natgillin/translations-raw huggingface dataset:
• the treatment of cutaneous dirofilariosis (skinworm) (adult stages of Dirofilaria repens)
• zdravljenje kožne oblike dirofilarioze (kožna glista) (odrasle oblike Dirofilaria repens),
One pipette of Advocate spot-on solution for Small Cats (0.4 ml) should be administered per animal.
Belemu dihurju nanesemo 1 merilno kapalko zdravila Advocate, kožni nanos, raztopina za male mačke (0,4 ml).
To prevent licking, apply topically to the skin restricting the area of application to the animal's neck at the base of the skull.
Ker je zdravilo grenko, se lahko živali, ki po nanosu ližejo mesto aplikacije, slinijo.
In endemic areas regular monthly application will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.
Na področjih, ki so okužena z Dirofilaria immitis, mesečno dajanja zdravila preprečuje ponovne infestacije z različnimi vrstami glist.
Then hold the pipette in an upright position, and twist and pull off cap.
Vzemite merilno kapalko iz ovojnine, držite jo navpično, zavrtite in snemite pokrov, obrnite ga in prebodite plastično zaporo na merilni kapalki kot kaže slika.
Care should be taken that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.
Še posebno moramo paziti, da tretirana žival in/ali druge živali, ki so z njo v tesnem stiku, zdravila ne zaužijejo.
Veterinary medicinal product subject to prescription.
Po posvetu z veterinarjem zamenjamo zdravilo.
In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms.
Na področjih, ki so okužena z Dirofilaria immitis, mesečno dajanja zdravila preprečuje ponovne okužbe z različnimi vrstami glist.
For cats, the corresponding “Advocate for cats” product (0.4 or 0.8 ml), which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used.
Pri mačkah uporabljamo ustrezno obliko zdravila Advocate za mačke (0,4 ali 0,8 ml), ki vsebuje 100
Imidacloprid has minimal pharmacological activity in mammals.
Farmakološki učinek imidakloprida je pri sesalcih neznaten.
Moxidectin is active against larval stages (L3, L4) of Dirofilaria immitis.
Moksidektin deluje na ličinke gliste Dirofilaria immitis (oblike L3, L4) kakor tudi na želodčno-črevesne nematode.
Thelazia for ferrets
Velikost merilne kapalke
Advocate 400 mg + 100 mg spot-on solution for extra-large dogs Imidacloprid, moxidectin
Advocate 400 mg + 100 mg, kožni nanos, raztopina za zelo velike pse.
The European Commission granted a marketing authorisation valid throughout the European Union for Provenge on 6 September 2013.
Evropska komisija je dovoljenje za promet z zdravilom Provenge, veljavno po vsej Evropski uniji, odobrila dne 6. septembra 2013.
In a main study involving 512 patients, the average overall survival for patients treated with Provenge was 25.8 months, compared with 21.7 months for patients given placebo.
V glavni študiji, v katero je bilo vključenih 512 bolnikov, je bilo povprečno celokupno preživetje pri bolnikih, zdravljenih z zdravilom Provenge, 25,8 meseca, pri bolnikih, ki so prejemali placebo, pa 21,7 meseca.
The full EPAR for Provenge 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) za zdravilo Provenge je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The leukapheresis and infusion are repeated on two further occasions, each approximately 2 weeks apart.
Levkaferezo in infundiranje je treba nato ponoviti še dvakrat v približno 2-tedenskih razmikih.
It must be given under the supervision of a doctor experienced in the treatment of prostate cancer and in an environment where resuscitation equipment is available.
Dajati ga je treba pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem raka prostate, in v okolju, kjer je na voljo oprema za oživljanje.
What measures are being taken to ensure the safe and effective use of Provenge?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Provenge?
The patient should be monitored for at least half an hour after the infusion.
Bolnika je treba spremljati še najmanj pol ure po infundiranju.
This is a summary of the European public assessment report (EPAR) for Provenge.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Provenge.
What is Provenge and what is it used for?
Kaj je zdravilo Provenge in za kaj se uporablja?
Other information about Provenge
Druge informacije o zdravilu Provenge
Further studies will also be carried out to provide additional supportive data on the effectiveness of Provenge.
