colloidal), Hypromellose, Titanium dioxide E171, Talc, Macrogol 6000.
28 film-coated tablets
28 pillola miksija b’ rita
Oral use Do not suck or chew tablets Read the package leaflet before use
Għall- użu orali M’ għandekx terda jew tomgħod il- pilloli Aqra l- fuljett ta ’ tagħrif qabel l- użu
Keep out of the reach and sight of children
Żomm fejn ma ’ jintlaħaqx u ma ’ jidhirx mit- tfal
The tablets also contain lactose
Il- pilloli fihom ukoll lactose
Store in the original package in order to protect from moisture
Aħżen fil- pakkett oriġinali sabiex tiproteġi mill- umdità
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
Medicinal product subject to medical prescription
Prodott mediċinali li jingħata bir- riċetta tat- tabib
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
44 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
84 film-coated tablets
84 pillola miksija b’ rita
45 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
46 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ ISTRIXXI JEW FUQ IL- FOLJI
Mon Tue Wed Thu Fri Sat Sun
It- Tnejn It- Tlieta L- Erbgħa Il- Ħamis Il- Ġimgħa Is- Sibt Il- Ħadd
46 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Bondronat 6 mg concentrate for solution for infusion ibandronic acid
Bondronat 6 mg konċentrat għal soluzzjoni għall- infużjoni ibandronic acid
Each vial contains 6 mg of ibandronic acid (as monosodium salt, monohydrate).
Kull kunjett fih 6 mg ta ’ ibandronic acid (bħala monosodium salt, monohydrate)
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT GĦANDU JINŻAMM FEJN MA ’ JINTLAĦAQX U MA ’ JIDHIRX MIT- TFAL
No special storage requirements prior to reconstitution.
Ma hemm l- ebda prekawzjonijiet speċjali għal ħażna qabel ir- rikostituzzjoni.
48 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
49 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
5 vials
5 Kunjetti
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
51 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
10 vials
10 Kunjetti
After dilution the infusion solution is stable for 24 hours at 2 °C – 8 °C (in a refrigerator)
Wara li jiġi dilwit is - soluzzjoni għall- infużjoni hija stabbli għal 24 siegħa f’ temperatura ta ’ bejn 2 °C – 8 °C (fil- friġġ)
52 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
53 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI IŻ- ŻGĦAR EWLENIN
Bondronat 6 mg concentrate for solution for infusion ibandronic acid I. V. use
Bondronat 6 mg konċentrat għal soluzzjoni għall- infużjoni ibandronic acid Użu I. V.
54 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF
INFORMATION FOR THE USER
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
Read all of this leaflet carefully before you start using this medicine.
Aqra dan- il fuljett kollu qabel tibda tuża din il- mediċina
You may need to read it again.
Jista jkollok bżonn terġa 'taqrah.
- If you have any further questions, ask your doctor or your pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Do not pass it on to others.
TAGĦTIHIEX lil persuni oħra.
It may harm them, even
Tista ’ tagħmlilhom il- ħsara,
if their symptoms are the same as yours.
anki jekk ikollom l- istess sintomi bħall tiegħek.
What Bondronat is and what it is used for 2.
X’ inhu Bondronat u għalxiex jintuża 2.
Before you use Bondronat 3.
QABEL ma tuża Bondronat 3.
How to use Bondronat 4.
Kif għandek tuża Bondronat 4.
How to store Bondronat 6.
Kif taħżen Bondronat 6.
WHAT BONDRONAT IS AND WHAT IT IS USED FOR
X’ INHU BONDRONAT U GĦALXIEX JINTUŻA
The active substance of Bondronat, ibandronic acid, belongs to the group of medicines known as bisphosphonates.
Is- sustanza attiva ta ’ Bondronat, ibandronic acid, tappartjeni għall- grupp ta ’ mediċini magħrufa bħala bisfosfonati.
It inhibits increased loss of calcium from the bones (bone resorption), thus normalising elevated serum calcium levels.
Huwa jinibixxi t- telf żejjed ta ’ kalċju mill- għadam (assorbiment mill- ġdid ta ‘ l- għadam), għalhekk jreġġa 'għan- normal il- livelli għoljin ta ’ kalċju fis- serum.
It also prevents bone complications and fractures related to the spread of cancer cells into bone.
Jipprevjeni ukoll il- komplikazzjonijiet u l- fratturi fl- għadam relatati mal- firxa taċ- ċelloli tal- kanċer fl- għadam.
Bondronat is indicated for:
Bondronat huwa indikat għal:
- Pathologically (abnormally) elevated serum calcium levels (hypercalcaemia) as a result of
- Livelli pataloġikament (mhux normali) għoljin ta ’ kalċju fis- serum (iperkalċemja) bħala riżultat
tumours
ta ’ tumuri
- Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy
- Prevenzjoni ta ’ episodji skeletriċi (fratturi patoloġiċi, komplikazzjonijiet fl- għadam li jeħtieġu r -
or surgery) in patients with breast cancer and bone metastases.
radjuterapija jew il- kirurġija) f’ pazjenti b’ kanċer tas- sider u metastasi fl- għadam.
BEFORE YOU USE BONDRONAT
QABEL MA TUŻA BONDRONAT
During treatment your blood may be monitored to ensure that you are receiving the correct dose of Bondronat.
Waqt il- kura d- demm tiegħek jista ’ jkun monitorjat sabiex ikun assigurat li int qed tirċievi d- doża ta ’ Bondronat korretta.
If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Bondronat
Jekk qed taħt kura dentali jew se tingħata kirurġija dentali, għid lid- dentist tiegħek li inti qed tirċievi kura b’ Bondronat.
