FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinically relevant effects of Duaklir Genuair on ECG parameters (including QT-interval) compared with aclidinium, formoterol and placebo were seen in Phase III studies of 6 to 12 months duration conducted in approximately 4,000 patients with COPD.
Slovenian: V 6- do 12-mesečnih študijah 3. faze pri približno 4.000 bolnikih s KOPB niso opazili nobenih klinično pomembnih učinkov zdravila Duaklir Genuair na parametre elektrokardiograma (vključno z intervalom QT) v primerjavi z aklidinijem, formoterolom in placebom.
English: Duaklir Genuair 340 mcg/12 mcg inhalation powder aclidinium/formoterol fumarate dihydrate
Slovenian: Duaklir Genuair 340/12 μg prašek za inhaliranje aklidinij/formoterolijev fumarat dihidrat za inhaliranje
English: NN:
Slovenian: Začetek:
English: Duaklir Genuair is unlikely to affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Malo verjetno je, da bi zdravilo Duaklir Genuair vplivalo na vašo sposobnost upravljanja vozil in strojev.
English: You should not use this medicine to treat a sudden attack of breathlessness or wheezing.
Slovenian: Zdravilo Duaklir Genuair je indicirano za vzdrževalno (dolgotrajno) zdravljenje KOPB in ga ne smete uporabljati za zdravljenje nenadnega napada zadihanosti ali piskajočega dihanja.
English: Milk: 5 days.
Slovenian: Mleko: 5 dni.
English: No data on overdosing are available.
Slovenian: Podatki o predoziranju niso na voljo.
English: Wash the udder if it is dirty.
Slovenian: Operite vime, če je umazano.
English: Similar concentrations were reached at 12 and 24 hours after a second infusion at a 24 hour interval.
Slovenian: Podobne koncentracije so bile dosežene v 12 in 24 urah po drugi infuziji v 24 urnem presledku.
English: Pirlimycin has a basic pKa (8.5).
Slovenian: Pirlimicin ima bazično pKa (8,5).
English: Norbrook Laboratories Limited Station Works, Camlough Road, Newry, County Down, BT35 6JP
Slovenian: Station Works, Camlough Road, Newry, County Down, BT35 6JP
English: This means it will be more active in an acid environment and tends to concentrate, relative to plasma, in areas with lower pH, such as abscesses.
Slovenian: To pomeni, da je bolj učinkovit v kislem okolju in se koncentrira, glede na plazmo, v področjih z nizkim pH, kot so abscesi.
English: Of the dose infused, 10-13% is excreted in the urine, and 24-30% via the faeces; the remainder is excreted in the milk.
Slovenian: Po vnosu enkratnega odmerka se 10-13 % zdravila izloči z urinom in 24-30% z iztrebki, preostanek pa se izloči z mlekom.
English: Gram-positive isolates with an MIC > 2 µg/ml are to be considered resistant.
Slovenian: Grampozitivni izolati z MIC>2 μg/ml se štejejo kot rezistentni.
English: Date of last renewal: 08/02/2006
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 08/02/2006
English: After intramammary infusion, mean parent concentrations in milk were 10.3 µg/ml at 12 hours and 0.77 µg/ml at 24 hours.
Slovenian: Po intramamarni infuziji je bila koncentracija v mleku 10,3 μg/ml v 12 urah in 0,77 μg/ml v 24 urah.
English: Any unused veterinary medical product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with the local requirements.
Slovenian: Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi zahtevami.
English: Antiinfectious agents/ Antibiotics
Slovenian: učinkovine proti infekcijam/anti biotiki
English: Do not treat cows with palpable udder changes due to chronic subclinical mastitis.
Slovenian: Ne zdravite krav, ki imajo otipljive spremembe na vimenu zaradi kroničnega subkliničnega mastitisa.
English: Pirlimycin
Slovenian: Pirlimicin
English: Resistance against pirlimycin.
Slovenian: Rezistenca na pirlimicin.
