qanastek/EMEA-V3 huggingface dataset:
Other common side effects include rash, cramps in the muscles, pain in the muscles and joints, and headache.
Effetti sekondarji komuni oħra jinkludu raxx, bugħawwieġ, uġigħ fil- muskoli u l- ġogi u uġigħ ta ’ ras.
It also includes flu-like symptoms (aches, pain, feeling of discomfort, fatigue) which are usually mild, are short-lasting and disappear soon after you have taken the first dose..So you should be able to carry on taking Bondenza.
Jinkludu wkoll sintomi li jixbħu lill- influwenza (weġgħat, uġigħ, ma tħossokx sew, għeja), li ġeneralment huma ħfief, jgħaddu malajr u jisparixxu ftit wara li tkun ħadt l- ewwel doża.
Bondenza can irritate the oesophagus, although you can usually avoid this by taking your dose as described in this leaflet.
Kellem lit- tabib tiegħek jekk xi effetti isiru problema jew jibqgħu għal żmien twil.
These are uncommon side effects, but if you develop symptoms such as severe pain in the chest, severe pain after swallowing food or drink, severe nausea, or vomiting, tell your doctor straight away.
Bondenza jista ’ jirrita l- esofagu, għalkemm ġeneralment tista ’ tevita dan billi tieħu d- doża tiegħek kif spjegat f’ dan il- fuljett Dawn l- effetti sekondarji mhux komuni, iżda jekk tiżviluppa sintomi bħal uġigħ sever fis- sider, uġigħ sever wara li tibla ’ l- ikel jew xorb, tqalligħ sever, jew rimmettar, għid lit- tabib tiegħek minnufih.
Other uncommon side effects are dizziness and back pain.
Effetti sekondarji mhux komuni oħrajn huma sturdament u uġigħ ta ’ dahar.
Rare side effects are swelling and itching of the face, lips and mouth.
Effetti sekondarji rari huma nefħa u ħakk fil- wiċċ, xufftejn u ħalq.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
43 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE BONDENZA
KIF TAĦŻEN BONDENZA
Keep out of the reach and sight of children.
Żommu fejn ma ’ jintlaħaqx u ma ’ jidhirx mit- tfal.
There are no special storage instructions.
M’ hemmx struzzjonijiet għall- ħażna speċjali.
Do not use after the expiry date which is stated on the carton after “EXP”.
Tużax wara id- data ta ’ skadenza li tidher fuq il- kartuna wara “ EXP ”.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
What Bondenza contains
X’ fih Bondenza
- The active substance is ibandronic acid.
- Is- sustanza attiva hi ibandronic acid.
One tablet contains 150 mg of ibandronic acid.
Pillola waħda fiha 150 mg ta ’ ibandronic acid.
tablet core: lactose monohydrate, povidone, cellulose microcrystalline, crospovidone, stearic acid purified, silica colloidal anhydrous
Qalba tal- pillola: lactose monohydrate, povidone, cellulose microcrystalline, crospovidone, stearic acid purified, silica colloidal anhydrous
tablet coat: hypromellose, titanium dioxide, talc, macrogol 6000
Rita tal- pillola: hypromellose, titanium dioxide, talc, macrogol 6000
What Bondenza looks like and contents of the pack
Id- Dehra ta ’ Bondenza u l- kontenuti tal- pakkett:
Bondenza tablets are white to off white, of oblong shape and marked “BNVA” on one side, and “150” on the other side.
Il- pilloli Bondenza tablets huma bojod sa offwajt, ta ’ forma oblung u mmarkati b ’ “ BNVA ” fuq naħa, u b ’ “ 150 ” fuq in- naħa l- oħra.
The tablets are supplied in blisters containing 1 or 3 tablets.
Il- pilloli huma disponnibli f’ folji li fihom pillola waħda 1 jew 3 pilloli.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Marketing Authorisation Holder:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Il- manifattur Roche Pharma AG Emil- Barell- Strasse 1 D- 79639 Grenzach- Wyhlen Il- Ġermanja
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għall kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
España Faes Farma, S.A.
España Faes Farma S. A.
Tel: +34 – 94 481 83 00
Tel: +34 - 94 481 83 00
France Roche Tél: +33 (0) 1 46 40 50 00
France Roche România Tél: +33 (0) 1 46 40 50 00
România Roche România S.R.L.
Roche România S. R. L.
This leaflet was last approved in {date}
45 Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
45 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 /.
46 REMINDER STICKERS TEXT
46 KLIEM FUQ IT- TIKKETTI BIEX TIFTAKAR
PLANNING WHEN TO TAKE BONDENZA
PJAN TA ’ META TIEĦU BONDENZA
The dose of Bondenza is one tablet once a month.
Id- doża ta ’ Bondenza hija pillola waħda darba fix- xahar.
Choose one day of the month that will be easy to remember:
Għażel ġurnata tax- xahar li tkun faċli biex tiftakar:
- either the same date (such as the 1st of each month)
- jew l- istess data (bħall- ewwel ta ’ kull xahar)
- or the same day (such as the first Sunday of each month).
- jew l- istess ġurnata (bħall- ewwel Ħadd ta ’ kull xahar).
Use the peel-off stickers below to mark the dates on your calendar.
Uża t- tikketti li jitqaxxru taħt biex timmarka d- dati fuq il- kalendarju tiegħek.
Once you’ve taken your tablet, put a tick in the box on the sticker.
Ladarba tkun ħadt il- pillola tiegħek, immarka l- kaxxa fuq it- tikketta.
PEEL-OFF STICKERS FOR YOUR PERSONAL CALENDAR
TIKKETTI LI JITQAXXRU GĦALL- KALENDARJU PERSONALI TIEGĦEK
Monthly tablet Monthly tablet
Pillola tax- xahar Pillola tax- xahar
Monthly tablet
Pillola tax- xahar
It’s important to keep taking Bondenza every month.
Huwa importanti li tibqa ’ tieħu Bondenza kull xahar.
47 PACKAGE LEAFLET:
47 FULJETT TA ’ TAGĦRIF:
Bondenza 3 mg solution for injection ibandronic acid
Bondenza 3 mg soluzzjoni għall- injezzjoni Ibandronic acid
Before you use Bondenza 3.
Qabel ma ’ tuża Bondenza 3.
How to use Bondenza 4.
