natgillin/translations-raw huggingface dataset:
Sufficient antipsychotic coverage with oral risperidone or the previous antipsychotic should be ensured during the three-week lag period following the first RISPERDAL CONSTA injection (see section 5.2).
V prvih treh tednih po prvem injiciranju zdravila RISPERDAL CONSTA je treba poskrbeti, da bolniki dodatno jemljejo ustrezen antipsihotik, risperidon v peroralni obliki ali antipsihotik, ki so ga jemali predhodno (glejte poglavje 5.2).
RISPERDAL CONSTA extended release microspheres in the vial must be reconstituted only in the solvent in the syringesupplied in the dose pack, and must be administered only with the Needle-Pro safety needle supplied in the dose pack.
Prašek RISPERDAL CONSTA v viali, smemo rekonstituirati samo v vehiklu v napolnjeni injekcijski brizgi, ki je priložena v škatlici, uporabite pa ga lahko le s priloženo Needle-Pro varnostno iglo.
Batch
Zaporka
For risperidone-naive patients, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with RISPERDAL CONSTA (see section 4.2).
Bolnike, ki še niso bili zdravljeni z risperidonom, moramo pred prvim injiciranjem zdravila RISPERDAL CONSTA najprej nekaj dni zdraviti z risperidonom v peroralni obliki, da ocenimo kako ga prenašajo (glejte poglavje 4.2).
Janssen Pharmaceutica N.V. Turnhoutseweg 30, 2340 Beerse, Belgium
Turnhoutseweg 30, 2340 Beerse, Belgija
cardiovascular disorder or circulation disorders of the brain
Ušesne bolezni, vključno z motnjami labirinta
Instructions for Needle-Free Vial Access Device
Navodila za uporabo pakiranja s pripomočkom Alaris
• Intense itching of the skin, reduced sensation of skin to pain and touch, a sensation of tingling,
• močno srbenje kože, zmanjšana občutljivost kože na bolečino in dotik, občutek zvenenja, zbadanje ali odrevenelost kože, gnojno vnetje pod kožo, izpadanje las, akne, suha koža
RISPERDAL CONSTA and associated names (see Annex I) 37.5 mg powder and solvent for prolonged-release suspension for intramuscular injection
in sorodna imena (glejte Dodatek 1) 37,5 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
Prolonged-release microcapsule and solvent for suspension for injection
Mikrokapsule in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
Weight gain
Izhodiščna vrednost
Urinary incontinence Skin and subcutaneous tissue disorders Common
Bolezni sečil Pogosti urinska inkontinenca Bolezni kože in podkožja Pogosti izpuščaj, ekcem
CONSTA may cause low blood pressure.
Zdravilo RISPERDAL CONSTA lahko zniža krvni tlak.
Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally] {Name and address}
[Poglavje bo dopolnjeno nacionalno] Imetnik dovoljenja za promet z zdravilom in izdelovalec [Glejte Dodatek 1 - poglavje bo dopolnjeno nacionalno] {Ime in naslov}
Powder and solvent for prolonged-release suspension for injection
Prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
sleepiness
Dojenje
Intestinal obstruction, Pancreatitis Renal and urinary disorders Common
Redki intestinalna obstrukcija, pankreatitis
Vision blurred, Conjunctivitis
Očesne bolezni Pogosti zamegljen vid, konjunktivitis
Šmartinska 53, Ljubljana, Slovenia powder and solvent for suspension for injection
Šeimyniškiu g.1A, Vilna, Litva suspenzijo za injiciranje s podaljšanim sproščanjem
Pyrexia, Peripheral oedema, Chest pain, Fatigue, Pain, Injection site pain, Asthenia, Influenza like illness
Splošne težave in spremembe na mestu aplikacije Pogosti zvišana telesna temperatura, periferni edem, bolečine v prsih, utrujenost, bolečine, bolečine na mestu injiciranja, astenija, gripi podobna bolezen
Discard the vial and the vial access device appropriately.
Vialo in nastavek zavržemo v skladu s predpisi.
