natgillin/translations-raw huggingface dataset:
The mean maximum concentration (Cmax) was 1,655 ± 332 ng/ml in plasma at 2-4 hours (Tmax) after a 2.5 mg/kg afoxolaner dose.
Srednja maksimalna koncentracija v plazmi (Cmax) je 1,655 ± 332 ng/ml 2-4 ure (Tmax) po dajanju odmerka 2,5 mg/kg afoksolanera.
Afoxolaner acts at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes.
Afoksolaner deluje na od ligandov odvisne klorove kanalčke, predvsem tiste, ki so pod vplivom nevrotransmiterja gamaaminobutirične kisline (GABA), s čimer zavirajo pre- in post-sinaptični prehod kloridnih ionov skozi celično membrano.
The tablets are chewable and palatable to most dogs.
Tablete so žvečljive in okusne večini psov.
Monthly administration of the product until two negative skin scrapings are obtained one month apart.
Zdravilo se daje enkrat mesečno do dveh negativnih ostružkov kože, vzetih v razmiku 1 meseca.
Afoxolaner is an insecticide and acaricide belonging to the isoxazoline family.
Afoksolaner je insekticid in akaricid iz skupine isoksazolinov.
Afoxolaner distributes into tissues with a volume of distribution of 2.6 ± 0.6 l/kg and a systemic clearance value of 5.0 ± 1.2 ml/hr/kg.
Afoksolaner se v tkiva prerazporedi z volumnom distribucije 2.6 ± 0,6 l/kg in sistemskim clearance 5,0 ± 1,2 ml/uro/kg.
After oral administration in dogs, afoxolaner was shown to have high systemic absorption following administration.
Po peroralnem dajanju pri psih ima afoksolaner visoko sistemsko absorbcijo.
Each chewable tablet contains: Afoxolaner MERIAL
Vsaka tableta vsebuje: Afoxolaner MERIAL
For each strength, the chewable tablets are available in the following pack sizes: Carton with 1 blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet.
Za vsako jakost so žvečljive tablete pakirane v naslednjih velikostih pakiranja: Škatlica z 1 pretisnim omotom z 1, 3 ali 6 žvečljivimi tabletami, ali 15 pretisnih omotov z 1 žvečljivo tableto.
Monthly administration of the product for two consecutive months.
Dajanje enkrat mesečno dva zaporedna meseca.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in breeding dogs.
Varnost zdravila za uporabo v veterinarski medicini v obdobju brejosti in laktacije ali razploda ni bila ugotovljena.
Monthly intervals throughout the flea and/or tick seasons, based on local epidemiological situations.
Zdravite v mesečnih intervali skozi vso sezono bolh/klopov, na podlagi lokalnih epidemioloških razmer.
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
Mild gastrointestinal effects (vomiting, diarrhoea), pruritus, lethargy, anorexia, and neurological signs (convulsions, ataxia and muscle tremors) have been reported very rarely.
Zelo redko so se pojavili blagi gastrointestinalni učinki (bruhanje, driska), pruritus, letargija, anoreksija in nevrološki znaki (konvulzije, ataksija in mišični tremor).
Treatment of tick infestation in dogs (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus).
Zdravljenje infestacije s klopi pri psih (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus).
Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Imetnik dovoljenja za promet z zdravilom: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Treatment of demodicosis (caused by Demodex canis):
Zdravljenje demodikoze (ki jo povzroča Demodex canis):
Bodyweight of dog (kg)
Telesna masa psa (kg)
Treatment of demodicosis (caused by Demodex canis).
Zdravljenje demodikoze (ki jo povzroča Demodex canis).
The selective toxicity of afoxolaner between insect/acarines and mammals may be inferred by the differential sensitivity of the insect/acarines' GABA receptors versus mammalian receptors.
Sklepa se, da je selektivna toksičnost afoksolanera drugačna pri insektih/pršicah in sesalcih zaradi razlike v občutljivosti GABA receptorjev.
The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Zdravilo je lahko del strategije zdravljenja in preprečevanja alergijskih dermatitisov, ki jih povzroča bolhavost
One carton contains one blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet.
Ena škatla z enim pretisnim omotom z 1, 3 ali 6 žvečljivimi tabletami, ali 15 pretisnih omotov z
Afoxolaner (mg)
afoksolaner (mg)
The product kills fleas before egg production and therefore prevents household contamination.
