FrancophonIA/ELRC3.0 huggingface dataset:
English: QUANTITY OF THE ACTIVE SUBSTANCE 56.25 mg
Slovenian: OVOJNINAH PRETISNI OMOT (56,25 mg)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/066/007 (3 pipettes)
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/066/007 (3 merilne kapalke) EU/2/06/066/008 (6 merilnih kapalk) EU/2/06/066/009 (30 merilnih kapalk)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/066/010 (3 pipettes)
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/066/010 (3 merilne kapalke) EU/2/06/066/011 (6 merilnih kapalk) EU/2/06/066/012 (30 merilnih kapalk)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/066/001 (3 pipettes)
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/066/001 (3 merilne kapalke) EU/2/06/066/002 (6 merilnih kapalk) EU/2/06/066/003 (30 merilnih kapalk)
English: It is given once a day for seven days.
Slovenian: Zdravilo se daje enkrat dnevno sedem dni.
English: This summary was last updated in June 2008.
Slovenian: Povzetek je bil nazadnje posodobljen 06-2008.
English: It is available in three pack sizes; 8.8, 17.5 and 35.1 ml bottles for dogs.
Slovenian: Na voljo je v treh oblikah pakiranja: stekleničkah po 8,8, 17,5 in 35,1 ml za pse.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Posatex to S-P Veterinary, United Kingdom on 23/06/2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Posatex, veljavno po vsej Evropski uniji, odobrila družbi S-P Veterinary, Združeno kraljestvo, dne 23.06.2008.
English: The inside of the ear should be cleaned and dried before treatment.
Slovenian: Notranjost ušesa je treba pred zdravljenjem očistiti in osušiti.
English: Other information about Posatex:
Slovenian: Druge informacije o zdravilu Posatex:
English: Equal numbers of dogs were assigned to each group, of different breeds, ages, sex and weight.
Slovenian: V vsaki skupini je bilo enako število psov različnih pasem, starosti, spola in teže.
English: The number of ear drops to use depends on the weight of the dog and varies from two to eight.
Slovenian: Število kapljic za uho je odvisno od teže psa in znaša med dva in osem.
English: They often lead to the ear(s) being inflamed (red, swollen and itchy).
Slovenian: Pogosto povzročijo, da se uho(ušesa) vname(jo) (postanejo rdeča, zatečena in srbeča).
English: This veterinary medicine has been developed especially for dogs and is not for use in humans.
Slovenian: To veterinarsko zdravilo je namenjeno samo psom in se ne sme uporabljati za ljudi.
English: The use of ear preparations may be associated with damage to hearing, usually temporary and primarily in older dogs.
Slovenian: Uporaba pripravkov za ušesa je lahko povezana z okvaro sluha, običajno začasno in predvsem pri starejših psih.
English: It works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Slovenian: Deluje tako, da preprečuje nastajanje ergosterola, ki je pomemben del glivičnih celičnih sten.
English: Mometasone furoate monohydrate is a steroid, which is a type of substance that helps to reduce inflammation.
Slovenian: Mometazon furoat monohidrat je steroid, kar je vrsta snovi, ki pomaga ublažiti vnetje.
English: What benefit has Posatex shown during the studies?
Slovenian: Kakšne koristi je zdravilo Posatex izkazalo med študijami?
English: Posatex at the recommended dose and following 7 days of treatment was as effective as the comparator medicine in improving the symptoms (redness, swelling, ear discharge, discomfort) of ear infections in dogs with acute or recurrent bacterial or fungal infections.
Slovenian: Zdravilo Posatex je bilo v priporočenem odmerku in po 7-dnevnem zdravljenju enako učinkovito kot primerjalno zdravilo pri izboljševanju simptomov (pordelost, otekanje, izcedek iz ušesa, nelagodnost) vnetij ušesa pri psih z akutnimi ali ponavljajočimi bakterijskimi ali glivičnimi vnetji.
English: If accidental skin contact occurs, wash immediately with lots of water.
