FrancophonIA/ELRC3.0 huggingface dataset:
English: The capsule shell contains: gelatin, titanium dioxide (E171) and red iron oxide (E172) The printing ink contains: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).
Slovenian: • Ovojnica kapsule vsebuje: želatino, titanov dioksid (E171), rumeni železov oksid (E172) in rdeči železov oksid (E172).
English: Therefore, no dose modification is required for ixazomib with co-administration of strong CYP3A inhibitors.
Slovenian: Pri sočasni uporabi iksazomiba in močnih zaviralcev CYP3A odmerka iksazomiba ni treba prilagajati.
English: Three percent of patients in the ixazomib regimen and 1% of patients in the placebo regimen had a platelet count ≤ 10,000/mm3 during treatment.
Slovenian: Med zdravljenjem je število trombocitov ≤ 10.000/mm3 imelo 3 % bolnikov, ki so se zdravili z režimom zdravljenja z iksazomibom, in 1 % bolnikov, ki so se zdravili z režimom zdravljenja s placebom.
English: • Withhold ixazomib.
Slovenian: • Zdravljenje z iksazomibom zadržite.
English: What you need to know before you take NINLARO
Slovenian: Kaj je zdravilo NINLARO in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo NINLARO Kako jemati zdravilo NINLARO Možni neželeni učinki
English: For each adverse reaction, one or more of the three medicinal products was discontinued in ≤ 1% of patients in the ixazomib regimen.
Slovenian: Pri režimu zdravljenja z iksazomibom so pri vsakem neželenem učinku zdravljenje z enim od treh zdravil ali več prekinili pri ≤ 1 % bolnikov.
English: Dosing schedule: NINLARO taken with lenalidomide and dexamethasone Take medicine 28-day cycle (a 4-week cycle) Week 1
Slovenian: 23. do 28. dan iksazomib lenalidomid  dnevno  dnevno  dnevno deksametazon   = jemanje zdravila
English: Polska Takeda Pharma sp. z o.o
Slovenian: Takeda Italia S.p.A.
English: Wash your hands and dry them very well.
Slovenian: Umijte si roke in jih dobro osušite.
English: You may need urgent medical treatment.
Slovenian: Morda potrebujete nujno zdravniško pomoč.
English: Prepare a clean working area.
Slovenian: Pripravite čisto delovno površino.
English: This target has not been established clinically.
Slovenian: Ta cilj ni bil ugotovljen klinično.
English: • You should normally have your injections at the same times each day.
Slovenian: • Praviloma morate injekcije dobiti vsak dan ob istih časih.
English: It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days.
Slovenian: Zelo pomembno je, da antibiotik jemljete v pravem odmerku, ob pravem času in pravo število dni.
English: Children under 3 months of age
Slovenian: Otroci, mlajši od 3 mesecev
English: Your doctor may do blood tests from time to time.
Slovenian: Zdravnik vam bo morda od časa do časa opravil preiskave krvi.
English: Check that the vial is intact and has not been damaged.
Slovenian: Preverite, da je viala nedotaknjena in da ni poškodovana.
English: Alternative therapies were also discussed.
Slovenian: Razprava se je navezovala tudi na alternativne terapije.
English: 2745-663 Barcarena, Portugal
Slovenian: 2745-663 Barcarena, Portugalska
English: • Being breathless when you do not expect it.
Slovenian: • Pojav zadihanosti, kadar je ne pričakujete.
English: If you miss an injection, you should have it as soon as possible.
Slovenian: Če izpustite injekcijo, jo morate dobiti čim prej.
English: 2719 EE, Zoetermeer, Netherlands
Slovenian: 2719 EE, Zoetermeer, Nizozemska
English: The CHMP noted that the indication of neutropenia is currently approved in most of the Member States.
Slovenian: CHMP je navedel, da je indikacija nevtropenije trenutno odobrena v večini držav članic.