Zdravilo ubije bolhe preden lahko izležejo jajčeca, zato preprečuje kontaminacijo okolice z razvojnimi oblikami.
Further monthly administration of the product may be required based on clinical assessment and skin scrapings.
Na podlagi klinične ocene in kožnega ostružka je lahko potrebno z mesečnim zdravljenjem še nadaljevati.
Afoxolaner is active against adult fleas as well as several tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum and Haemaphysalis longicornis.
Afoksolaner učinkuje na odrasle bolhe kot tudi številne vrste klopov, kot so Dermacentor reticulatus in D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum, in Haemaphysalis longicornis.
Treatment of flea and tick infestations:
Razpored zdravljenja: Zdravljenje infestacij z bolhami in klopi:
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli po EXP. Za shranjevanje zdravila niso potrebna posebna navodila.
Dogs 2-4 kg Dogs >4-10 kg Dogs >10-25 kg Dogs >25-50 kg
Psi 2 4 kg Psi >4-10 kg Psi >10-25 kg Psi >25-50 kg
Chewable tablets
Žvečljive tablete
Name and address of the manufacturer responsible for batch release
Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij MERIAL
The metabolites and parent compound are eliminated from the body via urinary and biliary excretion with the majority eliminated in the bile.
Metaboliti in izhodiščna snov se izločilo iz telesa preko ledvic in jeter, večinoma preko žolča.
For oral use.
Peroralno dajanje.
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.
Da pride do izpostavljenosti učinkovini, se morajo bolhe in klopi pritrditi na gostitelja in pričeti s hranjenjem.
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis):
Zdravljenje garjavosti (ki jo povzroča Sarcoptes scabiei var. canis):
{DD/MM/YYYY}
DD/MM/LLLL
Soy protein fines Braised beef flavouring Povidone (E1201) Macrogol 400
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi koruzni škrob proteini soje okus govedine povidon (E1201) makrogol 400 makrogol 4000 makrogol 15 hidroksistearat glicerol (E422)
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis).
Zdravljenje garjavosti (ki jo povzroča Sarcoptes scabiei var. canis).
MERIAL
KARENCA
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton
PODATKI NA ZUNANJI OVOJNINI Škatla
chewable tablets for dogs 2-4 kg chewable tablets for dogs >4-10 kg chewable tablets for dogs >10-25 kg chewable tablets for dogs >25-50 kg
Žvečljive tablete za pse 2 4 kg Žvečljive tablete za pse >4 10 kg Žvečljive tablete za pse >10 25 kg Žvečljive tablete za pse >25 50 kg
Special precautions to be taken by the person administering the veterinary medicinal product to animals To prevent children from getting access to the veterinary medicinal product, remove only one chewable tablet at a time from the blister.
Iz omota odstranite le eno tableto naenkrat, da bi preprečili otrokom morebiten dostop do zdravila za uporabo v veterinarski medicini.
Mottled red to reddish brown, circular shaped (tablets for dogs 2-4 kg), or rectangular shaped (tablets for dogs >4-10 kg, tablets for dogs >10-25 kg and tablets for dogs >25-50 kg).
Lisaste rdeče ali rdeče-rjave, okrogle (tablete za pse 2-4 kg) ali pravokotne tablete (tablete za pse >4-10 kg, tablete za pse >10-25 kg in tablete za pse >25-50 kg).
No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age when treated with 5 times the maximum dose repeated 6 times at intervals of two to four weeks.
6-kratnim zdravljenjem s 5-kratnikom največjega odmerka v dvotedenskih do štiritedenskih intervalih.
No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age when treated with 5 times the maximum dose repeated 6 times at intervals of 2-4 weeks.
Pri zdravih mladičih pasme beagle, starih 8 tednov in več niso opazili nobenih neželenih učinkov med
Afoxolaner MERIAL tablets are chewable and palatable to most dogs.
