natgillin/translations-raw huggingface dataset:
The product appears to show no interference with antibodies derived from the mother bird and can be safely administered to day-old chickens and chicks in the egg without presenting any apparent safety problem or inducing an immunosuppressive effect.
Zdravilo ne kaže medsebojnega vplivanja s protitelesi, dobljenimi iz starševske ptice, in ga je mogoče varno vbrizgati tudi v en dan stare piščance ter piščance v jajcih brez varnostnih težav ali spodbujanja imunosupresivnega učinka.
No information is available on the safety and efficacy from the concurrent use with any other vaccine, except Merial attenuated vaccines against Marek's disease, Newcastle disease and Infectious bronchitis.
Ni podatkov o varnosti ter učinkovitosti ob sočasni uporabi tega cepiva s katerimkoli drugim razen z Merialovim atenuiranim cepivom proti Marekovi bolezni, atipični kokošji kugi in infekcioznemu bronhitisu.
Whilst the vaccine is unlikely to affect male fertility, a warning has nevertheless been included in the SPC.
Čeprav je učinek cepiva na plodnost samcev malo verjeten, je v Povzetek glavnih značilnosti zdravil (SPC) kljub temu vključeno tudi opozorilo.
Only healthy birds should be vaccinated and the product should not be used in birds in lay and breeding birds.
Cepite lahko le zdrave ptice, cepiva pa ne smete uporabljati pri pticah v obdobju valjenja in za vzrejne ptice.
As for any turkey Herpesvirus (HVT) live vaccine, the product is excreted from vaccinated birds and may spread to turkeys.
Kot velja za vsako živo cepivo puranjega herpesvirusa (HVT), lahko cepljene ptice izločajo cepivo, ki se lahko prenese na purane.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Vaxxitek HVT+IBD exceed the risks of its use in chickens and recommended that Vaxxitek HVT+IBD be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so koristni učinki uporabe zdravila Vaxxitek HVT+IBD pri piščancih večji od tveganj, zato priporoča odobritev dovoljenja za promet z zdravilom Vaxxitek HVT+IBD.
Vaxxitek HVT + IBD contains vaccine strains which induce an active immunity and a serological response (detected antibodies) against the two diseases.
Zdravilo Vaxxitek HVT + IBD vsebuje cepne seve, ki spodbudijo aktivno imunost in serološki odziv (prisotnost protiteles) proti obema boleznima.
In the absence of specific studies, no other vaccine should be administered at the same time when the product is injected into eggs.
Ker ni podatkov o posebnih študijah, se odsvetuje sočasna uporaba tega cepiva z drugimi cepivi, če ste ga vbrizgali v jajca.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) VAXXITEK HVT+IBD EPAR summary for the public
EMEA/V/C/065 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) VAXXITEK HVT+IBD Povzetek EPAR za javnost
The studies demonstrated that Vaxxitek HVT+IBD is effective in the active immunisation of chickens and chicks in the egg against Infectious Bursal disease.
Študije so dokazale, da je zdravilo Vaxxitek HVT+IBD učinkovito pri aktivni imunizaciji piščancev in nerojenih piščancev v jajcu na bolezen Gumboro.
Other information about Vaxxitek HVT+IBD:
Druge informacije o zdravilu Vaxxitek HVT+IBD:
Information on the prescription status of this product may be found on the label/outer package.
Podatke o predpisovanju tega zdravila so navedeni na nalepki na škatli zdravila.
The European Commission granted a marketing authorisation valid throughout the European Union, for Vaxxitek HVT+IBD to Merial S.A.S.
Evropska komisija je dovoljenje za promet z zdravilom Vaxxitek HVT+IBD, veljavno po vsej Evropski uniji, odobrila družbi Merial S.A.S.
Vaxxitek HVT+IBD is also used to reduce mortality, clinical signs and effects of Marek's disease, a herpes virus infection of chickens.
Zdravilo Vaxxitek HVT+IBD se uporablja tudi za zmanjšanje smrtnosti, ublažitev kliničnih znakov in učinkov Marekove bolezni, ki je okužba piščancev z virusom herpesa.
Vaxxitek HVT+IBD is used to prevent the deaths of chickens and to reduce clinical signs and effects of Infectious Bursal disease which is a disease which damages the immune system of chickens.
