FrancophonIA/ELRC3.0 huggingface dataset:
English: All needles and syringes should be disposed of in a sharps container.
Slovenian: Vse igle in injekcijske brizge zavrzite v vsebnik za ostre odpadke.
English: Used to draw medicinal solution from the vial into the syringe.
Slovenian: Uporablja se, da raztopino iz viale povlečete v injekcijsko brizgo.
English: The solution should be clear or slightly yellow.
Slovenian: Raztopina mora biti bistra do rahlo rumenkasta.
English: Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
Slovenian: Pri uporabi tega zdravila natančno upoštevajte napotke v tem navodilu ali navodila zdravnika, farmacevta ali medicinske sestre.
English: Alternatively, you can place the dosing syringe in a refrigerator at 2°C to 8°C and you must use it within 8 hours.
Slovenian: Druga možnost je, da pripravljeno injekcijsko brizgo hranite v hladilniku pri temperaturi od 2 °C do 8 °C.
English: Prepare the vial of TAKHZYRO
Slovenian: Pripravite vialo zdravila TAKHZYRO.
English: This is because TAKHZYRO in the blood may interfere with some laboratory tests, leading to inaccurate results
Slovenian: Pred izvedbo laboratorijskih preiskav za ugotavljanje strjevanja krvi zdravniku povejte, da uporabljate zdravilo TAKHZYRO, saj lahko zdravilo TAKHZYRO v krvi vpliva na nekatere laboratorijske preiskave, kar povzroči netočne rezultate.
English: Step 2: Attach blunt tip vial access needle to syringe a) Screw the 18 gauge blunt tip vial access needle to the 3 ml syringe.
Slovenian: 2. korak: Pritrdite iglo s topo konico za dostop do viale a) Iglo velikosti 18 s topo konico za dostop do viale privijte na 3-ml injekcijsko brizgo.
English: How to inject TAKHZYRO
Slovenian: Kako injicirati zdravilo TAKHZYRO
English: unscrew the syringe by holding the top of the needle and turning the syringe counter clockwise.
Slovenian: e) Ne da bi odstranili iglo iz viale, injekcijsko brizgo odvijte tako, da držite vrh igle in obračate injekcijsko brizgo v levo.
English: Only use the syringes, blunt-tip vial access needles and pointed-tip injection needles one time.
Slovenian: Injekcijske brizge, igle s topo konico za dostop do viale in injekcijske igle s konico za injiciranje uporabite samo enkrat.
English: Renal and hepatic impairment
Slovenian: Bolniki z okvaro ledvic in jeter
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij Shire Pharmaceuticals Ireland Limited
English: 150mg q4wks (N=28)
Slovenian: 150 mg vsake 4 tedne (N = 28)
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Slovenian: ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: b) Push the plunger down to inject air into the vial and hold the plunger down.
Slovenian: b) Bat potisnite navzdol, da v vialo injicirate zrak,
English: 300 mg q4wks (N=29)
Slovenian: 300 mg vsake 4 tedne (N = 29)
English: • Empty 3 ml syringe
Slovenian: • prazno 3-ml injekcijsko brizgo
English: Do not recap the needle.
Slovenian: Na iglo ne dajajte pokrovčka.
English: TAKHZYRO contains sodium
Slovenian: Zdravilo TAKHZYRO vsebuje natrij
English: This pack also contains: 3 ml syringe 18 gauge access needle Injection needle
Slovenian: 3-ml injekcijsko brizgo iglo za dostop velikosti 18G injekcijsko iglo
English: Lanadelumab provides sustained control of plasma kallikrein activity and thereby limits bradykinin generation in patients with HAE.
Slovenian: S trajnim nadzorom aktivnosti plazemskega kalikreina lanadelumab zavira nastajanje bradikinina pri bolnikih s HAE.
