natgillin/translations-raw huggingface dataset:
Subjects with severe renal impairment (CLcr  30 mL/min) receiving oral administration of 10 mg ibandronic acid daily for 21 days, had 2-3 fold higher plasma concentrations than subjects with normal renal function (CLcr ≥80 mL/min).
Bolniki s hudo motnjo ledvičnega delovanja (CLcr ≤ 30 ml/min), ki so peroralno prejemali 10 mg ibandronske kisline na dan 21 dni, so imeli 2 do 3-krat višje plazemske koncentracije kot osebe z normalno ledvično funkcijo (CLcr ≥ 80 ml/min).
Salutas Pharma GmbH Dieselstrasse 5, 70839 Gerlingen Germany
Salutas Pharma GmbH Dieselstrasse 5, 70839 Gerlingen Nemčija
These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture.
Ti zlomi se pojavijo po majhni travmi ali brez nje in pri nekaterih bolnikih se pojavi bolečina stegna ali dimelj, pogosto povezana z lastnosti slikanja stresnih zlomov,
Ibandronic acid Sandoz tablets contain lactose and should not be administered to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Tablete Ibandronska kislina Sandoz vsebujejo laktozo, zato jih ne smemo dajati bolnikom z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze in galaktoze.
Elderly No dose adjustment is necessary (see section 5.2).
Starejši bolniki Prilagajanje odmerkov ni potrebno (glejte poglavje 5.2).
• severe stomach pain.
• huda bolečina v želodcu.
Urinary concentrations of the bone resorption marker CTx (Cterminal telopeptide released from Type I collagen) were significantly reduced in the ibandronic acid group compared to placebo.
Koncentracije označevalca resorpcije kosti CTx (C-terminalni telopeptid, ki se sprosti s kolagena tipa I) v seču so bile v skupini zdravljeni z ibandronsko kislino v primerjavi s placebom značilno znižane.
Also some other medicines can affect the way Ibandronic acid Sandoz works.
Prav tako lahko druga zdravila vplivajo na delovanje zdravila Ibandronska kislina Sandoz.
Very rare (may affect up to 1 in 10,000 people)
Zelo redki (pojavijo se lahko pri do 1 od 10.000 bolnikov)
Ibandronic acid Sandoz is indicated in adults for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Zdravilo Ibandronska kislina Sandoz je indicirano za preprečevanje z okostjem povezanih dogodkov (patološke frakture, zapleti, pri katerih je potrebno obsevanje ali kirurški poseg) pri odraslih bolnikih z rakom dojke in metastazami v kosteh.
• pain or sore in your mouth or jaw.
• bolečina ali razjeda v ustih ali čeljusti.
Table 3 Secondary Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Sekundarni rezultati učinkovitosti (bolniki z rakom dojke z metastatično boleznijo kosti).
Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Ibandronic acid Sandoz is given to patients with active upper gastrointestinal problems (e.g. known Barrett's oesophagus, dysphagia, other oesophageal diseases, gastritis, duodenitis or ulcers).
Zaradi možnega draženja in poslabšanja osnovne bolezni, je pri dajanju zdravila Ibandronska kislina Sandoz bolnikom z aktivnimi težavami v zgornjem delu prebavne cevi (npr. Barrettov požiralnik, disfagija, druge bolezni ezofagusa, gastritis, duodenitis ali razjede) potrebna previdnost.
This is because aminoglycosides and Ibandronic acid Sandoz can both lower the amount of calcium in your blood.
To je zato, ker lahko oboji, aminoglikozidi in zdravilo Ibandronska kislina Sandoz znižajo raven kalcija v krvi.
What Ibandronic acid Sandoz is and what it is used for
Kaj je zdravilo Ibandronska kislina Sandoz in za kaj ga uporabljamo
Posology The recommended dose is one 50 mg film-coated tablet daily.
Odmerjanje Priporočeni odmerek je ena 50 mg filmsko obložena tableta na dan.
Patients with known hypersensitivity to other bisphosphonates Caution is to be taken in patients with known hypersensitivity to other bisphosphonates.
Bolniki z znano preobčutljivostjo za druge difosfonate Pri bolnikih z znano preobčutljivostjo za druge difosfonate je potrebna previdnost.
