FrancophonIA/ELRC3.0 huggingface dataset:
English: DOCETAXEL KABI in combination with platinum agents in chemotherapy-naïve patients
Slovenian: DOCETAKSEL KABI v kombinaciji s platinskimi zdravili pri bolnikih, ki še niso bili zdravljeni s kemoterapijo
English: Tabulated list of adverse reactions in non-small cell lung cancer for DOCETAXEL KABI 75 mg/m² in combination with cisplatin
Slovenian: Tabelarični prikaz neželenih učinkov zdravila DOCETAKSEL KABI 75 mg/m2 v kombinaciji s cisplatinom pri nedrobnoceličnem pljučnem raku
English: Anorexia (G3/4: 12.0%) Nervous system Dysgeusia/Parosmia
Slovenian: Srčne bolezni aritmija (S3/4: 2,0 %) ishemija miokarda
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/770/002
English: Nervous system disorders
Slovenian: Bolezni živčevja:
English: • haemorrhage
Slovenian: • vnetje požiralnika,
English: Anaemia (G3/4: 9.2%); Thrombocytopenia (G3/4: 5.2%)
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija (S3/4: 76,3 %), anemija (S3/4: 9,2 %), trombocitopenija (S3/4: 5,2 %)
English: Alopecia ( persisting: < 3%); Skin disorder (G3/4: 0.6%);
Slovenian: Bolezni kože in podkožja alopecija (persistentna: < 3%), toksični učinki na koži (S3/4: 0,6 %), spremembe nohtov (S3/4: 0,4 %)
English: Hypersensitivity reactions (frequency not known) have been reported with docetaxel in patients who previously experienced hypersensitivity reactions to paclitaxel.
Slovenian: Pri bolnikih, ki so predhodno imeli preobčutljivostne reakcije na paklitaksel, so bile zabeležene preobčutljivostne reakcije na docetaksel (pogostnost ni znana).
English: Gastrointestinal haemorrhage (severe: 0.3%)
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija (huda: 0,5 %)
English: Tabulated list of adverse reactions in non-small cell lung cancer for DOCETAXEL KABI 75 mg/m² single agent
Slovenian: Tabelarični prikaz neželenih učinkov monoterapije z zdravilom DOCETAKSEL KABI 75 mg/m2 pri nedrobnoceličnem pljučnem raku
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/770/003
English: General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
Slovenian: Redko so poročali o pojavu pomnjenja obsevanja.
English: Lethargy; Pain
Slovenian: letargija, bolečine
English: p = Hazard ratio*
Slovenian: 95 % IZ p = razmerje tveganj*
English: Myalgia (severe: 1.4%)
Slovenian: z 1,4 %), astenija (8,5 % v prim.
English: In study TAX316 alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736FAC patients(87.6%).. At the end of the follow-up period actual median follow-up time of 8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Slovenian: V študiji TAX316 je alopecija trajala še naprej v obdobju spremljanja po koncu kemoterapije pri 687 od 744 bolnic (92,3 %), ki so prejemale TAC, in 645 od 736 bolnic (87,6 %), ki so prejemale FAC.
English: Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Slovenian: Infekcijske in parazitske bolezni okužba (S3/4: 3,3 %) Bolezni krvi in limfatičnega sistema nevtropenija (S3/4: 32 %), anemija (S3/4: 4,9 %)
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 20 mg/1 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Slovenian: DOCETAKSEL KABI 20 mg/1 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
English: • fever or chills
Slovenian: • povišana telesna temperatura ali mrzlica,
English: Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Slovenian: Člen 30 Direktive 2001/83/ES, kakor je bila spremenjena, napotitev na podlagi različnih sklepov, ki so jih sprejel države članice.
English: Also, not all Member States had authorised the medicine for use in children.
Slovenian: Prav tako niso vse države članice zdravila odobrile za uporabo pri otrocih.
