FrancophonIA/ELRC3.0 huggingface dataset:
English: ● abdominal discomfort and distension
Slovenian: ● občutek neugodja v trebuhu in napihnjenost trebuha (abdominalna distenzija),
English: • pain in extremity
Slovenian: • bolečine v okončinah,
English: Flebogamma DIF 50 mg/ml should be infused intravenously at an initial rate of 0.01 - 0.02 ml/kg/min for the first thirty minutes.
Slovenian: Zdravilo Flebogamma DIF 50 mg/ml infundirajte intravensko z začetno hitrostjo 0,01-0,02 ml/kg/min prvih trideset minut.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: - neznana (ni mogoče oceniti iz razpoložljivih podatkov) V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: NAME OF THE MEDICINAL PRODUCT Flebogamma DIF 50 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Slovenian: IME ZDRAVILA Flebogamma DIF 50 mg/ml raztopina za infundiranje humani polispecifični imunoglobulin (i.v.
English: If well tolerated, advance to 0.02 ml/kg/min for the second 30 minutes.
Slovenian: Če bolnik infundiranje dobro prenaša, povečajte hitrost infundiranja na 0,02 ml/kg/min v naslednjih 30 minutah.
English: Vital signs (body temperature, blood pressure, heart rate and respiratory rate) should be observed during the infusion of Flebogamma DIF.
Slovenian: Med infundiranjem zdravila Flebogamma DIF je treba opazovati vitalne znake (telesno temperaturo,
English: Haemolytic anaemia can develop subsequent to IVIg therapy due to enhanced red blood cells (RBC) sequestration.
Slovenian: Hemolitična anemija se lahko pojavi po zdravljenju z zdravili z i.v.
English: Flebogamma DIF should be infused intravenously at an initial rate of 0.01 ml/kg/min for the first thirty minutes.
Slovenian: Zdravilo Flebogamma DIF infundirajte intravensko z začetno hitrostjo 0,01 ml/kg/min prvih trideset minut.
English: ● pain in extremity
Slovenian: ● bolečine v okončinah,
English: In patients at risk for thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.
Slovenian: Pri bolnikih, pri katerih obstaja tveganje za trombembolične neželene učinke, je treba zdravila z i.v.
English: ● haematoma
Slovenian: ● vrtoglavica,
English: Again, if tolerated, advance to 0.04 ml/kg/min for the third 30 minutes.
Slovenian: Če bolnik infundiranje še naprej dobro prenaša, povečajte hitrost infundiranja na 0,04 ml/kg/min v naslednjih 30 minutah.
English: How to use Flebogamma DIF
Slovenian: Za kaj uporabljamo zdravilo Flebogamma DIF
English: Blood pressure systolic increased, Body temperature increased, Coombs test positive
Slovenian: Preiskave zvišan sistolični krvni tlak, zvišana telesna temperatura, pozitiven Coombov test pogosti občasni znižan sistolični krvni tlak občasni občasni zvišana alanin aminotransferaza, zvišan krvni tlak redki
English: Talk to your doctor, pharmacist or nurse before using Flebogamma DIF.
Slovenian: Pred začetkom uporabe zdravila Flebogamma DIF se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Flebogamma DIF is supplied as 5 g/50 ml, 10 g/100 ml and 20 g/200 ml.
Slovenian: Zdravilo Flebogamma DIF je na voljo v vialah po 5 g/50 ml, 10 g/100 ml in 20 g/200 ml. Velikost pakiranja: 1 viala.
English: Aseptic meningitis syndrome has been reported to occur in association with IVIg treatment.
Slovenian: Ig so opisali pojav sindroma aseptičnega meningitisa.
English: Chest discomfort, Chest pain, Fatigue, Feeling cold, Infusion site reaction, Malaise, Oedema peripheral, Pain
Slovenian: reakcija na mestu infundiranja, splošno slabo počutje, periferni edem, bolečina občasni občutek živčnosti, bolezen, podobna gripi, eritem na mestu infundiranja,
English: Rare (may affect up to 1 in 1000 infusions):
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1000 infuzij): • preobčutljivost,
English: ● urticaria
Slovenian: ● sopenje,
English: ● hypersensitivity
Slovenian: ● občutek živčnosti,
English: Flebogamma DIF should be infused intravenously at an initial rate of 0.01 - 0.02 ml/kg/min for the first thirty minutes.
Slovenian: Zdravilo Flebogamma DIF infundirajte intravensko z začetno hitrostjo 0,01-0,02 ml/kg/min prvih trideset minut.
