FrancophonIA/ELRC3.0 huggingface dataset:
English: VCAM-1, CS-1 and osteopontin that mediates the firm adhesion and transmigration of leukocytes into the brain parenchyma and may perpetuate the inflammatory cascade in CNS tissue.
Slovenian: V okviru vnetja osrednjega živčnega sistema pri MS je interakcija α4β1 z VCAM-1, CS-1 in osteopontinom posrednik čvrste adhezije in transmigracije levkocitov v možganski parenhim in lahko ohranja vnetno kaskado v tkivu osrednjega živčnega sistema.
English: TYSABRI contains 2.3 mmol (or 52 mg) sodium per vial of medicinal product.
Slovenian: Zdravilo TYSABRI vsebuje 2,3 mmol (ali 52 mg) natrija na vialo zdravila.
English: In post marketing experience,serious, life-threatening, and sometimes fatal cases of encephalitis and meningitis caused by herpes simplex or varicella zoster have been reported in multiple sclerosis patients receiving TYSABRI.
Slovenian: V izkušnjah v obdobju po začetku trženja so pri bolnikih z multiplo sklerozo, zdravljenih z zdravilom TYSABRI, poročali o resnih, življenjsko nevarnih in včasih smrtnih primerih encefalitisa in meningitisa, ki ju povzročajo virusi herpes simplex ali virusi varicella zoster.
English: Spontaneous serious adverse reactions of liver injury have been reported during the post marketing phase.
Slovenian: V obdobju trženja so poročali o spontanih hudih neželenih reakcijah zaradi okvare jeter.
English: Consistent with the pharmacological activity of natalizumab, altered trafficking of lymphocytes was seen as white blood cell increases as well as increased spleen weights in most in vivo studies.
Slovenian: V skladu s farmakološko aktivnostjo natalizumaba se je pokazala spremenjena izmenjava limfocitov tako, da je v večini študij in vivo poraslo število levkocitov, masa vranice pa se je povečala.
English: Do not use this medicine if you notice particles in the liquid and/or the liquid in the vial is discoloured.
Slovenian: Če v tekočini opazite delce in/ali če je tekočina v viali obarvana, tega zdravila ne smete uporabiti.
English: Gently invert the TYSABRI solution to mix completely.
Slovenian: Nežno obrnite raztopino zdravila TYSABRI, da se povsem premeša.
English: The diluted medicinal product is to be used as soon as possible and within 8 hours of dilution.
Slovenian: Raztopino uporabite takoj, ko je mogoče, vendar najpozneje 8 ur po razredčitvi.
English: If a woman becomes pregnant while taking TYSABRI, discontinuation of the medicinal product should be considered.
Slovenian: Ženske, ki zanosijo med jemanjem zdravila TYSABRI, morajo razmisliti o prekinitvi zdravljenja z zdravilom.
English: Patients are to be observed during the infusion and for 1 hour after the completion of the infusion (see section 4.8).
Slovenian: Bolnika se v času infundiranja in 1 uro po končanem infundiranju opazuje za znake in simptome preobčutljivostnih reakcij (glejte poglavje 4.8).
English: Other medicines and TYSABRI Tell your doctor if you are taking or have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli zdravilo.
English: Presence of anti-JC virus antibodies Level of the antibody response (index) for patients without a history of immunosuppressant treatment
Slovenian: Raven odziva protiteles (indeks) za bolnike brez zdravljenja z imunopresivi v anamnezi
English: When diluted in 100 ml sodium chloride 9 mg/ml (0.9%) the medicinal product contains 17.7 mmol (or 406 mg) sodium.
Slovenian: Pri redčenju s 100 ml natrijevega klorida 9 mg/ml (0,9 %) vsebuje zdravilo 17,7 mmol (ali 406 mg) natrija.
English: When diluted (see section 6.6), the solution for infusion contains approximately 2.6 mg/ml of natalizumab.
Slovenian: Razredčena raztopina za infundiranje (glejte poglavje 6.6) vsebuje približno 2,6 mg/ml natalizumaba.
