natgillin/translations-raw huggingface dataset:
Following intravenous dosing the volume of distribution at steady-state (Vss) was 31.7 l/kg.
Volumen distribucije v fazi stabilizacije koncentracije (VSS), določen po intravenoznem vnosu je 31.7 L/kg.
Ovine, caprine
Govedo: s.c.
The volume of distribution at steady-state (VSS) determined after intravenous administration was 13.2 l/kg.
Volumen distribucije v fazi stabilizacije koncentracije (VSS), določen po intravenoznem vnosu je 13,2 L/kg.
The volume of distribution at steady-state (Vss) determined after intravenous administration was 13.2 L/kg.
Volumen distribucije v fazi stabilizacije koncentracije (VSS), določen po intravenoznem vnosu je 13,2 l/kg.
A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/10 kg bodyweight) in the neck.
Enkratno intramuskularno dajanje tulatromicina v odmerku 2,5 mg/kg telesne mase (kar ustreza 1 ml na 10 kg telesne mase) na področje vratu.
Withdrawal period: Meat and offal: 22 days.
Meso in organi: Govedo: 22 dni.
Strength Pharmaceutical Form
Jakost Farmacevtska oblika Pot uporabe Stična ovojnina Vsebina (koncentracija)
(Invented) name Strength Pharmaceutical Form
Zaščiteno ime Jakost Farmacevtska oblika Pot uporabe
Talk to your doctor or pharmacist before taking this medicine if you have any of the following conditions.
Pred začetkom jemanja tega zdravila se posvetujte z zdravnikom ali farmacevtom, če imate katero od naslednjih stanj.
The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Pristojni organi države članice lahko v sodelovanju z referenčno državo članico posodobijo informacije o zdravilu, kot je primerno, v skladu s postopki, opisanimi v poglavju 4 naslova III Direktive 2001/83/ES.
The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Obstoječe informacije o zdravilu je treba posodobiti (vstavitev, zamenjava ali izbris besedila, kot je ustrezno) tako, da bodo odražale spodaj navedeno dogovorjeno besedilo.
4.3 Contraindications [The following contraindication should be included]
4.3 Kontraindikacije [Vključiti je treba naslednjo kontraindikacijo]
These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Te spremembe ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo so rezultat napotitvenega postopka.
What you need to know before you are given <invented name> Do not use <invented name and strength(s)>:
Kaj morate vedeti, preden boste prejeli zdravilo <izmišljeno ime> Ne uporabljajte zdravila <izmišljeno ime in jakost(i)>:
[A warning should be included as follows.
[Vključiti je treba naslednje opozorilo.
4.4 Special warnings and precautions for use [The following warning should be included] Immune System Effects
4.4 Posebna opozorila in previdnostni ukrepi [Vključiti je treba naslednje opozorilo] Učinki na imunski sistem
Administration of <invented name and strength(s)> should be stopped, and the patient's condition should be treated accordingly.
Dajanje zdravila <izmišljeno ime in jakost(i)> je treba prekiniti in bolnikovo stanje ustrezno zdraviti.
If you are allergic or suspected to be allergic to cow's milk.
Če ste alergični ali obstaja sum, da ste alergični na kravje mleko.
[A warning should be included as follows]
[Vključiti je treba naslednje opozorilo]
In case of combined package leaflet with strength(s) not included in Annex I, the strength(s) of products in Annex I should be specified in the subheading above]
V primeru kombiniranega navodila za uporabo zdravila z jakostjo (jakostmi), ki ni(so) vključena (vključene) v Prilogo I, je treba jakost(i) zdravil iz Priloge I navesti v zgornjem podnaslovu.]
Cow's milk allergy [The following clarification in brackets should be included in case of combined SmPC with strength(s) not included in Annex I] (the following paragraphs only apply to <invented name and strength(s)>)
Alergija na kravje mleko [naslednje pojasnilo v oklepaju je treba vključiti v primeru kombiniranega povzetka glavnih značilnosti zdravila z jakostjo (jakostmi), ki ni(so) vključena (vključene) v Prilogo I] (naslednji odstavki se nanašajo samo na zdravilo <izmišljeno ime in jakost(i)>)
OTHER [A warning should be included as follows] Do not use in cow's milk allergy patients.
