natgillin/translations-raw huggingface dataset:
- uncommon: affects 1 to 10 users in 1,000
- občasni: pojavijo se pri 1 do 10 od 1000 bolnikov,
- rare: affects 1 to 10 users in 10,000
- redki: pojavijo se pri 1 do 10 od 10. 000 bolnikov,
- very rare: affects less than 1 user in 10,000
- zelo redki: pojavijo se pri manj kot 1 od 10. 000 bolnikov,
- not known: frequency cannot be estimated from the available data.
- ni znano: pogostnosti ni mogoče oceniti na podlagi podatkov, ki so na voljo.
Common side effects are heartburn, indigestion, diarrhoea, stomach ache, nausea and flatulence.
Pogosti neželeni učinki so zgaga, slaba prebava, driska, bolečina v trebuhu, slabost in vetrovi.
Other common side effects include rash, cramps in the muscles, pain in the muscles and joints, and headache.
Drugi pogosti neželeni učinki vključujejo izpuščaj, krče v mišicah, bolečino v mišicah in sklepih ter glavobol.
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.
Jemanje zdravila Bondenza lahko nadaljujete.
Talk to your doctor if any effects become troublesome or last a long time.
Če kateri koli neželeni učinek postane hujši ali traja dlje, se posvetujte s svojim zdravnikom.
Bondenza can irritate the oesophagus, although you can usually avoid this by taking your dose as described in this leaflet.
Zdravilo Bondenza lahko draži požiralnik, čemur pa se lahko izognete, če zdravilo jemljete natančno po navodilih.
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.
To so občasni neželeni učinki, a če pri vas nastopijo simptomi, kot so huda bolečina v prsih, huda bolečina po požiranju hrane ali pijače, huda slabost ali bruhanje, o tem takoj obvestite svojega zdravnika.
Other uncommon side effects are dizziness and back pain.
Ostala občasna neželena učinka sta omotica in bolečina v hrbtu.
Rare side effects are swelling and itching of the face, lips and mouth.
Redki neželeni učinki so otekanje in srbenje obraza, ustnic in ust.
HOW TO STORE BONDENZA
SHRANJEVANJE ZDRAVILA BONDENZA
Do not use after the expiry date which is stated on the carton after “EXP”.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake Uporabno do.
What Bondenza contains
Kaj vsebuje zdravilo Bondenza
One tablet contains 150 mg of ibandronic acid.
Vsaka filmsko obložena tableta vsebuje 150 mg
tablet coat: hypromellose, titanium dioxide, talc, macrogol 6000
obloga tablet: hipromeloza, titanov dioksid, smukec in makrogol 6000.
Bondenza tablets are white to off white, of oblong shape and marked “BNVA” on one side, and “150” on the other side.
Bondenza tablete so bele do sivo bele barve, podolgovate oblike z oznako “ BNVA ” na eni strani in “ 150 ” na drugi strani.
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Imetnik dovoljenja za promet z zdravilom Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW Velika Britanija
Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Izdelovalec Roche Pharma AG Emil- Barell- Strasse 1 D- 79639 Grenzach- Wyhlen Nemčija
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na lokalno predstavništvo imetnika dovoljenja za promet z zdravilom:
България Рош България ЕООД Тел: +359 2 818 44 44
45 България Рош България ЕООД Тел: +359 2 818 44 44
46 REMINDER STICKERS TEXT
46 Navodilo je bilo odobreno {MM/ LLLL}
- either the same date (such as the 1st of each month)
1. v mesecu),
- or the same day (such as the first Sunday of each month).
- ali isti dan (npr. prvo nedeljo v mesecu).
Monthly tablet Monthly tablet
Mesečna tableta Mesečna tableta
Monthly tablet
Mesečna tableta
It’s important to keep taking Bondenza every month.
Pomembno je, da nadaljujete mesečno jemanje Bondenze.
INFORMATION FOR THE USER
48 NAVODILO ZA UPORABO
How to use Bondenza 4.
Kaj morate vedeti, preden boste uporabili zdravilo Bondenza 3.
Possible side effects 5.
Kako uporabljati zdravilo Bondenza 4.
- smoking cigarettes, or drinking too much alcohol
- kajenje cigaret ali čezmerno pitje alkohola,
If you have no symptoms you may not know if you have the condition.
