FrancophonIA/ELRC3.0 huggingface dataset:
English: - The active substance is fluciclovine (18F).
Slovenian: - Učinkovina je [18F]fluciklovin.
English: Images should only be interpreted by readers trained in the interpretation of PET images with fluciclovine (18F).
Slovenian: Slike sme razlagati samo osebje, usposobljeno za razlago slik PET z [18F]fluciklovinom.
English: Talk to your nuclear medicine doctor if you are under 18 years old.
Slovenian: Če ste mlajši od 18 let, se pogovorite s specialistom nuklearne medicine.
English: A PET scan with fluciclovine (18F) should be administered by appropriately qualified healthcare professionals.
Slovenian: Slikanje s pozitronsko emisijsko tomografijo (PET) z [18F]fluciklovinom morajo opraviti ustrezno usposobljeni zdravstveni delavci.
English: Chemical and physical in-use stability has been demonstrated for Axumin 1600 MBq/mL for 8 hours and for Axumin 3200 MBq/mL for 10 hours.
Slovenian: Dokazano je, da je zdravilo Axumin 1600 MBq/ml kemijsko in fizikalno stabilno 8 ur in zdravilo Axumin 3200 MBq/ml 10 ur.
English: ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
English: Axumin 3200 MBq/mL solution for injection 10 hours from the time of calibration (ToC)
Slovenian: Axumin 3200 MBq/ml raztopina za injiciranje 10 ur od časa umerjanja (ToC, time of calibration)
English: Image interpretation errors can occur with PET with fluciclovine (18F) (see section 5.1).
Slovenian: Pri pozitronski emisijski tomografiji lahko pride do napak pri razlagi slik PET, izdelanih z [18F]fluciklovinom (glejte poglavje 5.1).
English: For larger lesions, uptake equal to or greater than bone marrow is considered suspicious for cancer.
Slovenian: Pri večjih lezijah kaže na verjetnost raka privzem, enak ali večji od privzema v kostni mozeg.
English: Talk to your nuclear medicine doctor before you are given Axumin if you: - have kidney problems - are on a low sodium diet (see section "Axumin contains sodium").
Slovenian: - imate težave z ledvicami; - se morate držati diete z malo natrija (glejte poglavje »Zdravilo Axumin vsebuje natrij«).
English: The medicinal product may be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection by up to a factor of 8.
Slovenian: Zdravilo se lahko razredči z 0,9-odstotno (9 mg/ml) raztopino natrijevega klorida za injiciranje, tako da je volumen končne raztopine za do 8-krat večji.
English: Fluciclovine is not metabolised in vivo.
Slovenian: Fluciklovin se ne presnavlja in vivo.
English: For small lesions (<1 cm diameter) focal uptake greater than blood pool should be considered suspicious for cancer.
Slovenian: Pri majhnih lezijah (s premerom < 1 cm) kaže na verjetnost raka žariščni privzem, ki je večji kot v ožilju.
English: The activity of fluciclovine (18F) has to be measured with an activimeter immediately prior to injection.
Slovenian: Tik pred injiciranjem je treba z merilnikom aktivnosti izmeriti aktivnost [18F]fluciklovina.
English: Axumin 1600 MBq/mL solution for injection 8 hours from the time of calibration (ToC)
Slovenian: Axumin 1600 MBq/ml raztopina za injiciranje 8 ur od časa umerjanja (ToC, time of claibration)
English: How Axumin is used
Slovenian: Kako uporabljati zdravilo Axumin
English: Axumin 1600 MBq/mL solution for injection Axumin 3200 MBq/mL solution for injection
Slovenian: Axumin 1600 MBq/ml raztopina za injiciranje Axumin 3200 MBq/ml raztopina za injiciranje
English: Axumin is for multidose use.
Slovenian: Zdravilo Axumin je namenjeno za večkratno uporabo (več odmerkov).
English: It should be recommended to the patient that they do not undertake any significant exercise for at least a day before the fluciclovine (18F) scan.
Slovenian: Bolniku je treba odsvetovati večjo telesno dejavnost vsaj en dan pred slikanjem z uporabo
English: Fluciclovine (18F) uptake is not specific for prostate cancer and may occur with other types of cancer, prostatitis and benign prostatic hyperplasia.