Izvedla bo tudi nadaljnje študije za pridobitev dodatnih podatkov v podporo učinkovitosti zdravila Provenge.
A risk management plan has been developed to ensure that Provenge is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Provenge je bil pripravljen načrt obvladovanja tveganj.
Provenge autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (sipuleucel-T)
Provenge avtologne mononuklearne celice iz periferne krvi, aktivirane s PAP-GM-CSF (sipuleucel-T)
It contains immune cells that are extracted from the patient's blood.
Vsebuje imunske celice, pridobljene iz bolnikove krvi.
The main risks included acute infusion reactions, toxicities associated with the leukapheresis procedure and infections, but the CHMP considered that these were manageable and adequately addressed by risk minimisation measures for this medicine.
Glavna tveganja vključujejo akutne reakcije na infundiranje, toksične učinke, povezane s postopkom levkafereze, in okužbe, vendar je CHMP menil, da so ta tveganja obvladljiva in ustrezno nadzorovana z ukrepi za zmanjšanje tveganj, ki so bili sprejeti za to zdravilo.
Around half an hour before each infusion, the patient should take paracetamol and an antihistamine to reduce infusion-related reactions with Provenge.
Približno pol ure pred vsakim infundiranjem mora bolnik vzeti paracetamol in antihistaminik za zmanjšanje reakcij, povezanih z infundiranjem zdravila Provenge.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Provenge's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Provenge večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
It will also supply cards for patients to record the scheduled leukapheresis and infusion dates.
Priskrbela bo tudi kartice za bolnike za beleženje predvidene levkafereze in datumov infuzij.
It is used when the cancer is metastatic (has spread to other parts of the body), and when medical or surgical castration (stopping the production of male hormones) has not worked or no longer works but treatment with chemotherapy (medicines that kill fast-growing cells like cancer cells) is not yet considered appropriate.
Uporablja se, kadar je rak metastatski (razširjen na druge dele telesa) in kadar kastracija z zdravili ali kirurška kastracija (prekinitev izločanja moških hormonov) ni bila učinkovita ali ne učinkuje več, zdravljenje s kemoterapijo (zdravili, ki uničijo hitro rastoče celice, kot so rakave celice) pa še ni primerno.
Once prepared, the medicine is given as an infusion lasting around 1 hour.
Ko je zdravilo pripravljeno, se bolniku vbrizga v obliki infuzije, ki traja približno 1 uro.
What are the risks associated with Provenge?
Kakšna tveganja so povezana z zdravilom Provenge?
What benefits of Provenge have been shown in studies?
Kakšne koristi je zdravilo Provenge izkazalo v študijah?
It is not intended to provide practical advice on how to use Provenge.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
In addition, the company that markets Provenge will provide educational materials for doctors and patients on how to use the medicine and the leukapheresis procedure.
Poleg tega bo družba, ki trži zdravilo Provenge, zagotovila izobraževalno gradivo za zdravnike in bolnike z navodili za uporabo zdravila in postopka levkafereze.
The company will also set up an EUbased registry of patients treated with Provenge in order to monitor overall survival and side effects reported (particularly stroke and heart attack), and will provide data from a US-based registry.
Prav tako bo družba v EU vzpostavila register bolnikov, zdravljenih z zdravilom Provenge, ki bo namenjen spremljanju celokupnega preživetja in poročil o neželenih učinkih (zlasti možganski in srčni kapi), ter priskrbela podatke iz registra v ZDA.
The CHMP concluded that the improvement in overall survival seen with Provenge is important for patients.
CHMP je menil, da je izboljšanje celokupnega preživetja, ki so ga opazili pri uporabi zdravila Provenge, pomembno za bolnike.
These cells are then mixed outside the patient's body with a ‘fusion protein', which is taken up by the cells.
Tem celicam nato zunaj bolnikovega telesa primešajo „fuzijsko beljakovino“, ki jo privzamejo celice.
Provenge is a cancer medicine that is prepared specifically for each patient using their own immune cells (cells that form part of the body's natural defences).
Provenge je zdravilo proti raku, ki se pripravi za vsakega bolnika posebej iz njegovih lastnih imunskih celic (tj. celic, ki so del naravnega obrambnega sistema telesa).
