FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon (may affect up to 1 in 100 people): • increase in white blood cells (leukocytosis)
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): • zmanjšanje števila trombocitov, kar zmanjša sposobnost strjevanja krvi (trombocitopenija)
English: Solution for injection/infusion Multipack: 10 (2 packs of 5) pre-filled syringes containing 0.8 mL.
Slovenian: raztopina za injiciranje/infundiranje Skupno pakiranje:10 (2 pakiranji po 5) napolnjenih injekcijskih brizg, ki vsebujejo 0,8 ml.
English: Hypersensitivity-type reactions including anaphylaxis, rash, urticaria, angioedema, dyspnoea and hypotension occurring on initial or subsequent treatment have been reported in clinical studies and in post marketing experience.
Slovenian: V kliničnih študijah in v obdobju trženja zdravila so poročali o preobčutljivostnih reakcijah, vključno z anafilakso, izpuščajem, urtikarijo, angioedemom, dispnejo in hipotenzijo, ki so se pojavile na začetku ali v nadaljevanju zdravljenja.
English: Solution for injection/infusion Multipack: 10 (2 packs of 5) pre-filled syringes containing 0.5 mL.
Slovenian: raztopina za injiciranje/infundiranje Skupno pakiranje:10 (2 pakiranji po 5) napolnjenih injekcijskih brizg, ki vsebujejo 0,5 ml.
English: For reversal of neutropenia
Slovenian: Zaustavitev napredovanja nevtropenije
English: Solution for injection/infusion
Slovenian: raztopina za injiciranje/infundiranje.
English: In clinical studies, > 90 % of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
Slovenian: bolnikov odzvalo na te odmerke, tako da so za ustavitev napredovanja nevtropenije v povprečju potrebovali 2 dni.
English: Geriatric Use
Slovenian: Subkutana uporaba
English: For patients who have not had extensive chemotherapy, one leukapheresis is often sufficient.
Slovenian: Pri bolnikih, ki niso bili izpostavljeni dolgotrajni kemoterapiji,
English: The most serious adverse reactions that may occur during filgrastim treatment include: anaphylactic reaction, serious pulmonary adverse events (including interstitial pneumonia and ARDS), capillary leak syndrome, severe splenomegaly/splenic rupture, transformation to myelodysplastic syndrome or leukaemia in SCN patients, GvHD in patients receiving allogeneic bone marrow transfer or peripheral blood cell progenitor cell transplant and sickle cell crisis in patients with sickle cell disease.
Slovenian: sindrom kapilarne prepustnosti, hudo splenomegalijo/rupturo vranice, preobrazbo v mielodisplastični sindrom ali levkemijo pri bolnikih s SCN, GvHD pri bolnikih z alogensko presaditvijo kostnega mozga ali krvotvornih matičnih celic v periferno kri ter srpastocelično krizo pri bolnikih s srpastocelično anemijo.
English: Solution for injection/infusion 5 pre-filled syringes containing 0.5 mL.
Slovenian: raztopina za injiciranje/infundiranje 5 napolnjenih injekcijskih brizg, ki vsebujejo 0,5 ml.
English: • decreased feeling of sensitivity, especially in the skin (hypoaesthesia)
Slovenian: • zmanjšan občutek občutljivosti, zlasti na dotik (hipestezija) • mravljinčenje ali odrevenelost dlani ali stopal (parestezija)
English: Ratiograstim 30 MIU/0.5 mL solution for injection/ infusion Ratiograstim 48 MIU/0.8 mL solution for injection/infusion
Slovenian: Ratiograstim 30 milijonov i.e./0,5 ml raztopina za injiciranje/infundiranje Ratiograstim 48 milijonov i.e./0,8 ml raztopina za injiciranje/infundiranje
English: Box for the prescribed dose
Slovenian: Uporabljajte v skladu s spodnjimi navodili: Škatla za predpisani odmerek
English: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 mL (60 MIU/mL, 600 microgram/mL).
