FrancophonIA/ELRC3.0 huggingface dataset:
English: Bottles of 100 or 500 hard capsules.
Slovenian: Steklenice, ki vsebujejo po 100 ali 500 trdih kapsul.
English: High doses of cysteamine impair the ability of lactating mothers to feed their pups.
Slovenian: Visoki odmerki cisteamina zmanjšujejo sposobnost samic, da v obdobju laktacije prehranjujejo svoje mladiče.
English: In some cases, these skin lesions were associated with vascular proliferation, skin striae and bone lesions first seen during an X-ray examination.
Slovenian: V nekaterih primerih so bile te kožne lezije povezane z vaskularno proliferacijo, kožnimi strijami in lezijami kosti, ki so jih najprej opazili pri rentgenskem slikanju.
English: Do not use CYSTAGON - if you -or your child- are allergic (hypersensitive) to cysteamine bitartrate or penicillamine or any of the other ingredients of Cystagon.
Slovenian: Ne uporabljajte zdravila CYSTAGON: - če ste sami ali če je vaš otrok alergičen na (preobčutljiv za) cisteaminijev bitartrat ali penicilamin ali katerokoli drugo sestavino zdravila CYSTAGON; - če ste noseči, to je še posebno pomembno v prvem trimesečju; - če dojite.
English: The leucocyte cystine level reaches its minimum (mean ( sd) value: 1.8  0.8 hours) slightly later than the peak plasma cysteamine concentration (mean ( sd) value: 1.4  0.4 hours) and returns to its baseline level as the plasma cysteamine concentration decreases at 6 hours post-dose.
Slovenian: Koncentracija cistina v levkocitih doseže svojo najnižjo vrednost (povprečje (± sd): 1,8 ± 0,8 h) malo kasneje, kot je dosežena najvišja koncentracija cisteamina v plazmi (povprečje (± sd): 1,4 ± 0,4 h), in se vrne na izhodiščno vrednost, ko se 6 ur po aplikaciji zniža koncentracija cisteamina v plazmi.
English: It is not known if cysteamine is removed by haemodialysis.
Slovenian: Ni znano, če se cisteamin odstrani s hemodializo.
English: Reported adverse reactions are listed below, by system organ class and by frequency.
Slovenian: V nadaljevanju so navedeni do sedaj opaženi neželeni učinki glede na prizadeti organski sistem in pogostnost.
English: Experience has occasionally shown that some forms of cysteamine are less well tolerated (i.e. leading to more adverse events) when patients are on dialysis.
Slovenian: Občasne izkušnje kažejo, da bolniki na dializi slabše prenašajo nekatere oblike cisteamina (t.j., nekatere oblike pri njih povzročajo več neželenih učinkov kot druge).
English: Teratogenic effects have been described in rats when cysteamine is administered over the period of organogenesis at a dose of 100 mg/kg/day.
Slovenian: Teratogeni učinki so opisani pri podganah, ki so dobivale cisteamin v odmerkih 100 mg/kg/dan v obdobju organogeneze.
English: In one clinical study, baseline white cell cystine levels were 3.73 (range 0.13 to 19.8) nmol hemicystine/mg protein and were maintained close to 1 nmol hemicystine/mg protein with a cysteamine dose range of 1.3 to 1.95 g/m2/day.
Slovenian: V eni od kliničnih študij so bile izhodiščne vrednosti cistina v levkocitih 3,73 (razpon 0,1319,8) nmol hemicistina/mg beljakovin, z odmerki cisteamina med 1,3 - 1,95 g/m2/dan pa so uspeli ohranjati koncentracijo približno 1 nmol hemicistina/mg beljakovin.
