FrancophonIA/ELRC3.0 huggingface dataset:
English: However, since excretion in urine is minimal and the major route of elimination is via the faeces, renal impairment is not expected to affect the pharmacokinetics of radium-223 dichloride.
Slovenian: Ker se izloča v majhnih količinah s sečem in večinoma z blatom, ni pričakovati, da bi okvara ledvic vplivala na farmakokinetiko [223Ra]radijevega klorida.
English: The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Slovenian: Za opis določenega učinka, njegovih sinonimov in sorodnih stanj so uporabljeni najustreznejši izrazi po klasifikaciji MedDRA.
English: Alpha1 emission (Gy/MBq)
Slovenian: Emisija delcev alfa1 (Gy/MBq)
English: In a clinical study, the addition of Xofigo to abiraterone acetate and prednisone/prednisolone, increased the incidence of fractures approximately three-fold in the Xofigo arm (see sections 4.8 and 5.1).
Slovenian: V klinični študiji se je incidenca zlomov v skupini, ki je prejemala zdravilo Xofigo, po dodajanju zdravila Xofigo abirateronacetatu in prednizonu/prednizolonu približno trikrat povečala (glejte poglavji 4.8 in 5.1).
English: Each vial contains 6 mL of solution (6600 kBq radium-223 dichloride at the reference date).
Slovenian: Ena viala vsebuje 6 ml raztopine (6600 kBq [223Ra]radijevega klorida na referenčni dan).
English: As Xofigo is excreted in the faeces, it may make acute inflammation of your bowels worse.
Slovenian: Ker se zdravilo Xofigo izloča z blatom, lahko poslabša akutno vnetje črevesja.
English: Dose-limiting myelotoxicity was seen in dogs after single administration of 497 kBq radium-223 dichloride per kg body weight (9 times the clinically recommended activity).
Slovenian: Mielotoksičnost, ki omejuje velikost odmerka, so pri psih opazili po enkratni uporabi 497 kBq [223Ra]radijevega klorida na kg telesne mase (9-kratnik klinično priporočene aktivnosti).
English: The efficacy and safety of cytotoxic chemotherapy performed after treatment with Xofigo has not been established.
Slovenian: Varnost in učinkovitost citotoksične kemoterapije po zdravljenju z zdravilom Xofigo nista bili dokazani.
English: Additionally, there are uncertainties about the effects of Xofigo in combination with other systemic medicines used to treat metastatic prostate cancer.
Slovenian: Xofigo v kombinaciji z drugimi sistemskimi zdravili, ki se uporabljajo za zdravljenje metastatskega raka prostate.
English: Subgroup survival analysis showed a consistent survival benefit for treatment with Xofigo, independent of use of bisphosphonates at baseline and prior use of docetaxel.
Slovenian: Analiza preživetja po podskupinah je pokazala dosledno korist zdravljenja z zdravilom Xofigo za preživetje,
English: Contact your doctor immediately if you notice the following symptoms as they may be signs of thrombocytopenia or neutropenia (see above): - any unusual bruising, - more bleeding than usual after injury, - fever, - or if you seem to be catching a lot of infections.
Slovenian: Takoj se posvetujte z zdravnikom, če opazite naslednje simptome, saj so lahko znaki trombocitopenije ali nevtropenije (glejte zgoraj):
English: Xofigo 1100 kBq/mL solution for injection radium Ra 223 dichloride
Slovenian: Xofigo 1100 kBq/ml raztopina za injiciranje [223Ra]radijev klorid
English: Cases of osteonecrosis of the jaw (dead tissue in the jaw bone which is mainly seen in patients who have been treated with bisphosphonates) have occurred in patients treated with Xofigo.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Xofigo, so se pojavili primeri osteonekroze čeljusti (mrtvo tkivo čeljustnice, ki se pojavlja predvsem pri bolnikih, zdravljenih z difosfonati).
English: Storage should be in accordance with national regulation on radioactive materials.
Slovenian: Shranjujte v skladu z nacionalnimi predpisi za radioaktivne snovi.