During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Med zdravljenjem z difosfonati je treba bolnikom svetovati, da poročajo o vseh bolečinah v stegnih, kolkih ali dimljah, in pri vseh bolnikih, ki imajo te simptome, oceniti nepopolni zlom stegnenice.
Blood parathyroid hormone increased
Preiskave povečanje paratiroidnega hormona v krvi
Table 2 Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Rezultati učinkovitosti (bolniki z rakom dojke z metastatično boleznijo kosti).
If you have been told by your doctor that you cannot tolerate or digest some sugars (e.g. if you have a galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose absorption), talk to your doctor before taking this medicine.
Zdravilo Ibandronska kislina Sandoz vsebuje laktozo Če vam je zdravnik povedal, da nekaterih vrst sladkorja ne morete prenašati ali prebavljati (npr. če imate intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali težave z absorpcijo glukoze/galaktoze), se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Ibandronic acid Sandoz administration.
Invazivne zobozdravstvene posege se lahko med zdravljenjem opravi le po temeljitem razmisleku, zlasti se jim je treba izogibati v času blizu termina prejema zdravila Ibandronska kislina Sandoz.
There are no adequate data from the use of ibandronic acid in pregnant women.
Podatki o uporabi ibandronske kisline pri nosečnicah so nezadostni.
What you need to know before you take Ibandronic acid Sandoz
Kaj morate vedeti, preden boste vzeli zdravilo Ibandronska kislina Sandoz
The management plan of the patients who develop ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ.
Za bolnike, pri katerih se razvije osteonekroza čeljusti (ONJ), morata načrt zdravljenja v tesnem sodelovanju pripraviti lečeči zdravnik in zobozdravnik oziroma oralni kirurg, ki ima izkušnje z zdravljenjem osteonekroze čeljusti (ONJ).
The deterioration in Quality of Life and WHO performance status was significantly less in ibandronic acid 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.
• Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes).
• Med jemanjem svoje tablete in naslednjo uro po tem (60 minut) morate ostati v pokončnem (stoječem ali sedečem) položaju.
In healthy male volunteers and postmenopausal women, intravenous ranitidine caused an increase in ibandronic acid bioavailability of about 20% (which is within the normal variability of the bioavailability of ibandronic acid), probably as a result of reduced gastric acidity.
Antagonisti H2 ali druga zdravila, ki povečajo želodčni pH Pri zdravih moških prostovoljcih in ženskah v postmenopavzi je intravenski ranitidin povečal biološko uporabnost ibandronske kisline za 20 % (kar je znotraj normalne variabilnosti biološke uporabnosti ibandronske kisline).
Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Ker acetilsalicilno kislino, nesteroidna protivnetna zdravila (NSAID) in difosfonate povezujejo z gastrointestinalnim draženjem, je pri sočasnem jemanju potrebna previdnost.
glycerol dibehenate, colloidal anhydrous silica.
gliceroldibehenat, brezvodni koloidni silicijev dioksid.
The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, and ocular inflammation (see paragraph “Description of selected adverse reactions” and section 4.4).Treatment was most frequently associated with a decrease in serum calcium to below normal range (hypocalcaemia), followed by dyspepsia.
Najresnejši poročani neželeni učinki so anafilaktična reakcija/šok, atipični zlomi stegnenice, osteonekroza čeljusti, draženje v prebavilih in vnetje oči (glejte odstavek »Opis izbranih neželenih učinkov« in poglavje 4.4).
You can drive and use machines as it's expected that Ibandronic acid Sandoz has no or negligible effect on your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Vozila in stroje smete upravljati, saj se pričakuje, da zdravilo Ibandronska kislina Sandoz nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in uporavljanja strojev.
Milk or antacids should be given to bind ibandronic acid.
Za vezavo ibandronske kisline je treba zaužiti mleko ali antacide.
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 priporočamo, da bolnik zaužije tablete po postu prek noči (post naj traja najmanj 6 ur), po zaužitem odmerku pa naj počaka še najmanj 30 minut pred pitjem ali hranjenjem (glejte poglavje 4.2).
Talk to your doctor first if you want to drive, use machine or tools.
Pred vožnjo in uporabo strojev ali orodja se posvetujte s svojim zdravnikom.
(duodenum) that is bleeding, or that your stomach is inflamed (gastritis)
(dvanajstniku) ali vnetja želodca (gastritis).