Slovenian: Privzem [18F]fluciklovina ni specifičen za raka prostate in se lahko pojavi pri drugih vrstah raka,
English: The adult effective dose resulting from the administration of the recommended activity of 370 MBq of fluciclovine (18F) is 8.2 mSv.
Slovenian: Efektivni odmerek za odrasle po aplikaciji priporočene aktivnosti 370 MBq [18F]fluciklovina je
English: Renal/Hepatic impairment The pharmacokinetics in patients with renal or hepatic impairment have not been characterised.
Slovenian: Farmakokinetike pri bolnikih z okvaro ledvic ali jeter niso opredelili.
English: Fluciclovine (18F) PET-CT was restricted to the abdomino-pelvic region.
Slovenian: Slikanje PET-CT s fluciklovinom [18F] je bilo omejeno na območje trebuha in medenice.
English: 88.6% for all three readers while specificity ranged from 17.2-53.6%.
Slovenian: Občutljivost [18F]fluciklovina na podlagi bolnika je bila višja od 88,6 % za vse tri razlagalce, medtem ko je bila specifičnost v razponu 17,2
English: The PSA value may affect the diagnostic performance of fluciclovine (18F) PET. (see section 5.1, Pharmacodynamic properties).
Slovenian: [18F]fluciklovina (glejte poglavje 5.1 Farmakodinamične lastnosti).
English: Concentrated hydrochloric acid Sodium hydroxide Water for injections
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev citrat koncentrirana klorovodikova kislina natrijev hidroksid voda za injekcije
English: Volume: {xx.x} mL
Slovenian: Prostornina: {xx,x} ml
English: True positive (%) False positive (%) True negative (%) False negative (%) Sensitivity [95% CI] Specificity [95% CI]
Slovenian: Resnično pozitivni Lažno pozitivni Resnično negativni Lažno negativni
English: Each multidose vial contains 1 to 10 mL of solution, corresponding to 3200 to 32000 MBq at the date and time of calibration (ToC).
Slovenian: Ena večodmerna viala vsebuje od 1 do 10 ml raztopine, kar ustreza od 3200 MBq do 32.000 MBq ob datumu in uri umerjanja (ToC, time of calibration).
English: After administration of Axumin you should:
Slovenian: Pred prejemom zdravila Axumin ne smete:
English: Patient and region based diagnostic performance of fluciclovine 18F PET vs histopathology
Slovenian: Diagnostična uspešnost slikanja PET z [18F]fluciklovinom na podlagi bolnika in telesnega predela v primerjavi s histopatologijo
English: Axumin is administered intravenously as an injection into your vein followed by a flush of sodium chloride solution to ensure that you receive the full dose.
Slovenian: Temu sledi izpiranje z raztopino natrijevega klorida, ki zagotovi, da dobite celoten odmerek.
English: Axumin 3200 MBq/mL solution for injection fluciclovine (18F)
Slovenian: Axumin 3200 MBq/ml raztopina za injiciranje [18F]fluciklovin
English: Paediatric population There is no relevant use of fluciclovine (18F) in the paediatric population.
Slovenian: [18F]fluciklovin ni namenjen za uporabo pri pediatrični populaciji.
English: Each multidose vial contains 1 to 10 mL of solution, corresponding to 1600 to 16000 MBq at the date and time of calibration (ToC).
Slovenian: Ena večodmerna viala vsebuje od 1 do 10 ml raztopine, kar ustreza od 1600 do 16.000 MBq [18F]fluciklovina ob datumu in uri umerjanja (ToC, time of calibration).
English: Axumin 3200 MBq/mL solution for injection
Slovenian: Axumin 3200 MBq/ml raztopina za injiciranje
English: Advanced Accelerator Applications, 13005 Marseille, France Nucleis SA, 4000 Liège, Belgium
Slovenian: Nucleis SA, 4000 Liège, Belgija.
English: Axumin 1600 MBq/mL solution for injection fluciclovine (18F)
Slovenian: Axumin 1600 MBq/ml raztopina za injiciranje [18F]fluciklovin intravenska uporaba
English: The detection of prostate cancer recurrence in prostate/prostate bed, regional lymph nodes, bone, soft tissue and non-regional lymph nodes by fluciclovine (18F) PET has been reported.
