FrancophonIA/ELRC3.0 huggingface dataset:
English: Tepoxalin and its metabolites are highly protein-bound, more than 98%.
Slovenian: Tepoksalin in njegovi presnovki se dobro vežejo na proteine, v več kot v 98 odstotkih.
English: If vomiting continues, administer anti-emetics.
Slovenian: Če se bruhanje še vedno pojavlja, uporabite antiemetike.
English: After a treatment period of 7-10 days, the condition of the dog should be re-evaluated in order to establish the need for continuation of treatment.
Slovenian: Po 7-10 dnevnem zdravljenju se psa ponovno pregleda, da se ugotovi ali je potrebno nadaljevati z zdravljenjem.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilna učinkovina
English: If such use cannot be avoided, close veterinary supervision to monitor for gastrointestinal blood loss is necessary.
Slovenian: Če se uporabi ne moremo izogniti, je potrebna pozorna klinična oskrba za nadzor morebitne izgube krvi v prebavilih.
English: Do not use after the expiry date, which is stated on the blister.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na pretisnem omotu.
English: If there are such undesirable effects, treatment should be discontinued immediately.
Slovenian: Če se neželeni učinki pojavijo, je potrebno zdravljenje takoj prenehati.
English: 1 box containing 1 or 3 blisters.
Slovenian: 1 škatla vsebuje 1 ali 3 pretisne omote.
English: Special precautions to be taken by the person administering the medicinal product to animals
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
English: • has cardiac or hepatic disease
Slovenian: • z boleznimi srca ali jeter
English: The tablet will disintegrate upon contact with moisture.
Slovenian: Tableta se bo v stiku z vlago razgradila.
English: The acid metabolite is a potent, active cyclooxygenase inhibitor and prolongs the activity of the parent compound.
Slovenian: Kisli presnovek je močan, aktiven zaviralec ciklooksigenaze in podaljša delovanje izvorne sestavine.
English: 1 box containing 1, 3 or 6 blisters.
Slovenian: 1 škatla vsebuje 1, 3 ali 6 pretisnih omotov.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMA) http://www.ema.europa.eu.
English: Each blister contains 10 oral lyophilisates.
Slovenian: Vsak pretisni omot vsebuje 10 peroralnih liofilizatov.
English: Other NSAIDs, diuretics, anticoagulants and substances with high plasma protein binding may compete for binding leading to potentially toxic effects.
Slovenian: Druga NSPVZ, diuretiki, antikoagulanti in druge sestavine z veliko sposobnostjo vezave na proteine krvne plazme lahko tekmujejo pri vezavi, kar vodi v možnost pojava škodljivih učinkov.
English: Tepoxalin
Slovenian: Tepoksalin
English: • is dehydrated, hypovolaemic or hypotensive, as there is an increased risk of renal toxicity.
Slovenian: • ki so dehidrirane, hipovolemične ali hipotenzivne, ker obstaja povečana nevarnost toksičnega učinka na ledvice.
English: 10 mg/kg once daily.
Slovenian: 10 mg/kg enkrat dnevno.
English: During clinical trial testing of the product, the incidence of gastrointestinal reactions (diarrhoea/vomiting) was 10%.
Slovenian: V času kliničnega preiskušanja proizvoda je bila pojavnost želodčno črevesnih reakcij (driska/bruhanje) 10 %.
English: Tepoxalin is rapidly (Tmax of approximately 2 hours) absorbed after oral administration in dogs.
Slovenian: Tepoksalin se po peroralnem vnosu pri psih hitro absorbira (Tmax je približno 2 uri).
English: Ensure the food or treat containing the medication is completely consumed.
Slovenian: Prepričajte se, da je zaužita celotna količina hrane, ki vsebuje zdravilo.
English: During clinical trial testing of the product, the incidence of gastrointestinal reactions (diarrhoea/vomiting) occurred in 1 out of 10 animals.
Slovenian: V času kliničnega preiskušanja proizvodaso se želodčno črevesne reakcije (driska/bruhanje) pojavile pri 1 od 10 živali.
English: OTHER INFORMATION Not all pack sizes may be marketed.
Slovenian: DRUGE INFORMACIJE Ni nujno, da so v prometu vsa navedena pakiranja.
English: In case of ingestion of a number of oral lyophilisates by a person, the advice of a doctor should be sought immediately.
Slovenian: V primeru, da neka oseba zaužije številne peroralne liofilizate, se takoj posvetujte z zdravnikom.
