FrancophonIA/ELRC3.0 huggingface dataset:
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Grasustek Vsebina pakiranja in dodatne informacije
English: Additionally, a higher incidence of febrile neutropenia was observed in younger children aged 0-5 years (75 %) compared to older children aged 6-11 years and 12-21 years (70 % and 33 %, respectively) and adults (see sections 4.8 and 5.2).
Slovenian: Poleg tega so pri mlajših otrocih, starih od 0-5 let, ugotovili pogostejši pojav febrilne nevtropenije (75 %) kot pri starejših otrocih, starih od 6-11 let (70 %) in od 12-21 let (33 %), ter pri odraslih (glejte poglavji 4.8 in 5.2).
English: • If you get left upper abdominal pain or pain at the tip of your shoulder.
Slovenian: • če začutite bolečino levo zgoraj v trebuhu ali v predelu lopatice.
English: Uncommon pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported.
Slovenian: Občasno so poročali o pljučnih neželenih učinkih, vključno z intersticijsko pljučnico, pljučnim edemom, pljučnimi infiltrati in pljučno fibrozo.
English: USV Private Limited D-115, TTC Industrial Area, Shirvane Navi Mumbai - 400706, Maharashtra, INDIA
Slovenian: Navi Mumbai - 400706, Maharashtra, Indija
English: 01-607 Warsaw, Poland Tel: + 48 22 460 92 00
Slovenian: Tel: + 48 22 460 92 00
English: • redness at the site of injection.
Slovenian: • pordelost na mestu injiciranja;
English: • Inflammation of aorta (the large blood vessel which transports blood from the heart to the body),
Slovenian: • vnetje aorte (velike krvne žile, po kateri teče kri iz srca v telo); glejte poglavje 2,
English: Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see section 4.8).
Slovenian: Po uporabi pegfilgrastima so poročali o na splošno asimptomatskih primerih splenomegalije in primerih rupture vranice, vključno z nekaj smrtnimi primeri (glejte poglavje 4.8).
English: This medicinal product contains 30 mg sorbitol in each 6 mg dose which is equivalent to 50 mg/ml.
Slovenian: Vsak 6-miligramski odmerek tega zdravila vsebuje 30 mg sorbitola, kar je enakovredno vsebnosti 50 mg/ml.
English: • if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the skin that itch
Slovenian: • če se vam pojavi alergijska reakcija, vključno s šibkostjo, padcem krvnega tlaka, težavami z dihanjem, otekanjem obraza (anafilakso), pordelostjo in navali vročine, izpuščajem na koži in predeli kože, ki srbijo;
English: Serious allergic reactions, including anaphylaxis can occur in patients receiving pegfilgrastim (uncommon) (see section 4.4).
Slovenian: Pri bolnikih, ki prejemajo pegfilgrastim, se lahko pojavijo resne alergijske reakcije, vključno z anafilakso (občasno) (glejte poglavje 4.4).
English: Nature and contents of container
Slovenian: Vrsta ovojnine in vsebina
English: Push the plunger all the way down as far as it will go to inject all of the solution.
Slovenian: Bat potisnite povsem do konca in tako injicirajte celotno raztopino.
English: What you need to know before you use Grasustek
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Grasustek Ne uporabljajte zdravila Grasustek:
English: Av. V. Holjevca 40 , 10000 Zagreb, Hrvatska Tel:+385 1 6641 830
Slovenian: Hrvatska Tel:+385 1 6641 830
English: In two randomised, double-blind, pivotal studies in patients with high risk stage II-IV breast cancer undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 11 daily administrations).
Slovenian: II.-IV. stadiju na mielosupresivni kemoterapiji z doksorubicinom in docetakselom je uporaba pegfilgrastima v obliki enega samega odmerka na cikel skrajšala trajanje nevtropenije in pojav febrilne nevtropenije, podobno kot so to opazili pri vsakodnevni uporabi filgrastima (mediana števila dnevnih aplikacij je bila 11).
English: Each pack contains 1 glass pre-filled syringe with an attached stainless steel needle and needle cap.
Slovenian: Ena škatla vsebuje 1 stekleno napolnjeno injekcijsko brizgo s pričvrščeno iglo iz nerjavečega jekla in pokrovčkom igle.
English: Special populations Renal impairment No dose change is recommended in patients with renal impairment, including those with end-stage renal disease.
