natgillin/translations-raw huggingface dataset:
In some cases, histology showed a membranous glomerulonephritis of the renal allograft and hypersensitivity interstitial nephritis.
U nekim slučajevima, histologija je pokazala membranozni glomerulonefritis alogeničnog bubrežnog presatka te hipersenzitivni intersticijski nefritis.
Most patients will already be receiving phosphate supplements and the dose of these may need to be altered when CYSTAGON is substituted for phosphocysteamine.
Većina će bolesnika već primati nadomjestke fosfata te može biti potrebno prilagoditi njihovu dozu kada se CYSTAGON zamijeni fosfocisteaminom.
What CYSTAGON is and what it is used for Before you use CYSTAGON How to use CYSTAGON Possible side effects
Što je CYSTAGON i za što se koristi Prije nego počnete primjenjivati CYSTAGON
- Very common: vomiting, nausea, diarrhoea, loss of appetite, fever and sensation of sleep
- Vrlo često: povraćanje, mučnina, proljev, gubitak apetita, vrućica i osjećaj pospanosti
• For children up to age 12 years, CYSTAGON dosing should be on the basis of body surface area (g/m 2/day).
• Za djecu do 12 godina, CYSTAGON treba dozirati na temelju površine tijela (g/m 2/dan).
The decrease in leucocyte cystine levels is correlated to the cysteamine plasma concentration over the six hours following the administration of CYSTAGON.
Pad razine cistina u leukocitima korelira s koncentracijom cisteamina u plazmi kroz šest sati nakon primjene CYSTAGONA.
Monitoring of blood cell count is recommended on a regular basis.
Savjetuje se redovito praćenje krvne slike.
- In contrast to phosphocysteamine, another active substance close to cysteamine bitartrate, CYSTAGON does not contain phosphate.
Za razliku od fosfocisteamina, druge djelatne tvari bliske cisteaminditartratu, CYSTAGON ne sadrži fosfat.
The dose should be raised if there is adequate tolerance and the leucocyte cystine level remains >1 nmol hemicystine/mg protein.
Dozu treba povećati ako je tolerancija dobra, a razina cistina u leukocitima ostane >1 nmol hemicistina/mg proteina.
Breast-feeding CYSTAGON must not be used during breast-feeding.
Dojenje CYSTAGON se ne smije koristiti tijekom dojenja.
The in vitro plasma protein binding of cysteamine, which is mostly to albumin, is independent of plasma drug concentration over the therapeutic range, with a mean ( sd) value of 54.1 % ( 1.5).
Vezanje cisteamina za proteine plazme in vitro, a većinom se veže za albumin, unutar terapijskog raspona neovisno je o koncentraciji lijeka u plazmi, sa srednjom vrijednosti ( sd) od 54,1 % ( 1,5).
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.
Iskustvo je povremeno pokazalo da se neki oblici cisteamina lošije podnose (tj. dovode do više nuspojava) kad su bolesnici na dijalizi.
It is therefore recommended to monitor regularly skin and to consider X-ray examinations of the bone as necessary.
Stoga se preporučuje redovito kontrolirati kožu te po potrebi razmotriti rendgenske preglede kostiju.
Reproduction studies showed embryofoetotoxic effects (resorptions and post-implantation losses) in rats at the 100 mg/kg/day dose level and in rabbits receiving cysteamine 50 mg/kg/day.
Reproduktivna ispitivanja pokazala su embriofetotoksične učinke (resorpcije te gubitke nakon implantacije) kod štakora pri razini doza od 100 mg/kg/dan te kod kunića koji su primali cisteamin od 50 mg/kg/dan.
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.
Nakon pojedinačne oralne doze cisteamin bitartrata koja je ekvivalentna 1,05 g slobodne baze cisteamina kod zdravih dobrovoljaca, srednje vrijednosti ( sd) za vrijeme potrebno za postizanje vršne koncentracije te za postizanje vršne koncentracije u plazmi iznose 1,4 ( 0,5) sati odnosno 4,0 ( 1,0) µg/ml.
CYSTAGON has minor or moderate influence on the ability to drive and use machines CYSTAGON may cause drowsiness.
CYSTAGON malo ili umjereno utječe na sposobnost upravljanja vozilima i rada na strojevima.
