natgillin/translations-raw huggingface dataset:
Prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment: one 15 mg capsule every day, your doctor may adjust your dose to one 30 mg capsule every day. 
Preprečevanje razjede dvanajstnika ali želodca pri bolnikih, ki potrebujejo neprekinjeno zdravljenje z nesteroidnimi antirevmatiki: ena 15-miligramska kapsula vsak dan, zdravnik lahko odmerek spremeni v eno 30-miligramsko kapsulo vsak dan.
Agopton and associated names 15 mg capsules Agopton and associated names 30 mg capsules [See Annex 1- To be completed nationally] Lansoprazole 
Agopton in povezana imena 15 mg kapsule Agopton in povezana imena 30 mg kapsule [Glejte Dodatek I - Izpolni država članica.]
Reflux oesophagitis: 
Refluksni ezofagitis:
Agopton and associated names 15 mg oro-dispersible tablets Agopton and associated names 30 mg oro-dispersible tablets [See Annex 1- To be completed nationally] Lansoprazole 
Agopton in povezana imena 15 mg orodisperzibilne tablete Agopton in povezana imena 30 mg orodisperzibilne tablete [Glejte Dodatek I - Izpolni država članica.]
- Ask you pharmacist if you need more information or advice. 
- Če želite dodatne informacije ali nasvet, se posvetujte s farmacevtom.
treatment (NSAID treatment is used against pain or inflammation) - Treatment of Zollinger-Ellison syndrome. 
- zdravljenje ali preprečevanje razjede dvanajstnika ali želodca pri bolnikih, ki potrebujejo neprekinjeno zdravljenje z nesteroidnimi antirevmatiki (nesteroidni antirevmatiki se uporabljajo proti bolečinam ali vnetjem) - zdravljenje Zollinger-Ellisonovega sindroma
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains lansoprazole 30 mg 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka kapsula vsebuje 30 mg lansoprazola.
• Prophylaxis of NSAID-associated gastric ulcers, duodenal ulcers, gastroduodenal erosions, and prevention of the associated symptoms, in patients who require continued NSAID treatment 
• Profilaksa z NSAID povezanih razjed želodca, razjed dvanajstnika in erozij v želodcu in dvanajstniku ter preprečevanje povezanih simptomov pri bolnikih, ki potrebujejo nadaljnje zdravljenje z NSAID
Treatment of duodenal ulcer: one 30 mg capsule every day for 2 weeks 
Zdravljenje razjede dvanajstnika: ena 30-miligramska kapsula vsak dan 2 tedna.
In particular tell your doctor if you are taking medicines containing any of the following active substances as Agopton may affect the way these drugs work: - ketoconazole, itraconazole, rifampicin (used to treat infections) - digoxin (used to treat heart problems) - theophylline (used to treat asthma) - tacrolimus (used to prevent transplant rejection) - fluvoxamine (used to treat depression and other psychiatric diseases) - antacids (used to treat heartburn or acid regurgitation) - sucralfate (used for healing ulcers) - St John´s wort (Hypericum perforatum) (used to treat mild depression) 
- digoksin (za zdravljenje težav s srcem) - teofilin (za zdravljenje astme) - takrolimus (za preprečevanje zavrnitve presadkov) - fluvoksamin (za zdravljenje depresije in drugih psihiatričnih bolezni) - antacidi (za zdravljenje zgage ali vzdigovanja kisline) - sukralfat (za zdravljenje razjed) - šentjanževka (Hypericum perforatum) (za zdravljenje blage depresije)
• Treatment of NSAID-associated gastric ulcers, duodenal ulcers and gastroduodenal erosions, and relief of the associated symptoms, in patients requiring continued NSAID 
• Zdravljenje z jemanjem NSAID povezanih razjed želodca, razjed dvanajstnika in erozij v želodcu in dvanajstniku ter lajšanje povezanih simptomov pri bolnikih, ki potrebujejo nadaljnje zdravljenje z NSAID
STATEMENT OF ACTIVE SUBSTANCE(S) Each single dose sachet contains lansoprazole 30 mg 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka vrečica z enkratnim odmerkom vsebuje 30 mg lansoprazola.
