natgillin/translations-raw huggingface dataset:
Iasibon concentrate for solution for infusion should be administered as an intravenous infusion over 2 hours.
Zdravilo Iasibon koncentrat za raztopino za infundiranje je treba aplicirati v obliki intravenske infuzije 2 uri.
Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalcev, odgovornih za sproščanje serije Koncentrat za raztopino za infundiranje
Special populations
Starejša populacija
Prior to treatment with Iasibon the patient should be adequately rehydrated with 9 mg/ml (0.9%) sodium chloride.
Pred zdravljenjem z zdravilom Iasibon izvedemo ustrezno hidracijo bolnika z raztopino natrijevega klorida 9 mg/ml (0,9-%).
(≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare
(≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
Albumin-corrected Serum calcium (mg/dl)
ali korigirani kalcij v serumu (mg/dl)
Pooled data from these studies demonstrated a significant advantage for Ibandronate 50 mg p.o. over placebo in the reduction in SREs measured by the SMPR (p=0.041).
Združeni podatki teh študij so pokazali značilno prednost ibandronske kisline (50 mg), dane peroralno, pred placebom v zmanjšanju SRE, ki so jih merili s SMPR (p = 0,041).
• Do not use this medicine after the expiry date which is stated on the folding box and on the label after EXP.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Iasibon contains lactose.
Zdravilo Iasibon vsebuje laktozo.
Drink a full glass of milk before you go. Do not make yourself sick.
Popijte poln kozarec mleka.
Paediatric population (see section 4.2 and section 5.1) There are no data on the use of Iasibon in patients less than 18 years old.
Pediatrična populacija (glejte poglavji 4.2 in 5.1) O uporabi zdravila Iasibon pri bolnikih, mlajših od 18 let, ni podatkov.
Therefore, it is recommended that the tablets should be taken after an overnight fast (at least 6 hours) and fasting should continue for at least 30 minutes after the dose has been taken (see section 4.2).
Zato je priporočljivo, da bolnik vzame tablete po postu prek noči (post naj traja najmanj 6 ur), po vzetem odmerku pa mora miniti vsaj 30 minut, preden bolnik zaužije pijačo ali hrano (glejte poglavje 4.2).
Patients with cardiac impairment Overhydration should be avoided in patients at risk of cardiac failure.
Pri bolnikih z nevarnostjo srčnega popuščanja se je treba izogibati hiperhidraciji.
A repeated dose may be considered in case of insufficient response or if your illness reappears.
V primeru nezadostnega odziva ali, če se vaša bolezen ponovno pojavi, se lahko razmisli o ponovnem odmerku.
Medicinal products and supplements (including calcium) should similarly be avoided prior to taking Iasibon tablets.
Pred jemanjem tablet Iasibon se je prav tako treba izogibati jemanjem drugih zdravil in dodatkov (vključno s kalcijem).
Paediatric population(see section 4.2 and section 5.2) The safety and efficacy of Iasibon in children and adolescents below the age of 18 years have not been established.
Pediatrična populacija (glejte poglavji 4.2 in 5.2) Varnost in učinkovitost zdravila Iasibon pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration.
Po peroralnem jemanju je absorpcija ibandronske kisline v zgornjem delu gastrointestinalnega trakta hitra.
Clinical studies in patients with breast cancer and bone metastases have shown that there is a dose dependent inhibitory effect on bone osteolysis, expressed by markers of bone resorption, and a dose dependent effect on skeletal events.
Klinične študije pri bolnikih z rakom dojke in metastazami v kosteh so pokazale, da je zaviralni učinek na osteolizo kosti odvisen od odmerka, ki se izraža z označevalci resorpcije kosti ter da so dogodki, povezani z okostjem, odvisni od odmerka.
Do not take Iasibon - if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are listed in section 6 - if you have problems with your food pipe /gullet (oesophagus) such as narrowing or difficulty swallowing - if you cannot stand or sit upright for at least one hour (60 minutes) at a time - if you have or ever had low calcium in your blood.
• Zdravila Iasibon ne smete prejeti:če ste alergični (preobčutljivi) na ibandronsko kislino ali katerokoli drugo sestavino tega zdravila, navedeno v poglavju 6; • če imate ali ste kadarkoli imeli nizke koncentracije kalcija v krvi.
