natgillin/translations-raw huggingface dataset:
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 preprečevanja z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh 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.
Primary Efficacy Endpoints The primary endpoint of the trial was the skeletal morbidity period rate (SMPR).
Primarni cilj raziskave učinkovitosti Primarni cilj raziskave je bil stopnja hitrosti obolevnosti okostja (SMPR – skeletal morbidity period rate).
- radiotherapy to bone for treatment of fractures/ impending fractures
- zdravljenje kosti z obsevanjem zaradi fraktur/ pretečih fraktur,
- surgery to bone for treatment of fractures
- operacija kosti za zdravljenje fraktur,
- vertebral fractures
- vertebralne frakture,
- non-vertebral fractures.
- nevertebralne frakture.
Data from this study demonstrated a significant advantage for intravenous Bondronat 6 mg over placebo in the reduction in SREs measured by the time-adjusted SMPR (p=0.004).
Podatki raziskave so pokazali signifikantno prednost zdravila Bondronat 6 mg, danega intravensko, pred placebom v zmanjšanju SRE, ki so jih merili s SMPR (p = 0, 004).
The number of SREs was also significantly reduced with Bondronat 6 mg and there was a 40% reduction in the risk of a SRE over placebo (relative risk 0.6, p = 0.003).
Pri bolnikih, zdravljenih z zdravilom Bondronat 6 mg, je bilo število SRE značilno zmanjšano, tveganje za nastanek SRE pa 40% manjše (relativno tveganje 0, 6, p = 0, 003) v primerjavi s placebom.
Efficacy results are summarised in Table 3.
Rezultati učinkovitosti so povzeti v preglednici 3.
9 Table 3
9 Preglednica 3.
Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Rezultati učinkovitosti (bolniki z rakom dojke in metastatično boleznijo kosti).
All Skeletal Related Events (SREs) Placebo Bondronat 6 mg p-value n=158 n=154
Vsi z okostjem povezani dogodki (SREs) Placebo Bondronat 6 mg p- vrednost n = 158 n = 154
Secondary Efficacy Endpoints A statistically significant improvement in bone pain score was shown for intravenous Bondronat 6 mg compared to placebo.
Sekundarni cilj raziskave učinkovitosti V primerjavi s placebom se je pri zdravilu Bondronat 6 mg, danim intravensko, pokazalo statistično značilno izboljšanje rezultata pri bolečini v kosteh.
A tabular summary of these secondary efficacy results is presented in Table 4.
Preglednica 4 nudi tabelaričen pregled sekundarnih rezultatov učinkovitosti.
Secondary Efficacy
Sekundarni rezultati učinkovitosti (bolniki z rakom metastatično boleznijo kosti).
Results (Breast
dojke in
cancer Patients with Metastatic Bone Disease)
Placebo Bondronat 6 mg n = 158 n = 154
Placebo n=158
p- vrednost
Bondronat 6 mg p-value n=154
bolečina v kosteh *
Bone pain *
0, 21
0.21
– 0, 28
-45.4
– 45, 4
-10.3
– 10, 3
The overall adverse event profile of ibandronic acid following the 15 minute infusion was consistent with the known safety profile over longer infusion times and no new safety concerns were identified relating to the use of a 15 minute infusion time.
V povezavi s 15 minutno infuzijo niso ugotovili novih varnostnih pomislekov.
A 15 minute infusion time has not been studied in cancer patients with a creatinine clearance of < 50ml/ min.
15 minutne infuzije pri bolnikih z rakom, ki imajo očistek kreatinina < 50 ml/ min, niso proučevali.
Distribution After initial systemic exposure, ibandronic acid rapidly binds to bone or is excreted into urine.
Porazdelitev Po prvotni sistemski izpostavljenosti se ibandronska kislina hitro veže v kostno tkivo ali pa se izloči prek ledvic.
Protein binding in human plasma is
Pri ljudeh znaša navidezni terminalni volumen porazdelitve najmanj 90 l, količina odmerka, ki doseže kosti, je ocenjena na 40 do 50% odmerka, ki je v krvnem obtoku.
10 approximately 87% at therapeutic concentrations, and thus drug-drug interaction due to displacement is unlikely.
Vezava na 10 plazemske beljakovine pri ljudeh je pri terapevtskih koncentracijah približno 87 -%, zato so medsebojna delovanja med zdravili zaradi izpodrivanja malo verjetna.
Metabolism There is no evidence that ibandronic acid is metabolized in animals or humans.
Presnova Ni dokazov, da bi se ibandronska kislina pri ljudeh in živalih presnavljala.
