natgillin/translations-raw huggingface dataset:
Published studies suggest noninferiority of pantoprazole compared to other PPIs (Study VMG305 and M3 
Objavljene študije nakazujejo, da pantoprazol ni dosegal slabših rezultatov od drugih zaviralcev protonske črpalke (študiji VGM305 in M3
The most frequent adverse events (≥5%) included diarrhoea, headache, and nausea. 
Najpogosteje zabeležena neželena učinka sta driska in glavobol, oba se pojavita pri približno 1% bolnikov.
symptoms after 7 and 28 days of 
Olajšanje simptomov GERB po 7 in 28 dneh zdravljenja
Table 1 Overview of the design of the main studies Study Design 
DODATEK I POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Placebo 
Batch
It inhibits basal and stimulated acid secretion in animals and man via the covalent binding H+/K+ ATP-ase, also known as the “gastric proton pump” located in the secretory membrane of the parietal cell. 
Pantoprazol se pretvori v svojo aktivno obliko, ciklični sulfenamid, v kislem okolju parietalnih celic, kjer zavira H+,K+ ATPazni encim, to je končno stopnjo v tvorbi klorovodikove kisline v želodcu.
Comparator 
dimetikon
In these studies between 57 and 78% of patients reported relief from heartburn at day 7 and 73-83% at day 14. 
V teh študijah je v skupini s pantoprazolom delež bolnikov s popolnim izboljšanjem zgage po 7 dneh znašal med 54,0% in 80,6%.
1.2 Steps taken for the assessment of the product 
4.2 Odmerjanje in način uporabe
2.7 Data exclusivity 
6.2 Inkompatibilnosti
Endoscopic healing of GORD Stage I after 8 weeks of treatment 
Endoskopsko zdravljenje GERB stopnje I po 8 tednih zdravljenja
Tablets are packed in Alu/Alu blisters without cardboard reinforcement or Alu/Alu blisters with cardboard reinforcement (blister wallet). 
Zdravilo CONTROLOC Control se dobi v Alu/Alu pretisnih omotih s ali brez kartonske opore.
The application concerns the supply as non-prescription medicine. 
NAČIN IZDAJANJA ZDRAVILA Izdaja zdravila je brez recepta.
Number of patients with this adverse drug reaction 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Baseline data 
PODATKI V BRAILLOVI PISAVI
- Date of authorisation: - Marketing authorisation granted by: 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
Pantoprazole was superior to ranitidine 
Pantoprazol je dosegal boljše rezultate od ranitidina
Sample size 
Okvara ledvic
Overall, the low incidence rate of adverse events during the post-marketing period is reassuring. 
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
However, this is not considered representative for the general population. 
Možno tveganje za ljudi ni znano.
Table 5 Relief rate of acid eructation in study BGI022 
Farmakoterapevtska skupina: zaviralci protonske črpalke, oznaka ATC: A02BC02
Pan 20, Ran 150 bid weeks 
Pan 20, Ran 150 dvakrat dnevno tednov
The assay, identification and related substances are determined by an in-house HPLC method. 
Opozorila in druge pomožne snovi so navedene v navodilu za uporabo.
CONTROLOC Control is presented in form of gastro-resistant tablets containing pantoprazole as an active substance. 
Zdravilo CONTROLOC Control vsebuje zdravilno učinkovino pantoprazol, ki blokira »črpalko«, ki proizvaja želodčno kislino.
Results of 17 randomized controlled clinical studies (i.e. two pivotal and 15 supportive studies), in which pantoprazole 20mg was investigated with regard to relief of reflux symptoms as a primary or secondary endpoint, have been presented. 
V retrospektivni analizi 17 študij na 5960 bolnikih z gastroezofagealno refluksno boleznijo (GERB), ki so jih zdravili z monoterapijo 20 mg pantoprazola, so s standardizirano metodologijo ocenjevali simptome, povezane z refluksom kisline, npr. zgago in regurgitacijo kisline.
The results also show an early onset of the clinical effect, with rates of complete relief of heartburn between 54.0% and 80.6% achieved after 7 days of treatment with pantoprazole 20 mg. A further improvement in the symptom relief rates was observed after 14 days and 28 days of treatment, respectively. 
