FrancophonIA/ELRC3.0 huggingface dataset:
English: Median time to relapse (re-increase of albumin-corrected serum calcium 2.9 mmol/l) was 30 to 40 days for patients treated with zoledronic acid versus 17 days for those treated with pamidronate 90 mg (p-values: 0.001 for 4 mg and 0.007 for 8 mg zoledronic acid).
Slovenian: Mediana časa do ponovnega pojava bolezni (ponovno zvišanje za albumin korigiranega serumskega kalcija ≥ 2,9 mmol/l) je bila pri bolnikih, zdravljenih z zoledronsko kislino, 30 do 40 dni, pri tistih, ki so bili zdravljeni s pamidronatom 90 mg, pa 17 dni (vrednosti p: 0,001 za 4 mg in 0,007 za 8 mg zoledronske kisline).
English: * Includes vertebral and non-vertebral fractures ** Accounts for all skeletal events, the total number as well as time to each event during the trial NR Not Reached
Slovenian: * zajema vertebralne in nevertebralne zlome ** velja za vse skeletne dogodke, tako za njihovo celotno število kot za trajanje vsakega dogodka med preskušanjem
English: The most frequent finding in the repeat-dose studies consisted of increased primary spongiosa in the metaphyses of long bones in growing animals at nearly all doses, a finding that reflected the compound's pharmacological antiresorptive activity.
Slovenian: Najpogostejša ugotovitev v študijah večkratnih odmerkov je bilo zvečanje primarne spongiozne kostne substance v metafizah dolgih kosti pri rastočih živalih pri skoraj vseh odmerkih; ta ugotovitev odseva farmakološki antiresorpcijski učinek zdravila.
English: - After opening the bag, the product should be used immediately in order to avoid microbial contamination.
Slovenian: - Ko steklenico odprete, morate zdravilo porabiti takoj, da bi preprečili onesnaženje z mikroorganizmi.
English: Your doctor, nurse or pharmacist knows how to store Zoledronic Acid Hospira properly (see section
Slovenian: Vaš zdravnik, medicinska sestra ali farmacevt vedo, kako je treba zdravilo Zoledronska kislina Hospira pravilno shranjevati (glejte poglavje 6).
English: • Monitoring of serum creatinine should be considered in at-risk patients.
Slovenian: • Pri bolnikih s povečanim tveganjem je treba razmisliti o spremljanju koncentracije kreatinina v serumu.
English: In patients with Paget's disease, symptoms due to low blood calcium, such as muscle spasms, or numbness, or a tingling sensation especially in the area around the mouth have been reported.
Slovenian: Pri bolnikih s Pagetovo boleznijo so zaradi nizke koncentracije kalcija v krvi poročali o simptomih, kot so mišični krči, odrevenelost ali občutek zbadanja, posebno v predelu okrog ust.
English: Clinical experience with acute overdose of zoledronic acid is limited.
Slovenian: Klinične izkušnje z akutnim prevelikim odmerjanjem zoledronske kisline so omejene.
English: Very common (may affect more than 1 in 10 people): − Low level of phosphate in the blood.
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov): − nizka koncentracija fosfata v krvi.
English: - Do not use this medicine after the expiry date which is stated on the carton.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: What Zoledronic Acid Hospira looks like and contents of the pack Zoledronic Acid Hospira is supplied as a liquid concentrate (referred to as a ‘concentrate for solution for infusion' or ‘sterile concentrate') in a vial.
Slovenian: Izgled zdravila Zoledronska kislina in vsebina pakiranja Zdravilo Zoledronska kislina Hospira je tekoči koncentrat (imenovan "koncentrat za raztopino za infundiranje" ali "sterilni koncentrat") v viali.
English: - Pregnancy and breast-feeding (see section 4.6).
Slovenian: - Nosečnost in dojenje (glejte poglavje 4.6).
English: Small observed increases in AUC(0-24hr), by about 30% to 40% in mild to moderate renal impairment, compared to a patient with normal renal function, and lack of accumulation of medicinal product with multiple doses irrespective of renal function, suggest that dose adjustments of zoledronic acid in mild (Clcr = 50-80 ml/min) and moderate renal impairment down to a creatinine clearance of 35 ml/min are not necessary.
Slovenian: Majhno zvečanje AUC(0-24hr) za okrog 30 do 40 %, ki so ga opazili pri bolnikih z blago do zmerno ledvično okvaro v primerjavi z bolniki z normalnim ledvičnim delovanjem, in odsotnost kopičenja zdravila ob večkratnih odmerkih, ne glede na ledvično delovanje, kažeta, da prilagajanje odmerka zoledronske kisline pri blagi (Clcr = 50 do 80 ml/min) in zmerni ledvični okvari z znižanim očistkom kreatinina do 35 ml/min ni potrebno.