Do not use Bondronat:
Tużax Bondronat:
- if you are allergic (hypersensitive) to the active substance or any of the other ingredients of
- jekk int allerġiku (tbagħti minn sensittività eċċessiva) għas- sustanza attiva jew kwalunkwe mis -
Bondronat.
sustanzi l- oħra ta 'Bondronat.
Bondronat should not be used in children.
Bondronat ma għandux jintuża fuq tfal.
Take special care with Bondronat: if you know or believe that you may have:
Oqgħod attent ħafna b’ Bondronat: jekk taf jew taħseb li għandek:
- hypersensitivity to other bisphosphonates
- Ipersensittività għall- bisfosfonati l- oħra
- low blood calcium
- Livell baxx ta ’ kalċju fid- demm
- other disturbances of mineral metabolism (such as vitamin D deficiency)
- Disturbi oħra fil- metaboliżmu ta ’ minerali (bħal defiċjenza ta ’ Vitamina D).
- severe kidney disease (renal insufficiency i. e. creatinine clearance < 30 ml/ min)
- Mard serju fil- kliewi (insuffiċjenza renali i. e. it- tneħħija tal- kreatinina < 30 mL/ min)
Using other medicines:
Meta tieħu mediċini oħra:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
No interaction was observed when ibandronic acid was administered concomitantly with tamoxifen, or melphalan/ prednisolone.
Ma ġiet osservata l- ebda interazzjoni meta ingħata ibandronic acid flimkien ma ’ tamoxifen, jew melphalan/ prednisolone.
Caution is advised when bisphosphonates are administered with aminoglycosides since both agents can lower serum calcium levels for prolonged periods.
Kawtela hija rakkomandata meta jingħataw il- bisfosfonati ma ’ l- aminoglycosides minħabba li ż- żewġ prodotti jistgħu jbaxxu l- livelli tal- kalċju fis- serum għall- perijodi twal.
Caution should also be paid to the possible existence of simultaneous hypomagnesaemia (reduced magnesium levels).
Wieħed irid joqgħod attent ukoll għall- possibilità ta ’ eżistenza simultanja ta ’ ipomanjesemjia (livelli mnaqqsa ta ’ manjesju).
Pregnancy and breast-feeding You should not be given Bondronat if you are pregnant or if you are breast-feeding.
Tqala u Treddigħ Ma għandekx tingħata Bondronat jekk inti tqila jew qed tredda ’.
Driving and using machines:
Sewqan u tħaddim ta ’ magni:
The effects of Bondronat on the ability to drive or to use machines has not been studied.
L- effetti ta ’ Bondronat fuq il- ħila biex issuq jew tuża magni ma ġewx studjati.
HOW TO USE BONDRONAT
KIF GĦANDEK TUŻA BONDRONAT
You will be given Bondronat as an infusion. Your doctor will determine how much Bondronat you will be given depending on your illness.
It- tabib tiegħek għandu jiddetermina kemm għandek tingħata Bondronat skond il- marda tiegħek.
Your doctor may adjust your dose if you have kidney problems.
It- tabib tiegħek jista ’ jaġġusta id- doża tiegħek jekk għandek problemi bil- kliewi.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqst lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Bondronat can cause side effects although not everybody gets them.
Bħal kull mediċina oħra, Bondronat jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The side effects listed below were seen when Bondronat was given intravenously.
L- effetti sekondarji elenkati ‘ l isfel kienu osservati meta Bondronat ingħata ġol- vina.
• Side effects described as very common were experienced in more than 1 in 10 patients. • Side effects described as common were experienced by up to 1 in 10 patients. • Side effects described as rare or very rare were experienced by fewer than 1 in 100 patients
• L- effetti sekondarji deskritti bħala komuni ħafna dehru f’ iżjed minn f’ pazjent 1 minn kull 10 pazjenti. • L- effetti sekondarji deskritti bħala komuni dehru f’ mhux iżjed minn pazjent 1 minn kull 10 pazjenti. • L- effetti sekondarji deskritti bħala rari jew rari ħafna dehru f’ inqas minn pazjent 1 minn kull 100 pazjent.
Common side effects are flu-like symptoms (including fever, chills, bone pain and aching muscles), tiredness, diarrhea, indigestion, vomiting, headache, dizziness, gastrointestinal pain, sore throat, and swelling of the lower limbs.
Effett sekondarju komuni ħafna huwa żjieda fit- temperatura tal- ġisem, Effetti sekondarji komuni huma sintomi simili għall- influwenza (inklużi deni, tkexkix, uġigħ fl- għadam u uġigħ fil- muskoli), għeja, dijarrea, indiġestjoni, rimettar, uġigħ ta ’ ras, sturdament, uġigħ gastro- intestinali, uġigħ fil- griżmejn u nefħa fil- parti ta ’ isfel tar- riġlejn.
These symptoms usually disappear within a couple of hours/ days.
Dawn is- sintomi normalment jisparixxu f’ perijodu ta ’ ftit sigħat jew ġranet.
Less commonly patients have reported infections, strange taste, cataracts, bundle branch block, tooth disorder, skin problems, aching joints, arthritis, and thirst.
Inqas komuni, pazjenti rrapportaw infezzjonijiet, togħma stramba, kataratti, bundle branch block, mard tas- snien, problemi fil- ġilda, uġigħ fil- ġogi, artrite u għatx.