Zdravilo Vaxxitek HVT+IBD se uporablja za preprečevanje smrtnosti piščancev in ublažitev kliničnih znakov in učinkov bolezni Gumboro, ki poškoduje imunski sistem piščancev.
What benefit has Vaxxitek HVT+IBD shown during the studies?
Kakšne koristi je zdravilo Vaxxitek HVT+IBD izkazalo med raziskavami?
Vaxxitek HVT+IBD is a recombinant vaccine intended for use against Infectious Bursal Disease (also known as Gumboro Disease) and Marek's Disease in chickens.
Zdravilo Vaxxitek HVT+IBD je rekombinantno cepivo, ki je namenjeno za uporabo proti bolezni Gumboro in Marekovi bolezni pri piščancih.
What is the risk associated with Vaxxitek HVT+IBD?
Kakšna tveganja so povezana z zdravilom Vaxxitek HVT+IBD?
Why has Vaxxitek HVT+IBD been approved?
Zakaj je bilo zdravilo Vaxxitek HVT+IBD odobreno?
What is Vaxxitek HVT+IBD?
Kaj je zdravilo Vaxxitek HVT+IBD?
How has Vaxxitek HVT+IBD been studied?
Kako je bilo zdravilo Vaxxitek HVT+IBD raziskano?
What is Vaxxitek HVT+IBD used for?
Za kaj se zdravilo Vaxxitek HVT+IBD uporablja?
How does Vaxxitek HVT+IBD work?
Kako zdravilo Vaxxitek HVT+IBD deluje?
The European Commission granted a marketing authorisation valid throughout the European Union for Pritor on 11 December 1998.
Evropska komisija je dovoljenje za promet z zdravilom Pritor, veljavno po vsej Evropski uniji, izdala 11. decembra 1998.
What measures are being taken to ensure the safe and effective use of Pritor?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pritor?
The full EPAR for Pritor 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 Pritor je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Pritor
Druge informacije o zdravilu Pritor
Pritor must not be used in women who are more than three months pregnant.
Zdravila Pritor ne smejo uporabljati ženske, ki so noseče več kot tri mesece.
What benefit has Pritor shown during the studies?
Kakšne koristi je zdravilo Pritor izkazalo med študijami?
Pritor is a medicine that contains the active substance telmisartan.
Pritor je zdravilo, ki vsebuje zdravilno učinkovino telmisartan.
A risk management plan has been developed to ensure that Pritor is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Pritor je bil pripravljen načrt obvladovanja tveganj.
This is a summary of the European public assessment report (EPAR) for Pritor.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pritor.
Pritor is used to treat essential hypertension (high blood pressure) in adults.
Zdravilo Pritor se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih.
For more information about treatment with Pritor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Pritor preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pritor.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The CHMP decided that Pritor's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Pritor večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pritor, 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.
The active substance in Pritor, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Zdravilna učinkovina v zdravilu Pritor, telmisartan, je „antagonist receptorjev angiotenzina II“, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
What is the risk associated with Pritor?
Kakšna tveganja so povezana z zdravilom Pritor?
Why has Pritor been approved?
Zakaj je bilo zdravilo Pritor odobreno?
Hypotension may be more common in patients receiving Pritor to prevent cardiovascular problems.
Hipotenzija je lahko pogostejša pri bolnikih, ki zdravilo Pritor jemljejo za preprečevanje srčno-žilnih težav.
For the prevention of cardiovascular problems, 80 mg Pritor once a day has been studied in one main study involving almost 26,000 patients aged 55 years or over who had heart or artery disease, had had a stroke, or had diabetes and were at high risk of cardiovascular problems.
Za preprečevanje srčno-žilnih težav so zdravilo Pritor v odmerku 80 mg enkrat dnevno proučevali v eni glavni študiji, v katero je bilo vključenih skoraj 26 000 bolnikov, starih 55 let ali več, ki so imeli srčno ali arterijsko bolezen, so doživeli možgansko kap ali imeli sladkorno bolezen in pri katerih je obstajalo veliko tveganje za srčno-žilne težave.
In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, Pritor must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension).