Slovenian: Ena napolnjena injekcijska brizga vsebuje 30 milijonov mednarodnih enot [i.e.] (300 mikrogramov) filgrastima v 0,5 ml (60 M i.e./ml, 600 mikrogramov/ml).
English: Solution for injection/infusion 5 pre-filled syringes containing 0.8 mL.
Slovenian: raztopina za injiciranje/infundiranje 5 napolnjenih injekcijskih brizg, ki vsebujejo 0,8 ml.
English: Based on reported data for another filgrastim product similar to the reference product, comparable findings plus increased foetal malformations were observed at 100 µg/kg/day, a maternally toxic dose which corresponded to a systemic exposure of approximately 50-90 times the exposures observed in patients treated with the clinical dose of 5 µg/kg/day.
Slovenian: Na osnovi podatkov za drugo zdravilo, ki vsebuje filgrastim in je podobno referenčnem zdravilu, so primerljive ugotovitve ter zvečano število malformacij ploda opazili pri 100 µg/kg/dan, pri odmerku,
English: Pulmonary adverse reactions, in particular interstitial lung disease, have been reported after G-CSF administration.
Slovenian: Po uporabi G-CSF so poročali o neželenih učinkih na pljučih, še posebno o intersticijski bolezni pljuč.
English: Ratiograstim is supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5) pre-filled syringes.
Slovenian: Zdravilo Ratiograstim je na voljo v pakiranjih po 1, 5 ali 10 napolnjenih injekcijskih brizg ali v obliki skupnih pakiranj po 10 (2 pakiranji po 5) napolnjenih injekcijskih brizg.
English: ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Slovenian: ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm
English: Paediatric use in the SCN and cancer settings
Slovenian: Pediatrična uporaba pri bolnikih s hudo kronično nevtropenijo in rakom
English: Do not use any Ratiograstim that is left in the syringe.
Slovenian: Zdravila Ratiograstim, ki morebiti ostane v injekcijski brizgi, ne smete več uporabiti.
English: Fertility Filgrastim did not affect reproductive performance or fertility in male or female rats (see section 5.3).
Slovenian: Filgrastim ni vplival na sposobnost razmnoževanja ali plodnost podganjih samcev ali samic.
English: Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 mL (60 MIU/mL, 600 microgram/mL).
Slovenian: Vsaka napolnjena injekcijska brizga vsebuje 48 milijonov mednarodnih enot [i.e.] (480 mikrogramov) zdravila filgrastim v 0,8 ml (60 M i.e./ml, 600 mikrogramov/ml).
English: Ratiograstim 30 MIU/0.5 mL solution for injection/infusion Filgrastim
Slovenian: Ratiograstim 30 M i.e./0,5 ml raztopina za injiciranje/infundiranje filgrastim
English: The first dose of filgrastim should be administered at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.
Slovenian: Bolnik lahko prvi odmerek filgrastima prejme po najmanj 24 urah po citotoksični kemoterapiji oziroma po najmanj 24 urah v primeru presaditve kostnega mozga.
English: However, in view of the potential risks associated with severe leukocytosis, a white blood cell count should be performed at regular intervals during filgrastim therapy.
Slovenian: Poročali niso o nobenih neželenih učinkih, ki bi jih lahko neposredno pripisali tej stopnji levkocitoze, vendar je treba glede na potencialno tveganje, povezano s pojavom hude levkocitoze, pri teh bolnikih med zdravljenjem s filgrastimom redno določati število belih krvničk.
English: It is important to contact your doctor immediately - if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea).
Slovenian: - če se vam pojavi alergijska reakcija, vključno z oslabelostjo, padcem krvnega tlaka, težavami z dihanjem, zatekanjem obraza (anafilaksa), kožnim izpuščajem, srbečim izpuščajem (koprivnica),
English: There were no differences in the safety profiles for paediatric patients treated for SCN.
Slovenian: Varnostni profili bolnikov, ki so jih zdravili za hudo kronično nevtropenijo, se niso razlikovali od varnostnih profilov drugih bolnikov.