English: Safety and Efficacy issues
Slovenian: - Vprašanja varnosti in učinkovitosti
English: The latter manufacturer is also approved in the majority of the MSs and is therefore also mentioned in the harmonised documentation.
Slovenian: Zadnji izdelovalec je odobren tudi v večini držav članic in je zato omenjen tudi v usklajeni dokumentaciji.
English: • if you have had severe diarrhoea after taking other antibiotics.
Slovenian: • če ste kdaj imeli hudo drisko po jemanju drugih antibiotikov.
English: Small amounts of this medicine may pass into the breast milk and it may affect the baby.
Slovenian: Majhna količina tega zdravila lahko pride v materino mleko in lahko vpliva na otroka.
English: Do not take a double dose (two injections at the same time) to make up for a forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka (dveh injekcij hkrati), če ste pozabili vzeti prejšnji odmerek.
English: • The injection may take about 5 minutes or between 15 and 30 minutes.
Slovenian: • Injiciranje lahko traja okrog 5 minut ali od 15 do 30 minut.
English: Damage to red blood cells (not known) The signs include:
Slovenian: Okvara rdečih krvnih celic (neznano) Med znaki so:
English: However, if it is almost time for your next injection, skip the missed injection.
Slovenian: Če pa je že skoraj čas za naslednjo injekcijo, preskočite izpuščeno injekcijo.
English: The main areas for harmonisation were as follows.
Slovenian: Glavna področja uskladitve so bila:
English: Severe allergic reactions
Slovenian: Hude alergijske reakcije
English: The safety and efficacy of meropenem in children under 3 months of age have not been established and the optimal dose regimen has not been identified.
Slovenian: Varnost in učinkovitost meropenema pri otrocih do 3 mesecev starosti nista ugotovljeni in optimalna shema odmerjanja ni določena.
English: • Red or brown urine.
Slovenian: • Rdeč ali rjav urin.
English: In particular, tell your doctor or nurse if you are taking any of the following medicines:
Slovenian: Še zlasti morate zdravniku ali medicinski sestri povedati, če jemljete katero od naslednjih zdravil:
English: • However, some patients, parents and carers are trained to give Meronem at home.
Slovenian: • Vendar pa se nekateri bolniki, starši in negovalci naučijo dajati zdravilo Meronem doma.
English: • The dose depends on the type of infection that you have, where the infection is in the body and how serious the infection is.
Slovenian: • Odmerek je odvisen od vrste okužbe, od tega, kje v telesu je okužba in kako resna je.
English: The signs may include a sudden onset of:
Slovenian: Znaki lahko vključujejo nenaden pojav:
English: • Swelling of the face, lips, tongue or other parts of the body.
Slovenian: • Otekanja obraza, ustnic, jezika ali drugih delov telesa.
English: Instructions for doing this are provided in this leaflet (in the section called ‘Instructions for giving Meronem to yourself or someone else at home').
Slovenian: Navodila za to so navedena v nadaljevanju (v poglavju z naslovom "Navodila za dajanje zdravila Meronem sebi ali komu drugemu doma").
English: Studies 3591IL/0065 and 3591IL/0022 included only paediatric patients but studies 3591IL/0020 and 3591IL/0021 included both paediatric and adult patients.
Slovenian: Študiji 3591IL/0065 in 3591IL/0022 sta vključevali samo pediatrične bolnike, študiji 3591IL/0020 in 3591IL/0021 pa sta vključevali pediatrične in odrasle bolnike.
English: Quality issues
Slovenian: - Vprašanja kakovosti
English: note 3
Slovenian: opomba 3
English: The CHMP adopted a harmonised text for this section.
Slovenian: Odbor CHMP je sprejel usklajeno besedilo za to poglavje.
English: C/ Serrano Galvache 56 Edificio Roble 28033 Madrid
Slovenian: C/ Serrano Galvache 56 Edificio Roble 28033 Madrid Španija
English: Revisions were also made to the table of antibacterial spectrum.