Po 7 dneh je delež bolnikov s popolnim izboljšanjem simptomov regurgitacije kisline znašal med 61,5% in 84,4%, po 14 dneh med 67,7% in 90,4% ter po 28 dneh med 75,2% in 94,5%.
Endoscopic healing of GORD Stage I after 4 weeks of treatment 
Endoskopsko zdravljenje GERB stopnje I po 4 tednih zdravljenja
• Adverse events 
• DRUGI POGOJI
Endoscopic healing of GORD Stage II/III 
Endoskopsko zdravljenje GERB stopnje I
Patients with conditions for whom a nonprescription use of pantoprazole would not be appropriate, like patients with current erosive lesions of the upper gastrointestinal tract (e.g. reflux esophagitis stage I-V, erosive gastritis, were excluded. 
Odmerka pantoprazola ni potrebno zmanjšati pri bolnikih z okvarjeno ledvično funkcijo (vključno z bolniki na dializi, ki odstrani samo zanemarljive količine pantoprazola).
1.1 Submission of the dossier 
6.1 Seznam pomožnih snovi
Appropriate compatibility studies of the active substance with different excipients have been performed. 
Medsebojnega delovanja z drugimi snovmi, ki se presnavljajo z istim encimskim sistemom, ni mogoče izključiti.
From the safety database all the adverse reactions reported in clinical trials and post-marketing have been included in the Summary of Product Characteristics. 
Neželeni učinki pantoprazola v kliničnih študijah in poročilih o post-marketinših izkušnjah Pogostnost Organski sistemi
Concomitant intake of food has no influence on the bioavailability of pantoprazole. 
Sočasen vnos hrane ni imel vpliva na biološko razpoložljivost (AUC ali Cmax), povečal pa je variabilnost v časovnem zamiku (tlag).
The success rate was similar in patients treated for more than 17 days and in patients treated between 11 and 17 days in the pantoprazole group, while the success rate was slightly lower with longer treatment in the ranitidine group. 
Bolniki utegnejo opaziti zmanjšanje simptomov po približno enem dnevu zdravljenja s pantoprazolom, včasih pa ga je potrebno jemati 7 dni za dosego popolnega nadzora nad zgago.
Endoscopic healing of GORD Stage I after 4 weeks 
Endoskopsko zdravljenje GERB stopnje I po 4 tednih
Since the elimination half-life in these patients is still shorter than the dosing interval of 24 hours, no accumulation of pantoprazole was observed following multiple dosing. 
Čeprav ima glavni presnovek daljši razpolovni čas (2-3 ure), je izločanje še vedno hitro in zato ne pride do akumulacije.
2.8 Overall conclusions, risk/benefit assessment and recommendation 
4.4 Posebna opozorila in previdnostni ukrepi
The claimed indication at time of application read as follows: “Treatment of reflux symptoms (e.g. heartburn, acid regurgitation)” 
Zdravilo CONTROLOC Control se uporablja za kratkotrajno zdravljenje znakov refluksa (na primer zgaga, regurgitacija kisline) pri odraslih.
As reflux symptoms are common and can affect the quality of life of the majority of sufferers a proton pump inhibitor is usually used as a first-line treatment. 
Zmanjšana kislost v želodcu iz kakršnegakoli razloga - vključno z zaviralci protonske črpalke - poveča število želodčnih bakterij, ki so običajno prisotne v prebavilih.
The effect increases with dose and over time and reaches steady state after a few days. 
Vzemite naslednji normalni odmerek naslednji dan ob običajnem času.
These included diarrhoea, abdominal pain, headache, nausea, chest pain and rash. 
Bolezni prebavil driska; slabost / bruhanje; napihovanje in napenjanje v trebuhu; zaprtje; suha usta; bolečine in neugodje v trebuhu
anaphylactic reaction and anaphylactic shock) Depression (and all aggravations) Urticaria Weight changes Arthralgia Myalgia Bilirubin increased Oedema peripheral Body temperature increased Angioedema Leukopenia very rare 
Splošne težave in spremembe na mestu aplikacije astenija, utrujenost in slabo počutje povišana telesna temperatura; periferni edem
No further information on the contraindicated symptoms or the consequences of the treatment is available. 