Zdravilo Afoxolaner MERIAL učinkuje na odrasle bolhe kot tudi številne vrste klopov, kot so
Afoxolaner MERIAL 11 mg dogs 2-4 kg Afoxolaner MERIAL 28 mg dogs >4-10 kg Afoxolaner MERIAL 68 mg dogs >10-25 kg Afoxolaner MERIAL 136 mg dogs >25-50 kg afoxolaner
Afoxolaner MERIAL 11 mg psi 2-4 kg Afoxolaner MERIAL 28 mg psi >4-10 kg Afoxolaner MERIAL 68 mg psi >10-25 kg Afoxolaner MERIAL 136 mg psi >25-50 kg
To be supplied only on veterinary prescription.
Pretisni omot IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs >4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs >10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs >25-50 kg
Afoxolaner MERIAL 11 mg žvečljive tablete za pse 2-4 kg Afoxolaner MERIAL 28 mg žvečljive tablete za pse >4-10 kg Afoxolaner MERIAL 68 mg žvečljive tablete za pse >10-25 kg Afoxolaner MERIAL 136 mg žvečljive tablete za pse >25-50 kg
EMEA/H/C/product number
EMEA/H/C/številka zdravila
The main measure of effectiveness was based on the proportion of patients who had a complete response to treatment.
Glavno merilo učinkovitosti je temeljilo na deležu bolnikov, ki so se na zdravljenje v celoti odzvali.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Če ste vključeni v klinično preskušanje ali program sočutne uporabe in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je zdravljenje predpisal.
In particular, the Committee could not conclude on the clinical benefit of the medicine.
Odbor zlasti ni mogel podati sklepa o klinični koristi zdravila.
The summary of the opinion of the Committee for Orphan Medicinal Products for Istodax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Istodax je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 15 November 2012.
Po preučitvi podlage za to zahtevo je CHMP ponovno pregledal prvotno mnenje in dne 15. novembra 2012 potrdil zavrnitev vloge za dovoljenje za promet z zdravilom.
Refusal of the marketing authorisation for Istodax (romidepsin) EMA/725439/2012
Zavrnitev vloge za dovoljenje za promet z zdravilom Istodax (romidepsin) EMA/725439/2012
The effects of Istodax were first tested in experimental models before being studied in humans.
Učinki zdravila Istodax so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
In the study, Istodax was not compared with any other treatment.
V študiji zdravila Istodax niso primerjali z nobeno drugo obliko zdravljenja.
The company that applied for authorisation is Celgene Europe Ltd.
Vlogo za dovoljenje je predložila družba Celgene Europe Ltd.
However, the fact that Istodax was not compared with any other treatment did not allow the Committee to conclude on the clinical benefit of the medicine in terms of overall survival (how long the patients lived) or progression-free survival (how long the patients lived without their disease getting worse).
Vendar zaradi dejstva, da zdravila Istodax niso primerjali z nobeno drugo obliko zdravljenja, Odbor ni mogel oceniti kliničnih koristi zdravila v smislu celokupnega preživetja (kako dolgo so bolniki živeli) ali preživetja brez napredovanja bolezni (kako dolgo so bolniki živeli, ne da bi se bolezen poslabšala).
Istodax is a medicine that contains the active substance romidepsin.
Istodax je zdravilo, ki vsebuje zdravilno učinkovino romidepsin.
As it was not compared with any other treatment, it was not possible to establish whether the observed effects were due to the medicine or due to the disease characteristics of patients in the main study.
Ker ga niso primerjali z nobeno drugo obliko zdravljenja, ni bilo mogoče ugotoviti, ali so bili opaženi učinki povezani z zdravilom ali z značilnostmi bolezni bolnikov, zajetih v študiji.
Peripheral T-cell lymphoma is a cancer of a type of white blood cells called T-cells, which are part of the immune system.
Periferni T-celični limfom je rak vrste krvnih celic, imenovanih T-celice, ki so del imunskega sistema.
What is Istodax?
Kaj je zdravilo Istodax?
The CHMP also noted that, due to an oversight, the company failed to provide an adequate certificate of Good Manufacturing Practice for the site where the medicine is manufactured, which is legally required.
CHMP je ugotovil tudi, da družba pomotoma ni predložila ustreznega zakonsko predpisanega potrdila o dobri proizvodni praksi za prostor, kjer poteka proizvodnja zdravila.
Therefore it was not possible to conclude that the benefits of the medicine outweigh the risks and the CHMP confirmed its initial negative opinion.
Posledično CHMP ni mogel oceniti, ali koristi zdravila odtehtajo z njim povezana tveganja, zato je potrdil svoje prvotno negativno mnenje.