English: Each mL of solution contains 1100 kBq radium Ra 223 dichloride (radium-223 dichloride), corresponding to 0.58 ng radium-223 at the reference date.
Slovenian: 1 ml raztopine vsebuje 1100 kBq [223Ra]radijevega klorida (radium Ra 223 dichloride), kar ustreza 0,58 ng [223Ra]radija na referenčni dan.
English: A statistically significant overall survival benefit of treatment could not be demonstrated in the subgroups of patients with fewer than 6 metastases (HR for radium-223 to placebo 0.901; 95% CI [0.553 -1.466], p=0.674) or a baseline total alkaline phosphatase (ALP) < 220 U/L (HR 0.823; 95% CI [0.633 -1.068], p=0.142) in the phase III ALSYMPCA study.
Slovenian: [223Ra]radij v primerjavi s placebom 0,901; 95-% IZ [0,553-1,466], p = 0,674) ali z izhodiščno vrednostjo celokupne alkalne fosfataze (ALP) < 220 enot/l (razmerje ogroženosti 0,823; 95-% IZ [0,633-1,068], p = 0,142).
English: Grade 3 and 4 thrombocytopenia was observed in 5.9% of patients treated with Xofigo and in 6.7% of patients receiving placebo (see section 4.4).
Slovenian: Trombocitopenijo stopnje 3 in 4 so opazili pri 5,9 % bolnikov, zdravljenih z zdravilom Xofigo in pri 6,7 % bolnikov, ki so prejemali placebo (glejte poglavje 4.4).
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, faeces, vomiting etc.
Slovenian: Pri uporabi radiofarmakov obstaja zaradi zunanjega sevanja ali kontaminacije z razlitim sečem, blatom,
English: Demographic and baseline disease characteristics (interim analysis population) were similar between the Xofigo and placebo groups and are shown below for Xofigo:
Slovenian: Demografske in izhodiščne značilnosti bolezni (vmesna analiza populacije) so bile podobne med skupino,
English: If you take or have taken bisphosphonates or other medicines to protect your bone health or steroids (e.g. prednisone/prednisolone) prior to treatment with Xofigo, please tell your doctor.
Slovenian: Obvestite svojega zdravnika, če jemljete ali ste jemali difosfonate ali druga zdravila za zaščito kosti ali steroide (npr. prednizon/prednizolon) pred zdravljenjem z zdravilom Xofigo.
English: - The active substance is: radium Ra 223 dichloride (radium-223 dichloride).
Slovenian: - Učinkovina je [223Ra]radijev klorid (radium Ra 223 dichloride).
English: Safety and efficacy of concomitant chemotherapy with Xofigo have not been established.
Slovenian: Varnost in učinkovitost sočasne kemoterapije z zdravilom Xofigo nista bili dokazani.
English: Compared with placebo, there was a significant difference in favour of Xofigo for all five serum biomarkers for bone turnover studied in a phase II randomised study (bone formation markers: bone alkaline phosphatase [ALP], total ALP and procollagen I N propeptide [PINP], bone resorption markers: C-terminal crosslinking telopeptide of type I collagen / serum C-terminal crosslinked telopeptide of type I collagen [S-CTX-I] and type I collagen crosslinked C-telopeptide [ICTP]).
Slovenian: kostna alkalna fosfataza [ALP], celokupna vrednost alkalne fosfataze in prokolagen I N propeptid [PINP], označevalci resorpcije kosti: C-terminalni prečno povezani telopeptid kolagena tipa I / serumski C-terminalni prečno povezani telopeptid kolagena tipa I [S-CTX-I] in prečno povezani C-telopeptid kolagena tipa I [ICTP]).
English: - If you experience any new or unusual pain or swelling in bone region prior, during or after your treatment with Xofigo, you should consult your doctor.
Slovenian: - Če se vam pred, med ali po zdravljenju z zdravilom Xofigo pojavi kakršna koli nova ali nenavadna bolečina ali oteklina v predelu kosti, se posvetujte z zdravnikom.