DRUGI PODATKI [Vključiti je treba naslednje opozorilo] Ne uporabljajte pri bolnikih z alergijo na kravje mleko.
<Invented name and strength(s)> contains lactose <monohydrate> produced from bovine origin as an excipient and may therefore contain trace amounts of cow's milk proteins (the allergens of cow's milk).
Zdravilo <izmišljeno ime in jakost(i)> kot pomožno snov vsebuje laktozo <monohidrat> govejega izvora, zato lahko vsebuje sledove beljakovin kravjega mleka (alergene kravjega mleka).
OTHER SPECIAL WARNING(S), IF NECESSARY [A warning should be included as follows] Do not use in cow's milk allergy patients.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA [Vključiti je treba naslednje opozorilo] Ne uporabljajte pri bolnikih z alergijo na kravje mleko.
Serious allergic reactions have occurred in patients allergic to cow's milk.
Pri bolnikih, alergičnih na kravje mleko, so se pojavile resne alergijske reakcije.
Patients with known or suspected allergy to cow's milk must not be administered <invented name and strength(s)> (see section 4.3).
Bolniki z znano alergijo na kravje mleko ali sumom nanjo ne smejo prejemati zdravila <izmišljeno ime in jakost(i)> (glejte poglavje 4.3).
<Invented name and strength(s)> is contraindicated in patients with a known or suspected allergy to cow's milk (see section 4.4).
Zdravilo <izmišljeno ime in jakost(i)> je kontraindicirano pri bolnikih z znano alergijo na kravje mleko ali sumom nanjo (glejte poglavje 4.4).
<invented name and strength(s)> contains cow's milk proteins If you are allergic or suspected to be allergic to cow's milk, you must not be given this medicine as it may contain trace amounts of cow's milk proteins.
Če ste alergični ali obstaja sum, da ste alergični na kravje mleko, tega zdravila ne smete prejeti, saj lahko vsebuje sledove beljakovin kravjega mleka.
Serious allergic reactions, including bronchospasm and anaphylaxis, were reported in patients allergic to cow's milk proteins who were treated for acute allergic conditions.
Pri bolnikih, alergičnih na beljakovine kravjega mleka, ki so se zdravili zaradi akutnih alergijskih stanj, so poročali o resnih alergijskih reakcijah, vključno z bronhospazmom in anafilakso.
Allergic reactions to cow's milk proteins should be considered in patients receiving <invented name and strength(s)> for the treatment of acute allergic conditions in whom symptoms worsen or who are presenting new allergic symptoms (see section 4.3).
Pri bolnikih, ki prejemajo zdravilo <izmišljeno ime in jakost(i)> za zdravljenje akutnih alergijskih stanj, pri katerih se simptomi poslabšajo ali se pojavijo novi alergijski simptomi, je treba upoštevati možnost alergijskih reakcij na beljakovine kravjega mleka (glejte poglavje 4.3).
MA (EU) number
Štvilka (EU) dovoljenja za promet
Immediate Packaging Pack size
100 mg filmska obložena tableta
Severe neutropenia lasted on average for 1.4 days.
Huda nevtropenija je v povprečju trajala 1,4 dni.
The main measure of effectiveness was the duration of severe neutropenia.
Glavno merilo učinkovitosti je bilo trajanje hude nevtropenije.
This is comparable with 1.6 days and 1.8 days reported in other studies found in the literature using filgrastim.
To je primerljivo z 1,6 dni in 1,8 dni, o katerih so poročali v drugih študijah v literaturi, v katerih so uporabljali filgrastim.
The European Commission granted a marketing authorisation valid throughout the European Union for Accofil on 18 September 2014.
Evropska komisija je dovoljenje za promet z zdravilom Accofil, veljavno po vsej Evropski uniji, izdala 18. septembra 2014.