English: ● urinary infection
Slovenian: ● okužba sečil,
English: Asthma, Cough, Dyspnoea, Epistaxis, Nasal discomfort, Laryngeal pain
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora bronhitis, sopenje pogosti občasni produktivni kašelj občasni občasni astma, kašelj, dispneja, epistaksa,
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Replacement therapy in adults, children and adolescents (2 - 18 years) in: - Primary immunodeficiency syndromes (PID) with impaired antibody production - Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l
Slovenian: *PSAF = neuspeh pri doseganju vsaj 2-kratnega zvišanja titra protiteles IgG po cepljenju s pnevmokoknimi polisaharidnimi in polipeptidnimi antigenskimi cepivi Imunomodulacija pri odraslih, otrocih in mladostnikih (2-18 let) pri: - Primarni imunski trombocitopeniji (ITP) pri bolnikih z velikim tveganjem za krvavitve ali pred kirurškim posegom za korekcijo števila trombocitov - Guillain-Barréjevem sindromu
English: Epistaxis, Nasal congestion, Upper-airway cough syndrome, Sinus pain, Dyspnoea
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora sopenje pogosti občasni epistaksa, zamašen nos, sindrom kašlja zgornjih dihal, bolečina v sinusih,
English: ● flatulence
Slovenian: ● flatulenca (napenjanje),
English: Loop diuretics Avoidance of concomitant use of loop diuretics
Slovenian: Treba se je izogniti sočasni uporabi diuretikov henlejeve zanke.
English: Conjunctivitis, Maculopathy, Vision blurred
Slovenian: Očesne bolezni fotofobija pogosti občasni konjuktivitis, makulopatija, zamegljen vid občasni
English: Ear pain
Slovenian: Okvara jeter
English: Abdominal pain, Abdominal pain upper, Diarrhoea, Flatulence
Slovenian: Pogostnost na infundiranje bolečine v trebuhu, driska, navzea,
English: ● dry mouth
Slovenian: ● modrica,
English: Tabulated list of adverse reactions
Slovenian: Povzetek neželenih učinkov v obliki preglednice
English: ● haemoglobin decreased
Slovenian: ● zmanjšanje koncentracije hemoglobina,
English: Therefore a detailed history with regard to HFI symptoms has to be taken of each patient prior to receiving Flebogamma DIF.
Slovenian: Flebogamma DIF vzeti natančno anamnezo simptomov HFI.
English: Primary immunodeficiency syndromes Starting dose:
Slovenian: Multifokalna motorična nevropatija (MMN) Začetni odmerek:
English: Device dislocation
Slovenian: Odmerjanje
English: Blood pressure fluctuation, Flushing
Slovenian: krvni tlak, srčni utrip in frekvenco dihanja).
English: Limb discomfort, Muscle spasms, Muscle tightness, Neck pain, Pain in extremity
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v hrbtu, artralgija, mialgija pogosti občasni krči v mišicah, bolečine v vratu, bolečine v okončinah občasni redki
English: What Flebogamma DIF is
Slovenian: Flebogamma DIF, kot je omotica.
English: ● arthralgia (joint pain)
Slovenian: ● artralgija (bolečine v sklepih),
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Infekcijske in parazitske bolezni nazofaringitis občasni občasni
English: ● heart rate decreased
Slovenian: ● povečano število retikulocitov, ● znižanje srčnega utripa.
English: ● lymphoedema
Slovenian: ● urtikarija,
English: • asthenia (fatigue)
Slovenian: ● siljenje na bruhanje (navzea),
English: Arthralgia, Musculoskeletal discomfort Uncommon
Slovenian: Psihiatrične motnje nenormalno vedenje občasni redki
English: 0.4 g/kg/d on day 1, possibly repeated once within 3 days for 2 - 5 days
Slovenian: 1. dan, možna ponovitev odmerjanja enkrat v 3 dneh
English: What measures are being taken to ensure the safe and effective use of Prevymis?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Prevymis?
English: The usual recommended dose by mouth or as an infusion is 480 mg once daily.
Slovenian: Običajni priporočeni peroralni odmerek ali odmerek v obliki infuzije je 480 mg enkrat na dan.
English: What is Prevymis and what is it used for?
Slovenian: Kaj je zdravilo Prevymis in za kaj se uporablja?
English: All patients in this study were CMV seropositive, meaning they had come into contact with the virus before and were likely to be carrying it in an inactive form.
