FrancophonIA/ELRC3.0 huggingface dataset:
English: 50 mg tablets:
Croatian: Tablete od 50 mg:
English: • tingling or numbness of the hands or feet
Croatian: • oticanje potkoljenica i stopala
English: Three multicentre, randomized, double-blind, placebo-controlled studies in a total of 1239 adult patients have been conducted to assess the efficacy of retigabine as adjunctive therapy of partial onset seizures, with or without secondary generalisation.
Croatian: Kako bi se procijenila djelotvornost retigabina kao dodatne terapije kod parcijalnih napadaja s ili bez sekundarne generalizacije, provedena su tri multicentrična, randomizirana, dvostruko slijepa ispitivanja kontrolirana placebom na ukupno 1239 odrasla bolesnika.
English: You must look out for certain symptoms while you are taking Trobalt, to reduce the risk of any problems.
Croatian: Kako biste umanjili rizik od mogućih problema, morate pripaziti na određene simptome tijekom uzimanja lijeka Trobalt.
English: 6.6 Special precautions for disposal No special requirements.
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Lijek ne zahtjeva posebne uvjete čuvanja.
English: Summary of percentage changes in 28-day total partial seizure frequency and responder rates
Croatian: Sažetak postotka promjene ukupnog broja parcijalnih napadaja tijekom 28 dana i stope bolesnika s odgovorom
English: A reduction in the initial and maintenance dose of Trobalt is recommended in elderly patients.
Croatian: preporučuje se smanjenje početne doze i doze održavanja lijeka Trobalt za 50%.
English: Packs containing 21or 84 film-coated tablets.
Croatian: Pakiranje sadrži 21 ili 84 filmom obložene tablete.
English: The retigabine AUC was increased by approximately 50% in volunteers with moderate hepatic impairment (Child-Pugh score 7 to 9) and by approximately 100% in volunteers with severe hepatic impairment (Child-Pugh score >9), relative to healthy volunteers.
Croatian: U usporedbi sa zdravim dobrovoljcima, AUC retigabina je bio povišen za oko 50% u dobrovoljaca s umjerenim oštećenjem jetre (Child-Pugh zbroj bodova 7 do 9), te za oko 100% u dobrovoljaca s teškim oštećenjem jetre
English: The total daily starting dose is 150 mg/day and during the titration period the total daily dose should be increased by a maximum of 150 mg every week, according to the individual patient response and tolerability.
Croatian: Ukupna dnevna početna doza je 150 mg/dan, te se tijekom titracijskog razdoblja prema individualnom terapijskom odgovoru i podnošljivosti bolesnika treba povisiti svakog tjedna za najviše 150 mg.
English: Laboratoire GlaxoSmithKline Tél.
Croatian: Magyarország GlaxoSmithKline Kft.
English: Don't stop taking Trobalt without advice Take Trobalt for as long as your doctor recommends.
Croatian: Uzimajte Trobalt onoliko dugo koliko Vam je liječnik preporučio.
English: Pigment changes (discolouration) of ocular tissues, including the retina have been reported in longterm clinical studies with retigabine, sometimes but not always in conjunction with pigment changes of the skin, lips or nails (see below paragraph and section 4.8).
Croatian: Tijekom dugoročnih kliničkih ispitivanja s retigabinom prijavljene su promjene pigmentacije u tkivima oka (diskoloracija) koje uključuju i promjene na mrežnici, a ponekad su, ali ne i uvijek, bile praćene promjenama pigmentacije kože, usana ili noktiju (vidjeti sljedeći odlomak i dio 4.8).
English: Purple, round, film-coated tablets of 5.6 mm, marked with “RTG 50” on one side.
Croatian: Ljubičaste, okrugle, filmom obložene tablete promjera 5,6 mm, s oznakom "RTG 50" na jednoj strani.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Trobalt in paediatric patients aged 0 to below 2 years with Lennox Gastaut Syndrome (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Trobalt u pedijatrijskih bolesnika od 0 do 2 godine s Lennox Gastaut sindromom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: All patients should undergo comprehensive ophthalmological examinations at baseline and at least every six months, which should include visual acuity, slit-lamp examination, dilated fundus photography, and macular OCT imaging.
Croatian: Svim bolesnicima potrebno je provesti sveobuhvatan oftalmološki pregled na početku liječenja i zatim barem svakih šest mjeseci, koji mora uključivati ispitivanje vidne oštrine, pregled slit lampom, fotografiju fundusa s dilatacijom i optički koherentnu tomografiju (OCT) makule.
English: No dose adjustment is required in patients with mild renal impairment (creatinine clearance 50 to 80 ml/min; see section 5.2).