Pri bolnikih s sladkorno boleznijo tipa 2 ali bolnikih z zmerno ali hudo okvaro ledvic se zdravilo Pritor ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo aliskiren (zdravilo za zdravljenje esencialne hipertenzije).
In the treatment of essential hypertension, Pritor was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Kar zadeva zdravljenje esencialne hipertenzije, je bilo zdravilo Pritor pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba in je imelo podobne učinke kot druga zdravila za zdravljenje hipertenzije.
Side effects with Pritor are not common.
Neželeni učinki zdravila Pritor niso pogosti.
By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke.
Telmisartan z zaviranjem receptorjev, na katere se angiotenzin II običajno veže, prepreči učinek hormona, kar privede do znižanja krvnega tlaka, to pa posledično zmanjša tveganja, povezana s visokim krvnim tlakom, kot sta srčni napad ali možganska kap.
Various doses of Pritor were compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine).
Različne odmerke zdravila Pritor so primerjali s placebom (zdravilom brez zdravilne učinkovine) in drugimi zdravili za zniževanje krvnega tlaka (atenololom, lizinoprilom, enalaprilom in amlodipinom).
Pritor was compared with ramipril (another medicine to prevent cardiovascular problems), and with the combination of both medicines.
Zdravilo Pritor so primerjali z ramiprilom (drugim zdravilom za preprečevanje srčno-žilnih težav) in kombinacijo obeh zdravil.
For the treatment of essential hypertension, Pritor has been studied in 2,647 patients who took Pritor either alone or in combination with hydrochlorothiazide.
Za zdravljenje esencialne hipertenzije so zdravilo Pritor raziskali pri 2 647 bolnikih, ki so zdravilo Pritor jemali bodisi kot samostojno zdravilo bodisi pa v kombinaciji s hidroklorotiazidom.
The doctor should monitor the patient's blood pressure closely when starting Pritor, and may decide to adjust the patient's blood pressure-lowering medication.
Ob začetku zdravljenja z zdravilom Pritor mora zdravnik skrbno spremljati bolnikov krvni tlak in se lahko odloči za prilagoditev odmerka zdravila za zniževanje bolnikovega krvnega tlaka.
It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.
Hkrati srcu olajša črpanje krvi, kar pripomore k manjšemu tveganju za pojav srčno žilnih težav v prihodnosti.
Pritor is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Zdravilo Pritor se uporablja tudi za preprečevanje kardiovaskularnih težav (težav s srcem in krvnimi žilami), kot sta srčni infarkt ali možganska kap.
Pritor must not be used in people who have severe liver problems or bile problems.
Zdravila Pritor prav tako ne smejo uporabljati osebe, ki imajo huda obolenja jeter ali žolčnika.
For the treatment of essential hypertension, the usual recommended dose of Pritor is 40 mg once a day, but some patients may benefit from using 20 mg once a day.
Običajni priporočeni odmerek zdravila Pritor za zdravljenje esencialne hipertenzije znaša 40 mg enkrat dnevno, čeprav za nekatere bolnike zadostuje že 20-miligramski odmerek enkrat na dan.
However, the following side effects are seen in between 1 and 10 patients in 1,000: upper respiratory tract infection (colds) including inflammation of the throat and sinuses, urinary tract infection (infection of the structures that carry urine) including bladder infection, anaemia (low red blood cell counts), hyperkalaemia (high blood potassium levels), depression, insomnia (difficulty sleeping), syncope (fainting), vertigo (a spinning sensation), bradycardia (slow heart rate), hypotension (low blood pressure), dyspnoea (difficulty breathing), cough, abdominal pain (stomach ache), diarrhoea, dyspepsia (heartburn), flatulence (gas), vomiting, hyperhidrosis (excessive sweating), pruritus (itching), rash, myalgia (muscle pain), back pain, muscle spasms, renal impairment
Vendar so pri 1 do 10 bolnikih od 1 000 opazili okužbe zgornjih dihal (prehlade), vključno z vnetjem grla in sinusov, okužbe sečil (okužbe struktur za odvajanje urina), vključno z vnetjem mehurja, anemijo (nizko število rdečih krvničk), hiperkaliemijo (visoke ravni kalija v krvi), depresijo, nespečnost, sinkopo (kratkotrajno izgubo zavesti), vrtoglavico,
For the full list of all side effects reported with Pritor, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Pritor, glejte navodilo za uporabo.