Slovenian: Če pride do nenamernega stika s kožo, nemudoma izperite z obilico vode.
English: By blocking DNA gyrase, orbifloxacin prevents the bacteria from making DNA and stops them making proteins and growing, resulting in their death.
Slovenian: Orbifloksacin z zaviranjem DNK giraze bakterijam prepreči, da izdelajo DNK in prenehajo izdelovati beljakovine ter rasti, kar povzroči njihovo odmrtje.
English: Posatex is used to treat dogs that suffer from acute or recurrent episodes of ear infections (otitis externa).
Slovenian: Zdravilo Posatex se uporablja za zdravljenje psov, ki trpijo zaradi akutnih ali ponavljajočih epizod vnetja ušesa (otitis externa).
English: Orbifloxacin is an antibiotic that belongs to the group fluoroquinolones.
Slovenian: Orbifloksacin je antibiotik, ki spada v skupino fluorokinolonov.
English: What is the risk associated with Posatex?
Slovenian: Kakšna tveganja so povezana z zdravilom Posatex?
English: It works by blocking an enzyme called ‘DNA gyrase', which is important in allowing bacteria to make copies of their DNA.
Slovenian: Deluje tako, da zavira enzim, imenovan „DNK giraza“, ki bakterijam omogoča, da izdelajo kopije svojega DNK.
English: Two of the active substances in Posatex, orbifloxacin and posaconazole, work against the cause of the infection, while the third one, mometasone furoate monohydrate, works on the inflammation.
Slovenian: Dve zdravilni učinkovini v zdravilu Posatex, orbifloksacin in posokonazol, delujeta proti vzroku okužbe, medtem ko tretja, mometazon furoat monohidrat, deluje proti vnetju.
English: The ear drop suspension is easy to apply by the owner and therefore increased success in the treatment of an ear infection can be expected when the medicinal product is used as directed.
Slovenian: Lastnik lahko kapljice za uho v obliki suspenzije brez težav aplicira, zato je mogoče pričakovati večji uspeh zdravljenja vnetij ušes, kadar se zdravilo uporablja v skladu z navodili.
English: Posatex has been studied in dogs in both laboratory and field trials.
Slovenian: Zdravilo Posatex je bilo preučeno na psih v laboratoriju in v preskušanjih na terenu.
English: Ear infections in dogs can be caused by bacteria or fungi.
Slovenian: Vnetja ušes pri psih lahko povzročijo bakterije ali glivice.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) POSATEX
Slovenian: EMEA/V/C/122 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) POSATEX
English: Mild reddening of the ear has been observed.
Slovenian: Opažena je bila blaga pordelost ušesa.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Posatex exceed its risks for the treatment of acute otitis externa and acute exacerbations of recurrent otitis externa in dogs and recommended that Posatex be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Posatex pri zdravljenju akutnega vnetja ušes in akutnih izbruhov ponavljajočega vnetja ušes pri psih večje od z njim povezanih tveganj, ter priporočil, da se za zdravilo Posatex odobri dovoljenje za promet.
English: Posatex is an ear drop suspension, white to off white in colour.
Slovenian: Zdravilo Posatex so kapljice za uho v obliki suspenzije bele do sivo-bele barve.
English: Without ergosterol, the fungus is killed or prevented from spreading.
Slovenian: Brez ergosterola glivica odmre oziroma se ne more širiti.
English: Why has Posatex been approved?
Slovenian: Zakaj je bilo zdravilo Posatex odobreno?
English: Posaconazole is an antifungal that belongs to the group triazoles.
Slovenian: Posokonazol je protiglivično sredstvo, ki spada v skupino triazolov.
English: Posatex contains three active substances: orbifloxacin, mometasone furoate monohydrate and posaconazole.
Slovenian: Zdravilo Posatex vsebuje tri zdravilne učinkovine: orbifloksacin, mometazon furoat monohidrat in posokonazol.
English: For a full list of all side-effects reported with Posatex, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Posatex, glejte navodilo za uporabo.