Croatian: U bolesnika s umjerenim ili teškim oštećenjem bubrega (klirens kreatinina <50 ml/min; vidjeti dio 5.2)
English: Each pack contains blisters of 21or 84 film-coated tablets.
Croatian: Jedno pakiranje sadrži blistere s 21 ili 84 filmom obložene tablete.
English: Pigment changes (discolouration) of the skin, lips or nails have been reported in long-term clinical studies with retigabine, sometimes but not always in conjunction with pigment changes of ocular tissues (see above paragraph and section 4.8).
Croatian: Tijekom dugoročnih kliničkih ispitivanja s retigabinom prijavljene su promjene pigmentacije (diskoloracija) kože, usana ili noktiju, ponekad, ali ne i uvijek, praćene pigmentnim promjenama u tkivima oka, (vidjeti prethodni odlomak i dio 4.8).
English: 200 mg tablets:
Croatian: Tablete od 200 mg:
English: Study 205 (n=396; n=303)
Croatian: Ispitivanje 205 (n=396; n=303) Ukupni broj parcijalnih napadaja (medijan) % promjene
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojavu možete prijaviti izravno putem nacionalnog sustava za prijavu navedenog u Dodatku V.
English: Tel: + 386 (0)1 280 25 00 medical.x.si@gsk.com
Croatian: GlaxoSmithKline d.o.o. Tel: + 386 (0)1 280 25 00 medical.x.si@gsk.com
English: The primary efficacy endpoints were: - percentage change in the 28-day total partial seizure frequency from baseline to the double-blind phase (titration and maintenance phases combined) in all three studies - responder rate (defined as the percentage of patients with a ≥50% reduction in 28-day total partial seizure frequency) from baseline to the maintenance phase (Studies 301 and 302 only).
Croatian: • postotak promjene ukupnog broja parcijalnih napadaja tijekom 28 dana od početnog razdoblja do dvostruko-slijepe faze (kombinirane faze titracije i održavanja) u sva tri ispitivanja
English: 400 mg tablets:
Croatian: Tablete od 400 mg:
English: Green, round, film-coated tablets of 7.1 mm, marked with “RTG 100” on one side.
Croatian: Zelene, okrugle, filmom obložene tablete promjera 7,1 mm, s oznakom "RTG 100" na jednoj strani.
English: In a single-dose study, there were no clinically significant effects on retigabine AUC in volunteers with mild hepatic impairment (Child-Pugh score 5 to 6).
Croatian: U ispitivanju jednokratne doze na dobrovoljcima s blagim oštećenjem jetre (Child-Pugh zbroj bodova 5 do 6) nisu uočene klinički značajne promjene AUC-a retigabina.
English: If at any time you have these thoughts,
Croatian: Ako Vam se u bilo kojem trenutku pojave takve misli, odmah obavijestite svog liječnika.
English: Polyvinyl alcohol Titanium dioxide (E171) Talc (E553b) Iron oxide yellow (E172).
Croatian: Tablete od 200 mg: poli(vinilni alkohol) titanijev dioksid (E171) talk (E553b) željezov oksid, žuti (E172) sojin lecitin ksantanska guma
English: INFORMATION IN BRAILLE trobalt 50 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU trobalt 50 mg
English: GROUDS FOR ONE ADDITIONAL RENEWAL
Croatian: TEMELJI ZA JEDNU DODATNU OBNOVU ODOBRENJA ZA STAVLJANJE LIJEKA U
English: − The need to inform patients that TROBALT may cause pigment changes in ocular tissues, including the retina, and also in the skin, lips and/or nails, as well as a distinct form of macular abnormality with features of vitelliform maculopathy;
Croatian: halucinacije i psihotične poremećaje te potreba za odgovarajućim titriranjem doze radi minimaliziranja tih rizika. - potreba informiranja bolesnika da TROBALT može uzrokovati promjene pigmentacije u tkivima oka (diskoloracija) koje uključuju i promjene na mrežnici, te također promjene pigmentacije (diskoloracija) kože, usana ili noktiju te poseban oblik makularnog poremećaja sa značajkama viteliformne makulopatije; - potreba za sveobuhvatan oftalmološki pregled koji uključuje ispitivanje oštrine vida,
English: 4.9 Overdose
Croatian: 4.9 Predoziranje Simptomi i znakovi
English: Tell your doctor immediately if you get any of these symptoms.
Croatian: Ako dobijete bilo koji od ovih simptoma, odmah obavijestite svog liječnika.
English: Trobalt 100 mg film-coated tablets are green, round and marked “RTG 100” on one side.