A lower initial dose of 12.5 mg may be appropriate when clinical factors warrant dose adjustment, such as in patients with hepatic or renal impairment, for certain drug interactions that increase risperidone plasma concentrations (see section 4.5), or in patients who have a history of poor tolerability to psychotropic medications.
Pri bolnikih z ledvično in jetrno okvaro, bolnikih ki jemljejo zdravila, ki povečujejo plazemsko koncentracijo risperidona (glejte poglavje 4.5) ali pri bolnikih, ki slabo prenašajo psihotropna zdravila je lahko začetni odmerek risperidona 12,5 mg.
RISPERDAL CONSTA come in a form of a powder that must be mixed with only the solution in the syringe supplied in the dose pack, and must be administered only with the Needle-Pro safety needle supplied in the dose pack.
Prašek RISPERDAL CONSTA v viali, smemo rekonstituirati samo v vehiklu v napolnjeni injekcijski brizgi, ki je priložena v škatlici, uporabite pa ga lahko le s priloženo Needle-Pro varnostno iglo.Ne zamenjujte sestavin v škatlici.
Pull sheath away from the needle - do not twist sheath as needle may be loosened from NeedlePro device.
OPOZORILO: Da se izognemo poškodbam s kontaminirano iglo, ne smemo: namenoma odstraniti pripomočka Needle-Pro, izravnati igle ali pritrditi pripomočka Needle-Pro, če je igla skrivljena ali poškodovana, neprevidno ravnati s pripravo za zaščito injekcijske igle, saj lahko igla pomoli iz varovalnega tulca.
02130 Espoo Finland suspension for injection
8 41470 Neuss Nemčija suspenzijo za injiciranje
Pull sheath away from the needle -do not twist sheath as needle may be loosened from NeedlePro device.
Tulca ne smemo sukati, saj lahko spoj med iglo in pripomočkom Needle-Pro popusti.
Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment.
Pri sočasni uporabi risperidona in antihipertenzivov v obdobju po prihodu zdravila na trg so opazili klinično pomembno hipotenzijo.
RISPERDAL CONSTA and associated names (see Annex I) 25 mg powder for prolonged-release suspension for intramuscular injection
in sorodna imena (glejte Dodatek 1) 25 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
Jaundice Reproductive system and breast disorders Common
Bolezni krvi in limfatičnega sistema
Perform a onehanded technique by GENTLY pressing the needle protection device against a flat surface.
Obarvana zaporka pokrovček priprava za zaščito igle varovalni tulec
Keeping the empty syringe and needle aligned, attach the second needle with an easy clockwise twisting motion to the luer connection of the syringe.
Drugo iglo z lahnim zasukom v smeri urinega kazalca namestimo na nastavek luer na injekcijski brizgi pri tem pazimo, da sta prazna brizga in igla poravnani.
urinary tract infection, increase in body temperature, urinary incontinence, sinus infection, viral infection, ear infection, nose congestion, sore throat, ‘pink eye', flu-like illness, cough
• oteženo dihanje, okužba pljuč (pljučnica), gripa, okužba dihalnih poti, okužba sečnih poti, povišana telesna temperatura, uhajanje urina, vnetje sinusov, virusna infekcija, okužba ušesa, zamašen nos,
Dizziness, tiredness, and vision problems may occur during treatment with RISPERDAL CONSTA.
Med jemanjem zdravila RISPERDAL CONSTA lahko pride do vrtoglavice, utrujenosti in težav z vidom.
Attach the luer connection of the Needle-Pro device with an easy clockwise twisting motion to the syringe.
Na injekcijsko brizgo z lahnim zasukom v smeri urinega kazalca pritrdimo nastavek luer na Needle-Pro pripomočku.
Cerebrovascular adverse events (CVAE)
Cerebrovaskularni neželeni dogodki
QUALITATIVE AND QUANTITATIVE COMPOSITION [To be completed nationally]
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN [Poglavje bo dopolnjeno nacionalno]
Skin lesion, Skin disorder, Skin discoloration, Seborrheic dermatitis, Hyperkeratosis, Dandruff, Erythema
Kožne rane, bolezni kože, razbarvanje kože, seboroični dermatitis, hiperkeratoza, prhljaj, eritem Bolezni mišično-skeletnega sistema in vezivnega tkiva Rabdomioliza, otekanje sklepov, nenormalna telesna drža, okorelost sklepov Bolezni sečil
If you stop using RISPERDAL CONSTA
Če ste prenehali uporabljati zdravilo RISPERDAL CONSTA Zdravilo ne bo več učinkovalo.