English: How to use TAKHZYRO
Slovenian: Kako uporabljati zdravilo TAKHZYRO
English: Disodium phosphate dihydrate Citric acid monohydrate Histidine
Slovenian: natrijev hidrogenfosfat dihidrat citronska kislina monohidrat histidin natrijev klorid polisorbat 80 voda za injekcije
English: Do not use if you see particles or a change in colour.
Slovenian: Če vidite delce ali je barva spremenjena, je ne uporabite.
English: Transfer TAKHZYRO into syringe and switch to the pointed-tip injection needle 4.
Slovenian: Zdravilo TAKHZYRO prenesite v injekcijsko brizgo in iglo za dostop do viale zamenjajte z iglo za injiciranje.
English: Place all used syringes and needles in the sharps container.
Slovenian: Vse uporabljene injekcijske brizge in igle zavrzite v vsebnik za ostre odpadke.
English: 150 mg q4wks
Slovenian: 150 mg vsake 4 tedne
English: How TAKHZYRO works
Slovenian: Kako deluje zdravilo TAKHZYRO
English: Nervous system disorders
Slovenian: Bolezni živčevja omotica pogosti
English: Be sure that you read, understand and follow the step-by-step instructions for injecting TAKHZYRO.
Slovenian: Obvezno je, da navodila za injiciranje zdravila TAKHZYRO, razložena po korakih, preberete, razumete in upoštevate.
English: g) Screw the 27 gauge ½-inch (0.4 x 13 mm)
Slovenian: g) Na injekcijsko brizgo privijte injekcijsko) iglo velikosti 27 ½ palca (0,4 x 13 mm) s konico za dajanje.
English: What TAKHZYRO contains
Slovenian: Kaj vsebuje zdravilo TAKHZYRO
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA subkutana uporaba
English: • The active substance is lanadelumab.
Slovenian: Učinkovina je lanadelumab.
English: Avoid vigorous agitation.
Slovenian: Ne stresajte sunkovito.
English: Shire Pharmaceuticals Ireland Limited Blocks 2 and 3 Miesian Plaza 50-58 Baggot Street Lower Dublin 2
Slovenian: 50-58 Baggot Street Lower
English: Inject TAKHZYRO
Slovenian: Injicirajte zdravilo TAKHZYRO.
English: • One 27 gauge ½-inch (0.4 x 13 mm) pointed tip injection needle.
Slovenian: • Eno iglo za injiciranje premera 27G in dolžine ½ palca (0,4 x 13 mm) z ostro konico.
English: TAKHZYRO contains the active substance lanadelumab.
Slovenian: Zdravilo TAKHZYRO vsebuje učinkovino lanadelumab.
English: What TAKHZYRO is used for
Slovenian: Za kaj uporabljamo zdravilo TAKHZYRO
English: Too much bradykinin leads to symptoms of HAE like swelling and pain on the,
Slovenian: Preveč bradikinina povzroči simptome HAE, kot sta otekanje in bolečina rok in nog obraza, vek, ustnic in jezika, grla (larinksa), zaradi česar je dihanje lahko oteženo, spolovil.
English: One vial contains 300 mg of lanadelumab* in 2 mL solution.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 300 mg lanadelumaba* v 2 ml raztopine.
English: • Alcohol wipes
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: • 18 gauge blunt tip vial access needle • 27 gauge ½ inch (0.4 x 13 mm) pointed tip administration (injection) needle.
Slovenian: prazno 3-ml injekcijsko brizgo, iglo za dostop do viale premera 18G s topo konico, iglo za injiciranje premera 27G in dolžine ½ palca (0,4 x 13 mm) z ostro konico.
English: Solution for injection
Slovenian: FARMACEVTSKA OBLIKA raztopina za injiciranje
English: 300 mg q4wks
Slovenian: 300 mg vsake 4 tedne
English: Subcutaneous use Read the package leaflet before use For single use only
Slovenian: POSTOPEK UPORABE Pred uporabo preberite priloženo navodilo!
English: TAKHZYRO 300 mg solution for injection lanadelumab This medicine is subject to additional monitoring.