English: Very common: Lethargy, pyrexia Common: Asthenia
Slovenian: Zelo pogosto: letargija, pireksija Pogosto: oslabelost
English: What CYSTAGON is and what it is used for Before you use CYSTAGON How to use CYSTAGON Possible side effects
Slovenian: Navodilo vsebuje: Kaj je zdravilo CYSTAGON in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo CYSTAGON Kako uporabljati zdravilo CYSTAGON Možni neželeni učinki Shranjevanje zdravila CYSTAGON Dodatne informacije
English: Do not store above 25°C and keep the container tightly closed in order to protect from light and moisture.
Slovenian: Shranjujte pri temperaturi do 25 °C, v vsebniku, ki mora biti tesno zaprt za zagotovitev zaščite pred svetlobo in vlago.
English: Uncommon: Anaphylactic reaction
Slovenian: Občasno: anafilaktična reakcija
English: - Your doctor could require controlling the blood cell count on a regular basis.
Slovenian: - Mogoče bo zdravnik potreboval redne kontrolne preiskave krvne slike.
English: MANUFACTURER'S BATCH NUMBER Batch {number}
Slovenian: ŠTEVILKA SERIJE Serija {številka}
English: In cases of patients with kidney transplants, anti-rejection treatments have been used with cysteamine.
Slovenian: V primeru bolnikov s presajenimi ledvicami so se skupaj s cisteaminom uporabljala tudi zdravila za preprečevanje zavrnitvene reakcije.
English: However, acidic drinks, e.g. orange juice, should generally be avoided as the powder tends not to mix well and may precipitate out.
Slovenian: Odsvetujejo pa uporabo kislih pijač, npr. pomarančnega soka, ker se slabo mešajo s praškom, ki lahko zato precipitira.
English: These mainly involve the gastrointestinal and central nervous systems.
Slovenian: Ti običajno prizadenejo prebavni trakt in osrednji živčni sistem.
English: CYSTAGON has minor or moderate influence on the ability to drive and use machines CYSTAGON may cause drowsiness.
Slovenian: CYSTAGON ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
English: Nephropathic cystinosis must have been diagnosed by both clinical signs and biochemical investigations (leucocyte cystine measurements).
Slovenian: Diagnozo nefropatske cistinoze je treba ugotavljati ob upoštevanju kliničnih znakov kot tudi s pomočjo biokemičnih preiskav (merjenje cistina v levkocitih).
English: CYSTAGON should be taken or given only by mouth and exactly as your or your child's doctor directs.
Slovenian: CYSTAGON se sme dajati oz. jemati le peroralno (z zaužitjem) in to natančno po navodilih vašega ali otrokovega zdravnika.
English: Breast-feeding CYSTAGON must not be used during breast-feeding.
Slovenian: Dojenje Zdravila CYSTAGON med dojenjem ne smete uporabljati.
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte zdravnikom ali farmacevtom.
English: - Common: abdominal pain or discomfort, unpleasant breath and body odour, skin eruption, gastroenteritis, fatigue, headache, encephalopathy (brain disorder) and liver function test abnormalities.
Slovenian: - Pogosto: bolečine ali nelagodje v trebuhu, neprijeten zadah iz ust in telesni vonj, kožni izpuščaji, gastroenteritis (prebavne motnje), utrujenost, glavobol, encefalopatija (bolezen možganov) in nenormalni izvidi testov jetrnih funkcij.
English: • For patients over age 12 and over 50 kg weight, the recommended CYSTAGON dose is 2 g/day, divided four times daily.
Slovenian: • Pri bolnikih starejših od 12 let in telesno maso nad 50 kg znaša priporočeni odmerek CYSTAGONa 2 g/dan, porazdeljeno v 4 odmerke na dan.
English: CYSTAGON is indicated for the treatment of proven nephropathic cystinosis.
Slovenian: CYSTAGON je indiciran za zdravljenje dokazane nefropatske cistinoze.
English: Patients with hepatic insufficiency: Dose adjustment is not normally required; however, leucocyte cystine levels should be monitored.
Slovenian: Prilagajanje odmerka običajno ni potrebno; kljub temu pa je treba nadzorovati koncentracijo cistina v levkocitih.