Kif għandek tuża Bondenza 4.
Bondenza may help lower the chances of breaking bones (fractures).
Bondenza jista ’ jgħin inaqqas ir- riskju ta ’ ksur ta ’ għadam (fratturi).
Bondenza 3 mg solution for injection in pre-filled syringes is a solution for intravenous injection by a health care professional.
Bondenza 3 mg soluzzjoni għall- injezzjoni f’ siringi mimlija għal- lest hija soluzzjoni għall- injezzjoni ġol- vini minn professjonist fil- qasam tas- saħħa.
Do not inject Bondenza yourself.
Tinjettax Bondenza inti stess.
- smoking cigarettes, or drinking too much alcohol
- tipjip ta ’ sigaretti, jew xorb ta ’ alkoħol żejjed
Bondenza prevents loss of bone from osteoporosis, thus helping to rebuild lost bone.
Bondenza jipprevjeni telf ta ’ l- għadam mill- osteoporożi, u b’ hekk jgħin biex jerġa jibni mill- ġdid l - għadam mitluf.
Therefore, Bondenza makes bones less likely to break.
Għalhekk Bondenza jagħmel l- għadam inqas suxxettibbli għal ksur.
48 A healthy lifestyle will also help you to get the most benefit from your treatment.
48 Stil ta ’ ħajja b’ saħħitha ukoll jgħinek biex tieħu l- benefiċċju massimu mill- kura tiegħek.
This includes eating a balanced diet rich in calcium and vitamin D, walking or other weight-bearing exercise, not smoking and not drinking too much alcohol.
Dan jinkludi li tiekol dieta bilanċjata b’ ħafna kalċju u vitamina D, li timxi jew tagħmel eżerċizzju ieħor ta ’ rfigħ ta ’ piżijiet; li ma tpejjipx u li ma tixrobx wisq alkoħol.
BEFORE YOU USE BONDENZA
QABEL MA ’ TUŻA BONDENZA
Do not use Bondenza
Tużax Bondenza
- if you have, or had in the past, low blood calcium.
Jekk jogħoġbok kellem lit- tabib
Please consult your doctor
tiegħek
- if you are allergic (hypersensitive) to ibandronic acid or any of the other ingredients in
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal ibandronic acid, jew għal xi
Bondenza injection
wieħed mis- sustanzi l- oħra tal- injezzjoni Bondenza.
Take special care with Bondenza Some patients need to be especially careful when using Bondenza.
Oqgħod attent ħafna b’ Bondenza Xi pazjenti għandhom joqgħodu attenti ħafna meta jużaw Bondenza.
Tell your doctor:
Għid lit- tabib tiegħek:
- if you have or have ever had kidney problems, kidney failure or have needed dialysis, or if you
- Jekk għandek jew qatt kellek problemi fil- kliewi, insuffiċjenza tal- kliewi jew kellek bżonn
have any other disease that may affect your kidneys
dijalisi, jew jekk għandek xi mard ieħor li jista ’ jaffettwa l- kliewi tiegħek
- if you have any disturbance of mineral metabolism (such as vitamin D deficiency)
- Jekk għandek xi disturbi fil- metaboliżmu tal- minerali (bħal defiċjenza ta ’ vitamina D).
If you are
Għandek tieħu supplimenti ta ’ kalċju u vitamina D waqt li qed tirċievi Bondenza.
unable to do so, you should inform your doctor.
Jekk ma tistax tagħmel dan, għandek tinforma lit- tabib tiegħek.
Taking other medicines Tell your doctor, nurse or pharmacist if you are taking, or have recently taken, any other medicines.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib, ners jew spiżjar jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra.
Mention to your doctor, nurse or pharmacist anything you are taking which you bought over the counter, without a prescription.
Semmi lit- tabib, ners jew spiżjar kull ħaġa li qed tieħu li xtrajt mingħajr riċetta.
Pregnancy and breast-feeding You should not be given Bondenza if you are pregnant, or if there is a possibility you may become pregnant.
Tqala u Treddigħ M’ għandekx tingħata Bondenza jekk inti tqila, jew jekk hemm possibilità li tista ’ toħroġ tqila.
If you are breast-feeding, you will need to stop breast-feeding in order to receive Bondenza.
Jekk qed tredda ’, se jkollok bżonn twaqqaf it- treddigħ sabiex tirċievi Bondenza.
Driving and using machines You can drive and use machines as it’s very unlikely that Bondenza will affect your ability to drive and use machines.
Sewqan u tħaddim ta ’ magni Tista ’ issuq u tħaddem magni għax huwa improbabbli ħafna li Bonviva jaffettwa l- abbilità tiegħek li issuq u tħaddem magni.
HOW TO USE BONDENZA
KIF GĦANDEK TUŻA BONDENZA
The recommended dose of Bondenza for the intravenous injection is 3 mg (1 pre-filled syringe) once every 3 months.
Id- doża rakkomandata ta ’ Bondenza għall- injezzjoni ġol- vini hija 3 mg (siringa mimlija għal- lest waħda) darba kull 3 xhur.
The injection should be given into the vein by a physician or qualified/trained health care worker.
L- injezzjoni għandha tingħata ġol- vina minn tabib jew ħaddiem ikkwalifikat/ imħarreġ fil- qasam mediku.
Do not administer the injection to yourself.
Tagħtix l- injezzjoni lilek innifsek.
The solution for injection must be administered into a vein only, and not anywhere else in the body.
Is- soluzzjoni għall- injezzjoni għandha tingħata ġo vina biss, u fl- ebda post ieħor fil- ġisem.
Continuing to use Bondenza To get the most benefit from the treatment it is important to continue receiving the injections every 3 months for as long as your doctor prescribes it for you.
Kompli uża Bondenza Biex tieħu l- aktar benefiċċju mill- kura huwa mportanti li tkompli tirċievi l- injezzjonijiet kull 3 xhur, sakemm jippreskrivihomlok it- tabib tiegħek.
Bondenza can treat osteoporosis only for as long as you keep receiving the treatment, even though you will not be able to see or feel a difference.
Bondenza jista ’ jikkura l- osteoporożi biss sakemm tibqa ’ tirċievi l- kura, għalkemm ma tkunx tista ’ tara jew tħoss id- differenza.
You should also take calcium and vitamin-D supplements, as recommended by your doctor.