In rare cases, patients have reported the following: gastroenteritis, oral thrush, vaginitis, benign skin growth, sleep disturbance, anxiety, affect lability, memory loss, numbness round the mouth (paraesthesia circumoral), hyperaesthesia, hypertonia, nerve root lesion, neuralgia, migraine, cerebrovascular disorder, parosmia, deafness, heart and circulatory problems (including palpitations, myocardial ischaemia, hypertension, varicose veins), lymphoedema, lung oedema, stridor, gastritis,
F’ każi rari, pazjenti rrapportaw is- segwenti: gastroenterite, infezzjoni fil- ħalq ikkawżata mill- moffa, vaġinite, tkabbir beninju tal- ġilda, disturbi fl- irqad, ansjetà, lijabilità affettiva, telf ta ’ memorja, tarix
56 cheilitis, difficulty swallowing (dysphagia), mouth ulceration, gall stones cholelithiasis, rash, hair loss, cystitis, renal cyst, urinary retention, pelvic pain, injection site pain, weight loss, and hypothermia.
57 madwar il- ħalq (parasteżija ċirkumorali), iperesteżija, ipertonija, ferita ta ’ l- għerq tan- nerv, nevralġija, migranja, mard ċerbovaskulari, parosomija, truxija, problemi tal- qalb u taċ- ċirkolazzjoni (inklużi palpitazzjonijiet, iskemja mijokardjali, ipertensjoni, vini varikużi), limfoedema, edema tal- pulmun, stridor, gastrite, kelite, diffikultà biex tibla (disfaġja), ulċerazzjoniji tal- ħalq, kolelitajażi ta ’ ġebel fil - marrara, raxx, telf tax- xagħar, ċistite, ċesta tal- kliewi, żamma ta ’ l- urina, uġigħ pelviku, uġigħ fil- lok ta ’ l- injezzjoni, telf tal- piż u ipotermija.
Bondronat may also cause changes in laboratory tests carried out by your doctor, these include; low calcium (metal), low phosphate (mineral), raised liver enzyme and raised creatinine, parathyroid disorder (hormone) in the blood, low hemoglobin (and rarely blood dyscrasia).
Bondronat jista ’ jkawża bdil fit- testijiet fil- laboratorju mwettqa mit- tabib tiegħek, dawn jinkludu; livell ta ’ kalċju baxx (metall), fosfat baxx (minerali), żieda fl- enżima tal- fwied u krejatinina għola, mard tal- paratirojde (ormon) fid- demm, emoglobina baxx (u rarament diskrażja tad- demm).
Very rarely, patients have had an allergic reaction to Bondronat which may cause wheezing and breathlessness or skin rashes.
Rari ħafna, xi pazjenti kellhom reazzjoni allerġika għal Bondronat li jista ’ jwassal għal tħarħir u qtugħ ta ’ nifs jew raxxijiet fil- ġilda.
HOW TO STORE BONDRONAT
KIF TAĦŻEN BONDRONAT
The shelf-life of Bondronat 2 mg is 5 years.
Bondronat 2 mg idum tajjeb fil- ħażna għal 5 snin.
After dilution the infusion solution is stable for 24 hours at 2-8 °C(in a refrigerator).
Wara li jiġi dilwit is- soluzzjoni għall- infużjoni tibqa ’ stabbli għal 24 siegħa f’ temperatura ta ’ bejn 2 - 8 °C (fil- friġġ).
Do not use Bondronat after the expiry date which is stated on the folding box and on the label.
Tużax Bondronat wara d- data ta ’ skadenza li tidher fuq il- kaxxa li tintewa u fuq it- tikketta.
Do not use Bondronat if you notice that the solution is not clear or contains particles.
Tużax Bondronat jekk tinnota li s- soluzzjoni mhijiex ċara jew fiha xi frak.
Unused solution should be discarded.
Soluzzjoni li ma tintużax għandha tintrema.
What Bondronat contains
X’ fih Bondronat:
- One vial with 2 ml concentrate for solution for infusion contains2 mg ibandronic acid (as
- Kunjett wieħed b’ 2 ml konċentrat għas- soluzzjoni għall- infużjoni fih 2 mg ibandronic acid
2.25 mg ibandronic acid, monosodium salt, monohydrate).
(bħala 2. 25 mg ibandronic acid, monosodium salt, monohydrate).
- The other ingredients are sodium chloride, acetic acid, sodium acetate and water for injections.
- Is- sustanzi l- oħra huma sodium chloride, acetic acid, sodium acetate u ilma għall- injezzjonijiet.
What Bondronat looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett:
Bondronat is a colourless, clear solution.
Bondronat huwa soluzzjoni bla kulur u ċar.
Bondronat is supplied as packs containing 1 vial (2 ml type I glass vial).
Bondronat huwa fornit f’ pakketti li fihom kunjett 1 (kunjett tal- ħġieġ ta ’ 2 ml tat- tip I).
Manufacturer Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany
58 Roche Diagnostics GmbH Sandhofer Strasse 116 D- 68305 Mannheim Ġermanja
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
This leaflet was last approved in {MM/ YYYY}
Dan il- fuljett kien approvat l- aħħar f ’ [XX/ SSSS]
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu /.
------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only
------------------------------------------------------------------------------------------------------------------------- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku jew professjonisiti fil - qasam tal- kura tas- saħħa
Dosage:
Dożaġġ:
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.
Prevenzjoni ta ’ Episodji Skeletriċi f’ Pazjenti b’ Kanċer tas- Sider u Metastasi fl - Għadam Id- doża rrakkomandata għall- prevenzjoni ta ’ episodji skeletriċi f’ pazjenti b’ kanċer tas- sider u metastasi fl- għadam hija ta ’ 6 mg ġol- vina li tingħata kull 3- 4 ġimgħat.
The dose should be infused over at least 15 minutes.
Id- doża għandha tingħata fuq medda ta ’ mill- inqas 15- il minuta.