English: Cysteamine reacts with cystine to form the mixed disulfide of cysteamine and cysteine.
Slovenian: Cisteamin v reakciji s cistinom tvori mešani disulfid cisteamina in cisteina ter cistein.
English: In some cases, histology showed a membranous glomerulonephritis of the renal allograft and hypersensitivity interstitial nephritis.
Slovenian: S histološko preiskavo sta bila v nekaj primerih ugotovljena glomerulonefritis presajene ledvice in preobčutljivostni intersticijski nefritis.
English: The mean white cell cystine level attained during treatment was 1.7 + 0.2 nmol hemicystine/mg protein.
Slovenian: Povprečna vrednost cistina v levkocitih, ki so jo dosegli med zdravljenjem, je znašala 1,7 0,2 nmol hemicistina/mg beljakovin.
English: The dose should be raised if there is adequate tolerance and the leucocyte cystine level remains >1 nmol hemicystine/mg protein.
Slovenian: Odmerek je treba povečati, če je prenašanje primerno dobro in koncentracija cistina v levkocitih vztraja pri vrednosti > 1 nmol hemicistina/mg beljakovin.
English: - Very common: vomiting, nausea, diarrhoea, loss of appetite, fever and sensation of sleep
Slovenian: - Zelo pogosto: bruhanje, slabost, driska, izguba teka, zvišana telesna temperatura in občutek zaspanosti.
English: What CYSTAGON looks like and contents of the pack Hard Capsules - Cystagon 50 mg: white, opaque hard capsules with CYSTA 50 on the body and MYLAN on the cap.
Slovenian: Izgled zdravila CYSTAGON in vsebina pakiranja Trde kapsule - Cystagon 50 mg: bele, neprosojne trde kapsule z napisom CYSTA 50 na spodnjem delu in MYLAN na zgornjem delu.
English: Common: Skin odour abnormal, rash Uncommon: Hair colour changes, skin striae, skin fragility (molluscoid pseudotumor on elbows)
Slovenian: Pogosto: nenormalen vonj kože, izpuščaj Občasno: spremembe barve las, kožne strije, nežna koža, ki se zlahka poškoduje (moluskoidni psevdotumor na komolcih)
English: These skin lesions were associated with vascular proliferation, skin striae and bone lesions.
Slovenian: Te kožne lezije so bile povezane z vaskularno proliferacijo, kožnimi strijami in lezijami kosti.
English: Very common: Vomiting, nausea, diarrhoea Common: Abdominal pain, breath odour, dyspepsia, gastroenteritis
Slovenian: Zelo pogosto: bruhanje, slabost, driska Pogosto: bolečine v trebuhu, ustni zadah, dispepsija, gastroenteritis
English: Following a single oral dose of cysteamine bitartrate equivalent to 1.05 g of cysteamine free base in healthy volunteers, the mean ( sd) values for the time to peak and peak plasma concentration are 1.4 ( 0.5) hours and 4.0 ( 1.0) µg/ml, respectively.
Slovenian: Po enkratnem peroralnem odmerku cisteaminijevega bitartrata, ki ustreza 1,05 g proste baze cisteamina, je pri zdravih prostovoljcih povprečen (± sd) čas do dosežene najvišje koncentracije 1,4 (± 0,5) h, najvišja plazemska koncentracija pa znaša 4,0 (± 1,0) µg/ml.
English: A desiccant unit containing black activated carbon and silica gel granules is included in the bottle.
Slovenian: V plastenki je še sušilno sredstvo, ki vsebuje aktivno oglje in zrnca silicijevega dioksida.
English: What CYSTAGON contains - The active substance is cysteamine bitartrate (mercaptamine bitartrate).
Slovenian: Kaj vsebuje zdravilo CYSTAGON - Zdravilna učinkovina je cisteaminijev bitartrat (merkaptaminijev bitartrat).