Slovenian: Popravke so vnesli tudi v tabelo protibakterijskega spektra.
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Slovenian: Pristojni nacionalni organi, ki jih medsebojno usklajuje referenčna država članica, bodo zagotovili, da bodo imetniki dovoljenja za promet z zdravilom izpolnili naslednje pogoje:
English: You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells.
Slovenian: Pojavi se vam lahko pozitiven izvid določene preiskave (Coombsovega testa); takšen izvid kaže prisotnost protiteles, ki lahko uničujejo rdeče krvne celice.
English: Meropenem is primarily excreted unchanged by the kidneys; approximately 70 % (50 -75 %) of the dose is excreted unchanged within 12 hours.
Slovenian: Meropenem se izloči predvsem nespremenjen skozi ledvice; približno 70 % (50-75 %) odmerka se nespremenjenega izloči v 12 urah.
English: It is unknown whether meropenem is excreted in human milk.
Slovenian: Ni znano, ali se meropenem pri človeku izloča v mleko.
English: Frequency one unit dose every 12 hours half of one unit dose every 12 hours half of one unit dose every 24 hours
Slovenian: Pogostnost ena enota odmerka na 12 ur pol enote odmerka na 12 ur pol enote odmerka na 24 ur
English: If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken.
Slovenian: Če se pojavi huda alergijska reakcija, je treba uporabo zdravila prekiniti in uvesti ustrezne ukrepe.
English: In the process of being cancelled
Slovenian: V procesu ukinitve
English: • Other changes in your blood.
Slovenian: • Druge spremembe krvi.
English: Streptococcus pyogenes (Group A)
Slovenian: Streptococcus pyogenes (skupina A)
English: Resistant (R) (mg/l)
Slovenian: rezistenten (R) (mg/l)
English: Warning - You should only give this medicine to yourself or someone else at home after a doctor or nurse has trained you.
Slovenian: Opozorilo - To zdravilo smete sebi ali komu drugemu doma dati šele, ko vas je tega naučil zdravnik ali medicinska sestra.
English: • Your injection should not be mixed with or added to solutions that contain other medicines.
Slovenian: • Vaše raztopine za injiciranje se ne sme mešati z drugimi zdravili ali je dodajati raztopinam, ki vsebujejo druga zdravila.
English: Meronem should not be used because it may decrease the effect of sodium valproate.
Slovenian: Zdravila Meronem se ne sme uporabljati, ker lahko zmanjša učinek natrijevega valproata.
English: • Increased numbers of platelets in your blood (shown in a blood test).
Slovenian: • Povečano število trombocitov v krvi (pokaže se na preiskavi krvi).
English: Approximately 60 % of the dose is excreted in urine over 12 hours as meropenem with a further 12 % as metabolite.
Slovenian: Približno 60 % odmerka se izloči v urinu v 12 urah kot meropenem in dodatnih 12 % kot presnovek.
English: Lower doses to treat such infections have to be avoided because of the risk of sub-optimal concentrations.
Slovenian: Nižjim odmerkom se je treba pri zdravljenju takih okužb izogibati zaradi tveganja za neoptimalne koncentracije.
English: Remove the Meronem bottle (vial) from the packaging.
Slovenian: Vzemite stekleničko (vialo) zdravila Meronem iz pakiranja.
English: AstraZeneca AS Hoffsveien 70 B/Postboks 200 Vinderen 0319 OSLO Norway
Slovenian: AstraZeneca AS Hoffsveien 70 B/Postboks 200 Vinderen 0319 OSLO Norveška
English: Meropenem is mentioned as a recommended drug in therapeutic guidelines and the indication “Intra-abdominal infections” is approved in all 29 European countries.
Slovenian: Zdravilo Meropenem se v terapevtskih smernicah omenja kot priporočeno zdravilo, indikacija „intraabdominalne okužbe“ pa je odobrena v vseh 29 evropskih državah.