English: Adrenals Brain
Slovenian: Nadledvične žleze Možgani
English: Bayer A/S Tlf: +45-45 23 50 00
Slovenian: Tlf: +45-45 23 50 00
English: In patients with bone fractures, orthopaedic stabilisation of fractures should be performed before starting or resuming treatment with Xofigo.
Slovenian: Pri bolnikih z zlomi kosti je treba zlome pred začetkom ali nadaljevanjem zdravljenja z zdravilom Xofigo ortopedsko oskrbeti.
English: Radiation protection precautions in accordance with national regulations must therefore be taken.
Slovenian: V skladu z nacionalnimi in lokalnimi predpisi je treba vnaprej poskrbeti za zaščito pred sevanjem.
English: Xofigo is excreted mainly via the faeces.
Slovenian: Zdravilo Xofigo se izloča predvsem z blatom.
English: Grade 3 and 4 thrombocytopenia was observed in 6.3% of patients treated with Xofigo and in 2% of patients receiving placebo (see section 4.4).
Slovenian: Trombocitopenijo stopnje 3 in 4 so opazili pri 6,3 % bolnikov, zdravljenih z zdravilom Xofigo, in pri 2 % bolnikov, ki so prejemali placebo (glejte poglavje 4.4).
English: Beta emission (Gy/MBq)
Slovenian: Emisija delcev beta (Gy/MBq)
English: Pain relief
Slovenian: Lajšanje bolečine
English: - If you have osteoporosis or a known increased risk for fractures (e.g. recent bone fracture, fragility), or take or have been taking steroids (e.g. prednisone/prednisolone), please tell your doctor.
Slovenian: nedavni zlom kosti, krhkost), jemljete ali ste jemali steroide (npr. prednizon/prednizolon).
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Xofigo Vsebina pakiranja in dodatne informacije
English: - Xofigo contributes to your overall long-term cumulative radiation exposure.
Slovenian: - Zdravilo Xofigo prispeva k splošni dolgotrajni kumulativni izpostavljenosti bolnika sevanju.
English: Depending on the volume administered, this medicine can contain up to 54 mg sodium (main component of cooking/table salt) per dose.
Slovenian: Odvisno od injiciranega volumna lahko to zdravilo vsebuje do 54 mg natrija (glavne sestavine kuhinjske soli) na odmerek, kar je enako 2,7 % priporočenega največjega dnevnega vnosa natrija za odrasle osebe.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xofigo in all subsets of the paediatric population in the treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms) and in the treatment of multiple myeloma (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Xofigo za vse podskupine pediatrične populacije za zdravljenje vseh stanj, ki sodijo v kategorijo malignih neoplazem
English: Each mL of solution contains 1100 kBq radium-223 dichloride, corresponding to 0.58 ng radium-223 at the reference date.
Slovenian: 1 ml raztopine vsebuje 1100 kBq [223Ra]radijevega klorida, kar ustreza 0,58 ng [223Ra]radija na referenčni dan.
English: There is a potential risk that radiation from Xofigo could affect your fertility.
Slovenian: Zdravilo Xofigo ima lahko škodljiv vpliv na vašo plodnost.
English: No case of retinal detachment has been reported in clinical trials.
Slovenian: V kliničnih preskušanjih niso poročali o odstopu mrežnice.
English: Before the first administration, the absolute neutrophil count (ANC) should be ≥ 1.5 x 109/l, the platelet count ≥ 100 x 109/l and haemoglobin ≥ 10.0 g/dl.
Slovenian: Pred prvo uporabo mora biti absolutno število nevtrofilcev (ANC) ≥ 1,5 x 109/l,
English: Uterine polyps (endometrial stroma) were observed in female rats after single or repeated administration of ≥ 359 kBq/kg body weight radium-223 dichloride (≥ 6.5 times the clinically recommended activity).
Slovenian: Pri podganjih samicah so po enkratni ali večkratni uporabi ≥ 359 kBq/kg telesne mase [223Ra]radijevega klorida (≥ 6,5-kratnik klinično priporočene aktivnosti) opazili polipe v maternici (stroma endometrija).