Croatian: Trobalt filmom obložene tablete od 100 mg su zelene, okrugle sa oznakom “RTG 100” na jednoj strani.
English: Uncommon side effects These may affect up to 1 in 100 people:
Croatian: Mogu se javiti u do 1 na 100 osoba:
English: Withdrawal seizures
Croatian: Prijavljivanje nuspojava
English: Multipack: 168 (2 packs of 84) film-coated tablets
Croatian: OBLIK I SADRŽAJ Višestruko pakiranje: 168 (2 pakiranja po 84) filmom obloženih tableta
English: Purple, oblong, film-coated tablets of 8.1 mm x 18 mm, marked with “RTG-400” on one side.
Croatian: Ljubičaste, duguljaste, filmom obložene tablete dimenzija 8,1 mm x 18 mm, s oznakom "RTG-400" na jednoj strani.
English: Trobalt 200 mg film-coated tablets are yellow, oblong and marked “RTG-200” on one side.
Croatian: Trobalt filmom obložene tablete od 200 mg su žute, duguljaste sa oznakom “RTG-200” na jednoj strani.
English: In a single-dose study, retigabine was eliminated more slowly by healthy elderly volunteers (66 to 82 years of age) relative to healthy young adult volunteers, resulting in a higher AUC (approximately 40 to 50%) and longer terminal half-life (30%) (see section 4.2).
Croatian: U ispitivanju jednokratne doze retigabin se u starijih zdravih dobrovoljaca (od 66 do 82 godine), u usporedbi sa zdravim mlađim dobrovoljcima, izlučivao sporije što je rezultiralo višim AUC-om (oko
English: If you have kidney or liver problems, your doctor may give you a reduced dose of Trobalt.
Croatian: Liječnik Vam može dati manju dozu lijeka Trobalt ako imate problema s bubrezima ili jetrom.
English: Each tablet contains 50 mg retigabine
Croatian: Svaka tableta sadrži 50 mg retigabina
English: GlaxoSmithKline d.o.o.
Croatian: GlaxoSmithKline S.p.A.
English: Yellow, oblong, film-coated tablets of 7.1 mm x 14 mm, marked with “RTG-200” on one side.
Croatian: Žute, duguljaste, filmom obložene tablete dimenzija 7,1 mm x 14 mm s oznakom "RTG 200" na jednoj strani.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Trobalt in paediatric patients aged 2 to below 18 years with Lennox Gastaut Syndrome, and in paediatric patients aged 0 to below 18 years with partial onset seizures (see section 4.2 for information on paediatric use) .
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Trobalt u pedijatrijskih bolesnika starosti od 2 do 18 godina s Lennox Gastaut sindromom, te u pedijatrijskih bolesnika od 0 do 18 godina s parcijalnim napadajima (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Green, oblong, film-coated tablets of 7.1 mm x 16 mm, marked with “RTG-300” on one side.
Croatian: Zelene, duguljaste, filmom obložene tablete dimenzija 7,1 mm x 16 mm, s oznakom "RTG-300" na jednoj strani.
English: INFORMATION IN BRAILLE trobalt 200 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU trobalt 200 mg
English: 300 mg tablets:
Croatian: Tablete od 300 mg: :
English: Total partial seizure frequency (median) % change -18% ~ Responder rate
Croatian: Ispitivanje 301 (n=305; n=256) Ukupni broj parcijalnih napadaja (medijan) % promjene
English: Trobalt can affect the results of some tests.
Croatian: Ako trebate obaviti pretrage krvi ili urina Trobalt može utjecati na rezultate nekih pretraga.
English: Trobalt is for oral use.
Croatian: Trobalt se uzima kroz usta.
English: Each tablet contains 200 mg retigabine
Croatian: Svaka tableta sadrži 200 mg retigabina
English: Trobalt 300 mg film-coated tablets are green, oblong and marked “RTG-300” on one side.
Croatian: Trobalt filmom obložene tablete od 300 mg su zelene, duguljaste sa oznakom “RTG-300” na jednoj strani.
English: : + 33 (0)1 39 17 84 44 diam@gsk.com
Croatian: Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44 diam@gsk.com
English: INFORMATION IN BRAILLE trobalt 400 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU trobalt 400 mg
English: The doctor will weigh up the benefit to you against any risk to your baby of taking Trobalt while you are pregnant.
Croatian: Trobalt za vrijeme trudnoće u usporedbi s bilo kojim rizikom za Vaše dijete.
English: A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe renal impairment (creatinine clearance <50 ml/min; see section 5.2).