Keeping the syringe and needle aligned, attach the needle with an easy clockwise twisting motion to the luer connection of the syringe.
Iglo z lahnim zasukom v smeri urinega kazalca pritrdimo na nastavek luer na injekcijski brizgi, pri tem pazimo, da sta brizga in igla poravnani.
• Neck pain, buttock pain, musculoskeletal chest pain, pain during injection procedure, chest discomfort, swelling and thickening of skin at injection site
• bolečine v vratu, bolečine v zadnjici, mišično-skeletne bolečine v prsih, bolečine ob injiciranju,
Unscrew the syringe from the vial access device.
Injekcijsko brizgo z iglo izvlečemo iz viale.
Seat the needle firmly on the Needle-Pro device with a push and clockwise twist.
Iglo s pritiskom in zasukom v smeri urinega kazalca trdno pričvrstimo na pripomoček Needle-Pro.
RISPERDAL CONSTA and associated names (see Annex I) 50 mg powder and solvent for prolongedrelease suspension for intramuscular injection
in sorodna imena (glejte Dodatek 1) 50 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
Over time efficacy was maintained with RISPERDAL CONSTA (Figure 1).
Učinkovitost zdravila RISPERDAL CONSTA se ni zmanjšala po daljšem obdobju.
How to store RISPERDAL CONSTA Further information
SHRANJEVANJE ZDRAVILA RISPERDAL CONSTA
Muscular weakness, Neck pain, Buttock pain, Musculoskeletal chest pain Endocrine disorders Rare
Občasni mišična šibkost, bolečine v vratu, bolečine v zadnjici, mišično-skeletne bolečine prsnega koša Bolezni endokrinega sistema Redki nepravilno izločanje antidiuretskega hormona Presnovne in prehranske motnje Občasni povečan apetit, zmanjšan apetit
The risk/benefit of further treatment with RISPERDAL CONSTA should be assessed if clinically relevant orthostatic hypotension persists.
Če klinično pomembna hipotenzija ne izgine, je pred nadaljnjim zdravljenjem z zdravilom RISPERDAL CONSTA potrebno oceniti razmerje med koristjo in tveganjem.
Dyspnoea, Cough, Nasal congestion, Pharyngolaryngeal pain
Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti dispneja, kašelj, kongestija nosne sluznice, faringo-laringealna bolečina
--1 Modified live Porcine Respiratory and Reproductive Syndrome Virus, strain 96V198: 102.2 - 105.2 CCID50* per 2 ml *Cell culture infectious dose 50%
--1 Modificiran živi virus prašičjeg reprodukcijskeg in respiratorneg sindroma, sev 96V198: 102,2 - 105,2 CCID50* per 2 ml *50 % infektivnega odmerka za tkivno kulturo
Packaging Content
Način uporabe Pakiranje Vsebina Velikost pakiranja
Dogs should be treated for as long as is needed.
Pse je treba zdraviti tako dolgo, kot je potrebno.
Further information on Onsior can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Onsior so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Onsior received a marketing authorisation valid throughout the EU on 16 December 2008.
Zdravilo Onsior je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 16. decembra 2008.
Other information about Onsior:
Druge informacije o zdravilu Onsior:
The tablets are given once a day at the same time every day, at a dose range of 1 - 2.4 mg per kg bodyweight depending on whether one or two tablets are required.
Tablete se dajejo enkrat dnevno ob istem času vsak dan, in sicer v odmerku v razponu 1-2,4 mg na kilogram telesne mase, odvisno od tega, ali sta potrebni ena ali dve tableti.
The European Medicines Agency decided that Onsior's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je odločila, da so koristi zdravila Onsior večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
In very rare cases, lethargy may be observed.
V zelo redkih primerih se lahko pojavi tudi letargija.