Each oro-dispersible tablet contains <white to pale brownish white enteric-coated granules>. 
Vsaka orodisperzibilna tableta vsebuje <oranžna do temno rjava mikrozrnca>.
Treatment of duodenal ulcer: one 30 mg oro-dispersible tablet every day for 2 weeks 
Zdravljenje razjede dvanajstnika: ena 30-miligramska orodisperzibilna tableta vsak dan 2 tedna.
Lactation: 
Dojenje:
6.3 Shelf life [To be completed nationally] 
6.3 Rok uporabnosti [Izpolni država članica.]
MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Dodatek I - Izpolni država članica.]
Higher exposure to lansoprazole in comparison to adults has been seen in infants below the age of 2-3 months with doses of both 1.0 mg/kg and 0.5 mg/kg body weight given as a single dose. 
Pri otrocih, mlajših od dva do tri mesece, so pri enkratnih odmerkih 1,0 in 0,5 mg/kg telesne mase opazili večjo izpostavljenost lansoprazolu kot pri odraslih.
Treatment of inflammation in your oesophagus (reflux oesophagitis): one 30 mg capsule every day for 4 weeks 
Zdravljenje vnetja požiralnika (refluksnega ezofagitisa): ena 30-miligramska kapsula vsak dan 4 tedne.
GROUNDS FOR AMENDMENTS OF THE SUMMARY OF PRODUCTS CHARACTERISTICS LABELLING AND PACKAGE LEAFLET 
PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
STATEMENT OF ACTIVE SUBSTANCE(S) Each oro-dispersible tablet contains lansoprazole 15 mg 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka orodisperzibilna tableta vsebuje 15 mg lansoprazola.
Posology and methods of administration 
Odmerjanje in način uporabe
You should check with your doctor if you are not sure how to take your medicine. 
Če niste prepričani, kako jemati zdravilo, se posvetujte z zdravnikom.
Treatment of inflammation in your oesophagus (reflux oesophagitis): one 30 mg oro-dispersible tablet every day for 4 weeks 
Zdravljenje vnetja požiralnika (refluksnega ezofagitisa): ena 30-miligramska orodisperzibilna tableta vsak dan 4 tedna.
Agopton contains sucrose. 
Zdravilo Agopton vsebuje saharozo.
• Prophylaxis of NSAID-associated gastric ulcers, duodenal ulcers and relief of symptoms in patients requiring continued therapy 
• Profilaksa razjed želodca in dvanajstnika, povezanih z jemanjem NSAID, ter lajšanje simptomov pri bolnikih, ki potrebujejo nadaljnje zdravljenje
Take your medicine exactly as your doctor has told you. 
Pri jemanju zdravila natančno upoštevajte zdravnikova navodila.
• Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk (see section 
• profilakso razjed želodca in dvanajstnika, povezanih z NSAID, pri bolnikih s povečanim tveganjem (glej poglavje 4.2), ki potrebujejo nadaljnje zdravljenje
STATEMENT OF ACTIVE SUBSTANCE(S) Each oro-dispersible tablet contains lansoprazole 30 mg 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka orodisperzibilna tableta vsebuje 30 mg lansoprazola.
• Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment 
• zdravljenjem benignih razjed želodca in dvanajstnika, povezanih z NSAID, pri bolnikih, ki potrebujejo nadaljnje zdravljenje z NSAID
NAME OF THE MEDICINAL PRODUCT Agopton and associated names 15 mg capsules [See Annex I - To be completed nationally] lansoprazole 
Agopton in povezana imena 15 mg kapsule [Glejte Dodatek I - Izpolni država članica.]
Your doctor might instruct you to take the tablet with a syringe, in case you have serious difficulties with swallowing. 
Če imate resne težave pri požiranju, vam bo morda zdravnik naročil, da vzamete tableto z brizgo.
NAME OF THE MEDICINAL PRODUCT Agopton and associated names 15 mg oro-dispersible tablet [See Annex I - To be completed nationally] lansoprazole 
Agopton in povezana imena 15 mg orodisperzibilne tablete [Glejte Dodatek I - Izpolni država članica.]
15mg 
4,5 mg aspartama.
