FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies employing planar imaging techniques, Quadramet accumulates with a lesion-tonormal bone ratio of approximately 5 and a lesion-to-soft tissue ratio of approximately 6.
Slovenian: V kliničnih študijah, kjer uporabljajo planarne tehnike slikanja, se Quadramet v lezijah kopiči v razmerju približno 5:1 glede na normalno kostno tkivo in v razmerju 6:1 glede na mehko tkivo.
English: The data on the safety of repeated dosing are limited and based on compassionate use of the product.
Slovenian: Podatki o varnosti ponovne aplikacije so skromni in temeljijo le na poročilih pri uporabi tega zdravila pri majhnem številu bolnikov.
English: Once injected it concentrates in bone lesions.
Slovenian: Po injiciranju se zbira v kostnih lezijah.
English: This medicinal product is a clear, colourless to light amber solution which is packed in a 15 ml colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated chlorobutyl/natural rubber stopper and aluminium flip-off overseal.
Slovenian: Zdravilo je bistra, brezbarvna do svetlo jantarna raztopina, ki je v 15-ml brezbarvni viali iz stekla tipa I po Evropski farmakopeji, zaprta s teflonsko prevlečenim klorobutilnim zamaškom iz naravne gume in aluminijasto zaščitno zaporko.
English: 15 ml colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated chlorobutyl/natural rubber stopper and aluminium flip-off overseal.
Slovenian: Brezbarvna 15-ml viala iz vlečenega stekla tipa I po Evropski farmakopeji, zaprta s teflonsko prevlečenim klorobutilnim zamaškom iz naravne gume in aluminijasto zaščitno zaporko.
English: Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Slovenian: Uporabnik mora pri pripravi radiofarmakov upoštevati zahteve varstva pred sevanji in farmacevtske kakovosti.
English: In clinical trials white blood cell and platelet counts decreased to a nadir of approximately 40 % to 50 % of baseline 3 to 5 weeks after a dose, and generally returned to pre-treatment levels by 8 weeks post treatment.
Slovenian: V kliničnih preskušanjih je ob največjem padcu število levkocitov in trombocitov znašalo približno 40% - 50% njihove izhodiščne vrednosti; te najnižje vrednosti so bile zabeležene 3-5 tednov po aplikaciji odmerka in so se zopet vrnile v izhodiščno stanje 8 tednov po terapiji.
English: Adverse drug reactions such as nausea, vomiting, diarrhoea and sweating were reported.
Slovenian: Poročajo o neželenih učinkih, kot so navzea, bruhanje, driska in znojenje.
English: • in patients having received chemotherapy or hemi-body external radiation therapy in a preceding period of 6 weeks.
Slovenian: • pri bolnikih, ki so se v preteklih 6 tednih zdravili s kemoterapijo ali zunanjim obsevanjem polovice telesa.
English: Repeated dose administration of samarium (153Sm)-EDTMP to dogs indicated a slightly longer time for depressed bone marrow and peripheral haematological parameters to recover when compared to recovery following only single dose administration.
Slovenian: (153Sm)-EDTMP pri psih traja nekoliko dlje, da se prizadeti kostni mozeg in periferni hematološki parametri spet normalizirajo.
English: One single dose of 37 megabecquerel (Becquerel is the unit in which radioactivity is measured) of Quadramet per kilogram of body weight is to be injected.
Slovenian: Injicira se enkratni odmerek 37 MBq (Becquerel je enota za merjenje radioaktivnosti) Quadrameta na kilogram telesne mase.
English: You may exceptionally feel a slight increase in bone pain a few days after Quadramet injection.
Slovenian: Izjemoma se lahko zgodi, da boste nekaj dni po injekciji Quadrameta občutili močnejše bolečine v kosteh.
English: How to take Quadramet
Slovenian: Kako jemati zdravilo Quadramet
English: Quadramet being supplied as a single-dose vial, an accidental overdose is unlikely to occur.
Slovenian: Glede na to, da je Quadramet na razpolago v enoodmernih vialah, naključno preveliko odmerjanje ni verjetno.
English: Radiation dose estimates for bone and marrow assume that radioactivity is deposited on bone surfaces, in accordance with autoradiograms of bone samples taken from patients who received Quadramet.
Slovenian: Pri oceni prejetih doz sevanja na kosti in kostni mozeg se predvideva, da se, skladno z avtoradiogrami kostnih vzorcev odvzetih bolnikom, ki so prejemali zdravilo Quadramet, radioaktivnost nalaga na površini kosti..