Three days before the infusion, a procedure called leukapheresis is performed to collect immune cells from the patient's blood, and these are then sent to a manufacturing facility to prepare the medicine.
Tri dni pred infundiranjem se opravi postopek, imenovan levkafereza, s katerim se iz bolnikove krvi pridobijo imunske celice, ki se nato pošljejo v proizvodni obrat, kjer pripravijo zdravilo.
This type of prostate cancer is called castration-resistant matastatic prostate cancer.
Tovrstni rak prostate se imenuje na kastracijo odporen metastatski rak prostate.
Provenge is used to treat adult men with cancer of the prostate (a gland of the male reproductive system) who have few or no symptoms.
Zdravilo Provenge se uporablja za zdravljenje odraslih moških z rakom prostate (žleze moškega reproduktivnega sistema), ki imajo malo simptomov oziroma jih sploh nimajo.
For more information about treatment with Provenge, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Provenge preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The fusion protein consists of prostatic acid phosphatase (PAP), a molecule found in most prostate cancer cells, attached to granulocyte-macrophage colony-stimulating factor (GM-CSF), a molecule that activates immune cells.
Fuzijsko beljakovino sestavlja prostatična kisla fosfataza (PAP - prostatic acid phosphatase), tj. molekula, ki jo najdemo v večini celic raka prostate in je vezana na granulocitne makrofagne kolonije spodbujajoči faktor (GM-CSF - granulocytemacrophage colony-stimulating factor), tj. molekulo, ki aktivira imunske celice.
Why is Provenge approved?
Zakaj je bilo zdravilo Provenge odobreno?
When the immune cells are infused back into the patient, they stimulate an immune response against PAP, resulting in the immune system attacking and killing prostate cancer cells because they contain PAP.
Ko se imunske celice infundirajo nazaj v bolnika, spodbudijo imunski odziv proti PAP in s tem povzročijo, da imunski sistem napade in uniči celice raka prostate, ki vsebujejo PAP.
Provenge is a type of advanced therapy medicine called a ‘somatic cell therapy product'.
Zdravilo Provenge je vrsta zdravila za napredno zdravljenje, ki se imenuje „zdravilo za somatsko celično zdravljenje“.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Provenge, 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 uporabo za zdravilo Provenge vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Serious side effects with Provenge include severe acute infusion reactions, severe infection (catheter sepsis and staphylococcal bacteraemia), heart attack and cerebrovascular events (related to the blood supply to the brain).
Resni neželeni učinki zdravila Provenge vključujejo hude akutne reakcije na infundiranje, hudo okužbo (sepso zaradi katetra in stafilokokno bakteriemijo), srčno kap in cerebrovaskularne dogodke (povezane z oskrbo možganov s krvjo).
Provenge can only be obtained with a prescription.
Izdaja zdravila Provenge je le na recept.
The most common side effects with Provenge (which may affect more than 1 in 10 people) include chills, fatigue (tiredness), pyrexia (fever), nausea (feeling sick), arthralgia (joint pain), headache and vomiting.
Najpogostejši neželeni učinki zdravila Provenge (ki lahko prizadenejo več kot 1 osebo od 10) vključujejo mrzlico, utrujenost, pireksijo (povišano telesno temperaturo), navzeo (slabost), artralgijo (bolečine v sklepih), glavobol in bruhanje.
For practical information about using Provenge, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Provenge naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Provenge is an immunotherapy, a medicine that stimulates the immune system to kill cancer cells.
Provenge je zdravilo za imunoterapijo, kar pomeni, da spodbuja imunski sistem k uničevanju rakavih celic.
For the full list of all side effects reported with Provenge, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Provenge, glejte navodilo za uporabo.
Provenge is available as a liquid dispersion for infusion (drip) into a vein.
Zdravilo Provenge je na voljo v obliki tekoče disperzije za infundiranje (kapalno infuzijo) v veno.
Regarding its safety, the CHMP noted that Provenge was generally well tolerated.
V zvezi z varnostjo je menil, da so bolniki zdravilo Provenge na splošno dobro prenašali.
Provenge was shown to improve overall survival (the average length of time the patients lived) of patients with castration-resistant metastatic prostate cancer, compared with placebo (a dummy treatment).