NAME OF THE MEDICINAL PRODUCT Agopton and associated names 30 mg capsules [See Annex I - To be completed nationally] lansoprazole 
Agopton in povezana imena 30 mg kapsule [Glejte Dodatek I - Izpolni država članica.]
LAPRAZOL FasTab 15 mg 
LAPRAZOL FasTab 15 mg orodisperzibilna tableta peroralna uporaba
<OTC> 
<{e-pošta}>
Agopton and associated names (see Annex I) 30 mg gastro-resistant granules for oral suspension [See Annex I - To be completed nationally] 
Agopton in povezana imena (glejte Dodatek I), 30 mg gastrorezistentna zrnca za peroralno suspenzijo.
Urticaria, itching, rash 
Urtikarija, srbenje, izpuščaj
NAME OF THE MEDICINAL PRODUCT Agopton and associated names 30 mg oro-dispersible tablet [See Annex I - To be completed nationally] lansoprazole 
Agopton in povezana imena 30 mg orodisperzibilne tablete [Glejte Dodatek I - Izpolni država članica.]
PACKAGE LEAFLET: INFORMATION FOR THE USER Agopton and associated names 30 mg gastro-resistant granules for oral suspension [See Annex 1- To be completed nationally] Lansoprazole 
NAVODILO ZA UPORABO Agopton in povezana imena 30 mg gastrorezistentna zrnca za peroralno suspenzijo.
WHAT AGOPTON IS AND WHAT IT IS USED FOR The active ingredient in Agopton is lansoprazole, which is a proton pump inhibitor. 
Kaj vsebuje zdravilo Agopton - Zdravilna učinkovina je lansoprazol.
30 mg 
30 mg kapsula peroralna uporaba
please tell your doctor or pharmacist. 
Če dvomite, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
LAPRAZOL FasTab 30 mg 
LAPRAZOL FasTab 30 mg orodisperzibilna tableta peroralna uporaba
Do not crush or chew 
Zrnc ne žvečite in ne zdrobite.
United Kingdom 
Velika Britanija:
GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally] 
SEZNAM POMOŽNIH SNOVI [Izpolni država članica.]
Date of first authorisation: 18 January 2017 
Datum prve odobritve: 18. januar 2017
• It is very important that you do not miss the dose of this medicine. 
• Zelo pomembno je, da ne izpustite odmerka tega zdravila.
Activity in vitro and in vivo 
Aktivnost in vitro in in vivo
Unopened vial: 3 years. 
Neodprta viala: 3 leta
From a microbiological point of view, the product must be used immediately. 
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj.
• The diluted solution can be infused via a central line or peripheral catheter. 
• Razredčeno raztopino je mogoče infundirati skozi centralno linijo ali periferni kateter.
Genotoxicity and carcinogenic potential have not been evaluated. 
Genotoksičnosti in kancerogenosti niso ovrednotili.
Your dose will be calculated using your body weight. 
Odmerek bodo izračunali glede na vašo telesno maso.
You can also report side effects directly the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
• You will get ZINPLAVA in one dose and it will take about 1 hour. 
• Zdravilo ZINPLAVA boste prejeli v enkratnem odmerku in prejemali ga boste približno 1 uro.
No formal interactions studies with other medicinal products were conducted. 
Uradnih študij medsebojnega delovanja z drugimi zdravili niso izvedli.
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment should be instituted. 
V primeru prevelikega odmerjanja je treba bolnike skrbno spremljati glede znakov in simptomov neželenih učinkov in uvesti ustrezno simptomatsko zdravljenje.
• When people get CDI, they are usually given an antibiotic to get rid of the infection, but CDI can often come back within weeks or months. 
• Ljudje, ki zbolijo za CDI, običajno prejmejo antibiotik, ki odpravi okužbo, a pogosto se zgodi, da se CDI v nekaj tednih ali mesecih ponovi.
The median age was 65 years, 85 % were white, 57 % were female, and 68 % were inpatients. 
Mediana starost je bila 65 let, 85 % je bilo belcev, 57 % je bilo žensk in 68 % je bilo bolnišničnih bolnikov.
Adjusted Difference (95% CI) 
Korigirana razlika (95 % IZ)
ATC code: J06BB21 
Oznaka ATC: J06BB21.