English: Ref. EMEA/CHMP/466849/2009 EMEA/H/A-30/1003
Slovenian: : EMEA/714052/2009 EMEA/H/A-30/1003
English: The review was carried out under an ‘Article 30' referral1.
Slovenian: Pregled je bil izveden v skladu z napotitvenim postopkom1.iz člena 30.
English: 23 October 2008
Slovenian: 23. oktober 2008
English: Why was Meronem reviewed?
Slovenian: Zakaj je bilo zdravilo Meronem pregledano?
English: 23 July 2009
Slovenian: 23. julij 2009
English: The CHMP agreed on a harmonised list of contra-indications.
Slovenian: CHMP se je sporazumel o usklajenem seznamu kontraindikacij.
English: It works by attaching to certain types of protein on the surface of the bacteria cells.
Slovenian: Deluje tako, da se veže na določene vrste beljakovine na površini bakterijskih celic.
English: The CHMP agreed on the following diseases for which the medicine may be used:
Slovenian: CHMP se je strinjal, da se zdravilo sme uporabljati za naslednje bolezni:
English: The Committee noted that for most indications Meronem should be used for children above three months of age, but that doctors should retain the option of treating younger children.
Slovenian: Odbor je ugotovil, da naj bi se za večino indikacij zdravilo Meronem uporabljalo pri otrocih v starosti od treh mesecev dalje, da pa naj zdravniki zdravila ne dajejo še mlajšim otrokom.
English: Because the recommended dose for both adults and children differed among Member States, the CHMP recommended harmonised dosage schedules:
Slovenian: Ker so bile med državami članicami razlike v priporočenih odmerkih tako za odrasle kot za otroke, je CHMP predlagal usklajen režim odmerjanja:
English: Meronem and associated names are authorised in the EU via national procedures.
Slovenian: Zdravilo Meronem in z njim povezana imena so bila v EU odobrena z nacionalnimi postopki.
English: • intra- and post-partum infections (infections during and after childbirth);
Slovenian: • okužbe intra- in post-partum (okužbe med porodom in po njem);
English: Questions and answers on the referral for Meronem and associated names meropenem powder for solution for injection or infusion 500 mg and 1 g
Slovenian: Vprašanja in odgovori v zvezi z napotitvijo za Meronem in z njim povezana imena meropenem prašek za raztopino za injiciranje ali infundiranje 500 mg in 1 g
English: The Committee also harmonised the SPC section on interactions with other medicines.
Slovenian: Odbor je uskladil tudi poglavje o medsebojnem delovanju z drugimi zdravili.
English: The company that markets Meronem is AstraZeneca.
Slovenian: Družba, ki trži zdravilo Meronem, je AstraZeneca.
English: The active substance in Meronem, meropenem, is an antibiotic that belongs to the group ‘carbapenems'.
Slovenian: Zdravilna učinkovina zdravila Meronem, meropenem, je antibiotik, ki spada v skupino „karbapenemov“.
English: This prevents the bacteria from building the walls that surround their cells, which kills the bacteria.
Slovenian: Bakteriji preprečuje, da bi okoli svojih celic zgradila zid, kar jo ubije.
English: • broncho-pulmonary infections in patients with cystic fibrosis;
Slovenian: • bronho-pulmonarne okužbe pri bolnikih s cistično fibrozo;
English: The CHMP harmonised the SPC section on special warnings and retained warnings about convulsions and hepatic reactions.
Slovenian: CHMP je v povzetku glavnih značilnosti zdravila uskladil poglavja o posebnih opozorilih in obdržal opozorilo o konvulzijah in jetrnih reakcijah.
English: On 1 October 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Meronem and associated names in the EU.
Slovenian: Dne 1. oktobra 2008 je Evropska komisija zadevo napotila na CHMP, da bi v EU uskladili dovoljenja za promet za zdravilo Meronem in z njim povezana imena.
English: The new wording mentions that medicines containing valproic acid should be avoided when taking Meronem.