English: The active substance in Pirsue 5mg/ml intramammary solution for cattle is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Zdravilna učinkovina v PIRSUE 5 mg/ml intramamarna raztopina za govedo je dovoljena učinkovina kot je navedena v tabeli 1(dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010:
English: The treatment consists of eight infusions of one syringe every 24 hours.
Slovenian: Zdravljenje je sestavljeno iz osmih vnosov, en injektor vsakih 24 ur.
English: MANUFACTURER'S BATCH NUMBER Lot{number}
Slovenian: PROIZVAJALČEVA ŠTEVILKA SERIJE Lot {številka}
English: Wash hands and any exposed skin with soap and water and remove contaminated clothing immediately after use.
Slovenian: Ob morebitnem stiku rok ali kože z intramamarno raztopino, si morate umiti roke z vodo in milom in odstraniti onesnažena oblačila takoj po uporabi.
English: Cross-resistance may occur between pirlimycin and other lincosamides or macrolides.
Slovenian: Možna je navzkrižna rezistenca med pirlimicinom in ostalimi linkozamidi ali makrolidi.
English: Enteric bacteria such as E. coli are intrinsically resistant to pirlimycin.
Slovenian: Črevesne bakterije kot so E. Coli so intrizično rezistentne na pirlimicin.
English: Gently insert the cannula into the teat canal; carefully infuse the product.
Slovenian: Nežno vstavite konico injektorja v seskov kanal; previdno vnesite zdravilo.
English: Intramammary use.
Slovenian: Intramamarna uporaba.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal 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 so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/
English: The product is indicated for use in lactating dairy cows and can be used during pregnancy.
Slovenian: Zdravilo je namenjeno zdravljenju krav v laktaciji in se lahko uporablja v obdobju brejosti.
English: The following instructions should therefore be followed carefully.
Slovenian: Natančno upoštevajte navodila za uporabo.
English: Meat and offal: 23 days.
Slovenian: Meso in organi: 23 dni.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label and the container.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki oziroma zunanji ovojnini.
English: Push plunger with continuous pressure gently and slowly to dispense entire contents into the gland and massage the quarter to distribute the product into the milk cistern.
Slovenian: Potiskajte bat injektorja z enakomernim pritiskom, nežno in počasi, da izpraznite celotno vsebino v mlečno žlezo in masirajte vimensko četrt tako dolgo, da se zdravilo razporedi po mlečni cisterni.
English: Ensure adequate cleansing of the teat (and udder - if needed) before infusion.
Slovenian: Pred vnosom zagotovite ustrezno čiščenje seskov (in vimena, če je to potrebno).
English: Infuse one syringe (50 mg pirlimycin) into each infected quarter.
Slovenian: Vnesite vsebino enega injektorja (50 mg pirlimicina) v vsako okuženo vimensko četrt.
English: Keep the syringes in the original container.
Slovenian: Shranjujte injektorje v originalni ovojnini.
English: Hold eyelids open to ensure complete contact with water.
Slovenian: Veke držite široko odprte, da zagotovite spiranje celotne površine z vodo.
English: Pirlimycin has been shown to accumulate in polymorphonuclear cells, however, intracellular killing of Staphylococcus aureus was not demonstrated.
Slovenian: Pirlimicin se kopiči v polimorfonuklearnih celicah, kljub temu pa intracelularno ne ubija bakterije Staphylococcus aureus.
English: Medicines should not be disposed of via wastewater or household waste.
Slovenian: Ne odvrzite zdravila v odpadno vodo ali med godpodinjske odpadke.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/01/2001
Slovenian: Datum pridobitve dovoljenja za promet: 29/01/2001
English: Care must be taken not to introduce pathogens into the teat in order to reduce the risk of E. coli infections.
Slovenian: Pazite, da pri vnosu ne vnašate patogenih mikroorganizmov, saj s tem zmanjšate možnost infekcije z E. coli.