English: Safety and efficacy of Xofigo have not been studied in patients with hepatic impairment.
Slovenian: Varnosti in učinkovitosti zdravila Xofigo pri bolnikih z okvaro jeter niso preučevali.
English: No case of osteosarcoma has been reported in clinical studies with Xofigo.
Slovenian: V kliničnih študijah z zdravilom Xofigo niso poročali o primerih osteosarkomov.
English: Therefore, Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone (see section 4.3).
Slovenian: Uporaba zdravila Xofigo v kombinaciji z abirateronacetatom in prednizonom/prednizolonom je kontraindicirana (glejte poglavje 4.3).
English: Bone marrow suppression, notably thrombocytopenia, neutropenia, leukopenia and pancytopenia, has been reported in patients treated with Xofigo (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z zdravilom Xofigo, so poročali o supresiji kostnega mozga, predvsem o trombocitopeniji, nevtropeniji, levkopeniji in pancitopeniji (glejte poglavje 4.8).
English: In the phase III study, cases of ONJ have been reported in 0.67% patients (4/600) in the Xofigo arm compared to 0.33% patients (1/301) in the placebo arm.
Slovenian: (4/600) bolnikov, ki so prejemali zdravilo Xofigo, v primerjavi z 0,33 % bolnikov (1/301), ki so prejemali placebo.
English: Retinal detachment was seen in dogs after a single injection of activities of 166 and 497 kBq per kg body weight (3 and 9 times the clinically recommended dose), but not after repeated administration of the clinically recommended activity of 55 kBq per kg body weight once every 4 weeks for 6 months.
Slovenian: 9-kratnik klinično priporočenega odmerka) opazili odstop mrežnice, ne pa tudi pri večkratni uporabi klinično priporočene aktivnosti 55 kBq na kg telesne mase vsake 4 tedne v obdobju 6 mesecev.
English: Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone (see section 4.4).
Slovenian: Uporaba zdravila Xofigo v kombinaciji z abirateronacetatom in prednizonom/prednizolonom je kontraindicirana (glejte poglavje 4.4).
English: No data are available for patients with severe (CLCR < 30 mL/min) renal impairment or end-stage renal disease.
Slovenian: Za bolnike s hudo okvaro ledvic ali odpovedjo ledvic (očistek kreatinina < 30 ml/min) ni podatkov.
English: However, all patients with ONJ were also exposed to prior or concomitant bisphosphonates (e.g. zoledronic acid) and prior chemotherapy (e.g. docetaxel).
Slovenian: Vendar so vsi bolniki z osteonekrozo čeljusti predhodno ali sočasno uporabljali difosfonate (npr.
English: B. PACKAGE LEAFLET
Slovenian: SVINČENI VSEBNIK
English: United Kingdom Bayer plc
Slovenian: Magyarország Bayer Hungária KFT
English: Tel: +44 (0) 118 206 3000
Slovenian: Bayer plc Tel: +44 (0) 118 206 3000
English: Common (may affect up to 1 in 10 people) - decrease in the number of white blood cells (leukopenia) - decrease in the number of neutrophils, a type of white blood cells (neutropenia, which may lead to an increased risk of infection) - decrease in the number of red and white blood cells and blood platelets (pancytopenia) - injection site reactions (e.g. redness of the skin [erythema], pain and swelling)
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - zmanjšanje števila belih krvnih celic (levkopenija) - zmanjšanje števila nevtrofilcev, določene vrste belih krvnih celic (nevtropenija, ki lahko poveča tveganje za okužbe)
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija nevtropenija, pancitopenija, levkopenija limfopenija
English: Animal reproduction studies have not been conducted with Xofigo.
Slovenian: Študij o delovanju zdravila Xofigo na sposobnost razmnoževanja pri živalih niso izvedli.
English: Gamma emission (Gy/MBq)
Slovenian: Emisija žarkov gama (Gy/MBq)
English: No dose adjustment is considered necessary in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter odmerka ni treba prilagajati.