Slovenian: Novo besedilo opozarja, da se je treba med zdravljenjem z zdravilom Meronem izogibati jemanju valprojske kisline.
English: • for broncho-pulmonary infections in cystic fibrosis and acute bacterial meningitis, the CHMP recommended a dose of 2 g every eight hours in adults and children weighing over 50 kg, and 40 mg/kg every eight hours in children aged from three months to 11 years and those weighing less than 50 kg.
Slovenian: • Pri bronhopulmonalnih okužbah pri cistični fibrozi in akutnem bakterijskem meningitisu je CHMP priporočil odmerek 2 g vsakih osem ur pri odraslih in otrocih, ki tehtajo več kot 50 kg, ter 40 mg/kg vsakih osem ur pri otrocih, starih od treh mesecev do 11 let, in osebah, ki tehtajo manj kot 50 kg.
English: • acute bacterial meningitis (inflammation of the membranes that surround the brain and spine).
Slovenian: • akutni bakterijski meningitis (vnetje membran, ki obkrožajo možgane in hrbtenico).
English: London, 23 July 2009 Doc.
Slovenian: London, 19. oktobra 2009 Sklic dok.
English: The European Medicines Agency has completed a review of Meronem and associated names.
Slovenian: Evropska agencija za zdravila je zaključila pregled zdravila Meronem in z njim povezanih imen.
English: It is also available in the EU under the trade names Optinem and Merrem.
Slovenian: V EU je na voljo tudi pod trgovskima imenoma Optinem in Merrem.
English: The Committee recommended that Meronem should not be used in patients who are hypersensitive to any carbapenem medicine or in patients who have severe hypersensitivity to any type of beta-lactam anti-bacterial medicines such as penicillins or cephalosporins.
Slovenian: Odbor je priporočil, naj se zdravilo Meronem ne uporablja pri bolnikih, ki so preobčutljivi na karbapenemska zdravila, ali pri bolnikih, ki so prekomerno preobčutljivi na katero koli vrsto beta-laktamskih protibakterijskih zdravil, kot so penicilini ali cefalosporini.
English: At the start of the referral, some of the indications such as skin and skin tissue infections and urinary tract infections or infections of the female reproductive system were not approved in all Member States.
Slovenian: Ob začetku napotitvenega postopka nekatere indikacije, kot so okužbe kože, kožnih tkiv, sečil ali ženskih reproduktivnih organov niso bile odobrene v vseh državah članicah.
English: At the start of the referral, some Member States did not include hypersensitivity (allergy) to carbapenems, penicillins or other beta-lactam antibiotics as contra-indications (situations where the medicine must not be used) and some Member States included hypersensitivity to excipients (other ingredients in the medicine).
Slovenian: Na začetku napotitvenega postopka nekatere države niso vključile preobčutljivosti za (alergije na) karbapeneme, peniciline ali druge beta-laktamske antibiotike kot kontraindicirane (stanja, ko se zdravilo ne sme uporabljati), nekatere države pa so vključile preobčutljivost na pomožne snovi (druge sestavine zdravila).
English: It contains the active substance meropenem.
Slovenian: Vsebuje zdravilno učinkovino meropenem.
English: • for pneumonia, complicated urinary tract infections, complicated intra-abdominal infections, intraand post-partum infections and complicated skin and soft tissue infections, the recommended dose in adults and children weighing more than 50 kg should 500 mg or 1 g every eight hours, while children aged from three months to 11 years and those weighing less than 50 kg should be given 10 or 20 mg/kg every eight hours.
Slovenian: • Pri pljučnici, zapletenih okužbah sečil, zapletenih intraabdominalnih okužbah, okužbah med porodom in po njem ter pri zapletenih okužbah kože in mehkih tkiv, je priporočeni odmerek pri odraslih in otrocih, ki tehtajo več kot 50 kilogramov, 500 mg ali 1 g vsakih osem ur, pri otrocih, starih od tri mesece do 11 let in tistih, ki tehtajo manj kot 50 kg, pa 10 ali 20 mg/kg vsakih osem ur.