English: Also packaged as 120 x 10 ml syringes in a plastic bucket.
Slovenian: Injektorji so pakirani tudi kot 120 x 10 ml injektorjev v plastičnem vedru.
English: Pirlimycin hydrochloride is a semi-synthetic lincosamide antibiotic.
Slovenian: Pirlimicin hidroklorid je polsintetični antibiotik iz skupine linkozamidov.
English: Cattle (lactating dairy cows)
Slovenian: Govedo (krave v laktaciji).
English: They work by binding to the 50S ribosomal subunit, therefore hindering the aminoacyl-tRNA binding and inhibiting the peptidyltransferase reaction, which interferes with protein synthesis within the bacteria.
Slovenian: Delujejo tako, da preprečuje sintezo beljakovin s tem, da se veže na podenoto bakterijskega ribosoma (50S), s tem zavirajo vezavo aminoacilne-tRNK, kar pri občutljivih bakterijah povzroči moteno aktivnost peptidiltransferaze.
English: Treatment of infections due to Gram-negative bacteria such as E. coli.
Slovenian: Zdravljenje infekcij, ki jih povzročajo gramnegativne bakterija kot je E.coli.
English: Where necessary, wash teats thoroughly with warm water containing a suitable dairy cleansing agent and dry them thoroughly.
Slovenian: Kadar je treba, temeljito operite vime s toplo vodo, ki vsebuje primerno čistilno sredstvo (namenjeno čiščenju vimena) in ga nato temeljito osušite.
English: Other provisions
Slovenian: DRUGE INFORMACIJE
English: The lincosamides (clindamycin, lincomycin, and pirlimycin) inhibit protein synthesis in Gram-positive and in anaerobic bacteria as well as in Mycoplasma spp.
Slovenian: linkomicin in pirlimicin) inhibirajo sintezo beljakovin pri grampozitivnih in anaerobnih bakterijah kot tudi pri Mycoplasmi spp.
English: The teat end should be cleaned until no more dirt appears on the swab.
Slovenian: Konico seska čistite toliko časa, da na krpi ne ostajajo več sledovi umazanije.
English: Administration: by intramammary infusion only.
Slovenian: Način uporabe: samo intramamarno.
English: The excipients listed in section 6.1 of the SPC are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: Pomožne snovi, navedene v poglavju 6.1 SPC, ne spadajo v področje uporabe Uredbe (ES) št.
English: Clean hands before handling the cow's udder.
Slovenian: Pred prijemanjem vimena si operite roke.
English: ATC vet code: QJ51FF90
Slovenian: Farmakoterapevtska skupina: Antibiotiki za intramamarno uporabo Oznaka ATC vet: QJ51FF90
English: For the treatment of subclinical mastitis in lactating cows due to Gram-positive cocci susceptible to pirlimycin including staphylococcal organisms such as Staphylococcus aureus, both penicillinase-positive and penicillinase-negative, and coagulase-negative staphylococci; streptococcal organisms including Streptococcus agalactiae, Streptococcus dysgalactiae and Streptococcus uberis.
Slovenian: Za zdravljenje subkliničnega mastitisa pri kravah v obdobju laktacije, ki ga povzročajo grampozitivni koki, občutljivi na pirlimicin, vključno s stafilokoki kot so Staphylococcus aureus (penicilinaza pozitivni, penicilinaza negativni in koagulaza negativni stafilokoki), streptokoki, vključno s Streptococcus agalctiae, Streptococcus dysgalactiae in Streptococcus uberis.
English: Do not touch cleaned teat ends before administering the infusion substance.
Slovenian: Čistih konic seskov se ne dotikajte vse do vnosa zdravila.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/027/001
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/00/027/001
English: Insertion: Remove the white end cap by pulling straight up.
Slovenian: Vnos: s potegom odstranite bel pokrovček.