Slovenian: IME ZDRAVILA IN POT(I) UPORABE TAKHZYRO 300 mg raztopina za injiciranje lanadelumab subkutana uporaba
English: Secondary endpoint - Number of HAE attacks requiring acute treatment from Day 0 to 182 LS Mean (95% CI) monthly attack rate b
Slovenian: Sekundarni opazovani dogodek - število napadov HAE, ki jih je bilo treba akutno zdraviti, od 0. do 182. dneva
English: pointed-tip injection needle to the syringe.
Slovenian: f) Injekcijsko iglo s konico za dajanje velikosti
English: • One 18 gauge blunt tip vial access needle.
Slovenian: • Eno iglo za dostop do viale premera 18G s topo konico.
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovenian: Rezultat za prehranjevanje
English: TAKHZYRO total
Slovenian: Zdravilo TAKHZYRO skupaj
English: What you need to know before you use TAKHZYRO 3.
Slovenian: Kaj je zdravilo TAKHZYRO in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo TAKHZYRO Kako uporabljati zdravilo TAKHZYRO Možni neželeni učinki
English: Criteria
Slovenian: DRUGI PODATKI
English: Return the syringe to an upright position.
Slovenian: Pritrdite iglo s topo konico za dostop do viale.
English: • Muscle pain
Slovenian: NALEPKA (VIALA)
English: UNIT PACK CARTON
Slovenian: ŠTEVILKA SERIJE Lot
English: Adverse drug reaction
Slovenian: Neželeni učinek zdravila
English: Each vial contains 300 mg lanadelumab.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 300 mg lanadelumaba.
English: 20 October 2011
Slovenian: 20. oktober 2011
English: The final opinion was converted into a Decision by the European Commission on 20 October 2011.
Slovenian: Končno mnenje je bilo spremenjeno v sklep Evropske komisije dne 20. oktobra 2011.
English: The referral procedure started on 14 April 2010.
Slovenian: Napotitveni postopek se je začel dne 14. aprila 2010.
English: Veterinary Medicines and Product Data Management
Slovenian: Veterinarska zdravila in upravljanje podatkov o zdravilu
English: The Committee appointed Dr Bruno Urbain as rapporteur and Mrs Ruth Kearsley as co-rapporteur.
Slovenian: Odbor je za poročevalca določil dr. Bruna Urbaina, za soporočevalko pa go. Ruth Kearsley.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended summary of product characteristics in Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Prilogi I. Znanstveni zaključki so na voljo v Prilogi II, dopolnjeni povzetek glavnih značilnosti zdravila pa v Prilogi III.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of Synulox Lactating Cow and associated names and differences between the summary of product characteristics (SPC) of the product as authorised in the Member States, the issue was referred on 26 March 2010 by Belgium and Denmark to the CVMP under Article 34(1) of Directive 2001/82/EC.
Slovenian: Zaradi različnih nacionalnih odločitev držav članic v zvezi z odobritvijo zdravila Synulox Lactating Cow in povezana imena ter razlik med povzetki glavnih značilnosti zdravila (SPC), odobrenimi v državah članicah, sta Belgija in Danska zadevo dne 26. marca 2010 napotili na CVMP v skladu s členom 34(1) Direktive 2001/82/ES.
English: Written explanations were provided by the marketing authorisation holders on 18 August 2010 and 8 February 2011.
Slovenian: Imetniki dovoljenja za promet z zdravilom so pisne razlage podali dne 18. avgusta 2010 in 8. februarja 2011, ustne obrazložitve pa 4. maja 2011.
English: The reason for divergent national decisions regarding the authorisation of the products was mainly the justification of the combination of amoxicillin/clavulanic acid/prednisolone for the treatment of bovine mastitis.
Slovenian: Razlog za razlike med nacionalnimi odločitvami o odobritvi zdravil je bil v glavnem v utemeljitvi kombinacije amoksicilin/klavulanska kislina/prednizolon za zdravljenje bovinega mastitisa.
