natgillin/translations-raw huggingface dataset:
Wilzin was not compared to either a dummy treatment, or to the medicines already used in Wilson’ s disease.
Večina bolnikov je zdravilo prejemala v okviru » nekontrolirane « raziskave: zdravila Wilzin niso primerjali ne s placebom ne z zdravili, ki se sicer uporabljajo za zdravljenje Wilsonove bolezni.
The main measure of effectiveness was whether patients had adequate control of copper levels.
Glavni pokazatelj učinkovitosti je bilo, ali je pri bolnikih doseženo ustrezno vzdrževanje ravni bakra.
Wilzin was shown to be effective in significantly reducing copper absorption and reducing the amount of copper in the body.
Zdravilo Wilzin se je izkazalo kot učinkovito pri zmanjševanju absorpcije bakra in zmanjševanju količine bakra v telesu.
In the main study, 91% of patients had adequate control of their copper levels within the first year of treatment with Wilzin.
V okviru glavne raziskave je 91% bolnikov v prvem letu zdravljenja z zdravilom Wilzin doseglo ustrezno vzdrževanje ravni bakra.
The most common side effect is gastric irritation.
Najpogostejši neželeni učinek zdravila je draženje želodca.
This is usually worst with the first morning dose and disappears after the first few days of treatment.
Navadno so težave najhujše pri prvem jutranjem odmerku, po prvih nekaj dneh zdravljenja pa izginejo.
Delaying the first dose to midmorning or taking the dose with a little protein-containing food (e. g. meat) may help.
Preložitev prvega odmerka na sredino dopoldneva ali jemanje odmerka z malo beljakovinske hrane (npr. mesa) navadno olajša simptome.
Other side effects include increases in certain blood enzymes.
Drugi neželeni učinki vključujejo povečanje koncentracij nekaterih encimov v krvi.
For the full description of the side effects reported with Wilzin, please see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Wilzin, najdete v Navodilih za uporabo.
Wilzin should not be given to patients who are allergic to zinc.
Zdravilo Wilzin se ne sme dajati bolnikom, ki so alergični na cink.
As Wilson’ s disease is a fatal disease, and the medicines that are already used for the disease have side effects, the Committee for Medicinal products for Human Use (CHMP) decided that Wilzin’ s benefits are greater than its risks and recommended Marketing Authorisation.
Z ozirom na dejstvo, da je Wilsonova bolezen smrtna ter da imajo zdravila, ki se že uporabljajo, neželene učinke, je Odbor za zdravila za uporabo v humani medicini (CHMP) odločil, da so koristi zdravila Wilzin večje od z njim povezanih tveganj, ter priporočil, da se za zdravilo Wilzin podeli dovoljenje za promet z zdravilom.
The European Commission granted a marketing authorisation valid throughout the European Union for Wilzin to Orphan Europe SARL, on 13 October 2004.
Evropska komisija je dovoljenje za promet z zdravilom Wilzin, veljavno po vsej Evropski uniji, odobrila družbi Orphan Europe SARL dne 13. oktobra 2004.
See http: / /pharmacos. eudra. org/ F2/ register/ o050. htm for the Orphan designation for Wilzin.
http: // pharmacos. eudra. org/ F2/ register/ o050. htm.
The full EPAR for Wilzin can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Wilzin je na voljo tukaj.
Hard capsule Hard capsule
Steklenička (HDPE)
Bottle (HDPE) Bottle (HDPE)
Steklenička (HDPE)
250 capsules 250 capsules
250 kapsul
Each hard capsule contains 25 mg of zinc (corresponding to 83.92 mg of zinc acetate dihydrate).
Ena trda kapsula vsebuje 25 mg cinka (kar ustreza 83, 92 mg cinkovega acetata dihidrata).
Size 1 hard capsule with aqua blue opaque cap and body, imprinted "93-376”.
1 s pariško modrim neprozornim pokrovom in telesom, z napisom "93- 376 ”.
Treatment of Wilson’ s disease.
Zdravljenje Wilsonove bolezni.
Wilzin treatment should be initiated under the supervision of a physician experienced in the treatment of Wilson’ s disease (see section 4.4).
Zdravljenje z Wilzinom se mora uvesti pod nadzorom zdravnika, ki je izkušen v zdravljenju Wilsonove bolezni (glejte poglavje 4. 4).
There is no difference in dosage between symptomatic and presymptomatic patients.
Odmerjanje pri presimptomatskih bolnikih je enako kot pri simptomatskih bolnikih.
The usual dosage is 50 mg 3 times daily with a maximum dose of 50 mg 5 times daily. • Children and adolescents:
Običajno odmerjanje je 50 mg trikrat na dan, največji odmerek je 50 mg petkrat na dan. • Otroci in mladostniki:
The recommended dosage is as follows:
Priporočeno odmerjanje je:
- from 1 to 6 years:
- od 1 do 6 let:
25 mg twice daily
25 mg dvakrat na dan
- from 6 to 16 years if bodyweight under 57 kg:
- od 6 do 16 let, če je telesna masa manjša od 57 kg:
25 mg three times daily
25 mg trikrat na dan
- from 16 years or if bodyweight above 57 kg:
- od 16 let naprej ali če je telesna masa večja od 57 kg:
50 mg three times daily.