English: You should not use CYSTAGON if you are pregnant.
Slovenian: Če ste noseči, zdravila CYSTAGON ne smete uporabljati.
English: - A few cases of skin lesions on elbows like little hard lumps have been reported in children treated with high doses of different cysteamine preparations.
Slovenian: - Pri otrocih, zdravljenih z velikimi odmerki različnih pripravkov cisteamina, so poročali o nekaj primerih kožnih lezij na komolcih, ki so bili podobni trdim bulicam.
English: Common: Headache, encephalopathy Uncommon: Somnolence, convulsions
Slovenian: Pogosto: glavobol, encefalopatija Občasno: zaspanost, krči
English: You may already be receiving phosphate supplements and the dose of these may need to be changed when CYSTAGON is substituted for phosphocysteamine.
Slovenian: Če že prejemate fosfatne dodatke, bo morda potrebno ob nadomestitvi fosfocisteamina z zdravilom CYSTAGON njihovo odmerjanje ustrezno spremeniti.
English: CYSTAGON excretion in human's milk is unknown.
Slovenian: Ni znano, če se CYSTAGON izloča v materino mleko.
English: The goal of therapy is to keep leucocyte cystine levels below 1 nmol hemicystine/mg protein.
Slovenian: Cilj zdravljenja je vzdrževati koncentracijo cistina v levkocitih pod vrednostjo 1 nmol hemicistina/mg beljakovin.
English: 100 hard capsules (with a desiccant unit in the bottle) 500 hard capsules (with a desiccant unit in the bottle)
Slovenian: 100 trdih kapsul (v plastenki s sušilnim sredstvom) 500 trdih kapsul (v plastenki s sušilnim sredstvom)
English: Capsule content: microcrystalline cellulose, pregelatinized starch, magnesium stearate/sodium lauryl sulfate, colloidal silicon dioxide, croscarmellose sodium Capsule shell: gelatin, titanium dioxide,
Slovenian: Vsebina kapsule: mikrokristalna celuloza predgelirani škrob magnezijev stearat/natrijev lavrilsulfat koloidni silicijev dioksid premreženi natrijev karmelozat Ovoj kapsule: želatina titanov dioksid,
English: HDPE bottles of 100 and 500 hard capsules.
Slovenian: Plastenke iz HDPE, ki vsebujejo po 100 ali 500 trdih kapsul.
English: Uncommon: Joint hyperextension, leg pain, genu valgum, osteopenia, compression fracture, scoliosis.
Slovenian: Občasno: hiperekstenzija sklepov, bolečine v spodnjih udih, genu valgum, osteopenija, kompresijska fraktura, skolioza
English: Date of first authorisation: 23 June 1997.
Slovenian: DATUM PRVE PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 23. junij 1997
English: CYSTAGON therapy must be initiated promptly after confirmation of the diagnosis of nephropathic cystinosis to achieve maximum benefit.
Slovenian: Za dosego maksimalnega učinka je treba zdravljenje s CYSTAGONom uvesti takoj po potrditvi diagnoze nefropatske cistinoze.
English: Individuals with nephropathic cystinosis have elevations of white cell cystine above 2 nmol hemicystine/mg protein
Slovenian: Osebe z nefropatsko cistinozo imajo vrednosti cistina v levkocitih višje od 2 nmol hemicistina/mg beljakovin.
English: - Cystagon 150 mg: white, opaque hard capsules with CYSTAGON 150 on the body and MYLAN on the cap.
Slovenian: - Cystagon 150 mg: bele, neprosojne trde kapsule z napisom CYSTAGON 150 na spodnjem delu in MYLAN na zgornjem delu.