Children and adolescents ZINPLAVA should not be used in children and adolescents below 18 years of age. 
Otroci in mladostniki Zdravila ZINPLAVA se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
† See Description of selected adverse reactions below. 
† Glejte Opis izbranih neželenih učinkov spodaj.
• Call your doctor or health care professional right away to reschedule your appointment. 
• Takoj pokličite zdravnika oziroma zdravstvenega delavca in se dogovorite za obisk.
Industriepark 30 - Zone A 2220 Heist-op-den-Berg Belgium 
Industriepark 30 - Zone A 2220 Heist-op-den-Berg Belgija
Pharmacotherapeutic group: Antiinfectives for systemic use, specific immunoglobulins. 
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje infekcij, specifični imunoglobulini.
The safety profile of ZINPLAVA was assessed in two Phase 3 clinical studies. 
Varnostni profil zdravila ZINPLAVA so ocenili v dveh kliničnih študijah 3. faze.
These patients presented with risk factors primarily but not exclusively associated with higher risk of CDI recurrence. 
Ti bolniki so imeli prisotne dejavnike tveganja, s katerimi je največkrat (ne pa izključno) povezano višje tveganje za ponovitev CDI.
History of one or more episodes of CDI in past 6 months Immunocompromised Severe CDI 
Anamneza enega ali več pojavov CDI v zadnjih 6 mesecih Imunska oslabelost Huda CDI
• you are allergic to bezlotoxumab or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na bezlotoksumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). 
Pogostnosti neželenih učinkov so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Characteristic at study entry 
Značilnost ob vključitvi v študijo
ZINPLAVA should be administered as a single intravenous infusion of 10 mg/kg (see below and section 6.6). 
Zdravilo ZINPLAVA je treba aplicirati kot enkratno intravensko infuzijo v odmerku 10 mg/kg (glejte spodaj in poglavje 6.6).
Twenty one (21) percent of the patients were immunocompromised and 16 % presented with clinically severe CDI. 
Enaindvajset (21) odstotkov bolnikov je bilo imunsko oslabelih in 16 % jih je imelo klinično hudo CDI.
Store in a refrigerator 2 °C to 8 °C. 
Shranjujte v hladilniku (2 °C do 8 °C).
Among the 976/1554 (62 %) patients who had a positive baseline stool culture for C. difficile a hypervirulent strain (ribotypes 027, 078 or 244) was isolated in 22 % (217 of 976 patients), of which the majority (87 %, 189 of 217 strains) were ribotype 027. 
Med 976/1554 (62 %) bolniki, ki so imeli v izhodišču pozitivno fekalno kulturo za C. difficile, so hipervirulentne seve (ribotipi 027, 078 in 244) izolirali pri 22 % (217 od 976 bolnikov); večina teh sevov (87 %, 189 od 217 sevov) je bila ribotipa 027.
• You should keep taking your antibiotic for CDI as directed by your doctor. 
• Antibiotik za zdravljenje CDI morate jemati še naprej, kot vam je naročil zdravnik.
The mean volume of distribution of bezlotoxumab was 7.33 L (CV: 16 %). 
Povprečni volumen porazdelitve bezlotoksumaba je 7,33 l (CV: 16 %).
Fertility studies have not been conducted in animals. 
Študij plodnosti na živalih niso izvedli.
These time limits include storage of the infusion solution in the IV bag through the duration of infusion. 
Te časovne meje vključujejo shranjevanje raztopine za infundiranje v intravenski vrečki med trajanjem infuzije.
In clinical studies, serious adverse reactions occurring within 12 weeks following infusion were reported in 29 % of ZINPLAVA-treated patients and 33 % in patients receiving placebo. 
V kliničnih študijah so o resnih neželenih učinkih, ki so se pojavili v 12 tednih po infundiranju, poročali pri 29 % bolnikov, zdravljenih z zdravilom ZINPLAVA, in pri 33 % bolnikov, ki so prejemali placebo.
Of the total 28 % had one or more episodes of CDI within the six months prior to the episode under treatment (18 % of the patients had one, 7 % had two and a few patients had 3 or more prior episodes). 