Ibandronic acid should not be used during lactation.
Ibandronske kisline se ne sme uporabljati med dojenjem.
Rare hereditary problems
Redke dedne bolezni
How to store Ibandronic acid Sandoz Contents of the pack and other information
Shranjevanje zdravila Ibandronska kislina Sandoz Vsebina pakiranja in dodatne informacije
Rare (may affect up to 1 in 1,000 people)
Redki (pojavijo se lahko pri 1 od 1.000 bolnikov)
All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Ibandronic acid Sandoz.
Vsem bolnikom je treba naročiti, naj med zdravljenjem z zdravilom Ibandronska kislina Sandoz skrbijo za dobro ustno higieno in redno opravljajo preglede pri zobozdravniku, v primeru simptomov v ustni votlini, kot so majavost zob, bolečina, oteklina, slabo celjenje ali izcedek iz ran, pa naj takoj obvestijo zdravnika.
Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
Pri bolnikih, ki imajo atipični zlom stegnenice, je treba premisliti o prekinitvi zdravljenja z difosfonati na podlagi individualne ocene koristi in tveganja.
Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture.
Zlomi so pogosto obojestranski; zato je treba pri bolnikih, ki se zdravijo s difosfonati, in imajo zlom srednjega dela stegnenic, pregledati tudi stegnenico na drugi nogi.
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 ibandronic acid.
Kljub temu je pri bolnikih, ki se zdravijo z ibandronsko kislino, priporočljivo, glede na klinično oceno posameznega bolnika, nadzirati njihovo ledvično funkcijo, kalcij v serumu ter fosfate in magnezij.
INFORMATION IN BRAILLE Ibandronic acid Sandoz 50 mg
PODATKI V BRAILLOVI PISAVI Ibandronska kislina Sandoz 50 mg
Hepatic impairment (see section 4.2)
Jetrna okvara (glejte poglavje 4.2)
Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis.
Pri zdravljenju z difosfonati so poročali o atipičnih subtrohanternih in diafizealnih stegneničnih zlomih, pretežno pri bolnikih, ki so se dolgo časa zdravili za osteoporozo.
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 potrebna previdnost (glejte poglavje 4.4).
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 kateri koli naslednji resni neželeni učinek, ki lahko zahteva nujno zdravstveno oskrbo, se takoj posvetujte z medicinsko sestro ali zdravnikom:
Chest pain, influenza-like illness, malaise, pain
Splošne težave in spremembe na mestu aplikacije astenija bolečina v prsih, gripi podobna bolezen, splošno slabo počutje, bolečina
No specific information is available on the treatment of overdosage with ibandronic acid.
Za ravnanje pri prevelikem odmerjanju z ibandronsko kislino ni posebnih priporočil.
Your doctor may ask you to undergo a dental examination before starting treatment with Ibandronic acid Sandoz.
Zdravnik vam bo morda svetoval, da pred začetkom zdravljenja z zdravilom Ibandronska kislina Sandoz opravite zobozdravstveni pregled.
Ibandronic acid Sandoz 50 mg film-coated tablets ibandronic acid
Ibandronska kislina Sandoz 50 mg filmsko obložene tablete ibandronska kislina
In particular, tell your doctor or pharmacist if you are taking any of the following medicines: supplements containing calcium, magnesium, iron or aluminium acetylsalicylic acid and non-steroidal anti-inflammatory medicines called “NSAIDs”, such as ibuprofen or naproxen.
Svojemu zdravniku ali farmacevtu povejte še zlasti, če jemljete katero od naslednjih zdravil: • dodatke, ki vsebujejo kalcij, magnezij, železo ali aluminij,
Atypical fractures of the femur
Atipični zlomi stegnenice
• severe adverse skin reactions
• hudi neželeni učinki na koži.
- Water is the only drink that should be taken with Ibandronic acid Sandoz.
Voda je edina tekočina, ki jo lahko bolnik zaužije z zdravilom Ibandronska kislina Sandoz.
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, morajo bolniki prejeti dodatke kalcija, vitamina D ali oboje.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo Ibandronska kislina Sandoz Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
However, no dosage adjustment is required when ibandronic acid is administered with H2-antagonists or medicinal products that increase gastric pH.
Pri sočasnem jemanju ibandronske kisline s H2-antagonisti ali zdravili, ki zvečajo pH želodca, pa prilagajanje odmerkov ni potrebno.