How to store CYSTAGON Further information
Kako čuvati CYSTAGON Dodatne informacije
Uncommon: Anaphylactic reaction
Manje često: Anafilaktička reakcija
- Uncommon: skin striae, skin lesion (little-hard lumps on elbows), joint laxity, leg pain, bone fracture, scoliosis (deviation of the vertebral column), bone deformity and fragility, hair discoloration, severe allergic reaction, somnolence, fits, nervousness, hallucination, decrease in white blood cells, gastrointestinal ulcer manifested by bleeding in the digestive tract and effect on the kidney manifested by swelling of the extremities and weight gain.
- Manje često: strije na koži, lezije kože (male tvrde kvržice na laktovima), labavost zglobova, bol u nogama, prijelom kosti, skolioza (iskrivljenje kralježnice), deformacija i lomljivost kostiju, promjena boje kose, teška alergijska reakcija, pospanost, napadaji, nervoza, halucinacije, smanjen broj bijelih krvnih stanica, čir na želucu ili crijevima koji se očituje krvarenjem u probavnom sustavu te učinak na bubreg koji se očituje oticanjem udova i porastom tjelesne težine.
CYSTAGON should not be used during pregnancy, particularly during the first trimester, unless clearly necessary (see section 4.6 and section 5.3), as it is teratogenic in animals.
CYSTAGON se ne smije koristiti tijekom trudnoće, osobito tijekom prvog tromjesečja, osim ako nije izričito neophodan (vidjeti dio 4.6 te dio 5.3), jer je teratogen kod životinja.
CYSTAGON treatment should be initiated under the supervision of a physician experienced in the treatment of cystinosis.
Liječenje CYSTAGONOM treba započeti pod nadzorom liječnika s iskustvom u liječenju cistinoze.
For patients over age 12 and over 50 kg weight, the usual dose is 2g/day.
Kod bolesnika starijih od 12 godina te s više od 50 kg tjelesne težine, uobičajena doza je 2g/dan.
Single doses of the drug inhibit prolactin secretion in animals.
Pojedinačne doze lijeka inhibiraju izlučivanje prolaktina kod životinja.
In some the patients, the skin lesions on elbows regressed after CYSTAGON dose reduction.
U nekih bolesnika, kožne promjene na laktovima su se povukle nakon smanjenja doze CYSTAGONA.
Treatment with CYSTAGON should continue indefinitely, as instructed by your doctor.
Liječenje lijekom CYSTAGON treba nastaviti do daljnjeg, kao što Vam je savjetovao Vaš liječnik.
Oral cysteamine has not been shown to prevent eye deposition of cystine crystals.
Nije se pokazalo da oralni cisteamin sprječava odlaganje kristala cistina u očima.
HDPE bottles of 100 and 500 hard capsules.
HDPE bočice sa 100 i 500 tvrdih kapsula.
In some cases, these skin lesions were associated with vascular proliferation, skin striae and bone lesions first seen during an X-ray examination.
U nekim slučajevima, ove kožne promjene povezivale su se s vaskularnom proliferacijom, strijama na koži i lezijama kostiju koje su prvo zabilježene tijekom rendgenskog pregleda.
White blood cell (WBC) cystine levels should therefore be monitored to adjust the dose.
Stoga treba pratiti razinu cistina u leukocitima (Lkc) kako bi se prilagodila doza.
The use of doses higher than 1.95g/m2/day is not recommended (see sections 4.2 and 4.8).
Ne preporuča se upotreba doza viših od 1,95g/m2/dan (vidjeti dijelove 4.2 i 4.8).
High doses of cysteamine, either by oral or parenteral routes, produce duodenal ulcers in rats and mice but not in monkeys.
Visoke doze cisteamina, primijenjene bilo oralnim bilo parenteralnim putem, uzrokovale su ulkuse dvanaesnika kod štakora i miševa, ali ne kod majmuna.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU
CYSTAGON excretion in human's milk is unknown.
Nije poznato da li se CYSTAGON izlučuje u majčino mlijeko u ljudi.