Slovenian: Pri slikanju PET z [18F]fluciklovinom so poročali o odkritju ponovitve raka prostate v prostati/ležišču prostate, regionalnih bezgavkah, kosteh, mehkem tkivu in neregionalnih bezgavkah.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING SHIELD LABEL
Slovenian: NALEPKA NA ŠČITNIKU
English: Axumin 1600 MBq/mL solution for injection
Slovenian: Axumin 1600 MBq/ml raztopina za injiciranje
English: Parosmia
Slovenian: Slikanje
English: - avoid any close contact with young children and pregnant women for the 12 hours following the injection - urinate frequently in order to eliminate the product from your body.
Slovenian: - 12 ur po injiciranju ne bodite v tesnih stikih z majhnimi otroki in nosečnicami;
English: V09IX12.
Slovenian: 8,2 mSv.
English: How Axumin is stored
Slovenian: Shranjevanje zdravila Axumin
English: Testes
Slovenian: ZDRAVILA
English: Axumin 1600 MBq/mL solution for injection One vial contains 1 to 10 mL of solution, corresponding to 1600 to 16000 MBq at calibration time.
Slovenian: Axumin 1600 MBq/ml raztopina za injiciranje Ob datumu in uri umerjanja (ToC-time of calibration) en ml raztopine vsebuje 1600 MBq [18F]fluciklovina.
English: If you get any side effects talk to your nuclear medicine doctor.
Slovenian: Če imate kakršna koli vprašanja, se obrnite na specialista nuklearne medicine.
English: Each mL of solution contains 1600 MBq fluciclovine (18F) at date and time of calibration (ToC).
Slovenian: En ml raztopine vsebuje 1600 MBq [18F]fluciklovina ob datumu in uri umerjanja (ToC, time of calibration).
English: Each mL of solution for injection contains 1600 MBq of fluciclovine (18F) at date and time of calibration (ToC).
Slovenian: En ml raztopine za injiciranje vsebuje 1600 MBq [18F]fluciklovina ob datumu in uri umerjanja (ToC).
English: Each mL of solution contains 3200 MBq of fluciclovine (18F) at the date and time of calibration (ToC).
Slovenian: En ml raztopine vsebuje 3200 MBq [18F]fluciklovina ob datumu in uri umerjanja (ToC, time of claibration).
English: Extraprostatic (pelvic and distal recurrence)
Slovenian: (medenična in distalna ponovitev)
English: An additional study BED002 conducted a blinded read of fluciclovine (18F) PET-CT images from the
Slovenian: [95 % IZ] Specifičnost [95 % IZ] V dodatni študiji BED002 so izvedli slepo razlaganje slik PET-CT, izdelanih z [18F]fluciklovinom, iz podatkov podskupine Emory v študiji BED001 s 3 razlagalci slik.
English: Breasts
Slovenian: Parozmija
English: Axumin 3200 MBq/mL solution for injection One vial contains 1 to 10 mL of solution, corresponding to 3200 to 32000 MBq at calibration time.
Slovenian: Ena viala vsebuje od 1 do 10 ml raztopine, kar ustreza od 3200 do 32.000 MBq ob času umerjanja.
English: Tabulated list of adverse reactions
Slovenian: Organski sistem po MedDRA NEŽELENI UČINKI
English: The activity per vial ranges from 1600 MBq to 16000 MBq at the date and time of calibration.
Slovenian: Aktivnost na vialo ob datumu in uri umerjanja se giblje med 1600 MBq in 16.000 MBq.
English: Each mL of solution contains 3200 MBq fluciclovine (18F) at date and time of calibration (ToC).The activity per vial ranges from 3200 MBq to 32000 MBq at the date and time of calibration.
Slovenian: Ob datumu in uri umerjanja (ToC, time of calibration) se aktivnost na vialo giblje med 3200 in 32.000 MBq.
English: Norsk medisinsk syklotronsenter AS, 0372 Oslo, Norway.
Slovenian: Seibersdorf Labor GmbH, 2444 Seibersdorf, Avstrija Norsk medisinsk syklotronsenter AS, 0372 Oslo, Norveška Advanced Accelerator Applications, 13005 Marseille, Francija.