English: This may also help to reduce resistance through reducing horizontal transmission of inadequately treated infections due to antibiotic-resistant pathogens.
Slovenian: S tem se lahko zmanjša tudi odpornost, in sicer z zmanjšanjem horizontalnega prenosa neprimerno zdravljenih okužb zaradi patogenov, odpornih na antibiotike.
English: However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism.
Slovenian: Vendar je vezava na beljakovine tako majhna, da zaradi nje ni pričakovati medsebojnih delovanj z drugimi spojinami.
English: The conditions of the Marketing Authorisation are listed in Annex IV.
Slovenian: Pogoji dovoljenja za promet z zdravilom so navedeni v Dodatku IV.
English: The information presented reflects that currently approved for Dainippon Sumitomo Pharma and for ACS Dobfar SpA, and includes additional information and the changes that have taken place up to date.
Slovenian: Predstavljene informacije odražajo trenutno odobrene informacije za družbi Dainippon Sumitomo Pharma in ACS Dobfar SpA ter vključujejo dodatne informacije in spremembe, do katerih je prišlo do tega datuma.
English: • The medicine must be mixed with another liquid (the diluent).
Slovenian: • Zdravilo je treba zmešati z drugo tekočino (topilom).
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MERONEM AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA MERONEM IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: • The dose for children over 3 months old and up to 12 years of age is decided using the age and weight of the child.
Slovenian: • Odmerek za otroke v starosti od 3 mesecev do 12 let se določi glede na starost in otrokovo telesno maso.
English: Pack sizes of 1 or 10 vials.
Slovenian: Pakiranja z 1 ali 10 vialami.
English: WHAT MERONEM IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO MERONEM IN ZA KAJ GA UPORABLJAMO
English: Meronem is indicated for the treatment of the following infections in adults and children over 3 months of age (see sections 4.4 and 5.1):
Slovenian: Meronem je pri odraslih in otrocih, starejših od 3 mesecev, indiciran za zdravljenje naslednjih okužb (glejte poglavji 4.4 in 5.1):
English: The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below.
Slovenian: Odmerek za odrasle in mladostnike je treba prilagoditi, če je očistek kreatinina manjši kot 51 ml/min, kakor je prikazano spodaj.
English: Your doctor will decide on the dose that you need.
Slovenian: Zdravnik bo odločil, kolikšen odmerek potrebujete.
English: Rare • Fits (convulsions).
Slovenian: Redki • Napadi krčev (konvulzije).
English: The required dose should be administered after completion of the haemodialysis cycle.
Slovenian: Potrebni odmerek je treba dati po dokončanem ciklusu hemodialize.
English: Meronem belongs to a group of medicines called carbapenem antibiotics.
Slovenian: Zdravilo Meronem spada v skupino zdravil, imenovanih karbapenemski antibiotiki.
English: This is because Meronem can affect the way some medicines work and some medicines can have an effect on Meronem.
Slovenian: Zdravilo Meronem namreč lahko vpliva na delovanje nekaterih zdravil in nekatera zdravila lahko vplivajo na zdravilo Meronem.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from meropenem therapy taking into account the benefit of therapy for the woman.
Slovenian: Odločiti se je treba bodisi za prenehanje dojenja bodisi za prekinitev/prenehanje zdravljenja z meropenemom, upoštevaje koristi zdravljenja za žensko.
English: Do not use Meronem after the expiry date which is stated on the container.
Slovenian: Zdravila Meronem ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vsebniku.
English: Instructions for giving Meronem to yourself or someone else at home Some patients, parents and carers are trained to give Meronem at home.
Slovenian: Navodila za dajanje zdravila Meronem sebi ali komu drugemu doma Nekateri bolniki, starši in negovalci se naučijo dajati zdravilo Meronem doma.
English: MIC summary data was also included.
Slovenian: Vključili so tudi povzetek podatkov o MIC.
English: The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate sent to a reference laboratory.