Od vseh bolnikov je imelo 28 % bolnikov enega ali več pojavov CDI v šestih mesecih pred zdravljeno epizodo CDI (18 % bolnikov je imelo en pojav, 7 % dva pojava in nekaj bolnikov 3 ali več predhodnih pojavov).
Table 3 shows the results of a prospectively planned combined analysis of the CDI recurrence rates in pre-specified subgroups of patients at high risk for CDI recurrence across the two Phase 3 Trials. 
V preglednici 3 so navedeni izidi prospektivno načrtovanih kombiniranih analiz deležev ponovitev CDI v vnaprej opredeljenih podskupinah bolnikov z visokim tveganjem za ponovitev CDI v dveh preskušanjih 3. faze.
Overall, 51 % were ≥ 65 years, 29% were ≥ 75 years and 39 % received one or more systemic antibacterial agents during the 12 week follow-up period. 
Skupno je bilo 51 % starih ≥ 65 let, 29 % je bilo starih ≥ 75 let in 39 % je med 12-tedenskim obdobjem spremljanja prejemalo enega ali več sistemskih protibakterijskih zdravil.
• We don't know if ZINPLAVA will harm your baby while you are pregnant. 
• Ni znano, ali zdravilo ZINPLAVA škoduje vašemu otroku med nosečnostjo.
The following factors had no clinically meaningful effect on the exposure of bezlotoxumab and no dose adjustment is required: age (range 18 to 100 years), gender, race, ethnicity, renal impairment, hepatic impairment, and presence of co-morbid conditions. 
Naslednji dejavniki niso klinično pomembno vplivali na izpostavljenost bezlotoksumabu in prilagoditev odmerka ni potrebna: starost (od 18 do 100 let), spol, rasa, etnična pripadnost, okvara ledvic, okvara jeter in prisotnost sočasnih bolezni.
Therapeutic monoclonal antibodies do not typically have significant drug-drug interaction potential, as they do not directly affect cytochrome P450 enzymes and are not substrates of hepatic or renal transporters. 
Terapevtska monoklonska protitelesa običajno nimajo pomembnega potenciala za medsebojno delovanje z zdravili, saj neposredno ne vplivajo na encime citokroma P450 in niso substrat za jetrne oziroma ledvične prenašalce.
What ZINPLAVA is and what it is used for 2. 
Kaj je zdravilo ZINPLAVA in za kaj ga uporabljamo 2.
• Discard vial(s) and all unused contents. 
• Vialo/viale in vso neporabljeno vsebino zavrzite.
• You and your doctor should decide together if you will use ZINPLAVA. 
• Skupaj z zdravnikom se morate odločiti, ali boste prejeli zdravilo ZINPLAVA.
The CDI recurrence rates are shown in Table 2. 
Deleži ponovitev CDI so navedeni v preglednici 2.
This leaflet was last revised in {month YYYY}. 
Navodilo je bilo nazadnje revidirano
Patients received a 10- to 14-day course of oral antibacterial therapy for CDI (metronidazole, vancomycin or fidaxomicin, chosen by the investigator). 
Bolniki so prejeli od 10- do 14-dnevno peroralno protibakterijsko zdravljenje za CDI (metronidazol, vankomicin ali fidaksomicin; zdravilo je izbral raziskovalec).
A similar proportion of patients were receiving oral metronidazole (48 %) or oral vancomycin (48 %) and only 4 % were receiving fidaxomicin as antibacterial treatment for CDI. 
Delež bolnikov, ki so prejemali peroralni metronidazol (48 %), je bil podoben deležu tistih, ki so prejemali peroralni vankomicin (48 %), in samo 4 % bolnikov je kot protibakterijsko zdravljenje CDI prejelo fidaksomicin.
• ZINPLAVA must not be co-administered with other medicinal products simultaneously through the same infusion line. 
• Zdravila ZINPLAVA se po isti infuzijski liniji ne sme aplicirati sočasno z nobenim drugim zdravilom.
In clinical trials, healthy subjects received up to 20 mg/kg, which was generally well tolerated. 
V kliničnih študijah so zdravi preiskovanci prejeli do 20 mg/kg, kar so na splošno dobro prenesli.