Raziskave niso odkrile zmanjšane plodnosti ali teratogenih učinkov.
Conditions with special interest (rhabdomyolysis, pancytopenia, respiratory tract infections, hip fracture, cardiovascular events, pancreatitis, and serious skin reactions) identified during the postmarketing period do not raise concerns. 
Kljub temu pa v ciljanih raziskavah z karbamazepinom, kofeinom, diazepamom, diklofenakom, digoksinom, etanolom, glibenklamidom, metropololom, naproksenom, nifedipinom, fenitoinom, piroksikamom, teofilinom in peroralnimi kontraceptivi, ki vsebujejo levonorgestrel in etinilestradiol, klinično zaznavnih interakcij niso ugotovili.
• User consultation 
NAVODILA ZA UPORABO
Balance 
Odmerjanje
The initial application was submitted by Nycomed GmbH (EMEA/H/C/1013). 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
These studies showed that pantoprazole 20mg was superior to placebo and histamine2-receptor antagonist in the complete relief from heartburn and was non-inferior to other proton pump inhibitors. 
Pantoprazol je dosledno dosegal boljše rezultate v primerjavi s placebom in antagonisti receptorjev H2 ter enakovredne rezultate glede na druge zaviralce protonske črpalke.
With regard to serious adverse events the most common were thrombocytopenia, angioedema, urticaria and hepatitis. 
- Resne alergijske reakcije (redke): preobčutljivostne reakcije, imenovane anafilaktične reakcije, anafilaktični šok in angioedem.
4 weeks Rather severe heartburn, acid regurgitation, pain on swallowing 
povišan bilirubin poškodba jeter; zlatenica; odpoved jeter
Non-prescription medicines for relief from heartburn include antacids, alginates, histamine2-receptor antagonist and proton pump inhibitors (PPIs). 
Ne jemljite zdravila CONTROLOC Control z ostalimi zdravili, ki zavirajo izločanje kisline v vašem želodcu, kot so drugi zaviralci protonske črpalke (omeprazol, lansoprazol ali rabeprazol) ali blokatorji H2 receptorjev (npr. ranitidin, famotidin).
Regurgitation is defined as the perception of flow of refluxed gastric content into the mouth or hypopharynx. 
Pojavnost teh neoplazem je združena s spremenjeno razgradnjo tiroksina v jetrih podgan, ki jo povzroča pantoprazol.
The pharmacokinetics is unaltered in patients with renal failure. 
DOVOLJENJA ZA PROMET Z ZDRAVILOM Izdaja zdravila je brez recepta v lekarnah.
formulations of pantoprazole have equipotent effect on intragastric pH. 
Pantoprazol se presnavlja v jetrih preko encimskega sistema citokrom P450.
The synthesis of the drug substance is performed without optically active reagents and results in a racemate. 
Zaviranje je odvisno od odmerka in deluje tako na osnovno kot tudi na izzvano izločanje kisline.
Na+ 
Zdravljenj e
Treatment with oral doses of pantoprazole once daily leads to a dose-related increase in the 24 h intragastric pH and in the concentration of serum gastrin. 
Mehanizem, ki privede do nastanka želodčnih karcinoidov s substituiranimi benzimidazoli so natančno preučili in zaključili, da gre za sekundarno reakcijo na močno povišan serumski gastrin, ki je posledica kroničnega zdravljenja z visokimi odmerki.
It usually occurs after large meals or after eating spicy foods, citrus products, fats, chocolates or drinking alcohol. 
To lahko vključuje: čokolado, poprovo meto, zeleno meto, mastno in ocvrto hrano, kislo hrano, začinjeno hrano, agrume, sadne sokove,
Pantozol 40 mg gastro-resistant tablets 
FARMACEVTSKA OBLIKA gastrorezistentna tableta
The active substance is chemically designated as sodium 5-(difluoromethoxy)-2-[(RS)-[(3,4-dimethoxypyridin- 2-yl)methyl] sulphinyl] benzimidazol-1-ide sesquihydrate (Chemical Name) and has the following structure: 
Obloga hipromeloza povidon K 25 titanov dioksid (E 171) rumeni železov oksid (E 172) propilenglikol kopolimer metakrilne kisline in etilakrilata 1:1 natrijev lavrilsulfat polisorbat 80 trietilcitrat
The majority of patients with reflux symptoms can be controlled at the self-care level or a primary care level. 