BEFORE YOU USE CYSTAGON
PRIJE NEGO POČNETE PRIMJENJIVATI CYSTAGON
If you forget to take CYSTAGON:
Ako ste zaboravili primjeniti CYSTAGON
The goal of therapy is to keep leucocyte cystine levels below 1 nmol hemicystine/mg protein.
Cilj terapije je održati razinu cistina u leukocitima ispod 1 nmol hemicistina/mg proteina.
A closer monitoring of the leucocyte cystine levels is recommended in these patients.
Kod ovih se bolesnika savjetuje pažljivije praćenje razine cistina u leukocitima.
CYSTAGON is indicated for the treatment of proven nephropathic cystinosis.
CYSTAGON je indiciran za liječenje dokazane nefropatske cistinoze.
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.
Kako CYSTAGON izgleda i sadržaj pakovanja Tvrde kapsule - Cystagon 50 mg: bijele, neprozirne tvrde kapsule s CYSTA 50 na tijelu i MYLAN na kapici.
Cysteamine reacts with cystine to form the mixed disulfide of cysteamine and cysteine.
Cisteamin reagira s cistinom stvarajući miješani disulfid cisteamina i cisteina te cistein.
The mean white cell cystine level attained during treatment was 1.7 + 0.2 nmol hemicystine/mg protein.
Srednja vrijednost razine cistina u leukocitima postignuta tijekom liječenja bila je 1,7 + 0,2 nmol hemicistina/mg proteina.
Common: Skin odour abnormal, rash Uncommon: Hair colour changes, skin striae, skin fragility (molluscoid pseudotumor on elbows)
Često: Abnormalan miris kože, osip Manje često: Promjene boje kose, strije na koži, fragilnost kože (moluskoidan pseudotumor na laktovima)
Common: Liver function tests abnormal
Često: Poremećaj testova jetrene funkcije
- Common: abdominal pain or discomfort, unpleasant breath and body odour, skin eruption, gastroenteritis, fatigue, headache, encephalopathy (brain disorder) and liver function test abnormalities.
Često: bol ili nelagoda u trbuhu, neugodan zadah i miris tijela, kožne promjene, gastroenteritis, umor, glavobolja, encefalopatija (poremećaj mozga) i abnormalnosti testova jetrene funkcije.
What CYSTAGON contains - The active substance is cysteamine bitartrate (mercaptamine bitartrate).
Što CYSTAGON sadrži - Djelatna tvar je cisteaminditartarat (merkaptaminditartarat).
These lesions were associated with skin striae and bone lesions such as fracture and bone deformities, and with laxity of joints.
Ove su lezije bile povezane sa strijama na koži i lezijama kostiju poput prijeloma i deformiteta kostiju te s povećanom elastičnosti zglobova.
Capsule content: microcrystalline cellulose, pregelatinized starch, magnesium stearate/sodium lauryl sulfate, colloidal silicon dioxide, croscarmellose sodium Capsule shell: gelatin, titanium dioxide,
Sadržaj kapsule: celuloza, mikrokristalična, škrob, prethodno geliran, magnezijev stearat/natijev laurilsulfat, silicijev dioksid, koloidni, karmelozanatrij, umrežena Ovojnica kapsule: želatina, titanijev dioksid,
Administration of cysteamine in neonate rats induced cataracts.
Primjena cisteamina kod mladunčadi štakora dovela je do katarakti.
The use of doses higher than 1.95 g/m2/day is not recommended (see section 4.4).
Ne preporučuje se primjena doza viših od 1,95 g/m2/dan (vidjeti dio 4.4).
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.
Kod bolesnika u stadiju dinamičke ravnoteže, ove su vrijednosti 1,4 ( 0,4) sati odnosno 2,6 ( 0,9) µg/ml, nakon doze u rasponu od 225 do 550 mg.
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
- Pomoćne tvari su mikrokristalična celuloza, škrob, prethodno geliran, magnezijev stearat/natrijev laurilsulfat, koloidni silicijev dioksid, umrežena karmelozanatrij, ovojnica kapsule: želatina, titanijev dioksid, crna tinta na tvrdim kapsulama (E172).
HOW TO USE CYSTAGON
KAKO PRIMJENJIVATI CYSTAGON
Experimental administration of the drug causes depletion of somatostatin in several animal species.
Eksperimentalna primjena lijeka kod nekoliko životinjskih vrsta dovela je do deplecije somatostatina.