English: • Sore throat and runny or blocked up nose
Slovenian: • vnetje žrela in zamašen nos ali nosni izcedek • tresavica
English: • Use aseptic technique when preparing TYSABRI solution for intravenous (IV) infusion.
Slovenian: • Pri pripravi raztopine zdravila TYSABRI za intravensko infundiranje uporabite aseptično tehniko.
English: Rate ratio 0.33 CI95% 0.26 ; 0.41
Slovenian: Razmerje stopnje 0,33 IZ95 % 0,26 ; 0,41
English: Visually inspect the diluted medicinal product for particles or discolouration prior to administration.
Slovenian: Pred dajanjem vizualno preverite razredčeno raztopino glede delcev ali obarvanja.
English: TYSABRI 300 mg concentrate for solution for infusion natalizumab
Slovenian: TYSABRI 300 mg koncentrat za raztopino za infundiranje natalizumab
English: For those with a lower risk of PML, your doctor may repeat the test regularly to check if anything has changed if:
Slovenian: Zdravnik lahko teste pri bolnikih, pri katerih je tveganje za PML manjše, redno ponavlja, da ugotovi,
English: 4.5 Interaction with other medicinal products and other forms of interaction TYSABRI is contraindicated in combination with beta-interferons or glatiramer acetate (see section
Slovenian: Zdravilo TYSABRI je kontraindicirano v kombinaciji z interferoni beta ali glatiramer acetatom (glejte poglavje 4.3).
English: The anti-JCV antibody assay (ELISA) should not be used to diagnose PML.
Slovenian: Za postavitev diagnoze PML ne uporabljajte testa protiteles proti JCV (ELISA).
English: There is no evidence of a specific pattern of birth defects with TYSABRI.
Slovenian: Pri zdravilu TYSABRI ni dokazov o posebnem vzorcu prirojenih okvar.
English: NAME OF THE MEDICINAL PRODUCT TYSABRI 300 mg concentrate for solution for infusion
Slovenian: IME ZDRAVILA TYSABRI 300 mg koncentrat za raztopino za infundiranje
English: When diluted in 100 ml sodium chloride 9 mg/ml (0.9%) this medicinal product contains 17.7 mmol (or 406 mg) sodium per dose.
Slovenian: Pri redčenju s 100 ml natrijevega klorida 9 mg/ml (0,9 %) vsebuje zdravilo 17,7 mmol (ali 406 mg) natrija na odmerek.
English: TYSABRI contains sodium
Slovenian: Zdravilo TYSABRI vsebuje natrij
English: This leaflet was last revised in {MM/YYYY}.
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA <{MM/LLLL}>
English: Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: 15 ml koncentrata za raztopino za infundiranje dodajte 100 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje.
English: • Patients with a high anti-JCV antibody index who have received more than 2 years of
Slovenian: • Bolniki z visokim indeksom protiteles proti JCV, ki so se z zdravilom TYSABRI
English: Speak to your doctor or nurse immediately if you notice any of the following
Slovenian: Če opazite kar koli od naslednjega, se takoj posvetujte z zdravnikom ali medicinsko sestro.
English: Relapse rate
Slovenian: Stopnja recidivov
English: Cases of JCV GCN have also been reported during postmarketing use of TYSABRI.
Slovenian: V obdobju po začetku trženja zdravila TYSABRI so poročali tudi o primerih JCV GCN.
English: After dilution with sodium chloride 9 mg/ml (0.9%) solution for injection, immediate use is recommended.
Slovenian: Priporoča se, da z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje razredčeno raztopino takoj uporabite.
English: Sodium phosphate, monobasic, monohydrate, Sodium phosphate, dibasic, heptahydrate, Sodium chloride (see section 2 ‘TYSABRI contains sodium'), Polysorbate 80 (E433)
Slovenian: Druge sestavine so: natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat heptahidrat natrijev klorid (glejte poglavje 2 ‘Zdravilo TYSABRI vsebuje natrij') polisorbat 80 (E433) voda za injekcije
English: Each vial contains 2.3 mmol (or 52 mg) sodium.