English: STATEMENT OF ACTIVE SUBSTANCES Pirlimycin hydrochloride equivalent to 50 mg pirlimycin per 10 ml syringe
Slovenian: Pirlimicin hidroklorid, ekvivalentno 50 mg pirlimicina na 10 ml injektor.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Intramammary use
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
English: Flush eyes with water for 15 minutes immediately after exposure.
Slovenian: Če pride infuzija v kontakt z očmi, moramo oči spirati z vodo 15 minut.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/027/001-003
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/00/027/001-003
English: Pirlimycin Bovine 100 µg/kg 100 µg/kg
Slovenian: 100 μg/kg 100 μg/kg 1000 μg/kg 400 μg/kg 100 μg/kg meso maščoba jetra ledvica mleko
English: PACKAGE LEAFLET: Pirsue 5 mg/ml intramammary solution for cattle
Slovenian: Pirsue 5 mg/ml intramamarna raztopina za govedo
English: Avoid contact with the solution.
Slovenian: Izogibajte se direktnemu stiku z intramamarno raztopino.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {label on the syringe}
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Following infusion, dip all teats with a disinfectant teat dip.
Slovenian: Po končanem vnosu, vse seske potopite v razkužilno kopel za seske.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Pirsue 5 mg/ml intramammary solution for cattle
Slovenian: NAVODILO ZA UPORABO Pirsue 5 mg/ml intramamarna raztopina za govedo
English: Disinfect teat end using a suitable cleansing agent.
Slovenian: Konico seska nato razkužite s primernim čistilnim sredstvom.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Pirsue 5 mg/ml
Slovenian: Pirsue 5 mg/ml
English: Use a separate disinfectant towelette for each teat.
Slovenian: Za čiščenje vsakega seska uporabimo nov razkužilni robček.
English: Name and address of the manufacturers responsible for batch release
Slovenian: Ime in naslov proizvajalca(proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij
English: Anhydrous citric acid
Slovenian: Brezvodna citronska kislina Natrijev citrat Voda za injekcije
English: PACKAGE SIZE 8 x 10 ml intramammary syringes 24 x 10 ml intramammary syringes 120 x 10 ml intramammary syringes
Slovenian: PODATKI NA ZUNANJI OVOJNINI 8×10 ml injekorji
English: WITHDRAWAL PERIOD(S) Meat and offal: 23 days.
Slovenian: 4.11 Karenca Meso in organi: 23 dni.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Možna je navzkrižna rezistenca med pirlimicinom in ostalimi linkozamidi ali makrolidi.
English: Susceptibility testing of the target bacteria should be carried out prior to treatment.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Pred uporabo zdravila je priporočljivo narediti antibiogram.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 8 x 10 ml syringes in an outer carton box 24 x 10 ml syringes in an outer carton box, including 3 package inserts 120 x 10 ml syringes in a plastic bucket, including 15 package inserts
Slovenian: 24×10 ml injektorji, dodana 3 navodila za uporabo 120×10 ml injektorji, dodanih 15 navodil za uporabo
English: 6.5 Nature and composition of immediate packaging Sterile aqueous solution in 10 ml polyethylene intramammary syringes, packaged as 8 x 10 ml, 24 x 10 ml in an outer cardboard box.
Slovenian: Injektorji so v kartonski škatli in sicer: 8x10 ml ali 24x10 ml injektorjev.
English: Muscle Fat
Slovenian: Pirlimicin govedo
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 50 mg Pirlimycin
Slovenian: 50 mg pirlimicina
English: PHARMACEUTICAL FORM Intramammary solution
Slovenian: FARMACEVTSKA OBLIKA
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: Proizvajalec, odgovoren za sproščanje serij: Norbrook Laboratories Limited
English: To be supplied only on veterinary prescription.