Bolniki z dolgoročnimi ponavljajočimi se simptomi prebavnih motenj ali zgage morajo redno obiskovati svojega zdravnika.
Patients in this study were at least 18 years old and had heartburn of at least moderate intensity for at least the previous 3 months. 
• So starejši od 55 let in so se jim pojavili novi simptomi ali pa so se ti nedavno spremenili.
1 FENDRICK AM et al., Self-Selection and Use Patterns of Over-the-Counter Omeprazole for Frequent Heartburn, Clinical Gastroenterology and Hepatology 2004;2:17-21 
Bolezni kože in podkožja izbruh izpuščaja/ eksantema; srbenje urtikarija; angioedem
Based on the review of data on quality, safety and efficacy the benefits of CONTROLOC Control outweigh the risks for the short-term treatment of reflux symptoms under the classification as medicinal product not subject to medical prescription. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
Gastro-oesophageal reflux disease (GORD) is defined as a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications. 
Refluks je vračanje kisline iz želodca v požiralnik (»prebavna cev«), ki lahko postane pekoče in boleče.
It has been proven that the drug substance can be reproducibly manufactured. 
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja.
The drug substance specification includes tests for identification (IR and sodium), appearance of solution, optical rotation, water content (Karl Fisher), heavy metals, related substances (HPLC), assay (titration), particle size (laser diffraction) and residual solvents (GC). 
Lahko pa jemljete zdravilo CONTROLOC Control z antacidi (npr. magaldrat, alginska kislina, natrijev hidrogenkarbonat, aluminijev hidroksid, magnezijev karbonat ali kombinacije naštetih), če je potrebno.
The manufacturing process has been applied unchanged over the recent years. 
V nekaj primerih je bil čas izločanja podaljšan.
Detailed description of the Pharmacovigilance system 
KAKO JEMATI ZDRAVILO CONTROLOC CONTROL
Furthermore bulk stability for the gastro-resistant tablets were submitted to guarantee stability prior to further processing. 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
Although spontaneous abortions and premature births did not occur with higher frequency, because animal studies have shown reproductive toxicity (signs of slight fetotoxicity were observed at doses above 5 mg/kg), patients are advised not to use pantoprazole during pregnancy. 
V 2 letnih raziskavah na glodalcih so pri podganah (samo v 1 študiji) in pri mišjih samicah opazili povečano število jetrnih tumorjev, ki naj bi nastali zaradi močno povečanega presnavljanja pantoprazola v jetrih.
The differences between pantoprazole and placebo in the relief from heartburn (table 2) were statistically significant at 1 and 2 weeks in both the intent-to-treat and per protocol populations (p<0.001, Fisher's Exact Test). 
Po uporabi pantoprazola pri bolnikih z okvarjenimi jetri (Child-Pugh razredi A, B in C) se razpolovni čas podaljša na 3 do 7 ur in vrednosti AUC narastejo s faktorjem 3-6, medtem ko poraste Cmax komaj opazno, s faktorjem 1,3 v primerjavi z zdravimi osebami.
The product specification is standard for tablets (modified release) and contains tests with suitable limits for appearance, mean mass, disintegration time, loss on drying, identification, dissolution (UV determination), content uniformity, assay (HPLC), purity - impurities and degradation products (HPLC), microbial limits. 
- Redki neželeni učinki: motnje vida kot je zamegljen vid, bolečine v sklepih, bolečine v mišicah, nihanje telesne mase, povišana telesna temperatura, otekanje okončin, alergijske reakcije, depresija, povečane vrednosti bilirubina in maščob v krvi (razvidno iz krvnih testov).
• Serious adverse event/deaths/other significant events 
• Imajo katerokoli drugo resno bolezen, ki vpliva na splošno dobro počutje.
Participant flow 
Okvara jeter
All analytical methods, except for particle size and residual solvents, are compendial and validation of these methods was not deemed necessary. 
V primeru prevelikega odmerjanja s kliničnimi znaki zastrupitve ni razen simptomatskega in podpornega zdravljenja nobenih posebnih priporočil za zdravljenje.