English: The full EPAR for Clopidogrel Krka 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 Klopidogrel Krka je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Krka on 23 September 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Klopidogrel Krka, veljavno po vsej Evropski uniji, izdala 23. septembra 2009.
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel Krka.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Klopidogrel Krka.
English: Clopidogrel Krka clopidogrel
Slovenian: Klopidogrel Krka klopidogrel
English: What measures are being taken to ensure the safe and effective use of Clopidogrel Krka?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Klopidogrel Krka?
English: What are the benefits and risks of Clopidogrel Krka?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Klopidogrel Krka?
English: This means that Clopidogrel Krka is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
English: The standard dose is one 75-mg tablet once a day.
Slovenian: Običajni odmerek zdravila je ena 75-miligramska tableta na dan.
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel Krka is used together with aspirin, the dose of which should not be higher than 100 mg.
Slovenian: Pri akutnem koronarnem sindromu in atrijski fibrilaciji se zdravilo Klopidogrel Krka uporablja skupaj z aspirinom, katerega odmerek ne sme biti višji od 100 mg.
English: It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Slovenian: Uporablja se pri tistih bolnikih, ki imajo vsaj en dejavnik tveganja za vaskularne dogodke, kot je srčni napad ali možganska kap, ki ne smejo jemati antagonistov vitamina K (drugega zdravila, ki preprečuje krvne strdke) in pri katerih je tveganje za krvavitve majhno.
English: Clopidogrel Krka can be started between a few days and 35 days after the attack;
Slovenian: Zdravilo Klopidogrel Krka se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Clopidogrel Krka have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Klopidogrel Krka upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: It is not intended to provide practical advice on how to use Clopidogrel Krka.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: For more information about treatment with Clopidogrel Krka, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Klopidogrel Krka preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Clopidogrel Krka has been shown to have comparable quality and to be bioequivalent to Plavix.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Klopidogrel Krka primerljivo raven kakovosti kot referenčno zdravilo Plavix ter da mu je biološko enakovredno.
English: Clopidogrel Krka is available as tablets containing 75 mg clopidogrel.
Slovenian: Zdravilo Klopidogrel Krka je na voljo v obliki tablet, ki vsebujejo 75 mg klopidogrela.
English: Because Clopidogrel Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Klopidogrel Krka generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Clopidogrel Krka is used to prevent problems caused by blood clots in adults who have:
Slovenian: Zdravilo Klopidogrel Krka se uporablja za preprečevanje težav, ki jih povzročajo krvni strdki pri odraslih:
English: What is Clopidogrel Krka and what is it used for?
Slovenian: Kaj je zdravilo Klopidogrel Krka in za kaj se uporablja?
English: Clopidogrel Krka is a ‘generic medicine'.
Slovenian: Zdravilo Klopidogrel Krka je „generično zdravilo“.
English: For practical information about using Clopidogrel Krka, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Klopidogrel Krka naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: • recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Slovenian: • ki so nedavno utrpeli ishemično kap (kap, ki jo povzroči pomanjkljiva oskrba določenega dela možganov s krvjo).
English: Because Clopidogrel Krka is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Slovenian: Ker je zdravilo Klopidogrel Krka generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
English: Other information about Clopidogrel Krka
Slovenian: Druge informacije o zdravilu Klopidogrel Krka
English: Clopidogrel Krka can be started between seven days and six months after the stroke;
Slovenian: Zdravilo Klopidogrel Krka se lahko začne jemati od sedem dni po kapi do šest mesecev po njej;
English: • atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
Slovenian: • ki trpijo za atrijsko fibrilacijo (nerednim hitrim krčenjem zgornjih srčnih preddvorov), pri katerih je treba zdravilo dajati skupaj z aspirinom.
English: • a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots).
Slovenian: • ki imajo akutni koronarni sindrom, pri katerem je treba zdravilo dajati skupaj z aspirinom (drugim zdravilom za preprečevanje krvnih strdkov).
English: The Agency recommended that Clopidogrel Krka be approved for use in the EU.
Slovenian: Priporočila je, da se zdravilo odobri za uporabo v EU.