Če jih nimate, morda ne boste vedeli, da imate to bolezen.
Bondenza prevents loss of bone from osteoporosis, thus helping to rebuild lost bone.
Bondenza preprečuje izgubo kostne mase zaradi osteoporoze in tako pomaga pri ponovni gradnji kosti.
Therefore, Bondenza makes bones less likely to break.
Bondenza zmanjša tveganje za zlom kosti.
48 A healthy lifestyle will also help you to get the most benefit from your treatment.
49 Zdrav način življenja vam bo prav tako pomagal, da bo vaše zdravljenje čimbolj uspešno.
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.
To vključuje uravnoteženo prehrano, bogato s kalcijem in vitaminom D, hojo ali druge telesne aktivnosti z vplivom na telesno maso, opustitev kajenja in zmerno pitje alkohola.
BEFORE YOU USE BONDENZA
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO BONDENZA
Do not use Bondenza
Ne uporabljajte zdravila Bondenza:
- if you have, or had in the past, low blood calcium.
Prosimo,
- if you are allergic (hypersensitive) to ibandronic acid or any of the other ingredients in
- če ste alergični (preobčutljivi) na ibandronsko kislino ali katerokoli sestavino zdravila Bondenza
Bondenza injection
v obliki injekcije.
Take special care with Bondenza Some patients need to be especially careful when using Bondenza.
Bodite posebno pozorni pri jemanju zdravila Bondenza Nekateri bolniki morajo biti pri uporabi zdravila Bondenza še posebno previdni.
- if you have or have ever had kidney problems, kidney failure or have needed dialysis, or if you
- če imate ali ste kdaj imeli težave z ledvicami, oslabljeno ledvično delovanje, ste potrebovali
have any other disease that may affect your kidneys
dializo ali pa imate katerokoli drugo bolezen, ki lahko vpliva na ledvice;
- if you have any disturbance of mineral metabolism (such as vitamin D deficiency)
- če imate kakršne koli motnje presnove mineralov (kot je pomanjkanje vitamina D).
If you are
- Med zdravljenjem z zdravilom Bondenza morate jemati dodatke kalcija in vitamina D.
unable to do so, you should inform your doctor.
Obvestite svojega zdravnika, če to ni mogoče.
Taking other medicines Tell your doctor, nurse or pharmacist if you are taking, or have recently taken, any other medicines.
Jemanje drugih zdravil Obvestite svojega zdravnika, medicinsko sestro ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo.
Mention to your doctor, nurse or pharmacist anything you are taking which you bought over the counter, without a prescription.
Omenite vsa zdravila, ki jih jemljete in ki ste jih dobili brez recepta.
Pregnancy and breast-feeding You should not be given Bondenza if you are pregnant, or if there is a possibility you may become pregnant.
Nosečnost in dojenje Če ste noseči ali če obstaja možnost, da bi lahko zanosili, ne smete dobivati zdravila Bondenza.
If you are breast-feeding, you will need to stop breast-feeding in order to receive Bondenza.
Če dojite, boste morali z dojenjem prenehati, da bi lahko dobivali zdravilo Bondenza.
HOW TO USE BONDENZA
KAKO UPORABLJATI ZDRAVILO BONDENZA
The recommended dose of Bondenza for the intravenous injection is 3 mg (1 pre-filled syringe) once every 3 months.
Priporočeni odmerek Bondenze za intravensko injiciranje je 3 mg (1 napolnjena injekcijska brizga) vsake 3 mesece.
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.
Nadaljevanje uporabe zdravila Bondenza Za najboljši izkoristek zdravljenja je pomembno, da nadaljujete s prejemanjem zdravila Bondenza vsake 3 mesece, dokler vam je zdravljenje predpisal zdravnik.
49 If too much Bondenza is given You may develop low levels of calcium, phosphorus or magnesium in the blood.
50 Če so vam dali večji odmerek zdravila Bondenza, kot bi smeli To lahko povzroči nizke koncentracije kalcija, fosforja ali magnezija v krvi.
If a dose of Bondenza is missed You should arrange an appointment to get the next injection as soon as possible.
Če ste pozabili odmerek zdravila Bondenza Dogovoriti se morate za termin za naslednjo injekcijo takoj, ko je mogoče.