Slovenian: Vsi bolniki v tej študiji so bili CMV-seropozitivni, kar pomeni, da so morali že prej priti v stik z virusom in so ga verjetno imeli v neaktivni obliki.
English: Many people have CMV in their body but it is usually inactive and it does not cause harm.
Slovenian: Citomegalovirus imajo v telesu številni ljudje, vendar je običajno neaktiven in ne povzroča škode.
English: It is not intended to provide practical advice on how to use Prevymis.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What benefits of Prevymis have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Prevymis izkazalo v študijah?
English: The European Medicines Agency therefore decided that Prevymis's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Prevymis večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Prevymis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Prevymis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What are the risks associated with Prevymis?
Slovenian: Kakšna tveganja so povezana z zdravilom Prevymis?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Prevymis have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Prevymis upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Why is Prevymis approved?
Slovenian: Zakaj je bilo zdravilo Prevymis odobreno?
English: This is a summary of the European public assessment report (EPAR) for Prevymis.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Prevymis.
English: For more information about treatment with Prevymis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Prevymis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Other information about Prevymis
Slovenian: Druge informacije o zdravilu Prevymis
English: Of the patients receiving Prevymis, about 38% (122 out of 325) had signs of CMV becoming active 24 weeks after the stem cell transplant compared with 61% of the patients (103 out of 170) receiving placebo.
Slovenian: Znake citomegalovirusa, ki se je aktiviral 24 tednov po presaditvi matičnih celic, je imelo 38 % (122 od 325) bolnikov, ki so prejemali zdravilo Prevymis, v primerjavi z 61 % bolnikov (103 od 170), ki so prejemali placebo.
English: For CMV to multiply, its genetic material (DNA) needs to be copied and packaged into protein shells to produce more viruses that can then infect other cells.
Slovenian: Da se citomegalovirus lahko razmnožuje, se mora njegov genetski material (DNK) kopirati in nalagati v beljakovinske ovojnice, da nastane več virusov, ki lahko nato okužijo druge celice.
English: The full EPAR for Prevymis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Prevymis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Terminase is involved in packaging the DNA in the protein shells of the virus.
Slovenian: Terminaza je udeležena pri ovijanju DNK v beljakovinske ovojnice virusa.
English: The most common side effects with Prevymis (which may affect up to 1 in 10 people) are nausea (feeling sick), diarrhoea and vomiting.
Slovenian: Najpogostejši neželeni učinki zdravila Prevymis (ki se lahko pojavijo pri največ 1 bolniku od 10) so navzeja (slabost), driska in bruhanje.
English: Doctors should consider official guidance on the use of antiviral medicines when using Prevymis.
Slovenian: Zdravniki morajo pri uporabi zdravila Prevymis upoštevati uradne smernice za uporabo protivirusnih zdravil.
English: Because the number of patients with CMV disease is low, the disease is considered ‘rare', and Prevymis was designated an ‘orphan medicine' (a medicine used in rare diseases) on 15 April 2011.
Slovenian: Ker je bolnikov z obolenjem zaradi okužbe s citomegalovirusom malo, velja ta bolezen za redko, zato je bilo zdravilo Prevymis 15. aprila 2011 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: The combination of Prevymis and ciclosporin must not be used with dabigatran, atorvastatin, pitavastatin, rosuvastatin and simvastatin.
Slovenian: Kombinacija zdravila Prevymis in ciklosporina se ne sme uporabljati z dabigatranom, atorvastatinom, pitavastatinom, rosuvastatinom in simvastatinom.
English: Prevymis is available as tablets to be taken by mouth and as a concentrate that is made up into a solution for infusion (drip) into a vein and given over about an hour.
Slovenian: Zdravilo Prevymis je na voljo v obliki tablet, ki jih je treba zaužiti peroralno, in v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno, ki se daje približno eno uro.
English: Prevymis must not be used together with the medicine pimozide, or ergot medicines such as ergotamine and dihydroergotamine.
Slovenian: Zdravilo Prevymis se ne sme uporabljati v kombinaciji z zdravilom pimozid ali zdravili iz rženih rožičkov, kot sta ergotamin in dihidroergotamin.
English: For practical information about using Prevymis, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Prevymis naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: By blocking the enzyme, the medicine prevents viruses from developing properly, so that CMV cannot multiply and infect other cells.
Slovenian: Zdravilo z zaviranjem tega encima virusom preprečuje, da bi se pravilno razvijali, zato se citomegalovirus ne more pomnoževati in okužiti drugih celic.