English: If a person accidentally takes the medicine, seek medical advice immediately and show the package leaflet or the label to a doctor.
Slovenian: Če pride do nenamernega zaužitja zdravila pri človeku, se nemudoma posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
English: What is Posatex?
Slovenian: Kaj je zdravilo Posatex?
English: What is Posatex used for?
Slovenian: Za kaj se zdravilo Posatex uporablja?
English: In both studies the effectiveness of Posatex was compared with that of ear drops containing three similar active substances.
Slovenian: Dve večji preskušanji na terenu sta bila izvedeni eno v Evropi in eno v ZDA: V obeh študijah so učinkovitost zdravila Posatex primerjali z učinkovitostjo kapljic za uho, ki vsebujejo tri podobne zdravilne učinkovine.
English: How does Posatex work?
Slovenian: Kako zdravilo Posatex deluje?
English: How has Posatex been studied?
Slovenian: Kako je bilo zdravilo Posatex raziskano?
English: The bioavailability is 100% by definition.
Slovenian: Biološka uporabnost je po definiciji 100 %.
English: This study should be conducted according to an agreed protocol.
Slovenian: Študijo je treba izvesti v skladu z dogovorjenim protokolom.
English: → Talk to your doctor immediately.
Slovenian: → Takoj se posvetujte z zdravnikom.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of cART.
Slovenian: Take reakcije so navadno opazili v prvih nekaj tednih ali mesecih po uvedbi cART.
English: The trial was composed of three discrete periods:
Slovenian: Preskušanje je potekalo v treh ločenih obdobjih:
English: Do not give this medicine to children and adolescents below 18 years of age.
Slovenian: Tega zdravila ne smete dajati otrokom in mladostnikom, mlajšim od 18 let.
English: Results are similar to the adult population (≥18 to 65 years of age), however no definite conclusions can be drawn.
Slovenian: Rezultati so podobni kot pri odraslem prebivalstvu (≥ 18 do 65 let), vendar dokončnih zaključkov ni mogoče oblikovati.
English: Precautions to prevent transmission should be taken in accordance with national guidelines.
Slovenian: Previdnostni ukrepi za preprečevanje prenosa morajo biti v skladu z nacionalnimi smernicami.
English: This is less likely if you receive Trogarzo regularly and without gaps in treatment.
Slovenian: To je manj verjetno, če zdravilo Trogarzo prejemate redno in brez vrzeli v zdravljenju.
English: Frequencies are defined as very common
Slovenian: Pogostnost je opredeljena kot: zelo pogosti
English: 95% CI*
Slovenian: 95-% IZ*
English: The relevance of this effect for human pregnancy and lactation remains unknown.
Slovenian: Pomen tega učinka na nosečnost in dojenje pri ljudeh še ni znan.
English: Toxicity to reproduction and development
Slovenian: Toksičnost za razmnoževanje in razvoj
English: • It is very important that you are given Trogarzo every 2 weeks as instructed by your doctor.
Slovenian: • Zelo pomembno je, da zdravilo Trogarzo prejmete vsaka dva tedna po navodilih zdravnika.
English: Trial TMB-301
Slovenian: Preskušanje TMB-301
English: Trial TNX-355.03
Slovenian: Preskušanje TNX-355.03
English: Patients in all three arms also received an OBR.
Slovenian: Bolniki vseh treh skupin so prejeli tudi OBR.
English: Date of first authorisation: {DD month YYYY}
Slovenian: Datum prve odobritve: {DD. mesec LLLL}
English: ATC code: J05AX23
Slovenian: Oznaka ATC: J05AX23
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: V primeru pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: Resistance With INSTI resistance Without INSTI resistance OSS
Slovenian: odpornost z odpornostjo proti INSTI brez odpornosti proti INSTI OSS
English: Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time (this is called ‘immune reconstitution inflammatory syndrome').
Slovenian: Vaš imunski sistem se lahko okrepi in se začne boriti proti okužbam, ki so bile dolgo časa prikrite v vašem telesu (to imenujemo „vnetni sindrom imunske obnove“ ).
