natgillin/translations-raw huggingface dataset:
The depletion from tissues was consistent with the plasma half-life.
Izločanje iz tkiv je bilo skladno z razpolovno dobo v plazmi.
Sarolaner was determined to have low clearance (0.12 ml/min/kg) and a moderate volume of distribution (2.81 l/kg).
Sarolaner ima nizek renalni očistek (0.12 ml/min/kg) in zmeren volumen porazdelitve (2.81 l/kg).
As demodicosis is a multi-factorial disease, it is advisable to also treat any underlying disease appropriately.
Ker je demodikoza večplastna bolezen, je priporočljivo, da obenem ustrezno zdravite tudi osnovno bolezen.
Ticks on the animal prior to administration are killed within 24 hours.
Klopi, ki so že na živali pred dajanjem zdravila, so ubiti znotraj 24 ur.
For each strength, the chewable tablets are available in a carton with 1 blister of 3 tablets.
Za vsako jakost so žvečljive tablete na voljo v kartonski škatli z 1 pretisnim omotom s po 3 tabletami.
To prevent children from accessing the product, only one chewable tablet at a time should be removed from the blister pack and only when required.
Da bi preprečili otrokom dostop do zdravila, se mora iz pretisnega omota vzeti le posamezna tableta naenkrat in samo kadar je to potrebno.
For the treatment of demodicosis (caused by Demodex canis) the administration of a single dose once monthly for three consecutive months is efficacious and leads to a marked improvement of clinical signs.
Za zdravljenje demodikoze (ki jo povzroča Demodex canis) je uporaba enkratnega odmerka, enkrat mesečno, tri zaporedne mesece, učinkovita in vodi do izrazitega izboljšanja kliničnih znakov.
No treatment-related clinical signs were observed.
Pri tem niso opazili nobenih kliničnih znakov povezanih z zdravljenjem.
Laboratory studies in rats and rabbits have not produced any evidence of any teratogenic effects.
Z laboratorijskimi študijami na kuncih in podganah teratogeni učinki niso bili dokazani.
Mild and transient gastrointestinal signs such as vomiting and diarrhoea, transient neurological disorders such as tremor, ataxia or convulsion and systemic disorders such as lethargy, anorexia/inappetence may occur in very rare cases.
Blagi in prehodni gastrointestinalni znaki, kot so bruhanje in driska, prehodne nevrološke motnje, kot so tremor, ataksija ali konvulzije in sistemske motnje kot so letargija, anoreksija/inapetenca se lahko pojavijo v zelo redkih primerih.
The number embossed on one side refers to the strength (mg) of the tablets: “5”, “10”, ”20”, “40”, “80” or “120”.
Številka vtisnjena na eni strani žvečljive tablete se nanaša na jakost (v mg) tablet: "5", “10”, ”20”, “40”, “80” or “120”.
Parasites need to start feeding on the host to become exposed to sarolaner; therefore, the transmission of infectious parasite-borne diseases cannot be excluded.
Paraziti se morajo začeti hraniti na gostitelju, da so izpostavljeni sarolanerju, zato tveganja prenašanja infekcijskih bolezni, ki jih prenašajo paraziti, ni mogoče izključiti.
The veterinary medicinal product should be administered at a dose of 2-4 mg/kg bodyweight in accordance with the following table:
Zdravilo je treba dajati v odmerku 2 do 4 mg/kg telesne teže, v skladu z naslednjo preglednico:
One carton contains one blister of 3 tablets.
En karton vsebuje 1 pretisni omot z 3 tabletami.
Aluminium foil/foil blister package.
Aluminijev folija/folija pretisni omot.
ATC vet code: QP53BE03.
Farmakoterapevtska skupina: Ektoparazitiki za sistemsko uporabo Oznaka ATCvet: QP53BE03.
Number of tablets to be administered
Število tablet, ki jih je treba dati
Sarolaner is well tolerated in Collies with a deficient multidrug-resistance-protein 1 (MDR1 -/-) following single oral administration at 5 times the recommended dose.
Sarolaner so dobro prenašali koliji z nezadostnim MDR 1-/- (multidrug-resistance-protein 1) po enkratnem peroralnem dajanju 5krat večjega odmerka od priporočenega.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
A. PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) D. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
Zdravilo se lahko uporablja kot del strategije zdravljenja dermatitisa zaradi alergije na bolhe (Flea Allergy Dermatitis - FAD).
Sarolaner was dose proportional in Beagle dogs when dosed from the intended use dose of 2-4 mg/kg, to 20 mg/kg.