English: HOW TO STORE CYSTAGON
Slovenian: SHRANJEVANJE ZDRAVILA CYSTAGON
English: Capsule content: microcrystalline cellulose, pregelatinized starch, magnesium stearate/sodium lauryl sulfate, colloidal silicon dioxide, croscarmellose sodium Capsule shell: gelatin, titanium dioxide, black ink on hard capsules containing E172
Slovenian: - Pomožne snovi so mikrokristalna celuloza, predgelirani škrob, magnezijev stearat/natrijev lavrilsulfat, koloidni silicijev dioksid, premreženi natrijev karmelozat, ovoj kapsule: želatina, titanov dioksid, črnilo na trdih kapsulah (E172).
English: Administration of cysteamine in neonate rats induced cataracts.
Slovenian: Prejemanje cisteamina je pri novorojenih podganah povzročilo nastanek sive mrene.
English: Normal individuals and heterozygous subjects for cystinosis have white cell cystine levels of < 0.2, and usually below 1 nmol hemicystine/mg protein, respectively.
Slovenian: Pri normalnih osebah, je koncentracija cistina v levkocitih < 0,2, pri osebah, heterozigotnih za cistinozo, pa običajno nižja od 1 nmol hemicistina/mg beljakovin.
English: CYSTAGON 50 mg Hard Capsules CYSTAGON 150 mg Hard Capsules Cysteamine bitartrate (mercaptamine bitartrate)
Slovenian: CYSTAGON 50 mg trde kapsule CYSTAGON 150 mg trde kapsule Cisteaminijev bitartrat (merkaptaminijev bitartrat)
English: CYSTAGON has minor or moderate influence on the ability to drive ans use machines CYSTAGON may cause drowsiness.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev CYSTAGON lahko povzroča zaspanost.
English: Hard Capsule White, opaque hard capsules with CYSTA 50 on the body and MYLAN on the cap.
Slovenian: trda kapsula Bele, neprosojne trde kapsule z oznako CYSTA 50 na spodnjem delu in MYLAN na zgornjem delu.
English: These lesions were associated with skin striae and bone lesions such as fracture and bone deformities, and with laxity of joints.
Slovenian: Te lezije so bile povezane s kožnimi strijami in deformacijami kosti ter ohlapnostjo sklepov.
English: EU/1/97/039/003 (100 hard capsules per bottle), EU/1/97/039/004 (500 hard capsules per bottle).
Slovenian: ŠTEVILKI DOVOLJENJ ZA PROMET EU/1/97/039/003 (100 trdih kapsul v plastenki), EU/1/97/039/004 (500 trdih kapsul v plastenki).
English: Always use CYSTAGON exactly as your doctor or your child's doctor has told you.
Slovenian: Pri uporabi zdravila CYSTAGON natančno upoštevajte navodila svojega ali otrokovega zdravnika.
English: White blood cell (WBC) cystine levels should therefore be monitored to adjust the dose.
Slovenian: Zaradi prilagajanja odmerka je zato treba spremljati koncentracijo cistina v belih krvničkah - levkocitih (L).
English: In this leaflet:
Slovenian: NN:
English: EU/1/97/039/001 (100 hard capsules per bottle), EU/1/97/039/002 (500 hard capsules per bottle).
Slovenian: ŠTEVILKI DOVOLJENJ ZA PROMET EU/1/97/039/001 (100 trdih kapsul v plastenki), EU/1/97/039/002 (500 trdih kapsul v plastenki).
English: - To avoid any risk of aspiration in the lungs, the capsules should not be given to children under the age of approximately 6 years.
Slovenian: - Do približno 6. leta starosti otrokom ne smete dajati trdih kapsul, ker obstaja nevarnost, da bi otrok kapsulo aspiriral v pljuča.
English: Each hard capsule contains 50 mg of cysteamine (as mercaptamine bitartrate) .
Slovenian: Ena trda kapsula zdravila CYSTAGON 50 mg vsebuje 50 mg cisteamina (v obliki merkaptaminijevega bitartrata).
English: You should contact your or your child's doctor or the hospital emergency department immediately if more medicine has been taken than has been prescribed, drowsiness develops .