English: • If you miss an appointment, ask your doctor straight away when to schedule your next dose.
Slovenian: • Če zamudite termin, se nemudoma posvetujte z zdravnikom, kdaj načrtovati naslednji odmerek.
English: Standard supportive measures should be applied as required, including monitoring of vital signs as well as observation of the clinical status of the patient.
Slovenian: Po potrebi je treba izvajati standardne podporne ukrepe, vključno s spremljanjem življenjskih znakov in opazovanjem kliničnega stanja bolnika.
English: The elimination is nonlinear and concentration-dependent.
Slovenian: Izločanje je nelinearno in odvisno od koncentracije.
English: The use of an investigational drug as a component of the optimized background regimen was allowed.
Slovenian: Uporaba preiskovanega zdravila kot sestavnega dela optimizirane osnovne sheme je bila dovoljena.
English: 4 vials (5.32 mL)
Slovenian: 4 viale (5,32 ml)
English: This will reduce the amount of virus in your body, and keeps it at a low level.
Slovenian: To zmanjša količino virusa HIV v vašem telesu in ga ohranja na nizki ravni.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1359/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1359/001
English: This is because Trogarzo has not been studied in this age group.
Slovenian: Razlog za to je, da zdravilo Trogarzo v tej starostni skupini ni bilo preučeno.
English: 10 vials (13.3 mL)
Slovenian: 10 vial (13,3 ml)
English: It is recommended that women of childbearing potential use an effective method of contraception during treatment.
Slovenian: Priporočljivo je, da ženske v rodni dobi med zdravljenjem uporabljajo učinkovito kontracepcijo.
English: {DD month YYYY}
Slovenian: {DD. mesec LLLL}
English: CD4 cells are a type of white blood cell that are important in helping your body to fight infection.
Slovenian: Celice CD4 so vrsta belih krvnih celic, ki pomembno pomagajo vašemu telesu pri boju proti okužbam.
English: End of control period End of functional monotherapy period
Slovenian: konec obdobja nadzorovanja konec obdobja funkcionalne monoterapije
English: Ibalizumab is active against HIV-1 group M isolates (subtypes A, B, C, D, E, or O).
Slovenian: Ibalizumab je aktiven proti izolatom virusa HIV-1 iz skupine M (podtipi A, B, C, D, E ali O).
English: When this is stably kept at undetectable levels, the chances that you can still pass on HIV to your sexual partners become negligible.
Slovenian: Če se ta stabilno ohranja na nezaznavnih ravneh, postanejo možnosti, da še vedno prenesete HIV na svoje spolne partnerje, zanemarljive.
English: Marketing Authorisation Holder and manufacturer Theratechnologies International Limited 10 Earlsfort Terrace,
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec Theratechnologies International Limited 10 Earlsfort Terrace,
English: Patients in Arm A and B arm who experienced virologic failure had the option of switching to a new OBR.
Slovenian: Bolniki v skupinah A in B, ki so doživeli virološki neuspeh, so imeli možnost prehoda na novo OBR.
English: If you stop and there is a gap in your treatment, the level of HIV virus in your blood may begin to rise.
Slovenian: Če prenehate in v vašem zdravljenju pride do vrzeli, se lahko raven virusa HIV v vaši krvi začne povečevati.
English: This is a type of protein called a ‘monoclonal antibody' that can attach to a specific target in the body.
Slovenian: To je vrsta beljakovine, imenovana „monoklonsko protitelo“, ki se lahko veže na specifično mesto v telesu.
English: Demonstrating drug susceptibility by both genotypic and phenotypic testing was required, when testing by both methods was technically feasible.
Slovenian: Občutljivost zdravila je bilo treba dokazati z genotipskim in fenotipskim testiranjem, če je bilo preskušanje z obema metodama tehnično izvedljivo.
English: The body weight range was very narrow in the population PK model, and the impact of body weight may not be precisely estimated.