English: N = 541 Placebo N = 268 Xofigo N = 541 Placebo N = 268
Slovenian: (N = 541) in najboljšo standardno nego ali ustrezni placebo in najboljšo standardno nego (N = 268).
English: An increased risk of death and fractures was observed in a clinical study, where Xofigo was added to abiraterone acetate and prednisone/prednisolone in patients with asymptomatic or mildly symptomatic castration resistant prostate cancer.
Slovenian: Zdravljenje bolnikov z asimptomatskimi ali blago simptomatskimi metastazami v kosteh V klinični študiji, kjer so bolnikom z asimptomatskim ali blago simptomatskim na kastracijo odpornim rakom prostate zdravilo Xofigo dodali abirateronacetatu in prednizonu/prednizolonu, so opazili povečano tveganje za smrt in zlome kosti.
English: Gallbladder wall LLI2 Wall
Slovenian: Stena tankega črevesa
English: In EOD4 (“superscan”) patients, thrombocytopenia (all grades) was reported in 19.6% of patients treated with Xofigo and in 6.7% of patients receiving placebo.
Slovenian: Pri bolnikih z napredovalim difuznim kopičenjem v kosteh (EOD4, »superscan«) so o trombocitopeniji (vseh stopenj) poročali pri 19,6 %
English: Heart wall Kidneys
Slovenian: Stena srca
English: Hepatic impairment
Slovenian: Trebušna slinavka
English: No cases of cancer caused by Xofigo have been reported in clinical trials with a follow-up of up to three years.
Slovenian: Iz kliničnih preskušanj, v katerih so bolnike spremljali do tri leta, niso poročali o primerih raka, ki bi ga povzročilo zdravilo Xofigo.
English: Small intestine wall Stomach wall ULI3 wall
Slovenian: Stena spodnjega dela debelega črevesa
English: Urinary bladder wall Uterus
Slovenian: Stena sečnega mehurja
English: Other medicines and Xofigo No interaction studies with other medicines have been done.
Slovenian: Študij medsebojnega delovanja z drugimi zdravili niso izvedli.
English: How Xofigo is stored
Slovenian: Shranjevanje zdravila Xofigo
English: - If you plan to take Xofigo following treatment with abiraterone and prednisone/prednisolone, you must wait 5 days before starting treatment with Xofigo.
Slovenian: - Če načrtujete jemanje zdravila Xofigo po zdravljenju z abirateronom in prednizonom/prednizolonom,
English: Time-to-event analysis (95% CI) [no. (%) of patients] [median no. of months] Hazard ratio < 1 favours Xofigo p-value
Slovenian: [št. (%) bolnikov] [mediana št. mesecev] razmerje ogroženosti
English: Preventive measures such as the use of bisphosphonates or denosumab should be considered before starting or resuming treatment with Xofigo (see section 4.8).
Slovenian: Pred začetkom zdravljenja ali pred ponovnim zdravljenjem z zdravilom Xofigo je treba razmisliti o preventivnih ukrepih, kot je uporaba difosfonatov ali denozumaba
English: Ovaries
Slovenian: Ledvice
English: Lymphopenia
Slovenian: Ščitnica
English: Common
Slovenian: stabilen
English: No cases of Xofigo-induced cancer have been reported in clinical trials in follow-up of up to three years.
Slovenian: V kliničnih preskušanjih, v katerih so bolnike spremljali do tri leta, niso poročali o primerih raka, ki bi ga povzročilo zdravilo Xofigo.
English: Solution for injection
Slovenian: NAČIN IZDAJANJA ZDRAVILA
English: A risk of osteonecrosis of the jaw (dead tissue in the jaw bone which is mainly seen in patients who have been treated with bisphosphonates) cannot be excluded (see section 4).
Slovenian: predvsem pri bolnikih, zdravljenih z difosfonati) ni mogoče izključiti (glejte poglavje 4).
English: No dose adjustment is considered necessary in patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati.