Albumin-corrected Serum calcium (mmol/l)
korigirani kalcij v serumu (mmol/l)
Do not take a double dose to make up for a forgotten dose.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.Če jemljete tablete vsak dan, izpustite pozabljeni odmerek.
The deterioration in Quality of Life was significantly less in Ibandronate treated patients compared with placebo.
Poslabšanje kakovosti življenja je bilo pri bolnikih, zdravljenih z ibandronsko kislino, v primerjavi s placebom značilno manjše.
In order to avoid potential incompatibilities Iasibon concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% dextrose solution.
Da bi se izognili možnim inkompatibilnostim, lahko zdravilo Iasibon koncentrat za raztopino za infundiranje razredčimo le z izotonično raztopino natrijevega klorida ali 5-% raztopino glukoze.
Do not take this medicine if any of the above apply to you.
Če se karkoli od zgoraj naštetega nanaša na vas, tega zdravila ne smete prejeti.
While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications.
Medtem ko v nadzorovanih kliničnih preskušanjih niso opazili povečanega tveganja pri uporabi peroralnih difosfonatov, so v obdobju trženja zdravila poročali o želodčnih razjedah in razjedah na dvanajstniku, med katerimi je bilo nekaj hudih primerov z zapleti.
• kidney cyst (fluid-filled sac in the kidney).
• ledvična cista (vrečka v ledvicah napolnjena s tekočino).
Iasibon 50 mg film-coated tablets ibandronic acid
Iasibon 50 mg filmsko obložene tablete ibandronska kislina
Blood alkaline phosphatase increase, weight decrease
zvišan kreatinin zvišane koncentracije alkalne fosfataze v krvi, znižanje telesne mase
Iasibon contains the active substance ibandronic acid.
Zdravilo Iasibon vsebuje zdravilno učinkovino ibandronsko kislino.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 January 2011
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/10/659/003 DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 21. januar 2011 Datum zadnjega podaljšanja: 30. september 2015
Your doctor may do regular blood tests while you are receiving Iasibon.
Med zdravljenjem z zdravilom Iasibon bo zdravnik verjetno naredil običajne preiskave krvi, da bo preveril, če prejemate pravi odmerek zdravila.
To avoid potential incompatibilities Iasibon concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% glucose solution.
Da se izognemo možnim nezdružljivostim, lahko koncentrat za raztopino za infundiranje Iasibon razredčimo le z izotonično raztopino natrijevega klorida ali 5-% raztopino glukoze.
A 15 minute infusion time has not been studied in cancer patients with a creatinine clearance of <50 ml/min.
15-minutne infuzije pri bolnikih z rakom, ki imajo očistek kreatinina < 50 ml/min, niso proučevali.
Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration (see section 4.4).
Acetilsalicilna kislina in nesteroidna protivnetna zdravila (NSAID) Ker acetilsalicilno kislino, nesteroidna protivnetna zdravila (NSAID) in difosfonate povezujejo z gastrointestinalnim draženjem, je pri sočasnem jemanju teh zdravil potrebna previdnost (glejte poglavje 4.4).
See also dosage section above for patients with renal impairment
Glejte tudi zgornje poglavje o odmerjanju pri bolnikih z ledvično okvaro.
Data from this study demonstrated a significant advantage for intravenous Ibandronate 6 mg over placebo in the reduction in SREs measured by the time-adjusted SMPR (p=0.004).
Podatki raziskave so pokazali signifikantno prednost ibandronske kisline (6 mg), dane intravensko, pred placebom v zmanjšanju SRE, ki so jih merili s SMPR (p = 0,004).
For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment
Pri bolnikih z zmerno ledvično okvaro (CLcr ≥ 30 in < 50 ml/min) ali hudo ledvično okvaro (CLcr
• if you have high or low blood levels of vitamin D or any other minerals
• če imate visoke ali nizke koncentracije vitamina D ali drugih mineralov v krvi; če imate težave z ledvicami, .
Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
O osteonekrozi čeljustnic so poročali tudi pri bolnikih z osteoporozo, ki so difosfonate prejemali peroralno.
Iasibon should not be mixed with calcium containing solutions.
Zdravila Iasibon ne smemo mešati z drugimi raztopinami, ki vsebujejo kalcij.
Common (may affect up to 1 in 10 people): • feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/ food pipe)
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) • bolečina ali razjeda v vaših ustih ali čeljusti.
After reconstitution: Store at 2°C - 8°C (in a refrigerator).