Slovenian: Razpon telesne mase je bil pri modelu populacijske farmakokinetike zelo ozek in vpliv telesne mase morda ni natančno ocenjen.
English: This medicine reduces the amount of HIV in your body.
Slovenian: To zdravilo zmanjša količino virusa HIV v vašem telesu.
English: Do not change the schedule of your Trogarzo infusions or any of your other antiretroviral medicines without talking to your doctor first.
Slovenian: • Ne spreminjajte urnika svojih infuzij zdravila Trogarzo ali drugih protiretrovirusnih zdravil, ne da bi se najprej posvetovali z zdravnikom.
English: The HIV virus infects cells in your blood called ‘CD4' or ‘T-cells'.
Slovenian: Virus HIV okuži celice v vaši krvi, imenovane „CD4“ ali „T-celice“.
English: A pre- and post-natal developmental study was performed in cynomolgus monkeys.
Slovenian: Pred- in postnatalna razvojna študija je bila izvedena na opicah vrste cynomolgus.
English: This behaviour is characteristic of saturable (capacity-limited) elimination kinetics.
Slovenian: To obnašanje je značilno za kinetiko nasičenega (s kapaciteto omejenega) izločanja.
English: Subjects must have been treated with antiretrovirals for at least 6 months and be failing or had recently failed therapy (i.e., in the last 8 weeks).
Slovenian: Preiskovanci so se morali vsaj 6 mesecev neuspešno zdraviti s protiretrovirusnimi zdravili ali pa so morali biti neuspešno zdravljeni pred kratkim (tj. v zadnjih 8 tednih).
English: Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period and ibalizumab should not be used during breast-feeding.
Slovenian: Znano je, da se humani IgG prve dni po rojstvu izloča v materino mleko, njegova koncentracija pa se kmalu za tem zniža; zato v tem kratkem obdobju ni mogoče izključiti tveganja za dojenega otroka in se ibalizumab med dojenjem ne sme uporabljati.
English: Do not drive or use machines after you have been given Trogarzo if you do not feel well enough.
Slovenian: Ne vozite in ne upravljajte strojev, če se po prejetju zdravila Trogarzo ne počutite dovolj dobro.
English: If a reaction occurs, the infusion should be discontinued and appropriate medical therapies should be administered.
Slovenian: Če pride do reakcije, je treba infuzijo prekiniti in zagotoviti ustrezno zdravljenje.
English: This dose was administered as it is at least 10-fold the estimated free clinical AUC and Cmax for the 800 mg Q2W dose.
Slovenian: Ta odmerek je bil uporabljen, ker je vsaj 10-krat večji od ocenjene proste klinične AUC in Cmax za odmerek 800 mg Q2W.
English: Patients experiencing these symptoms should be advised to use caution when driving or using machines until symptoms abate.
Slovenian: pri katerih se pojavijo ti simptomi, je treba svetovati, naj bodo previdni pri vožnji ali uporabi strojev, dokler se simptomi ne ublažijo.
English: How you will be given Trogarzo The drip (infusion) will be given into a vein over 15 to 30 minutes.
Slovenian: Kako vam bodo dajali zdravilo Trogarzo Kapalno infuzijo (infuzijo) boste prejemali v veno 15-30 minut.
English: * The OSS indicates the number of fully active drugs in a subject's Optimized Background Regimen (OBR) based on both current and available historical resistance test results.
Slovenian: * OSS (Overall Susceptibility Score) označuje število popolnoma aktivnih zdravil v preiskovančevi optimizirani osnovni shemi (OBR - Optimized Background Regimen), ki temelji na trenutnih in razpoložljivih preteklih rezultatih testa odpornosti.
English: Maintenance dose of 800 mg
Slovenian: vzdrževalni odmerek 800 mg
English: If you are not sure, talk to your doctor or nurse before being given Trogarzo.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali medicinsko sestro, preden prejmete zdravilo Trogarzo.
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na viali in škatli poleg oznake „EXP“.