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING METALLIC BOX / LEADPOT
Slovenian: PODATKI NA ZUNANJI OVOJNINI KOVINSKA ŠKATLA / SVINČENI VSEBNIK
English: Radiopharmaceuticals may be received, used and administered only by authorised persons in designated clinical settings.
Slovenian: Prejemanje, uporaba in dajanje radiofarmakov sme potekati le v določenih kliničnih ustanovah, poseg pa smejo izvajati le za to pooblaščene osebe.
English: or similar phosphonates) or to any of the excipients excipients listed in section 6.1.
Slovenian: • preobčutljivost za zdravilno učinkovino (etilendiamintetrametilenfosfonat (EDTMP) ali podobne fosfonate) ali katerokoli pomožno snov, navedeno v poglavju 6.1
English: What Quadramet contains
Slovenian: Kaj vsebuje zdravilo Quadramet
English: MINIMUM PARTICULARS TO APPEAR ON SMALL INTERMEDIATE PACKAGING UNITS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: The operator should be careful to protect the eyes while inspecting the solution for clarity.
Slovenian: Med preverjanjem bistrosti raztopine si mora oseba, ki preverja, zaščititi oči.
English: If therefore Quadramet administration is deemed necessary, formula feeding should be substituted for breastfeeding and the expressed feeds discarded.
Slovenian: Če je torej v tem obdobju zdravljenje s Quadrametom nujno, moramo namesto dojenja uvesti hranjenje z umetnim mlekom, izločeno materino mleko pa zavreči.
English: Non-radioactive Sm-EDTMP showed no mutagenic potential in a battery of in vivo and in vitro tests.
Slovenian: V seriji in vivo in in vitro testov neradioaktivni Sm-EDTMP ni imel mutagenega potenciala.
English: Quadramet is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.
Slovenian: Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Quadramet pri otrocih pod 18 let ni priporočljiva.
English: Hypersensitivity reactions including rare cases of anaphylactic reaction have been reported after Quadramet administration.
Slovenian: Po dajanju zdravila Quadramet poročajo tudi o preobčutljivostnih reakcijah, vključno z redkimi primeri anafilaktične reakcije.
English: The product label includes the appropriate storage conditions and the expiry date for the batch of product.
Slovenian: Na ovojnini so navedeni pogoji za pravilno shranjevanje in rok uporabnosti za zdravila iz te serije.
English: This is usually mild and self-limiting and occurs within 72 hours of injection.
Slovenian: Ta reakcija je običajno blaga, pojavi se v 72 urah po aplikaciji in izgine sama od sebe.
English: F-91192 Gif-sur-Yvette cedex France
Slovenian: F-91192 GIF-SUR-YVETTE Cedex FRANCIJA
English: F-91192 GIF-SUR-YVETTE Cedex FRANCE
Slovenian: F-91192 Gif-sur-Yvette cedex Francija
English: Do not take Quadramet: If you are allergic to ethylene diamine tetramethylene phosphonic acid (EDTMP) or similar phosphonate compounds or any of the other ingredients of this medicine (listed in section 6), If you are pregnant, If you have received chemotherapy or hemibody field external radiation therapy in a preceding period of 6 weeks.
Slovenian: • če ste alergični na etilen-diamin-tetrametilen-fosfonsko kislino (EDTMP) ali fosfonatom podobne sestavine ali katero koli drugo sestavino tega zdravila (seznam sestavin je naveden v poglavju 6),
English: Each vial contains 1.5 ml (2 GBq at reference) to 3.1 ml (4 GBq at reference) of solution for injection.
Slovenian: Ena viala vsebuje 1,5 ml (2 GBq na referenčni datum) do 3,1 ml (4 GBq na referenčni datum) raztopine za injiciranje.
English: Bladder catheterisation should be undertaken in patients with urinary obstruction.
Slovenian: Pri bolnikih z boleznimi sečil je potrebna kateterizacija mehurja.
English: 1 day from the activity reference time stated on the label.
Slovenian: 1 dan od datuma kalibracije, navedenega na ovojnini.
English: Gallbladder Ascending colon wall Descending colon wall Small intestine Myocardial wall Kidneys
Slovenian: jajčniki jetra koža ledvice maternica mišice možgani nadledvične žleze pljuča površina kosti prsni koš rdeči kostni mozeg ščitnica stena ascendentnega kolona 0,005 stena descendentnega kolona stena sečnega mehurja stena miokarda tanko črevo testisi timus trebušna slinavka vranica želodec žolčnik
English: Each ml of solution contains 1.3 GBq Samarium (153Sm) lexidronam pentasodium at the reference date
Slovenian: En ml raztopine vsebuje 1,3 GBq (153Sm)samarij-leksidronam, pentanatrijeve soli, na referenčni datum
English: Radiation dose to the body can be limited by promoting a diuresis and frequent voiding of urine.