Slovenian: V primeru takšnega izolata je treba ponoviti identifikacijo in preiskave antimikrobne občutljivosti; če je rezultat potrjen, je treba izolat poslati v referenčni laboratorij.
English: - the Summary of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Slovenian: - povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, je bil ocenjen na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora.
English: Italy: MERREM
Slovenian: Italija: MERREM
English: The CHMP agreed with the updated harmonised wording proposed for the sections Pregnancy and Lactation in section 4.6, that was in line with the ‘Guideline on risk assessment of medicinal products on human reproduction and lactation (EMEA/CHMP/203927/2005, July 2008)'
Slovenian: Nosečnost in dojenje, usklajeno s „Smernicami o oceni tveganja zdravil za človeško reprodukcijo in dojenje (EMEA/CHMP/203927/2005, julij 2008)“.
English: There is no experience in children with renal impairment.
Slovenian: Izkušenj pri otrocih z okvaro ledvic ni.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.
Slovenian: Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta ali zdravilo rastlinskega izvora.
English: There are limited data to support the application of these dose adjustments for a unit dose of 2 g.
Slovenian: Malo je podatkov, ki podpirajo uporabo teh prilagoditev odmerka za enoto odmerka 2 g.
English: • if you have health problems, such as liver or kidney problems.
Slovenian: • če imate kakšne zdravstvene težave, npr. z jetri ali ledvicami.
English: Remove the needle from the vial and shake the vial well for about 5 seconds, or until all the powder has dissolved.
Slovenian: Potegnite iglo iz viale in vialo dobro pretresajte približno 5 sekund oziroma dokler se ves prašek ne raztopi.
English: After rapid administration (5 minutes or less) the pharmacokinetics are biexponential but this is much less evident after 30 minutes infusion.
Slovenian: Po hitrem dajanju (5 minut ali manj) je farmakokinetika bieksponentna, po 30-minutnem infundiranju pa je to mnogo manj opazno.
English: These include reduced numbers of platelets (which may make you bruise more easily), increased numbers of some white blood cells, decreased numbers of other white cells and increased amounts of a substance called ‘bilirubin'.
Slovenian: Med njimi so zmanjšanje števila trombocitov (zaradi česar se vam lahko poveča nagnjenost h krvavitvam), povečanje števila nekaterih belih krvnih celic, zmanjšanje števila drugih belih krvnih celic in večja količina snovi, imenovane "bilirubin".
English: A further 28% is recovered as the microbiologically inactive metabolite.
Slovenian: Dodatnih 28 % se pojavi v obliki mikrobiološko neaktivnega presnovka.
English: They are for use for species not mentioned in the table and footnotes.
Slovenian: Namenjeni sta za uporabo pri vrstah, ki niso omenjene v preglednici ali opombah.
English: You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to yours.
Slovenian: Ne jemljite antibiotikov, ki so bili predpisani drugim ljudem, tudi če so imeli okužbo, podobno vaši.
English: Your doctor will tell you how to give Meronem.
Slovenian: Zdravnik vam bo povedal, kako dajati zdravilo Meronem.
English: Based on the Quality data submitted, the CHMP concluded that the product should not be stored above 30°C and that the reconstituted solution should not be frozen.
Slovenian: Na temelju predloženih podatkov o kakovosti je CHMP zaključil, da se zdravilo ne sme shranjevati pri temperaturi nad 30 °C in da se rekonstituirana raztopina ne sme zamrzovati.
English: Children who weigh over 50 kg will be given an adult dose.
Slovenian: Otroci, ki tehtajo več kot 50 kg, dobijo odmerek za odrasle.
English: Draw up the recommended amount of sterile ‘Water for Injections' into the syringe.
Slovenian: Potegnite priporočeno količino sterilne "vode za injekcije" v brizgo.
English: 1 Meropenem breakpoints for Streptococcus pneumoniae and Haemophilus influenzae in meningitis are 0.25/1 mg/L.