Sarolaner je bil sorazmeren odmerku pri psih pasme Beagle pri odmerjanju od predpisanega odmerka 2 do 4mg/kg do odmerka 20 mg/kg.
Tablet strength (mg sarolaner)
Jakost tablete (mg sarolanerja)
The primary route of elimination is biliary excretion of parent molecule, with elimination through the faeces.
Glavna pot izločanja je izločanje matične molekule z žolčem v blato.
The veterinary medicinal product kills newly emerged fleas on the dog before they can lay eggs and therefore it prevents environmental flea contamination in areas to which the dog has access.
To zdravilo ubije bolhe, ki pridejo na psa po dajanju zdravila, preden bi lahko izlegle jajčeca in tako prepreči onesnaženje okolja z bolhami na področjih, do katerih ima pes dostop.
Use appropriate combination of available strengths to achieve the recommended dose of 2-4 mg/kg.
Uporabite ustrezno kombinacijo razpoložljivih jakosti tablet, da dosežete priporočen odmerek 2 do 4 mg/kg telesne teže.
For ticks (I. ricinus), the onset of efficacy is within 12 hours of attachment during the 28 day period after product administration.
Pri klopih (I. ricinus) je začetek delovanja zdravila znotraj 12 ur po pritrditvi v obdobju 28 dni po dajanju zdravila.
Sarolaner does not interact with known insecticidal binding sites of nicotinic or other GABAergic insecticides such as neonicotinoids, fiproles, milbemycins, avermectins, and cyclodienes.
Sarolaner ne deluje medsebojno z znanimi mesti vezave nikotinskih in drugih GABAergičnih insekticidov kot so neonikotinoidi, fiproli, milbemicini, avermektini in ciklodieni.
Special warnings for each target species:
Posebni previdnostni ukrepi za vsako ciljno žival:
For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis).
Zdravljenje infestacij z bolhami (Ctenocephalides felis in Ctenocephalides canis).
In the overdose groups, transient and self-limiting neurological signs were observed in some animals: mild tremors at 3 times the maximum exposure dose and convulsions at 5 times the maximum exposure dose.
V skupinah psov s prekomernim odmerjanjem, so pri nekaterih živalih opazili naslednje prehodne in samoomejujoče nevrološke znake: blago tresenje pri 3krat večjem odmerku od največjega priporočenega in krče pri 5-krat večjem odmerku od največjega priporočenega.
MiPet Easecto tablets are chewable and palatable and readily consumed by dogs when offered by the owner.
Tablete MiPet Easecto so žvečljive in okusne, zato jih psi radi sprejmejo od lastnika.
For the treatment of sarcoptic mange (Sarcoptes scabiei).
Za zdravljenje garjavosti (Sarcoptes scabiei).
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.
V primeru nenamernega zaužitja, se takoj posvetujete z zdravnikom in mu pokažite zdravniku navodilo za uporabo ali ovojnino.
During clinical field trials, no interactions between MiPet Easecto chewable tablets for dogs and routinely used veterinary medicinal products were observed.
Med terenskimi kliničnimi testiranji niso opazili nobenih interakcij z rutinsko uporabljenimi zdravili za uporabo v veterinarski medicini.
For the treatment of ear mite infestations (Otodectes cynotis).
Za zdravljenje ušesne garjavosti (Otodectes cynotis).
In laboratory safety studies, no interactions were observed when sarolaner was co-administered with milbemycin oxime, moxidectin and pyrantel pamoate.
Med laboratorijskimi varnostnimi testiranji niso opazili nobenih interakcij med sarolanerjem in sočasnim dajanjem milbemicin oksima, moksidektina ali pirantel pamoata.
Sarolaner is highly bound to plasma proteins and might compete with other highly bound drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) and the cumarin derivative warfarin.
Sarolaner se močno veže na plazemske beljakovine in se lahko kosa z drugimi močno vezanimi zdravili, kot so nesteroidna protivnetna zdravila (NSAID) in kumarinski derivat varfarin.
MiPet Easecto chewable tablets sarolaner (mg)
MiPet Easecto žvečljive tablete sarolaner (mg)
For the treatment of ear mite infestations (Otodectes cynotis) a single dose should be administered.
Za zdravljenje ušesne garjavosti (ki jo povzroča Otodectes cynotis), je treba dati enkratni odmerek zdravila.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in animals intended for breeding.
Varnost zdravila v obdobju brejosti, laktacije in pri psih za vzrejo ni bila ugotovljena.