Dosage / Infusion time 1
Dożaġġ / Ħin ta ’ I- infużjoni1
100 ml
6mg / 1 siegħa
6 mg / 1 hour / 1 hour
2mg / 1 siegħa
500 ml 500 ml
500ml
Tumour-induced Hypercalcemia Bondronat is usually administered in a hospital setting.
Iperkalċemja kkawżata minn Tumur Bondronat huwa normalment mogħti l- isptar.
The dose is determined by the doctor considering the following factors.
Id- doża hija determinata mit- tabib li jikkonsidra il- fatturi li ġejjin.
Consideration should be given to the severity of the hypercalcaemia as well as the tumour type.
Fil- parti l -
In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥ 3 mmol/ l or ≥ 12 mg/ dl) 4 mg will be an adequate single dosage.
60 kbira tal- pazjenti b’ iperkalċemja severa (kalċju fis- serum ikkoreġut bl- albumina * ≥3 mmol/ l jew ≥12 mg/ dl) doża waħda ta '4 mg hija adegwata.
Albumin-corrected Serum calcium (mmol/ l)
Kalċju fis- serum ikkoreġut bl - = albumina (mmol/ l)
=
Jew
Serum calcium (mmol/ l) - [0.02 x albumin (g/ l)] + 0.8 or
kalċju fis- serum (mmol/ l) - [0. 02 x albumina (g/ l)] + 0. 8
Albumin-corrected Serum calcium (mg/ dl)
Kalċju fis- serum ikkoreġut bl - = albumina (mg/ dl)
Serum calcium (mg/ dl) + 0.8 x [4 - albumin (g/ dl)]
kalċju fis- serum (mg/ dl) + 0. 8 x [4 - albumina (g/ dl)]
In most cases a raised serum calcium level can be reduced to the normal range within 7 days.
Fil- maġġoranza tal- każijiet, livell għoli ta ’ kalċju fis- serum jista ’ jitnaqqas għal livell normali f’ 7 ijiem.
The median time to relapse (reincrease of serum albumin corrected serum calcium above 3 mmol/ l) was 18-19 days for the 2 mg and 4 mg doses.
Iż- żmien medjan sa biex il- livell jerġa jgħola (ir- ritorn għal- livelli ta ’ 'l fuq minn 3 mmol/ l ta ’ kalċju fis- serum ikkoreġut bl- albumina) kien ta ’ 18 – 19- il ġurnata b' dożi ta ’ 2 mg u 4 mg.
The median time to relapse was 26 days with a dose of 6 mg.
Iż- żmien medjan biex il- livell jerġa jogħla kien ta ’ 26 ġurnata b' doża ta ’ 6 mg.
Method and route of administration Bondronat concentrate for solution for infusion should be administered as an intravenous infusion.
Il- metodu u rotta ta ’ l- amministrazzjoni Bondronat konċentrat għal soluzzjoni għall- infużjoni għandu jingħata bħala infużjoni ġol- vina.
For this purpose the contents of the vial are to be used as follows:
Għal dan il- għan il- kontenut tal- kunjett għandu jiġi wżat kif ġej:
• Hypercalcaemia - added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over 1-2 hours. • Prevention of Skeletal Events - added to 100 ml isotonic sodium chloride solution or 100 ml 5% dextrose solution and infused over at least 15 minutes.
Prevenzjoni ta ’ Episodji Skeletriċi - miżjud ma ’ soluzzjoni ta ’ 100 ml ta ’ soluzzjoni ta ’ sodium chloride isotoniku jew ma ’ soluzzjoni ta ’ 100 ml 5% dextrose fuq medda ta ’ mill - anqas 15- il minuta.
See also dosage section above for patients with renal impairment.
Ara wkoll is- sezzjoni hawn fuq dwar id- dożaġġ għall- pazjenti b’ indeboliment renali.
In order to avoid potential incompatibilities, Bondronat concentrate for solution for infusion should only be mixed with isotonic sodium chloride solution or with 5% dextrose solution.
Sabiex jiġu evitati inkompatibilitajiet potenzjali, Bondronat konċentrat għal soluzzjoni għall- infużjoni għandu jitħallat biss ma ’ soluzzjoni ta ’ sodium chloride isotoniku jew soluzzjoni ta ’ 5% dextrose.
Calcium containing solutions should not be mixed with Bondronat concentrate for solution for infusion.
Soluzzjonijiet li fihom il- kalċju ma għandhomx jitħalltu ma ’ Bondronat konċentrat għal soluzzjoni għall- infużjoni.
Diluted solutions are for single use.
Soluzzjonijiet dilwiti huma għall- użu ta ’ darba biss.
Only clear solutions without particles should be used.
Għandhom jintużaw soluzzjonijiet ċari mingħajr frak.
It is recommended that the product once diluted be used immediately (see point 5 of this leaflet “ HOW TO STORE BONDRONAT”).
Huwa rrakkommandat li l- prodott la darba jkun dilwit jintuża immedjatament (ara l- punt 5 ta ’ dan il - fuljett “ KIF TAĦŻEN BONDRONAT ”).
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 Bondronat concentrate for solution for infusion is administered intravenously.
Peress illi amministrazzjoni bi żball ġo l- arterja ta ’ preparazzjonijiet mhux espressament rrakkomandati għal dan l- iskop kif ukoll amministrazzjoni ħdejn il- vina jista ’ jwassal għal ħsara tat - tessut, għandha tingħata attenzjoni sabiex il- konċentrat ta ’ Bondronat għal soluzzjoni għall- infużjoni jiġi amministrat ġol- vina.