Bondenza, like other similar medicines, may cause a drop in the levels of calcium in your blood.
Bondenza lahko, podobno kot druga podobna zdravila, povzroči zmanjšanje koncentracije kalcija v vaši krvi.
Very common side effects are mild symptoms which start within 1 day of the first injection.
Zelo pogosti neželeni učinki so blagi simptomi, ki se začnejo v prvem dnevu prve injekcije.
About half (1 in 20) experience aches or pains in the muscles, bones or joints.
Približno polovica (1 od 20) izkusi bolečine v mišicah, kosteh ali sklepih.
The other half may have flu-like symptoms (fever, chills or feverishness and aches or pains in the muscles, bones and joints).
Druga polovica ima lahko gripi podobne simptome (povišana telesna temperatura, mrzlica ali vročičnost ter bolečine v mišicah, kosteh in sklepih).
In most cases these symptoms are mild and will not need any treatment.
V večini primerov so ti simptomi blagi in ne potrebujejo zdravljenja.
Taking paracetamol may help relieve these symptoms.
Jemanje paracetamola jih lahko olajša.
The symptoms should go away quickly (within 2-3 days of the injection) and they do not usually come back after the second injection.
Po drugi injekciji pa se ponavadi ne pojavijo ponovno.
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.
Če se slučajno pojavijo tudi po drugi injekciji, so navadno blažji in popolnoma izginejo po tretji ali nadaljnjih injekcijah.
Other common side effects are:
Ostali pogosti neželeni učinki so:
- headache
- glavobol,
- fatigue
- utrujenost,
- rash
- izpuščaj,
- diarrhoea
- diareja.
Uncommon side effects are skin reactions at the injection site, such as redness, pain and swelling.
Občasni neželeni učinki so reakcije na mestu injiciranja, kot so rdečina, bolečina in otekanje.
Rare side effects are swelling of the face, lips and mouth may occur.
Redki neželeni učinki so otekanje obraza, ustnic in ust.
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”.
Zdravila Bondenza 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini poleg oznake Uporabno do in na brizgi poleg oznake 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.
51 Oseba, ki daje zdravilo mora neuporabljeno raztopino, uporabljeno brizgo in injekcijsko iglo zavreči, slednji v za to primerno posodo.
What Bondenza 3 mg solution for injection in pre -filled syringes contains
Kaj vsebuje zdravilo Bondenza 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
One pre-filled syr inge contains 3 mg of ibandronic acid
Ena napolnjena injekcijska brizga vsebuje 3 mg
in 3 ml of solution (as 3.375 mg of ibandronic acid, monosodium salt, monohydrate).
ibandronske kisline v 3 ml raztopine (kot 3, 375 mg natrijevega ibandronata monohidrata).
- The other ingredients are sodium chloride, acetic acid, sodium acetate trihydrate and water for
To
This medicinal product contains less than 1 mmol sodium (23 mg) per dose (3 ml), i.e. essentially ‘sodium-free’.
zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek (3 ml), kar v bistvu pomeni ‛ brez natrija ’.
What Bondenza 3 mg solution for injection in pre-filled syringes looks like and contents of the pack
Izgled zdravila Bondenza 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi in vsebina pakiranja
Each pre- filled syringe contains 3 ml of solution.
Vsaka napolnjena injekcijska brizga vsebuje 3 ml raztopine.
Marketing Authorisation Holder Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Imetnik dovoljenja za promet z zdravilom Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW Velika Britanija
Manufacturer Roche Diagnostics GmbH Sandhoferstrasse 116 D-68305 Mannheim Germany.
Izdelovalec Roche Diagnostics GmbH Sandhoferstrasse 116 D- 68305 Mannheim Nemčija
This leaflet was last approved in {date}
Navodilo je bilo odobreno {MM/ LLLL}
52 ----------------------------------------------------------------------------------------------------------------------------- This information is intended for medical or healthcare professionals only.
53 ----------------------------------------------------------------------------------------------------------------------------- Naslednje informacije so namenjene samo zdravstvenemu osebju:
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.
Kjer zdravilo Bondenza dajemo skozi obstoječi intravenski infuzijski kanal, je intravenski infuzat lahko le izotonična raztopina natrijevega klorida ali 50 mg/ ml (5 -%) raztopina glukoze.