English: Meronem is used to treat various bacterial infections including infections of the lungs, urinary tract (structures that carry urine), the abdomen, skin, the female reproductive system and brain.
Slovenian: Zdravilo Meronem se uporablja za zdravljenje različnih bakterijskih vnetij, na primer pljuč, sečil (struktur v telesu, ki odvajajo urin), trebuha, kože, ženskih reproduktivnih organov in možganov.
English: Meronem may also be used in patients with neutropenic fever (fever associated with low levels of neutrophils, a type of white blood cell) that is suspected to be caused by bacterial infection.
Slovenian: Zdravilo Meronem se lahko uporablja tudi pri bolnikih z nevtropenično povišano telesno temperaturo (ki je povezana z nizkimi ravnmi nevtrofilcev, vrsto belih krvnih telesc), za katero se domneva, da je posledica bakterijske okužbe.
English: What is Meronem?
Slovenian: Kaj je zdravilo Meronem?
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SPCs, labelling and package leaflets should be harmonised across the EU.
Slovenian: CHMP je na osnovi predloženih podatkov in znanstvene razprave v odboru menil, da je treba po vsej EU uskladiti povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo.
English: Meronem is a powder that is made up into a solution for injection or infusion.
Slovenian: Zdravilo Meronem je prašek za pripravo raztopine za injiciranje ali infundiranje.
English: • pneumonia (infection of the lungs);
Slovenian: • pljučnico (okužba pljuč);
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Meronem and associated names in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMEA je sklenil, da je treba v Evropski uniji uskladiti informacije o predpisovanju za zdravilo Meronem in z njim povezana imena.
English: • complicated skin and soft tissue infections;
Slovenian: • zapletene okužbe kože in mehkih tkiv:
English: This has led to divergences across member states in the way the medicine can be used, as seen in the differences in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed.
Slovenian: Zaradi tega je med državami članicami prišlo do razlik v načinu, kako naj se zdravilo uporablja, kar je razvidno iz razlik v povzetkih glavnih značilnosti zdravila, označevanju, navodilih za uporabo v državah, kjer se zdravilo trži Zato je usklajevalna skupina za postopek medsebojnega priznavanja in decentralizirane postopke-humana zdravila (CMD(h)) ugotovila, da zdravilo Meronem potrebuje uskladitev.
English: Company responses provided on: 26 January 2009 Opinion date:
Slovenian: Datum izdaje mnenja:
English: • complicated urinary tract infections;
Slovenian: • zapletene trebušne okužbe;
English: A European Commission decision on this opinion will be issued in due course.
Slovenian: Evropska komisija je odločbo izdala dne 15. oktobra 2009.
English: • complicated infections in the abdomen;
Slovenian: • zapletene okužbe sečil;
English: This summary was last updated in 07-2009.
Slovenian: Povzetek je bil nazadnje posodobljen 07-2009.
English: • patients with peripheral arterial disease (problems with blood flow in the arteries); The medicine can only be obtained with a prescription.
Slovenian: • bolnikom s periferno arterijsko boleznijo (težavami s pretokom krvi v arterijah); Zdravilo se dobi samo na recept.
English: GmbH can be started between a few days and 35 days after the attack;
Slovenian: Pharma GmbH se lahko začne jemati od nekaj dni po napadu do 35 dni po njem;
English: The standard dose of Clopidogrel Acino Pharma GmbH is one 75 mg tablet once a day, taken with or without food.
Slovenian: Običajni odmerek zdravila Clopidogrel Acino Pharma GmbH je ena 75-miligramska tableta enkrat na dan, ki se vzame s hrano ali brez nje.