Slovenian: Ena viala vsebuje 2,3 mmol (ali 52 mg) natrija.
English: Your doctor may test your blood to check if you have antibodies to the JC virus before you start treatment with TYSABRI.
Slovenian: Vaš zdravnik vam bo morda pred začetkom zdravljenja z zdravilom TYSABRI dal pregledati kri, da ugotovi morebitno prisotnost protiteles proti virusu JC.
English: If you miss your usual dose of TYSABRI, arrange with your doctor to receive it as soon as you can. You can then continue to receive your dose of TYSABRI every 4 weeks.
Slovenian: Če ste izpustili običajni odmerek zdravila TYSABRI, se z zdravnikom dogovorite, da ga boste prejeli čim prej.
English: What TYSABRI looks like and contents of the pack TYSABRI is a clear, colourless to slightly cloudy liquid.
Slovenian: Zdravilo TYSABRI je bistra, brezbarvna ali rahlo motna tekočina.
English: TYSABRI will be given to you by a doctor experienced in the treatment of MS.
Slovenian: Kako uporabljati zdravilo TYSABRI Zdravilo TYSABRI da zdravnik z izkušnjami v zdravljenju MS.
English: A condition called JCV GCN (JC virus granule cell neuronopathy) is also caused by JC virus and has occurred in some patients who have been given TYSABRI.
Slovenian: Virus JC lahko povzroči tudi bolezen, imenovano JCV GCN (JCV nevropatija zrnatih celic), o kateri so poročali pri nekaterih bolnikih, zdravljenih z zdravilom TYSABRI.
English: The reactions are reported as MedDRA preferred terms under the MedDRA primary system organ class.
Slovenian: Neželeni učinki so navedeni z izrazi, ki jih priporoča MedDRA in glede na MedDRA organske sisteme.
English: Some patients with a past medical history of an abnormal liver test have experienced an exacerbation of abnormal liver test while on TYSABRI.
Slovenian: Pri nekaterih bolnikih, katerih testi so v preteklosti pokazali nepravilnosti v delovanju jeter, so se vrednosti med jemanjem zdravila TYSABRI še poslabšale.
English: After dilution (see section 6.6), the infusion is to be administered over approximately 1 hour and patients are to be observed during the infusion and for 1 hour after the completion of the infusion for signs and symptoms of hypersensitivity reactions.
Slovenian: Bolnika se v času infundiranja in 1 uro po končanem infundiranju opazuje za znake in simptome preobčutljivostnih reakcij.
English: Breast-feeding should be discontinued during treatment with TYSABRI.
Slovenian: Med zdravljenjem z zdravilom TYSABRI je treba prenehati z dojenjem.
English: This is because patients who received one or two doses of TYSABRI and then had a gap in treatment of three months or more, were more likely to have an allergic reaction when resuming treatment.
Slovenian: TYSABRI, nato pa prekinili zdravljenje za tri mesece ali več, pogosteje pojavile alergije, ko so ponovno pričeli z zdravljenjem.
English: In addition to this leaflet you will be given a Patient Alert Card, which contains important safety information that you need to know before you are given TYSABRI (pronounced tie-SA-bree) and during treatment with TYSABRI.
Slovenian: Poleg teh navodil boste prejeli tudi kartico s posebnimi opozorili za bolnika, ki vsebuje pomembne informacije v zvezi z varnostjo, za katere morate vedeti, preden začnete z zdravljenjem z zdravilom
English: Each vial of TYSABRI contains 2.3 mmol (or 52 mg) of sodium.
Slovenian: Ena viala zdravila TYSABRI vsebuje 2,3 mmol (ali 52 mg) natrija.
English: • Feeling sick (nausea)
Slovenian: • huda alergija (preobčutljivost)
English: After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Po končanem infundiranju sperite intravensko linijo z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje.
English: In 10% of patients antibodies against natalizumab were detected in 2-year controlled clinical trials in MS patients.