English: 3ULI: upper large intestine
Slovenian: raztopina za injiciranje 6 ml
English: Hydrochloric acid, dilute
Slovenian: estrogene, estramustin ali ketokonazol.
English: Sodium chloride
Slovenian: [223Ra]radijev klorid
English: Your doctor might prescribe you a drug to prevent bone fractures before starting or continuing treatment with Xofigo.
Slovenian: Xofigo vam bo zdravnik morda predpisal zdravilo za preprečevanje zlomov kosti.
English: The European Commission issued a decision on 22 October 2015.
Slovenian: Evropska komisija je sklep izdala 22. oktobra 2015.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a veterinary medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain).
Slovenian: To je postopek, pri katerem ena od držav članic („referenčna država članica“, v tem primeru Združeno kraljestvo) oceni zdravilo za uporabo v veterinarski medicini glede tega, ali se zanj lahko izda dovoljenje za promet, ki bo veljavno v tej državi in drugih državah članicah („zadevnih državah članicah“, v tem primeru Avstrija, Belgija, Bolgarija, Ciper, Republika Češka republika, Danska, Estonija, Francija, Nemčija, Grčija, Madžarska, Irska, Italija, Latvija, Litva, Luksemburg, Malta, Nizozemska, Poljska, Portugalska, Romunija, Slovaška, Slovenija in Španija).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 October 2015
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that a risk to the environment has been identified due to accumulation of zinc, but that there is some uncertainty associated with the scale of this risk.
Slovenian: Na podlagi trenutno razpoložljivih podatkov in znanstvene razprave v odboru CVMP je ta zaključil, da je bilo ugotovljeno tveganje za okolje zaradi kopičenja cinka, vendar da obstaja določena negotovost glede obsega tega tveganja.
English: On 6 May 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the veterinary medicinal product Gutal 1000 g/kg premix for medicated feeding stuff for piglets.
Slovenian: Evropska agencija za zdravila je 6. maja 2015 zaključila arbitražni postopek, do katerega je prišlo zaradi nesoglasja med državami članicami Evropske unije (EU) glede izdaje dovoljenja za promet z zdravilom za uporabo v veterinarski medicini Gutal 1 000 g/kg predmešanica za zdravilno krmno mešanico za prašičke.
English: However, the Member States were not able to reach an agreement and the Veterinary Medicines Directorate of the United Kingdom referred the matter to the CVMP for arbitration on 30 September
Slovenian: Vendar države članice niso mogle doseči soglasja, zato je direktorat za zdravila za uporabo v veterinarski medicini v Združenem kraljestvu 30. septembra 2014 zadevo napotil na odbor CVMP v arbitražo.
English: The grounds for the referral were concerns raised by France and The Netherlands that the marketing authorisation of Gutal may present a potential serious risk to the environment and that the risk mitigation measures proposed to control the risk are inadequate to control or prevent continuous zinc accumulation and, in addition, they are not feasible to implement in all pig farms.
Slovenian: Razlog za napotitev so bili pomisleki Francije in Nizozemske v zvezi s tem, da bi izdaja dovoljenja za promet z zdravilom Gutal lahko pomenila resno tveganje za okolje in da ukrepi za zmanjšanje tveganja, predlagani za obvladovanje tveganja, niso ustrezni, da bi lahko obvladali ali preprečili stalno kopičenje cinka, poleg tega pa jih ne bi mogli izvajati na vseh prašičjih farmah.
English: Thus the CVMP concluded that the concerns expressed by France and the Netherlands should not prevent the granting of marketing authorisations and recommended marketing authorisation be granted in the concerned Member States.
Slovenian: Tako je zaključil, da pomisleki, ki sta jih izrazili Francija in Nizozemska, ne bi smeli preprečiti izdaje dovoljenj za promet z zdravilom, in priporočil, da se v zadevnih državah članicah izda dovoljenje za promet z zdravilom.
English: The CVMP also recommended that the product information for Gutal be amended.
Slovenian: Priporočil je tudi, da se informacije o zdravilu Gutal spremenijo.