Għandek tieħu ukoll supplimenti ta ’ kalċju u vitamina D, kif irrakkomandat mit- tabib tiegħek.
49 If too much Bondenza is given You may develop low levels of calcium, phosphorus or magnesium in the blood.
Jekk tingħata Bondenza aktar milli suppost Tista ’ tiżviluppa livelli baxxi ta ’ kalċju, fosfru jew manjesju fid- demm.
Your doctor may take steps to correct such changes and may give you an injection containing these minerals.
It- tabib tiegħek jista ’ jieħu passi biex jikkoreġi dawn il- bidliet u jista ’ jtik injezzjoni li fiha dawn il- minerali.
If a dose of Bondenza is missed You should arrange an appointment to get the next injection as soon as possible.
49 Jekk tinsa tieħu doża Boviva Għandek tirranġa appuntament biex tieħu l- injezzjoni li jmiss malajr kemm jista ’ jkun.
After that, go back to getting the injections every 3 months from the date of the most recent injection.
Wara kompli ħu l- injezzjonijiet kull 3 xhur mid- data ta ’ l- aktar injezzjoni reċenti.
- very rare: affects less than 1 user in 10,000
- rari ħafna: jaffettwaw inqas minn persuna waħda minn kull 10, 000 li qed jużawh
Bondenza, like other similar medicines, may cause a drop in the levels of calcium in your blood.
Bondenza, bħal mediċini simili oħra, jista ’ jikkawża tnaqqis fil- livelli ta ’ kalċju fid- demm tiegħek.
Very common side effects are mild symptoms which start within 1 day of the first injection.
Effetti sekondarji komuni ħafna huma sintomi ħfief li jibdew sa ġurnata mill- ewwel injezzjoni.
About half (1 in 20) experience aches or pains in the muscles, bones or joints.
Madwar nofs (1 minn 20) jesperjenzaw weġgħat jew uġigħ fil- muskoli, għadam u ġogi.
The other half may have flu-like symptoms (fever, chills or feverishness and aches or pains in the muscles, bones and joints).
In- nofs l- ieħor jista ’ jkollom sintomi jixbħu lill- influwenza (deni, tkexkix ta ’ bard jew tħoss li għandek id- deni u weġgħat jew uġigħ fil- muskoli, għadam u ġogi).
In most cases these symptoms are mild and will not need any treatment.
Fil- biċċa l- kbira tal- każijiet, dawn is- sintomi huma ħfief u ma jkolhom bżonn l- ebda kura.
Taking paracetamol may help relieve these symptoms.
It- teħid ta ’ paracetamol jista ’ jgħin biex itaffi dawn is- sintomi.
The symptoms should go away quickly (within 2-3 days of the injection) and they do not usually come back after the second injection.
Is- sintomi għandhom jgħaddu malajr (fi żmien 2- 3 ijiem mill- injezzjoni) u ġeneralment ma jerġgħux jiġru wara t- tieni injezzjoni.
If they do occur after the second injection, they will usually be milder and will usually go away completely after the third or later injection.
Jekk iseħħu wara t- tieni injezzjoni, normalment ikunu eħfef u s- soltu jgħaddu għal kollox wara t- tielet injezzjoni jew wara injezzjonijiet sussegwenti.
Other common side effects are:
Effetti sekondarji komuni oħra huma:
- fatigue
- għeja
- rash
- raxx
- diarrhoea
- dijarea
Uncommon side effects are skin reactions at the injection site, such as redness, pain and swelling.
Effetti sekondarji mhux komuni huma reazzjonijiet fil- ġilda fil- post ta ’ l- injezzjoni, bħal ħmura, uġigħ u nefħa.
Rare side effects are swelling of the face, lips and mouth may occur.
Effetti sekondarji rari huma nefħa tal- wiċċ, xufftejn u ħalq.
Do not use Bondenza 3 mg solution for injection in pre-filled syringes after the expiry date which is stated on the carton and on the syringe after “EXP”.
Tużax Bondenza 3 mg soluzzjoni għall- injezzjoni f’ siringi mimlija għal- lest wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq is- siringa wara “ EXP ”..
The person giving the injection should throw away any unused solution and put the used syringe and injection needle into an appropriate disposal container.
Il- persuna li tagħti l- injezzjoni għandha tarmi kull soluzzjoni li ma ntużatx u tpoġġi is- siringa wżata u l- labra ta ’ l- injezzjoni f’ kontenitur għar- rimi xieraq.
What Bondenza 3 mg solution for injection in pre -filled syringes contains
Bondenza 3 mg soluzzjoni għall- injezzjoni f’ siringi mimlija għal- lest fih
One pre-filled syr inge contains 3 mg of ibandronic acid
Siringa waħda mimlija għal- lest fiha 3 mg ta ’ ibandronic
in 3 ml of solution (as 3.375 mg of ibandronic acid, monosodium salt, monohydrate).
acid f’ 3 ml ta ’ soluzzjoni (bħala 3. 375 mg ibandronic acid, monosodium salt, monohydrate)..
- The other ingredients are sodium chloride, acetic acid, sodium acetate trihydrate and water for
- Is- sustanzi l- oħra huma sodium chloride, acetic acid, sodium acetate trihydrate u ilma għall -
injections.
injezzjonijiet.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose (3 ml), i.e. essentially ‘sodium-free’.
Dan il- prodott mediċnali fih inqas minn 1 mmol sodium (23 mg) kull doża (3 ml), i. e. essenzjalment ‘ bla sodju ’.
What Bondenza 3 mg solution for injection in pre-filled syringes looks like and contents of the pack
Id- Dehra ta ’ Bondenza 3mg soluzzjoni għall- injezzjoni f’ siringi mimlija għal- lest u l- kontenuti tal- pakkett:
Bondenza 3 mg solution for injection in pre-filled syringes is a clear colourless solution.
Bondenza 3 mg soluzzjoni għall- injezzjoni f’ siringi mimlija għal- lest huwa soluzzjoni ċara u bla kulur.
Each pre- filled syringe contains 3 ml of solution.
Kull siringa mimlija għal- lest fiha 3 ml ta ’ soluzzjoni.
Bondenza is available in packs of 1 pre-filled syringe and 1 injection needle or 4 pre-filled syringes and 4 injection needles.