Slovenian: Pri bolnikih z okvarjenim delovanjem ledvic, vključno z bolniki z boleznijo ledvic v zadnjem stadiju, se sprememba odmerka ne priporoča.
English: Common
Slovenian: Splošno
English: INFORMATION IN BRAILLE Grasustek 6 mg
Slovenian: Grasustek 6 mg
English: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Slovenian: 4.1 Terapevtske indikacije Skrajšanje trajanja nevtropenije in v primeru nastanka febrilne nevtropenije pri odraslih bolnikih, ki prejemajo citotoksično kemoterapijo za maligne tvorbe (z izjemo kronične mieloične levkemije in mielodisplastičnih sindromov).
English: The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who received
Slovenian: Farmakokinetiko pegfilgrastima so raziskali pri 37 pediatričnih bolnikih s sarkomom, ki so po dokončanju kemoterapije z VAdriaC/IE prejeli 100 µg/kg pegfilgrastima.
English: Studies in rats indicated that reproductive performance, fertility, oestrous cycling, days between pairing and coitus, and intrauterine survival were unaffected by pegfilgrastim given subcutaneously.
Slovenian: Študije, opravljene na podganah, so pokazale, da subkutano dovajanje pegfilgrastima ne vpliva na sposobnosti razmnoževanja, plodnost, pojatvene cikle, dni med seznanjanjem in parjenjem ter preživetje v maternici.
English: Clear, colourless solution for injection.
Slovenian: raztopina za injiciranje Bistra, brezbarvna raztopina za injiciranje.
English: Alvogen Romania SRL 44B, Theodor Pallady Blvd. 3rd district, 032266
Slovenian: 44B, Theodor Pallady Blvd.
English: Keep the syringe and sharps disposal container out of sight and reach of children.
Slovenian: Brizgo in vsebnik za ostre odpadke shranjujte nedosegljivo otrokom.
English: • Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors.
Slovenian: • Pri bolnikih z rakom in zdravih darovalcih so redko poročali o vnetju aorte (velike krvne žile, po kateri teče kri iz srca v telo).
English: Sæmundargötu 15-19, 101 Reykjavík, Ísland Tel: +354 522 2900
Slovenian: Sæmundargötu 15-19, 101 Reykjavík, Ísland
English: Grasustek contains the active substance pegfilgrastim.
Slovenian: Zdravilo Grasustek vsebuje učinkovino pegfilgrastim.
English: What Grasustek looks like and contents of the pack
Slovenian: Izgled zdravila Grasustek in vsebina pakiranja
English: Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell trait or sickle cell disease (see section 4.8).
Slovenian: Pri bolnikih s srpastimi celicami ali srpastocelično anemijo je bila uporaba pegfilgrastima povezana s srpastocelično krizo (glejte poglavje 4.8).
English: Sodium acetate * Sorbitol (E420) Polysorbate 20
Slovenian: sorbitol (E420)
English: years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 μg·hr/ml) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 μg·hr/ml and 29.3 ± 23.2 μg·hr/ml, respectively) (see section 5.1).
Slovenian: (47,9 ± 22,5 µg h/ml) kot pri otrocih, starih od 6-11 let (22,0 ± 13,1 µg·h/ml) in od 12-21 let (29,3 ± 23,2 µg h/ml) (glejte poglavje 5.1).
English: Grasustek contains sorbitol (E420) and sodium
Slovenian: Zdravilo Grasustek vsebuje sorbitol (E420) in natrij
English: Do not try to inject yourself if you have not been trained.
Slovenian: Če vas samoinjiciranja še niso naučili, si injekcij ne poskušajte dajati sami.
English: Allow the pre-filled syringe to reach room temperature before injecting.
Slovenian: Pred injiciranjem mora napolnjena injekcijska brizga doseči sobno temperaturo.
English: Warning/Precaution: DO NOT lift the product by the plunger or needle cover.
Slovenian: Opozorilo/previdnostni ukrep: Izdelka NE DRŽITE za bat ali za pokrovček igle.
English: On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies.
Slovenian: Novo napolnjeno injekcijsko brizgo in druge pripomočke položite na čisto, dobro osvetljeno delovno površino.
