natgillin/translations-raw huggingface dataset:
In all cases, dose should be adjusted according to therapeutic monitoring (see section 4.4.
U svim slučajevima, dozu treba prilagoditi prema terapijskom praćenju (vidjeti dio 4.4.).
The aim of the treatment is to maintain the plasma free copper (also known as non-ceruloplasmin plasma copper) below 250 microgram/l (normal: 100-150 microgram/l) and the urinary copper excretion below 125 microgram/24 h (normal: < 50 microgram/24 h).
Cilj liječenja je održati slobodan bakar u plazmi (također poznat kao ne-ceruloplazminski bakar u plazmi) ispod 250 mikrograma/l (normalno: 100-150 mikrograma/l) te izlučivanje bakra mokraćom ispod 125 mikrograma/24 h (normalno: < 50 mikrograma/24 h).
Wilson's disease (hepatolenticular degeneration) is an autosomal recessive metabolic defect in hepatic excretion of copper in the bile.
Wilsonova bolest (hepatolentikularna degeneracija) je autosomno recesivan metabolički poremećaj jetrenog izlučivanja bakra putem žuči.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
POSEBNE MJERE ZA UKLANJANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU
The weight of evidence, from in vitro and in vivo tests, suggests that zinc has no clinically relevant genotoxic activity.
Težina dokaza, iz in vitro i in vivo testova, upućuju da cink nema klinički značajnu genotoksičnu aktivnost.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Unutar svake kategorije učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
Although rare, clinical deterioration may occur at the beginning of the treatment, as has also been reported with chelating agents.
Iako rijetko, na početku liječenja može doći do kliničkog pogoršanja, što je također zabilježeno s kelirajućim agensima.
Urinary copper levels are usually increased with chelation therapy such as penicillamine or trientine.
Razina bakra u mokraći obično je povišena uz kelirajuću terapiju poput penicilamina ili trientina.
4.9 Overdose
4.9 Predoziranje
Copper accumulation in the liver leads to hepatocellular injury and eventual cirrhosis.
Nakupljanje bakra u jetri dovodi do hepatocelularnog oštećenja i moguće ciroze.
In these patient groups, urinary copper levels should be kept a little above the upper limit of normal or in the high normal range (i.e. 40 - 50 microgram/24 h).
Kod ovih skupina bolesnika, razinu bakra u mokraći treba održavati malo iznad gornje granice normalne vrijednosti ili u rasponu visokih normalnih vrijednosti (tj. 40 - 50 mikrograma/24 h).
Since the mechanism of action of zinc is an effect on copper uptake at the level of the intestinal cell, pharmacokinetic evaluations based on blood levels of zinc do not provide useful information on zinc bioavailability at the site of action.
S obzirom da cink djeluje tako što utječe na unos bakra na razini stanica crijeva, farmakokinetičke procjene temeljene na razini cinka u krvi ne daju korisne informacije o bioraspoloživosti cinka na mjestu djelovanja.
Wilzin is indicated in the treatment of Wilson's disease, which is a rare inherited defect in copper excretion.
Wilzin je indiciran za liječenje Wilsonove bolesti, koja je rijetki nasljedni poremećaj izlučivanja bakra.
• Keep out of the reach and sight of children.
• Čuvati izvan dohvata i pogleda djece.
Manufacturer
Proizvođač
Keep out of the reach and sight of children.
Čuvati izvan dohvata i pogleda djece.
If you have been prescribed Wilzin with another anti-copper agent, such as penicillamine, keep an interval of at least 1 hour between the two medicines.
Ako Vam je propisan Wilzin s drugim lijekom za snižavanje bakra, poput penicilamina, između uzimanja ova dva lijeka održavajte razmak od najmanje 1 sat.
Hypersensitivity to the active substance or to any of the excipients.
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari.
If you forget to take Wilzin: Do not take a double dose to make up for a forgotten individual dose.
Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu pojedinačnu dozu.
• Periodic Safety Update Reports
• Periodička izvješća o neškodljivosti
Wilzin must be taken on an empty stomach, at least 1 hour before or 2-3 hours after meals.
Wilzin se mora uzeti na prazan želudac, najmanje 1 sat prije ili 2-3 sata nakon obroka.