Croatian: U bolesnika s umjerenim ili teškim oštećenjem bubrega (klirens kreatinina <50 ml/min; vidjeti dio 5.2) preporučuje se smanjenje početne doze i doze održavanja lijeka Trobalt za 50%.
English: Dysphagia
Croatian: Dojenje
English: Trobalt 400 mg film-coated tablets are purple, oblong and marked “RTG-400” on one side.
Croatian: Trobalt filmom obložene tablete od 400 mg su ljubičaste, duguljaste sa oznakom “RTG-400” na jednoj strani.
English: België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.
Croatian: België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. Tél/Tel: + 32 (0)10 85 52 00
English: Carmine (E120).
Croatian: mg na dan).
English: Read the package leaflet before use Oral use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku
English: INFORMATION IN BRAILLE trobalt 300 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU trobalt 300 mg
English: GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com
Croatian: KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com
English: INFORMATION IN BRAILLE trobalt 100 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU trobalt 100 mg
English: A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe hepatic impairment (Child-Pugh score ≥7; see section 5.2).
Croatian: U bolesnika s umjerenim ili teškim oštećenjem jetre (Child-Pugh zbroj bodova ≥7; vidjeti dio 5.2)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/011, EU/1/11/681/012
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/681/011, EU/1/11/681/012
English: The steady state volume of distribution of retigabine is 2 to 3 l/kg following intravenous dosing.
Croatian: Nakon intravenskog doziranja volumen distribucije retigabina u stanju dinamičke ravnoteže je 2 do 3
English: Each tablet contains 300 mg retigabine
Croatian: Svaka tableta sadrži 300 mg retigabina
English: Each tablet contains 400 mg retigabine
Croatian: Svaka tableta sadrži 400 mg retigabina
English: Peripheral oedema
Croatian: • kožni osip
English: Tel: + 420 222 001 111 cz.info@gsk.com
Croatian: GlaxoSmithKline s.r.o. Tel: + 420 222 001 111 cz.info@gsk.com
English: Tell the doctor that you are taking Trobalt, well in advance.
Croatian: Ako trebate imati operaciju u općoj anesteziji: Znatno unaprijed obavijestite svog liječnika da uzimate Trobalt.
English: Each tablet contains 100 mg retigabine
Croatian: Svaka tableta sadrži 100 mg retigabina
English: NAME OF THE MEDICINAL PRODUCT Trobalt 50 mg film-coated tablets
Croatian: NAZIV LIJEKA Trobalt 50 mg filmom obložene tablete
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/009, EU/1/11/681/010
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/681/009, EU/1/11/681/010
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of retigabine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka filmom obložena tableta sadrži 300 mg retigabina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/004, EU/1/11/681/005
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/681/004, EU/1/11/681/005
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of retigabine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka filmom obložena tableta sadrži 50 mg retigabina.
English: NAME OF THE MEDICINAL PRODUCT Trobalt 300 mg film-coated tablets
Croatian: NAZIV LIJEKA Trobalt 300 mg filmom obložene tablete
English: NAME OF THE MEDICINAL PRODUCT Trobalt 400 mg film-coated tablets
Croatian: NAZIV LIJEKA Trobalt 400 mg filmom obložene tablete
English: Slovenská republika GlaxoSmithKline Slovakia s. r. o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
Croatian: Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
English: NAME OF THE MEDICINAL PRODUCT Trobalt 200 mg film-coated tablets
Croatian: NAZIV LIJEKA Trobalt 200 mg filmom obložene tablete
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg of retigabine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka filmom obložena tableta sadrži 400 mg retigabina.
English: NAME OF THE MEDICINAL PRODUCT Trobalt 100 mg film-coated tablets
Croatian: NAZIV LIJEKA Trobalt 100 mg filmom obložene tablete
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of retigabine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka filmom obložena tableta sadrži 200 mg retigabina.
English: • tremors
Croatian: • omaglica
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of retigabine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka filmom obložena tableta sadrži 100 mg retigabina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/001, EU/1/11/681/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/681/001, EU/1/11/681/002
English: Adverse reactions such as dizziness, somnolence, diplopia and blurred vision were reported in controlled clinical studies, particularly during titration (see section 4.8).
Croatian: U kontroliranim kliničkim ispitivanjima, osobito tijekom titracije (vidjeti dio 4.8), zabilježene su nuspojave poput omaglice, somnolencije, diplopije i zamućenja vida.
English: Magnesium stearate
Croatian: Česte nuspojave
English: Magyarország GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
Croatian: GlaxoSmithKline d.o.o. Tel: + 385 1 6051999
English: Risk related to antiepileptic medicinal products in general Specialist advice should be given to women who are of childbearing potential.