English: The product is intended for the treatment of bovine clinical mastitis in lactating cows.
Slovenian: Zdravilo je namenjeno zdravljenju bovinega kliničnega mastitisa pri kravah v obdobju laktacije.
English: Further to the resignation of Mrs Ruth Kearsley as CVMP member, Ms Helen Jukes was appointed to replace her and took over the co-rapporteurship.
Slovenian: Ruth Kearsley z mesta članice CVMP je bila kot zamenjava določena ga. Helen Jukes, ki je prevzela vlogo soporočevalke.
English: International non-proprietary name (inn): amoxicillin trihydrate, potassium clavulanate, prednisolone
Slovenian: Mednarodno nelastniško ime (INN): amoksicilin trihidrat, kalijev klavulanat, prednizolon
English: Synulox Lactating Cow and associated names is a 3 g pale cream/buff coloured oily suspension presented in disposable intramammary syringes containing 200 mg amoxicillin as amoxicillin trihydrate, 50 mg clavulanic acid as potassium clavulanate and 10 mg prednisolone.
Slovenian: Zdravilo Synulox Lactating Cow in povezana imena je na voljo v intramamarnih brizgah za enkratno uporabo, ki vsebujejo 3 g oljne suspenzije svetlo kremne/bež barve z 200 mg amoksicilina v obliki amoksicilin trihidrata, 50 mg klavulanske kisline v obliki kalijevega klavulanata in 10 mg prednizolona.
English: This combination is effective against β-lactamase producing organisms.
Slovenian: Ta kombinacija je učinkovita proti organizmom, ki tvorijo β-laktamaze.
English: Amoxicillin is a broad spectrum bactericidal β-lactam antibiotic.
Slovenian: Amoksicilin je baktericidni β-laktamski antibiotik širokega spektra.
English: Prednisolone is an anti-inflammatory corticosteroid.
Slovenian: Prednizolon je protivnetni kortikosteroid.
English: The main sections of disharmony of the existing SPCs related to indications, posology and withdrawal periods.
Slovenian: Nesoglasja v obstoječih povzetkih glavnih značilnosti zdravila zadevajo poglavja, ki se nanašajo na indikacije, odmerjanje in obdobja karence.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP considered that the benefit/risk profile for Synulox Lactating Cow and associated names remains positive subject to
Slovenian: CVMP je na podlagi ocene trenutno razpoložljivih podatkov, ki sta jo pripravila poročevalca, menil, da po spremembi dovoljenj za promet z zdravilom v skladu s povzetkom glavnih značilnosti zdravila razmerje med koristmi in tveganji za zdravilo Synulox Lactating Cow in povezana imena ostaja pozitivno, zato je dne 7. junija 2011 sprejel pozitivno mnenje.
English: Clavulanic acid inactivates β-lactamases.
Slovenian: Klavulanska kislina inaktivira betalaktamaze.
English: This summary was last updated in January 2012.
Slovenian: Povzetek je bil nazadnje posodobljen januarja 2012.
English: In very rare cases, they may be serious or fatal.
Slovenian: V zelo redkih primerih so lahko resni ali povzročijo smrtni izid.
English: These side effects occur usually within the first week of treatment and are generally temporary.
Slovenian: Običajno se pojavijo v prvem tednu zdravljenja in so ponavadi začasni.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Acticam on 9 December 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Acticam, veljavno po vsej Evropski uniji, odobrila dne 9. decembra 2008.
English: Other information about Acticam:
Slovenian: Druge informacije o zdravilu Acticam:
English: What benefit has Acticam shown during the studies?
Slovenian: Kakšne koristi je zdravilo Acticam izkazalo med študijami?
English: They disappear once treatment has stopped.
Slovenian: Po prekinitvi zdravljenja izzvenijo.
English: Acticam has been investigated in comparison with Metacam which is already authorised in the EU.
Slovenian: Zdravilo Actican so proučevali v primerjavi z zdravilom Metacam, ki že ima dovoljenje za promet v EU.