In the prevention of cardiovascular problems, Pritor had a similar effect to ramipril, with around 17% of patients dying, being admitted to hospital because of cardiovascular problems, or having a heart attack or stroke.
Pri preprečevanju srčno-žilnih težav je bilo zdravilo Pritor enako učinkovito kot ramipril, pri čemer je okoli 17 % bolnikov umrlo, bilo hospitaliziranih zaradi srčno-žilnih težav oziroma je doživelo srčni napad ali možgansko kap.
How has Pritor been studied?
Kako je bilo zdravilo Pritor raziskano?
What is Pritor used for?
Za kaj se zdravilo Pritor uporablja?
What is Pritor?
Kaj je zdravilo Pritor?
How is Pritor used?
Kako se zdravilo Pritor uporablja?
(reduced kidney function) including sudden kidney failure, chest pain, asthenia (weakness) and increased blood levels of creatinine (a marker of muscle breakdown).
bradikardijo (zelo počasen srčni utrip), hipotenzijo (nizek krvni tlak), dispnejo (oteženo dihanje), kašelj, bolečine v trebuhu (bolečine v želodcu), drisko, dispepsijo (zgago), napenjanje (vetrove), bruhanje, hiperhidrozo (prekomerno potenje), pruritus (srbenje), izpuščaje, mialgijo (bolečine v mišicah), bolečine v hrbtu, krče v mišicah, okvaro ledvic (zmanjšano delovanje ledvic), vključno z njihovo odpovedjo, bolečine v prsih, astenijo (šibkost) in povečane ravni kreatinina v krvi (znak razgradnje mišic).
How does Pritor work?
Kako zdravilo Pritor deluje?
24 January 2014
24. januar 2014
The main measure of effectiveness was the change in symptoms such as itching intensity and sleep disturbance after 4 weeks of treatment based on a standard scoring system.
Glavno merilo učinkovitosti je bila sprememba simptomov, kot sta na primer intenzivnost srbenja in motnje spanca, po 4 tednih zdravljenja, ki so jo določili s standardnim sistemom ocenjevanja.
The effects of Winfuran were first tested in experimental models before being studied in humans.
Učinki zdravila Winfuran so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) EMA/33514/2014
Umik vloge za pridobitev dovoljenja za promet z zdravilom Winfuran (nalfurafin) EMA/33514/2014
Although an additional analysis showed a modest benefit in a subpopulation of patients with a severe form of uraemic pruritus, the CHMP considered that the clinical relevance had not been shown.
Dodatna analiza je sicer pokazala skromne koristi pri podskupini bolnikov s hudo obliko uremičnega pruritusa, vendar je odbor CHMP menil, da klinična pomembnost ni bila dokazana.
It was to be available as a concentrate for solution for infusion into a vein.
Na voljo naj bi bilo v obliki koncentrata za raztopino za infundiranje v žilo.
The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes for Winfuran.
Družba je odbor CHMP obvestila, da trenutno ne potekajo nobena klinična preskušanja ali programi sočutne uporabe zdravila Winfuran.
Although the exact cause of uraemic pruritus is not known it is thought that the itching is linked to an excessive activity of certain receptors called mu-opioid receptors in the brain and skin.
Natančen vzrok uremičnega pruritusa ni znan, vendar se domneva, da je srbenje povezano s čezmerno dejavnostjo določenih receptorjev v možganih in koži, ki jih imenujemo mu-opioidni receptorji.
The effects of Winfuran were compared with placebo (a dummy treatment) in one main study involving 339 patients with uraemic pruritus who were on regular dialysis.
Učinke zdravila Winfuran so primerjali s placebom (zdravilom brez zdravilne učinkovine) v eni glavni študiji, v kateri je sodelovalo 339 bolnikov z uremičnim pruritusom, ki so potrebovali redno dializo.
On 17 January 2014, Toray International U.K. Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Winfuran, intended for the treatment of severe uraemic pruritus (a form of itching) in patients with end-stage kidney disease on dialysis.
Družba Toray International U.K. Limited je dne 17. januarja 2014 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Winfuran, namenjenim zdravljenju hudega uremičnega pruritusa (oblike srbenja) pri bolnikih s končno odpovedjo ledvic, ki potrebujejo dializo.