Slovenian: V dveletnih kontroliranih kliničnih preskušanjih pri bolnikih z MS so bila pri 10 % bolnikov odkrita protitelesa proti natalizumabu.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION TYSABRI 300 mg concentrate for solution for infusion natalizumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE TYSABRI 300 mg koncentrat za raztopino za infundiranje natalizumab intravenska uporaba
English: Continuous dosing with TYSABRI is important, especially during the first few months of treatment.
Slovenian: Neprekinjeno odmerjanje zdravila TYSABRI je pomembno še posebej prvih nekaj mesecev zdravljenja, zato ker so se pri bolnikih, ki so prejeli enega ali dva odmerka zdravila
English: Tell your doctor immediately if you have, or think you have, any sort of infection (see side effects).
Slovenian: Če imate ali mislite, da imate kakršno koli vrsto okužbe (glejte neželene učinke), o tem takoj obvestite zdravnika.
English: • Prescriber name, signature and date
Slovenian: • ime, podpis in datum zdravnika, ki predpisuje zdravilo
English: What TYSABRI contains
Slovenian: Kaj vsebuje zdravilo TYSABRI
English: Platelet counts were also reduced in offspring born to mothers treated with natalizumab until parturition, however there was no evidence of anaemia in these offspring.
Slovenian: Potomci, rojeni materam, tretiranih z natalizumabom do skotitve, so imeli zmanjšano število trombocitov, vendar niso kazali znakov anemije.
English: In cases of significant liver injury TYSABRI should be discontinued.
Slovenian: V primeru hujših okvar jeter je treba zdravljenje z zdravilom TYSABRI prekiniti.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg of natalizumab.
Slovenian: En ml koncentrata vsebuje 20 mg natalizumaba.
English: MedDRA System Organ Class Adverse reaction
Slovenian: Organski sistem po MedDRA Neželeni učinek
English: Discontinue administration of TYSABRI and initiate appropriate therapy at the first symptoms or signs of hypersensitivity.
Slovenian: Ob pojavu prvih simptomov ali znakov preobčutljivosti prenehajte z dajanjem zdravila TYSABRI in uvedite ustrezno zdravljenje.
English: • You may not be able to use TYSABRI if you are currently receiving or have previously received medicines that affect your immune system, e.g. mitoxantrone or cyclophosphamide.
Slovenian: • Če trenutno jemljete ali ste predhodno prejemali zdravila, ki vplivajo na imunski sistem, npr.
English: Relapse free
Slovenian: (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: • After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: • Po končanem infundiranju sperite intravensko linijo z natrijevim kloridom 9 mg/ml (0,9 %)
English: • Being sick (vomiting)
Slovenian: • srbeč izpuščaj (koprivnica)
English: Randomised
Slovenian: Preizkušanci
English: Dilute before infusion.
Slovenian: Pred infundiranjem razredčite.
English: • Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: • 15 ml koncentrata za raztopino za infundiranje dodajte 100 ml natrijevega klorida 9 mg/ml
English: • Urinary tract infection
Slovenian: • okužbe sečil
English: Rare side effects that may affect up to 1 in 1,000 people:
Slovenian: • progresivna multifokalna levkoencefalopatija (PML) Redki neželeni učinki, ki lahko prizadenejo največ 1 od 1.000 bolnikov:
English: In patients considered at high risk treatment with TYSABRI should only be continued if the benefits outweigh the risks.
Slovenian: Pri bolnikih, pri katerih je tveganje veliko, se sme zdravljenje z zdravilom TYSABRI nadaljevati le,
English: In 2-year controlled clinical trials in MS patients, an infusion-related event was defined as an adverse event occurring during the infusion or within 1 hour of the completion of the infusion.
Slovenian: opredelili kot neželen dogodek, ki se pojavi med infundiranjem ali v eni uri od zaključenega infundiranja.
English: In 2-year controlled clinical trials in MS patients TYSABRI treatment was associated with increases in circulating lymphocytes, monocytes, eosinophils, basophils and nucleated red blood cells.