English: If the product is swallowed by a person, the advice of a doctor should be sought immediately.
Slovenian: V primeru, da zdravilo nenamerno zaužije človek, se je treba nemudoma posvetovati z zdravnikom.
English: What is the risk associated with Acticam?
Slovenian: Kakšna tveganja so povezana z zdravilom Acticam?
English: Why has Acticam been approved?
Slovenian: Zakaj je bilo zdravilo Acticam odobreno?
English: People with known hypersensitivity (allergic) to meloxicam should avoid contact with the product.
Slovenian: Osebe z znano preobčutljivostjo (alergijo) za nesteroidna protivnetna zdravila naj se izogibajo stiku z zdravilom.
English: Meloxicam acts by inhibition of prostaglandin synthesis.
Slovenian: Meloksikam učinkuje tako, da zavira sintezo prostaglandinov.
English: Acticam should not be administered to pregnant or lactating animals as the safety of the product has not been established in these cases.
Slovenian: Zdravilo Acticam se ne sme uporabljati pri brejih živalih ali živalih v obdobju laktacije, ker varnost zdravila v teh primerih ni bila ugotovljena.
English: Studies have been carried out to prove that Acticam is ‘bioequivalent' to the reference veterinary medicine: this means that Acticam is equivalent to Metacam 1.5 mg/ml suspension in the way it is absorbed and used by the body.
Slovenian: Študije so pokazale, da je zdravilo Acticam „biološko enakovredno“ referenčnemu veterinarskemu zdravilu, to pomeni, da je zdravilo Acticam enako zdravilu Metacam 1,5 mg/ml peroralna suspenzija glede načina, kako ga telo absorbira in uporabi.
English: Acticam contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Slovenian: Zdravilo Acticam vsebuje meloksikam, ki spada v skupino zdravil, ki jim pravimo nesteroidna protivnetna zdravila (NSPVZ).
English: Acticam should also not be used in animals suffering from gastrointestinal or hemorrhagic disorders and impaired renal or hepatic function, animals with known hypersensitivity to NSAIDs, and animals less than 6 weeks of age or in cats of less than 2 kg.
Slovenian: Zdravilo Acticam se ne sme uporabljati pri živalih z obolenji prebavil ali hemoragičnih obolenjih ter pri motnjah jetrne ali ledvične funkcije, živalih z ugotovljeno preobčutljivostjo na nesteroidna protivnetna zdravila ter živalih, mlajših od 6 tednov, ali mačkah, lažjih od 2 kg.
English: A study looked at how Acticam was absorbed and its effects in the body, in comparison with Metacam oral suspension 1.5mg/ml.
Slovenian: V študiji so proučevali absorbiranje zdravila Acticam ter njegove učinke na telo v primerjavi z zdravilom Metacam 1,5 mg/ml peroralna suspenzija.
English: What is Acticam used for?
Slovenian: Za kaj se zdravilo Acticam uporablja?
English: As the prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam reduces those responses.
Slovenian: Prostaglandini so snovi, ki povzročajo vnetje, bolečino, izločanje tekočine in zvišano telesno temperaturo, meloksikam pa zmanjšuje obseg teh odzivov.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Acticam has been shown to be bioequivalent to Metacam
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je menil, da se je zdravilo Acticam v skladu z zahtevami Evropske unije izkazalo kot biološko enakovredno zdravilu Metacam 1,5 mg/ml peroralna suspenzija.
English: Occasional side effects of Acticam are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools and apathy (lack of vitality).
Slovenian: Občasni neželeni učinki zdravila Acticam so enaki kot pri drugih nesteroidnih protivnetnih zdravilih in vključujejo izgubo teka, bruhanje, drisko, kri v blatu in apatijo (pomanjkanje vitalnosti).
English: Acticam is presented as an oral suspension 1.5 mg/ml for dogs (to be given mixed with food) and a solution for injection 5mg/ml.