English: Neutropenia may be due to bone marrow infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
Slovenian: kompleksom Mycobacterium avium ali malignim obolenjem, kot je limfom.
English: Graft versus Host
Slovenian: Reakcija presadka proti gostitelju (GvHD - Graft versus Host Disease)
English: Packs containing 1, 5 or 10 pre-filled syringes with 0.8 mL solution or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.8 mL solution.
Slovenian: Pakiranja po 1, 5 ali 10 napolnjenih injekcijskih brizg z 0,8 ml raztopine ali skupna pakiranja z 10 (2 pakiranji po 5) napolnjenimi injekcijskimi brizgami z 0,8 ml raztopine.
English: Ratiograstim can be used - to increase the number of white blood cells after treatment with chemotherapy to help prevent infections.
Slovenian: - za povečevanje števila belih krvničk po zdravljenju s kemoterapijo, kot pomoč pri preprečevanju okužb;
English: For the mobilisation of PBPCs in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation
Slovenian: Za izplavljanje matičnih celic v periferno kri pri bolnikih, zdravljenih z mielosupresivno ali mieloablativno terapijo, ki ji sledi avtologna presaditev matičnih celic iz periferne krvi
English: Talk to your doctor, pharmacist or nurse before using Ratiograstim.
Slovenian: Pred začetkom uporabe zdravila Ratiograstim se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Dilution to a final concentration less than 0.2 MIU (2 μg) per mL is not recommended at any time.
Slovenian: Zdravila nikoli ne smete razredčiti v tolikšni meri, da bi končna koncentracija padla pod 0,2 milijona i.e. (2 μg).
English: Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at > 2.0 x 109/L.
Slovenian: Glede na absolutno število nevtrofilcev pri posameznih bolnikih bodo morda potrebne nadaljnje prilagoditve odmerkov, zato da bi bilo število nevtrofilcev večje od 2,0 x 109/l.
English: • decrease of platelets which reduces the ability of blood to clot (thrombocytopenia)
Slovenian: zmanjšanje števila trombocitov, kar zmanjša sposobnost strjevanja krvi (trombocitopenija)
English: How to store Ratiograstim
Slovenian: Shranjevanje zdravila Ratiograstim
English: Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Slovenian: Imetnik dovoljenja za promet z zdravilom ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm
English: Prior to allogeneic PBPC transplantation, use of filgrastim for the mobilisation of PBPC in normal donors allows a collection of ≥ 4 x 10
Slovenian: Pred alogensko presaditvijo matičnih celic iz periferne krvi uporaba filgrastima za izplavljanje matičnih celic pri zdravih darovalcih omogoča, da se zbere ≥ 4 milijone CD34+ celic/kg telesne mase prejemnika pri večini darovalcev, ki so bili deležni dveh levkaferez.
English: If you have any of the following or combination of the following side effects: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Slovenian: oteklost ali zabuhlost, ki jo lahko spremlja manj pogostejše odvajanje urina, težko dihanje,
English: In normal stem cell donors an increase in white blood cells (leukocytosis) and a decrease of platelets may be seen this reduces the ability of your blood to clot (thrombocytopenia), these will be monitored by your doctor.
Slovenian: Pri zdravih darovalcih matičnih celic se lahko opazi povečanje števila belih krvničk (levkocitoza) in zmanjšanje števila trombocitov.
