FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 ml (200 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 80 mikrogramov darbepoetina alfa v 0,4 ml (200 µg/ml).
English: Package containing one or four pre-filled pens of a 100 µg Nespo solution for injection in 0.5 ml (200 µg/ml).
Slovenian: Pakiranje z eno ali štirimi napolnjenimi injekcijskimi brizgami, v katerih je raztopina za injiciranje Nespo s 100 µg Nespa v 0,5 ml (200 µg/ml).
English: NAME OF THE MEDICINAL PRODUCT Nespo 60 micrograms solution for injection in a pre-filled syringe.
Slovenian: IME ZDRAVILA Nespo 60 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/184/033
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/184/033
English: Package containing one or four pre-filled syringe(s) of a 50 µg Nespo solution for injection in 0.5 ml (100 µg/ml).
Slovenian: Pakiranje z eno ali štirimi napolnjenimi injekcijskimi brizgami, v katerih je raztopina za injiciranje Nespo z 50 µg Nespa v 0,5 ml (100 µg/ml).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 ml (500 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 150 mikrogramov darbepoetina alfa v 0,3 ml (500 µg/ml).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/184/038
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/184/038
English: Preclinical safety data
Slovenian: DRUGI PODATKI
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/184/039
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/184/039
English: Nespo 15 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Slovenian: Nespo 15 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Darbepoetin alfa
English: Nespo 20 µg Darbepoetin alfa IV/SC
Slovenian: Nespo 20 µg Darbepoetin alfa i.v./s.c.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/184/042
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/184/042
English: NAME OF THE MEDICINAL PRODUCT Nespo 10 micrograms solution for injection in a pre-filled syringe.
Slovenian: IME ZDRAVILA Nespo 10 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: Nespo 60 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Slovenian: Nespo 60 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Darbepoetin alfa
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/184/043
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/184/043
English: NAME OF THE MEDICINAL PRODUCT Nespo 20 micrograms solution for injection in a pre-filled syringe.
Slovenian: IME ZDRAVILA Nespo 20 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: Nespo 10 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Slovenian: Nespo 10 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Darbepoetin alfa
English: EU/1/01/184/047 1 pack EU/1/01/184/059 4 pack
Slovenian: EU/1/01/184/059 - pakiranje po 4
English: Nespo 80 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Slovenian: Nespo 80 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Darbepoetin alfa
English: NAME OF THE MEDICINAL PRODUCT Nespo 100 micrograms solution for injection in a pre-filled syringe.
Slovenian: IME ZDRAVILA Nespo 100 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: Nespo 100 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Slovenian: Nespo 100 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Darbepoetin alfa
English: Nespo 130 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Slovenian: Nespo 130 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Darbepoetin alfa
English: NAME OF THE MEDICINAL PRODUCT Nespo 300 micrograms solution for injection in a pre-filled syringe.
Slovenian: IME ZDRAVILA Nespo 300 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: Nespo 300 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Slovenian: Nespo 300 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Darbepoetin alfa
English: NAME OF THE MEDICINAL PRODUCT Nespo 50 micrograms solution for injection in a pre-filled syringe.
Slovenian: IME ZDRAVILA Nespo 50 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: Nespo 20 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Slovenian: Nespo 20 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Darbepoetin alfa
English: BLISTERED PRE-FILLED SYRINGE LABEL
Slovenian: NALEPKA NAPOLNJENE INJEKCIJSKE BRIZGE V PRETISNEM OMOTU
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 ml (200 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 100 mikrogramov darbepoetina alfa v 0,5 ml (200 µg/ml).
English: EU/1/01/184/048 1 pack EU/1/01/184/060 4 pack
Slovenian: EU/1/01/184/060 - pakiranje po 4
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/184/034
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/184/034
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 ml (100 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 50 mikrogramov darbepoetina alfa v 0,5 ml (100 µg/ml).
English: EU/1/01/184/045 1 pack EU/1/01/184/057 4 pack
Slovenian: EU/1/01/184/057 - pakiranje po 4
English: NAME OF THE MEDICINAL PRODUCT Nespo 30 micrograms solution for injection in a pre-filled syringe.
Slovenian: IME ZDRAVILA Nespo 30 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: Nespo 40 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Slovenian: Nespo 40 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Darbepoetin alfa
English: Nespo 30 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Slovenian: Nespo 30 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Darbepoetin alfa
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/184/041
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/184/041
English: EU/1/01/184/072 1 pack EU/1/01/184/073 4 pack
Slovenian: EU/1/01/184/073 - pakiranje po 4
English: NAME OF THE MEDICINAL PRODUCT Nespo 15 micrograms solution for injection in a pre-filled syringe.