For optimal control of tick and fleas infestations, the veterinary medicinal product should be administered at monthly intervals and continue throughout the flea and/or tick season based on local epidemiological situations.
Za optimalni nadzor infestacije s klopi in bolhami, je treba zdravilo dajati v mesečnih razmikih in nadaljevati z dajanjem skozi celotno sezono bolh in/ali klopov glede na krajevne epidemiološke situacije.
In a margin of safety study, the veterinary medicinal product was administered orally to 8 week old Beagle puppies at doses of 0, 1, 3, and 5 times the maximum exposure dose of 4 mg/kg at 28 day intervals for 10 doses.
V mejni varnostni študiji so zdravilo dajali peroralno 8 tednov starim psičkom pasme Beagle, v odmerkih, ki so bili 0, 1, 3 in 5 krat večji od največjega priporočenega odmerka 4 mg/kg telesne teže, po 10 odmerkov v 28 dnevnih presledkih,.
PSUR submissions for MiPet Easecto shall be synchronised and submitted at the same frequency as for Simparica.
D. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Vloge PSUR za MiPet Easecto se sinhronizirajo in pošiljajo enako pogosto kot pri Simparici.
PACKAGE LEAFLET: MiPet Easecto chewable tablets for dogs
NAVODILO ZA UPORABO MiPet Easecto žvečljive tablete za pse
Pregnancy and lactation:
Uporaba v obdobju brejosti in laktacije:
For the treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) a single dose should be administered at monthly intervals for two consecutive months.
Za zdravljenje garjavosti (ki jo povzroča Sarcoptes scabiei var. canis), je treba dajati enkratni odmerek zdravila enkrat mesečno, dva meseca zapored.
Plasma protein binding was determined in vitro and calculated at ≥99.9%.
Razpolovna doba je bila primerljiva pri intravenozni in peroralni poti 12 in 11 dan. Vezava na plazemske proteine je bila določena in vitro in je izračunana pri ≥99.9%.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN učinkovina:
Do not use this veterinary medicinal product after the expiry date which is stated on the blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP. Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
For fleas, the onset of efficacy is within 8 hours of attachment during the 28 day period after product administration.
Pri bolhah je začetek delovanja zdravila znotraj 8 ur po pritrditvi v obdobju 28 dni po dajanju zdravila.
Sarolaner blocks GABA- and glutamate-gated chloride channels in the central nervous system of insects and acarines.
Sarolaner inhibira GABA- in glutamat- odvisne kloridne kanale v centralnem živčnem sistemu insektov in pršic.
3 tablets
VELIKOST PAKIRANJA 3 tablete
In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 1.3 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
Zaradi pomanjkanja podatkov, se to zdravilo za uporabo v veterinarski medicini sme uporabljati za mladiče do 8 tednov starosti oziroma pri psih, ki tehtajo manj kot 1,3 kg le v skladu z oceno razmerja med koristjoin tveganjem, ki jo opravi odgovorni veterinar.
Mottled brown coloured, square shaped chewable tablets with rounded edges.
Lisasto rjavo obarvana žvečljiva tableta kvadratne oblike z zaobljenimi robovi.
Chewable tablets.
Žvečljiva tableta.
Sarolaner is active against adult fleas (Ctenocephalides felis and Ctenocephalides canis) as well as several tick species such as Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus, Rhipicephalus sanguineus and the mites Demodex canis, Otodectes cynotis and Sarcoptes scabiei.
(Ctenocephalides felis and Ctenocephalides canis) kot tudi na številne vrste klopov (Dermacentor reticulatus, , Ixodes hexagonus, , Ixodes ricinus, Rhipicephalus sanguineus) in garjavce: Demodex canis, Otodectes cynotis inSarcoptes scabiei.
No adverse effects were observed at the maximum exposure dose of 4 mg/kg.
Pri največjem priporočenem odmerku 4 mg/kg telesne teže ni bilo opaziti nobenih stranskih učinkov.
Read the package leaflet before use.
POSEBNA NAVODILA ZA SHRANJEVANJE Pred uporabo preberite navodilo za uporabo.
The blister pack should be returned into the carton immediately after use and the carton should be stored out of the sight and reach of children.
Preostale blistre je treba takoj po dajanju vrniti v škatlo; škatlo pa shranjevati nedosegljivo otrokom.
The veterinary medicinal product has immediate and persistent tick killing activity for at least 5 weeks.