English: The recommended dose is a single intravenous infusion of 5 mg zoledronic acid.
Slovenian: Priporočeni odmerek je ena intravenska infuzija s 5 mg zoledronske kisline.
English: Bone biopsy results showed bone of normal quality with no evidence of impaired bone remodelling and no evidence of mineralisation defects.
Slovenian: Rezultati biopsije kosti so pokazali, da je kost normalne kvalitete brez znakov okvare remodeliranja ali motenj mineralizacije.
English: • To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
Slovenian: • preprečevanje zapletov na kosteh, na primer zlomov, pri odraslih bolnikih z metastazami v kosteh (z razširitvijo raka s prvotnega mesta na kosti).
English: It belongs to a group of medicines called bisphosphonates and is used to treat Paget's disease of the bone in adults.
Slovenian: Pripada skupini zdravil, ki se imenujejo difosfonati in jih uporabljamo za zdravljenje bolnikov s Pagetovo boleznijo kosti.
English: In the trial for the prevention of clinical fractures following a recent hip fracture, vitamin D levels were not routinely measured but the majority of patients received a loading dose of vitamin D prior to zoledronic acid administration (see section 4.2).
Slovenian: V preskušanju za preprečevanje kliničnih zlomov po nedavnem zlomu kolka niso rutinsko merili ravni vitamina D, vendar je večina bolnikov pred dajanjem zoledronske kisline prejela začetni odmerek vitamina D (glejte poglavje 4.2).
English: The first randomised, double-blind, placebo-controlled study compared zoledronic acid 4 mg to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Slovenian: V prvi randomizirani, dvojno slepi študiji, nadzorovani s placebom, so primerjali zoledronsko kislino 4 mg s placebom za preprečevanje z okostjem povezanih dogodkov (SREs - skeletal related events) pri bolnikih z rakom prostate.
English: − if you have or have had a kidney problem.
Slovenian: − če imate ali ste v preteklosti imeli težave z ledvicami.
English: - Zoledronic Acid Hospira is ready for use.
Slovenian: - Zdravilo Zoledronska kislina Hospira je že pripravljeno za uporabo.
English: Very common (may affect more than 1 in 10 people):− Low level of phosphate in the blood.
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov): nizka koncentracija fosfata v krvi.
English: In clinical trials in osteoporosis, the change in creatinine clearance (measured annually prior to dosing) and the incidence of renal failure and impairment was comparable for both the zoledronic acid and placebo treatment groups over three years.
Slovenian: V kliničnih preskušanjih pri osteoporozi sta bili v treh letih sprememba očistka kreatinina (ki so jo merili enkrat letno pred odmerjanjem) in incidenca odpovedi ter okvare ledvic primerljivi med skupinama z zoledronsko kislino in s placebom.
English: Zoledronic acid was teratogenic in the rat at subcutaneous doses 0.2 mg/kg.
Slovenian: Zoledronska kislina je bila teratogena pri podganah pri subkutanih odmerkih ≥ 0,2 mg/kg.
English: 100 ml polypropylene bags with a polypropylene twist-off port fitted with a cap, with a polyester/polypropylene overwrap
Slovenian: 100 ml polipropilenske vreče s polipropilenskim odtržnim vhodom, na katerem je pokrov, z zunanjo ovojnino iz poliestra/polipropilena
English: Median time to onset of the first SRE was not reached in the zoledronic acid -treated arm at the end of the study and was significantly prolonged compared to placebo (p=0.007).
Slovenian: V skupini, zdravljeni z zoledronsko kislino, mediana časa do pojava prvega SRE ob koncu študije še ni bila dosežena, bila je močno podaljšana v primerjavi s placebom (p = 0,007).
English: Aseptic techniques must be followed during preparation of the infusion.
Slovenian: Med pripravo infuzije je treba uporabljati aseptične tehnike.
English: Your doctor, pharmacist or nurse knows how to store Zoledronic Acid Hospira properly.
Slovenian: Vaš zdravnik, farmacevt in medicinska sestra vedo, kako je treba zdravilo Zoledronska kislina Hospira pravilno shranjevati.
English: - 4.4 ml for 3.5 mg dose - 4.1 ml for 3.3 mg dose - 3.8 ml for 3.0 mg dose
Slovenian: - 4,4 ml za odmerek 3,5 mg - 4,1 ml za odmerek 3,3 mg - 3,8 ml za odmerek 3,0 mg
English: Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less than 2.10 mmol/l) occurred in 2.3% of zoledronic acid-treated patients in a large clinical trial compared to 21% of zoledronic acid-treated patients in the Paget's disease trials.