What measures are being taken to ensure the safe and effective use of Accofil?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Accofil?
The full EPAR and risk management plan summary for Accofil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Accofil sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This means that Accofil is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
To pomeni, da je zdravilo Accofil podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
Data from published studies indicate that the benefits and safety of filgrastim are similar in both adults and children receiving chemotherapy.
Podatki iz objavljenih študij kažejo, da so koristi in varnost filgrastima podobne tako pri odraslih kot pri otrocih, ki prejemajo kemoterapijo.
This is a summary of the European public assessment report (EPAR) for Accofil.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Accofil.
It can only be obtained with a prescription and treatment should be given in collaboration with a centre for cancer treatment.
Izdaja zdravila je le na recept, zdravljenje pa se lahko predpiše samo v sodelovanju s centrom za zdravljenje raka.
It is given by injection under the skin or infusion into a vein.
Zdravilo se daje z injekcijo pod kožo ali infuzijo v veno.
A risk management plan has been developed to ensure that Accofil is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Accofil je bil pripravljen načrt obvladovanja tveganj.
Patients were given the chemotherapy on day 1 of a three-week cycle, and then received one dose of Accofil the next day and daily for up to 14 days.
Bolnice so 1. dan tritedenskega ciklusa prejele kemoterapijo, naslednji dan pa so prejele en odmerek zdravila Accofil, ki so ga nato vsak dan prejemale še največ 14 dni.
The most common side effect with Accofil (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Najpogostejši neželeni učinek zdravila Accofil (opaženi pri več kot 1 bolniku od 10) so mišično-skeletne bolečine (bolečine v mišicah in kosteh).
The way Accofil is given, its dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment.
Način dajanja zdravila Accofil, velikost odmerka in trajanje zdravljenja so odvisni od tega, zakaj se zdravilo uporablja, ter od telesne mase bolnika in njegovega odziva na zdravljenje.
Other information about Accofil
Druge informacije o zdravilu Accofil
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Accofil has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami Evropske unije za podobna biološka zdravila dokazano, da ima zdravilo Accofil podoben profil kakovosti, varnosti in učinkovitosti kot zdravilo Neupogen.
It is not intended to provide practical advice on how to use Accofil.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Accofil is a medicine that is used to stimulate the production of white blood cells in the following situations:
Zdravilo Accofil se uporablja za spodbujanje tvorbe belih krvnih celic v naslednjih primerih:
Accofil was studied in one main study involving 120 female adult patients with breast cancer treated with chemotherapy known to cause neutropenia.
Zdravilo Accofil so proučili v eni glavni študiji, v katero so vključili 120 odraslih bolnic z rakom dojke, ki so se zdravile s kemoterapijo, za katero je znano, da povzroča nevtropenijo.
What are the risks associated with Accofil?
Kakšna tveganja so povezana z zdravilom Accofil?
What benefits of Accofil have been shown in studies?
Kakšne koristi je zdravilo Accofil izkazalo v študijah?
For the full list of all side effects and restrictions reported with Accofil, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev, o katerih so poročali pri uporabi zdravila Accofil, glejte navodilo za uporabo.
The reference medicine for Accofil is Neupogen.
Referenčno zdravilo za zdravilo Accofil je Neupogen.
The filgrastim in Accofil is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce filgrastim.
Filgrastim v zdravilu Accofil se pridobiva z metodo, imenovano „tehnologija rekombinantne DNK“: izdelajo ga bakterije, v katere so vstavili gen (DNK), s pomočjo katerega lahko tvorijo filgrastim.
What is Accofil and what is it used for?
Kaj je zdravilo Accofil in za kaj se uporablja?
• to help release cells from the bone marrow in patients who are about to donate blood stem cells for transplant;
• za pospeševanje sproščanja celic iz kostnega mozga pri bolnikih, ki naj bi darovali krvotvorne matične celice za presaditev;
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Accofil, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Filgrastim acts in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Filgrastim deluje na enak način kot naravno tvorjeni G-CSF, kar pomeni, da spodbuja kostni mozeg k tvorjenju večjega števila belih krvnih celic.