English: Psychiatic diorders
Slovenian: KLINIČNI PODATKI
English: EU/1/08/444/005 1 pre-filled syringe EU/1/08/444/006 5 pre-filled syringes EU/1/08/444/008 10 pre-filled syringes EU/1/08/444/011 1 pre-filled syringe with safety device EU/1/08/444/012 5 pre-filled syringes with safety device
Slovenian: EU/1/08/444/005 1 napolnjena injekcijska brizga EU/1/08/444/006 5 napolnjenih injekcijskih brizg EU/1/08/444/008 10 napolnjenih injekcijskih brizg
English: Infestations
Slovenian: Izplavljanje
English: Ratiograstim 48 MIU/0.8 mL solution for injection/ infusion Filgrastim
Slovenian: Ratiograstim 48 M i.e./0,8 ml raztopina za injiciranje/infundiranje filgrastim
English: EU/1/08/444/001 1 pre-filled syringe EU/1/08/444/002 5 pre-filled syringes EU/1/08/444/004 10 pre-filled syringes EU/1/08/444/009 1 pre-filled syringe with safety device EU/1/08/444/010 5 pre-filled syringes with safety device
Slovenian: EU/1/08/444/001 1 napolnjena injekcijska brizga EU/1/08/444/002 5 napolnjenih injekcijskih brizg EU/1/08/444/004 10 napolnjenih injekcijskih brizg brez
English: A detailed history of HFI symptoms has to be taken of each patient before giving this medicinal product.
Slovenian: Pred dajanjem zdravila mora biti pri bolniku narejena podrobna anamneza, povezana s simptomi dedne intolerance za frukozo.
English: In patients undergoing a stem cell or bone marrow transplant, Graft versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands or soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints.
Slovenian: Znaki in simptomi vključujejo izpuščaj na dlaneh in podplatih, razjede v ustih, črevesju, jetrih, koži ali očeh, pljučih, vagini in sklepih.
English: Acetic acid, glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi ocetna kislina, koncentrirana; ledocet natrijev hidroksid sorbitol (E420) polisorbat 80 voda za injekcije
English: The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MIU (10 μg)/kg/day for 5 to 7 consecutive days.
Slovenian: Če se uporablja samostojno, je priporočeni odmerek filgrastima za izplavljanje matičnih celic iz periferne krvi 1,0 x milijonov i.e. (10 μg)/kg/dan od 5 do 7 zaporednih dni.
English: Assessment of progenitor cell yields
Slovenian: Rezultati meritev števila celic CD34+
English: Respiratory failurea Pulmonary oedemaa
Slovenian: Bolezni živčevja glavobola omotica hipestezija parestezija
English: Meta-analysis
Slovenian: Metaanaliza
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: Aspartate aminotransf erase increased Gammaglutamyl transferase increased
Slovenian: žolčnika in žolčevodov hepatomegalija zvečanje vrednosti zvečanje vrednosti aspartataminotra alkalne fosfatazev krvi nsferaze zvečanje vrednosti gamaglutamil transferaze
English: Proteinuria Glomerulon ephritis
Slovenian: Bolezni sečil disurija hematurija proteinurija glomerulonefri tis nenormalni izvidi preiskav urina
English: Transfusion reactione a See section c (Description of selected adverse reactions) b There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section c) c Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain d Cases were observed in the post-marketing setting in patients undergoing bone marrow transplant or
Slovenian: c vključuje bolečino v kosteh, bolečino v hrbtu, artralgijo, mialgijo, bolečine v okončinah, mišičnoskeletne bolečine, mišično-skeletne bolečine v prsih, bolečine v vratu d v obdobju trženja so opažali primere pri bolnikih, ki so jim presadili kostni mozeg ali opravili izplavljanje PBPC
English: It is recommended to perform morphologic and cytogenetic bone marrow examinations in patients at regular intervals (approximately every 12 months).
Slovenian: (približno na vsakih 12 mesecev) opravi morfološke in citogenetske preiskave kostnega mozga.
English: Subsequently the dose may be individually adjusted every 1 to 2 weeks to maintain the average neutrophil count between 1.5 x 109/L and 10 x 109/L.
Slovenian: Za to, da bi povprečno število nevtrofilcev ostalo med 1,5 x 109/l in 10 x 109/l, se odmerek lahko prilagaja glede na posameznika vsak teden oz. vsaka dva tedna.
English: For PBPC mobilisation in normal donors, filgrastim should be administered at 1.0 MIU (10 μg)/kg/day for 4 to 5 consecutive days.