Recordati Rare Diseases Eco River Parc 30, rue des Peupliers F-92000 Nanterre France
Recordati Rare Diseases Eco River Parc 30, rue des Peupliers F-92000 Nanterre Francuska
Wilzin belongs to a group of medicines called Various Alimentary Tract and metabolism products.
Wilzin pripada skupini lijekova nazvanih Ostali lijekovi za probavni sustav i metabolizam.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Na tiskanoj uputi o lijeku mora se navesti naziv i adresa proizvođača odgovornog za puštanje navedene serije u promet.
Take special care with Wilzin
Budite posebno oprezni s Wilzinom
Dose adjustments to guarantee that the foetus will not become copper deficient must be done and close monitoring of the patient is mandatory (see section 4.4).
Doza se mora prilagoditi kako bi se garantiralo da fetus neće imati deficijenciju bakra i obavezno je pažljivo praćenje bolesnika (vidjeti dio 4.4).
Data on a limited number of exposed pregnancies in patients with Wilson's disease give no indication of harmful effects of zinc on embryo/foetus and mother.
Podaci iz ograničenog broja trudnoća kod bolesnica s Wilsonovom bolesti koje su uzimale cink nisu dali naznake štetnih učinaka cinka na embrij/fetus i majku.
blood amylase, lipase and alkaline phosphatase increased
porast amilaze, lipaze i alkalne fosfataze u krvi
ANNEX II
DODATAK II
POSSIBLE SIDE EFFECTS Like all medicines, Wilzin can cause side effects, although not everybody gets them..
Kao i svi drugi lijekovi, lijek Wilzin može uzrokovati nuspojave, iako se one neće pojaviti kod svih osoba.
Pharmacodynamic studies were conducted in Wilson's disease patients on the combination of Wilzin (50 mg three times daily) with ascorbic acid (1 g once daily), penicillamine (250 mg four times daily), and trientine (250 mg four times daily).
Provedene su farmakodinamske studije na bolesnicima s Wilsonovom bolesti koji su primali kombinaciju Wilzina (50 mg tri puta dnevno) s askorbatnom kiselinom (1 g jednom dnevno), penicilaminom (250 mg četiri puta dnevno), i trientinom (250 mg četiri puta dnevno).
Wilzin blocks the absorption of copper from the intestine thereby preventing its transfer into the blood and its further accumulation in the body.
Wilzin blokira apsorpciju bakra iz crijeva i na taj način sprečava njegov prijenos u krv te njegovo daljnje nakupljanje u tijelu.
Laboratory follow-up including haematological surveillance and lipoproteins determination should also be performed in order to detect early manifestations of copper deficiency, such as anaemia and/or leukopenia resulting from bone marrow depression, and decrease in HDL cholesterol and HDL/total cholesterol ratio.
Laboratorijsko praćenje, uključujući hematološki nadzor i određivanje lipoproteina treba također provoditi kako bi se otkrile rane manifestacije deficijencije bakra, poput anemije i/ili leukopenije koje proizlaze iz depresije koštane srži, te smanjenja HDL kolesterola i omjera HDL/ukupni kolesterol.
The faecal excretion is in the greatest part due to the passage of unabsorbed zinc but it is also due to endogenous intestinal secretion.
Izlučivanje stolicom najvećim je dijelom posljedica pasaže neapsorbiranog cinka, ali je također posljedica i endogenog crijevnog lučenja.
Treatment of overdose should be with gastric lavage or induced emesis as quickly as possible to remove unabsorbed zinc.
U liječenju predoziranja treba izvršiti ispiranje želuca ili izazvati povraćanje što je brže moguće kako bi se odstranio neapsorbirani cink.
- If you have any further questions, please ask your doctor or pharmacist.
- Ukoliko imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
Reproduction toxicology studies performed with different zinc salts showed no clinically relevant evidence of embryotoxicity, foetotoxicity or teratogenicity.
Ispitivanja reproduktivne toksikologije provedene s različitim cinkovim solima nisu pokazale klinički značajne dokaze embriotoksičnosti, fetotoksičnosti ili teratogenosti.
Unabsorbed copper is then eliminated in the stool.