Po rekonstituciji: shranjujte pri temperaturi med 2 °C in 8 °C (v hladilniku).
This is because aminoglycosides and Iasibon can both lower the amount of calcium in your blood.
Aminoglikozidi in zdravilo Iasibon lahko znižajo koncentracijo kalcija v krvi.
Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDS) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Acetilsalicilna kislina in nesteroidna protivnetna zdravila (NSAID) Ker acetilsalicilno kislino, nesteroidna protivnetna zdravila (NSAID) in difosfonate povezujejo z gastrointestinalnim draženjem, je pri sočasnem jemanju teh zdravil potrebna previdnost.
Osteonecrosis of the jaw is generally associated with tooth extraction and/ or local infection (including osteomyelitis).
Osteonekroza čeljustnic je navadno povezana z izdrtjem zoba ali lokalno okužbo (vključno z osteomielitisom) ali obojim.
Frequency categories are defined using the following convention: very common (>1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000),very rare
Neželeni učinki so navedeni po organskih sistemih in pogostnosti po MedDRA. Glede na pogostnost so neželeni učinki opredeljeni kot zelo pogosti (≥1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
• changes in blood test results such as Gamma GT or creatinine
• nizka koncentracija kalcija ali fosfatov v krvi, • spremembe v laboratorijskih vrednostih, kot sta gama GT ali kreatinin,
Children and adolescents Iasibon should not be used in children and adolescents below the age of 18 years.
Otroci in mladostniki Zdravilo Iasibon se ne sme uporabljati pri otrocih in mladostnikih, starih manj kot 18 let.
Patients should receive supplemental calcium and/or vitamin D if dietary intake is inadequate
Za vse bolnike je pomemben zadosten vnos kalcija in vitamina D. Če je vnos s hrano nezadosten,
For patients with moderate renal impairment (CLcr ≥30 and
Pri bolnikih z zmerno ledvično okvaro (CLcr ≥
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 Iasibon .
Glede na klinično oceno posameznega bolnika pa je ledvično funkcijo, serumske koncentracije kalcija, fosfata in magnezija pri bolnikih, ki se zdravijo z zdravilom Iasibon,
Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Glede na klinično presojo zdravnika, ki oceni razmerje med tveganjem in koristjo za vsakega bolnika posebej, je treba osnovati načrt ravnanja.
There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before a meal.
Če vzamemo ibandronsko kislino 60 minut pred obrokom,
An updated RMP should be submitted:
Posodobljen RMP je treba predložiti do{skrajni rok, ki ga določi CHMP}.
• if you have low calcium levels in your blood (hypocalcaemia).
• nizke koncentracije kalcija v krvi, • šibkost.
**See further information below †Identified in postmarketing experience.
bolečina na mestu injiciranja **Glejte nadaljne informacije spodaj † ugotovljeni po prihodu zdravila na trg
Cerebrovascular disorder, nerve root lesion , amnesia, migraine, neuralgia, hypertonia, hyperaestesia, paraesthesia circumoral, parosmia
motnje čuta za okus cerebrovask ularna bolezen, lezija živčnih korenov, amnezija, migrena, nevralgija, hipertonija, hiperastezija , parestezija okoli ust, parozmija
• a problem with your eyes called ‘cataracts'
• težava z očmi, imenovana očesna mrena,
This is because NSAIDs and Iasibon can both irritate your stomach and gut
NSAID in zdravilo Iasibon lahko dražijo želodec in črevo;
Table 1 lists adverse reactions from 2 pivotal phase III studies (Prevention of skeletal events in patients with breast cancer and bone metastases: 286 patients treated with ibandronic acid 50 mg administered orally), and from post-marketing experience.
Tabelarični prikaz neželenih učinkov Preglednica 1 prikazuje neželene učinke iz ključne študije faze III (preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh: 286 bolnikov se je zdravilo z zdravilom Iasibon 50 mg, dajanim peroralno) in iz obdobja po prihodu zdravila na trg.
Iasibon 6mg is supplied as packs containing 1, 5 and 10 vials (9 ml type I glass vial with a bromobutyl rubber stopper).
Zdravilo Iasibon 6 mg je na voljo v pakiranju po 1, 5 in 10 vial (9 ml viala iz stekla tipa I z zamaškom iz bromobutilne gume).
If you have breast cancer that has spread to your bones, then the recommended dose is 6 ampoules (6 mg) every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
Če imate raka dojke, ki se je razširil na kosti, je priporočeni odmerek 6 ampul (6 mg) vsake 3-4 tedne kot vsaj 15-minutna infuzija v veno.