The safety and efficacy of ZINPLAVA in patients below 18 years of age have not been established. 
Varnost in učinkovitost zdravila ZINPLAVA pri bolnikih, starih manj kot 18 let, nista bili dokazani.
• The bacteria responsible for CDI produce a toxin that can inflame and damage your colon, causing stomach pain and severe diarrhoea. 
• Bakterija, ki povzroča CDI, izdeluje toksin, ki lahko povzroči vnetje in okvaro debelega črevesa (kolona), kar povzroči bolečine v trebuhu in hudo drisko.
Tell your doctor or health care professional if you notice any of the side effects above. 
Zdravniku oziroma zdravstvenemu delavcu morate povedati, če opazite katerega od naštetih neželenih učinkov.
Randomisation was stratified by the antibacterial agent and hospitalisation status (inpatient vs. outpatient) at the time of study entry. 
Randomizacija je bila stratificirana glede na protibakterijsko zdravilo in hospitalizacijski status (bolnišnični bolniki v primerjavi z ambulantnimi) ob času vključitve v študijo.
ZINPLAVA should not be used during pregnancy unless the clinical condition of the woman requires treatment with bezlotoxumab. 
Zdravila ZINPLAVA ne smete uporabljati pri nosečnicah, razen če klinično stanje nosečnice zahteva zdravljenje z bezlotoksumabom.
• If you are pregnant or trying to get pregnant, tell your doctor. 
• Če ste noseči ali načrtujete zanositev, se posvetujte z zdravnikom.
The European Medicines Agency has deferred the obligation to submit the results of studies with ZINPLAVA in one or more subsets of the paediatric populations for the prevention of recurrence of Clostridium difficile infection (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom ZINPLAVA za eno ali več podskupin pediatrične populacije za preprečevanje ponovitve okužbe s Clostridium difficile (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• Withdraw the required volume from the vial(s) based on the patient's weight (in kg) and transfer into an IV bag containing either 0.9 % Sodium Chloride Injection, or 5 % Dextrose Injection, to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL. 
• Potrebno količino povlecite iz vial(e) glede na bolnikovo telesno maso (v kg) in jo prenesite v intravensko vrečko, ki vsebuje 0,9 % raztopino natrijevega klorida za injiciranje ali 5 % raztopino glukoze za injiciranje, da pripravite razredčeno raztopino s končno koncentracijo od 1 do 10 mg/ml.
Following treatment with ZINPLAVA in MODIFY I and MODIFY II, none of the 710 evaluable patients tested positive for treatment-emergent anti-bezlotoxumab antibodies. 
Po zdravljenju z zdravilom ZINPLAVA v preskušanjih MODIFY I in MODIFY II nihče izmed 710 ocenljivih bolnikov ni imel pozitivnega izvida testiranja za protitelesa proti bezlotoksumabu, nastala med zdravljenjem.
The baseline characteristics of the 781 patients receiving ZINPLAVA and 773 receiving placebo were generally similar across treatment groups. 
Izhodiščne značilnosti 781 bolnikov, ki so prejemali zdravilo ZINPLAVA, in 773 bolnikov, ki so prejemali placebo, so bile med terapevtskima skupinama na splošno primerljive.
The efficacy of ZINPLAVA (bezlotoxumab) was investigated in two randomised, double-blind, placebo-controlled, multicentre, Phase 3 studies (MODIFY I and MODIFY II) where 810 patients were randomised to bezlotoxumab and 803 to placebo. 
Učinkovitost zdravila ZINPLAVA (bezlotoksumaba) so raziskali v dveh randomiziranih, dvojno slepih, s placebom kontroliranih multicentričnih študijah 3. faze (MODIFY I in MODIFY II), v katerih je bilo 810 bolnikov randomiziranih na bezlotoksumab in 803 na placebo.
Talk to your doctor before you are given ZINPLAVA. 
Posvetujte se z zdravnikom, preden boste prejeli zdravilo ZINPLAVA.
The effects of various covariates on the pharmacokinetics of bezlotoxumab were assessed in a population pharmacokinetic analysis. 
Vplive različnih sospremenljivk na farmakokinetiko bezlotoksumaba so ocenili v populacijski farmakokinetični analizi.