Bondenza huwa disponibbli f’ pakketti ta ’ siringa waħda mimlija għal- lest u labra għall- injezzjoni waħda jew 4 siringi mimlija għal- lest u 4 labar għall- injezzjoni.
Marketing Authorisation Holder Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW Ir- Renju Unit
Manufacturer Roche Diagnostics GmbH Sandhoferstrasse 116 D-68305 Mannheim Germany.
Roche Diagnostics GmbH Sandhoferstrasse 116 D- 68305 Mannheim Il- Ġermanja
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għall kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
This leaflet was last approved in {date}
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 /.
52 ----------------------------------------------------------------------------------------------------------------------------- This information is intended for medical or healthcare professionals only.
52 -----------------------------------------------------------------------------------------------------------------------------
INFORMATION FOR THE HEALTHCARE PROFESSIONALS
TAGĦRIF GĦALL- PROFESSJONISTI FIL- QASAM TAS- SAĦĦA
Please see the Summary of Product Characteristics for more information.
Għal aktar tagħrif jekk jogħġbok ara s- Sommarju tal- Karatteristiċi tal- Prodott.
Administration of Bondenza 3 mg solution for injection in pre-filled syringe:
L- għoti ta ’ Bondenza 3 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest:
Bondenza 3 mg solution for injection in pre-filled syringe should be injected intravenously over a period of 15 - 30 seconds.
Bondenza 3 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest għandha tiġi njettata ġol- vini fuq perjodu ta ’ 15 - 30 sekonda.
The solution is irritant, therefore strict adherence to the intravenous route of administration is important.
Is- soluzzjoni hija rritanti, għalhekk huwa importanti li tintuża biss ir- rotta ġol- vini.
If you inadvertently inject into the tissues around the vein, patients may experience local irritation, pain and inflammation at the injection site.
Jekk bi żball injettajt ġot- tessuti ta ’ madwar il- vina, il- pazjenti jista ’ jkollhom esperjenza ta ’ rritazzjoni, uġigħ u nfjammazzjoni lokali fil- post ta ’ l- injezzjoni.
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.
Bondenza 3 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest m’ għandux jitħallat ma ’ soluzzjonijet li fihom il- kalċju (bħal soluzzjoni Ringer- Lactate, calcium heparin) jew prodotti mediċinali oħra li jingħataw ġol- vini.
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.
Fejn Bondenza jingħata minn ġo pajp ta ’ l- infużjoni ġol- vini eżistenti, l- infusat għal ġol- vini għandu jiġi ristrett għal isotonic saline jew soluzzjoni ta ’ 50 mg/ ml (5%) ta ’ glukosju.
Missed dose:
Doża minsija:
If a dose is missed, the injection should be administered as soon as convenient.
Jekk tintnesa doża, l- injezzjoni għandha tingħata minnufiħ meta konvenjenti.
Overdose:
Doża eċċessiva:
No specific information is available on the treatment of overdosage with Bondenza.
M’ hemmx tagħrif speċifiku disponibbli dwar il- kura ta ’ doża eċċessiva b’ Bondenza.
Based on knowledge of this class of compounds, intravenous overdosage may result in hypocalcaemia, hypophosphataemia, and hypomagnesaemia, which can cause paraesthesia.
Ibbażat fuq tagħrif ta ’ din il- klassi ta ’ sustanzi, doża eċċessiva ġol- vini tista ’ twassal għal ipokalċimja, ipofosfatimja, u ipomanjesimja, li jista ’ jikkawża parasteżija.
In severe cases intravenous infusion of appropriate doses of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, may be needed.
F’ każijiet severi jista ’ jkun hemm bżonn ta ’ infużjoni ġol- vini ta ’ dożi xierqa ta ’ calcium gluconate, potassium jew sodium phosphate, u magnesium sulfate.
General advice:
Parir ġenerali:
Bondenza 3 mg solution for injection in pre-filled syringe like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Bondenza 3 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest bħal bisphosphonates oħra mogħtija ġol- vini, jista ’ jikkawża tnaqqis temporanju fil- valuri ta ’ kalċju fis- serum.
Hypocalcaemia and other disturbances of bone and mineral metabolism should be assessed and effectively treated before starting Bondenza injection therapy.
Ipokalċimja u disturbi oħra tal- metaboliżmu ta ’ l- għadam u tal- minerali għandhom jiġu stmati u kkurati b’ mod effettiv qabel tinbeda terapija ta ’ injezzjoni b’ Bondenza.
Adequate intake of calcium and vitamin D is important in all patients.
Teħid xieraq ta ’ kalċju u vitamina D huwa importanti fil- pazjenti kollha.
All patients must receive supplemental calcium and vitamin D.
Il- pazjenti kollha għandhom jirċievu kalċju u vitamina D supplimentari.
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.
Pazjenti b’ mard fl- istess waqt, jew li jużaw prodotti mediċinali li għandhom il- potenzjal għall- effetti mhux mixtieqa fuq il- kilwa, għandhom jiġu nvistati regolarment waqt il- kura skond prattika medika tajba.
53 ANNEX IV
53 ANNESS IV
GROUNDS FOR ONE ADDITIONAL RENEWAL
BAŻI GĦAL TIĠDID IEĦOR
54 GROUNDS FOR ONE ADDITIONAL RENEWAL
54 BAŻI GĦAL TIĠDID IEĦOR
Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Bondenza remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Ibbażat fuq tagħrif li ġie disponibbli mindu ingħatat l- ewwel darba l- Awtorizzazzjoni għat- tqegħid fis - Suq, is- CHMP tikkonsidra li l- bilanċ ta ’ benefiċċju u riskju għal Bondenza għadu pożittiv, iżda tikkunsidra li l- profil ta ’ sigurtà tiegħu għandu jiġi sorveljat b’ attenzjoni għar- raġunijiet li ġejjin:
The effects of Bisphosphonates as a class, such as osteonecrosis of the jaw and atypical stress fractures require a review and continuous monitoring and assessment.
L- effetti ta ’ Bisphosphonates bħala klassi, bħal osteonekrosi tax- xedaq u fratturi mhux tipiċi kkawżati minn tensjoni, jeħtieġu analiżi mill- ġdid u sorveljanza u valutazzjoni kontinwa.