For the prevention of skeletal events in patients with breast cancer and bone metastases, the Iasibon infusion is repeated at 3-4 week intervals.
Za preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh infuzijo zdravila Iasibon ponovimo v 3- do 4-tedenskih intervalih.
Iasibon contains less than 1 mmol sodium (23 mg) per ampoule, i.e. essentially sodium free.
Iasibon vsebuje manj kot 1 mmol natrija (23 mg) na ampuli, kar v bistvu pomeni brez natrija.
There is no evidence for clinically relevant interethnic differences between Asians and Caucasians in ibandronic acid disposition.
Za klinično pomembne medetnične razlike v biološki uporabnosti ibandronske kisline med Azijci in
If you have breast cancer that has spread to your bones, then the recommended dose is 1 vial (6 mg) every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
Če imate raka dojke, ki se je razširil na kosti, je priporočeni odmerek 1 viala (6 mg) vsake 3-4 tedne kot vsaj 15 minutna infuzija v veno.
Patients with hepatic impairment
Bolniki z okvaro srca
The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis for the jaw, and ocular inflammation (see paragraph “description of selected adverse reactions” and section 4.4).
Najbolj resni neželeni učinki so anafilaktične reakcije/šok, atipični zlomi stegnenice, osteonekroza čeljustnic in vnetje oči (glejte odstavek “Opis izbranih neželenih učinkov” in poglavje 4.4).
Method of administration For intravenous administration.
Za intravensko uporabo.
Elderly (see section 4.2)
Starejši bolniki (glejte poglavje 4.2)
• a skin growth called a ‘benign skin neoplasm'
• rast kože imenovana benigna neoplazma kože,
For patients with mild renal impairment (CLcr ≥50 and <80 mL/min) no dosage adjustment is necessary.
Pri bolnikih z blago ledvično okvaro (CLcr ≥ 50 in < 80 ml/min) prilagajanje odmerkov ni potrebno.
NAME OF THE MEDICINAL PRODUCT Iasibon 50 mg film coated tablets
IME ZDRAVILA Iasibon 50 mg filmsko obložene tablete
Prevention of skeletal events in patients with breast cancer and bone metastases with Ibandronate 50 mg tablets was assessed in two randomized placebo controlled phase III trials with a duration of 96 weeks.
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh s 50-miligramskimi tabletami ibandronske kisline so raziskovali v dveh randomiziranih, s placebom kontroliranih preskušanjih faze III, ki so potekala 96 tednov.
Azotaemia (uraemia)
Nalepka (ampula)
H2-antagonists or other medicinal products that increase gastric pH.
Pri sočasnem jemanjuzdravila Iasibon s H2-antagonisti ali drugimi zdravili, ki zvečajo pH želodca, pa prilagajanje odmerkov ni potrebno.
Uncommon (may affect less than 1 in 100 people)
Občasni (pojavijo se lahko pri manj kot 1 od 100 bolnikov)
What Iasibon contains
Kaj vsebuje zdravilo Iasibon
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.
Priporočeni odmerek za preprečevanje dogodkov, povezanih z okostjem pri bolnikih z rakom dojke in metastazami v kosteh je 6 mg intravensko danih vsake 3 do 4 tedne.
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.
Ker so v predkliničnih študijah z velikimi odmerki ugotovili, da so ledvice in jetra tarčni organi za toksičnost, je treba pri zdravljenju spremljati ledvično in jetrno funkcijo.
Talk to a nurse or a doctor straight away if you notice any of the following serious side effects, you may need urgent medical treatment:
Če opazite katere od naštetih resnih neželenih učinkov, se takoj posvetujte z medicinsko sestro ali zdravnikom - morda boste potrebovali nujno medicinsko zdravljenje:
Care must be taken not to administer Iasibon concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage.
Paziti je treba, da koncentrata za raztopino za infundiranje zdravila Iasibon ne dajemo intraarterijsko ali paravensko, ker lahko to vodi v poškodbo tkiva.
Total clearance of ibandronic acid was reduced to 44 ml/min in the subjects with severe renal impairment compared with 129 mL/min in subjects with normal renal function.No dosage adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Celokupni očistek ibandronske kisline je bil pri bolnikih s hudo ledvično okvaro zmanjšan na 44 ml/min v primerjavi s 129 ml/min pri bolnikih z normalno ledvično funkcijo.