Istodax was expected to be used for the treatment of adults with peripheral T-cell lymphoma that no longer responds to or has come back after at least two previous therapies.
Zdravilo Istodax naj bi se uporabljalo za zdravljenje odraslih bolnikov s perifernim T-celičnim limfomom, ki se ne odziva več na terapije ali pa se je ponovno pojavil po vsaj dveh predhodnih terapijah.
On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Istodax, intended for the treatment of peripheral T-cell lymphoma.
Odbor za zdravila za uporabo v humani medicini (CHMP) je 19. julija 2012 sprejel negativno mnenje in priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Istodax, namenjenim za zdravljenje perifernega T-celičnega limfoma.
Refusal of the marketing authorisation for Istodax (romidepsin)
Zavrnitev vloge za dovoljenje za promet z zdravilom Istodax (romidepsin)
It was to be available as a powder and solvent to be made into a solution for infusion (drip into a vein).
Zdravilo naj bi bilo na voljo v obliki praška in vehikla za pripravo raztopine za infundiranje (kapalne infuzije v veno).
In November 2012, following the re-examination, the CHMP removed its concern over the certificate of Good Manufacturing Practice, but retained its other concerns.
Novembra 2012 je CHMP po ponovnem pregledu ugotovil, da ni več zadržka glede potrdila o dobri proizvodni praksi, drugi pomisleki pa še vedno ostajajo.
Istodax was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 October 2005 for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated).
Zdravilo Istodax je bilo dne 28. oktobra 2005 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje perifernega T-celičnega limfoma (nodalni, ekstranodalni in levkemični/diseminirani).
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Istodax.
Družba je CHMP obvestila, da zavrnitev nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Istodax.
The exact way that romidepsin works in peripheral T-cell lymphoma is not known, but its effects on genes that regulate cell proliferation and cell death are expected to lead to a reduction in the rate of growth and division of the cancer cells.
Natančen mehanizem delovanja romidepsina pri zdravljenju T celičnega limfoma ni znan, vendar naj bi njegovo delovanje na gene, ki uravnavajo proliferacijo in odmiranje celic, upočasnilo rast in delitev rakavih celic.
The company presented the results from one main study with Istodax involving 131 patients with peripheral T-cell lymphoma who had received previous treatment.
Družba je predložila rezultate ene glavne študije, v kateri je 131 bolnikov s perifernim T-celičnim limfomom, ki so predhodno že bili zdravljeni, prejemalo zdravilo Istodax.
What was Istodax expected to be used for?
Za kaj naj bi se zdravilo Istodax uporabljalo?
The active substance in Istodax, romidepsin, is expected to work by blocking the activity of proteins called histone deacetylases, which are involved in turning genes ‘on' and ‘off' within cells.
Zdravilna učinkovina v zdravilu Istodax, romidepsin, naj bi zavirala delovanje beljakovin, imenovanih histonske deacetilaze, ki sodelujejo v procesu aktiviranja in deaktiviranja genov v celicah.
How is Istodax expected to work?
Kako naj bi zdravilo Istodax delovalo?
In July 2012, the CHMP noted that the main study showed that Istodax had anti-tumour activity in terms of patients' response to treatment.
Julija 2012 je CHMP na podlagi odziva bolnikov na zdravljenje zaključil, da je študija pokazala, da je imelo zdravilo Istodax protitumorske učinke.
In both studies there were no cases of resistance to treatment after 48 weeks.
V obeh študijah po 48 tednih ni bilo nobenih primerov odpornosti na zdravljenje.
What measures are being taken to ensure the safe and effective use of Dovato?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Dovato?
An overview of Dovato and why it is authorised in the EU
Pregled zdravila Dovato in zakaj je odobreno v EU
As for all medicines, data on the use of Dovato are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Dovato stalno spremljajo.
Other information about Dovato
Druge informacije o zdravilu Dovato
Both active substances have already been authorised in the European Union as separate tablets: dolutegravir in 2014 and lamivudine in 1996.
Obe učinkovini sta v Evropski uniji že pridobili dovoljenje za promet v obliki ločenih tablet: dolutegravir leta 2014 in lamivudin leta 1996.
What benefits of Dovato have been shown in studies?
Kakšne koristi je zdravilo Dovato izkazalo v študijah?