English: Allogeneic haematopoietic stem cell transplantation involves using stem cells from a donor to replace the recipient's bone marrow cells to form new bone marrow that produces healthy blood cells.
Slovenian: Alogenska presaditev krvotvornih matičnih celic vključuje uporabo matičnih celic darovalca za zamenjavo prejemnikovih celic kostnega mozga, da bi nastal nov kostni mozeg, ki bi proizvajal zdrave krvne celice.
English: Letermovir, the active substance in Prevymis, blocks a virus enzyme called ‘terminase'.
Slovenian: Letermovir, zdravilna učinkovina v zdravilu Prevymis, zavira virusni encim, imenovan „terminaza“.
English: A main study involving 570 adults found Prevymis was more effective than placebo (a dummy treatment) in preventing CMV infection after allogeneic haematopoietic stem cell transplantation.
Slovenian: V glavni študiji, v katero je bilo vključenih 570 odraslih, se je izkazalo, da je zdravilo Prevymis pri preprečevanju okužbe s citomegalovirusom po alogenski presaditvi krvotvornih matičnih celic učinkovitejše od placeba (zdravila brez zdravilne učinkovine).
English: How is Prevymis used?
Slovenian: Kako se zdravilo Prevymis uporablja?
English: Treatment with Prevymis is started on the day of the transplant or on any day up to 28 days afterwards and it is continued for 100 days after the transplantation; longer treatment may be considered in some patients.
Slovenian: Če se sočasno uporablja ciklosporin (zdravilo za preprečevanje zavrnitve presadka), se odmerek zdravila Prevymis zmanjša na 240 mg enkrat na dan. Zdravljenje z zdravilom Prevymis se začne na dan presaditve ali na kateri koli dan do 28 dni pozneje in se nadaljuje še 100 dni po presaditvi; pri nekaterih bolnikih je lahko potrebno daljše zdravljenje.
English: Prevymis can only be obtained with a prescription, and treatment should be started by a doctor experienced in managing patients who have had an allogeneic haematopoietic stem cell transplant.
Slovenian: Predpisovanje in izdaja zdravila Prevymis je le na recept, zdravljenje pa mora uvesti zdravnik z izkušnjami z zdravljenjem bolnikov z alogenskim presadkom krvotvornih matičnih celic.
English: However, CMV can become active in patients whose immune system is weakened such as those having stem cell transplants.
Slovenian: Pri bolnikih, pri katerih je imunski sistem oslabljen, npr. po presaditvi matičnih celic, pa se lahko aktivira.
English: This is expected to prevent CMV disease in transplant recipients who already have CMV in their body.
Slovenian: To naj bi pri prejemnikih presadka, ki imajo citomegalovirus že v svojem telesu, preprečevalo okužbo zaradi njega.
English: Prevymis is an antiviral medicine used to prevent illness caused by cytomegalovirus (CMV) in adults having an allogeneic haematopoietic stem cell transplant to replace their bone marrow.
Slovenian: Zdravilo Prevymis je protivirusno zdravilo, ki se uporablja za preprečevanje bolezni, ki jo pri odraslih s presadkom krvotvornih matičnih celic za zamenjavo kostnega mozga povzroča citomegalovirus (CMV).
English: For the full list of side effects reported with Prevymis, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Prevymis, glejte navodilo za uporabo.
English: It has few side effects unlike other medicines used for the treatment of CMV disease which can damage bone marrow and affect blood cells.
Slovenian: V nasprotju z drugimi zdravili za zdravljenje okužbe s citomegalovirusom, ki lahko poškodujejo kostni mozeg in prizadenejo krvne celice, ima le malo neželenih učinkov.
English: How does Prevymis work?
Slovenian: Kako zdravilo Prevymis deluje?
English: Prevymis contains the active substance letermovir.
Slovenian: Zdravilo Prevymis vsebuje zdravilno učinkovino letermovir.
English: Prevymis is effective in preventing CMV from becoming active and causing disease in adult recipients of a stem cell transplantation to replace the bone marrow.
Slovenian: Zdravilo Prevymis pri odraslih prejemnikih presadka matičnih celic za zamenjavo kostnega mozga učinkovito preprečuje, da bi se citomegalovirus aktiviral in povzročil obolenje.
English: Date of first authorisation: 18 September 2015
Slovenian: Datum prve odobritve: 18. september 2015
English: See below.
Slovenian: Glejte spodaj.
English: These measures will help protect the environment.
Slovenian: Takšni ukrepi bodo pomagali varovati okolje.
English: A risk to newborns/infants cannot be excluded.