English: Why is Clopidogrel Krka approved?
Slovenian: Zakaj je bilo zdravilo Klopidogrel Krka odobreno?
English: The active substance in Clopidogrel Krka, clopidogrel, is an inhibitor of platelet aggregation.
Slovenian: Zdravilna učinkovina zdravila Klopidogrel Krka, klopidogrel, je zaviralec agregacije trombocitov.
English: How has Clopidogrel Krka been studied?
Slovenian: Kako je bilo zdravilo Klopidogrel Krka raziskano?
English: How is Clopidogrel Krka used?
Slovenian: Kako se zdravilo Klopidogrel Krka uporablja?
English: Clopidogrel Krka contains the active substance clopidogrel.
Slovenian: Zdravilo Klopidogrel Krka vsebuje zdravilno učinkovino klopidogrel.
English: How does Clopidogrel Krka work?
Slovenian: Kako zdravilo Klopidogrel Krka deluje?
English: Clopidogrel Krka can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Klopidogrel Krka je le na recept.
English: The joint PASS final study report submitted by the MAHs complies with their obligation to perform a PASS to evaluate the effectiveness of the risk minimisation activities as imposed during the Article 107i procedure EMA/H/A-107i/1357 for cyproterone/ethinylestradiol containing products.
Slovenian: Končno poročilo študije PASS, ki so jo predložili imetniki dovoljenj za promet, je v skladu z obveznostjo izvajanja PASS za ocenitev učinkovitosti ukrepov zmanjševanja tveganj, naloženih v okviru postopka člena 107i EMA/H/A-107i/1357 za zdravila, ki vsebujejo ciproteron/etinilestradiol.
English: Therefore, in view of available data regarding the joint PASS final study report, the PRAC Rapporteur considered that changes to the conditions of the marketing authorisation were warranted.
Slovenian: Zato na podlagi razpoložljivih podatkov glede končnega poročila študije PASS, poročevalec odbora PRAC meni, da so potrebne spremembe pogojev dovoljenj za promet z zdravili.
English: Grounds for the variation to the terms of the Marketing Authorisation(s) On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance cyproterone/ethinylestradiol and concerned by the PASS final report , the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Slovenian: Podlaga za priporočilo spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov rezultatov študije za zdravila, ki vsebujejo ciproteron/etinilestradiol in jih zadeva končno poročilo PASS, skupina CMDh meni, da je razmerje med koristjo in tveganjem zgoraj navedenih zdravil nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Further information on Renvela can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/renvela.
Slovenian: Nadaljnje informacije za zdravilo Renvela so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/renvela.
English: • adults and children from 6 years of age with chronic (long-term) kidney disease.
Slovenian: • odraslih in otrocih, starejših od šest let, s kronično (dolgotrajno) boleznijo ledvic.
English: The European Medicines Agency therefore concluded that Renvela's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Renvela večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Renvela?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Renvela?
English: Renvela received a marketing authorisation valid throughout the EU on 10 June 2009.
Slovenian: Za zdravilo Renvela je bilo 10. junija 2009 izdano dovoljenje za promet, veljavno po vsej EU.
English: Other information about Renvela
Slovenian: Druge informacije o zdravilu Renvela
English: Renvela should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Slovenian: Zdravilo Renvela je treba uporabljati sočasno z drugimi zdravili, na primer z dodatki kalcija in vitamina D, da se prepreči razvoj bolezni kosti.
English: As for all medicines, data on the use of Renvela are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Renvela stalno spremljajo.
English: Renvela must not be taken on an empty stomach and patients should keep to their prescribed diets.
Slovenian: Zdravilo Revela se ne sme jemati na prazen želodec, bolniki pa morajo upoštevati predpisano dieto.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Renvela have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Renvela upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Renvela is available as tablets (800 mg) and as powder (0.8 g, 1.6 g and 2.4 g) in a sachet to be taken 3 times a day with meals.
Slovenian: Zdravilo Renvela je na voljo v obliki tablet (800 mg) in praška (0,8 g, 1,6 g in 2,4 g) in se jemlje trikrat na dan z obroki.
English: Side effects reported with Renvela are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Renvela, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.