Slovenian: Prejeto dozo sevanja lahko omejimo s pospešeno diurezo in pogostim odvajanjem seča.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Quadramet 1.3 GBq/mL solution for injection Samarium (153Sm) lexidronam pentasodium
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Quadramet 1,3 GBq/ml raztopina za injiciranje (153Sm)samarij-leksidronam, pentanatrijeva sol Za intravensko uporabo
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting etc.
Slovenian: Aplikacija radiofarmakov predstavlja tveganje izpostavljenosti sevanju drugih oseb ali kontaminaciji zaradi razlitja urina, bruhanja ipd. Zaradi tega morate upoštevati nacionalne predpise glede previdnostnih ukrepov za zaščito pred ionizirajočimi sevanji.
English: Solution for injection in a single-dose vial.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Raztopina za injiciranje v enoodmerni viali.
English: The other ingredients are total EDTMP (as EDTMP.H2O), calcium-EDTMP sodium salt (as Ca), total sodium (as Na), water for injections.
Slovenian: Pomožne snovi so skupni EDTMP (v obliki EDTMP.H2O), kalcij-EDTMP natrijeva sol (v obliki Ca), skupni natrij (kot Na), voda za injekcije
English: Quadramet 1.3 GBq/mL solution for injection
Slovenian: Quadramet 1,3 GBq/ml raztopina za injiciranje
English: ATC Code: V10BX02
Slovenian: Farmakoterapevtska skupina: razni radioterapevtiki za lajšanje bolečin, Oznaka ATC: V10BX02
English: Total EDTMP (as EDTMP.H2O) Calcium-EDTMP sodium salt (as Ca) Total sodium (as Na) Water for injections
Slovenian: Skupni EDTMP (v obliki EDTMP.H2O) Kalcij-EDTMP natrijeva sol (v obliki Ca) Skupni natrij (kot Na) Voda za injekcije
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1.3 GBq Samarium (153Sm) lexidronam pentasodium at the reference date (corresponding to 20 to 80 µg/ml of samarium per vial) Samarium specific activity is approximately 16 - 65 MBq/µg of samarium.
Slovenian: En ml raztopine vsebuje 1,3 GBq (153Sm)samarij-leksidronam, pentanatrijeve soli, na referenčni datum (ustreza 20 do 80 µg/ml samarija na vialo)
English: NAME OF THE MEDICINAL PRODUCT Quadramet 1.3 GBq/mL solution for injection.
Slovenian: IME ZDRAVILA Quadramet 1,3 GBq/ml raztopina za injiciranje
English: How to store Quadramet
Slovenian: Shranjevanje zdravila Quadramet
English: The active substance is samarium (153Sm) lexidronam pentasodium.
Slovenian: Zdravilna učinkovina je (153Sm)samarij-leksidronam, pentanatrijeva sol.
English: Tc)-labelled biphosphonates on bone scan.
Slovenian: (99mTc) označene bifosfonate.
English: Verification of the dose to be administered and patient identification are necessary prior to administration of Quadramet.
Slovenian: Pred aplikacijo zdravila Quadramet morate verificirati odmerek in identificirati bolnika.
English: Total EDTMP (as EDTMP.H2O) Calcium-EDTMP sodium salt (as Ca) Total sodium (as Na) Water for Injections
Slovenian: SEZNAM POMOŽNIH SNOVI skupni EDTMP (v obliki EDTMP.H2O) kalcij-EDTMP natrijeva sol (v obliki Ca) skupni natrij (kot Na) voda za injekcije
English: Method and route of administration Quadramet is to be administered by slow injection into a vein.
Slovenian: Quadramet se injicira počasi v veno.
English: Please refer to the SmPC (SmPC should be included in the box)
Slovenian: Glejte Povzetek glavnih značilnosti zdravila (Povzetek glavnih značilnosti zdravila naj bi bil vključen v škatlo).
English: Samarium (153Sm) lexidronam pentasodium.
Slovenian: (153Sm)samarij-leksidronam, pentanatrijeva sol
English: Decreases in white blood cell and platelet counts and anaemia were observed in patients receiving Quadramet.
Slovenian: Pri bolnikih, ki so prejemali Quadramet, so opazili zmanjšanje števila levkocitov in trombocitov ter pojav anemije.