English: Isolated cases of sickle cell crises have been reported in patients with sickle cell trait or sickle cell disease (uncommon in sickle cell patients) (see section 4.4).
Slovenian: Pri bolnikih s srpastimi celicami ali s srpastocelično anemijo so v posameznih primerih poročali o srpastocelični krizi (občasno pri bolnikih s srpastocelično anemijo) (glejte poglavje 4.4).
English: Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30 °C) it must either be used within 3 days or disposed of.
Slovenian: Ko injekcijsko brizgo vzamete iz hladilnika in le-ta doseže sobno temperaturo (pod 30 °C), jo morate v
English: Remove the pre-filled syringe from blister as shown.
Slovenian: Napolnjeno injekcijsko brizgo vzemite z ovitka tako, kot kaže slika.
English: • coughing up blood (haemoptysis)
Slovenian: • izkašljevanje krvi (hemoptiza).
English: A higher frequency of serious adverse reactions in younger children aged 0-5 years (92 %) has been observed compared to older children aged 6-11 and 12-21 years respectively (80 % and 67 %) and adults.
Slovenian: Pri mlajših otrocih, starih od 0-5 let, so ugotovili večjo pogostnost resnih neželenih učinkov (92 %) kot pri starejših otrocih, starih od 6-11 let ter od 12-21 let (80 % oziroma
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon [≥
Slovenian: Med začetnim ali nadaljnjim zdravljenjem s pegfilgrastimom so se pojavile reakcije preobčutljivostne vrste, vključno z izpuščajem na koži, urtikarijo, angioedemom, dispnejo, eritemom, zardevanjem in hipotenzijo (občasno [≥1/1.000 do <1/100]).
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Izogibajte se močnemu stresanju.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: FARMACEVTSKI PODATKI Seznam pomožnih snovi natrijev acetat *
English: Uncommon side effects (may affect up to 1 in 100 people)
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 oseb):
English: Rare side effects (may affect up to 1 in 1,000)
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 oseb):
English: In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving
Slovenian: V multicentrični, randomizirani, odprti študiji II.
English: Thrombocytopenia Leukocytosis1
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija1; levkocitoza1
English: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with pegfilgrastim.
Slovenian: Med začetnim ali nadaljnjim zdravljenjem s pegfilgrastimom je bila opisana preobčutljivost, vključno z anafilaktičnimi reakcijami.
English: • are planning to have a baby
Slovenian: • načrtujete zanositev.
English: A small (n = 83), Phase II, randomised, double-blind study in patients receiving chemotherapy for de novo acute myeloid leukaemia compared pegfilgrastim (single dose of 6 mg) with filgrastim, administered during induction chemotherapy.
Slovenian: faze pri bolnikih, ki so prejemali kemoterapijo zaradi de novo akutne mieloične levkemije, je primerjala pegfilgrastim (enkraten 6-miligramski odmerek) s filgrastimom ob aplikaciji med indukcijsko kemoterapijo.
English: The entire dose has to be administered to trigger the guard.
Slovenian: Za sprostitev varnostnega ščitnika morate injicirati celotni odmerek.
English: Uncommon elevations in liver function tests (LFTs) for ALT (alanine aminotransferase) or AST (aspartate aminotransferase), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy.
Slovenian: Občasno so se bolnikom, ki so po citotoksični kemoterapiji prejeli pegfilgrastim, pojavila zvišanja jetrnih funkcijskih testov (LFT) za ALT (alanin-aminotransferaze) ali AST (aspartat-aminotransferaze).
English: Grasustek 6 mg solution for injection in pre-filled syringe
Slovenian: Grasustek 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Haemoptysis
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora sindrom akutne dihalne stiske pljučni neželeni učinki (intesticijska pljučnica, pljučni edem, pljučni infiltrati in pljučna fibroza) hemoptiza pljučna hemoragija
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Grasustek.
Slovenian: Če uporabljate zdravilo Grasustek, morate prenehati dojiti, razen če vam zdravnik ne naroči drugače.
English: The injections should be given into the thigh, abdomen or upper arm. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
English: Uncommonly, cases have resulted in respiratory failure or ARDS, which may be fatal (see section 4.4).
Slovenian: ARDS, ki sta lahko smrtno nevarna (glejte poglavje 4.4).
English: (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 x 109) was observed in younger children aged 0-5 years (8.9 days) compared to older children aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults.