Neapsorbirani bakar se zatim izlučuje stolicom.
Death occurred in a 35 year-old woman on the fifth day after ingestion of 6 g of zinc (40 times the proposed therapeutic dose) and was attributed to renal failure and haemorrhagic pancreatitis with hyperglycaemic coma.
Kod 35-godišnje žene peti dan nakon ingestije 6 g cinka (40 puta više od preporučene terapijske doze) došlo je do smrtnog ishoda koji je bio pripisan zatajenju bubrega i hemoragičnom pankreatitisu s hiperglikemijskom komom.
It allows continued monitoring of the benefit/risk balance of the medicinal product.
Time se omogućuje kontinuirano praćenje omjera koristi i rizika lijeka.
Reporting of suspected adverse reactions
Prijavljivanje sumnji na nuspojavu
Another adolescent who ingested 4 g of zinc had serum zinc level of about 50 mg/l 5 hours later and only experienced severe nausea, vomiting and dizziness.
Drugi adolescent koji je uzeo 4 g cinka imao je 5 sati nakon toga razinu cinka u serumu od oko 50 mg/l te je samo imao tešku mučninu, povraćanje i vrtoglavicu.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU I UNUTRAŠNJEM PAKOVANJU
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Nevertheless, while awaiting zinc induced duodenal metallothionein production and consequential effective inhibition of copper absorption, zinc acetate dehydrate could be administered initially in symptomatic patients in combination with a chelating agent.
Međutim, dok se čeka cinkom potaknuta proizvodnja metalotioneina u dvanaesniku te posljedična učinkovita inhibicija apsorpcije bakra, cinkov acetat dihidrat može se inicijalno primijeniti kod simptomatskih bolesnika u kombinaciji s kelirajućim agensom.
Please discuss the matter with your Wilson's disease doctor if this affects you.
Molimo, ako se ovo odnosi na Vas, taj problem raspravite sa svojim liječnikom koji se bavi liječenjem Wilsonove bolesti.
Important information about some of the ingredients of Wilzin Wilzin 50 mg hard capsules contains sunset yellow FCF (E110) which may cause allergic reactions.
Važne informacije o nekim sastojcima Wilzina Wilzin 50 mg tvrde kapsule sadrže boju sunset yellow FCF (E110) koja može izazvati alergijske reakcije.
White HDPE bottle with a polypropylene and HDPE closure and contains a filler (cotton coil).
Bijela HDPE bočica s polipropilenskim i HDPE zatvaračem koja sadrži umetak od pamučne vate.
No conventional carcinogenicity study has been conducted with zinc acetate dihydrate.
Sa cinkovim acetat dihidratom nisu provedene konvencionalne studije karcinogenosti.
In treated patients, assays of urinary and/or plasma zinc may be a useful measure of treatment compliance.
Kod bolesnika koji primaju terapiju, mjerenje cinka u mokraći i/ili plazmi može biti korisna mjera za suradljivost.
Symptomatic patients must be initially treated with a chelating agent; once copper levels are below toxic thresholds and patients are clinically stable, maintenance treatment with Wilzin can be considered.
Simptomatske bolesnike mora se početno liječiti kelirajućim agensom; kada je razina bakra ispod praga toksičnosti i bolesnici postanu klinički stabilni, može se razmotriti terapija održavanja Wilzinom.
Like with all anti-copper agents overtreatment carries the risk of copper deficiency, which is especially harmful for children and pregnant women since copper is required for proper growth and mental development.
Kao kod svih lijekova koji snižavaju bakar prekomjerno liječenje nosi rizik deficijencije bakra, što je osobito štetno za djecu i trudnice jer je bakar potreban za pravilan rast i mentalni razvoj.
The oral LD50 is approximately 300 mg zinc/kg body weight (about 100 to 150 times the human therapeutic dose).
Oralna LD50 je oko 300 mg cinka/kg tjelesne težine (oko 100 do 150 puta viša od terapijske doze kod ljudi).
Zinc is absorbed in the small intestine and its absorption kinetics suggest a tendency to saturation at increasing doses.
Cink se apsorbira u tankom crijevu te kinetika njegove apsorpcije sugerira sklonost zasićenju pri porastu doza.