Uraemic pruritus is a persisting form of itching that occurs in some patients whose kidneys are not functioning properly.
Uremični pruritus je trdovratna oblika srbenja, ki se pojavi pri nekaterih bolnikih, katerih ledvice ne delujejo pravilno.
The main study failed to show that Winfuran was more effective than placebo at relieving itching.
V glavni študiji niso uspeli dokazati, da je zdravilo Winfuran učinkovitejše od placeba pri lajšanju srbenja.
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Winfuran (nalfurafin)
Winfuran is a medicine that contains the active substance nalfurafine.
Winfuran je zdravilo, ki vsebuje zdravilno učinkovino nalfurafin.
What is Winfuran?
Kaj je zdravilo Winfuran?
Winfuran activates different opioid receptors, called kappa receptors, which block the activity of the mu-opioid receptors and therefore relieve the itching in patients with uraemic pruritus.
Zdravilo Winfuran aktivira druge opioidne receptorje, imenovane receptorji kapa, ki zavrejo delovanje opioidnih receptorjev mi in posledično ublažijo srbenje pri bolnikih z uremičnim pruritusom.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Winfuran did not outweigh its risks and it concluded that the medicine could not have been approved on the basis of the data presented by the company.
Zato je CHMP v času umika menil, da koristi zdravila Winfuran ne odtehtajo z njim povezanih tveganj, in zaključil, da na podlagi podatkov, ki jih je predložila družba, zdravila ni mogoče odobriti.
Winfuran was to be used in patients with end-stage renal disease (when the kidneys have stopped working completely) and who are on dialysis (a technique for removing waste products from the blood).
Zdravilo Winfuran naj bi se uporabljalo pri bolnikih, ki imajo končno odpoved ledvic (stanje, ko ledvice povsem prenehajo delovati) in potrebujejo dializo (postopek odstranjevanja odpadnih snovi iz krvi).
Winfuran was expected to be used for the treatment of patients with severe uraemic pruritus.
Zdravilo Winfuran naj bi se uporabljalo za zdravljenje bolnikov s hudim uremičnim pruritusom.
Winfuran was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 September 2002 for uraemic pruritus.
Zdravilo Winfuran je bilo dne 11. septembra 2002 določeno kot „zdravilo sirota‟ (zdravilo za zdravljenje redkih bolezni) za uremični pruritus.
The CHMP's main concern was that the benefits of Winfuran in the treatment of uraemic pruritus had not been sufficiently shown.
Glavni zadržek odbora CHMP je bil, da koristi zdravila Winfuran pri zdravljenju uremičnega pruritusa niso bile zadovoljivo dokazane.
What was Winfuran expected to be used for?
Za kaj naj bi se zdravilo Winfuran uporabljalo?
Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Winfuran for the treatment of severe uraemic pruritus.
Na podlagi pregleda podatkov je odbor v času umika vloge izrazil negativno mnenje in priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Winfuran za zdravljenje hudega uremičnega pruritusa.
In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided do not allow the Committee to conclude on a positive benefit-risk balance.
Družba je v uradnem dopisu navedla, da se je za umik vloge odločila, ker je odbor CHMP menil, da na podlagi predloženih podatkov ni mogoče zaključiti, da je razmerje med koristmi in tveganji zdravila pozitivno.
How is Winfuran expected to work?
Kako naj bi zdravilo Winfuran delovalo?
The recommended dose is one capsule taken once a day with food for 12 or 24 weeks.
Priporočeni odmerek je ena kapsula, ki se jemlje enkrat na dan skupaj s hrano v obdobju 12 ali 24 tednov.
What measures are being taken to ensure the safe and effective use of Olysio?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Olysio?
This is a summary of the European public assessment report (EPAR) for Olysio.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Olysio.
The full EPAR and risk management plan summary for Olysio 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 Olysio sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Olysio is available as 150 mg capsules.
Zdravilo Olysio je na voljo v obliki 150-miligramskih kapsul.
The Agency also considered that the data available support the use of Olysio in combination with sofosbuvir.
Agencija je zato menila, da razpoložljivi podatki podpirajo uporabo zdravila Olysio v kombinaciji s sofosbuvirjem.