Slovenian: faze pri pediatričnih bolnikih s sarkomom (n = 37), ki so dobili 100 µg/kg pegfilgrastima po 1. ciklusu kemoterapije z vinkristinom, doksorubicinom in ciklofosfamidom (VAdriaC/IE), so pri mlajših otrocih, starih od 0-5 let, ugotovili dolgotrajnejšo hudo nevtropenijo (nevtrofilci < 0,5 × 109) (8,9 dneva) kot pri starejših otrocih, starih od 6-11 let (6 dni) in od 12-21 let (3,7 dneva), in pri odraslih.
English: Grasustek 6 mg solution for injection in a pre-filled syringe pegfilgrastim
Slovenian: Grasustek 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi pegfilgrastim
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml (10 mg/ml) solution for injection.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima v 0,6 ml (10 mg/ml) raztopine za injiciranje.
English: The needle has flexible, rigid needle shield.
Slovenian: Igla je zaščitena z upogljivim trdnim ščitnikom igle.
English: There were no adverse effects observed in offspring from pregnant rats given pegfilgrastim subcutaneously, but in rabbits pegfilgrastim has been shown to cause embryo/foetal toxicity (embryo loss) at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose.
Slovenian: Pri potomcih brejih podgan, ki so jim subkutano dali pegfilgrastim, niso opazili neželenih učinkov, pri kuncih pa so pokazali, da pegfilgrastim v kumulativnih odmerkih, ki znašajo približno 4-kratni odmerek,
English: Uncommon events of cutaneous vasculitis have been reported in patients treated with pegfilgrastim.
Slovenian: Občasno so pri bolnikih, ki so jih zdravili s pegfilgrastimom, poročali o dogodkih kožnega vaskulitisa.
English: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration.
Slovenian: Po dajanju G-CSF so poročali o neželenih učinkih na pljučih, zlasti o intersticijski pljučnici.
English: Water for injections
Slovenian: polisorbat 20 voda za injekcije
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni prebavil navzea1 Bolezni kože in podkožja
English: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim.
Slovenian: Pri bolnikih, ki so prejemali filgrastim in pegfilgrastim, so poročali o primerih glomerulonefritisa.
English: USE OF THE MEDICINAL PRODUCT
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTERED SYRINGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA BRIZGO V PRETISNEM OMOTU
English: Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients.
Slovenian: Po dajanju G-CSF zdravim osebam in onkološkim bolnikom so poročali o aortitisu.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe 1 pre-filled syringe with automatic needle guard (0.6 ml).
Slovenian: Ena napolnjena injekcijska brizga z avtomatičnim ščitnikom igle (0,6 ml).
English: Injection site reactions, including injection site erythaema (uncommon) as well as injection site pain (common events) have occurred on initial or subsequent treatment with pegfilgrastim.
Slovenian: Med začetnim ali nadaljnjim zdravljenjem s pegfilgrastimom so se pojavile reakcije na mestu injiciranja, vključno z eritemom na mestu injiciranja (občasno) in tudi bolečino na mestu injiciranja (pogosto).
English: Pulmonary adverse events
Slovenian: Neželeni dogodki na pljučih
English: In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20 % (docetaxel 100 mg/m2 every 3 weeks for 4 cycles).
Slovenian: V dvojno slepi, s placebom kontrolirani študiji pri bolnicah z rakom na dojki so ocenili učinek pegfilgrastima na pojav febrilne nevtropenije po uporabi takšne sheme kemoterapije, ki je povezana z 10
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BLISTERED SYRINGE LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in less than 1 % of patients receiving pegfilgrastim.
Slovenian: Pri manj kot 1 % bolnikov, ki dobivajo pegfilgrastim, so opazili število belih krvničk, ki je enako 100 × 109/l ali višje.
English: Common side effects (may affect up to 1 in 10 people)
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 oseb):
English: Croatia
Slovenian: Magyarország
English: Hypersensitivity reactions;
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije; anafilaksija
English: Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 ml solution for injection.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima* v 0,6 ml raztopine za injiciranje.
English: APPROPRIATE
Slovenian: Pomembno
English: Vascular Disorders
Slovenian: kožni vaskulitis
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution for injection.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima v 0,6 ml raztopine za injiciranje.