No studies on the effects on the ability to drive and use machines have been performed.
Nisu provedene studije utjecaja na sposobnost upravljanja vozilima i rada na strojevima.
BEFORE YOU TAKE WILZIN
PRIJE NEGO POČNETE UZIMATI WILZIN
The capsule shell contains gelatin, titanium dioxide (E171) and either brilliant blue FCF (E133) for Wilzin 25 mg, or sunset yellow FCF (E110) for Wilzin 50 mg.
Ovojnica kapsule sadrži želatinu, titanijev dioksid (E171) te ili brilliant blue FCF (E133) za Wilzin 25 mg ili sunset yellow FCF (E110) za Wilzin 50 mg.
The capsule shell contains sunset yellow FCF (E110), which may cause allergic reactions.
Ovojnica kapsule sadrži boju sunset yellow FCF (E110), koja može uzrokovati alergijske reakcije.
To administer Wilzin to children who are unable to swallow capsules, open the capsule and mix the powder with a little water (possibly flavoured with sugar or syrup).
Da biste dali Wilzin djeci koja nisu sposobna gutati kapsule, otvorite kapsulu te pomiješajte prah s malo vode (u koju može biti dodan šećer ili sirup).
The active substance is zinc.
Djelatna tvar je cink.
6.1 List of excipients Capsule content maize starch magnesium stearate
Sadržaj kapsule kukuruzni škrob magnezijev stearat
Values of urinary zinc above 2 mg/24 h and of plasma zinc above 1250 microgram/l generally indicate adequate compliance.
Vrijednosti cinka u mokraći veće od 2 mg/24 h te cinka u plazmi veće od 1250 mikrograma/l općenito upućuju na primjerenu suradljivost.
PHARMACEUTICAL FORM AND CONTENTS
OBLIK I SADRŽAJ
The absorption of zinc may be reduced by iron and calcium supplements, tetracyclines and phosphorus-containing compounds, while zinc may reduce the absorption of iron, tetracyclines, fluoroquinolones.
Apsorpciju cinka mogu smanjiti dodaci željeza i kalcija, tetraciklini i tvari koje sadrže fosfor, a cink može smanjiti apsorpciju željeza, tetraciklina i fluorokinolona.
Caution should be exercised when switching patients with portal hypertension from a chelating agent to Wilzin, when such patients are doing well and the treatment is tolerated.
Treba biti oprezan prilikom zamjene kelirajućeg agensa s Wilzinom kod bolesnika s portalnom hipertenzijom, kad su takvi bolesnici dobro i podnose liječenje.
When the liver capacity of storing copper is exceeded copper is released into the blood and is taken up in extra hepatic sites, such as the brain, resulting in motor disorders and psychiatric manifestations.
Kada se pređe kapacitet jetre za pohranu bakra, bakar se otpušta u krv te ga preuzimaju druga tkiva, poput mozga, što dovodi do poremećaja motorike i psihijatrijskih manifestacija.
Substances in food, especially phytates and fibres, bind zinc and prevent it from entering the intestinal cells.
Tvari u hrani, osobito fitati i vlakna, vežu cink i sprečavaju njegov ulazak u stanice crijeva.
ANNEX III
DODATAK III
The urinary excretion of copper is an accurate reflection of body loading with excess copper only when patients are not on chelation therapy.
Izlučivanje bakra mokraćom precizan je pokazatelj viška bakra u tijelu jedino kada bolesnici nisu na kelirajućoj terapiji.
The bound copper is then eliminated in the stool following desquamation of the intestinal cells.
Vezani bakar se zatim eliminira stolicom nakon deskvamacije stanica crijeva.
5.3 Preclinical safety data
5.3 Neklinički podaci o sigurnosti primjene
HOW TO TAKE WILZIN
KAKO UZIMATI WILZIN
If you have any further questions on the use of this medicine, ask your doctor.
U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku.
In children who are unable to swallow capsules, these should be opened and their content suspended in a little water (possibly sugar or syrup flavoured water).
Kod djece koja nisu u stanju progutati kapsule, treba ih otvoriti i njihov sadržaj pomiješati u malo vode (u koju može biti dodan šećer ili sirup).