Slovenian: IME ZDRAVILA Nespo 15 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: EU/1/01/184/027 1 pack EU/1/01/184/028 4 pack
Slovenian: EU/1/01/184/028 - pakiranje po 4
English: You can press a cotton ball or gauze over the injection site
Slovenian: Nanj lahko pritisnete s koščkom vate ali gaze.
English: EU/1/01/184/023 1 Pack EU/1/01/184/024 4 pack
Slovenian: EU/1/01/184/024 - pakiranje po 4
English: EU/1/01/184/050 1 pack EU/1/01/184/062 4 pack
Slovenian: EU/1/01/184/062 - pakiranje po 4
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 80 micrograms of darbepoetin alfa in 0.4 ml (200 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En napolnjeni injekcijski peresnik vsebuje 80 mikrogramov darbepoetina alfa v 0,4 ml (200 µg/ml).
English: EU/1/01/184/025 1 Pack EU/1/01/184/026 4 pack
Slovenian: EU/1/01/184/026 - pakiranje po 4
English: Nespo is used to treat symptomatic anaemia in adult cancer patients with non-bone marrow cancers (non-myeloid malignancies) who are receiving chemotherapy.
Slovenian: Nespo uporabljamo za zdravljenje simptomatske anemije pri odraslih bolnikih, ki imajo nemieloidnega
English: Not applicable.
Slovenian: Nespo si nikdar
English: NAME OF THE MEDICINAL PRODUCT Nespo 80 micrograms solution for injection in a pre-filled pen.
Slovenian: IME ZDRAVILA Nespo 80 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: EXP.:
Slovenian: do:".
English: EU/1/01/184/054 1 pack EU/1/01/184/066 4 pack
Slovenian: EU/1/01/184/066 - pakiranje po 4
English: EU/1/01/184/046 1 pack EU/1/01/184/058 4 pack
Slovenian: EU/1/01/184/058 - pakiranje po 4
English: EU/1/01/184/069 1 pack EU/1/01/184/070 4 pack
Slovenian: EU/1/01/184/067 - pakiranje po 4
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 40 micrograms of darbepoetin alfa in 0.4 ml (100 µg/ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En napolnjeni injekcijski peresnik vsebuje 40 mikrogramov darbepoetina alfa v 0,4 ml (100 µg/ml).
English: Nespo 10 µg Darbepoetin alfa IV/SC
Slovenian: Nespo 10 µg Darbepoetin alfa i.v./s.c.
English: NAME OF THE MEDICINAL PRODUCT Nespo 50 micrograms solution for injection in a pre-filled pen.
Slovenian: IME ZDRAVILA Nespo 50 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: NAME OF THE MEDICINAL PRODUCT Nespo 60 micrograms solution for injection in a pre-filled pen.
Slovenian: IME ZDRAVILA Nespo 60 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: NAME OF THE MEDICINAL PRODUCT Nespo 300 micrograms solution for injection in a pre-filled pen.
Slovenian: IME ZDRAVILA Nespo 300 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: EU/1/01/184/052 1 pack EU/1/01/184/064 4 pack
Slovenian: EU/1/01/184/064 - pakiranje po 4
English: NAME OF THE MEDICINAL PRODUCT Nespo 15 micrograms solution for injection in a pre-filled pen.
Slovenian: IME ZDRAVILA Nespo 15 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: EU/1/01/184/051 1 pack EU/1/01/184/063 4 pack
Slovenian: EU/1/01/184/063 - pakiranje po 4
English: NAME OF THE MEDICINAL PRODUCT Nespo 20 micrograms solution for injection in a pre-filled pen.
Slovenian: IME ZDRAVILA Nespo 20 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: NAME OF THE MEDICINAL PRODUCT Nespo 40 micrograms solution for injection in a pre-filled pen.
Slovenian: IME ZDRAVILA Nespo 40 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: NAME OF THE MEDICINAL PRODUCT Nespo 100 micrograms solution for injection in a pre-filled pen.
Slovenian: IME ZDRAVILA Nespo 100 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: EU/1/01/184/049 1 pack EU/1/01/184/061 4 pack
Slovenian: EU/1/01/184/061 - pakiranje po 4
English: NAME OF THE MEDICINAL PRODUCT Nespo 10 micrograms solution for injection in a pre-filled pen.
Slovenian: IME ZDRAVILA Nespo 10 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: NAME OF THE MEDICINAL PRODUCT Nespo 30 micrograms solution for injection in a pre-filled pen.