Elimination The range of observed apparent half-lives is broad and dependent on dose and assay sensitivity, but the apparent terminal half-life is generally in the range of 10-60 hours.
Navidezni terminalni razpolovni čas je v splošnem v razponu od 10 do 60 ur.
However, early plasma levels fall quickly, reaching 10% of peak values within 3 and 8 hours after intravenous or oral administration respectively.
Zgodnje plazemske koncentracije hitro padejo, 10% največje vrednosti dosežejo 3 ure po intravenskem in 8 ur po peroralnem dajanju.
Total clearance of ibandronic acid is low with average values in the range 84-160 ml/ min.
Skupni očistek ibandronske kisline je nizek, povprečna vrednost znaša od 84 do 160 ml/ min.
Renal clearance (about 60 ml/ min in healthy postmenopausal females) accounts for 50-60% of total clearance and is related to creatinine clearance.
Ledvični očistek (okoli 60 ml/ min pri zdravih ženskah v postmenopavzi) znaša okoli 50 do 60% celotnega očistka in je soroden kreatininskemu očistku.
Pharmacokinetics in Special Populations
Farmakokinetika pri posebnih skupinah
Race There is no evidence for clinically relevant interethnic differences between Asians and Caucasians in ibandronic acid disposition.
Rasa Za klinično pomembne medetnične razlike v biološki uporabnosti ibandronske kisline med Azijci in Kavkazijci ni dokazov.
Patients with renal impairment Exposure to ibandronic acid in patients with various degrees of renal impairment is related to creatinine clearance (CLcr).
Bolniki z ledvično okvaro Izpostavljenost ibandronski kislini pri bolnikih z različnimi stopnjami ledvične okvare je povezana s kreatininskim očistkom (CLcr).
In clinical pharmacology trial WP18551, after a single dose intravenous administration of 6 mg (15 minutes infusion), mean AUC0-24 increased by 14% and 86%, respectively, in subjects with mild (mean estimated CLcr=68.1 mL/ min) and moderate (mean estimated CLcr=41.2 mL/ min) renal impairment compared to healthy volunteers (mean estimated CLcr=120 mL/ min).
V kliničnem farmakološkem preskušanju WP18551 se je po enkratnem 6- mg odmerku, danem intravensko (15 minutna infuzija), povprečna vrednost AUC0- 24 pri ljudeh z blago ledvično okvaro (ocenjeno povprečje CLcr = 68, 1 ml/ min) povečala za 14%, pri ljudeh z zmerno ledvično okvaro (ocenjeno povprečje CLcr = 41, 2 ml/ min) pa za 86% v primerjavi z zdravimi prostovoljci (ocenjeno povprečje CLcr = 120 ml/ min).
Mean Cmax was not increased in patients with mild renal impairment and increased by 12% in patients with moderate renal impairment.
Povprečna Cmax se pri bolnikih z blago ledvično okvaro ni povečala, pri bolnikih z zmerno ledvično okvaro pa se je povečala za 12%.
There is no evidence of a reduction in tolerability associated with an increase in exposure.
Dokazov o zmanjšanem prenašanju zdravila zaradi povečane izpostavljenosti ni.
However, an adjustment in the dose or infusion time is recommended in patients being treated for the prevention of skeletal events in patients with breast cancer and bone metastases (see section 4.2).
Kljub temu se priporoča prilagajanje odmerka ali časa infuzije pri bolnikih z rakom dojke in metastazami v kosteh, ki se zdravijo zaradi preprečevanja z okostjem povezanih dogodkov (glejte poglavje 4. 2).
Further, as protein binding of ibandronic acid is approximately 87% at therapeutic concentrations, hypoproteinaemia in severe liver disease is unlikely to lead to clinically significant increases in free plasma concentration.
Vezava ibandronske kisline na beljakovine pri terapevtskih koncentracijah je približno 87 -%, zato hipoproteinemija pri bolnikih s hudo jetrno okvaro verjetno ne povzroča klinično značilnih povišanj prostih plazemskih koncentracij.
Elderly In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Starejši bolniki Večvariantna analiza je pokazala, da starost med vsemi preizkušanimi farmakokinetičnimi parametri ni neodvisen dejavnik.
Children and adolescents There are no data on the use of Bondronat in patients less than 18 years old.
Otroci in mladostniki O uporabi zdravila Bondronat pri bolnikih, mlajših od 18 let, ni zadostnih podatkov.
11 Effects in non-clinical studies were observed only at exposures sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
11 Predklinične učinke so opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
As with other bisphosphonates, the kidney was identified to be the primary target organ of systemic toxicity.