Slovenian: Če je prišlo do zaužitja večje količine zdravila od predpisane ali če se pojavi zaspanost, se morate nemudoma obrniti na svojega ali otrokovega zdravnika oz. na urgentni oddelek bolnišnice.
English: EU/1/97/039/003 - 100 hard capsules EU/1/97/039/004 - 500 hard capsules
Slovenian: EU/1/97/039/004 - 500 trdih kapsul
English: Each hard capsule contains 150 mg of cysteamine (as mercaptamine bitartrate) .
Slovenian: Ena trda kapsula zdravila CYSTAGON 150 mg vsebuje 150 mg cisteamina (v obliki merkaptaminijevega bitartrata).
English: Marketing Authorisation Holder Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du Général de Gaulle F-92800 Puteaux
Slovenian: Imetnik dovoljenja za promet z zdravilom Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du Général de Gaulle F-92800 Puteaux
English: Cases of Ehlers-Danlos like syndrome and vascular disorders on elbows have been reported in children chronically treated with high doses of different cysteamine preparations (cysteamine chlorhydrate or cystamine or cysteamine bitartrate) mostly above the maximal dose 1.95 g/m2/day.
Slovenian: Pri otrocih, kronično zdravljenih z velikimi odmerki različnih pripravkov cisteamina (cisteaminijev klorhidrat ali cistamin ali cisteaminijev bitartrat), večinoma večjimi od največjega odmerka 1,95 g/m2/dan, so poročali o primerih Ehlers-Danlosovemu podobnega sindroma in vaskularnih motnjah na komolcih.
English: EU/1/97/039/001 - 100 hard capsules EU/1/97/039/002 - 500 hard capsules
Slovenian: EU/1/97/039/002 - 500 trdih kapsul
English: CYSTAGON 150 mg hard capsules Cysteamine
Slovenian: CYSTAGON 150 mg trde kapsule cisteamin
English: CYSTAGON 150 mg hard capsules
Slovenian: CYSTAGON 150 mg trde kapsule
English: BEFORE YOU USE CYSTAGON
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO CYSTAGON
English: Cases of Ehlers-Danlos like syndrome and vascular disorders on elbows have been reported in children treated with high doses of different cysteamine preparations (cysteamine chlorhydrate or cystamine or cysteamine bitartrate) mostly above the maximal dose 1.95 g/m2/day.
Slovenian: Pri otrocih, zdravljenih z velikimi odmerki različnih pripravkov cisteamina (cisteaminijev klorhidrat ali cistamin ali cisteaminijev bitartrat), večinoma večjimi od največjega odmerka 1,95 g/m2/dan, so poročali o primerih Ehlers-Danlosovemu podobnega sindroma in vaskularnih motnjah na komolcih.
English: CYSTAGON 50 mg hard capsules
Slovenian: CYSTAGON 50 mg trde kapsule
English: Hard Capsule White, opaque hard capsules with CYSTAGON 150 on the body and MYLAN on the cap.
Slovenian: Bele, neprosojne trde kapsule z oznako CYSTAGON 150 na spodnjem delu in MYLAN na zgornjem delu.
English: Hypersensitivity to the active substance or to any of the excipients The use of CYSTAGON is contra-indicated during breast-feeding.
Slovenian: Uporaba CYSTAGONa med dojenjem je kontraindicirana.
English: In patients at steady state, these values are 1.4 ( 0.4) hours and 2.6 ( 0.9) µg/ml, respectively, after a dose ranging from 225 to 550 mg. Cysteamine bitartrate (CYSTAGON) is bioequivalent to cysteamine hydrochloride and phosphocysteamine.
Slovenian: Po odmerku v razponu od 225 do 550 mg so pri bolnikih v stanju dinamičnega ravnovesja te vrednosti 1,4 (± 0,4) h in 2,6 (± 0,9) µg/ml.