Slovenian: IME ZDRAVILA Nespo 30 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: ∅ Do not twist the grey needle cap ∅ Do not try to put the needle cap back onto the pre-filled pen
Slovenian: ∅ Ne poskušajte pokrovčka igle znova natakniti na napolnjeni injekcijski peresnik
English: Nespo 15 µg injection Darbepoetin alfa
Slovenian: Nespo 15 mikrogramov raztopina za injiciranje v viali Darbepoetin alfa
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.375 ml pre-filled syringe contains 15 micrograms darbepoetin alfa (40 micrograms/ml).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 0,375-ml napolnjena injekcijska brizga vsebuje 15 mikrogramov darbepoetina alfa
English: Each 0.3 ml pre-filled syringe contains30 micrograms darbepoetin alfa (100 micrograms/ml).
Slovenian: Ena 0,3-ml napolnjena injekcijska brizga vsebuje 30 mikrogramov darbepoetina alfa
English: EU/1/01/184/053 1 pack EU/1/01/184/065 4 pack
Slovenian: EU/1/01/184/065 - pakiranje po 4
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 ml (200 µg/ml).
Slovenian: En napolnjeni injekcijski peresnik vsebuje 130 mikrogramov darbepoetina alfa v 0,65 ml (200 µg/ml).
English: EU/1/01/184/056 1 pack EU/1/01/184/068 4 pack
Slovenian: EU/1/01/184/068 - pakiranje po 4
English: EU/1/01/184/013 1 pack EU/1/01/184/014 4 pack
Slovenian: EU/1/01/184/030 - pakiranje po 4
English: Nespo 130 micrograms solution for injection in a pre-filled pen Darbepoetin alfa
Slovenian: Nespo 130 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku Darbepoetin alfa
English: This section contains information on how to give yourself an injection of Nespo.
Slovenian: NAVODILA ZA INJICIRANJE Z NAPOLNJENO INJEKCIJSKO BRIZGO NESPA To poglavje obsega informacije o tem, kako si sami injicirate zdravilo Nespo.
English: Vascular disorders
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: Nespo 40 µg injection Darbepoetin alfa SC
Slovenian: Nespo 40 mikrogramov raztopina za injiciranje v viali Darbepoetin alfa
English: Medicinal product subject to medical prescription.
Slovenian: Farmakoterapevtska skupina: druga zdravila za zdravljenje slabokrvnosti.
English: Annex I List of medicinal products affected by the procedure
Slovenian: Seznam zdravil, ki so vključena v postopek
English: Fusafungine, 0.125 Mg/Dose
Slovenian: Latvija fuzafungin, 0,125 mg/odmerek Pršilo za nos/usta, raztopina
English: Luxembourg Servier Benelux N.V.-S.A.
Slovenian: Luksemburg Servier Benelux N.V.-S.A.
English: Belgium Servier Benelux N.V.-S.A.
Slovenian: Servier Benelux N.V.-S.A.
English: Bulgaria биопарокс Fusafungine 50mg/10 Ml
Slovenian: Bolgarija биопарокс
English: Date of first authorisation: 07 April 2014.
Slovenian: Datum prve odobritve: 07. april 2014.
English: • Drink straight away
Slovenian: • Takoj popijte.
English: Treatment should be stopped immediately in this case.
Slovenian: tem primeru je treba takoj prekiniti zdravljenje.
English: Date of latest renewal: 18 December 2018.
Slovenian: Datum zadnjega podaljšanja: 18. december 2018
English: Results from literature suggest the following:
Slovenian: Podatki iz literature kažejo naslednje:
English: It is especially important to tell your doctor if you are taking any of the following:
Slovenian: Še posebej pomembno je, da zdravniku poveste, če jemljete katero koli od naslednjih zdravil:
English: Use in infants, children and adolescents
Slovenian: Uporaba pri dojenčkih, otrocih in mladostnikih
English: • crystals in urine.
Slovenian: • kristali v urinu.
English: Other malformations were observed; however, the exact nature of these findings is unknown.
Slovenian: Opazili so tudi druge nepravilnosti, vendar pa dejanska narava teh ugotovitev ni znana.
English: Triglyceride absorption is always normal.
Slovenian: Absorpcija trigliceridov je vedno normalna.
English: • You may notice granules appearing in your stools; this is normal.
Slovenian: • Lahko se zgodi, da boste v blatu opazili zrnca; to je normalno.
English: 4 g (one sachet) three times per day.
Slovenian: 4 g (ena vrečica) trikrat na dan.