English: Tepoxalin is a dual cyclooxygenase / 5-lipoxygenase inhibitor with anti-inflammatory activity.
Slovenian: Tepoksalin je dvojni zaviralec ciklooksigenaze / 5-lipoksigenaze s protivnetnim delovanjem.
English: • is hypersensitive to the product
Slovenian: • ki so preobčutljive na zdravilo
English: Tepoxalin is not watersoluble and becomes very sticky upon wetting.
Slovenian: Tepoksalin ni topen v vodi in postane po vlaženju zelo lepljiv.
English: Plasma concentrations of the acid metabolite are higher than those of the parent compound in the dog.
Slovenian: Koncentracije kislega presnovka v krvni plazmi so višje kot koncentracije matične sestavine.
English: • is pregnant or lactating or in bitches intended for breeding
Slovenian: • v času brejosti in laktacije, ter pri psicah, ki so namenjene za razplod
English: Oral administration of 10 mg tepoxalin / kg bodyweight results in inhibition of prostaglandin and leukotriene synthesis.
Slovenian: Po peroralnem vnosu 10 mg tepoksalina/kg telesne mase pride do zaviranja sinteze prostaglandinov in leukotrienov.
English: Do not use in pregnant or lactating dogs or in bitches intended for breeding.
Slovenian: Ne uporabljajte pri psicah v času brejosti ali laktacije in pri psicah namenjenih za razplod.
English: Do not use in dehydrated, hypovolaemic or hypotensive dogs, as there is an increased risk of renal toxicity.
Slovenian: Zdravila ne dajemo dehidriranim, hipovolemičnim ali hipotenzivnim psom, ker obstaja povečana nevarnost toksičnega učinka na ledvice.
English: Tepoxalin must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Slovenian: Tepoksalina ne smemo dajati skupaj z drugimi NSPVZ ali glukokortikoidi.
English: MANUFACTURER'S BATCH NUMBER Batch {number}
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Serija {številka}
English: Zubrin oral lyophilisates for dogs
Slovenian: Zubrin peroralni liofilizat za pse
English: 10 mg tepoxalin per kg bodyweight once daily.
Slovenian: 10 mg tepoksalina na kg telesne mase enkrat dnevno.
English: 5.2 Pharmacokinetic properties
Slovenian: 5.2 Farmakokinetične posebnosti
English: Tepoxalin is extensively converted to its acid metabolite.
Slovenian: Tepoksalin se v veliki meri pretvori v svoj kisli presnovek.
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Slovenian: ODMEREK ZA POSAMEZNE ŽIVALSKE VRSTE TER NAČIN UPORABE IN DAJANJA ZDRAVILA
English: D. STATEMENT OF THE MRLs Not applicable
Slovenian: D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Navedba ni smiselna
English: If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought.
Slovenian: Če se pojavijo stranski učinki, prenehajte z zdravljenjem in se posvetujte z veterinarjem.
English: Ensure hands are dry to prevent the tablet from sticking to fingers.
Slovenian: Roke morajo biti suhe, zato da preprečimo morebitno lepljenje na prste.
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Slovenian: A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA
English: Tepoxalin must not be administered in conjunction with other NSAIDs or glucocorticosteroids, diuretics or anticoagulants.
Slovenian: Tepoksalina ne smemo dajati skupaj z drugimi NSPVZ ali analgetiki, glukokortikoidi, diuretiki, inantikoagulanti.
English: When this is not possible, or when dogs resist having the product placed directly into the mouth, put the tablet immediately before administration into a small amount of moistened food, or in a moist treat.
Slovenian: Zdravilo dajte psom 1-2 uri po hranjenju.V kolikor to ni mogoče ali ko zdravila ne morete dati psom neposredno v gobec, vstavite tableto neposredno pred dajanjem v manjšo količino navlažene hrane ali v navlažen obrok.
English: 10 mg/kg of body weight once daily.
Slovenian: 10 mg/kg telesne mase enkrat dnevno.
English: Manufacturer for the Batch Release:
Slovenian: Izdelovalec, odgovoren za sprostitev serije:
English: C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Slovenian: C. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABO
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/028/002-008
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/00/028/002-008
English: At a therapeutic dose of 10 mg/kg, the Cmax of tepoxalin was 1.08 ± 0.37 μg/ml in dogs fed a low fat meal and 1.19 ± 0.29 μg/ml in dogs fed a high fat meal.