English: Clopidogrel Acino Pharma GmbH is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Slovenian: Zdravilo Clopidogrel Acino Pharma GmbH se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
English: This means that Clopidogrel Acino Pharma GmbH is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Slovenian: To pomeni, da je zdravilo Clopidogrel Acino Pharma GmbH podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Acino Pharma GmbH has been shown to have comparable quality and to be bioequivalent to Plavix.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel Acino Pharma GmbH primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
English: clopidogrel EPAR summary for the public
Slovenian: klopidogrel Povzetek EPAR za javnost
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Acino Pharma GmbH to Acino Pharma GmbH on 21 September 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel Acino Pharma GmbH, veljavno po vsej Evropski uniji, odobrila družbi Acino Pharma GmbH dne 21. septembra 2009.
English: Because Clopidogrel Acino Pharma GmbH is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Slovenian: Ker je zdravilo Clopidogrel Acino Pharma GmbH generično zdravilo in je biološko enakovredno referenčnemu zdravilu, velja, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Clopidogrel Acino Pharma GmbH can be given to the following groups of patients:
Slovenian: Zdravilo Clopidogrel Acino Pharma GmbH se lahko daje naslednjim skupinam bolnikov:
English: Because Clopidogrel Acino Pharma GmbH is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Slovenian: Ker je zdravilo Clopidogrel Acino Pharma GmbH generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
English: Other information about Clopidogrel Acino Pharma GmbH:
Slovenian: Druge informacije o zdravilu Clopidogrel Acino Pharma GmbH:
English: The Committee recommended that Clopidogrel Acino Pharma GmbH be given marketing authorisation.
Slovenian: Odbor je zato priporočil, da se za zdravilo Clopidogrel Acino Pharma GmbH odobri dovoljenje za promet.
English: Clopidogrel Acino Pharma GmbH is a ‘generic medicine'.
Slovenian: Clopidogrel Acino Pharma GmbH je „generično zdravilo“.
English: Clopidogrel Acino Pharma GmbH is a medicine that contains the active substance clopidogrel.
Slovenian: Clopidogrel Acino Pharma GmbH je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
English: Clopidogrel Acino Pharma GmbH can be started between seven days and six
Slovenian: Zdravilo Clopidogrel Acino Pharma GmbH se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
English: The active substance in Clopidogrel Acino Pharma GmbH, clopidogrel, is an inhibitor of platelet aggregation.
Slovenian: Zdravilna učinkovina v zdravilu Clopidogrel Acino Pharma GmbH, klopidogrel, je zaviralec agregacije trombocitov.
English: What are the benefit and risk of Clopidogrel Acino Pharma GmbH?
Slovenian: Kakšne so koristi in tveganja, povezana z zdravilom Clopidogrel Acino Pharma GmbH?
English: Clopidogrel Acino Pharma
Slovenian: Zdravilo Clopidogrel Acino
English: The full EPAR for Clopidogrel Acino Pharma GmbH can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel Acino Pharma GmbH je na voljo tukaj.
English: Why has Clopidogrel Acino Pharma GmbH been approved?
Slovenian: Zakaj je bilo zdravilo Clopidogrel Acino Pharma GmbH odobreno?
English: What is Clopidogrel Acino Pharma GmbH used for?
Slovenian: Za kaj se zdravilo Clopidogrel Acino Pharma GmbH uporablja?
English: What is Clopidogrel Acino Pharma GmbH?
Slovenian: Kaj je zdravilo Clopidogrel Acino Pharma GmbH?
English: How does Clopidogrel Acino Pharma GmbH work?
Slovenian: Kako zdravilo Clopidogrel Acino Pharma GmbH deluje?
English: How has Clopidogrel Acino Pharma GmbH been studied?
Slovenian: Kako je bilo zdravilo Clopidogrel Acino Pharma GmbH raziskano?
English: How is Clopidogrel Acino Pharma GmbH used?
Slovenian: Kako se zdravilo Clopidogrel Acino Pharma GmbH uporablja?