The active substance in Accofil, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Zdravilna učinkovina v zdravilu Accofil, filgrastim, je zelo podobna človeški beljakovini, ki jo imenujemo granulocitne kolonije stimulirajoči faktor (granulocyte colony stimulating factor - G-CSF).
More information can be found in the summary of product characteristics (also part of the EPAR).
Za več informacij glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
Therefore, the CHMP's view was that, as for Neupogen, the benefit outweighs the identified risks and recommended that it be approved for use in the EU.
Zato je menil, da so njegove koristi, tako kot pri zdravilu Neupogen, večje od znanih tveganj, in priporočil, da se odobri za uporabo v EU.
Studies were carried out to show that Accofil produces similar levels of the active substance in the body to Neupogen and increases the numbers of neutrophils in a comparable way.
Izvedene so bile študije, v katerih so dokazovali, da zdravilo Accofil tvori podobne ravni zdravilne učinkovine v telesu kot zdravilo Neupogen in da poveča število nevtrofilcev na primerljiv način.
• to treat persistent neutropenia in patients with advanced Human-Immunodeficiency-Virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
• za zdravljenje trdovratne nevtropenije pri bolnikih z napredovalo okužbo z virusom humane imunske pomanjkljivosti (HIV), z namenom zmanjšanja tveganja za bakterijske okužbe, ko druge oblike zdravljenja niso primerne.
Other side effects may be seen in more than 1 patient in 10, depending on the condition that Accofil is being used for.
Pri več kot 1 bolniku od 10 se lahko pojavijo drugi neželeni učinki, ki so odvisni od bolezenskega stanja, za katerega se zdravilo Accofil uporablja.
For more information about treatment with Accofil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Accofil preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Accofil is available as a solution for injection or infusion (drip) in pre-filled syringes.
Zdravilo Accofil je na voljo v obliki raztopine za injiciranje ali infundiranje (kapalno infuzijo) v napolnjenih injekcijskih brizgah.
For practical information about using Accofil, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Accofil naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
• to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving cytotoxic chemotherapy (medicines to treat cancer by killing cells);
• za skrajšanje trajanja nevtropenije (nizke ravni nevtrofilcev, ki so vrsta belih krvnih celic) in zmanjšanje pojavljanja febrilne nevtropenije (nevtropenije s povišano telesno temperaturo) pri bolnikih, ki prejemajo citotoksično kemoterapijo (zdravila za zdravljenje raka, ki ubijajo celice);
Accofil, which contains the active substance filgrastim, is a ‘biosimilar medicine'.
Zdravilo Accofil, ki vsebuje zdravilno učinkovino filgrastim, je „biološko podobno“ zdravilo.
• to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
• za povečanje števila nevtrofilcev in zmanjšanje tveganja za okužbe pri bolnikih z nevtropenijo, ki so imeli v preteklosti hude ponavljajoče se okužbe;
Why is Accofil approved?
Za kaj je bilo zdravilo Accofil odobreno?
• to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at risk of long-term, severe neutropenia;
• za skrajšanje trajanja nevtropenije pri bolnikih, ki se zdravijo s terapijo, katere cilj je uničenje celic kostnega mozga pred presaditvijo kostnega mozga (npr. pri nekaterih bolnikih z levkemijo), pri katerih obstaja tveganje za dalj časa trajajočo hudo nevtropenijo;
How is Accofil used?
Kako se zdravilo Accofil uporablja?
How does Accofil work?
Kako zdravilo Accofil deluje?
10 (2 x 5) pre-filled pens (multipack)
10 (2 x 5) napolnjenih injekcijskih peresnikov (multipakiranje)
Content (concentration) Package size
Vsebina (koncentracija)
Invented name Strength Pharmaceutical form Route of administration Packaging
Izmišljeno ime Jakost
Powder: 1000 IU
Pot uporabe Ovojnina
Further information on Carmustine Obvius can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Karmustin Obvius so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The medicine is used when initial treatment has not worked or the cancer has come back.