Kot pri drugih bisfosfonatih so bile ledvice primarni tarčni organ sistemske toksičnosti.
No indication of carcinogenic potential was observed.
Mutagenost in kancerogeni potencial Kancerogenega potenciala niso opazili.
No evidence of direct foetal toxicity or teratogenic effects were observed for ibandronic acid in intravenously treated rats and rabbits.
Vplivi na sposobnost za razmnoževanje Po intravenskem zdravljenju z ibandronsko kislino pri podganah in kuncih niso opazili neposrednih škodljivih vplivov na plod ali teratogenih učinkov.
Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those expected for this class of drug (bisphosphonates).
Neželeni učinki ibandronske kisline v študijah vplivov na sposobnost za razmnoževanje pri podganah so bili pričakovano značilni za to vrsto zdravil (bisfosfonati).
Sodium chloride Acetic acid (99%) Sodium acetate Water for injections
Natrijev klorid Ocetna kislina (99%) Natrijev acetat Voda za injekcije
To avoid potential incompatibilities Bondronat concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% glucose solution.
Da bi se izognili možnim inkompatibilnostim, lahko koncentrat za raztopino za infundiranje Bondronat razredčimo le z izotonično raztopino natrijevega klorida ali 5 -% raztopino glukoze.
5 years After reconstitution:
5 let Po rekonstituciji:
24 hours.
24 ur.
No special precautions for storage prior to reconstitution.
Za shranjevanje pred rekonstitucijo niso potrebna posebna navodila.
Store at 2 °C – 8 °C (in a refrigerator).
Po rekonstituciji: shranjujte pri temperaturi med 2 °C in 8 °C (v hladilniku).
From a microbiological point of view, the product should be used immediately.
Če se zdravila ne uporabi takoj, je za trajanje in razmere shranjevanja pred uporabo odgovoren uporabnik.
Bondronat is supplied as packs containing 1 vial (2 ml type I glass vial).
Zdravilo Bondronat je na voljo v škatlah, v katerih je 1 viala (2 ml viala iz stekla tipa I).
Date of first Authorisation:
Datum prve pridobitve dovoljenja za promet:
25 June 1996
25. junij 1996
25 June 2006
25 junij 2006
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /..
Bondronat 50 mg Film Coated Tablets
Bondronat 50 mg filmsko obložene tablete
Each film-coated tablet contains 50 mg of ibandronic acid (as ibandronic sodium monohydrate).
Ena filmsko obložena tableta vsebuje 50 mg ibandronske kisline (v obliki natrijevega ibandronat monohidrata).
White to off-white film-coated tablets, of oblong shape engraved “ L2” on one side and “ IT” on the other side.
Filmsko obložene tablete Bele do sivo bele filmsko obložene tablete, podolgovate oblike z vgravirano oznako “ L2 ” na eni strani in “ IT ” na drugi strani.
Bondronat is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Bondronat je indiciran 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.
Plain water may be taken at any time during the course of Bondronat treatment.
Navadno (nemineralno) pitno vodo lahko med zdravljenjem z zdravilom Bondronat pijemo kadarkoli.
- The tablets should be swallowed whole with a full glass of plain water (180 to 240 ml) while the
- Tablete je treba pogoltniti cele s polnim kozarcem navadne pitne vode (180 do 240 ml), bolnik
patient is standing or sitting in an upright position.
mora pri tem stati ali sedeti pokončno.
- Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration.
- Bolniki tablet ne smejo žvečiti ali sesati, ker se lahko pojavi ulceracija žrela.
Please note that some mineral
- Navadna pitna voda (nemineralna) je edina tekočina, ki jo lahko bolnik zaužije z zdravilom
waters may have a higher concentration of calcium and therefore should not be used.
Prosimo, upoštevajte, da lahko nekatere mineralne vode vsebujejo višje koncentracije kalcija in jih zato ne smemo uporabljati.
Patients with hepatic impairment No dosage adjustment is required (see section 5.2).
14 Bolniki z jetrno okvaro Prilagajanje odmerkov ni potrebno (glejte poglavje 5. 2).
14 No dosage adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal to or greater than 30 ml/ min.
Bolniki z ledvično okvaro Pri bolnikih z blago do zmerno ledvično okvaro, ki imajo očistek kreatinina enak ali večji od 30 ml/ min, prilagajanje odmerkov ni potrebno.
Below 30 ml/ min creatinine clearance, the recommended dose is 50 mg once weekly.
Pri kreatininskem očistku, manjšem od 30 ml/ min, je priporočeni odmerek 50 mg enkrat na teden.
Elderly No dose adjustment is necessary.