60.1% to 69.8% Placebo 
Po 14 in 28 dneh je popolno izboljšanje zgage navajalo 62,9% do 88,6% oz. 68,1% do 92,3% bolnikov.
The per-protocol set included all patients of the full analysis set except those who fulfilled at least one of the major protocol violations. 
Predlagateljeva utemeljitev je temeljila na 6 „neobjavljenih” študijah, med katerimi jih je 5 bilo objavljenih v celoti, ena pa le v obliki povzetka.
Serious adverse drug reactions have therefore been rare. 
- Zelo redki neželeni učinki:
Unlike other proton pump inhibitors, pantoprazole has linear pharmacokinetics in a dose range of 10 - 80mg. 
V razponu odmerkov od 10 do 80 mg je plazemska kinetika pantoprazola linearna, tako za peroralni kot tudi za intravenski vnos.
Since in patients with liver cirrhosis the elimination half-life, the AUC and the maximum serum concentration is increased compared to healthy subjects, patients with liver disease should not be supplied with non-prescription pantoprazole without consulting a doctor. 
Če je pri bolniku predvidena endoskopija ali dihalni test s sečnino, se mora pred jemanjem tega zdravila posvetovati s svojim zdravnikom.
Tablet cores are produced by wet granulation. 
SEZNAM POMOŽNIH SNOVI Vsebuje sojin lecitin.
It was noted by the CHMP that the maximum effect of proton pump inhibitors is experienced following a few days treatment, while antacids and histamine receptor antagonists exert their effect without delay. 
Zmanjšanje znakov kislega refluksa in zgage utegnete opaziti že po 1 dnevu zdravljenja z zdravilom CONTROLOC Control, vendar to zdravilo ni namenjeno takojšnjemu olajšanju.
During extensive post-marketing experience, no safety concerns have been identified. 
6.6 Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev.
Mild symptoms occurring 2 or more days per week or moderate to severe symptoms occurring more than 1 day per week are often considered troublesome for patients. 
Mogoče bo za dosego zmanjšanja simptomov potrebno jemati tablete 2-3 dni zaporedoma.
It should be noted that the following overview of marketing authorizations concerns the prescriptiononly medicine with the exception of the approval in Sweden where pack sizes with 7 and 14 tablets of the 20 mg gastro-resistant tablets are approved for non-prescription use since 24-Feb-2000. 
Alu/Alu pretisni omoti, ki vsebujejo 7 ali 14 gastrorezistentnih tablet ali Alu/Alu pretisni omoti s kartonsko oporo, ki vsebujejo 7 ali 14 gastrorezistentnih tablet.
Table 9 Overview of adverse drug reactions 
PODATKI NA VMESNI OVOJNINI KARTONSKA OPORA
The study was a double-blind comparison of pantoprazole 20 mg and ranitidine 300 mg once daily in patients with reflux-related symptoms (heartburn, acid regurgitation or pain on swallowing) of at least ‘rather severe' intensity on a 7-point Likert Scale. 
Dokazano je bilo, da sočasen vnos atazanavirja 300 mg/ritonavirja 100 mg z omeprazolom (40 mg enkrat na dan) ali atazanavirja 400 mg z lanzoprazolom (60 mg v enkratnem odmerku) pri zdravih prostovoljcih povzroči znatno zmanjšanje biološke razpoložljivosti atazanavirja.
No difference has been found in the in-vitro or in-vivo activity of the two enantiomers. 
Farmakokinetika po enkratnem ali večkratnem vnosu se ne razlikuje.
The results of clinical studies where symptomatic relief of GORD was investigated show that pantoprazole provides relief of heartburn and acid regurgitation during a short-term treatment course (2-4 weeks). 
Čeprav v kliničnih farmakokinetičnih raziskavah niso opazili nobenega medsebojnega delovanja pri sočasni uporabi fenprokumona ali varfarina, so v post-marketinškem obdobju zabeležili nekaj posameznih primerov spremenjenih vrednosti INR (International Normalised Ratio) ob sočasnem zdravljenju.
Patients with new symptoms will be referred to a doctor. 