Zdravilo se uporablja, kadar začetno zdravljenje ni delovalo ali se je rak ponovil.
Carmustine Obvius (carmustine) EMA/273425/2018
Karmustin Obvius (karmustin) EMA/273425/2018
• Hodgkin's lymphoma and non-Hodgkin's lymphomas, types of cancer that originate from white blood cells.
• Hodgkinovega limfoma in ne-Hodgkinovih limfomov, tj. vrst raka, ki izvirajo iz belih krvnih celic.
• brain tumours, both those that develop directly in the brain and cancers that have spread from elsewhere in the body (metastatic brain tumours);
• možganskih tumorjev, in sicer tistih, ki se razvijejo neposredno v možganih, in rakov, ki so se razširili z drugih delov telesa (metastatskih možganskih tumorjev);
It interferes with the normal function and repair of DNA and RNA, the genetic instructions that cells need to function and multiply.
Ovira normalno delovanje in popravljanje DNK in RNK, tj. genetskih navodil, ki jih celice potrebujejo za delovanje in podvajanje.
A dose based on the patient's weight and height is given at intervals of at least 6 weeks, and should be adjusted according to the patient's blood cell counts.
Odmerek, ki temelji na bolnikovi telesni masi in višini, se daje v vsaj šesttedenskih presledkih in ga je treba prilagoditi glede na bolnikovo krvno sliko.
The European Medicines Agency concluded that, in accordance with EU requirements, Carmustine Obvius has been shown to be comparable to Carmubris.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Karmustin Obvius primerljivo z zdravilom Carmubris.
What measures are being taken to ensure the safe and effective use of Carmustine Obvius?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Karmustin Obvius?
Carmustine Obvius is a cancer medicine that is used, on its own or with other cancer medicines and treatments, to treat the following types of cancer:
Karmustin Obvius je zdravilo proti raku, ki se uporablja samostojno ali skupaj z drugimi zdravili in zdravljenji za zdravljenje naslednjih vrst raka:
Because Carmustine Obvius is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Karmustin Obvius generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
As for every medicine, the company provided studies on the quality of Carmustine Obvius.
Tako kot za vsako zdravilo je družba predložila študije o kakovosti zdravila Karmustin Obvius.
An overview of Carmustine Obvius and why it is authorised in the EU
Pregled zdravila Karmustin Obvius in zakaj je odobreno v EU
Studies on the benefits and risks of the active substance carmustine in the authorised uses have already been carried out with the reference medicine, Carmubris, and do not need to be repeated for Carmustine Obvius.
Študije o koristih in tveganjih učinkovine karmustina pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Carmubris, zato jih ni treba ponoviti za zdravilo Karmustin Obvius.
Other information about Carmustine Obvius
Druge informacije o zdravilu Karmustin Obvius
What are the benefits and risks of Carmustine Obvius?
Kakšne so koristi in tveganja zdravila Karmustin Obvius?
Carmustine Obvius (carmustine)
Karmustin Obvius (karmustin)
What is Carmustine Obvius and what is it used for?
Kaj je zdravilo Karmustin Obvius in za kaj se uporablja?
Carmustine Obvius is a ‘generic medicine'.
Zdravilo Karmustin Obvius je „generično zdravilo“.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Carmustine Obvius 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 Karmustin Obvius upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
This means that Carmustine Obvius contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Carmubris.
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Carmubris.
By damaging the DNA of cancer cells, carmustine can help kill them and prevent the cancer from growing and spreading.
Karmustin poškoduje DNK rakavih celic, jih tako uniči ter prepreči rast in širjenje raka.
Why is Carmustine Obvius authorised in the EU?
Zakaj je bilo zdravilo Karmustin Obvius odobreno v EU?
Carmustine, the active substance in this medicine, is a type of cancer medicine known as an alkylating agent.
Karmustin, učinkovina v tem zdravilu, je vrsta zdravila proti raku, znana kot alkilirajoča učinkovina.
For more information about using Carmustine Obvius, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Karmustin Obvius glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.