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 raztopina za injiciranje v napolnjeni injekcijski brizgi lahko kot drugi intravensko dajani bisfosfonati povzroči prehodno zmanjšanje koncentracije kalcija v serumu.
Hypocalcaemia and other disturbances of bone and mineral metabolism should be assessed and effectively treated before starting Bondenza injection therapy.
Hipokalcemijo in druge motnje v kosteh in presnovi mineralov moramo prepoznati in učinkovito zdraviti pred začetkom intravenskega zdravljenja z Bondenzo.
54 GROUNDS FOR ONE ADDITIONAL RENEWAL
54 DODATEK IV
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.
RAZLOGI ZA DODATNO PODALJŠANJE DOVOLJENJA ZA PROMET
55
55 RAZLOGI ZA DODATNO PODALJŠANJE DOVOLJENJA ZA PROMET
Bondronat is a medicine containing the active substance ibandronic acid.
Zdravilo Bondronat vsebuje zdravilno učinkovino ibandronska kislina.
It is available as a concentrate to be made up into a solution for infusion (drip into a vein) and as 50 mg tablets.
Na voljo je kot koncentrat, ki se pripravi v raztopino za infundiranje (dajanje tekočine v veno), ter kot 50 mg tablete.
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.
Zdravilo Bondronat se uporablja: • kot infuzija ali kot tablete za preprečevanje z okostjem povezanih dogodkov (zlomov kosti ali zapletov, ki zahtevajo zdravljenje) pri bolnikih z rakom dojke in metastazami v kosteh (ko se je rak razširil v kosti), • kot infuzija za zdravljenje tumorsko povzročene hiperkalciemije (visokih ravni kalcija v krvi).
Bondronat treatment should only be initiated by a doctor who has experience in the treatment of cancer.
Zdravljenje z zdravilom Bondronat lahko vpelje le zdravnik z izkušnjami pri zdravljenju raka.
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.
Pri preprečevanju z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh se zdravilo Bondronat daje kot infuzija v odmerku 6 mg vsake 3 do 4 tedne in se infundira vsaj 15 minut, ali kot ena tableta enkrat dnevno.
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.
Tableto mora bolnik vedno vzeti zjutraj na tešče, ko ni jedel vsaj šest ur, in vsaj 30 minut pred prvim obrokom ali pijačo.
The patient must not lie down for one hour after taking the tablet.
Tableto mora vzeti v stoječem ali sedečem položaju in popiti poln kozarec navadne vode.
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).
Pri zdravljenju tumorsko povzročene hiperkalciemije je odmerek infuzije 2 mg, če ima bolnik zmerno hiperkalciemijo (manj kot 3 mmol/ l), ali 4 mg, če ima bolnik hudo hiperkalciemijo (več kot 3 mmol/ l).
This will normally bring the blood calcium level down to normal levels within seven days.
Običajno s tem koncentracije kalcija v krvi znižamo na normalno vrednost v sedmih dneh.
The active substance in Bondronat, ibandronic acid, is a bisphosphonate.
Zdravilna učinkovina zdravila Bondronat, ibandronska kislina, je bisfosfonat.
It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Le- ta zavira delovanje osteoklastov, celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
Patients with tumours can have high blood levels of calcium, which is released from the bones.
Bolniki s tumorji utegnejo imeti v krvi visoke ravni kalcija, ki se sprošča iz kosti.
By preventing the breakdown of bones, ibandronic acid helps to reduce the levels of calcium released into the blood.
Ibandronska kislina s preprečevanjem razgradnje kosti pripomore k znižanju ravni kalcija, ki se sprosti v kri.
The reduction of bone loss also helps to make bones less likely to break, and this is useful in preventing fractures in breast cancer patients with bone metastases.
Z zmanjšanjem izgube kostne mase pripomore tudi k zmanjšanju verjetnosti zloma, kar je koristno za preprečevanje zlomov pri bolnikih z rakom dojke in metastazami v kosteh.
Bondronat has been studied in the treatment of hypercalcaemia due to cancer in three four-week studies involving a total of 343 patients.
Zdravilo Bondronat je bilo raziskano z vidika zdravljenja tumorsko povzročene hiperkalciemije v treh štiritedenskih študijah, v katere je bilo vključenih skupno 343 bolnikov.