When switching a patient on chelating treatment to Wilzin for maintenance therapy, the chelating treatment should be maintained and co-administered for 2 to 3 weeks since this is the time it takes for the zinc treatment to induce maximum metallothionein induction and full blockade of copper absorption.
Prilikom promjene bolesnikove terapije s kelirajućeg liječenja na terapiju održavanja Wilzinom, kelirajuće liječenje treba nastaviti i istodobno davati kroz 2-3 tjedna jer je toliko vremena potrebno da bi terapija cinkom dovela do maksimalne indukcije metalotioneina i potpune blokade apsorpcije bakra.
Recordati Rare Diseases Teл.
Recordati Rare Diseases Tel.
The active moiety in zinc acetate dihydrate is zinc cation, which blocks the intestinal absorption of copper from the diet and the reabsorption of endogenously secreted copper.
Aktivna skupina u cinkovom acetat dihidratu je cinkov kation, koji blokira crijevnu apsorpciju bakra iz hrane te reapsorpciju endogeno izlučenog bakra.
The other ingredients are maize starch and magnesium stearate.
Pomoćne tvari su kukuruzni škrob i magnezijev stearat.
• rare:
• rijetko:
The printing ink contains black iron oxide (E172) and shellac.
Tinta za označavanje sadrži crni željezov oksid (E172) i šelak.
Pharmacodynamic investigations of copper metabolism in patients with Wilson's disease included determinations of net copper balance and radiolabelled copper uptake.
Farmakodinamska ispitivanja metabolizma bakra kod bolesnika s Wilsonovom bolesti uključivale su određivanje ukupne ravnoteže bakra i unos radiaktivno označenog bakra.
Zinc induces the production of metallothionein in the enterocyte, a protein that binds copper thereby preventing its transfer into the blood.
Cink potiče proizvodnju metalotioneina u enterocitima, proteina koji veže bakar sprečavajući time njegov prijenos u krv.
Which treatment should be used, zinc or chelating agent should be decided by the physician.
Odluku koje liječenje koristiti, cink ili kelirajući agens, treba donijeti liječnik.
5.2 Pharmacokinetic properties
5.2 Farmakokinetička svojstva
Capsule shell gelatin titanium dioxide (E171) brilliant blue FCF (E133)
Ovojnica kapsule želatina titanijev dioksid (E171) brilliant blue FCF (E133)
Medicinal product subject to medical prescription.
Lijek se izdaje na recept.
• For adults: The usual dose is 1 hard capsule of Wilzin 50 mg (or 2 hard capsules of Wilzin 25 mg) three times daily with a maximum dose of 1 hard capsule of Wilzin 50 mg (or 2 hard capsules of Wilzin 25 mg) five times daily.
• Za odrasle: Uobičajena doza je 1 tvrda kapsula Wilzina od 50 mg (ili 2 tvrde kapsule Wilzina od 25 mg) tri puta dnevno s maksimalnom dozom od 1 tvrde kapsule Wilzina od 50 mg (ili 2 tvrde kapsule Wilzina od 25 mg) pet puta dnevno.
Wilzin 50 mg is an orange opaque hard capsule imprinted “93-377”.
Wilzin 50 mg je narančasta neprozirna tvrda kapsula s otisnutom oznakom “93-377”.
Wilzin 25 mg is an aqua blue hard capsule imprinted "93-376”.
Wilzin 25 mg je vodeno plava tvrda kapsula s otisnutom oznakom "93-376”.
System organ class
Organski sustav
Preclinical studies have been conducted with zinc acetate and with other zinc salts.
Provedene su pretklinička ispitivanja sa cinkovim acetatom i s drugim cinkovim solima.
CLINICAL PARTICULARS
KLINIČKI PODACI
Reported adverse reactions are listed below, by system organ class and by frequency.
Zabilježene nuspojave navedene su dolje, prema organskom sustavu i učestalosti.
4.2 Posology and method of administration
4.2 Doziranje i način primjene
Wilzin is available in hard capsules of 25 mg or 50 mg.
Wilzin je dostupan u tvrdim kapsulama od 25 mg ili 50 mg.
Three cases of acute oral overdose with zinc salts (sulphate or gluconate) have been reported in the literature.