English: Wait until the next dose is due, then take your normal dose.
Slovenian: Počakajte, da bo čas za naslednji odmerek, in nato vzemite običajni odmerek.
English: • if you are infected with HIV
Slovenian: • če ste okuženi z virusom HIV.
English: • nerve damage in the hands and feet,
Slovenian: • okvara živcev na rokah in stopalih,
English: The recommended schedule is 4 g every 8 hours.
Slovenian: Priporočena shema odmerjanja je 4 g vsakih 8 ur.
English: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Slovenian: Pogostnost, vrste in resnost neželenih učinkov pri otrocih naj bi bile enake kot pri odraslih.
English: Limited pharmacokinetic data suggest no substantial difference between adults and children.
Slovenian: Omejeni farmakokinetični podatki kažejo, da med odraslimi in otroki ni bistvenih razlik.
English: • Antituberculosis medicines or ethionamide (other treatments against tuberculosis)
Slovenian: • protituberkulozna zdravila ali etionamid (druga zdravila proti tuberkulozi);
English: • disturbance of gait and equilibrium.
Slovenian: • motnje hoje in ravnotežja.
English: • If some granules are left in the glass, add some more juice and drink straight away.
Slovenian: • Če nekaj zrnc ostane v kozarcu, dodajte še malo soka in takoj popijte.
English: This daily amount is divided into two doses spread out through the day.
Slovenian: Dnevni odmerek se razdeli na dva odmerka, porazdeljena čez cel dan.
English: • red spots on the skin,
Slovenian: • rdeče pike na koži,
English: Not known side effects (frequency cannot be estimated from the available data): • Hepatitis.
Slovenian: Neželeni učinki z neznano pogostnostjo (ni mogoče oceniti iz razpoložljivih podatkov) • hepatitis
English: • Digoxin (for heart disease)
Slovenian: • digoksin (za bolezni srca);
English: The acetylation process is not genetically determined as is the case for isoniazid.
Slovenian: Postopek acetilacije ni genetsko določen tako kot pri izoniazidu.
English: Studies in animals have shown some reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: What GRANUPAS is and what it is used for
Slovenian: Kaj je zdravilo GRANUPAS in za kaj ga uporabljamo
English: • if you are allergic to para-aminosalicylic acid or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na para-aminosalicilno kislino ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: Maximum daily dose is 12 g. Usual duration of treatment is 24 months.
Slovenian: Največji dnevni odmerek je 12 g. Zdravljenje običajno traja 24 mesecev.
English: • reduced ability to absorb nutrients from food ulcer,
Slovenian: • zmanjšana sposobnost absorpcije hranil iz hrane,
English: The recommended total dose per day is 150 mg for each kg of body weight.
Slovenian: Priporočeni skupni dnevni odmerek je 150 mg na kilogram telesne mase.
English: Malabsorption syndrome
Slovenian: Malabsorpcijski sindrom
English: Each box contains 30 sachets.
Slovenian: Ena škatla vsebuje 30 vrečic.
English: It should be drunk at once ensuring that the granules are not left in the glass.
Slovenian: Mešanico je treba popiti naenkrat in pri tem paziti, da zrnca ne ostanejo v kozarcu.
English: In a single dose (4 grams) pharmacokinetic study in healthy adult volunteers (N=11) the initial time to a 2 µg/mL serum level of aminosalicylic acid was 2 hours with a range of 45 minutes to 24 hours; the median time to peak was 6 hours with a range of 1.5 to 24 hours; the mean peak level was 20 µg/mL with a range of 9 to 35µg/mL: a level of 2 µg/mL was maintained for an average of 8 hours with a range of 5 to 9.5 a level of 1 µg/mL was maintained for an average of 8.8 hours with a range of 6 to 11.5 hours.
Slovenian: V farmakokinetični študiji enkratnega odmerka (4 g) pri zdravih odraslih prostovoljcih (n = 11) je bil začetni čas do serumske koncentracije aminosalicilne kisline 2 µg/ml 2 uri z razponom od 45 minut do 24 ur; mediana časa do največje koncentracije je bila 6 ur z razponom od 1,5 ure do 24 ur; povprečna največja koncentracija je bila 20 µg/ml z razponom od 9 do 35 µg/ml: koncentracija 2 µg/ml se je v povprečju ohranila 8 ur z razponom od 5 ur do 9,5 ure, koncentracija 1 µg/ml pa se je v povprečju ohranila 8,8 ure z razponom od 6 ur do 11,5 ure.
English: The dose in infants, children and adolescents will be calculated by your doctor based on the patient's body weight.