English: Caution: Avoid contact with the plunger and needle during the preparation of the syringe, The safety device is normally activated by pressure from the plunger on the syringe.
Slovenian: Varnostna naprava se običajno aktivira s pritiskom bata na brizgo.
English: Vertrieb
Slovenian: Sledljivost
English: Inspect the medicine content through the viewing window of the pre-filled syringe.
Slovenian: S pomočjo pregledovalnega okenca na napolnjeni injekcijski brizgi preglejte zdravilo.
English: Talk to your doctor, pharmacist or nurse before using Grasustek:
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Grasustek se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: The safety and efficacy of Grasustek have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Slovenian: Pri bolnikih, ki prejemajo kemoterapijo, povezano z odloženo mielosupresijo, na primer nitrozouree,
English: Capillary leak syndrome1
Slovenian: Bolezni živčevja glavobol1 Žilne bolezni sindrom kapilarne prepustnosti aortitis
English: After the injection is complete, one of the below alternatives can be followed : -Remove the needle from the injection site and release the plunger until the entire needle is covered by the guard.
Slovenian: - Odstranite iglo z mesta injiciranja in sprostite bat, tako da varnostni ščitnik prekriva celotno iglo.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution.
Slovenian: Ena napolnjena injekcijska igla vsebuje 6 mg pegfilgrastima v 0,6 ml raztopine.
English: România
Slovenian: Bucharest, Romania
English: Immune system Disorders
Slovenian: Organski sistem po MedDRA Neželeni učinki
English: How to store Grasustek
Slovenian: Shranjevanje zdravila Grasustek
English: Shelf life
Slovenian: USV Private Limited
English: Injection site pain Non-cardiac chest pain
Slovenian: bolečina v prsih, ki ne izvira iz srca reakcije na mestu injiciranja
English: PHARMACEUTICAL FORM Solution for injection.
Slovenian: raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Keep pre-filled syringes out of the sight and reach of children.
Slovenian: Napolnjene injekcijske brizge shranjujte nedosegljive otrokom.
English: This summary was last updated in May 2013.
Slovenian: Ta povzetek je bil nazadnje posodobljen 05-2013.
English: The authorisation was renewed on 29 January 2006.
Slovenian: Dovoljenje za promet z zdravilom je bilo podaljšano dne 29. januarja 2006.
English: Other information about Pirsue:
Slovenian: Druge informacije o zdravilu Pirsue:
English: The clinical effectiveness was studied in a large number of dairy herds in 8 European countries.
Slovenian: Klinično učinkovitost so preučili na velikem številu čred molznih krav v 8 evropskih državah.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Pirsue on 29 January 2001.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Pirsue, veljavno po vsej Evropski uniji, odobrila dne 29. januarja 2001.
English: Information was provided on the pharmaceutical quality, the tolerance of the product in cows and the safety in humans (people in contact with the product and consumers of meat and milk) and the environment.
Slovenian: Predloženi so bili podatki o farmacevtski kakovosti, toleranci na zdravilo pri kravah ter njegovi varnosti za ljudi (za ljudi, ki pridejo v stik z zdravilom, in ljudi, ki uživajo meso in mleko) in okolje.
English: Pirlimycin hydrochloride
Slovenian: Pirlimicin hidroklorid
English: As a result, the bacteria cannot produce any more protein and will stop growing.
Slovenian: Zaradi tega bakterije ne morejo več tvoriti beljakovin in posledično se njihova rast prekine.
English: Cows with subclinically infected udders were treated with Pirsue (once daily for 8 days) or with another antibiotic, authorised in the EU to treat these infections.
Slovenian: Krave s subklinično okužbo vimena so zdravili z zdravilom Pirsue (enkrat dnevno v trajanju 8 dni) ali z drugim antibiotikom, ki je dovoljen v EU za zdravljenje teh okužb.
English: Subclinical means that the infection is present but not sufficiently developed to produce clear clinical signs in the cow.
Slovenian: Subklinična okužba pomeni, da je okužba že prisotna, vendar se še ni dovolj razvila, da bi se pri kravi pokazali jasni klinični znaki.
English: Mastitis is an infection in the udder.
Slovenian: Mastitis je okužba vimena.
English: What is the risk associated with Pirsue?
Slovenian: Kakšna tveganja so povezana z zdravilom Pirsue?