Frequency of administration For treatment of tumour induced hypercalcemia, Bondronat concentrate for solution for infusion is generally given as a single infusion.
Frekwenza ta ’ l- amministrazzjoni Għal trattament ta’ iperkalċemja kkawżat minn tumur, Bondronat konċentrat għal soluzzjoni għall - infużjoni jingħata ġeneralment bħala infużjoni waħda.
For the prevention of skeletal events in patients with breast cancer and bone metastases, the Bondronat infusion is repeated at 3-4 week intervals.
Għall- prevenzjoni ta ’ episodji skeletriċi f’ pazjenti b’ kanċer tas- sider u metastażi fl- għadam, l - infużjoni ta ’ Bondronat hija ripetuta f’ intervalli ta ’ 3- 4 ġimgħat.
Duration of treatment A limited number of patients (50 patients) have received a second infusion for hypercalcaemia.
61 Tul tat- trattament Numru limitat ta ’ pazjenti (50 pazjent) irċevew it- tieni infużjoni għal iperkalċemjia.
Repeated treatment may be considered in case of recurrent hypercalcaemia or insufficient efficacy.
Trattament ripetut jista ’ jiġi ikkunsidrat f’ każ ta ’ iperkalċemja rikurrenti jew effikaċja insuffiċjenti.
For patients with breast cancer and bone metastases, Bondronat infusion should be administered every 3-4 weeks.
Għal- pazjenti b’ kanċer tas- sider u metastażi fl- għadam, l- infużjoni ta ’ Bondronat għandha tiġi amministrata kull 3- 4 ġimgħat.
In clinical trials, therapy has continued for up to 96 weeks.
Fil- provi kliniċi, it- terapija baqgħet sejra sa 96 ġimgħa.
Overdose Up to now there is no experience of acute poisoning with Bondronat concentrate for solution for infusion.
Doża eċċessiva Sa issa ma hemm l- ebda każ ta ’ doża eċċessiva b’ konċentrat ta’ Bondronat għal soluzzjoni għall - infużjoni.
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.
Minħabba li fi studji pre- kliniċi b’ dożi għolja kemm il- kliewi kif ukoll il- fwied instabu li kienu organi li setgħu kienu milquta minn tossiċittà, l- funzjoni tal- kliewi u tal- fwied għandhom jiġu mmonitorjati.
60 Clinically relevant hypocalcaemia (very low serum calcium levels) should be corrected by intravenous administration of calcium gluconate.
Ipokalċemija (livell baxx ħafna ta ’ kalċju fis- serum) li tkun klinikament relevanti għandha tkun trattata permezz ta ’ amministrazzjoni ġol- vina ta ’ calcium gluconate.
61 PACKAGE LEAFLET:
62 FULJETT TA ’ TAGĦRIF:
Bondronat 50 mg film-coated tablets ibandronic acid
Bondronat 50 mg pilloli miksija b’ rita ibandronic acid
Read all of this leaflet carefully before you start taking this medicine.
Aqra dan- il fuljett kollu qabel tibda tuża din il- mediċina
2.
X’ inhu Bondronat u għalxiex jintuża 2.
3.
Qabel ma tieħu Bondronat 3.
4.
Kif għandek tieħu Bondronat 4.
5.
Effetti sekondarji li jista ’ jkollu 5.
6.
Kif taħżen Bondronat 6.
Further information.
Aktar tagħrif
It inhibits increased loss of calcium from the bones (bone resorption), and prevents bone complications and fractures related to the spread of cancer cells into bone.
Hija tinibixxi it- telf żejjed ta ’ kalċju mill- għadam (assorbiment mill- ġdid ta ‘ l- għadam), u tipprevjeni il- komplikazzjonijiet u l- fratturi fl- għadam relatati mal- firxa taċ- ċelloli tal- kanċer fl - għadam.
Bondronat tablets are indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Il- pilloli ta ’ Bondronat huma indikati għall- prevenzjoni ta ’ episodji skeletriċi (fratturi patoloġiċi, komplikazzjonijiet fl- għadam li jeħtieġu r- radjuterapija jew il- kirurġija) f’ pazjenti b’ kanċer tas- sider u metastasi fl- għadam.
BEFORE YOU TAKE BONDRONAT
QABEL MA ’ TIEĦU BONDRONAT
Do not take Bondronat:
Tieħux Bondronat:
- if you are allergic (hypersensitive) to ibandronic acid or any of the other ingredients
- jekk int allerġiku (tbagħti minn sensittività eċċessiva) għal ibandronic acid jew kwalunkwe mis -
Bondronat should not be used in children.
Bondrant m’ għandux jintuża fit- tfal.
- severe kidney disease (renal insufficiency i. e. creatinine clearance < 30 mL/ min)
- Mard serju fil- kliewi (insuffiċjenza renali i. e. it- tneħħija tal- kreatinina < 30 mL/ min)
or when
Jew meta
- you have had problems in the past with your oesophagus (the tube that connects your mouth to
- kellek problemi fil- passat bl- osofagu tiegħek (il- passaġġ li jwassal minn ħalqek għall- istonku)
- you become aware of any signs or symptoms suggesting a possible reaction of the oesophagus
- ħassejtek konxju minn xi sinjali jew sintomi li jissuġġerixxu xi reazzjoni possibli ta ’ l- osofagu
(this may include: pain in the chest, heartburn, pain after swallowing drink and / or food).
(dan jista ’ jinkludi: uġigħ fis- sider, ħruq fl- istonku, uġigħ wara li tibla xi xorb u / jew ikel).
If this is the case, you should speak to your doctor without delay.