Zdravilo Provenge je v primerjavi s placebom (zdravilom brez zdravilne učinkovine) izboljšalo celokupno preživetje (povprečen čas preživetja) bolnikov z na kastracijo odpornim metastatskim rakom prostate).
How is Provenge used?
Kako se zdravilo Provenge uporablja?
How does Provenge work?
Kako zdravilo Provenge deluje?
Young children are most at risk, followed by adolescents.
Najbolj ogroženi so mlajši otroci, sledijo pa jim mladostniki.
Although group B meningococcal disease is relatively uncommon in Europe, it is more common in certain regions of Europe.
Čeprav je meningokokna bolezen skupine B v Evropi sorazmerno redka, je v določenih evropskih regijah pogostejša.
Further information on Bexsero can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Bexsero so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
A smaller supportive study was also carried out in adults and similar results were seen in this study.
V manjši podporni študiji, ki so jo opravili pri odraslih, so bili ugotovljeni podobni rezultati.
The second main study involved 1,631 adolescents aged between 11 and 17.
Druga glavna študija je vključevala 1 631 mladostnikov, starih od 11 do 17 let.
The number of injections given, and the interval between them, varies depending on the age of the patient.
Število injiciranih odmerkov in časovni razmak med njimi sta odvisna od starosti bolnika.
Bexsero should be used according to official recommendations.
Zdravilo Bexsero je treba uporabljati v skladu z uradnimi priporočili.
This means that the proteins are fixed onto a compound containing aluminium, to stimulate a better immune response.
To pomeni, da so beljakovine vezane na spojino, ki vsebuje aluminij, kar spodbudi boljši imunski odziv.
The first main study involved 2,627 children who were two months old when the study started.
V prvo glavno študijo je bilo vključenih 2 627 otrok, ki so bili ob začetku študije stari dva meseca.
Other information about Bexsero
Druge informacije o zdravilu Bexsero
The European Medicines Agency decided that Bexsero's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Bexsero večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Bexsero?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Bexsero?
Bexsero received a marketing authorisation valid throughout the EU on 14 January 2013.
Za zdravilo Bexsero je bilo 14. januarja 2013 izdano dovoljenje za promet, veljavno po vsej EU.
As for all medicines, data on the use of Bexsero are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Bexsero stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bexsero 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 Bexsero upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Invasive disease occurs when the bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spine) and septicaemia (blood infection).
Invazivna bolezen se pojavi, ko se bakterije razširijo po telesu in povzročijo resne okužbe, kot sta meningitis (okužba membran, ki obdajajo možgane in hrbtenjačo) in sepsa (okužba krvi).
Why is Bexsero authorised in the EU?
Zakaj je bilo zdravilo Bexsero odobreno v EU?
For more information about using Bexsero, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Bexsero glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Side effects reported with Bexsero are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Bexsero, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What benefits of Bexsero have been shown in studies?
Kakšne koristi zdravila Bexsero so se pokazale v študijah?
An overview of Bexsero and why it is authorised in the EU
Pregled zdravila Bexsero in zakaj je odobreno v EU
The effects of giving three doses of Bexsero at two-month intervals together with other routine infant vaccinations were compared with giving the routine vaccinations alone.
Učinke dajanja treh odmerkov zdravila Bexsero v razmaku dveh mesecev skupaj z drugimi rutinskimi cepljenji dojenčkov so primerjali z dajanjem samo rutinskih cepiv.
It is given by deep injection into a muscle, preferably into the shoulder muscle, or into the thigh muscle in children under two years old.
Zdravilo Bexsero se injicira globoko v mišico, po možnosti v ramensko mišico ali stegensko mišico pri otrocih, mlajših od dveh let.
What is Bexsero and what is it used for?
Kaj je zdravilo Bexsero in za kaj se uporablja?
What are the risks associated with Bexsero?
Kakšna tveganja so povezana z zdravilom Bexsero?
The effects of giving one, two or three doses of Bexsero (at intervals of at least one month) were compared with giving placebo (a dummy treatment).
Učinke dajanja enega, dveh ali treh odmerkov cepiva Bexsero (v razmaku vsaj enega meseca) so primerjali z dajanjem placeba (zdravila brez učinkovine).