Slovenian: Na podlagi laboratorijskih preiskav so ugotovili, da je do prehodnega asimptomatskega znižanja koncentracij kalcija pod okvir normalnih referenčnih vrednosti (pod 2,10 mmol/l) prišlo pri 2,3 % bolnikov, ki so prejemali zoledronsko kislino v obsežnem kliničnem preskušanju, v primerjavi z 21 % pri bolnikih, ki so prejemali zoledronsko kislino v preskušanjih zdravljenja Pagetove bolezni.
English: In a second study including solid tumours other than breast or prostate cancer, zoledronic acid 4 mg significantly reduced the proportion of patients with an SRE, delayed the median time to first SRE by > 2 months, and reduced the skeletal morbidity rate.
Slovenian: V drugi raziskavi, v katero so bili vključeni čvrsti tumorji, razen raka dojke in prostate, je zoledronska kislina 4 mg pomembno zmanjšala delež bolnikov, ki so doživeli SRE, podaljšala mediano časa do prvega SRE za > 2 meseca in zmanjšala stopnjo obolevnosti skeleta.
English: Pam 90 mg zoledronic acid
Slovenian: Pam 90 mg zoledronska kislina
English: Solution for infusion 1 intravenous bag
Slovenian: raztopina za infundiranje 1 intravenska vreča
English: − Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
Slovenian: − osteonekrozo so zelo redko opažali tudi na drugih kosteh in ne le na čeljustnici, še posebej na kolku in stegnu.
English: In patients who show evidence of renal deterioration during treatment, zoledronic acid should be withheld.
Slovenian: Bolnikom, pri katerih se med zdravljenjem pokažejo znaki poslabšanja ledvične funkcije, je treba zoledronsko kislino ukiniti.
English: Zoledronic Acid Hospira works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.
Slovenian: Zdravilo Zoledronska kislina Hospira deluje tako, da normalizira proces kostne premene, omogoči tvorbo normalne kostnine in tako kostem povrne čvrstost.
English: In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Slovenian: V kliničnih študijah so nadaljevali z zdravljenjem z zoledronsko kislino šele, ko se je koncentracija kreatinina vrnila na raven, ne za več kot 10% višjo od izhodiščne vrednosti (glejte poglavje 4.4).
English: - Anti-angiogenic medicines (used to treat cancer), since the combination of these with Zoledronic Acid Hospira has been associated with an increased risk of osteonecrosis of the jaw (ONJ).
Slovenian: − antiangiogena zdravila (uporabljamo jih pri zdravljenju raka), ker kombinacijo le-teh z zdravilom Zoledronska kislina Hospira povezujejo s povečanim tveganjem za osteonekrozo čeljustnic.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij referenčnega zdravila, ki vsebuje zoledronsko kislino za vse podskupine pediatrične populacije glede zdravljenja tumorsko povzročene hiperkalciemije in preprečevanja z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: What you need to know before you are given Zoledronic Acid Hospira
Slovenian: Kaj morate vedeti, preden vam bodo dali zdravilo Zoledronska kislina Hospira
English: It comes in 100 ml plastic bags as a readyto-use solution for infusion.
Slovenian: Na voljo je v 100 ml plastičnih vrečah kot raztopina za infundiranje, pripravljena za uporabo.
English: p-value Skeletal morbidity rate p-value Risk reduction of suffering from multiple events** (%)
Slovenian: vrednost p 0,009 stopnja obolevnosti skeleta vrednost p 0,005 zmanjšanje tveganja za pojav večkratnih dogodkov** (%)
English: Like all medicines, Zoledronic Acid Hospira can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Zoledronska kislina Hospira neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: - Severe renal impairment with creatinine clearance < 35 ml/min (see section 4.4).
Slovenian: - Huda okvara ledvic z očistkom kreatinina < 35 ml/min (glejte poglavje 4.4).
English: - For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 µmol/l), an increase of 0.5 mg/dl or 44 µmol/l;
Slovenian: - pri bolnikih z normalnim izhodiščnim serumskim kreatininom (< 1,4 mg/dl ali < 124 μmol/l), zvišanje za 0,5 mg/dl ali 44 μmol/l;
English: Zoledronic acid is contraindicated in patients with creatinine clearance < 35 ml/min (see sections 4.3 and 4.4).