PHARMACEUTICAL FORM Film-coated tablets.
FARMACEVTSKA OBLIKA Filmsko obložene tablete Bele okrogle bikonveksne tablete
• Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements
To lahko preprečite tako, da: • vzamete tableto kmalu po tem, ko zjutraj vstanete, preden zaužijete prvo hrano, pijačo,
Authorisation Holder.
priporočljivo spremljati.
Bioavailability was reduced by approximately 75% when Iasibon tablets were administered 2 hours after a standard meal.
Ko so tablete Iasibon jemali 2 uri po standardnem obroku, je bila biološka uporabnost zmanjšana za približno 75 %.
The safety and efficacy of Iasibon in children and adolescents below the age of 18 years have not been established.
Varnost in učinkovitost zdravila Iasibon pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
If you have a raised calcium level in your blood due to a tumour, then the recommended dose is a single administration of 2 mg or 4 mg, depending on the severity of your illness.
Če imate zvišano koncentracijo kalcija v krvi zaradi tumorja, je priporočeni odmerek 2 mg ali 4 mg v enkratnem odmerku, odvisno od resnosti bolezni.
Up to now there is no experience of acute poisoning with Iasibon concentrate for solution for infusion.
Ni poročil o primerih akutnega prevelikega odmerjanja z zdravilom Iasibon koncentratom za raztopino za infundiranje.
Posology Prevention of skeletal events in patients with breast cancer and bone metastases
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh
To convert the albumin-corrected serum calcium in mmol/l value to mg/dl, multiply by 4.
Če želimo korigirani kalcij v serumu, izražen v mmol/l, pretvoriti v mg/dl, vrednost pomnožimo s 4.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Pharmathen S.A.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom Pharmathen S.A.
• Treatment of tumour-induced hypercalcaemia - added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over 2 hours
• zdravljenje tumorsko povzročene hiperkalciemije - dodamo k 500 ml izotonične raztopine natrijevega klorida ali k 500 ml 5-% raztopine dekstroze in infundiramo 2 uri.
Hypersensitivity bronchospasm†, angioedema†
Bolezni imunskega sistema preobčutljivost bronhospazem angioedem†
If you have a raised calcium level in your blood due to a tumour then the recommended dose is a single administration of 1 ampoule (2 mg) or 2 ampoules (4 mg), depending on the severity of your illness.
Če imate zaradi tumorja povečano koncentracijo kalcija v krvi, je priporočeni odmerek enkratna uporaba 1 ampula (2 mg) ali 2 ampul (4 mg), odvisno od stopnje resnosti vaše bolezni.
Sodium chloride, glacial acetic acid, sodium acetate trihydrate and water for injections.
Natrijev klorid, koncentrirana ocetna kislina, natrijev acetat trihidrat in voda za injekcije.
The pain reduction was consistently below baseline throughout the entire study and accompanied by a significantly reduced use of analgesics compared to placebo.
Zmanjšanje bolečin je bilo skozi vso raziskavo pod vrednostjo pred začetkom zdravljenja v primerjavi s placebom, signifikantno pa je bila zmanjšana tudi uporaba analgezije.
Clinical studies in the prevention of skeletal events in patients with breast cancer and bone metastases Clinical studies in patients with breast cancer and bone metastases have shown that there is a dose dependent inhibitory effect on bone osteolysis, expressed by markers of bone resorption, and a dose dependent effect on skeletal events.
Klinične študije pri bolnikih z rakom dojke in metastazami v kosteh so pokazale, da je zaviralni učinek na osteolizo kosti odvisen od odmerka, ki se izraža z označevalci resorpcije kosti ter da so dogodki,
The deterioration in Quality of Life and WHO performance status was significantly less in Ibandronate treated patients compared with placebo.
Poslabšanje kakovosti življenja in status učinka po klasifikaciji Svetovne zdravstvene organizacije (SZO) sta bila pri bolnikih, zdravljenih z ibandronsko kislino, v primerjavi s placebom značilno manjša.
• swollen legs or feet
• otekanje nog in stopal,
Patients with disturbances of bone and mineral metabolism Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Iasibon therapy.
Pred začetkom zdravljenja metastatične bolezni kosti z zdravilom Iasibon je potrebno učinkovito zdraviti hipokalciemijo in druge motnje kosti in presnove mineralov.