• if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are listed in section 6
Preobčutljivost na ibandronsko kislino ali katero koli pomožno snov, navedeno v poglavju 6.1.
Patients with disturbances of bone and mineral metabolism Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Ibandronic acid Sandoz therapy.
Pred začetkom zdravljenja z zdravilom Ibandronska kislina Sandoz je hipokalciemijo in druge motnje kosti in presnove mineralov treba učinkovito zdraviti.
NAME OF THE MEDICINAL PRODUCT Ibandronic acid Sandoz 50 mg film-coated tablets
IME ZDRAVILA Ibandronska kislina Sandoz 50 mg filmsko obložene tablete
The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth.
Pri bolnikih z nezaceljenimi odprtimi lezijami mehkih tkiv v ustih je treba odložiti začetek zdravljenja ali začetek novega cikla zdravljenja.
Haemorrhage, duodenal ulcer, gastritis, dysphagia, dry mouth
Bolezni prebavil ezofagitis, bolečina v trebuhu, dispepsija, navzea krvavitev, razjeda na dvanajstniku, gastritis, disfagija, suha usta
Ibandronic acid Sandoz contains the active substance ibandronic acid.
Zdravilo Ibandronska kislina Sandoz vsebuje zdravilno učinkovino ibandronska kislina.
• if you cannot stand or sit upright for at least one hour (60 minutes) at a time
Nezmožnost stanja ali pokončnega sedenja vsaj 60 minut.
What Ibandronic acid Sandoz contains - The active substance is ibandronic acid.
Kaj vsebuje zdravilo Ibandronska kislina Sandoz - Zdravilna učinkovina je ibandronska kislina.
Cellulose, microcrystalline Crospovidone Maize starch pregelatinised Glycerol dibehenate Silica, anhydrous colloidal
Jedro tablete: povidon mikrokristalna celuloza krospovidon koruzni škrob, predgelirani gliceroldibehenat brezvodni koloidni silicijev dioksid
Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving ibandronic acid for oncology indications (see section 4.8).
Pri bolnikih, ki so prejemali ibandronsko kislino za indikacije v onkologiji, so v obdobju po prihodu zdravila na trg zelo redko poročali o osteonekrozi čeljusti (ONJ) (glejte poglavje 4.8).
Uncommon (may affect less than 1 in 100 people):
Občasni (pojavijo se lahko pri manj kot 1 od 100 bolnikov)
Primary Efficacy Endpoints
Primarni cilj raziskave učinkovitosti
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of ibandronic acid (as ibandronate sodium monohydrate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 50 mg ibandronske kisline (v obliki natrijevega ibandronata monohidrata).
A statistically significant improvement in bone pain score was shown for ibandronic acid 50 mg compared to placebo.
V primerjavi s placebom se je pri ibandronski kislini v odmerku 50 mg pokazalo statistično značilno izboljšanje rezultata pri bolečinah v kosteh.
Each film-coated tablet contains 50 mg of ibandronic acid (as ibandronate sodium monohydrate).
Vsaka filmsko obložena tableta vsebuje 50 mg ibandronske kisline (v obliki natrijevega ibandronata monohidrata).
Bioavailability was reduced by approximately 75% when ibandronic acid tablets were administered 2 hours after a standard meal.
Ko so tablete ibandronske kisline dali 2 uri po standardnem obroku, se je biološka uporabnost zmanjšala za 75 %.
Acetylsalicylic acid and NSAIDs
Acetilsalicilna kislina in nesteroidna protivnetna zdravila (NSAID)
What Ibandronic acid Sandoz looks like and contents of the pack The film-coated tablets are white, round biconvex tablets supplied in Polyamide/Al/PVC - Aluminum foil blister.
Izgled zdravila Ibandronska kislina Sandoz in vsebina pakiranja Filmsko obložene tablete so bele, okrogle, bikonveksne tablete, na voljo v pretisnih omotih (poliamid/Al/PVC - aluminijasta folija), v pakiranjih po 3, 6, 9, 28 in 84 tablet.
Paraesthesia, dysgeusia (taste perversion)
Bolezni živčevja parestezija, disgevzija (spremembe okušanja)
Keep taking Ibandronic acid Sandoz for as long as your doctor tells you.