Slovenian: Zdravilo Acticam je na voljo v obliki peroralne suspenzije za pse v odmerku 1,5 mg/ml (ki se zmeša s hrano) in raztopine za injiciranje v odmerku 5 mg/ml.
English: In case of accidental self-injection, medical advice should be sought immediately showing the package leaflet or the label to the physician.
Slovenian: V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
English: An oral follow-up therapy using meloxicam or other NSAIDs should not be used in cats, as no safe dosage for repeated oral administration has been established.
Slovenian: Pri mačkah zdravljenja ne smete nadaljevati s peroralno obliko meloksikama ali drugega nesteroidnega protivnetnega zdravila, ker pri njih še ni določen varen odmerek za takšno nadaljevalno peroralno zdravljenje.
English: Acticam contains meloxicam which belongs to a class of medicines having anti-inflammatory action.
Slovenian: Zdravilo Acticam vsebuje meloksikam, ki spada v skupino zdravil s protivnetnim delovanjem.
English: How does Acticam work?
Slovenian: Kako zdravilo Acticam deluje?
English: How has Acticam been studied?
Slovenian: Kako je bilo zdravilo Acticam raziskano?
English: The CVMP concluded that the benefits of Acticam exceed the risks for the alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders, reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery in dogs and reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery in cats and recommended that Acticam be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Acticam pri umirjanju vnetja in lajšanju bolečine pri akutnih in kroničnih mišičnoskeletnih obolenjih, lajšanju pooperativne bolečine in vnetja po ortopedskih operacijah in operacijah mehkega tkiva pri psih ter lajšanju pooperativne bolečine po ovariohisterektomiji in manjših operacijah mehkega tkiva pri mačkah večje od z njim povezanih tveganj, in priporočil, da se za zdravilo Acticam odobri dovoljenje za promet.
English: Acticam is a ‘generic': this means that Acticam is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam 1.5 mg/ml oral suspension).
Slovenian: To pomeni, da je podobno „referenčnemu veterinarskemu zdravilu“, ki je že bilo odobreno v EU (zdravilu Metacam 1,5 mg/ml peroralna suspenzija).
English: What is Acticam?
Slovenian: Kaj je zdravilo Acticam?
English: Dogs: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders and reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Slovenian: Psi: Umirjanje vnetja in lajšanje bolečine pri akutnih in kroničnih mišično-skeletnih obolenjih ter lajšanje pooperativne bolečine in zmanjšanje vnetja po ortopedskih operacijah in operacijah mehkega tkiva.
English: Acticam is efficacious in alleviating the inflammation and pain in both acute and chronic musculoskeletal disorders and reducing the post operative pain following orthopaedic and soft tissue surgery in dogs and in reducing the post-operative pain after ovariohysterectomy and minor soft tissue surgery in cats.
Slovenian: Zdravilo Acticam je učinkovito pri umirjanju vnetja in lajšanju bolečine pri akutnih in kroničnih mišično-skeletnih obolenjih ter lajšanju pooperativne bolečine po ortopedskih operacijah in operacijah mehkega tkiva pri psih ter lajšanju pooperativne bolečine po ovariohisterektomiji in manjših operacijah mehkega tkiva pri mačkah.
English: This summary was last updated in 11-2015.
Slovenian: Povzetek je bil nazadnje posodobljen 11-2015.
English: In children aged
Slovenian: Pri otrocih,
English: The European Commission granted a marketing authorisation valid throughout the European Union for CellCept on 14 February 1996.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom CellCept, veljavno po vsej Evropski uniji, izdala 14. februarja 1996.
English: What measures are being taken to ensure the safe and effective use of CellCept?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila CellCept?
English: This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.
Slovenian: Posledično ti niso tako učinkoviti pri prepoznavanju in napadanju presajenih organov, s čimer se zmanjša tveganje zavrnitve organa.
English: The full EPAR for CellCept 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 CellCept je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for CellCept.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo CellCept.