English: 1.3 GBq/ml at reference date.
Slovenian: Quadramet 1,3 GBq/ml raztopina za injiciranje.
English: Liver
Slovenian: Sevanje
English: Repaglinide Accord is taken before meals, normally up to 15 minutes before each main meal.
Slovenian: Zdravilo Repaglinid Accord se jemlje pred obroki, običajno največ 15 minut pred vsakim glavnim obrokom.
English: It is available as round tablets (0.5 mg, 1 mg and 2 mg).
Slovenian: Na voljo je v obliki okroglih tablet (0,5 mg, 1 mg in 2 mg).
English: Repaglinide Accord is not recommended for patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.
Slovenian: Uporaba zdravila Repaglinid Accord pri bolnikih, mlajših od 18 let, zaradi pomanjkanja informacij o varnosti in učinkovitosti v tej starostni skupini ni priporočljiva.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Repaglinide Accord on 22 December 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Repaglinid Accord, veljavno po vsej Evropski uniji, odobrila dne 22. decembra 2011.
English: This means that Repaglinide Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called NovoNorm.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu NovoNorm.
English: The full EPAR for Repaglinide Accord 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 Repaglinid Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: For more information about treatment with Repaglinide Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Repaglinid Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: EPAR summary for the public repaglinide
Slovenian: Povzetek EPAR za javnost repaglinid
English: What are the benefits and risks of Repaglinide Accord?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Repaglinid Accord?
English: Other information about Repaglinide Accord
Slovenian: Druge informacije o zdravilu Repaglinid Accord
English: This is a summary of the European public assessment report (EPAR) for Repaglinide Accord.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Repaglinid Accord.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Repaglinide Accord.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Repaglinid Accord, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Repaglinide Accord is a ‘generic medicine'.
Slovenian: Zdravilo Repaglinid Accord je „generično zdravilo“.
English: Because Repaglinide Accord 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 Repaglinid Accord generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The CHMP concluded that, in accordance with EU requirements, Repaglinide Accord has been shown to have comparable quality and to be bioequivalent to the reference medicine.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Repaglinid Accord primerljivo raven kakovosti kot referenčno zdravilo ter da mu je biološko enakovredno.
English: Repaglinide Accord is a medicine that contains the active substance repaglinide.
Slovenian: Repaglinid Accord je zdravilo, ki vsebuje zdravilno učinkovino repaglinid.
English: A doctor should regularly test the patient's blood glucose to find the lowest effective dose.
Slovenian: krvi mora zdravnik redno preverjati, da določi najmanjši učinkoviti odmerek.
English: Repaglinide Accord is used in patients who have type 2 diabetes (non-insulin-dependent diabetes).
Slovenian: Zdravilo Repaglinid Accord se uporablja pri bolnikih s sladkorno boleznijo tipa 2 (sladkorno boleznijo, ki ni odvisna od insulina).
English: Because Repaglinide Accord is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine.
Slovenian: Ker je zdravilo Repaglinid Accord generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu.
English: The Committee recommended that Repaglinide Accord be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Repaglinid Accord dobri dovoljenje za promet.
English: Page 2/2
Slovenian: Raven bolnikove glukoze v stran 2/2
English: Repaglinide Accord helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Slovenian: Zdravilo Repaglinid Accord spodbuja trebušno slinavko, da v času obroka tvori več insulina, zato se uporablja za nadzor sladkorne bolezni tipa 2.
English: Repaglinide Accord may also be used with metformin (another anti-diabetes medicine) in type 2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.
Slovenian: Zdravilo Repaglinid Accord se lahko uporablja tudi z metforminom (drugim zdravilom za sladkorno bolezen) pri bolnikih s sladkorno boleznijo tipa 2, pri katerih samo z metforminom ne moremo zadovoljivo nadzorovati ravni glukoze v krvi.
English: Why has Repaglinide Accord been approved?
Slovenian: Zakaj je bilo zdravilo Repaglinid Accord odobreno?
English: What is Repaglinide Accord?
Slovenian: Kaj je zdravilo Repaglinid Accord?
English: How has Repaglinide Accord been studied?
Slovenian: Kako je bilo zdravilo Repaglinid Accord raziskano?
English: What is Repaglinide Accord used for?
Slovenian: Za kaj se zdravilo Repaglinid Accord uporablja?
English: blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.
Slovenian: Zdravilo Repaglinid Accord se lahko uporablja tudi pri bolnikih s sladkorno boleznijo tipa 2, pri katerih so ravni glukoze v krvi po navadi dobro nadzorovane z dieto, vendar doživljajo obdobja prehodne izgube nadzora.