Slovenian: Pri psih, ki so bili hranjeni z obroki z visoko vsebnostjo maščob je bila Cmax 1.19 ± 0.29 μg/ml.
English: Do not use if your dog
Slovenian: Ne uporabljajte pri živalih:
English: Marketing Authorisation Holder
Slovenian: IMETNIKA DOVOLJENJA ZA PROMET
English: 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če
English: Typical undesirable side-effects associated with NSAIDs are vomiting, soft faeces/diarrhoea, blood in faeces, reduced appetite, lethargy and renal disorders.
Slovenian: Značilni stranski učinki uporabe nesteroidnih protivnetnih zdravil (NSPVZ)so bruhanje, mehko blato/driska, kri v blatu, zmanjšan apetit , letargija in ledvične motnje.
English: INDICATION(S) Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.
Slovenian: INDIKACIJA(E) Zmanjšanje vnetja in bolečine, ki jih povzročajo akutna in kronična mišičnoskeletna obolenja.
English: Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.
Slovenian: Zmanjšanje vnetja in bolečine, ki jih povzročajo akutna in kronična mišičnoskeletna obolenja.
English: • has had gastrointestinal ulceration or bleeding
Slovenian: • z želodčnimi ali črevesnimi razjedami ali s krvavitvijo
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only
Slovenian: BESEDILO “SAMO ZA ŽIVALI” Samo za živali.
English: PHARMACEUTICAL FORM Oral lyophilisates
Slovenian: FARMACEVTSKA OBLIKA peroralni liofilizat
English: Not applicable
Slovenian: Ni smiselno.
English: BATCH NUMBER Batch {number}
Slovenian: ŠTEVILKA SERIJE Serija {številka}
English: Special care should be taken when treating dogs with marked renal insufficiency.
Slovenian: Posebni previdnostni ukrepi so potrebni pri uporabi zdravila pri psih z okvaro ledvic.
English: INDICATIONS Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.
Slovenian: INDIKACIJE Zmanjšanje vnetja in bolečine, ki jih povzročajo akutna in kronična mišičnoskeletna obolenja.
English: To be supplied only on veterinary prescription.
Slovenian: Izdaja zdravila za uporabo v veterinarski medicini je le na recept.
English: Zubrin 50 mg oral lyophilisates for dogs Zubrin 100 mg oral lyophilisates for dogs Zubrin 200 mg oral lyophilisates for dogs Tepoxalin
Slovenian: Zubrin 50 mg peroralni liofilizat za pse Zubrin 100 mg peroralni liofilizat za pse Zubrin 200 mg peroralni liofilizat za pse Tepoksalin
English: SPECIAL STORAGE PRECAUTIONS Keep out of the reach and sight of children.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte nedosegljivo otrokom.
English: 6.5 Nature and composition of immediate packaging Zubrin oral lyophilisates are supplied in boxes with foil blisters.
Slovenian: Zubrin peroralni liofilizati se dobavljajo v škatlah z pretisnimi omoti.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER {50 mg}{100 mg}{200 mg}
Slovenian: {50 mg}{100 mg}{200 mg}
English: NSAID overdosage is characterised by vomiting, soft faeces/diarrhoea, blood in faeces, reduced appetite and lethargy.
Slovenian: Preveliko odmerjanje NSPVZ se kaže z bruhanjem, mehkim blatom/drisko, pojavom krvi v blatu, zmanjšanim apetitom in letargijo.
English: Vomiting or diarrhoea may occur due to treatment.
Slovenian: Posledice zdravljenja so lahko bruhanje in driska.
English: Peel back foil to reveal a single oral lyophilisate in the form of a round tablet.
Slovenian: Za odprtje posameznega peroralnega liofilizata, ki je v obliki okrogle tablete, odlepi folijo na zadnji strani.
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM” Zdravilo shranjujte nedosegljivo otrokom.
English: 50 mg / oral lyophilisate
Slovenian: 50 mg / peroralni liofilizat
English: No accumulation of tepoxalin or its acid metabolite was detected after multiple dosing over a broad dose range.
Slovenian: Po večkratnih vnosih odmerkov različnih količinah ni bilo opaženih kopičenj tepoksalina ali njegovega kislega presnovka.
English: Use is contraindicated in animals suffering from cardiac or hepatic disease, or where there is a history of gastrointestinal ulceration, or bleeding, or where there is hypersensitivity to the product.