Starejši bolniki Prilagajanje odmerkov ni potrebno.
Children and adolescents Bondronat is not recommended for patients below age 18 years due to insufficient data on safety and efficacy.
Otroci in mladostniki Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila Bondronat pri otrocih pod 18 let ni priporočljiva.
Hypersensitivity to ibandronic acid or to any of the excipients.
Preobčutljivost za ibandronsko kislino ali katerokoli pomožno snov.
Caution is indicated in patients with known hypersensitivity to other bisphosphonates.
Pri bolnikih z znano preobčutljivostjo za druge bisfosfonate je potrebna previdnost.
Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Bondronat therapy.
Pred začetkom zdravljenja z zdravilom Bondronat je hipokalciemijo in druge motnje kosti in presnove mineralov treba učinkovito zdraviti.
Patients should receive supplemental calcium and/ or vitamin D if dietary intake is inadequate.
Če je vnos s hrano nezadosten, morajo bolniki prejeti dodatke kalcija, vitamina D ali oboje.
Oral bisphosphonates have been associated with dysphagia, oesophagitis and oesophageal or gastric ulcers.
Peroralne bisfosfonate so povezovali z disfagijo, ezofagitisom, ulceroznim ezofagitisom in želodčno razjedo.
Therefore, patients should pay particular attention to the dosing instructions (see section 4.2).
Bolniki morajo posebej skrbno prebrati navodila za odmerjanje (glejte poglavje 4. 2).
Physicians should be alert to signs or symptoms signalling a possible oesophageal reaction during therapy, and patients should be instructed to discontinue Bondronat and seek medical attention if they develop symptoms of oesophageal irritation such as new or worsening dysphagia, pain on swallowing, retrosternal pain, or heartburn.
Če se pri bolnikih med zdravljenjem z zdravilom Bondronat pojavijo simptomi ezofagalnega vnetja, kot je pojav ali poslabšanje disfagije, bolečina pri požiranju, retrosternalna bolečina ali zgaga, morajo zdravljenje z zdravilom Bondronat prekiniti in takoj poiskati zdravniško pomoč.
Since NSAIDS are associated with gastrointestinal irritation, caution should be taken during concomitant oral medication with Bondronat.
Ker nesteroidna protivnetna zdravila (NSAID) povezujejo z gastrointestinalnim draženjem, je pri sočasnem peroralnem jemanju zdravil z zdravilom Bondronat potrebna previdnost.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e. g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
15 Pri bolnikih s sočasnimi dejavniki tveganja (npr. rak, kemoterapija, radioterapija, kortikosteroidi, slaba ustna higiena) je treba pred začetkom zdravljenja z bisfosfonati razmisliti o pregledu zobovja in primernih preventivnih zobozdravstvenih posegih.
15 While on treatment, these patients should avoid invasive dental procedures if possible.
Med zdravljenjem naj se ti bolniki, če je le mogoče, izogibajo invazivnim zobozdravstvenim posegom.
Drug-Food Interactions Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of Bondronat tablets.
Interakcije s hrano Pripravki, ki vsebujejo kalcij in druge večvalentne katione (kot so aluminij, magnezij, železo), vključno z mlekom in hrano, lahko vplivajo na absorpcijo tablet Bondronat.
Bioavailability was reduced by approximately 75% when Bondronat tablets were administered 2 hours after a standard meal.
Ko so tablete Bondronat jemali 2 uri po standardnem obroku, je bila biološka uporabnost zmanjšana za približno 75%.
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).
Drug-Drug Interactions When co-administered with melphalan/ prednisolone in patients with multiple myeloma, no interaction was observed.
Medsebojno delovanje z drugimi zdravili Pri sočasnem jemanju z melfalanom in prednizolonom pri bolnikih z multiplim mielomom medsebojnega delovanja niso opazili.
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.
To je verjetno posledica zmanjšane kislosti želodca.
However, no dosage adjustment is required when Bondronat is administered with H2-antagonists or other drugs that increase gastric pH.
Pri sočasnem jemanju zdravila Bondronat s H2- antagonisti ali drugimi zdravili, ki zvečajo pH želodca, pa prilagajanje odmerkov ni potrebno.
In relation to disposition, no drug interactions of clinical significance are likely.
Glede na razpoložljive podatke klinično pomembna medsebojna delovanja niso verjetna.
The secretory pathway does not appear to include known acidic or basic transport systems involved in the excretion of other active substances.
Zdi se, da poti izločanja ne vključujejo znanih kislinskih ali bazičnih transportnih sistemov, ki sodelujejo pri izločanju drugih zdravilnih učinkovin.