Slovenian: 1 Mejni vrednosti za meropenem za Streptococcus pneumoniae in Haemophilus influenzae pri meningitisu sta 0,25/1 mg/l.
English: Bedfordshire LU1 3LU United Kingdom
Slovenian: Bedfordshire LU1 3LU Velika Britanija
English: The tables below provide general recommendations for dosing.
Slovenian: Spodnja preglednica prikazuje splošna priporočila za odmerjanje.
English: The active substance meropenem trihydrate is manufactured by two manufacturers.
Slovenian: Zdravilno učinkovino meropenem trihidrat proizvajata dva izdelovalca.
English: In repeat dose studies of up to 6 months duration only minor effects were seen including a decrease in red cell parameters in dogs.
Slovenian: V študijah ponavljajočih se odmerkov, ki so trajale do 6 mesecev, so opazili samo manj pomembne učinke, vključno z zmanjšanjem eritrocitnih parametrov pri psih.
English: The CHMP noted that the safety profile of meropenem is well-known and that hypersensitivity including serious reactions is considered typical for the carbapenem class.
Slovenian: CHMP je ugotovil, da je varnostni profil meropenema dobro znan in da je preobčutljivost, vključno z resnimi reakcijami, značilna za razred karbapenemov.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Slovenian: Upoštevati je treba uradne smernice za primerno uporabo protibakterijskih zdravil.
English: Dose (based on “unit” dose range of 500 mg or 1 g or 2 g, see table above)
Slovenian: Odmerek (na podlagi "enote" razpona odmerka 500 mg ali 1 g ali 2 g, glejte preglednico zgoraj)
English: If you have a severe allergic reaction, stop having Meronem and see a doctor straight away.
Slovenian: Če imate hudo alergijsko reakcijo, nehajte uporabljati zdravilo Meronem in nemudoma pojdite k zdravniku.
English: Pharmacokinetic studies in healthy elderly subjects (65-80 years) have shown a reduction in plasma clearance, which correlated with age-associated reduction in creatinine clearance, and a smaller reduction in non-renal clearance.
Slovenian: Farmakokinetične študije pri zdravih starejših osebah (od 65 do 80 let) so pokazale manjši plazemski očistek (ki je koreliral s starostnim zmanjšanjem očistka kreatinina) in manjše zmanjšanje neledvičnega očistka.
English: As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see sections 4.3 and 4.8).
Slovenian: Tako kot pri vseh betalaktamskih antibiotikih so bile opisane resne in občasno smrtne preobčutljivostne reakcije (glejte poglavji 4.3 in 4.8).
English: This extrapolation is considered valid because the pathophysiology of meningitis and its bacterial aetiology are essentially the same in adults and children, with knowledge of the dose relationship between adults and children (40 mg/kg in children is equivalent to a 2 g unit dose in adults).
Slovenian: Ta ekstrapolacija se upošteva kot veljavna, ker sta patofiziologija meningitisa in njegova bakteriološka etiologija v bistvu enaki pri odraslih in otrocih ob poznavanju razmerja med odmerkom pri odraslih in otrocih (40 mg/kg pri otrocih je enakovredno 2 g enoti za odmerjanje pri odraslih).
English: You can then draw the liquid in the vials into the one syringe.
Slovenian: Potem lahko potegnete tekočino iz vial v eno brizgo.
English: However, limited pharmacokinetic data suggest that 20 mg/kg every 8 hours may be an appropriate regimen (see section 5.2).
Slovenian: Vendar maloštevilni farmakokinetični podatki kažejo, da bi lahko bila primerna shema 20 mg/kg na 8 ur (glejte poglavje 5.2).
English: Therefore, improvement in lung function is the key benefit to be derived from treatment with meropenem.
Slovenian: Zaradi tega je izboljšanje pljučne funkcije ključna korist, ki jo nudi zdravljenje z zdravilno učinkovino meropenem.