Individuals with nephropathic cystinosis have elevations of white cell cystine above 2 nmol hemicystine/mg protein
Pojedinci s nefropatskom cistinozom imaju povećane razine cistina u leukocitima preko 2 nmol hemicistina/mg proteina.
- Cystagon 150 mg: white, opaque hard capsules with CYSTAGON 150 on the body and MYLAN on the cap.
- Cystagon 150 mg: bijele, neprozirne tvrde kapsule s CYSTAGON 150 na tijelu i MYLAN na kapici.
Normal individuals and heterozygous subjects for cystinosis have white cell cystine levels of < 0.2, and usually below 1 nmol hemicystine/mg protein, respectively.
Normalni pojedinci imaju razinu cistina u leukocitima < 0,2, a heterozigotni ispitanici na cistinozu imaju razinu manju od 1 nmol hemicistina/mg proteina.
Bone disorders reported were genu valgum, leg pain and hyperextensive joints, osteopenia, compression fractures, and scoliosis.
Od poremećaja kostiju zabilježeni su genu valgum, bol u nogama i hiperekstenzivni zglobovi, osteopenija, kompresijski prijelomi, i skolioza.
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.
Zabilježeni su slučajevi sindroma nalik na Ehlers-Danlos i vaskularnih poremećaja na laktovima u djece koja su bila liječena visokim dozama različitih preparata cisteamina (cisteaminkloridom ili cistaminom ili cisteaminditartratom) većinom iznad maksimalne doze od 1,95 g/m2/dan.
These skin lesions were associated with vascular proliferation, skin striae and bone lesions.
Ove su kožne promjene bile povezivane s vaskularnom proliferacijom, strijama na koži te lezijama kostiju.
- 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.
- Kod djece liječene visokim dozama različitih preparata cisteamina zabilježeno je nekoliko slučajeva kožnih lezija na laktovima nalik na male tvrde kvrge.
Very common: Vomiting, nausea, diarrhoea Common: Abdominal pain, breath odour, dyspepsia, gastroenteritis
Vrlo često: Povraćanje, mučnina, proljev Često: Bol u trbuhu, zadah, dispepsija, gastroenteritis Manje često: Gastrointestinalni ulkus
Uncommon: Joint hyperextension, leg pain, genu valgum, osteopenia, compression fracture, scoliosis.
Manje često: Hiperekstenzija zglobova, bol u nogama, genu valgum, osteopenija, kompresijski prijelom, skolioza.
Hard Capsule White, opaque hard capsules with CYSTA 50 on the body and MYLAN on the cap.
Tvrda kapsula Bijele, neprozirne tvrde kapsule s CYSTA 50 na tijelu i MYLAN na kapici.
HOW TO STORE CYSTAGON
KAKO ČUVATI CYSTAGON
Hard Capsule White, opaque hard capsules with CYSTAGON 150 on the body and MYLAN on the cap.
Tvrda kapsula Bijele, neprozirne tvrde kapsule s CYSTAGON 150 na tijelu i MYLAN na kapici.
CYSTAGON 50 mg Hard Capsules CYSTAGON 150 mg Hard Capsules Cysteamine bitartrate (mercaptamine bitartrate)
CYSTAGON 50 mg tvrde kapsule CYSTAGON 150 mg tvrde kapsule cisteaminditartarat (merkaptaminditartarat)
Each hard capsule contains 50 mg of cysteamine (as mercaptamine bitartrate) .
Svaka tvrda kapsula sadrži 50 mg cisteamina (u obliku merkaptaminditartarata).
EU/1/97/039/001 - 100 hard capsules EU/1/97/039/002 - 500 hard capsules
EU/1/97/039/001 - 100 tvrdih kapsula EU/1/97/039/002 - 500 tvrdih kapsula
EU/1/97/039/003 - 100 hard capsules EU/1/97/039/004 - 500 hard capsules
EU/1/97/039/003 - 100 tvrdih kapsula EU/1/97/039/004 - 500 tvrdih kapsula
Each hard capsule contains 150 mg of cysteamine (as mercaptamine bitartrate) .
Svaka tvrda kapsula sadrži 150 mg cisteamina (u obliku merkaptaminditartarata).