Bexsero is available as a suspension for injection in a pre-filled syringe and can only be obtained with a prescription.
Zdravilo Bexsero je na voljo v obliki suspenzije za injiciranje v napolnjenih injekcijskih brizgah, njegovo predpisovanje in izdaja pa je le na recept.
The most common side effects with Bexsero in children up to 10 years of age (seen in more than 1 patient in 10) are eating disorders, sleepiness, unusual crying, headache, diarrhoea, vomiting, rash, arthralgia (joint pain), fever and irritability as well as tenderness, swelling, hardness and redness of the skin at the injection site.
Najpogostejši neželeni učinki zdravila Bexsero pri otrocih, starih do deset let (opaženi pri več kot 1 od 10 bolnikov), so motnje hranjena, zaspanost, neobičajen jok, glavobol, driska, bruhanje, izpuščaj, artralgija (bolečine v sklepih), povišana telesna temperatura in razdražljivost ter občutljivost, oteklina, zatrdlina in pordelost kože na mestu injiciranja.
Bexsero is a vaccine used to protect individuals from the age of two months against invasive meningococcal disease caused by one group of the bacterium Neisseria meningitidis (group B).
Zdravilo Bexsero je cepivo, ki se uporablja za zaščito oseb, starih vsaj dva meseca, pred invazivno meningokokno boleznijo, ki jo povzroča bakterija Neisseria meningitidis (skupina B).
The most common side effects with Bexsero in adolescents from 11 years of age and adults (seen in more than 1 patient in 10) are headache, nausea (feeling sick) and malaise (feeling unwell), myalgia (muscle pain) and arthralgia as well as pain, swelling, hardness and redness of the skin at the injection site.
Najpogostejši neželeni učinki zdravila Bexsero pri mladostnikih, starejših od 11 let, in odraslih (opaženi pri več kot 1 od 10 bolnikov) so glavobol, navzea (siljenje na bruhanje), slabo počutje, mialgija (bolečine v mišicah) in artralgija (bolečine v sklepih) ter bolečina, oteklina, zatrdlina in pordelost kože na mestu injiciranja.
For the full list of side effects and restrictions with Bexsero, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Bexsero glejte navodilo za uporabo.
Bexsero contains parts of the bacteria N. meningitidis group B.
Zdravilo Bexsero vsebuje dele bakterije N. meningitidis skupine B.
The study showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B. In addition, a single booster dose of Bexsero at 12 months of age produced a stronger immune response in children who had already received Bexsero than the first of two ‘catchup' doses in children of the same age who had not.
Študija je pokazala, da je zdravilo Bexsero učinkovito pri spodbujanju imunskega odziva proti bakteriji N. meningitidis skupine B. Študija je tudi pokazala, da je enkratni poživitveni odmerek zdravila Bexsero pri starosti 12 mesecev povzročil močnejši imunski odziv pri otrocih, ki so zdravilo Bexsero že prejeli, kot prvi od dveh naknadnih odmerkov pri otrocih iste starosti, ki zdravila prej niso prejeli.
This study was extended to look at the effects of giving a booster dose of Bexsero at or after 12 months of age to children who had already received Bexsero in early infancy, compared with giving two ‘catch-up' doses to those who had not.
Študija je bila razširjena tako, da so v njej proučevali učinke dajanja poživitvenega odmerka zdravila Bexsero otrokom, ki so to cepivo že prejeli kot dojenčki, pri starosti 12 mesecev ali po dopolnjenih 12 mesecih v primerjavi z dajanjem dveh naknadnih odmerkov otrokom, ki cepiva prej niso prejeli.
Two main studies showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B. The studies measured the production of protective antibodies which are able to kill the bacteria.
Dve glavni študiji sta pokazali, da je zdravilo Bexsero učinkovito pri spodbujanju imunskega odziva proti bakteriji N. meningitidis skupine B. V študijah so merili tvorbo zaščitnih protiteles, ki lahko uničijo bakterije.
How does Bexsero work?
Kako zdravilo Bexsero deluje?
How is Bexsero used?
Kako se zdravilo Bexsero uporablja?