Bolnikom je treba naročiti, da se posvetujejo z zdravnikom, če:
Follow-up 
Trajanje
2.3 Non-clinical aspects 
4.8 Neželeni učinki
62.9% to 83.0% H2RA (Ranitidine 300mg, Ranitidine 2x150 mg, Nizatidine 2x150 mg) 
V povprečju se približno 2,0 h - 2,5 h po vnosu (tmax) enkratnega peroralnega odmerka 20 mg doseže maksimalna serumska koncentracija (Cmax) približno 1-1,5 µg/ml, in te vrednosti po večkratnem vnosu ostanejo konstantne.
The printed tablets are put into the container closure systems. 
Tablete morate pogoltniti cele.
Day 7 PP (N=158) Day 14 PP (N=158) 
D-78467 Konstanz Nemčija tel. +49-(0)7531-84-0 fax: +49-(0)7531-84-2474
The secondary outcome was to assess the effects of pantoprazole and ranitidine in the following variables: - absence of heartburn during the 3 days prior to the second visit (after 28 days ±3 days of treatment) - safety and tolerability - influence of H.pylori status on efficacy - symptomatic improvement after 2 and 4 weeks of treatment, judged by a symptom score 
Bodite posebno pozorni pri zdravilu CONTROLOC Control Najprej se posvetujte s svojim zdravnikom, če: - ste se zaradi zgage ali prebavnih motenj neprekinjeno zdravili 4 tedne ali več - ste starejši od 55 let in zaradi prebavnih motenj dnevno jemljete zdravila brez recepta - ste starejši od 55 let in imate nove simptome ali pa so se ti nedavno spremenili - ste že imeli razjedo želodca ali operacijo želodca
Reflux of gastric acid into the oesophagus is mediated by different mechanisms such as transient lower oesophageal sphincter relaxations or reduced pressure, impaired oesophageal clearance and hiatus hernia. 
Ker se pantoprazol veže na encim distalno od celičnega receptorja, lahko zavira izločanje klorovodikove kisline neodvisno od stimulacije z drugimi snovmi (acetilholin, histamin, gastrin).
Active Substance 
peroralna uporaba
Since the manufacturing of the product is identical to the reference product, there is no requirement to specifically address the impurity profile of the new product from a nonclinical perspective. 
Ker so terapevtski odmerki pri človeku nizki, na ščitnici ni pričakovati neželenih učinkov.
The efficacy and safety of the 20 mg dose subject to medical prescription in the treatment of mild reflux disease and its symptoms is acknowledged. 
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba CONTROLOC Control 20 mg gastrorezistentnih tablet pri otrocih in mladostnikih pod 18 let ni priporočljiva.
In addition, the applicant proposed the classification for supply of CONTROLOC Control to “medicinal product not subject to medical prescription”. 
SHRANJEVANJE ZDRAVILA CONTROLOC CONTROL Zdravilo shranjujte nedosegljivo otrokom!
It is noted that specific aspects of the national implementation of a nonprescription status vary amongst Member States. 
Znaki prevelikega odmerjanja pri človeku niso znani.
Day 7 
Tabela 1.
All results are with specifications and show batch-to-batch and site-to-site consistency. 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Safety 
Nosečnost
The multiple level of significance was set to 5%, and an appropriate sample size was chosen to achieve a power of 90%. 
Porazdelitev Porazdelitveni volumen je približno 0,15 l/kg, vezava na serumske beljakovine pa je približno 98%.
Other GI symptoms (epigastric pain, retrosternal tightness, nausea, vomiting etc.) showed a considerable decrease. 
- Druge resne reakcije (pogostnost neznana): porumenitev kože in oči (zaradi resne okvare jeter), ali težave z ledvicami, kot so boleče uriniranje in bolečine v spodnjem delu hrbta z vročino.
Is freely soluble in water and in ethanol (96%), practically insoluble in hexane. 
Glavna pot izločanja njegovih presnovkov je preko ledvic (približno 80%), preostanek se izloča z blatom.
Licensing status: 
NAVODILO ZA UPORABO
Call your doctor immediately. 
Takoj pokličite zdravnika.
For safety reasons: 
Iz varnostnih razlogov:
Let your skin dry. 
Pustite, da se koža osuši.
Your injection could take about 10 seconds. 
Injiciranje lahko traja približno 10 sekund.