Slovenian: Nalepka na injektorju IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
English: Tablet
Slovenian: Pakiranje
English: EU/2/98/007/001 Clomicalm 5 mg
Slovenian: EU (MA) številka Izmišljeno ime Jakost Farmacevtska oblika
English: --1 Porcine circovirus type 2 ORF2 protein RP 1.0-3.75 * Relative potency (ELISA test) by comparison with a reference vaccine
Slovenian: --1 beljakovina ORF2 prašičjega cirkovirusa tipa 2 1,0 - 3,75 RP * relativna učinkovitost (preskus ELISA) v primerjavi z referenčnim cepivom
English: Suspension for
Slovenian: Karenca
English: The replacement acts in same way as naturally produced G-CSF.
Slovenian: Nadomestek deluje na enak način kot naravno proizvedeni G-CSF.
English: Patients can inject themselves if they have been trained appropriately.
Slovenian: Bolniki si lahko zdravilo vbrizgajo sami, če so bili ustrezno usposobljeni.
English: The marketing authorisation was renewed on 22 August
Slovenian: Dovoljenje za promet je bilo podaljšano 22. avgusta 2007.
English: Other information about Neupopeg:
Slovenian: Druge informacije o zdravilu Neupopeg:
English: Filgrastim has been available in other medicines in the European Union (EU) for a number of years.
Slovenian: Filgrastim je v Evropski uniji (EU) na voljo kot sestavina v drugih zdravilih že precej let.
English: Neupopeg treatment should be initiated and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Slovenian: Zdravljenje z zdravilom Neupopeg mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka ali boleznimi krvi.
English: What is the risk associated with Neupopeg?
Slovenian: Kakšna tveganja so povezana z zdravilom Neupopeg?
English: Neupopeg has been studied in two main studies involving 467 patients with breast cancer who were being treated with cytotoxic chemotherapy.
Slovenian: Zdravilo Neupopeg so raziskovali v dveh glavnih študijah, v katerih je sodelovalo 467 bolnikov z rakom na prsih, ki so bili zdravljeni s citotoksično kemoterapijo.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NEUPOPEG EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) NEUPOPEG Povzetek EPAR za javnost
English: Neupopeg is given as a single 6 mg injection under the skin around 24 hours after the end of each cycle of chemotherapy.
Slovenian: Zdravilo Neupopeg se daje kot enkratna 6 mg injekcija pod kožo približno 24 ur ob koncu vsakega cikla kemoterapije.
English: The main measure of effectiveness was the duration of severe neutropenia during the first cycle of chemotherapy.
Slovenian: Glavno merilo učinkovitosti je bilo trajanje hude nevtropenije med prvim ciklom kemoterapije.
English: What benefit has Neupopeg shown during the studies?
Slovenian: Kakšne koristi je zdravilo Neupopeg izkazalo med študijami?
English: The filgrastim in Neupopeg is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce filgrastim.
Slovenian: Filgrastim v zdravilu Neupopeg se proizvaja po metodi, imenovani „tehnologija rekombinantne DNK“: encim proizvede bakterija, ki je prejela gen (DNK) s pomočjo katerega postane sposobna tvoriti filgrastim.
English: Neupopeg should not be used in people who may be hypersensitive (allergic) to pegfilgrastim or any of the other ingredients.
Slovenian: Zdravila Neupopeg ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) pegfilgrastim ali katero koli drugo sestavino zdravila .
English: The most common side effects with Neupopeg (seen in more than 1 in 10 patients) are bone pain and raised levels of lactate dehydrogenase (a marker of red blood cell breakdown).
Slovenian: Najpogostejši neželeni učinki pri jemanju zdravila Neupopeg (opaženi pri več kot enem izmed 10 bolnikov) so bolečine v kosteh in povišane ravni laktatdehidrogenaze (označevalec razgradnje rdečih krvničk).
English: In both studies, the effectiveness of a single injection of Neupopeg was compared with multiple daily injections of filgrastim during each of four chemotherapy cycles.
Slovenian: V obeh študijah so primerjali učinkovitost enkratne injekcije zdravila Neupopeg z večkratnimi dnevnimi injekcijami filgrastima med vsakim od štirih ciklov kemoterapije.