Slovenian: Odmerek pri dojenčkih, otrocih in mladostnikih bo zdravnik izračunal glede na telesno maso bolnika.
English: The patient must be monitored carefully during the first three months of therapy and treatment must be discontinued immediately at the first sign of a rash, fever or other premonitory signs of intolerance.
Slovenian: Bolnika je treba natančno spremljati v prvih treh mesecih zdravljenja, ki ga je treba nemudoma prekiniti ob prvih znakih izpuščaja, vročine ali drugih zgodnjih znakih intolerance.
English: Use of GRANUPAS is not recommended in newborn babies (under 28 days of age).
Slovenian: Otroci Uporaba zdravila GRANUPAS ni priporočljiva pri novorojencih (mlajših od 28 dni).
English: If you experience any of these symptoms, you must contact to your doctor immediately.
Slovenian: Če opazite katerega koli od teh simptomov, se takoj posvetujte z zdravnikom.
English: • yellowing of skin or eyes (jaundice),
Slovenian: • porumenelost kože ali oči (zlatenica),
English: Together they constitute more than 90% of the total metabolites of PAS found in urine.
Slovenian: Skupaj tako predstavljata več kot 90 % vseh presnovkov para aminosalicilne kisline v urinu.
English: This is because small amounts of the medicine can pass into mother's milk.
Slovenian: Majhne količine zdravila se namreč lahko izločajo v materino mleko.
English: If a mild temperature rise or skin reaction develops, the increment is to be dropped back one level or the progression held for one cycle.
Slovenian: Če se pojavi rahlo zvišanje telesne temperature ali kožna reakcija, je treba odmerek zmanjšati za eno stopnjo nazaj ali pa ustaviti povečevanje odmerka za en ciklus.
English: The soft skeletons of the granules remain and may be seen in the stools.
Slovenian: Mehke lupinice zrnc se ohranijo in jih je mogoče opaziti v blatu.
English: There is no experience with overdose in humans.
Slovenian: Pri ljudeh ni izkušenj s prevelikim odmerjanjem.
English: Very rare Hypoglycemia.
Slovenian: zelo redki hipoglikemija
English: • prolonged bleeding time,
Slovenian: • podaljšan čas krvavitev,
English: In the event of overdose, it is recommended that the patient is monitored for any signs or symptoms of adverse reactions and that appropriate symptomatic treatment is instituted immediately.
Slovenian: V primeru prevelikega odmerjanja je priporočljivo spremljati bolnika glede znakov in simptomov neželenih učinkov in nemudoma uvesti simptomatsko zdravljenje.
English: Plasma protein binding is about 50 to 60%, the kinetic distribution has a half-life of 0.94 hours and a volume of distribution of 1.001 L/kg.
Slovenian: Vezava na plazemske beljakovine je približno 50 do 60-odstotna, kinetična porazdelitev ima razpolovno dobo 0,94 ure in volumen porazdelitve 1,001 l/kg.
English: The data available from a rat embryofoetal development study, where animals were given sodium aminosalicylate (3.85 to 385 mg/kg) were limited.
Slovenian: Podatki, ki so na voljo iz študije embriofetalnega razvoja, opravljene na podganah, ki so jim dajali natrijev aminosalicilat (od 3,85 do 385 mg/kg), so omejeni.
English: Under neutral conditions as are found in the small intestine or in neutral foods, the acid-resistant coating is dissolved within one minute.
Slovenian: V nevtralnih pogojih, kakršni so v tankem črevesu ali nevtralni hrani, se obloga, odporna proti kislinam, raztopi v eni minuti.
English: • Diphenylhydramine (for allergic reactions)
Slovenian: • difenilhidramin (za alergijske reakcije).
English: A dosing spoon is provided to measure small doses below 4 g for young children.
Slovenian: Za odmerjanje odmerkov, manjših od 4 g, namenjenih za majhne otroke, je priložena merilna žlička.
English: Reactions are rare after a total dosage of 1.5 g.
Slovenian: Reakcije po skupnem odmerku 1,5 g so redke.
English: to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnost je opredeljena takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: GRANUPAS can be taken with food.
Slovenian: Zdravilo GRANUPAS se lahko jemlje s hrano.
English: Any granules left-over at the bottom of the glass should be swallowed immediately by adding a small quantity of liquid.
Slovenian: Zrnca, ki ostanejo na dnu kozarca, je treba zaužiti takoj, potem ko se doda majhna količina tekočine.
English: • metallic taste,
Slovenian: • kovinski okus,