Jekk il- każ huwa hekk, għandek tkellem lit- tabib tiegħek bla dewmien ta ’ xejn.
- you are also taking non-steroidal anti-inflammatory drugs (NSAIDs), since both types of
- qed tieħu wkoll mediċini anti- inflammatorji u li mhux sterojdi (NSAIDs), peress li ż- żewġ tipi
medicinal products (NSAIDs and bisphosphonates) may cause irritation to the stomach and intestine.
ta ’ prodotti mediċinali (NSAIDs u bisfosfonati) jistgħu jikkawżaw irritazzjoni fl- istonku u l - intestini.
- You suffer from galactose intolerance, the Lapp lactase deficiency or have problems with
- Tbati minn intolleranza għall- galactose, defiċjenza ta ’ Lapp lactase jew għandek problemi bl -
glucose-galactose absorption
assorbiment ta ’ glucose- galactose
Taking other medicines:
Meta tieħu mediċini oħra:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or are taking supplements containing calcium, magnesium, iron or aluminium.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta, jew qed tieħu supplimenti li fihom il- kalċju, il- magneżju, il- ħadid jew l- aluminju.
When administered with H2-antagonists or other drugs that increase gastric pH Bondronat absorption may be slightly increased but no dose adjustment is needed.
Meta ġie amministrat ma ’ antagonisti ta ’ H2 jew mediċini oħra li jgħollu l- pH gastriku, l- assorbiment ta ’ Bondronat jista ’ jkun ftit miżjud iżda l- ebda aġġustament tad- doża ma tkun meħtieġa.
Caution should also be paid to the possible existence of simultaneous hypomagnesaemia (reduced magnesium levels).
Wieħed irid joqgħod attent ukoll għall- possibilità ta ’ eżstenza simultanja ta ’ ipomanjesemjia (livelli mnaqqsa ta ’ manjesju).
After taking your Bondronat tablet, wait at least 30 minutes before taking any other medication of the day, including indigestion tablets/ medicine, calcium supplements and vitamins.
Wara li tieħu l- pillola tiegħek ta ’ Bondronat, stenna għal mill- inqas 30 minuta qabel ma tieħu kull medikazzjoni oħra tal- ġurnata, inklużi pilloli/ mediċina ta ’ l- indiġestjoni, supplimenti tal- kalċju u vitamini.
Taking Bondronat with food and drink:
Meta tieħu Bondronat ma ’ l- ikel u max xorb:
Your Bondronat tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day.
Għandek tieħu l- pilloli ta ‘ Bondronat wara s- sawma ta ’ bil- lejl (mill- inqas 6 sigħat) u qabel l- ewwel ikel jew xorb tal- ġurnata.
Medications and supplements (including calcium) should similarly be avoided prior to taking Bondronat tablets.
Mediċini u supplimenti (inkluż il- kalċju) għandhom ukoll jiġu evitati qabel ma tieħu l- pilloli ta ’ Bondronat.
Fasting, including avoiding other medication and supplements should be continued for at least 30 minutes after taking the tablet.
Is- sawm, inkluż li ma tieħu l- ebda mediċini u supplimenti oħra għandu jitkompla għall mill- inqas 30 minuta wara li tittieħed il- pillola.
Plain water may be taken at any time during the course of Bondronat treatment.
Ilma waħdu jista ’ jittieħed f’ kull ħin matul il- kors ta ’ terapija b ’ Bondronat.
You should not take Bondronat if you are pregnant or if you are breast-feeding.
It- tqala u treddiegħ Ma għandekx tieħu Bondronat jekk inti tqila jew qed tredda ’.
The effects of Bondronat on the ability to drive or to use machines has not been studied.
Is- sewqan u tħaddim ta ’ magni L- effetti ta ’ Bondronat fuq il- ħila biex issuq jew tuża magni ma ġewx studjati.
Important information about some of the ingredients of Bondronat Bondronat tablets contain lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Bondronat Il- pilloli ta ’ Bondronat fihom lactose
HOW TO TAKE BONDRONAT
KIF GĦANDEK TIEĦU BONDRONAT
Always take Bondronat exactly as your doctor has told you.
Dejjem ħu Bondronat eżatt kif jgħidlek it- tabib tiegħek.
You should check with your doctor or pharmacist if you are not sure.
Għandek tiċċekkja mat- tabib jew l- ispiżjar jekk m’ intix ċert.
The usual dose of Bondronat is one tablet per day.
Id- doża normali ta ’ Bondronat hija ta ’ pillola waħda kuljum.
If you have severe kidney problems, your doctor may reduce your dose to one tablet per week.
Jekk għandek problemi serji fil- kliewi, it - tabib tiegħek jista ’ jnaqqas id- doża għall- pillola waħda fil- ġimgħa.
To reduce possible irritation, it is important that you follow the instructions below:
Biex tnaqqas il- possibilità ta ’ irritazzjoni, huwa importanti li ssegwi l- istruzzjonijiet li ġejjin:
- BEFORE taking your first food, drink or other medicinal products of the day, take your
- QABEL ma tieħu l- ewwel ikel, xorb jew prodotti mediċinali oħra tal- ġurnata, ħu l- pillola
Bondronat tablet with a full glass of plain water only (about 200 mL).
tiegħek ta ’ Bondronat ma ’ tazza mimlija b’ ilma biss (madwar 200 mL).
Do not take your tablet with any drink other than plain water
Tieħux il- pillola ma ’ xi xorb ieħor jekk mhux ilma waħdu.
- Do not chew, suck or allow the tablet to dissolve in your mouth.
- M’ għandekx tomgħod, terda jew tħalli l- pillola tinħall f’ ħalqek.