To zdravilo za uporabo v veterinarski medicini ima takojšnjo in trajno aktivnost ubijanja klopov najmanj 5 tednov.
The blister pack should then be returned into the carton immediately after use and the carton should be stored out of the sight and reach of children.
Preostale pretisne omote je treba takoj po dajanju vrniti v škatlo, škatlo pa shranjevati nedosegljivo otrokom.
For the treatment of tick infestations (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus).
Zdravljenje infestacij s klopi (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus in
MiPet Easecto 5 mg chewable tablets for dogs 1.3-2.5 kg MiPet Easecto 10 mg chewable tablets for dogs >2.5-5 kg MiPet Easecto 20 mg chewable tablets for dogs >5-10 kg MiPet Easecto 40 mg chewable tablets for dogs >10-20 kg MiPet Easecto 80 mg chewable tablets for dogs >20-40 kg MiPet Easecto 120 mg chewable tablets for dogs >40-60 kg
MiPet Easecto 5 mg žvečljive tablete za pse 1,3 - 2,5 kg MiPet Easecto 10 mg žvečljive tablete za pse >2,5-5 kg MiPet Easecto 20 mg žvečljive tablete za pse >5-10 kg MiPet Easecto 40 mg žvečljive tablete za pse >10-20 kg MiPet Easecto 80 mg žvečljive tablete za pse >20-40 kg MiPet Easecto 120 mg žvečljive tablete za pse >40-60 kg
MiPet Easecto 5 mg chewable tablets for dogs 1.3-2.5 kg MiPet Easecto 10 mg chewable tablets for dogs >2.5-5 kg MiPet Easecto 20 mg chewable tablets for dogs >5-10 kg MiPet Easecto 40 mg chewable tablets for dogs >10-20 kg MiPet Easecto 80 mg chewable tablets for dogs >20-40 kg MiPet Easecto 120 mg chewable tablets for dogs >40-60 kg sarolaner
MiPet Easecto 5 mg žvečljive tablete za pse 1,3 - 2,5 kg MiPet Easecto 10 mg žvečljive tablete za pse >2,5-5 kg MiPet Easecto 20 mg žvečljive tablete za pse >5-10 kg MiPet Easecto 40 mg žvečljive tablete za pse >10-20 kg MiPet Easecto 80 mg žvečljive tablete za pse >20-40 kg MiPet Easecto 120 mg žvečljive tablete za pse >40-60 kg sarolaner
for dogs 1.3-2.5 kg for dogs >2.5-5 kg for dogs >5-10 kg for dogs >10-20 kg for dogs >20-40 kg for dogs >40-60 kg
za pse 1,3-2,5 kg za pse >2,5-5 kg za pse >5-10 kg za pse >10-20 kg za pse >20-40 kg za pse >40-60 kg
4.7 Use during pregnancy, lactation or lay
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Varnost zdravila v obdobju brejosti, laktacije in pri psih za vzrejo ni bila ugotovljena.
Glucose, liquid (81.5% solids) Spray dried pork liver powder Hydrolysed vegetable protein Gelatin type A
6.1 Seznam pomožnih snovi hipromeloza acetat sukcinat, srednje stopnje laktoza monohidrat natrijev karboksimetilškrob silicijev dioksic, koloidni, brezvodni magnezijev stearat koruzni škrob saharoza glukoza, tekoča (81,5 % trdne snovi) aroma svinjskih jeter hidrolizirani rastlinski protein želatina tip A pšenični kalčki kalcijev hidrogenfosfat, brezvodni
Calcium hydrogen phosphate anhydrous
Rhipicephalus sanguineus).
Confectioner's sugar
PODATKI NA ZUNANJI OVOJNINI
Ref. EMEA/CHMP/384876/2008
EMEA/CHMP/674499/2008
London, 02 December 2008 Doc.
London, 2. decembra 2008 Sklic na dok.
Efexor depot, 37.5 mg, 75 mg, 150 mg, hard prolonged-release capsules, is an antidepressant, indicated for the treatment of major depressive episodes, for the prevention of recurrence of major depressive episodes, for the treatment of social anxiety disorder, panic disorders with or without agoraphobia, and generalized anxiety disorder.
Zdravilo Efexor depot, 37,5 mg, 75 mg, 150 mg, trde kapsule s podaljšanim sproščanjem, je antidepresiv, namenjen za zdravljenje hudih epizod depresije, za preprečevanje njihovega ponovnega pojava, zdravljenje socialnih anksioznih motenj, paničnih motenj z agorafobijo ali brez nje in generaliziranih anksioznih motenj.