U literaturi su zabilježena tri slučaja akutnog oralnog predoziranja cinkovim solima (sulfatom ili glukonatom).
The elimination of zinc results primarily from faecal excretion with relatively little from urine and sweat.
Eliminacija cinka prvenstveno je posljedica izlučivanja stolicom uz relativno malo putem mokraće i znoja.
Capsule shell gelatin titanium dioxide (E171) sunset yellow FCF (E110)
Ovojnica kapsule želatina titanijev dioksid (E171) sunset yellow FCF (E110)
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
• Pregnant women:
• Trudnice:
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Nakon dobivanja odobrenja lijeka važno je prijavljivanje sumnji na njegove nuspojave.
Name and address of the manufacturer responsible for batch release
Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
METHOD AND ROUTE(S) OF ADMINISTRATION
NAČIN I PUT(EVI) PRIMJENE LIJEKA
The recommended dosage is as follows: - from 1 to 6 years: 25 mg twice daily - from 6 to 16 years if bodyweight under 57 kg: 25 mg three times daily - from 16 years or if bodyweight above 57 kg: 50 mg three times daily.
Preporučena doza je sljedeća: - od 1 do 6 godina: 25 mg dva puta dnevno - od 6 do 16 godina ako je tjelesna težina ispod 57 kg: 25 mg tri puta dnevno - od 16 godina ili ako je tjelesna težina iznad 57 kg: 50 mg tri puta dnevno.
For the different dose regimens Wilzin is available in hard capsules of 25 mg or 50 mg.
Za različite sheme doziranja Wilzin je dostupan u obliku tvrdih kapsula od 25 mg ili 50 mg.
Capsule with orange opaque cap and body, imprinted "93-377”.
Kapsula s narančastom neprozirnom kapicom i tijelom, s otisnutom oznakom "93-377”.
See the package leaflet for further information.
Za dodatne informacije pogledajte Uputu o lijeku.
Printing ink black iron oxide (E172) shellac
Tinta za označavanje crni željezov oksid (E172) šelak
What Wilzin is and what it is used for Before you take Wilzin How to take Wilzin Possible side effects 5 How to store Wilzin Further information
Kako uzimati Wilzin 4. Moguće nuspojave 5. Kako čuvati Wilzin 6.
INSTRUCTIONS ON USE
15. UPUTE ZA UPORABU
OUTER CARTON BOX AND BOTTLE LABEL (Wilzin 25 mg hard capsules)
VANJSKA KARTONSKA KUTIJA I NALJEPNICA NA BOCI (Wilzin 25 mg tvrde kapsule)
Pregnancy
Trudnoća
OUTER CARTON BOX AND BOTTLE LABEL (Wilzin 50 mg hard capsules)
VANJSKA KARTONSKA KUTIJA I NALJEPNICA NA BOCI (Wilzin 50 mg tvrde kapsule)
Gastrointestinal disorders common:
Poremećaji probavnog sustava često:
Fractional zinc absorption is negatively correlated with zinc intake.
Udio apsorpcije cinka negativno korelira s unosom cinka.
affects 1 to 10 users in 100
pojavljuju se kod 1 do 10 na 100 bolesnika
A. LABELLING
OZNAČAVANJE
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
The most common undesirable effect is gastric irritation.
Najčešća nuspojava je iritacija želuca.
Capsule with aqua blue opaque cap and body, imprinted "93-376”.
Kapsula s vodeno plavom neprozirnom kapicom i tijelom, s otisnutom oznakom "93-376”.
The liver is the main storage for zinc and hepatic zinc levels are increased during maintenance therapy with zinc.
Jetra je glavno mjesto pohrane cinka te je razina cinka u jetri povećana tijekom terapije održavanja cinkom.
The same dose did not produce any symptoms except for vomiting in an adolescent who was treated by whole-bowel irrigation.
Ista doza kod adolescenta koji je liječen ispiranjem čitavog crijeva nije dovela do nikakvih simptoma osim povraćanja.
Zinc is excreted in human breast milk and zinc-induced copper deficiency in the breast-fed baby may occur.
Cink se izlučuje u majčino mlijeko te kod dojenog djeteta može doći do deficijencije bakra uzrokovane cinkom.