Slovenian: Odmerjanje Za postopek izplavljanja matičnih celic iz periferne krvi zdravi darovalci 4 do 5 dni zapored prejmejo filgrastim v odmerku 1,0 milijon i.e. (10 μg)/kg/dan.
English: There was a low frequency (approximately 3 %) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim.
Slovenian: V kliničnem preskušanju bolnikov s SCN, ki so dobivali filgrastim, so poročali o mielodisplastičnih sindromih (MDS) ali levkemiji, ki pa niso bili pogosti (pri približno 3 %).
English: Filgrastim may be given as a 24 hour subcutaneous continuous infusion or subcutaneous injection.
Slovenian: Filgrastim za izplavljanje matičnih celic iz periferne krvi pri samostojni uporabi: Filgrastim lahko dajemo v obliki 24-urne kontinuirane subkutane infuzije ali subkutane injekcije.
English: Cases of decreased bone density and osteoporosis have been reported in paediatric patients with SCN receiving chronic treatment with filgrastim.
Slovenian: Pediatrični bolniki s hudo kronično nevtropenijo Pri pediatričnih bolnikih s hudo kronično nevtropenijo, ki prejemajo kronično zdravljenje s filgrastimom, so poročali o primerih zmanjšane kostne gostote in osteoporoze.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na zdravilno učinkovino (zdravilne učinkovine) ali katero koli pomožno snov,
English: Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive medicinal products.
Slovenian: Tveganje, povezano s povečanimi odmerki mielosupresivnih zdravil Zdravljenje s filgrastimom samim ne izključuje možnosti pojava trombocitopenije in anemije pri jemanju mielosupresivnega zdravila.
English: Leukocytosi sa
Slovenian: Kožni vaskulitis
English: However, the administration of melphalan, carboplatin or BCNU together with filgrastim has been shown to be effective for progenitor mobilisation.
Slovenian: Dolgotrajna uporaba zdravil, kot so melfalan, karmustin (BCNU) in karboplatin pred poskusom izplavljanja krvotvornih matičnih celic, lahko zmanjša pričakovani donos teh celic, vendar pa je bilo ugotovljeno, da je uporaba melfalana, karboplatina ali BCNU skupaj s filgrastimom učinkovita pri izplavljanju krvnih matičnih celic.
English: Sickle cell crisis, in some cases fatal, have been reported with the use of filgrastim in patients with sickle cell trait or sickle cell disease.
Slovenian: Pri uporabi filgrastima pri bolnikih z genetsko predispozicijo za srpaste celice ali z anemijo srpastih celic so poročali o srpastoceličnih krizah, ki so bile v nekaterih primerih smrtne.
English: The recommended starting dose is 0.5 MIU (5 μg)/kg/day as a single dose or in divided doses.
Slovenian: Idiopatična ali ciklična nevtropenija Priporočeni začetni odmerek je 0,5 milijona i.e. (5 μg)/kg/dan v enkratnem odmerku ali v večkratnih odmerkih.
English: Diarrhoeaa, e Vomitinga,e Nauseaa
Slovenian: Bolezni prebavil diarejaa,e bruhanjea,e navzeaa bolečina v ustih zaprtjee
English: What Ratiograstim is used for
Slovenian: Za kaj uporabljamo zdravilo Ratiograstim
English: Splenic rupturea Sickle cell anaemia with crisisa
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija anemijae splenomegalijaa zmanjšanje vrednosti hemoglobinae levkocitozaa ruptura vranicea srpastocelična anemija s krizoa
English: Permanently discontinue Ratiograstim in patients with clinically significant hypersensitivity.
Slovenian: Pri bolnikih s klinično pomembno preobčutljivostjo je treba zdravljenje s filgrastimom trajno prekiniti.
English: Consideration should be given to temporary discontinuation or dose reduction of filgrastim in patients with severe chronic neutropenia who develop thrombocytopenia (platelet count < 100 x 109/l).
Slovenian: Pri bolnikih s hudo kronično nevtropenijo, pri katerih se pojavi trombocitopenija (število trombocitov < 100 x 109/l), je treba razmisliti o začasni prekinitvi zdravljenja ali zmanjšanju odmerka filgrastima.