Considering the safety profile of Bondenza and the large number of patients currently enrolled in clinical and post marketing studies for the product as well as the ongoing post-marketing obligations and the continued reports of adverse events received by the MAH, the safety profile will continue to be monitored closely and updates should be provided regularly to the CHMP through 1-yearly PSURs.
B’ konsiderazzjoni tal- profil ta ’ sigurtà ta ’ Bondenza u n- numru kbir ta ’ pazjenti li qed jieħdu sehem fl- istudji kliniċi u fi studji ta ’ wara t- tqegħid fis- suq dwar il- prodott, kif ukoll l- obligazzjonijiet ma jaqtgħux ta ’ wara t- tqegħid fis- suq u r- rapporti kontinwi ta ’ l- avvenimenti avversi li jirċievi l- MAH, il- profil ta ’ sigurtà se jkompli jiġi sorveljat mill- viċin u għandu jiġi pprovdut tiġdid b’ mod regolari lis - CHMP permezz ta ’ PSURs ta ’ darba fis- sena.
Therefore, considering the safety profile of Bondenza, which requires the submission of 1-yearly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.
Għalhekk, b’ konsiderazzjoni tal- profil ta ’ sigurtà ta ’ Bondenza, li jeħtieġ li jiġi sottomess PSURs darba fis- sena, is- CHMP ikkonkluda li l- MAH għandu jissottometti applikazzjoni oħra ta ’ tiġdid fi żmien 5 snin.
EPAR summary for the public
BONDRONAT Sommarju ta ’ l- EPAR għall- pubbliku
What is Bondronat?
X’ inhu Bondronat?
Bondronat is a medicine containing the active substance ibandronic acid.
Bondronat huwa mediċina li fiha s- sustanza attiva ibandronic acid.
It is available as a concentrate to be made up into a solution for infusion (drip into a vein) and as 50 mg tablets.
Huwa jiġi bħala konċentrat li jitħallat f’ soluzzjoni għal infużjoni (drip ġol- vina) u bħala pilloli ta ’ 50 mg.
What is Bondronat used for?
Għalxiex jintuża Bondronat?
Bondronat is used: • as an infusion or as a tablet to prevent ‘ skeletal events’ (broken bones or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone); • as an infusion to treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.
Bondronat jintuża: • bħala infużjoni jew bħala pillola biex jilqa ’ kontra ‘ episodji skeletali ’ (ksur ta ’ għadam jew kumplikazzjonijiet ta ’ l- għadam li jeħtieġu kura) f’ pazjenti b’ kanċer tas- sider u b’ metastasis fl - għadam (meta l- kanċer ikun infirex għall- għadam); • bħala infużjoni biex tikkura iperkalċimja (livelli għoljin ta ’ kalċju fid- demm) ikkawżata minn tumuri.
How is Bondronat used?
Kif jintuża Bondronat?
Bondronat treatment should only be initiated by a doctor who has experience in the treatment of cancer.
Il- kura bi Bondronat għandha tinbeda biss minn tabib li għandu esperjenza fil- kura tal- kanċer.
In the prevention of skeletal events in patients with breast cancer and bone metastases, Bondronat is either given as a 6 mg infusion lasting at least 15 minutes every three to four weeks, or as one tablet once a day.
Fil- prevenzjoni ta ’ episodji skeletali f’ pazjenti b’ kanċer tas- sider u metastasi fl- għadam, Bondronat jingħata jew bħala infużjoni ta ’ 6 mg li ddum għallinqas 15- il minuta kull tlieta sa erba ’ ġimgħat, jew bħala pillola darba kuljum.
The tablet must always be taken after the patient has eaten nothing for at least six hours overnight and at least 30 minutes before the first food or drink of the day, with a full glass of plain water while standing or sitting.
Il- pillola għandha tittieħed dejjem wara li l- pazjent ma jkun kiel xejn għal mill- inqas sitt sigħat bil- lejl u għallinqas 30 minuta qabel l- ewwel ikel jew xorb tal- ġurnata, ma ’ tazza ilma waħdu waqt li l- pazjent ikun bilwieqfa jew bilqiegħda.
The patient must not lie down for one hour after taking the tablet.
Għal siegħa wara li jieħu l- pillola, il - pazjent m’ għandux jimtedd.
In the treatment of tumour-induced hypercalcaemia, Bondronat is given as an infusion of 2 or 4 mg, depending on whether the patient ’ s hypercalcaemia is moderate (below 3 mmol/ l) or severe (above 3 mmol/ l).
Fil- kura ta ’ iperkalċimja mqanqla minn tumur, Bondronat jingħata bħala infużjoni ta ’ 2 jew 4 mg, jiddependi fuq jekk l- iperkalċimja tal- pazjent hijiex moderata (taħt 3 mmol/ l) jew qawwija (aktar minn 3 mmol/ l).
This will normally bring the blood calcium level down to normal levels within seven days.
Dan normalment iniżżel il- livell ta ’ kalċju fid- demm għal- livelli normali fi żmien sebat ijiem.
How does Bondronat work?
Kif jaħdem Bondronat?
The active substance in Bondronat, ibandronic acid, is a bisphosphonate.
Is- sustanza attiva f’ Bondronat, ibandronic acid, hija bisfosfonat.
It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Hija twaqqaf l- azzjoni ta ’ l - osteoklasti, iċ- ċelloli fil- ġisem li huma nvoluti fit- tkissir tat- tessut ta ’ l- għadam.
Patients with tumours can have high blood levels of calcium, which is released from the bones.
Pazjenti b’ tumuri jista ’ jkollhom livelli għoljin ta ’ kalċju fid- demm, li jiġi rilaxxat mill- għadam.
By preventing the breakdown of bones, ibandronic acid helps to reduce the levels of calcium released into the blood.
Billi jimpedixxi t- tkissir ta ’ l- għadam, ibandronic acid jgħin biex inaqqas il- livelli ta ’ kalċju rilaxxat fid - demm.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
It- tnaqqis ta ’ telf ta ’ l- għadam jgħin ukoll biex jagħmel l- għadam inqas suxxettibbli li 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. jinkiser, u dan huwa bżonnjuż għall- prevenzjoni ta ’ ksur f’ pazjenti b’ kanċer tas- sider b’ metastasi fl - għadam.
How has Bondronat been studied?
Kif ġie studjat Bondronat?
Bondronat has been studied in the treatment of hypercalcaemia due to cancer in three four-week studies involving a total of 343 patients.