Slovenian: Zoledronska kislina je kontraindicirana pri bolnikih z očistkom kreatinina < 35 ml/min (glejte poglavji 4.3 in 4.4).
English: - For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 µmol/l), an increase of 1.0 mg/dl or 88 µmol/l.
Slovenian: - pri bolnikih s patološkim izhodiščnim kreatininom (> 1,4 mg/dl ali > 124 μmol/l), zvišanje za 1,0 mg/dl ali 88 μmol/l.
English: Single and multiple 5 and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients yielded the following pharmacokinetic data, which were found to be dose independent.
Slovenian: Enkratne in večkratne 5-minutne in 15-minutne infuzije po 2, 4, 8 in 16 mg zoledronske kisline so pri 64 bolnikih dale naslednje farmakokinetične podatke, za katere so ugotovili, da so neodvisni od odmerka.
English: 6 ml, type I clear glass vial or 5 ml plastic vial, stoppered with a fluoropolymer-coated halo-butyl closure and sealed with an aluminium seal and flip-off top.
Slovenian: 6 ml, prozorna steklena viala iz stekla tipa I ali 5 ml plastična viala z zamaškom iz halobutila, prevlečenim s fluoropolimerom, zatesnjena z aluminijastim tesnilom in snemno zaporko.
English: In a pooled analysis of safety data from trials for the use of zoledronic acid for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
Slovenian: V združeni analizi podatkov o varnosti zdravila iz preskušanj zoledronske kisline pri preprečevanju z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajemajo kosti, so bile pogostnosti neželenih dogodkov, ki so vključevali okvaro ledvic in pri katerih je obstajal sum, da so povezani z zoledronsko kislino, (torej neželenih učinkov), naslednje: multipli mielom (3,2 %), rak prostate (3,1 %), rak dojke (4,3 %), tumor na pljučih in drugi čvrsti tumorji (3,2 %).
English: Acquired Fanconi syndrome General disorders and administration site conditions Common:
Slovenian: pridobljen Fanconijev sindrom Splošne težave in spremembe na mestu aplikacije Pogosti:
English: What Zoledronic Acid Hospira looks like and contents of the pack Zoledronic Acid Hospira is a clear and colourless solution.
Slovenian: Izgled zdravila Zoledronska kislina in vsebina pakiranja Zdravilo Zoledronska kislina Hospira je bistra in brezbarvna raztopina.
English: To assess the effects of 4 mg zoledronic acid versus pamidronate 90 mg, the results of two pivotal multicentre studies in patients with TIH were combined in a pre-planned analysis.
Slovenian: Za oceno učinkov 4 mg zoledronske kisline v primerjavi s pamidronatom 90 mg so v vnaprej načrtovani analizi združili rezultate dveh ključnih multicentričnih raziskav pri bolnikih s tumorsko povzročeno hiperkalciemijo (TIH).
English: While being treated with Zoledronic Acid Hospira, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Slovenian: V času zdravljenja z zdravilom Zoledronska kislina Hospira morate skrbeti za dobro ustno higieno (kar vključuje redno čiščenje zob) in redno hoditi na rutinske preglede k zobozdravniku.
English: Temporary interruption of zoledronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Slovenian: Razmisliti je treba o začasni prekinitvi zdravljenja z zoledronsko kislino, dokler se stanje ne razreši in dokler se ne zmanjša vpliv prispevajočih dejavnikov tveganja, če je to mogoče doseči.
English: - Carefully follow all the other instructions given to you by your doctor, nurse or pharmacist.
Slovenian: - Skrbno se ravnajte tudi po vseh drugih navodilih, ki jih dobite od svojega zdravnika, medicinske sestre ali farmacevta.
English: The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with zoledronic acid 4 mg every 3-4 weeks in oncology patients.
Slovenian: Neravnovesja, ki so ga opazili v tem preskušanju, niso opažali v drugih preskušanjih z zoledronsko kislino, vključno s preskušanji z zoledronsko kislino v odmerku 4 mg vsake 3-4 tedne pri onkoloških bolnikih.
English: Other medicines and Zoledronic Acid Hospira Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Zoledronska kislina Hospira Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
English: *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr=75 ml/min).
Slovenian: *Odmerke so izračunali tako, da so predpostavili ciljno vrednost AUC 0,66 (mg•hr/l) (CLcr=75 ml/min).
English: It is not known whether zoledronic acid is excreted into human milk.
Slovenian: Ni znano, ali se zoledronska kislina izloča v materino mleko pri ljudeh.
English: In the event of overdose leading to clinically significant hypocalcaemia, reversal may be achieved with supplemental oral calcium and/or an intravenous infusion of calcium gluconate.