English: Acute respiratory distress syndromea
Slovenian: Žilne bolezni hipertenzija hipotenzija venookluzivna bolezend sindrom kapilarne prepustnostia aortitis
English: Thrombocyt openia Anaemiae
Slovenian: Psihiatrične motnje insomnija
English: • nose bleeds (epistaxis)
Slovenian: • krvavitev iz nosu (epistaksa) • zaprtje
English: Fluid volume disturbances
Slovenian: (pirofosfatna hondrokalcino za) motnje volumna tekočine
English: 1 pre-filled syringe containing 0.8 mL 1 pre-filled syringe with safety device containing 0.8 mL 5 pre-filled syringes containing 0.8 mL 5 pre-filled syringes with safety device containing 0.8 mL 10 pre-filled syringes containing 0.8 mL
Slovenian: 1 napolnjena injekcijska brizga z varnostnim pripomočkom, ki vsebuje 0,8 ml
English: Do not increase the dose your doctor has given you.
Slovenian: Če ste uporabili večji odmerek zdravila Ratiograstim, kot bi smeli Ne povečajte odmerka, ki vam ga je dal zdravnik.
English: Page 2/2©EMEA 2006
Slovenian: Stran 2/2©EMEA 2006
English: This summary was last updated in September 2006.
Slovenian: Ta povzetek je bil nazadnje posodobljen 09-2006.
English: In most cases, these effects are mild and stop without any treatment.
Slovenian: V večini primerov so ti učinki blagi in izzvenijo brez zdravljenja.
English: The weight lowering effect was relatively moderate (in the range of 6-7 % of the weight before treatment).
Slovenian: Učinek nižanja telesne teže je bil relativno zmeren (v razponu 6-7 % telesne teže pred zdravljenjem).
English: Two large field trials were conducted, one in Europe and one in the USA, in healthy dogs which had a bodyweight 20% higher than recommended.
Slovenian: Opravljena sta bila dva velika preskusa na terenu (eden v Evropi, drugi v ZDA) na zdravih psih, katerih telesna teža je bila za 20 % višja od priporočene.
English: It is available in three pack sizes; 55 ml or 120 ml bottles for dogs weighing up to 36 kg and a 210 ml bottle for dogs weighing up to 48 kg.
Slovenian: Na voljo je v treh pakiranjih: plastenka s 55 ml ali 120 ml za pse, ki tehtajo do 36 kg, in plastenka z 210 ml za pse, ki tehtajo do 48 kg.
English: It is used as part of a programme that also includes controlling the dog's intake of food.
Slovenian: Uporablja se kot del programa, ki obsega tudi nadzor prehranskega vnosa.
English: This is related to the mode of action of the product.
Slovenian: Ta učinek je povezan z načinom delovanja zdravila.
English: The dogs also received other medicines during the study as required, such as vaccines, worming tablets, anti-flea or anti-tick treatments, antibiotics and anti-inflammatory medicines.
Slovenian: Psi so med preskusoma po potrebi prejemali tudi druga zdravila, npr. cepiva, tablete proti glistam, zdravila proti bolham in klopom, antibiotike in protivnetna zdravila.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Yarvitan to Janssen Animal Health B.V.B.A.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Yarvitan, veljavno po vsej Evropski uniji, odobrila družbi Janssen Animal Health B.V.B.A., Belgija, dne 14/11/2006.
English: If accidental eye contact occurs, flush immediately with lots of water.
Slovenian: Če pride do nenamernega stika z očmi, nemudoma izperite z obilico vode.
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 nenamerno zaužijete to zdravilo, se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko.
English: The dog then receives the medicine for a further 3 weeks, at the same time as the adjusted diet.
Slovenian: Pes nato prejema zdravilo dodatne 3 tedne sočasno s prilagojeno prehrano.
English: Other information about Yarvitan:
Slovenian: Druge informacije o zdravilu Yarvitan:
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 ni za prehrano ljudi.