Very common: Lethargy, pyrexia Common: Asthenia
Vrlo često: Letargija, vrućica Često: Astenija
EU/1/97/039/001 (100 hard capsules per bottle), EU/1/97/039/002 (500 hard capsules per bottle).
EU/1/97/039/001 (100 tvrdih kapsula u bočici), EU/1/97/039/002 (500 tvrdih kapsula u bočici).
EU/1/97/039/003 (100 hard capsules per bottle), EU/1/97/039/004 (500 hard capsules per bottle).
EU/1/97/039/003 (100 tvrdih kapsula u bočici), EU/1/97/039/004 (500 tvrdih kapsula u bočici).
CYSTAGON 150 mg hard capsules Cysteamine
CYSTAGON 150 mg tvrde kapsule cisteamin
CYSTAGON 150 mg hard capsules
CYSTAGON 150 mg tvrde kapsule
BOTTLE LABEL CYSTAGON 150 mg x 100 hard capsules BOTTLE LABEL CYSTAGON 150 mg x 500 hard capsules
NALJEPNICA NA BOČICI CYSTAGON 150 mg x 100 tvrdih kapsula NALJEPNICA NA BOČICI CYSTAGON 150 mg x 500 tvrdih kapsula
BOTTLE LABEL CYSTAGON 50 mg x 100 hard capsules BOTTLE LABEL CYSTAGON 50 mg x 500 hard capsules
NALJEPNICA NA BOČICI CYSTAGON 50 mg x 100 tvrdih kapsula NALJEPNICA NA BOČICI CYSTAGON 50 mg x 500 tvrdih kapsula
CYSTAGON 50 mg hard capsules
CYSTAGON 50 mg tvrde kapsule
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 .
Ako primjenite više lijeka CYSTAGON nego što ste trebali Trebate odmah obavijestiti svog liječnika ili liječnika Vašeg djeteta ili odjel za hitnu službu u bolnici.
OUTER CARTON CYSTAGON 150 mg x 100 hard capsules OUTER CARTON CYSTAGON 150 mg x 500 hard capsules
VANJSKA KARTONSKA KUTIJA CYSTAGON 150 mg x 100 tvrdih kapsula VANJSKA KARTONSKA KUTIJA CYSTAGON 150 mg x 500 tvrdih kapsula
OUTER CARTON CYSTAGON 50 mg x 100 hard capsules OUTER CARTON CYSTAGON 50 mg x 500 hard capsules
VANJSKA KARTONSKA KUTIJA CYSTAGON 50 mg x 100 tvrdih kapsula VANJSKA KARTONSKA KUTIJA CYSTAGON 50 mg x 500 tvrdih kapsula
CYSTAGON 50 mg hard capsules Cysteamine
CYSTAGON 50 mg tvrde kapsule cisteamin
Hypersensitivity to the active substance or to any of the excipients The use of CYSTAGON is contra-indicated during breast-feeding.
Korištenje CYSTAGONA kontraindicirana je tijekom dojenja.
Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du Général de Gaulle F-92800 Puteaux France
Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du Général de Gaulle F-92800 Puteaux Francuska
- 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.
- Nije se pokazalo da CYSTAGON sprečava nakupljanje kristala cistina u oku.
<Content (concentration)>
Sastav (koncentracija)
Immediate Packaging
Pakovanje
Date of first authorisation: 06/11/2015.
Datum prvog odobrenja: 06/11/2015.
This is particularly important when injecting small volumes.
To je naročito važno kad se ubrizgavaju male količine.
Avoid contact with the eyes and skin.
Izbjegavajte kontakt s očima ili kožom.
EXP {month/year} Once broached, use by __/__/__
EXP {mjesec/godina} Jednom odčepljen, upotrijebiti do __/__/__
Do not administer Dose 2 on Day 10.
Nemojte davati 2. dozu na 10. dan.
Pack size of 1.
Veličina pakovanja od 1.
Therefore, use only according to the benefit/risk assessment by the responsible veterinarian.
Prema tome, primijeniti samo nakon procjene odnosa koristi/rizika od strane odgovornog veterinara.
Once the optimal dose and dosing interval have been determined, maintain the same regimen.