Slovenian: Ne uporabljamo pri psicah v času brejosti in laktacije, ter pri psicah, ki so namenjene za razplod Zdravila ne dajemo živalim z boleznimi srca ali jeter ali tistim z želodčnimi ali črevesnimi razjedami ali s krvavitvijo in pri preobčutljivosti na zdravilo.
English: 200 mg / oral lyophilisate
Slovenian: 200 mg / peroralni liofilizat
English: Absorption of tepoxalin is facilitated via administration to dogs in a fed state.
Slovenian: Absorpcijo olajša dajanje tepoksalina v času sitosti.
English: 10 oral lyophilisates (EU/2/00/028/006) 30 oral lyophilisates (EU/2/00/028/007) 60 oral lyophilisates (EU/2/00/028/008)
Slovenian: ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/00/028/006 (1 pretisni omot) EU/2/00/028/007 (3 pretisni omoti) EU/2/00/028/008 (6 pretisnih omotov)
English: For animal treatment only - to be supplied only on veterinary prescription.
Slovenian: BESEDILO “SAMO ZA ŽIVALI” Samo za živali uporablja se le na osnovi recepta veterinarja.
English: 100 mg / oral lyophilisate
Slovenian: 100 mg /peroralni liofilizat
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 50 mg oral lyophilisates for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Zubrin 50 mg peroralni liofilizat za pse
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 200 mg oral lyophilisates for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Zubrin 200 mg peroralni liofilizat za pse
English: Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers
Slovenian: Zato da preprečite lepljenja peroralnega liofilizata na prste, imejte suhe roke.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 100 mg oral lyophilisates for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Zubrin 100 mg peroralni liofilizat za pse
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Active substance
Slovenian: NAVEDBA ZDRAVILNE UČINKOVIN(E) IN DRUGE(IH) SESTAVIN(E) Zdravilna učinkovina
English: At doses of 30 mg/kg and above, oral administration of tepoxalin is associated with discoloured faeces ranging in colour from white to yellow, which is the result of unabsorbed drug.
Slovenian: Barva blata je lahko bela do rumena, kar je posledica neabsorbiranega zdravila.
English: EU/2/00/028/005 (3 blisters)
Slovenian: (EU/2/00/028/005)
English: EU/2/00/028/003 (3 blisters)
Slovenian: (EU/2/00/028/003)
English: 10 oral lyophilisates (EU/2/00/028/004) 30 oral lyophilisates (EU/2/00/028/005)
Slovenian: ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/00/028/004 (1 pretisni omot) EU/2/00/028/005 (3 pretisni omoti)
English: Tepoxalin and its metabolites are excreted in the faeces (99%).
Slovenian: Tepoksalin in njegovi presnovki se izločajo z blatom
English: 10 oral lyophilisates (EU/2/00/028/002) 30 oral lyophilisates (EU/2/00/028/003)
Slovenian: ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/00/028/002 (1 pretisni omot) EU/2/00/028/003 (3 pretisni omoti)
English: In the case of overdosage discontinue therapy.
Slovenian: Če se pojavijo stranski učinki, takoj prenehamo z zdravljenjem.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Slovenian: POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDEOSKRBE IN UPORABE
English: EU/2/00/028/008 (6 blisters)
Slovenian: (EU/2/00/028/008)
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration and marketing authorisation holders in the member states
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: It is intended for long-term use.
Slovenian: Namenjeno je dolgotrajni uporabi.
English: This effect was maintained for up to four years.
Slovenian: Ta učinek je trajal do štiri leta.
English: The effect of these on the safety and effectiveness of the medicine is not fully known.
Slovenian: Učinek teh na varnost in učinkovitost zdravila še ni v celoti znan.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 16 December 2015.
Slovenian: Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 16. decembra 2015.
English: Aldurazyme laronidase
Slovenian: Aldurazyme laronidaza
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aldurazyme on 10 June 2003.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Aldurazyme, veljavno po vsej Evropski uniji, izdala 10. junija 2003.
English: Some of these are severe, but the number of side effects tends to decrease with time.
Slovenian: Nekateri učinki so resni, vendar njihovo število sčasoma upade.
English: The full EPAR for Aldurazyme 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 Aldurazyme je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: After this, the study continued for up to four years and all of the patients were treated with Aldurazyme.
Slovenian: Po tem se je študija nadaljevala še štiri leta, vsi bolniki pa so bili zdravljeni z zdravilom Aldurazyme.
English: Half of the children treated had a normal size liver at the end of the study.