Bondronat ġie studjat fil- kura ta ’ iperkalċimja dovuta għal kanċer fi tliet studji ta ’ erba ’ ġimgħat li b’ kollox involvew 343 pazjent.
Bondronat was not compared to any other treatment.
Bondronat ma tqabbilx ma ’ xi kura oħra.
The main measure of effectiveness was the change in the blood calcium levels.
Il- miżura ewlenija ta ’ effettività kienet il- bidla fil- livelli tal- kalċju fid- demm.
The effectiveness of Bondronat in preventing skeletal events in patients with breast cancer and bone metastases has been studied in 1,312 patients in three studies, one with the injection (466 patients) and two with the tablet (846 patients).
L- effettività ta ’ Bondronat fil- prevenzjoni ta ’ episodji skeletali f’ pazjenti b’ kanċer tas- sider u b’ metastasi fl- għadam ġiet studjata f’ 1, 312- il pazjent fi tliet studji, wieħed bl- injezzjoni (466 pazjent) u tnejn bil- pillola (846- il pazjent).
In all three studies, Bondronat was compared with placebo (a dummy treatment) over 96 weeks.
Fit- tliet studji kollha, Bondronat tqabbel ma ’ plaċebo (kura finta) fuq 96 ġimgħa.
The main measure of effectiveness was based on the number of new bone complications.
Il- miżura ewlenija ta ’ effettività kienet ibbażata fuq in- numru ta ’ kumplikazzjonijiet ġodda ta ’ l- għadam.
These included vertebral (spine) fractures, non-vertebral fractures and any bone complication that needed treatment either with radiotherapy or surgery.
Dawn inkludew ksur vertebrali (ta ’ l- ispina), ksur mhux vertebrali u kwalunkwe kumplikazzjoni ta ’ l- għadam li ħtieġet kura jew bir- radjuterapija jew bil- kirurġija.
What benefit has Bondronat shown during the studies?
Liema benefiċċju wera Bondronat waqt l- istudji mwettqa?
Bondronat was effective in treating hypercalcaemia due to cancer.
Bondronat kien effettiv fil- kura ta ’ iperkalċimja dovuta għal kanċer.
About a half to two thirds of the patients responded to a 2 mg dose of Bondronat, with blood calcium levels returning to within the normal range.
Madwar nofs sa żewġ terzi tal - pazjenti rreaġġixxew għal doża ta ’ 2 mg ta ’ Bondronat, b’ livelli ta ’ kalċju fid- demm li jirritornaw fil - medda normali.
About three quarters responded to a 4 mg dose.
Madwar tliet kwarti irreaġġixxew għal doża ta ’ 4 mg.
Bondronat was more effective than placebo as measured by the number of bone complications.
Bondronat kien aktar effettiv minn plaċebo kif imkejjel permezz tan- numru ta ’ kumplikazzjonijiet ta ’ l- għadam.
It took longer for patients on Bondronat injection or tablets to develop a new bone complication than for patients on placebo (50 to 76 weeks, compared with 33 to 48 weeks).
Pazjenti fuq injezzjoni jew pilloli ta ’ Bondronat ħadu aktar żmien biex jiżviluppaw kumplikazzjoni ġdida ta ’ l- għadam milli pazjenti fuq plaċebo (50 sa 76 ġimgħa meta mqabblin ma ’ 33 sa 48 ġimgħa).
Bondronat reduced the risk of having a skeletal related event by about 40%, compared with placebo.
Bondronat naqqas ir- riskju ta ’ żvilupp ta ’ episodju relatat ma ’ l- iskeletru b’ madwar 40%, meta mqabbel ma ’ plaċebo.
What is the risk associated with Bondronat?
X’ inhu r- riskju assoċjat ma ’ Bondronat?
The most common side effect with Bondronat (seen in more than 1 patient in 10) is pyrexia (rise in body temperature).
L- aktar effett sekondarju komuni b’ Bondronat (jidher f’ aktar minn pazjent 1 minn kull 10) huwa pireksja (tlugħ tat- temperatura tal- ġisem).
For the full list of all side effects reported with Bondronat, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrapportati b’ Bondronat, ara l- Fuljett ta ’ Tagħrif.
Bondronat should not be used in people who may be hypersensitive (allergic) to ibandronic acid or any of the other ingredients, or in patients who are sensitive to other bisphosphonates.
Bondronat m’ għandux jintuża minn nies li huma ipersensittivi (allerġiċi) għal ibandronic acid jew għal xi sustanza oħra tiegħu, jew minn pazjenti li huma sensittivi għal bifosfonati oħrajn.
Bondronat should not be used in children.
Bondronat m’ għandux jintuża mit- tfal.
As with all bisphosphonates, patients taking Bondronat may be at risk of osteonecrosis (death of bone tissue) in the jaw.
Bħal ma ’ jista ’ jiġri bil- bifosfonati kollha, pazjenti li jkunu qegħdin jieħdu Bondronat jistgħu jkunu f’ riskju ta ’ osteonekrożi (mewt tat- tessut ta ’ l- għadam) fix- xedaq.
Why has Bondronat been approved?
Għaliex ġie approvat Bondronat?
The Committee for Medicinal Products for Human Use (CHMP) decided that Bondronat’ s benefits are greater than its risks for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases, and the treatment of tumour-induced hypercalcaemia with or without metastases.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Bondronat huma akbar mir- riskji tiegħu għal prevenzjoni ta ’ episodji skeletali (ksur patoloġiku, kumplikazzjonijiet ta ’ l- għadam li jeħtieġu radjuterapija jew kirurġija) f’ pazjenti b’ kanċer tas- sider u b’ metastasi ta ’ l- għadam, u għall- kura ta ’ iperkalċimja dovuta għal tumur b’ metastasi jew mingħajrha.
The Committee recommended that Bondronat be given marketing authorisation.
Il- Kumitat irrakkomanda li Bondronat jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Bondronat:
Informazzjoni oħra dwar Bondronat:
The European Commission granted a marketing authorisation valid throughout the European Union to Roche Registration Limited for Bondronat on 25 June 1996.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq valida madwar l- Unjoni Ewropea għal Bondronat lil Roche Registration Limited fil- 25 ta ’ Ġunju 1996.