English: How is Repaglinide Accord used?
Slovenian: Kako se zdravilo Repaglinid Accord uporablja?
English: How does Repaglinide Accord work?
Slovenian: Kako zdravilo Repaglinid Accord deluje?
English: 1 produced in E. coli cells by recombinant DNA technology 2 adsorbed on aluminium hydroxide (0.5 mg Al3+)
Slovenian: 1 izdelano v celicah E. coli s tehnologijo rekombinantne DNA 2 adsorbirano na aluminijev hidroksid (0,5 mg Al3+)
English: 3 NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A), fHbp (factor H binding protein)
Slovenian: 3 NHBA (Neisserial heparin vezavni antigen), NadA (Neisseria adhezin A), fHbp (faktor H vezavna beljakovina)
English: --1 One dose (0.5 ml) contains: Recombinant Neisseria meningitidis group B NHBA fusion protein 1, 2, 3
Slovenian: --1 En odmerek (0,5 ml) vsebuje: rekombinantna fuzijska beljakovina NHBA iz Neisseria meningitidis skupine B 1, 2, 3
English: Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4 2
Slovenian: sev NZ98/254, izmerjen kot količina skupnih beljakovin, ki vsebuje PorA P1.4 2
English: Recombinant Neisseria meningitidis group B NadA protein 1, 2, 3
Slovenian: rekombinantna beljakovina NadA iz Neisseria meningitidis skupine B 1, 2, 3
English: Recombinant Neisseria meningitidis group B fHbp fusion protein 1, 2, 3
Slovenian: rekombinantna fuzijska beljakovina fHbp iz Neisseria meningitidis skupine B 1, 2, 3
English: 10 pre-filled syringes without needles
Slovenian: 10 napolnjenih injekcijskih brizg brez igel
English: 10 pre-filled syringes with needles
Slovenian: 10 napolnjenih injekcijskih brizg z iglami
English: 1 pre-filled syringe without needles
Slovenian: 1 napolnjena injekcijska brizga brez igel
English: 1 pre-filled syringe with needles
Slovenian: 1 napolnjena injekcijska brizga z iglami
English: The name of the medicine was changed to Granupas on 15 May 2014.
Slovenian: Ime zdravila je bilo 15. maja 2014 spremenjeno v Granupas.
English: They should be given a total of 150 mg per kilogram body weight every day, split into two doses.
Slovenian: Prejeti morajo skupno 150 mg na kilogram telesne mase vsak dan, razdeljeno na dva odmerka.
English: The first of these involved 166 patients with tuberculosis aged between 15 to 30 years.
Slovenian: V prvo študijo je bilo vključenih 166 bolnikov s tuberkulozo, starih od 15 do 30 let.
English: In children and adolescents, the daily dose depends on their weight.
Slovenian: Pri otrocih in mladostnikih je dnevni odmerek odvisen od njihove telesne mase.
English: What measures are being taken to ensure the safe and effective use of Granupas?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Granupas?
English: This is a summary of the European public assessment report (EPAR) for Granupas.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Granupas.
English: Other information about Granupas
Slovenian: Druge informacije o zdravilu Granupas
English: PAS has been used for many years in the EU for the combination treatment of tuberculosis.
Slovenian: Para-aminosalicilna kislina se v EU že več let uporablja za kombinirano zdravljenje tuberkuloze.
English: The most common side effects with Granupas (which may affect up to 1 in 10 people) are abdominal pain (stomach ache), vomiting, nausea, bloating, diarrhoea and soft stools, giddiness, disturbance in gait and balance, and allergic skin reactions and rash.
Slovenian: Najpogostejši neželeni učinki zdravila Granupas (ki se lahko pojavijo pri največ 1 bolniku od 10) so bolečine v trebuhu (želodcu), bruhanje, slabost, napenjanje, driska in mehko blato, vrtoglavica, motnje hoje in ravnotežja ter alergijske kožne reakcije in izpuščaji.
English: Granupas must not be taken by patients with severely reduced kidney function.
Slovenian: Zdravila Granupas ne smejo uporabljati bolniki z močno zmanjšanim delovanjem ledvic.
English: A dosing spoon is used to measure small doses for young children.
Slovenian: Za odmerjanje manjših odmerkov za majhne otroke se uporablja merilna žlička.
English: A risk management plan has been developed to ensure that Granupas is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Granupas je bil pripravljen načrt obvladovanja tveganj.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Granupas can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote za zdravilo Granupas je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.