English: However, the effect is unlikely to impact virologic outcome and does not warrant a dose adjustment.
Slovenian: Ta učinek pa verjetno ne bo vplival na virološki izid, zato prilagoditev odmerka ni potrebna.
English: Trogarzo is used in combination with other medicines.
Slovenian: Zdravilo Trogarzo se uporablja v kombinaciji z drugimi zdravili.
English: The majority of subjects in Trial TMB-301 were male (85%), white (55%) and between 23 and 65 years of age (mean [SD] age: 50.5 [11.0] years).
Slovenian: Večina preiskovancev v preskušanju TMB-301 je bila moških (85 %), belcev (55 %) in starih od 23 do 65 let (povprečna [SD] starost: 50,5 [11,0] leta).
English: This period was to establish the safety and durability of virologic suppression of ibalizumab when used in combination with an optimized background regimen.
Slovenian: To obdobje je bilo namenjeno ugotavljanju varnosti in trajnosti virološke supresije ibalizumaba, kadar se uporablja v kombinaciji z optimizirano osnovno shemo.
English: The subject had no adverse reactions associated with the positive immunogenicity result.
Slovenian: Preiskovanec ni imel neželenih učinkov, povezanih s pozitivnim rezultatom glede imunogenosti.
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Slovenian: Čeprav je bilo dokazano, da učinkovito preprečevanje virusnih okužb s protiretrovirusnim zdravljenjem bistveno zmanjša tveganje spolnega prenosa, manjšega preostalega tveganja ni mogoče izključiti.
English: abnormal results on tests of the heart's electrical activity (electrocardiogram)
Slovenian: • nenormalni rezultati pri preiskavah električne aktivnosti srca (elektrokardiogramu)
English: Trogarzo is used in adults to treat HIV infection that has not responded to a number of HIV treatments in the past.
Slovenian: Zdravilo Trogarzo se pri odraslih uporablja za zdravljenje okužbe z virusom HIV, ki se v preteklosti ni odzvala na številne oblike zdravljenja HIV.
English: This helps your body to increase the CD4 cell count in your blood.
Slovenian: To pomaga vašemu telesu povečati število celic CD4 v krvi.
English: Women who are HIV-positive must not breast feed because HIV infection can be passed on to the baby in breast milk.
Slovenian: Ženske, ki so okužene z virusom HIV, ne smejo dojiti, ker se okužba z virusom lahko prenese na otroka z materinim mlekom.
English: HIV-RNA (copies/mL)
Slovenian: HIV-RNK (kopije/ml)
English: Allergic reaction (hypersensivity).
Slovenian: • Alergijska reakcija (preobčutljivost)
English: It is also active against HIV-1 resistant to currently approved antiretroviral medicinal products and exhibits antiretroviral activity against R5-tropic, X4-tropic, and dual-tropic HIV-1.
Slovenian: Aktiven je tudi proti virusu HIV-1, odpornemu proti trenutno odobrenim protiretrovirusnim zdravilom, in ima protiretrovirusno delovanje proti R5-tropnim, X4-tropnim in dvojno tropnim virusom HIV-1.
English: MIAS Pharma Limited Suite 2 Stafford House, Strand Road, Portmarnock, Co. Dublin, D13 H525 Ireland
Slovenian: MIAS Pharma Limited Suite 2 Stafford House, Strand Road, Portmarnock, Co. Dublin, D13 H525 Irska
English: If the treating physician determines there is no additional clinical benefit for the patient in terms of viral load reduction, discontinuation of ibalizumab treatment should be considered, see section 5.1.
Slovenian: Če lečeči zdravnik ugotovi, da za bolnika ni nobene dodatne klinične koristi v smislu zmanjšanja virusne obremenitve, je treba razmisliti o možnosti prenehanja zdravljenja z ibalizumabom, glejte oddelek 5.1.
English: More than one vial of Trogarzo will be needed to get the required dose.
Slovenian: Za zahtevani odmerek bo potrebna več kot ena viala zdravila Trogarzo.