The marketing authorisation was renewed on 25 June 2001 and on 25 June 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fil- 25 ta ’ Ġunju 2001 u fil- 25 ta ’ Ġunju 2006.
The full EPAR for Bondronat is available here.
L- EPAR sħiħ għal Bondronat jista ’ jiġi konsultat hawnhekk.
This summary was last updated in 04-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi 04- 2008.
Bondronat 2 mg Concentrate for solution for infusion
Bondronat 2 mg Konċentrat għal soluzzjoni għall- infużjoni
One vial with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as 2.25 mg ibandronic acid, monosodium salt, monohydrate).
Kunjett wieħed b’ 2 ml konċentrazzjoni għal soluzzjoni għall- infużjoni fih 2 mg ibandronic acid (bħala 2. 25 mg ibandronic acid, monosodium salt, monohydrate).
For a full list of excipients, see section 6.1.
Għall- lista kompleta ta ’ sustanzi mhux attivi, ara Sezzjoni 6. 1.
Clear, colourless solution.
Konċentrat għal soluzzjoni għall- infużjoni Soluzzjoni ċara, bla kulur.
Bondronat is indicated for
Il- Bondronat huwa indikat għall -
- Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy
- prevenzjoni ta ’ eventi skeletriċi (fratturi patoloġiċi, kumplikazzjonijiet fl- għadam li jirrikjedu
or surgery) in patients with breast cancer and bone metastases.
radjuterapija jew kirurġija) f’ pazjenti b’ kanċer tas- sider u metastażi fl- għadam.
- Treatment of tumour-induced hypercalcaemia with or without metastases.
- Trattament ta ’ l- iperkalċemja kkawżata minn tumuri bi jew mingħajr metastażi.
Bondronat therapy should only be initiated by physicians experienced in the treatment of cancer.
Terapija b’ Bondronat għandha tingħata biss minn tobba li għandhom esperjenza fil- kura tal- kanċer.
For intravenous administration.
Għandu jingħata ġol- vina.
For single use only.
Għal użu ta ’ darba biss.
Only clear solution without particles should be used.
Għandha tintuża biss soluzzjoni ċara mingħajr frak.
Prevention of Skeletal Events in Patients with Breast Cancer and Bone Metastases
Prevenzjoni ta ’ Episodji Skeletriċi f’ Pazjenti b’ kanċer tas- Sider u Metastażi fl- għadam
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.
Id- doża rrakkomandata għall- prevenzjoni ta ’ eventi skeletriċi f’ pazjenti b’ kanċer tas- sider u metastażi fl- għadam hija ta '6 mg b’ injezzjoni fil- vina li tingħata kull 3- 4 ġimgħat.
The dose should be infused over at least 15 minutes.
Id- doża għandha tkun mogħtija fuq medda ta 'mill- anqas 15- il minuta.
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.
Għall- infużjoni, il- kontenut ta ’ kunjett( i) għandu jiżdied biss ma ’ 100 ml soluzzjoni ta ’ isotonic sodium chloride jew 100 ml 5% soluzzjoni ta ’ glucose.
A shorter (i. e.
Ħin ta ’ infużjoni iqsar (i. e.
15 min) infusion time should only be used for patients with normal renal function or mild renal impairment.
15- il minuta) għandha tintuża biss għall- pazjenti b’ funzjoni renali normali jew indeboliment renali ħafif.
There are no data available characterizing the use of a shorter infusion time in patients with creatinine clearance below 50 ml/ min.
M’ hemmx tagħrif disponibbli ikkaratterizzat għall- użu ta ’ ħin ta ’ infuzjoni iqsar f’ pazjenti bi tneħħija ta ’ creatinine taħt 50 ml/ min.
Prescribers should consult the section Patients with Renal Impairment (Section 4.2) for recommendations on dosing and administration in this patient group.
It- tobba għandhom jaraw is- sezzjoni Pazjenti b’ indeboliment tal- kliewi (Sezzjoni 4. 2) għall- rakkomandazzjonijiet dwar id- dożaġġ u l - għotja f’ dan il- grupp ta ’ pazjenti.
Treatment of Tumour-Induced Hypercalcaemia
Trattament ta ’ l- iperkalċemja Kkawżata minn Tumur
Prior to treatment with Bondronat the patient should be adequately rehydrated with 9 mg/ ml (0.9%) sodium chloride.
Qabel it- trattament b’ Bondronat il- pazjent għandu jiġi rrijidratat biżżejjed b’ 9 mg/ ml (0. 9%) sodium chloride.
Consideration should be given to the severity of the hypercalcaemia as well as the tumour type.
Għandha tiġi kkunsidrata s- severità ta ’ l- iperkalċemja kif ukoll it- tip tat- tumur.
In general patients with osteolytic bone metastases require lower doses than patients with
B’ mod
2 the humoral type of hypercalcaemia.
2 ġenerali pazjenti b’ metastażi ostejolitiku fl- għadam jirrikjedu dożi aktar baxxi minn pazjenti b’ iperkalċemja tat- tip umorali.
In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥ 3 mmol/ l or ≥ 12 mg/ dl) 4 mg is an adequate single dosage.
Fil- parti l- 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.
In patients with moderate hypercalcaemia (albumin-corrected serum calcium < 3 mmol/ l or < 12 mg/ dl) 2 mg is an effective dose.
F’ pazjenti b’ iperkalċemja moderata (kalċju fis- serum ikkoreġut bl- albumina < 3 mmol/ l jew < 12 mg/ dl) 2 mg hija doża effettiva.
The highest dose used in clinical trials was 6 mg but this dose does not add any further benefit in terms of efficacy.
L- għola doża użata f’ provi kliniċi kienet ta ’ 6 mg iżda din id- doża ma żżid l- ebda vantaġġ ieħor f’ termini ta ’ effikaċja.
* Note albumin-corrected serum calcium concentrations are calculated as follows:
* Nota: il- konċentrazzjonijiet tal- kalċju fis- serum ikkoreġut bl- albumina huma kkalkulati kif ġej:
Albumin-corrected serum calcium (mmol/ l)
Kalċju fis- serum ikkoreġut bl - = albumina (mmol/ l)
Or
Jew
serum calcium (mmol/ l) - [0.02 x albumin (g/ l)] + 0.8
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)]
To convert the albumin-corrected serum calcium in mmol/ l value to mg/ dl, multiply by 4.