It works by blocking an enzyme called cyclooxygenase 2 (COX-2).
Deluje z zaviranjem encima, imenovanega ciklooksigenaza 2 (COX-2).
The solution for injection can also cause pain on injection.
Raztopina za injiciranje lahko povzroči tudi bolečino pri injiciranju.
After the end of the operation, sufficient pain control was seen up to 24 hours in dogs and up to 52 hours (2 days) in cats.
Po končanem operativnem posegu je bilo opaženo, da je bila bolečina zadostno ublažena do 24 ur pri psih in do 52 ur (dva dneva) pri mačkah.
An overview of Onsior and why it is authorised in the EU
Pregled zdravila Onsior in zakaj je odobreno v EU
Onsior is available as tablets in five different strengths (6 mg for cats and 5 mg, 10 mg, 20 mg, and 40 mg for dogs) and as a solution for injection (20 mg/ml for dogs and cats).
Zdravilo Onsior je na voljo v obliki tablet petih jakosti (6 mg za mačke ter 5 mg, 10 mg, 20 mg in 40 mg za pse) in kot raztopina za injiciranje (20 mg/ml za pse in mačke).
What are the risks associated with Onsior?
Kakšna tveganja so povezana z zdravilom Onsior?
What benefits of Onsior have been shown in studies?
Kakšne koristi je zdravilo Onsior izkazalo v študijah?
Why is Onsior authorised in the EU?
Zakaj je zdravilo Onsior odobreno v EU?
For more information about using Onsior, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij o uporabi zdravila Onsior glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
Pain was assessed by the veterinarian based on the animal's behaviour and responses to touching the inflamed area or moving the affected joint.
Veterinar je bolečino ocenil na podlagi vedenja živali in njihovih odzivov na dotik vnetega predela ali premikanje prizadetega sklepa.
In dogs, an increase in liver enzymes after long-term treatment with the tablets is common (which may affect up to 1 in 10 animals).
Pri psih se po dolgotrajnejšem zdravljenju s tabletami pogosto pojavi povišanje jetrnih encimov (ki lahko prizadenejo največ 1 žival od 10).
The active substance in Onsior, robenacoxib, belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Zdravilna učinkovina v zdravilu Onsior, robenakoksib, spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSAID).
If the tablets are accidentally swallowed by a person, in particular by small children, or self-injection occurs with the solution for injection, the advice of a doctor should be sought immediately.
V primeru nenamernega zaužitja tablet, zlasti pri otrocih, ali samoinjiciranja raztopine za injiciranje, se je treba nemudoma posvetovati z zdravnikom.
The solution for injection is given as an injection under the skin to cats or dogs around 30 minutes before the start of the operation at a dose of 2 mg/kg bodyweight.
Raztopina za injiciranje se mačkam ali psom injicira v podkožje približno 30 minut pred začetkom operativnega posega, pri čemer je odmerek 2 mg/kg telesne mase.
What is Onsior and what is it used for?
Kaj je zdravilo Onsior in za kaj se uporablja?
This enzyme is involved in producing substances called prostaglandins, which are involved in pain and inflammation.
Ta sodeluje pri tvorbi snovi, imenovanih prostaglandini, ki povzroča bolečine in vnetja.
Onsior was as effective as the comparator NSAIDs and more effective than placebo.
Zdravilo Onsior je bilo enako učinkovito kot primerjalna nesteroidna protivnetna zdravila in učinkovitejše od placeba.
In a clinical study, Onsior tablets increased the activity in 10 of 35 cats with chronic musculoskeletal disorders (as measured by activity monitors on a neck collar) and scores of behaviour, quality of life, temperament and apparent happiness of cats compared to placebo (a dummy treatment).
V okviru klinične študije so tablete zdravila Onsior povečale aktivnost pri 10 mačkah od 35 s kroničnimi kostno-mišičnimi obolenji (kar se je izmerilo z napravami na ovratnicah za spremljanje aktivnosti) ter izboljšale rezultate glede vedenja, kakovosti življenja, razdražljivosti in navideznega zadovoljstva mačk v primerjavi s placebom (zdravilom brez zdravilne učinkovine).