Bondronat was not compared to any other treatment.
Zdravila Bondronat niso primerjali z nobeno drugo vrsto zdravljenja.
The main measure of effectiveness was the change in the blood calcium levels.
Glavno merilo učinkovitosti je bila sprememba ravni kalcija v krvi.
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).
Učinkovitost zdravila Bondronat pri preprečevanju z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh je bila raziskana pri 1312 bolnikih v treh študijah: v eni je bilo preučeno injiciranje (466 bolnikov), v dveh pa dajanje tablet (846 bolnikov).
In all three studies, Bondronat was compared with placebo (a dummy treatment) over 96 weeks.
V vseh treh študijah so zdravilo Bondronat 96 tednov primerjali s placebom (zdravilom brez zdravilne učinkovine).
The main measure of effectiveness was based on the number of new bone complications.
Glavno merilo učinkovitosti je temeljilo na številu novih z okostjem povezanih dogodkov.
These included vertebral (spine) fractures, non-vertebral fractures and any bone complication that needed treatment either with radiotherapy or surgery.
Ti dogodki so vključevali zlome vretenc (hrbtenice), zlome na drugih mestih in vse z okostjem povezane zaplete, pri katerih je bilo potrebno obsevanje ali kirurški poseg.
Bondronat was effective in treating hypercalcaemia due to cancer.
Zdravilo Bondronat je bilo učinkovito pri zdravljenju tumorsko povzročene hiperkalciemije.
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.
Približno polovica do dve tretjini bolnikov se je odzvalo na odmerek 2 mg zdravila Bondronat tako, da so se ravni kalcija v krvi znižale na normalno vrednost.
About three quarters responded to a 4 mg dose.
Približno tri četrtine bolnikov se je odzvalo na odmerek 4 mg.
Bondronat was more effective than placebo as measured by the number of bone complications.
Zdravilo Bondronat je bilo učinkovitejše od placeba pri merjenju števila z okostjem povezanih zapletov.
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).
Pri bolnikih, ki so prejemali injekcije ali tablete zdravila Bondronat, so se novi z okostjem povezani zapleti pojavili kasneje (od 50 do 76 tednov) kot pri bolnikih, ki so prejemali placebo (od 33 do 48 tednov).
Bondronat reduced the risk of having a skeletal related event by about 40%, compared with placebo.
Zdravilo Bondronat je v primerjavi s placebom zmanjšalo tveganje z okostjem povezanega zapleta za približno 40%.
The most common side effect with Bondronat (seen in more than 1 patient in 10) is pyrexia (rise in body temperature).
Najpogostejši neželeni učinek zdravila Bondronat (opažen pri več kot 1 bolniku izmed 10) je pireksija (zvišana telesna temperatura).
For the full list of all side effects reported with Bondronat, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Bondronat, glejte navodilo za uporabo.
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.
Zdravila Bondronat ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) ibandronsko kislino ali katero koli drugo sestavino zdravila, niti osebe, ki so občutljive za druge bisfosfonate.
Bondronat should not be used in children.
Zdravila Bondronat ne smejo uporabljati otroci.
As with all bisphosphonates, patients taking Bondronat may be at risk of osteonecrosis (death of bone tissue) in the jaw.
Zdravilo Bondronat, kot vsi bisfosfonati, zviša tveganje za osteonekrozo (odmrtja kostnega tkiva) čeljusti.
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Bondronat za preprečevanje z okostjem povezanih dogodkov (patološke frakture, zapleti, pri katerih je potrebno obsevanje ali kirurški poseg) pri bolnikih z rakom dojke in metastazami v kosteh ter za zdravljenje tumorsko povzročene hiperkalciemije z metastazami ali brez njih večje od z njim povezanih tveganj.
The Committee recommended that Bondronat be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Bondronat odobri dovoljenje za promet.
Other information about Bondronat:
Druge informacije o zdravilu Bondronat:
The European Commission granted a marketing authorisation valid throughout the European Union to Roche Registration Limited for Bondronat on 25 June 1996.
Evropska Komisija je dovoljenje za promet z zdravilom Bondronat, veljavno po vsej Evropski uniji, odobrila družbi Roche Registration Limited dne 25. junija 1996.