On 3 May 2007, the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Efexor depot.
Komisija je dne 3. maja 2007 agenciji EMEA predložila napotitev v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, da bi uskladila na nacionalni ravni odobrene povzetke glavnih značilnosti zdravila (SPC), označevanja in navodila za uporabo zdravila Efexor depot.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Efexor depot approved across EU Member States, with respect to the treatment of major depressive episodes, the prevention of recurrence of major depressive episodes, the treatment of social anxiety disorder, panic disorders with or without agoraphobia, and generalized anxiety disorder.
Podlaga za napotitev so bila razhajanja med povzetki glavnih značilnosti zdravila (SPC) Efexor depot, ki so bili odobreni v državah članicah EU v zvezi z zdravljenjem hudih epizod depresije, preprečevanjem njihovega ponovnega pojava, zdravljenjem socialnih anksioznih motenj, paničnih motenj z agorafobijo ali brez nje in generaliziranih anksioznih motenj.
The CHMP gave a positive opinion on 24 July 2008 with a subsequent revision on 25 September 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Efexor depot.
CHMP je dne 24. julija 2008 izdal pozitivno mnenje, temu pa je dne 25. septembra 2008 sledila revizija, na podlagi katere se priporoča 2008 uskladitev povzetkov glavnih značilnosti zdravila (SPC), označevanj in navodil za uporabo zdravila Efexor depot.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Efexor depot and associated names International Non-Proprietary Name (INN): venlafaxine
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 30 ZA ZDRAVILO Efexor depot in z njim povezana imena
Further information on Ziextenzo can be found on the Agency's website: https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo.
Več informacij o zdravilu Ziextenzo je na voljo na spletni strani agencije: https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo.
What measures are being taken to ensure the safe and effective use of Ziextenzo?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ziextenzo?
This means that Ziextenzo is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
An overview of Ziextenzo and why it is authorised in the EU
Pregled zdravila Ziextenzo in zakaj je odobreno v EU
What benefits of Ziextenzo have been shown in studies?
Kakšne koristi zdravila Ziextenzo so se pokazale v študijah?
What is Ziextenzo and what is it used for?
Kaj je zdravilo Ziextenzo in za kaj se uporablja?
The most common side effect with Ziextenzo (which may affect more than 1 in 10 people) is pain in the bones.
Najpogostejši neželeni učinek zdravila Ziextenzo (ki se lahko pojavi pri več kot 1 bolniku od 10) je bolečina v kosteh.
Why is Ziextenzo authorised in the EU?
Zakaj je bilo zdravilo Ziextenzo odobreno v EU?
As for all medicines, data on the use of Ziextenzo are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ziextenzo stalno spremljajo.
Side effects reported with Ziextenzo are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Ziextenzo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Other information about Ziextenzo
Druge informacije o zdravilu Ziextenzo
Ziextenzo can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Predpisovanje in izdaja zdravila Ziextenzo je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem rakavih obolenj ali krvnih bolezni.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ziextenzo have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ziextenzo upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What are the risks associated with Ziextenzo?
Kakšna tveganja so povezana z zdravilom Ziextenzo?
Ziextenzo is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Zdravilo Ziextenzo se daje v obliki enkratnega 6-miligramskega odmerka, ki se injicira pod kožo vsaj 24 ur po koncu vsakega ciklusa kemoterapije (zdravljenja z zdravili proti raku).
For more information about using Ziextenzo, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Ziextenzo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The reference medicine for Ziextenzo is Neulasta.
Referenčno zdravilo za zdravilo Ziextenzo je zdravilo Neulasta.
The active substance in Ziextenzo, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Učinkovina zdravila Ziextenzo, pegfilgrastim, je oblika filgrastima, ki je zelo podoben človeški beljakovini, imenovani granulocitne kolonije spodbujajoči faktor (G-CSF).
All these data were considered sufficient to conclude that Ziextenzo will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Ziextenzo pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Neulasta.
The safety of Ziextenzo has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.
Varnost zdravila Ziextenzo je bila ocenjena in na podlagi vseh izvedenih študij so bili neželeni učinki zdravila ocenjeni kot primerljivi z neželenimi učinki referenčnega zdravila Neulasta.
Because Ziextenzo is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Ziextenzo.
Zdravilo Ziextenzo je podobno biološko zdravilo, zato študij o učinkovitosti in varnosti pegfilgrastima, izvedenih z zdravilom Neulasta, z zdravilom Ziextenzo ni treba ponavljati.