- After taking your Bondronat tablet, wait at least 30 minutes before taking your first food,
- Wara li tieħu l- pillola tiegħek ta ’ Bondronat, stenna mill- inqas 30 minuta qabel ma tieħu l -
beverage, or other medication of the day.
ewwel ikel, xorb jew xi mediċina oħra tal- ġurnata.
- You should remain in an upright (sitting or standing) position while taking Bondronat tablets
- Għandek tibqa ’ f’ posizzjoni dritta (bil- qiegħda jew bil- wieqfa) waqt li qed tieħu l- pilloli
and remain upright for 60 minutes after taking your tablet
Bondronat u tibqa’ f’ din il- posizzjoni għal 60 minuta wara li tkun ħadt il- pillola.
- It is important to continue taking Bondronat for as long as your doctor prescribes the medicine.
- Huwa importanti li tkompli tieħu Bondronat sakemm it- tabib tiegħek jibqa ’ jippreskrivi din il -
Bondronat can help with your condition only if you continue to take the tablets.
Bondronat jista ’ jgħinek fil- kondizzjoni tiegħek biss jekk tkompli tieħu l- pilloli.
If you take more Bondronat than you should:
Jekk tieħu aktar Bondronat milli suppost:
If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately.
Jekk tieħu ħafna pilloli bi żball, ixrob tazza mimlija ħalib u kkuntattja lit- tabib tiegħek immedjatament.
Do not make yourself vomit, and do not lie down.
Iġġiegħelx lilek innifsek tirremetti, u timteddx.
If you forget to take Bondronat:
Jekk tinsa tieħu Bondronat:
Do not take a double dose to make up for a forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Return to taking one tablet per day the following day, as usual.
Kompli ħu pillola waħda kuljum mill- ġurnata ta ’ wara, bħas- soltu.
Common side effects include indigestion, nausea, abdominal pain, oesophagitis, tiredness, and low calcium levels in the blood.
Effetti sekondarji komuni jinkludu indiġestjoni, dardir, uġigħ addominali, osofaġite, għejja u livelli baxxi ta ’ kalċju fid- demm.
Symptoms reported uncommonly include strange taste, tingling sensation (paraesthesia), dry mouth, bleeding gastrointestinal ulcer, difficulty swallowing, gastritis, itching, chest pain, flu-like symptoms, feeling unwell, and pain.
Sintomi li ġew irrapportati b’ mod mhux komuni jinkludu togħma stramba, sensazzjoni ta ’ tgħarix (parasteżija), nixfa fil- ħalq, ulċera gastrointestinali bi fasad, diffikultà biex tibla, gastrite, ħakk, uġigħ fis- sider, sintomi bħal ta ’ l- influwenza, tħossok ma tiflaħx u uġigħ.
Uncommonly, low hemoglobin, high levels of urea and high levels of parathyroid hormone have been reported from blood tests.
B’ mod mhux komuni ġew irrappurati minn, it- testijiet tad- demm urew livell ta ’ emoglobina baxx, livelli għolja ta ’ urea u livelli għolja ta ’ l- ormon tal- paratirojde.
Keep out of the reach and sight of children.
Żomm fejn ma ’ jintlaħaqx u ma ’ jidhirx mit- tfal.
Keep blister in the outer carton.
Żomm il- folja fil- kartuna ta ’ barra.
Do not use Bondronat after the expiry date which is stated on the blister and carton.
Tużaħx Bondronat wara d- data ta ’ l- iskadenza li tidher fuq l- istrixxa u l- kartuna.
- Each film-coated tablet contains 56.25 mg of ibandronic acid, monosodium salt, monohydrate,
- Kull pillola miksija b’ rita fiha 56. 25 mg ta ’ ibandronic acid, monosodium salt, monohydrate,
equivalent to 50 mg of ibandronic acid.
ekwivalenti għal 50 mg ta ’ ibandronic acid.
The other ingredients are:
Is- sustanzi l- oħra huma:
- tablet core: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, purified
- Il- qalba tal- pillola: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone,
stearic acid, colloidal anhydrous silica.
purified stearic acid, colloidal anhydrous silica
- tablet coat: hypromellose, titanium dioxide, talc, macrogol 6,000.
- Ir- rita tal- pillola: hypromellose, titanium dioxide, talc, macrogol 6, 000.
The film-coated tablets are of oblong shape and white to off-white in colour, engraved L2/ IT.
Il- pilloli miksija b’ rita huma ta ’ forma tawwalija, ta ’ lewn abjad jagħtu fl- offwajt, b’ inċiżjoni L2/ IT.
They are available in packs of 28 and 84 tablets.
Huma disponibbli f’ pakketti ta ’ 28 u 84 pillola.
Marketing Authorisation Holder Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW Ir- Renju Unit
Manufacturer Roche Pharma AG Emil-Barell-Str.
Manifattur Roche Pharma AG Emil- Barell- Str.
66 PACKAGE LEAFLET INFORMATION FOR THE USER
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
Before you use Bondronat 3.
Qabel ma tuża Bondronat 3.
Possible side effects 5.
X’ effetti oħra jista ’ jkollu 5.
It also prevents bone complications and fractures related to the spread of cancer cells into bone.
Jipprevjeni ukoll il - komplikazzjonijiet u l- fratturi fl- għadam relatati mal- firxa taċ- ċelloli tal- kanċer fl- għadam.
- Pathologically (abnormally) elevated serum calcium levels (hypercalcaemia) as a result of
- Livelli pataloġikament (mhux normali) għoljin ta ’ kalċju fias- serum (l- iperkalċemja) bħala
tumours
riżultat ta ’ tumuri.
of surgery) in patients with breast cancer and bone metastases..
radjuterapija jew il- kirurġija) f’ pazjenti b’ kanċer tas- sider u metastażi fl- għadam.