Slovenian: TYSABRI povezano s povišanim obtokom limfocitov, monocitov, eozinofilcev, bazofilcev in eritrocitov z jedrom.
English: MS and inhibits further recruitment of immune cells into inflamed tissue, thus reducing the formation or enlargement of MS lesions.
Slovenian: Blokada molekulske interakcije α4β1 s tarčnimi strukturami zmanjšuje vnetno aktivnost v možganih pri MS in preprečuje nadaljnje vključevanje imunskih celic v vnetno tkivo, kar zmanjšuje nastajanje ali povečevanje lezij zaradi MS.
English: Given that efficacy may be reduced or the incidence of hypersensitivity or infusion-related reactions may be increased in a patient with persistent antibodies, treatment should be discontinued in patients who develop persistent antibodies.
Slovenian: Ker se lahko pri bolnikih z obstojnimi protitelesi učinkovitost zmanjša ali poveča pojavnost preobčutljivosti ali z infuzijo povezanih reakcij,
English: How to store TYSABRI
Slovenian: Shranjevanje zdravila TYSABRI
English: • Information on PML and IRIS including the risk of developing PML during TYSABRI treatment stratified by prior treatment with immunosuppressants and JC virus infection.
Slovenian: • informacije o PML in IRIS, vključno s tveganjem za razvoj PML med zdravljenjem z zdravilom
English: TYSABRI therapy and without prior history of immunosuppressant therapy.
Slovenian: TYSABRI, opredeljeno glede na predhodno zdravljenje z imunosupresivi in okužbo z virusom JC
English: • Dizziness
Slovenian: • bruhanje
English: • TYSABRI must be diluted before it is given to you.
Slovenian: • Pred uporabo je treba zdravilo TYSABRI razredčiti.
English: Warnings and precautions Talk to your doctor before using TYSABRI.
Slovenian: Pred začetkom uporabe zdravila TYSABRI se posvetujte s svojim zdravnikom.
English: − Weight loss
Slovenian: Razredčena raztopina
English: Stopping TYSABRI therapy
Slovenian: Prenehanje zdravljenja z zdravilom TYSABRI
English: UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7410
Slovenian: UAB "JOHNSON & JOHNSON" Eesti filiaal
English: • Difficulty breathing
Slovenian: Težave z jetri
English: This includes:
Slovenian: ali se je kaj spremenilo, če:
English: Do not use if it is discoloured or if foreign particles are seen.
Slovenian: Obarvane raztopine ali raztopine, v kateri so delci, ne smete uporabiti.
English: Latvija
Slovenian: filiāle Latvijā
English: In 2-year controlled clinical trials in MS patients, the rate of infection was approximately 1.5 per patient-year in both natalizumab- and placebo-treated patients.
Slovenian: Okužbe, vključno s PML in oportunističnimi okužbami V dveletnih kontroliranih kliničnih preskušanjih pri bolnikih z MS je bila stopnja okužbe približno 1,5
English: • Severe allergy (hypersensitivity) • Progressive multifocal leukoencephalopathy (PML)
Slovenian: Bolezni živčevja glavobol pogosti omotica pogosti progresivna multifokalna levkoencefalopatija (PML)
English: One year endpoint
Slovenian: Opazovani dogodek - eno leto
English: Rare, serious cases of anaemia and haemolytic anaemia have been reported in patients treated with TYSABRI in post-marketing observational studies.
Slovenian: V opazovalnih študijah po prihodu zdravila na trg so pri bolnikih, zdravljenih z zdravilom Tysabri,
English: Urinary tract infection
Slovenian: raztopino za injiciranje.
English: Vomiting
Slovenian: Imunogenost
English: • Inspect the TYSABRI vial for particles prior to dilution and administration.
Slovenian: • Pred razredčitvijo in dajanjem zdravila TYSABRI preverite, ali so v viali delci.
English: EXP
Slovenian: CHMP.