Biex taqleb il- valur tal- kalċju fis- serum ikkoreġut bl- albumina minn mmol/ l għal mg/ dl, immultiplika b’ 4.
In most cases a raised serum calcium level can be reduced to the normal range within 7 days.
F’ ħafna każijiet livell għoli ta ’ kalċju fis- serum jista ’ jitnaqqas għal livell normali f’ 7 ijiem.
The median time to relapse (return of albumin-corrected serum calcium to levels above 3 mmol/ l) was 18 - 19 days for the 2 mg and 4 mg doses.
Iż- żmien medju 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 medju biex il- livell jerġa jgħola kien ta ’ 26 ġurnata b' doża ta ’ 6 mg.
A limited number of patients (50 patients) have received a second infusion for hypercalcaemia.
Numru limitat ta ’ pazjenti (50 pazjent) rċivew it- tieni infużjoni għall- iperkalċemija.
Repeated treatment may be considered in case of recurrent hypercalcaemia or insufficient efficacy.
Trattament ripetut jista ’ jiġi kkunsidrat f’ każ ta ’ iperkalċemja rikorrenti jew effikaċja insuffiċjenti.
Bondronat concentrate for solution for infusion should be administered as an intravenous infusion.
Il- konċentrat ta ’ Bondronat għal soluzzjoni għall- infużjoni għandu jingħata permezz ta ’ infużjoni fil - vina.
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.
Għal dan il- għan, il- kontenut tal- kunjetti għandu jkun miżjud ma ’ 500 ml ta ’ soluzzjoni ta ’ isotonic sodium chloride (jew 500 ml ta ’ 5% soluzzjoni ta ’ dextrose) u jiġi mogħti fuq medda ta ’ sagħtejn.
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 rakkomandati 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.
Patients with hepatic impairment No dosage adjustment is required (see section 5.2).
Pazjenti b’ indeboliment tal- fwied L- ebda aġġustament fid- doża ma huwa meħtieġ (ara sezzjoni 5. 2).
Patients with renal impairment There is no evidence of a reduction in tolerability associated with an increase in exposure to ibandronate in patients with various degrees of renal impairment.
Pazjenti b’ indeboliment tal- kliewi Ma hemm l- ebda evidenza ta ’ tnaqqis fit- tollerabilità assoċjata ma ’ żjieda fl- espożizzjoni għal ibandronate f’ pazjenti b’ diversi gradi ta ’ indeboliment renali.
However, for the prevention of skeletal events in patients with breast cancer and bone metastases the following recommendations should be followed:
Madankollu, għall- prevenzjoni ta ’ episodi skeletriċi f’ pazjenti b’ kanċer tas- sider u metastażi fl- għadam, ir- rakkomandazzjonijiet li ġejjin għandhom ikunu segwiti:
Creatinine Clearance
Tneħħija ta ’ Kreatinina
Dosage / Infusion time 1
/ Ħin ta ’ I- infużjoni1
Infusion Volume 2
Volum ta ’ l- Infużjoni 2
6 mg / 15 minutes
6mg / 15 minuta
100 ml
100ml
30 < CLcr < 50 < 30
30 < CLcr < 50
6 mg / 1 hour 2 mg / 1 hour
6mg / 1 siegħa
500 ml 500 ml
2mg / 1 siegħa
Administration every 3 to 4 week 2 0.9% sodium chloride solution or 5% glucose solution
500ml
A 15 minute infusion time has not been studied in cancer patients with CLCr < 50 mL/ min.
Amministrazzjoni kull 3 sa 4 ġimgħat 2 soluzzjoni ta ’ 0. 9% sodium chloride jew soluzzjoni ta ’ 5% glucose Ħin ta ’ l- infużjoni ta ’ 15- il minuta ma ġiex studjat f’ pazjenti tal- kanċer bi CLCr < 50 mL/ min.
Elderly No dose adjustment is required.
3 L- anzjani L- ebda aġġustament fid- doża ma huwa meħtieġ.
3 Children and adolescents Bondronat is not recommended for patients below age 18 years due to insufficient data on safety and efficacy.
Tfal u adoloxxenti Bondronat mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Caution is to be taken in patients with known hypersensitivity to other bisphosphonates.
Għandha tingħata attenzjoni f’ pazjenti b’ sensittività eċċessiva għal bisfosfonati oħrajn.
Bondronat should not be used in children.
Bondronat m' għandux jintuża fit- tfal.
Clinical studies have not shown any evidence of deterioration in renal function with long term Bondronat therapy.
Studji kliniċi ma wrewx evidenza ta ’ deterjorazzzjoni fil- funzjoni renali b’ terapija fit- tul ta ’ Bondronat.
Nevertheless, according to clinical assessment of the individual patient, it is recommended that renal function, serum calcium, phosphate and magnesium should be monitored in patients treated with Bondronat.
Madankollu, skond l- eżami kliniku tal- pazjent individwali, huwa rrikkmandat li jsir monitoraġġ tal- funzjoni renali, tal- kalċju fis- serum, tal- fosfat u tal- manjesju f’ pazjenti li jiġu trattati b’ Bondronat.
As no clinical data are available, dosage recommendations cannot be given for patients with severe hepatic insufficiency.
Minħabba li ma hemm l- ebda informazzjoni klinika, rakkomandazzjonijiet fuq id- doża ma jistgħux jingħataw lill- pazjenti b’ insuffiċjenza severa tal- fwied.
Overhydration should be avoided in patients at risk of cardiac failure.
Idratazzjoni żejda għandha tiġi evitata f’ pazjenti b’ riskju ta ’ insuffiċjenza tal- qalb.
Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Bondronat therapy for metastatic bone disease.
Nuqqas ta ’ kalċju u disturbi oħra fil- metaboliżmu ta ’ l- għadam u l- minerali għandhom jiġu trattati effettivament qabel ma tinbeda terapija b’ Bondronat għall- mard metastatiku ta ’ l- għadam.
Adequate intake of calcium and vitamin D is important in all patients.
Huwa importanti li l- pazjenti kollha jieħdu ammont adegwat ta ’ kalċju u vitamina D.
Patients should receive supplemental calcium and/ or vitamin D if dietary intake is inadequate.
Il- pazjenti għandhom jirċievu kalċju u/ jew vitamina D supplementari jekk l- ammonti fid- dieta ’ mhumiex adegwati.