Dovato is available as tablets containing 50 mg of dolutegravir and 300 mg of lamivudine.
Zdravilo Dovato je na voljo v obliki tablet, ki vsebujejo 50 mg dolutegravirja in 300 mg lamivudina.
Why is Dovato authorised in the EU?
Zakaj je bilo zdravilo Dovato odobreno v EU?
Side effects reported with Dovato are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Dovato, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dovato 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 Dovato upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What are the risks associated with Dovato?
Kakšna tveganja so povezana z zdravilom Dovato?
What is Dovato and what is it used for?
Kaj je zdravilo Dovato in za kaj se uporablja?
In these studies, 91% of patients with HIV-1 who took the Dovato combination no longer had detectable levels of HIV (below 50 copies per ml) after 48 week compared with 93% of those who were taking the triple combination.
V teh študijah pri 91 % bolnikov z virusom HIV-1, ki so jemali kombinacijo učinkovin v zdravilu Dovato, po 48 tednih ni bilo več zaznavnih ravni virusa HIV (pod 50 kopij na ml) v primerjavi s 93 % tistih, ki so jemali kombinacijo treh učinkovin.
Triple combination therapy is used for HIV treatment to reduce the chance of the virus becoming resistant to treatment.
Zdravljenje s kombinacijo treh učinkovin se uporablja za zdravljenje okužbe z virusom HIV za zmanjšanje možnosti, da bi virus postal odporen na zdravljenje.
Dolutegravir stops the activity of an enzyme called integrase (and is known as an integrase inhibitor), while lamivudine stops the activity of reverse transcriptase (and is known as a nucleoside reverse transcriptase inhibitor or NRTI).
Dolutegravir zavira delovanje encima, imenovanega integraza (in je znan kot zaviralec integraze), lamivudin pa ustavi delovanje reverzne transkriptaze (in je znan kot nukleozidni zaviralec reverzne transkriptaze ali NRTI).
Dovato does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Dovato ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
The most common serious side effects (which may affect up to 1 in 100 people) are allergic reactions, including rash and severe liver problems.
Najresnejši neželeni učinki (ki se lahko pojavijo pri največ 1 bolniku od 100) so alergijske reakcije, vključno z izpuščajem ali hudimi težavami z jetri.
This medicine contains the active substances dolutegravir and lamivudine and is used to treat infections that are not resistant to medicines of the same class as dolutegravir or to lamivudine.
To zdravilo vsebuje učinkovini dolutegravir in lamivudin ter se uporablja za zdravljenje okužb, ki niso odporne na zdravila iz istega razreda, kot je dolutegravir, ali na lamivudin.
The two active substances in Dovato, dolutegravir and lamivudine, block the activity of enzymes that the virus uses to make new copies of itself.
Obe učinkovini v zdravilu Dovato, dolutegravir in lamivudin, zavirata dejavnost encimov, ki jih virus uporablja za izdelavo novih kopij.
The most common side effects with Dovato (which may affect up to 1 in 10 people) are headache, diarrhoea, nausea and difficulty sleeping.
Najpogostejši neželeni učinki zdravila Dovato (ki se lahko pojavijo pri največ 1 bolniku od 10) so glavobol, driska, slabost in težave s spanjem.
Dovato received a marketing authorisation valid throughout the EU on 1 July 2019 Further information on Dovato can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dovato This overview was last updated in 08-2019.
Nadaljnje informacije o zdravilu Dovato so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/dovato
Two main studies, involving 1,441 patients, have shown that the combination of the two active substances in Dovato is as effective at lowering the amount of HIV in the blood as a triple combination therapy (dolutegravir plus tenofovir plus emtricitabine).
V dveh glavnih študijah, v kateri je bilo vključeno 1 433 bolnikov, sta pokazali, da je kombinacija obeh učinkovin v zdravilu Dovato enako učinkovita pri zniževanju količine virusa HIV v krvi kot zdravljenje s kombinacijo treh učinkovin (dolutegravir ter tenofovir in emtricitabin).
Dovato can only be obtained with a prescription and should be prescribed by a doctor who is experienced in managing HIV infection.
Predpisovanje in izdaja zdravila Dovato je le na recept, predpisati pa ga mora zdravnik z izkušnjami z zdravljenjem okužb z virusom HIV.