Jednom kada su određeni optimalna doza i interval doziranja, održavajte isti režim.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Za informacije o ovom veterinarsko-medicinskom proizvodu molimo kontaktirajte lokalnog predstavnika nositelja odobrenja za stavljanje u promet.
Before starting treatment with the veterinary medicinal product, it is important that Addison's disease has been definitively diagnosed.
Prije početka liječenja s veterinarsko-medicinskim proizvodom, važno je prethodno definitivno dijagnosticirati Addisonovu bolest.
Zycortal is an opaque white suspension.
Zycortal je neprozirna bijela suspenzija.
Zycortal replaces the mineralocorticoid hormones only.
Zycortal zamjenjuje samo mineralokortikoidne hormone.
Prior to a stressful situation, consider temporarily increasing the dose of glucocorticoid.
Prije stresne situacije, razmislite o privremenom povećanju doze glukokortikoida.
Use an appropriately graduated syringe to accurately administer the required dose volume.
Koristite odgovarajuće graduiranu štrcaljku kako biste mogli precizno primijeniti potrebnu dozu.
This product may cause adverse developmental effects on unborn children and neonates.
Ovaj proizvod može nepoželjno djelovati na razvoj nerođene djece i novorođenčadi.
In case of accidental spillage onto the skin or eyes, wash the affected area with water.
U slučaju nenamjernog prolijevanja na kožu ili u oči, isperite to područje s vodom.
Subsequent doses and long term management:
Naredne doze i dugotrajni režim:
≥ 24 to < 27
≥ 24 do < 27
32 to < 34
32 do < 34
This product may cause adverse effects on male reproductive organs and, as a result, fertility.
Proizvod može uzrokovati nepoželjno djelovanje na muške reprodukcijske organe te stoga i na plodnost.
Second dose of Zycortal:
Druga doza Zycortala:
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP.
Ne koristite ovaj veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i bočici nakon EXP.
Opaque white suspension.
Neprozirna bijela suspenzija.
Pancreas disorders have been reported very rarely following use of Zycortal.
Znakovi poremećaja funkcije gušterače su prijavljeni vrlo rijetko nakon primjene Zycortala.
The concurrent administration of glucocorticoids may contribute to these signs.
Istovremena primjena glukokortikoida može pridonijeti tim znakovima.
This product may cause pain and swelling at the injection site if accidentally self-administered.
Proizvod može dovesti do boli i oticanja na mjestu uboda ako se nehotično samoinjicira.
Marketing authorisation holder: Dechra Regulatory B.V.
Nositelj odobrenja za stavljanje u promet: Dechra Regulatory B.V.
In case of signs of overdose, the dog should be treated symptomatically, and subsequent doses reduced.
U slučaju znakova predoziranja, psa treba liječiti simptomatski, a naredne doze treba smanjiti.
Zycortal is intended for long term administration at intervals and doses dependent upon individual response.
Zycortal je namijenjen za dugotrajnu primjenu u intervalima i dozama koji ovise o individualnoj reakciji na liječenje.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Svi neupotrebljeni veterinarsko-medicinski proizvodi ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima
5531 AE Bladel The Netherlands
5531 AE Bladel Nizozemska
Pharmacotherapeutic group: corticosteroids for systemic use, mineralocorticoids ATCvet code: QH02AA03
Farmakoterapijska grupa: kortikosteroidi za sustavnu primjenu, mineralokortikoidi ATCvet kod: QH02AA03
If the dog's clinical signs have worsened or not resolved, adjust the dose of glucocorticoid and/or investigate other causes of the clinical signs.
Ako se psu kliničko stanje pogoršalo ili se nije popravilo, prilagodite dozu glukokortikoida i/ili istražite druge uzroke kliničkih simptoma.
Do not store above 30 C.
Nemojte čuvati pri temperaturi iznad 30 C.
4.7 Use during pregnancy, lactation or lay
4.7 Primjena tijekom graviditeta laktacije ili nesenja
For use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison's disease).
Koristi se kao nadomjesna terapija za nedostatak mineralokortikoida kod pasa s primarnim hipoadrenokorticizmom (Addisonova bolest).
• If the dog is both clinically normal and has a normal Na
• Ako je kliničko stanje psa normalno i ima normalni omjer Na