Slovenian: Polovica zdravljenih otrok je imela ob koncu študije jetra normalne velikosti.
English: These were measured before and after 26 weeks of treatment.
Slovenian: Meritve so bile opravljene pred 26-tedenskim zdravljenjem in po njem.
English: In children under five years of age, Aldurazyme reduced the levels of GAGs in the urine by about 60%.
Slovenian: Pri otrocih, mlajših od pet let, je zdravilo Aldurazyme zmanjšalo ravni GAG v urinu za približno 60 %.
English: The study was looking mainly at the safety of the medicine, but it also measured its ability to reduce the levels of GAGs in the urine and the size of the liver.
Slovenian: S študijo so proučevali zlasti varnost zdravila, merili pa so tudi njegovo sposobnost zmanjšanja ravni GAG v urinu ter velikost jeter.
English: This is a summary of the European public assessment report (EPAR) for Aldurazyme.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Aldurazyme.
English: Other information about Aldurazyme
Slovenian: Druge informacije o zdravilu Aldurazyme
English: Aldurazyme is given once a week as an infusion into a vein.
Slovenian: Zdravilo se daje enkrat na teden kot infuzija v veno.
English: Aldurazyme should be given in a hospital or clinic where resuscitation equipment is available, and patients may need to receive some medicines before the infusion to prevent an allergic reaction.
Slovenian: Zdravilo Aldurazyme je treba dati v ustreznem bolnišničnem ali kliničnem okolju, kjer je na voljo oprema za oživljanje, bolniki pa bodo pred infuzijo morda morali prejeti določena zdravila za preprečevanje alergijske reakcije.
English: For more information about treatment with Aldurazyme, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Aldurazyme preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: It is produced by a method known as ‘recombinant DNA technology': the enzyme is made by cells into which a gene (DNA) has been introduced that makes them able to produce laronidase.
Slovenian: Proizvaja se z metodo, imenovano „tehnologija rekombinantne DNK“, pri kateri encim izdelajo celice, ki so prejele gen (DNK), kar jim omogoča tvorjenje laronidaze.
English: Aldurazyme must not be used in people who are severely allergic to laronidase or any of the other ingredients.
Slovenian: Zdravila Aldurazyme ne smejo uporabljati osebe, ki so hudo alergične na laronidazo ali katero koli drugo sestavino zdravila.
English: Most of the side effects seen with Aldurazyme are reactions caused by the infusion procedure rather than the medicine itself.
Slovenian: Večina neželenih učinkov, opaženih pri uporabi zdravila Aldurazyme, so reakcije, ki se pojavijo zaradi postopka infuzije, in ne reakcije na samo zdravilo.
English: What benefit has Aldurazyme shown during the studies?
Slovenian: Kakšne koristi je zdravilo Aldurazyme izkazalo med študijami?
English: This means that substances called glycosaminoglycans (GAGs) are not broken down, so they build up in most of the organs in the body and damage them.
Slovenian: To pomeni, da se nekatere snovi, imenovane glikozaminoglikani (GAG), ne razgradijo in se kopičijo v večini telesnih organov, v katerih povzročajo škodo.
English: Aldurazyme was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval.
Slovenian: Zdravilo Aldurazyme je pridobilo dovoljenje za promet v „izjemnih okoliščinah“, saj so bile zaradi redkosti bolezni ob odobritvi zdravila na voljo le omejene informacije.
English: Almost all patients who receive Aldurazyme develop antibodies (proteins that are produced in response to Aldurazyme).
Slovenian: Skoraj pri vseh bolnikih, ki prejemajo zdravilo Aldurazyme, nastanejo protitelesa (beljakovine, ki nastanejo v odziv na zdravljenje s tem zdravilom).
English: Aldurazyme has also been studied in 20 children below the age of five years who received Aldurazyme for a year.
Slovenian: Zdravilo so proučevali tudi pri 20 otrocih, mlajših od pet let, ki so zdravilo Aldurazyme prejemali eno leto.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aldurazyme.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The study showed that Aldurazyme had improved both the FVC and the walking ability of patients at 26 weeks.
Slovenian: Študija je pokazala, da je zdravilo Aldurazyme izboljšalo forsirano vitalno kapaciteto (FVC) in zmožnost hoje bolnikov po 26 tednih.
English: What is the risk associated with Aldurazyme?
Slovenian: Kakšna tveganja so povezana z zdravilom Aldurazyme?