Če ste prenehali jemati zdravilo Ibandronska kislina Sandoz Zdravilo Ibandronska kislina Sandoz uporabljajte tako dolgo, kot vam naroči zdravnik.
A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Ibandronic acid Sandoz in patients with concomitant risk factors.
Pri bolnikih s spremljajočimi dejavniki tveganja je pred začetkom zdravljenja z zdravilom Ibandronska kislina Sandoz priporočljivo opraviti zobozdravniški pregled z ustreznimi preventivnimi zobozdravstvenimi ukrepi in oceniti razmerje med koristmi in tveganji pri vsakem posameznem bolniku.
How to take Ibandronic acid Sandoz
Kako jemati zdravilo Ibandronska kislina Sandoz
Do not take your tablet with any drink other than water
Tablete ne jemljite z nobenimi drugimi pijačami kot z vodo.
• if you have or ever had low calcium in your blood.
• nizka raven kalcija v krvi;
No dosage adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Ledvična okvara Pri bolnikih z blago ledvično okvaro (CLcr ≥ 50 in < 80 ml/min) prilagajanje odmerka ni potrebno.
Azotaemia (uraemia)
Bolezni sečil azotaemija (uremija)
The secretory pathway of renal elimination does not appear to include known acidic or basic transport systems involved in the excretion of other active substances In addition, ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and does not induce the hepatic cytochrome P450 system in rats.
Poleg tega ibandronska kislina pri ljudeh ne zavira glavnih jetrnih izoencimov P450, pri podganah pa ne spodbuja jetrnega sistema citokroma P450.
Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid.
Pri bolnikih, zdravljenih z intravensko ibandronsko kislino, so poročali o primerih anafilaktične reakcije/šoka, vključno s smrtnimi primeri.
• if you have any swallowing or digestion problems
• če imate težave s požiranjem ali prebavo,
Your doctor may do regular blood tests while you are taking Ibandronic acid Sandoz.
Morda bo zdravnik pri vas med jemanjem zdravila Ibandronska kislina Sandoz izvajal redne preglede krvi.
Each film-coated tablet contains 0.86 mg lactose (as lactose monohydrate).
Pomožne snovi z znanim učinkom: ena filmsko obložena tableta vsebuje 0,86 mg laktoze (v obliki laktoze monohidrata).
There are no pharmacokinetic data for ibandronic acid in patients who have hepatic impairment.
Pri bolnikih z jetrno okvaro za ibandronsko kislino ni farmakokinetičnih podatkov.
Table 1 Adverse Drug Reactions Reported for Oral Administration of Ibandronic acid System Organ
Neželeni učinki zdravila, o katerih so poročali pri peroralnem dajanju ibandronske kisline
Medicinal products and supplements (including calcium) should similarly be avoided prior to taking Ibandronic acid Sandoz tablets.
Pred jemanjem zdravila Ibandronska kislina Sandoz tablete se je prav tako treba izogibati jemanjem drugih zdravil in dodatkov (vključno s kalcijem).
Ocular inflammation events such as uveitis, episcleritis and scleritis have been reported with ibandronic acid.
Z uporabo ibandronske kisline so poročali o primerih vnetja oči kot so uveitis, episkleritis in skleritis.
Musculoskeletal and connective tissue disorders
Bolezni mišičnoskeletnega sistema in vezivnega tkiva atipični subtrohanterni in diafizealni stegneničnih zlomi†
How to store Ibandronic acid Sandoz
Shranjevanje zdravila Ibandronska kislina Sandoz
A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving ibandronic acid for cancer-related conditions.
Pri bolnikih, ki so prejemali obandronsko kislino za zdravljenje bolezenskih stanj, povezanih z rakom, so v obdobju po prihodu zdravila na trg zelo redko poročali o neželenem učinku, imenovanem osteonekroza čeljusti (ONJ) (poškodba kosti v čeljusti).
Class
Spol
Common (may affect up to 1 in 10 people): • feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/ food pipe)
• slabost s siljenjem na bruhanje, zgaga in neprijeten občutek pri požiranju (vnetje požiralnika/grla).
- Patients should not lie down for 60 minutes after taking Ibandronic acid Sandoz.
Po zaužitju zdravila Ibandronska kislina Sandoz bolniki 60 minut ne smejo leči.