English: More frequent MRIs (e.g. on a 3 to 6 monthly basis) using an abbreviated protocol should be considered for patients at higher risk of PML.
Slovenian: Za bolnike, pri katerih je tveganje za PML večje, je treba razmisliti o pogostejšem MRS (npr. vsake 3 do
English: EDSS-baseline, median (range)
Slovenian: mediana (razpon)
English: Inspect the TYSABRI vial for particles prior to dilution and administration.
Slovenian: Pred razredčitvijo in dajanjem zdravila TYSABRI preverite, ali so v viali delci.
English: In placebo-controlled trials in 1,617 MS patients treated with natalizumab for up to 2 years (placebo: 1,135), adverse events leading to discontinuation of therapy occurred in 5.8% of patients treated with natalizumab (placebo: 4.8%).
Slovenian: 2 leti (placebo: 1.135) je prišlo do neželenih učinkov, zaradi katerih je bilo zdravljenje prekinjeno, pri
English: Mean number of Gd-enhancing lesions
Slovenian: Povprečno število lezij, vidnih z gadolinijem
English: − Listlessness
Slovenian: • slabost
English: − Prolonged dizziness
Slovenian: Brez recidiva
English: Optimark gadoversetamide
Slovenian: Optimark gadoversetamid
English: The European Commission granted a marketing authorisation valid throughout the European Union for Optimark on 23 July 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Optimark, veljavno po vsej Evropski uniji, izdala 23. julija 2007.
English: The recommended dose is 0.2 ml per kilogram body weight.
Slovenian: Priporočeni odmerek je 0,2 ml na kilogram telesne mase.
English: Other information about Optimark:
Slovenian: Druge informacije o zdravilu Optimark:
English: What measures are being taken to ensure the safe and effective use of Optimark?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Optimark?
English: In addition, the company will provide annual reviews of cases of NSF and conduct a study on the accumulation of gadolinium in the bone.
Slovenian: Poleg tega bo zagotovila letna poročila primerov NSF in izvedla študijo o kopičenju gadolinija v kosteh.
English: The full EPAR for Optimark can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Optimark je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Each scan's clarity was scored on a four-point scale.
Slovenian: Jasnost vsake slike je bila ocenjena s štiristopenjsko lestvico.
English: The company that markets Optimark will ensure that all healthcare professionals who are expected to use this medicine are informed that it should not be used in children below 2 years as the effect of the medicine in this age group, such as its effect on immature kidneys, has not been studied.
Slovenian: Družba, ki trži zdravilo Optimark, bo poskrbela, da bodo vsi zdravstveni delavci, ki naj bi predpisovali to zdravilo, obveščeni, da se ne sme uporabljati pri otrocih, mlajših od dveh let, saj učinek zdravila pri tej starostni skupini, kot na primer učinek zdravila na nezrele ledvice, ni bil raziskan.
English: The scans were analysed by three radiologists (doctors specialised in carrying out and interpreting scans of the body).
Slovenian: Slike so analizirali trije radiologi (zdravniki, specializirani za slikanje telesa in tolmačenje slik).
English: In Optimark, the gadolinium is attached to another chemical so that the metal is not released in the body but stays ‘trapped' until it is eliminated from the body in the urine.
Slovenian: V zdravilu Optimark je gadolinij vezan na drugo kemijsko spojino, tako da se kovina v telesu ne sprosti, ampak ostane „ujeta“, dokler se z urinom ne izloči iz telesa.
English: This is a summary of the European public assessment report (EPAR) for Optimark.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Optimark.
English: As a result of this interaction, the water molecules give a stronger signal, and this helps to obtain a brighter picture.
Slovenian: Zaradi tega vpliva začnejo vodne molekule oddajati močnejši signal, kar omogoča jasnejšo sliko.
English: It is given as an injection into a vein, usually a vein in an arm.
Slovenian: Daje se z injekcijo v veno, po navadi v veno roke.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Optimark have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo zdravila Optimark, so prav tako vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The CHMP decided that Optimark's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Optimark večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.