English: It consists of filgrastim, a copy of a human protein called granulocyte colony stimulating factor (G-CSF), which has been ‘pegylated' (coated with a chemical called polyethylene glycol).
Slovenian: Sestavlja ga filgrastim, kopija človeške beljakovine, imenovane granulocitne kolonije spodbujajoči faktor (G-CSF), ki je bil „pegiliran“ (prevlečen s kemično spojino polietilenglikol).
English: Because it is pegylated in pegfilgrastim, the rate at which the medicine is removed from the body is decreased, allowing the medicine to be given less often.
Slovenian: V obliki pegfilgrastim je pegiliran, kar pomeni, da je izločanje iz telesa upočasnjeno in se zato zdravilo lahko daje manj pogosto.
English: It also cannot be used in patients with myelodysplastic syndromes, a disease in which too many white blood cells are produced, and which can develop into leukaemia.
Slovenian: Zdravila prav tako ne smejo prejemati osebe z mielodisplastičnim sindromom, boleznijo, pri kateri nastaja preveč belih krvničk in ki se lahko razvije v levkemijo.
English: In both studies, the patients had severe neutropenia for around 1.7 days during their first chemotherapy cycle.
Slovenian: V obeh študijah je huda nevtropenija pri bolnikih trajala 1,7 dneva med prvim ciklom kemoterapije.
English: Neupopeg is used in cancer patients to help with some of the side effects of their treatment.
Slovenian: Zdravilo Neupopeg se uporablja pri rakavih bolnikih za pomoč pri nekaterih neželenih učinkih njihovega zdravljenja.
English: The active substance in Neupopeg, pegfilgrastim, is an immunostimulant that belongs to the group ‘colony stimulating factors'.
Slovenian: Zdravilna učinkovina v zdravilu Neupopeg, pegfilgrastim, je imunostimulant, ki spada v skupino „kolonije spodbujajočih faktorjev“.
English: Most of the side effects seen in patients taking Neupopeg in studies are due to their underlying disease or chemotherapy.
Slovenian: Večino neželenih učinkov, opaženih pri bolnikih, ki so jemali zdravilo Neupopeg, je treba pripisati njihovim osnovnim boleznim ali kemoterapiji.
English: Chemotherapy (cancer treatment) that is cytotoxic (cell-killing) also kills white blood cells, which can lead to neutropenia (low white blood cell counts) and the development of infections.
Slovenian: Kemoterapija (zdravljenje raka), ki je citotoksična (torej taka, ki ubija celice) ubija tudi bele krvničke, kar lahko povzroči nevtropenijo (zmanjšano število belih krvničk) ter razvoj vnetij.
English: Neupopeg can be used for many types of cancer, except for chronic myeloid leukaemia (a cancer of the white blood cells).
Slovenian: Zdravilo Neupopeg se lahko uporablja pri mnogih vrstah raka, razen pri kronični mieloidni levkemiji (raku belih krvničk).
English: The Committee recommended that Neupopeg be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Neupopeg odobri dovoljenje za promet.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Neupopeg's benefits are greater than its risks for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Neupopeg pri skrajšanju trajanja nevtropenije in zmanjševanju pojavljanja febrilne nevtropenije pri bolnikih z malignimi obolenji, ki se zdravijo s citotoksično kemoterapijo, večje od z njim povezanih tveganj.
English: Filgrastim works by encouraging the bone marrow to produce more white blood cells, increasing white blood cell counts and treating neutropenia.
Slovenian: Filgrastim deluje tako, da kostni mozeg spodbuja k izdelavi več belih krvničk, s čimer se njihovo število poveča in zdravi nevtropenija.
English: It is available in a pre-filled syringe and a pre-filled pen (SureClick), each containing 6 mg pegfilgrastim.
Slovenian: Na voljo je kot napolnjena injekcijska brizga in napolnjeno injekcijsko pero (Sure Click), ki vsak vsebuje 6 mg pegfilgrastima.