English: • The Committee considered the referral under Article 13(2) of Regulation No 1234/2008.
Slovenian: • odbor je obravnaval napotitev po členu 13(2) Uredbe št. 1234/2008;
English: On the basis of the questions raised by the Netherlands the points to be considered by the CHMP were:
Slovenian: Na podlagi vprašanj, ki jih je izpostavila Nizozemska, je moral odbor CHMP proučiti naslednje:
English: Overall summary of the scientific evaluation of Oxynal and Targin and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil Oxynal in Targin ter povezanih imen (glejte Prilogo I)
English: As the reference and concerned member states were not able to reach an agreement in respect of the variation, on 2 May 2014, Germany triggered a referral under Article 13(2) of Regulation EC No
Slovenian: Ker referenčna in zadevne države članice niso mogle doseči soglasja v zvezi s spremembo, je Nemčija 2. maja 2014 sprožila napotitveni postopek v skladu s členom 13(2) Uredbe (ES) št. 1234/2008.
English: Further 10 patients out of 176 reported signs of physical dependence as a result of a specific follow-up visit 4 weeks after the end of the extension phase.
Slovenian: Nadaljnjih 10 od 176 bolnikov je poročalo o znakih telesne odvisnosti ob posebnem kontrolnem pregledu 4 tedne po zaključku podaljšane faze.
English: The MU Opiate Receptor Knock-out Mouse Shows Increased Sensitivity to Pain, Increased Motor Activity During the Sleep Period and Decreased Serum Iron Parallel to Human Restless Legs Syndrome.
Slovenian: 2 Walters AS et al. The MU Opiate Receptor Knock-out Mouse Shows Increased Sensitivity to Pain, Increased Motor Activity During the Sleep Period and Decreased Serum Iron Parallel to Human Restless Legs Syndrome.
English: However, the protocol did not stipulate dose tapering and in the majority of these subjects no tapering had been performed.
Slovenian: Vendar protokol ni določal postopnega zmanjševanja odmerka in pri večini teh preiskovancev ga niso postopno zmanjševali.
English: OXN PR is currently indicated in “severe pain, which can be adequately managed only with opioid analgesics”.
Slovenian: Zdravilo OXN PR je trenutno indicirano za „hudo bolečino, ki jo je mogoče zadovoljivo obvladati samo z opioidnimi analgetiki“.
English: Oxynal 10mg/5mg, 20mg/10mg prolonged-release tablets and Targin 5mg/2.5mg, 10mg/5mg, 20mg/10mg, 40mg/20mg prolonged-release tablets and associated names (OXN PR) are fixed combination products of oxycodone hydrochloride and naloxone hydrochloride.
Slovenian: Oxynal 10 mg/5 mg, 20 mg/10 mg tablete s podaljšanim sproščanjem in Targin 5 mg/2,5 mg, 10 mg/5 mg, 20 mg/10 mg, 40 mg/20 mg tablete s podaljšanim sproščanjem ter povezana imena (OXN PR) so zdravila s fiksno kombinacijo oksikodonijevega klorida in naloksonijevega klorida.
English: The results of the pivotal phase III clinical study are considered robust and consistent with respect to primary and secondary efficacy parameters (addressing severity and impact of the disease and quality of life) as well as with respect to responder rates and various subgroup analyses.
Slovenian: Rezultati ključne klinične študije 3. faze so bili ocenjeni kot prepričljivi in dosledni pri primarnih in sekundarnih parametrih učinkovitosti (ki so se nanašali na stopnjo resnosti in vpliv bolezni ter kakovost življenja) ter tudi pri stopnjah odziva in različnih analizah podskupin.
English: A detailed review of safety data from both the double-blind phase and extension phase (OXN3502/S) was conducted.
Slovenian: Opravljen je bil podroben pregled podatkov o varnosti iz dvojno slepe faze in podaljšane faze (OXN3502/S).