Slovenian: Klinično pomembno hipokalciemijo, ki je posledica prevelikega odmerka, lahko odpravimo z dodatkom peroralnega kalcija in/ali intravensko infuzijo kalcijevega glukonata.
English: Day 10
Slovenian: 10. dan
English: Other disturbances of mineral metabolism must also be effectively treated (e.g. diminished parathyroid reserve, intestinal calcium malabsorption).
Slovenian: Učinkovito je treba zdraviti tudi druge motnje presnove elektrolitov (kot sta zmanjšano delovanje ostanka obščitnice in okvarjena absorpcija kalcija v črevesju).
English: Population analysis showed that for a patient with creatinine clearance of 20 ml/min (severe renal impairment), or 50 ml/min (moderate impairment), the corresponding predicted clearance of zoledronic acid would be 37% or 72%, respectively, of that of a patient showing creatinine clearance of 84 ml/min.
Slovenian: Analize na populaciji so pokazale, da bi bil pri bolniku z očistkom kreatinina 20 ml/min (huda ledvična okvara) ali 50 ml/min (zmerna okvara) ustrezni napovedani očistek zoledronske kisline 37 % oziroma 72 % tistega pri bolniku, ki bi imel očistek kreatinina 84 ml/min.
English: The administration of doses up to 48 mg of zoledronic acid in error has been reported.
Slovenian: Poročali so o dajanju odmerkov zoledronske kisline do 48 mg po pomoti.
English: finding studies in patients with mild to moderate tumour-induced hypercalcaemia (TIH), effective doses tested were in the range of approximately 1.2-2.5 mg.
Slovenian: V študijah faze I za ugotavljanje odmerka pri bolnikih z blago do zmerno hiperkalciemijo, povzročeno s tumorjem (TIH), so bili testirani učinkoviti odmerki v razponu približno 1,2-2,5 mg.
English: Instructions for preparing reduced doses of Zoledronic Acid Hospira
Slovenian: Navodila za pripravo zmanjšanih odmerkov zdravila Zoledronska kislina Hospira
English: Zoledronic acid is not systemically metabolised and does not affect human cytochrome P450 enzymes in vitro (see section 5.2).
Slovenian: Zoledronska kislina se sistemsko ne presnavlja ter in vitro ne vpliva na encime citokroma P450 pri človeku (glejte poglavje 5.2).
English: Increases in serum creatinine also occur in some patients with chronic administration of zoledronic acid at recommended doses for prevention of skeletal related events, although less frequently.
Slovenian: Čeprav redkeje, se zvišanje serumskega kreatinina pojavlja tudi pri nekaterih bolnikih, ki kronično prejemajo zoledronsko kislino v priporočenih odmerkih za preprečevanje z okostjem povezanih dogodkov.
English: The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06-0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Slovenian: Varno območje, glede na učinke na ledvice, je bilo v dolgoročnih študijah večkratnih parenteralnih odmerkov na živalih ozko, vendar kumulativne koncentracije brez neželenih učinkov (NOAEL) pri enkratnih odmerkih (1,6 mg/kg) in pri do en mesec trajajočih študijah večkratnih odmerkov (0,060,6 mg/kg/dan) niso kazale učinkov na ledvice v odmerkih, ki so bili enakovredni največjemu nameravanemu človeškemu terapevtskemu odmerku ali ki so le-tega presegali.
English: The safety and efficacy of zoledronic acid in children and adolescents below 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zoledronske kisline pri otrocih in mladostnikih do 18 let nista bili dokazani.
English: 3 PHARMACEUTICAL FORM
Slovenian: FARMACEVTSKA OBLIKA
English: Other products containing zoledronic acid as active substance are available for oncology indications.
Slovenian: Obstajajo druga zdravila, ki vsebujejo učinkovino zoledronska kislina in se uporabljajo za onkološke indikacije.
English: For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Slovenian: Pri bolnikih, pri katerih se med difosfonatnim zdravljenjem razvije osteonekroza čeljustnic, lahko stomatološka operacija stanje poslabša.
English: Not known (frequency cannot be estimated from the available data) Severe allergic reactions including dizziness and difficulty breathing, swelling mainly of the face and throat, decreased blood pressure, dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea.
Slovenian: Pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov) hude alergijske reakcije, vključno z omotičnostjo in oteženim dihanjem, otekanje predvsem v obraz in grlo oziroma žrelo, znižan krvni tlak, dehidracija zaradi simptomov po odmerjanju, kot so zvišana telesna temperatura, bruhanje in driska.