Croatian: Žene koje mogu imati djecu treba savjetovati specijalist.
English: 21 film-coated tablets 84 film-coated tablets
Croatian: OBLIK I SADRŽAJ 21 filmom obložena tableta
English: It is recommended that the Trobalt dose is reduced over a period of at least 3 weeks, unless safety concerns require an abrupt withdrawal (see section 4.2).
Croatian: osim u slučaju kada je nagli prekid nužan zbog sigurnosnih razloga (vidjeti dio 4.2).
English: What Trobalt looks like and contents of the pack Trobalt 50 mg film-coated tablets are purple, round and marked “RTG 50” on one side.
Croatian: Trobalt filmom obložene tablete od 50 mg su ljubičaste, okrugle s oznakom “RTG 50” na jednoj strani.
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Croatian: Tel: + 39 (0)45 9218 111
English: Hepatic impairment
Croatian: Tegobe s mokrenjem
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/007
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/681/007
English: NAME OF THE MEDICINAL PRODUCT Trobalt 300 mg film-coated tablets retigabine
Croatian: Trobalt 300 mg filmom obložene tablete retigabin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/008
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/681/008
English: NAME OF THE MEDICINAL PRODUCT Trobalt 50 mg film-coated tablets retigabine
Croatian: Trobalt 50 mg filmom obložene tablete retigabin
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane povećanje tjelesne težine povećani apetit
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/009
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/681/009
English: Balance disorder Memory impairment
Croatian: Poremećaji oka pigmentne promjene zamućenje vida stečena viteliformna makulopatija
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/010
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/681/010
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/011
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/681/011
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/012
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/681/012
English: An effective maintenance dose is expected to be between 600 mg/day and 1,200 mg/day.
Croatian: mg/dan i 1200 mg/dan.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/681/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/681/001
English: NAME OF THE MEDICINAL PRODUCT Trobalt 200 mg film-coated tablets retigabine
Croatian: Trobalt 200 mg filmom obložene tablete retigabin
English: --1 Porcine circovirus type 2 ORF2 subunit antigen ≥ 2828 AU* Mycoplasma hyopneumoniae inactivated
Croatian: --1 Porcin cirkovirzs tip 2 ORF2 subjedinica antigena ≥ 2828 AU* Mycoplasma hyopneumoniae inaktivirana
English: Invented name
Croatian: Izmišljeni naziv
English: ≥ 2.69 RPU** * Antigenic Units as determined in the in vitro potency test (ELISA).
Croatian: ≥ 2.69 RPU** * Jedinice antigena određene in vitro testom potencije (ELISA).
English: Packaging Content Package size
Croatian: Način primjene Pakovanje Sadržaj Veličina pakovanja
English: ** Relative Potency Unit defined against a reference vaccine
Croatian: ** Relativne jedinice potencije određene od refentnog cjepiva
English: Strength Pharmaceutical form
Croatian: Farmaceuts ki oblik
English: EU (MA) Number
Croatian: EU broj
English: Withdrawal period
Croatian: Jačina
English: Route of administration
Croatian: Karencija
English: Packaging
Croatian: Unutarnje pakovanje
English: Strength Pharmaceutical Form Route of Administration
Croatian: Medicinal product no longer authorised
English: Name
Croatian: Put primjene
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Croatian: To znači da, iako ne postoji dovoljno dokaza iz kliničkih ispitivanja, učinkovitost ovih biljnih lijekova je vjerojatna i postoje dokazi o njihovoj sigurnoj primjeni na opisani način već najmanje 30 godina (uključujući najmanje 15 godina u EU-u).
English: If symptoms last longer than two weeks during the use of the medicine a doctor or qualified healthcare practitioner should be consulted.
Croatian: Ako simptomi tijekom primjene lijeka traju dulje od dva tjedna, potrebno je obratiti se liječniku ili kvalificiranom zdravstvenom radniku.
English: 31 May 2016 EMA/269745/2016
Croatian: EMA/269745/2016
English: Sandy everlasting EMA/269745/2016
Croatian: Cvijet smilja EMA/269745/2016
English: Sandy everlasting is the common name for the flowers of the plant Helichrysum arenarium (L.) Moench.
Croatian: Cvijet smilja je uobičajen naziv za cvjetove biljke Helichrysum arenarium (L.) Moench.
English: At the time of the HMPC assessment, no side effects had been reported with these medicines.
Croatian: U vrijeme kad je HPMC provodio ocjenu, nisu prijavljene nikakve nuspojave prilikom primjene ovih lijekova.