natgillin/translations-raw huggingface dataset:
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.
Because monoclonal antibodies may be excreted in human milk, a decision should be made whether to discontinue breast-feeding or to not administer ZINPLAVA, taking into account the importance of ZINPLAVA to the mother.
Monoklonska protitelesa se lahko pri človeku izločajo v materino mleko, zato se je treba odločiti med prenehanjem dojenja ali neuporabo zdravila ZINPLAVA, pri čemer je treba upoštevati pomen zdravila ZINPLAVA za mater.
ZINPLAVA acts by attaching to the toxin and blocking it, thereby preventing the symptoms of CDI from coming back.
Zdravilo ZINPLAVA deluje tako, da se veže na toksin in ga blokira in tako prepreči ponovitev simptomov CDI.
Each mL of concentrate contains 0.2 mmol sodium, which is 4.57 mg sodium.
En mililiter koncentrata vsebuje 0,2 mmol natrija, kar je 4,57 mg natrija.
Intravenous use after dilution Single dose vial
intravenska uporaba po razredčitvi viala za enkratni odmerek
• We don't know if ZINPLAVA gets in your breast milk and is passed to your baby.
• Ni znano, ali zdravilo ZINPLAVA prehaja v materino mleko in se tako prenaša na dojenčka.
Within each frequency grouping, adverse reactions are presented in order of decreasing frequency.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči pogostnosti.
In a Phase 1 clinical trial, healthy subjects received two consecutive doses of 10 mg/kg of bezlotoxumab separated by 12 weeks.
V kliničnem preskušanju 1. faze so zdravi preiskovanci prejeli dva zaporedna odmerka 10 mg/kg bezlotoksumaba v presledku 12 tednov.
All patients received concomitant standard of care antibacterial therapy for CDI.
Vsi bolniki so sočasno prejeli standardno protibakterijsko zdravljenje za CDI.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than a total of 24 hours at 2°C - 8°C or 16 hours at room temperature (at or below 25°C).
Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; skupni čas ne sme preseči 24 ur pri temperaturi od 2 °C do 8 °C oziroma 16 ur pri sobni temperaturi (25 °C ali manj).
The mean clearance of bezlotoxumab was 0.317 L/day (CV: 41 %) and the terminal half-life (t½) was approximately 19 days
Povprečni očistek bezlotoksumaba je bil 0,317 l/dan (CV: 41 %) in njegov terminalni razpolovni čas (t½) približno 19 dni (28 %).
The effect of age on the pharmacokinetics of bezlotoxumab was evaluated in patients ranging from 18 to 100 years of age.
Vpliv starosti na farmakokinetiko bezlotoksumaba so ocenili pri bolnikih v starosti od 18 do 100 let.
The adverse reactions after the second dose were not markedly different from those observed after the first dose, and are consistent with adverse reactions observed in the two Phase 3 trials (MODIFY I and MODIFY II; see section 5.1) in which all patients received a single dose.
Neželeni učinki po drugem odmerku niso bili bistveno drugačni od tistih, ki so jih opazili po prvem odmerku, in so skladni z neželenimi učinki, opaženimi v dveh preskušanjih 3. faze (MODIFY I in MODIFY II; glejte poglavje 5.1), v katerih so vsi bolniki prejeli enkraten odmerek.
There is no data regarding the efficacy of ZINPLAVA if given after the initial 10- to 14-days of antibacterial therapy for CDI.
Podatkov o učinkovitosti zdravila ZINPLAVA, ki bi bilo uporabljeno kasneje kot v prvih 10- do 14-dneh protibakterijskega zdravljenja CDI, ni na voljo.
Efficacy results did not point towards a benefit of ZINPLAVA in patients with no known risk factors for CDI.
Rezultati glede učinkovitosti niso pokazali koristi zdravila ZINPLAVA pri bolnikih brez znanih dejavnikov tveganja za CDI.
Table 3: CDI Recurrence Rate by Risk Factor Subgroup (MODIFY I and MODIFY II, Full Analysis Set
Preglednica 3: Delež ponovitev CDI po podskupinah glede na dejavnik tveganja (MODIFY I in MODIFY II, celotni nabor za analizo
• Prepare the diluted solution immediately after removal of the vial(s) from refrigerated storage, or the vial(s) may be stored at room temperature protected from light for up to 24 hours prior to preparation of the diluted solution.
• Razredčeno raztopino pripravite takoj, ko vialo/viale vzamete iz hladilnika; viala/viale so lahko shranjene tudi pri sobni temperaturi (zaščitene pred svetlobo) do 24 ur pred pripravo razredčene raztopine.
ZINPLAVA is a medicine that is given together with an antibiotic to prevent Clostridium difficile infection (CDI) from coming back in patients 18 years of age or older who have a high risk of CDI coming back.
Zdravilo ZINPLAVA je zdravilo, ki se skupaj z antibiotikom uporablja za preprečitev ponovne okužbe z bakterijo Clostridium difficile (CDI - Clostridium difficile infection) pri bolnikih, starih 18 let ali več, z visokim tveganjem za ponovitev CDI.
How you are given ZINPLAVA 4.
Kako boste prejeli zdravilo ZINPLAVA 4.
The clearance of bezlotoxumab increased with increasing body weight; the resulting exposure differences are adequately addressed by the administration of a weight-based dose.
Očistek bezlotoksumaba se je povečeval z naraščanjem telesne mase, a nastale razlike v izpostavljenosti ustrezno odtehta uporaba odmerka, določenega na podlagi telesne mase.
The toxin B epitope to which bezlotoxumab binds is conserved, though not identical, across all known toxin sequences.
Epitop toksina B, na katerega se veže bezlotoksumab, je ohranjen pri vseh znanih zaporedjih toksina, čeprav ne identičen.
Patients on oral vancomycin or oral fidaxomicin could have also received IV metronidazole.
Bolniki, ki so prejemali peroralni vankomicin ali peroralni fidaksomicin, so lahko prejeli tudi intravenski metronidazol.
Of the patients who experienced an infusion specific adverse reaction, the majority reported a reaction with a maximum intensity of mild (78 %) or moderate (20 %), and the majority of reactions resolved within 24 hours following onset.
Med bolniki, pri katerih so se pojavili za infuzijo specifični neželeni učinki, je večina navedla največjo intenzivnost učinka kot blago (78 %) ali zmerno (20 %); večina učinkov je minila v 24 urah po pojavu.
• You will get ZINPLAVA as an infusion (drip) into a vein.
• Zdravilo ZINPLAVA boste prejeli v infuziji ("kapalni") v veno.
Table 2: CDI Recurrence Rate Through 12 Weeks After Infusion (MODIFY I and MODIFY II, Full Analysis Set
Preglednica 2: Deleži ponovitev CDI v 12 tednih po infundiranju (MODIFY I in MODIFY II, celotni nabor za analizo
Bezlotoxumab is a human monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology.
Bezlotoksumab je humano monoklonsko protitelo, pridobljeno s tehnologijo rekombinantne DNA na ovarijskih celicah kitajskega hrčka.
Other medicines and ZINPLAVA Tell your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The most common adverse reactions following treatment with ZINPLAVA (reported in ≥ 4 % of patients within the first 4 weeks of infusion) were nausea, diarrhoea, pyrexia and headache.
Najpogostejši neželeni učinki po zdravljenju z zdravilom ZINPLAVA (poročani pri ≥ 4 % bolnikov v prvih 4 tednih po infundiranju) so bili navzea, diareja, zvišana telesna temperatura in glavobol.