English: Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du Général de Gaulle F-92800 Puteaux France
Slovenian: Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du Général de Gaulle F-92800 Puteaux Francija
English: OUTER CARTON CYSTAGON 150 mg x 100 hard capsules OUTER CARTON CYSTAGON 150 mg x 500 hard capsules
Slovenian: ZUNANJA KARTONSKA OVOJNINA CYSTAGON 150 mg x 100 trdih kapsul ZUNANJA KARTONSKA OVOJNINA CYSTAGON 150 mg x 500 trdih kapsul
English: BOTTLE LABEL CYSTAGON 150 mg x 100 hard capsules BOTTLE LABEL CYSTAGON 150 mg x 500 hard capsules
Slovenian: NALEPKA NA PLASTENKI CYSTAGON 150 mg x 100 trdih kapsul NALEPKA NA PLASTENKI CYSTAGON 150 mg x 500 trdih kapsul
English: OUTER CARTON CYSTAGON 50 mg x 100 hard capsules OUTER CARTON CYSTAGON 50 mg x 500 hard capsules
Slovenian: ZUNANJA KARTONSKA OVOJNINA CYSTAGON 50 mg x 100 trdih kapsul ZUNANJA KARTONSKA OVOJNINA CYSTAGON 50 mg x 500 trdih kapsul
English: CYSTAGON 50 mg hard capsules Cysteamine
Slovenian: CYSTAGON 50 mg trde kapsule cisteamin
English: - CYSTAGON has not been shown to prevent cystine crystals accumulating in the eye. Where cysteamine ophthalmic solution has been used for that purpose, its usage should continue.
Slovenian: - Ni dokazano, da bi CYSTAGON preprečeval kopičenje cistinskih kristalov v očesu.
English: BOTTLE LABEL CYSTAGON 50 mg x 100 hard capsules BOTTLE LABEL CYSTAGON 50 mg x 500 hard capsules
Slovenian: NALEPKA NA PLASTENKI CYSTAGON 50 mg x 100 trdih kapsul NALEPKA NA PLASTENKI CYSTAGON 50 mg x 500 trdih kapsul
English: <Content (concentration)>
Slovenian: Stična ovojnina Vsebina (koncentracija)
English: This is particularly important when injecting small volumes.
Slovenian: To je pomembno zlasti pri injiciranju majhnih količin.
English: Avoid contact with the eyes and skin.
Slovenian: Preprečite stik z očmi in kožo.
English: Therefore, use only according to the benefit/risk assessment by the responsible veterinarian.
Slovenian: Uporabite le v skladu z oceno razmerja korist/tveganje odgovornega veterinarja.
English: Date of first authorisation: 06/11/2015.
Slovenian: Datum pridobitve dovoljenja za promet: 06/11/2015.
English: Subsequent doses and long term management:
Slovenian: Nadaljnji odmerki in dolgotrajno upravljanje:
English: Once the optimal dose and dosing interval have been determined, maintain the same regimen.
Slovenian: Ko določite optimalni odmerek in interval odmerjanja, ohranite enak režim.
English: Prior to a stressful situation, consider temporarily increasing the dose of glucocorticoid.
Slovenian: Pred stresno situacijo razmislite o tem, da bi začasno povečali odmerek glukokortikoida.
English: Interim monitoring visit:
Slovenian: Vmesni obiski za spremljanje:
English: This product may cause adverse effects on male reproductive organs and, as a result, fertility.
Slovenian: To zdravilo lahko povzroči neželene učinke na moške razmnoževalne organe in posledično na plodnost.
English: In case of signs of overdose, the dog should be treated symptomatically, and subsequent doses reduced.
Slovenian: V primeru znakov prevelikega odmerjanja je treba psa zdraviti simptomatsko in zmanjšati naslednji odmerek.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in viali po “EXP”.
English: This product may cause adverse developmental effects on unborn children and neonates.
Slovenian: To zdravilo lahko povzroči neželene učinke na razvoj še nerojenih otrok in na novorojenčke.