16 It is not known whether ibandronic acid is excreted in human milk.
16 Zato se zdravila Bondronat med nosečnostjo ne sme uporabljati.
The safety profile of Bondronat is derived from controlled clinical trials in the approved indication and after the oral administration of Bondronat at the recommended dose.
Podatki o varnostnem profilu zdravila Bondronat izhajajo iz kontroliranih kliničnih preskušanj pri odobreni indikaciji in po peroralnem jemanju zdravila Bondronat v priporočenem odmerku.
In the pooled database from the 2 pivotal phase III trials (286 patients treated with Bondronat 50 mg), the proportion of patients who experienced an adverse reaction with a possible or probable relationship to Bondronat was 27%.
Združeni podatki dveh ključnih preskušanj faze III (z zdravilom Bondronat 50 mg so zdravili 286 bolnikov) kažejo, da je delež bolnikov, pri katerih se je pojavil neželeni učinek z možno ali verjetno povezavo z zdravilom Bondronat, znašal 27%.
Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥ 10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and < 0.1%), very rare (≤ 0.01%).
Neželeni učinki so razvrščeni v poglavja glede na pogostnost, in sicer od najbolj do najmanj pogostih: zelo pogosti (≥ 10%), pogosti (≥ 1% in < 10%), občasni (≥ 0, 1% in < 1%), redki (≥ 0, 01% in < 0, 1%) in zelo redki (≤ 0, 01%).
Table 1 lists common adverse reactions from the pooled phase III trials.
V preglednici 1 so navedeni združeni pogosti neželeni učinki, ki smo jih zbrali v preskušanjih faze III.
Adverse reactions that are equally frequent in both active and placebo or more frequent in placebo-treated patients are excluded.
Neželeni učinki, ki so enako pogosti pri učinkovini in pri placebu ali pa so pogostejši pri bolnikih, zdravljenih s placebom, v preglednico niso vključeni.
Adverse ReactionsReported Commonly and Greater than Placebo
Neželeni učinki, ki so se pojavili pogosteje in so bili močnejši kot pri placebu.
Placebo
Placebo Bondronat 50 mg per os na dan per os na dan (n = 277 bolnikov), (n = 286 bolnikov), število (%) število (%)
Bondronat 50 mg
Presnovne in prehranske motnje:
p. o. daily
hipokalciemija
p. o. daily
14 (5, 1)
(%)
27 (9, 4)
(n=286 patients) No.
Bolezni prebavil:
Hypocalcaemia Gastrointestinal Disorders
dispepsija navzeja abdominalna bolečina ezofagitis
Dyspepsia Nausea Abdominal Pain Oesophagitis General Disorders
13 (4, 7) 4 (1, 4) 2 (0, 7) 2 (0, 7)
13 (4.7) 4 (1.4) 2 (0.7) 2 (0.7)
20 (7, 0) 10 (3, 5) 6 (2, 1) 6 (2, 1)
20 (7.0) 10 (3.5) 6 (2.1) 6 (2.1)
Splošne težave:
Adverse drug reactions occurring at a frequency < 1%:
Neželeni učinki, ki so se pojavili v pogostnosti manj kot 1%:
The following list provides information on adverse drug reactions reported in study MF 4414 and MF 4434 occurring more frequently with Bondronat 50 mg than with placebo:
Spodaj navedene neželene učinke, ki so se pojavili pogosteje pri jemanju zdravila Bondronat 50 mg kot placeba, so opazili v študijah MF 4414 in MF 4434.
Uncommon:
Bolezni prebavil:
anaemia paraesthesia, dysgeusia (taste perversion) haemorrage, duodenal ulcer, gastritis, dysphagia, abdominal pain, dry mouth
anemija parestezija, dizgevzija (motnje čuta za okus) krvavitev, razjeda na dvanajstniku, gastritis, disfagija bolečina v trebuhu, suha usta
Skin and Subcutaneous Tissue Disorders Renal and Urinary Disorders General Disorders:
Bolezni kože in podkožja:
Investigations
Bolezni sečil:
pruritus azotaemia (uraemia) chest pain, influenza-like illness, malaise, pain Blood parathyroid hormone increased
pruritus azotemija (uremija)
17 Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
17 Splošne težave:
The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis.
bolečina v prsih, gripi podobna bolezen, občutek slabosti, bolečina
Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis).
Večina primerov je bila pri bolnikih z rakom, vendar tudi pri bolnikih, ki so se zdravili zaradi osteoporoze.
Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Zaradi možnosti vzdraženja požiralnika bruhanja ne smemo izzvati, bolnik pa mora ostati v povsem pokončnem položaju.