Slovenian: Tveganja za novorojence/dojenčke ni mogoče izključiti.
English: Tell your doctor if you think you may have another infection.
Slovenian: Zdravniku povejte, če menite, da imate drugo okužbo.
English: This medicine should not be given to children under 18 years old because there is not enough information on use in this age group.
Slovenian: Tega zdravila se ne sme uporabljati pri otrocih, mlajših od 18 let, ker o uporabi pri tej starostni skupini ni dovolj podatkov.
English: The preparation for each dose is shown below.
Slovenian: Priprava posameznih odmerkov je prikazana spodaj.
English: Modification of PBPs
Slovenian: spremembo PBP-jev
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravila se ne sme mešati z drugimi zdravili, razen s tistimi, ki so navedena v poglavju 6.6.
English: The duration of treatment should follow the recommendations in Table 1.
Slovenian: Glede trajanja zdravljenja je treba slediti priporočilom v preglednici 1.
English: Your doctor will decide on the dose that you need.
Slovenian: Zdravnik bo določil, kakšen odmerek potrebujete.
English: From a microbiological point of view, the medicinal product should be used immediately upon reconstitution.
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po rekonstituciji.
English: 1 hour
Slovenian: 1 ura
English: CAUTION: THE RECONSTITUTED SOLUTION IS NOT FOR DIRECT INJECTION.
Slovenian: OPOZORILO: REKONSTITUIRANA RAZTOPINA NI ZA NEPOSREDNO INJICIRANJE.
English: Safety and efficacy in paediatric patients have not been established.
Slovenian: Varnost in učinkovitost pri pediatričnih bolnikih nista bili dokazani.
English: Minimum Inhibitory Concentrations (mg/L)
Slovenian: Minimalne inhibitorne koncentracije (mg/l)
English: Your doctor may also want to test your blood to make sure you receive an appropriate dose, especially if you have to take this medicine for a long time.
Slovenian: Poleg tega vam bo zdravnik morda kontroliral tudi kri in tako preveril, da prejemate primeren odmerek zdravila, zlasti če to zdravilo prejemate dolgo časa.
English: The final volume is approximately 11.4 mL per vial.
Slovenian: Končna količina je približno 11,4 ml na vialo.
English: The medicinal product is photosensitive and should be protected from light when not stored in the original carton.
Slovenian: Zdravilo je občutljivo za svetlobo in ga je treba zaščititi pred svetlobo, kadar ni shranjeno v originalni škatli.
English: Tazobactam is a substrate for OAT1 and OAT3.
Slovenian: Tazobaktam je substrat OAT1 in OAT3.
English: **All doses of Zerbaxa are administered intravenously over 1 hour and are recommended for all indications.
Slovenian: **Vsi odmerki zdravila Zerbaxa se dajejo intravensko v teku 1 ure in so priporočeni za vse indikacije.
English: 15 to 29
Slovenian: 15 do 29
English: 7 days
Slovenian: 7 dni
English: 63963, Clermont Ferrand Cedex 9 France
Slovenian: 63963, Clermont Ferrand Cedex 9 Francija
English: Laboratory values
Slovenian: Laboratorijske vrednosti
English: 30 to 50
Slovenian: 30 do 50
English: After reconstitution, chemical and physical in-use stability has been demonstrated for 4 days at 2 to 8°C.
Slovenian: Po rekonstituciji sta kemična in fizikalna stabilnost med uporabo dokazani za 4 dni pri temperaturi od 2 °C do 8 °C.
English: If super infection occurs during or following treatment, appropriate measures should be taken.
Slovenian: Če se med ali po zdravljenju pojavi superinfekcija, je treba ustrezno ukrepati.
English: Minimum inhibitory concentration breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Slovenian: Mejne vrednosti minimalnih inhibitornih koncentracij, ki jih je določil Evropski odbor za testiranje občutljivosti za protimikrobna zdravila (EUCAST - European Committee on Antimicrobial Susceptibility Testing), so:
English: The safety and efficacy of ceftolozane/tazobactam in children and adolescents below 18 years of age have not yet been established.
Slovenian: Varnost in učinkovitost ceftolozana/tazobaktama pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
English: The dose depends on the type of infection that you have, where the infection is in your body and how serious the infection is.
Slovenian: Odmerek je odvisen od vrste okužbe in od tega, kje v telesu je okužba in kako resna je.
English: This leaflet was last revised in {month YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: Mechanisms of resistance
Slovenian: Mehanizmi odpornosti