Onsior must not be used with other NSAIDs or with glucocorticosteroids.
Zdravilo Onsior se ne sme uporabljati skupaj z drugimi nesteroidnimi protivnetnimi zdravili ali glukokortikosteroidi.
Cats should be given a single dose by mouth prior to orthopaedic surgery.
Mačkam je treba pred ortopedskim operativnim posegom dati enkratni peroralni odmerek.
Care should be taken when treating cats or dogs with known heart or kidney problems, animals that are dehydrated and cats with liver problems.
Pri zdravljenju mačk in psov z znanimi težavami s srcem ali ledvicami, dehidriranih živali ter mačk s težavami z jetri je potrebna pazljivost.
Onsior tablets given once a day reduced pain and improved mobility in both cats and dogs.
Tablete zdravila Onsior, ki so jih živali prejele enkrat dnevno, so zmanjšale bolečino in izboljšale gibljivost pri mačkah in psih.
Onsior is an anti-inflammatory veterinary medicine for use in cats and dogs to treat pain and inflammation.
Onsior je protivnetno zdravilo za uporabo v veterinarski medicini za zdravljenje bolečin in vnetij pri mačkah in psih.
In cats, Onsior tablets reduced moderate pain and inflammation associated with orthopaedic surgery for up to 2 days post operation when compared to animals that received placebo.
Pri mačkah so tablete zdravila Onsior zmanjšale zmerne bolečine in vnetje zaradi ortopedskega operativnega posega do dva dneva po posegu v primerjavi z živalmi, ki so prejemale placebo.
Onsior tablets must not be used in dogs or cats with existing problems affecting the stomach and gut, such as stomach ulcers or bleeding, or in dogs with liver problems.
Tablete zdravila Onsior se ne smejo uporabljati pri psih in mačkah, ki že imajo težave z želodcem in črevesjem, kot so razjede ali krvavitve v želodcu, ali pri psih s težavami z jetri.
How does Onsior work?
Kako zdravilo Onsior deluje?
In cats, Onsior tablets are used to treat pain and inflammation associated with acute (short term) and chronic (long term) musculoskeletal disorders (problems with the muscles and bones) and to reduce moderate pain and inflammation associated with orthopaedic (bone) surgery.
Pri mačkah se tablete zdravila Onsior uporabljajo za zdravljenje bolečin in vnetij, povezanih z akutnimi (kratkotrajnimi) in kroničnimi (dolgotrajnimi) kostno-mišičnimi obolenji (težavami z mišicami in kostmi), ter za zmanjšanje zmernih bolečin in vnetij, povezanih z ortopedskimi operativnimi posegi (operativnimi posegi na kosteh).
After surgery in cats, once daily treatment may be continued at the same dosage and at the same time every day for up to 2 days.
Po operativnem posegu se pri mačkah lahko zdravljenje z dajanjem enakega odmerka dnevno ob istem času nadaljuje do največ dva dneva.
By blocking the production of prostaglandins, robenacoxib reduces the pain and inflammation caused by musculoskeletal disorders, surgery or osteoarthritis.
Robenakoksib z zaviranjem tvorjenja prostaglandinov zmanjšuje bolečino in vnetje, ki ju povzročajo kostno-mišična obolenja, operativni poseg ali osteoartritis.
The solution for injection caused a gradual decrease in pain scores in cats and dogs after surgery.
Raztopina za injiciranje je postopno zmanjšala bolečino pri mačkah in psih po operativnem posegu.
The side effects of Onsior are similar to those seen with other NSAIDs.
Neželeni učinki zdravila Onsior so podobni tistim, ki so jih opazili pri drugih nesteroidnih protivnetnih zdravilih.
For a full list of side effects of Onsior, see the package leaflet.
Za celoten seznam neželenih učinkov zdravila Onsior glejte navodilo za uporabo.
Treatment in cats is limited to six days for acute musculoskeletal disorders and longer term for chronic musculoskeletal disorders, with monitoring by the veterinarian.