BEFORE YOU USE BONDRONAT
QABEL MA ’ TUŻA BONDRONAT
If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Bondronat.
Jekk qed taħt kura dentali jew se tingħata kirurġija dentali, għid lid- dentist tiegħek li inti qed tirċievi kura b’ Bondronat.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Caution should also be paid to the possible existence of simultaneous hypomagnesaemia (reduced magnesium levels).
Wieħed irid joqgħod attent ukoll għal possibilità ta ’ eżistenza simultanja ta ’ ipomanjesemjia (livelli mnaqqsa ta ’ manjesju).
The effects of Bondronat on the ability to drive or to use machines has not been studied.
L- effetti ta ’ Bondronat fuq il- ħila biex issuq jew tuża magni ma ġewx studjati
Like all medicines, Bondronat can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Bondronat jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These symptoms usually disappear within a couple of hours/ days.
Dawn is- sintomi normalment jispiarixxu f’ perijodu ta ’ ftit sigħat jew ġranet.
Less commonly patients have reported infections, strange taste, cataracts, bundle branch block, tooth disorder, skin problems, aching joints, arthritis, and thirst.
Inqas komuni, pazjenti rrapportaw infezzjonijiet, togħma stramba, kataratti, bundle branch block, mard tas- snien, problemi fil- ġilda, uġigħ fil- ġoġi, artrite u għatx.
In rare cases, patients have reported the following: gastroenteritis, oral thrush, vaginitis, benign skin growth, sleep disturbance, anxiety, affect lability, memory loss, numbness round the mouth (paraesthesia circumoral), hyperaesthesia, hypertonia, nerve root lesion, neuralgia, migraine, cerebrovascular disorder, parosmia, deafness, heart and circulatory problems (including palpitations, myocardial ischaemia, hypertension, varicose veins), lymphoedema, lung oedema, stridor, gastritis,
F’ każijiet rari, pazjenti rrapportaw is- segwenti: gastroenterite, infezzjoni fil- ħalq ikkawżata mill- moffa, vaġinite, tkabbir beninju tal- ġilda, disturbi fl- irqad, ansjetà, lijabilità affettiva, telf ta ’ memorja, tarix madwar il- ħalq (parasteżija ċirkumorali), iperesteżija, ipertonja, ferita ta ’ l- għerq tan- nerv, nevralġija, migranja, mard ċerbovaskulari, parosomija, truxija, problemi tal- qalb u taċ- ċirkolazzjoni (inklużi
68 cheilitis, difficulty swallowing (dysphagia), mouth ulceration, gall stones cholelithiasis, rash, hair loss, cystitis, renal cyst, urinary retention, pelvic pain, injection site pain, weight loss, and hypothermia.
69 palpitazzjonijiet, iskemja mijokardjali, ipertensjoni, vini varikużi), limfoedema, edema tal- pulmuun, stridor, gastrite, kelite, diffikultà biex tibla (disfaġja), ulċerazzjoniji tal- ħalq, kolelitajażi ta ’ ġebel fil - marrara, raxx, telf tax- xagħar, ċistite, ċesta tal- kliewi, żamma ta ’ l- urina, uġigħ pelviku, uġigħ fil- lok ta ’ l- injezzjoni, telf tal- piż u ipotermija.
Bondronat may also cause changes in laboratory tests carried out by your doctor, these include; low calcium (metal), low phosphate (mineral), raised liver enzyme and raised creatinine, parathyroid disorder (hormone) in the blood, low hemoglobin (and rarely blood dyscrasia).
Bondronat jista ’ jkawża bdil fit- testijiet fil- laboratorju mwettqa mit- tabib tiegħek, dawn jinkludu; livell ta ’ kalċju baxx (metall), fosfat baxx (minerali), żieda fl- enżima tal- fwied u krejatinina għola, mard tal- paratirojde (ormon) fid- demm, emoglobina baxx (u raraement diskrażjadyscrasia tad- demm).
The shelf-life of Bondronat 6 mg is 5 years.
Bondronat 6 mg idum tajjeb fil- ħażna għal 5 snin.
After dilution the infusion solution is stable for 24 hours at 2-8 °C (in a refrigerator).
Wara li jiġi dilwit is- soluzzjoni għall- infużjoni tibqa ’ stabbli għal 24 siegħa f’ temperatura ta ’ bejn 2 - 8 °C (fil- friġġ).
- One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as
- Kunjett wieħed b’ 6 ml konċentrat għas- soluzzjoni għall- infużjoni fih 6 mg ibandronic acid
6.75 mg ibandronic acid, monosodium salt, monohydrate).
(bħala 6. 75 mg ibandronic acid, monosodium salt, monohydrate).
- The other ingredients are sodium chloride, acetic acid, sodium acetate and water for injections.
- Is- sustanzi l- oħra huma sodium chloride, acetic acid, sodium acetate u ilma għall- injezzjonijiet
Bondronat is a colourless, clear solution.
Bondronat huwa soluzzjoni bla kulur u ċar
Bondronat is supplied as packs containing 1, 5 and 10 vials (6 ml type I glass vial).
Bondronat huwa fornit f’ pakketti li fihom 1, 5 jew 10 kunjetti (kunjett tal- ħġieġ ta ’ 6 ml tat- tip I).
Marketing Authorisation Holder 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW Ir- Renju Unit
Manufacturer Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany
Il- Manifattur Roche Diagnostics GmbH Sandhofer Strasse 116 D- 68305 Mannheim
69 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.