Pri mačkah je zdravljenje akutnih kostno-mišičnih obolenj omejeno na šest dni, kronična kostno-mišična obolenja pa se lahko zdravijo daljše obdobje, pod nadzorom veterinarja.
Hands should be washed after giving the medicine to a dog or cat.
Po dajanju zdravila psu ali mački si je treba umiti roke.
The most common side effects of the tablets and solution for injection are mild and transient effects on the stomach and gut, seen as vomiting, soft faeces and diarrhoea.
Najpogostejši neželeni učinki tablet in raztopine za injiciranje so blagi in prehodni učinki v želodcu in črevesju, opaženi kot bruhanje, mehko blato in driska.
It must not be used in animals that are pregnant, nursing puppies or kittens or being used for breeding, or that are hypersensitive (allergic) to robenacoxib or any of the other ingredients.
Zdravilo Onsior se ne sme uporabljati pri brejih živalih, psičkih ali muckih, ki se dojijo, ali živalih, ki so namenjene za razplod ali so preobčutljive za (alergične na) robenakoksib ali katero koli drugo sestavino zdravila.
For pregnant women, particularly those in the later stages of pregnancy, accidental ingestion or selfinjection of Onsior might be dangerous for the unborn child.
Nenamerno zaužitje ali samoinjiciranje zdravila Onsior je lahko pri nosečnicah, še posebno v poznejši nosečnosti, nevarno za nerojenega otroka.
Onsior contains the active substance robenacoxib.
Zdravilo Onsior vsebuje zdravilno učinkovino robenakoksib.
In dogs, Onsior tablets are used to treat pain and inflammation associated with chronic osteoarthritis (a long-term disease causing pain and inflammation in the joints).
Pri psih se tablete zdravila Onsior uporabljajo za zdravljenje bolečin in vnetij pri kroničnem osteoartritisu (dolgotrajni bolezni, ki povzroča bolečine in vnetja v sklepih).
Onsior was as effective as the comparator NSAIDs.
Zdravilo Onsior je bilo enako učinkovito kot primerjalna nesteroidna protivnetna zdravila.
After surgery in cats, a daily dose may be given for up to two further days.
Po operativnem posegu se pri mačkah lahko zdravljenje nadaljuje do največ dva dneva z dajanjem enega odmerka dnevno.
How is Onsior used?
Kako se zdravilo Onsior uporablja?
The solution for injection is used to treat pain and inflammation associated with orthopaedic or soft tissue surgery, such as neutering.
Raztopina za injiciranje se uporablja za zdravljenje bolečin in vnetij po operativnih posegih na kosteh ali mehkih tkivih, kot je sterilizacija.
The solution for injection is used to treat pain and inflammation associated with orthopaedic or soft tissue surgery.
Raztopina za injiciranje se uporablja za zdravljenje bolečin in vnetij po operativnih posegih na kosteh ali mehkih tkivih.
In cats, the 6-mg tablet and the solution for injection can be used interchangeably when used to reduce pain and inflammation associated with orthopaedic surgery.
Za zmanjšanje bolečin in vnetij po ortopedskih operativnih posegih pri mačkah se lahko 6-miligramska tableta in raztopina za injiciranje uporabljata izmenično.
Arzerra has been authorised since April 2010.
Zdravilo Arzerra je bilo odobreno aprila 2010.
The full European Public Assessment Report for Arzerra 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 Arzerra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The main measure of effectiveness was based on the number of patients who showed a partial or complete response to treatment.
Glavno merilo učinkovitosti je bilo število bolnikov, ki so se deloma ali popolnoma odzvali na zdravljenje.
On 10 November 2016, the CHMP adopted a positive opinion recommending an extension to this indication: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001131/smops/Positive/human_smop_ 001049.jsp&mid=WC0b01ac058001d127
1 Odbor CHMP je dne 10. novembra 2016 sprejel pozitivno mnenje, v katerem je priporočil razširitev te indikacije: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001131/smops/Positive/human_smop_ 001049.jsp&mid=WC0b01ac058001d127
After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Potem ko je odbor CHMP ocenil odgovore družbe na vprašanja, so nekatera vprašanja še vedno ostala nerešena.