50 mg trikrat na dan.
A dosage of 25 mg 3 times daily is usually effective but the dosage should be adjusted to copper levels (see section 4.4 and section 4.6).
Navadno je učinkovito odmerjanje 25 mg trikrat na dan, vendar je treba odmerjanje prilagoditi koncentracijam bakra (glejte poglavje 4. 4 in poglavje 4. 6).
In all cases, dosage should be adjusted according to therapeutic monitoring (see section 4.4.).
V vseh primerih je treba odmerjanje prilagoditi glede na terapevtsko spremljanje (glejte poglavje 4. 4).
Wilzin must be taken on an empty stomach, at least 1 hour before or 2-3 hours after meals.
Wilzin je treba jemati na prazen želodec, vsaj 1 uro pred obroki ali 2- 3 ure po obrokih.
It is also possible to take Wilzin with a little protein, such as meat (see section 4.5).
Wilzin se lahko vzame tudi z malo beljakovin, na primer mesa (glejte poglavje 4. 5).
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 2 the zinc treatment to induce maximum metallothionein induction and full blockade of copper absorption.
Kadar bolniku, ki se zdravi s kelatorji, zamenjujemo kelatorje z Wilzinom za vzdrževalno zdravljenje, je treba zdravljenje s kelatorji vzdrževati in nadaljevati skupaj z Wilzinom še 2 do 3 tedne, ker toliko 2 časa traja, da zdravljenje s cinkom povzroči maksimalno indukcijo metalotioneina in popolno blokado absorpcije bakra.
Therapeutic monitoring The aim of the treatment is to maintain the plasma free copper (also known as non-ceruloplasmin plasma copper) below 250 microgram/ l (normal:
Terapevtsko spremljanje Cilj zdravljenja je vzdrževanje koncentracije prostega bakra v plazmi (ki je znan tudi kot neceruloplazminski plazemski baker) pod 250 mikrogramov/ l (normalna koncentracija:
100-150 microgram/ l) and the urinary copper excretion below 125 microgram/ 24 h (normal: < 50 microgram/ 24 h).
100- 150 mikrogramov/ l) in izločanje bakra z urinom pod 125 mikrogrami/ 24 ur (normalno: < 50 mikrogramov/ 24 ur).
In treated patients, assays of urinary and/ or plasma zinc may be a useful measure of treatment compliance.
Pri zdravljenih bolnikih je lahko določanje cinka v urinu in/ ali plazmi koristno merilo tega, koliko se bolniki držijo navodil za zdravljenje.
Values of urinary zinc above 2 mg/ 24 h and of plasma zinc above 1250 microgram/ l generally indicate adequate compliance.
Vrednosti cinka v urinu, večje od 2 mg/ 24 ur, in cinka v plazmi, večje od 1250 mikrogramov/ l, na splošno kažejo, da se bolnik zadostno drži navodil.
40 – 50 microgram/ 24 h).
Pri teh skupinah bolnikov naj bodo ravni bakra v urinu vzdrževane malo nad zgornjo mejo normalnih vrednosti ali v visokem delu normalnega območja (t. j., 40 – 50 mikrogramov/ 24 ur).
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.
Opravljati je treba tudi kontrolne laboratorijske preiskave, s hematološkim nadzorom in določanjem lipoproteinov vred, da odkrijemo zgodnje znake pomanjkanja bakra, na primer anemijo in/ ali levkopenijo, ki sta posledica depresije kostnega mozga, in znižanje HDL holesterola in razmerja HDL/ celotni holesterol.
3 In case of gastric intolerance, often occurring with the morning dose, this dose may be delayed to mid- morning, between breakfast and lunch.
Če bolnikov želodec ne prenaša zdravila, kar se pogosto dogaja pri jutranjem odmerku, lahko bolnik ta odmerek preloži na sredino dopoldneva, na čas med zajtrkom in kosilom.
Other anti-copper agents 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).
Druga sredstva proti bakru Pri bolnikih z Wilsonovo boleznijo so opravili farmakodinamične študije kombinacije Wilzina (50 mg trikrat na dan) z askorbinsko kislino (1 g enkrat na dan), penicilamina (250 mg štirikrat na dan), in trientina (250 mg štirikrat na dan).
Other medicinal products 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.
Druga zdravila Absorpcijo cinka lahko zmanjšajo dodatki železa in kalcija, tetraciklini in spojine, ki vsebujejo fosfor, medtem ko cink lahko zmanjša absorpcijo železa, tetraciklinov in fluorokinolonov.
Food Studies of the co-administration of zinc with food performed in healthy volunteers showed that the absorption of zinc was significantly delayed by many foods (including bread, hard boiled eggs, coffee and milk).
Hrana Študije sočasnega jemanja cinka s hrano, opravljene na zdravih prostovoljcih, so pokazale, da so absorpcijo cinka pomembno upočasnile številne vrste hrane (med drugim kruh, trdo kuhana jajca, kava in mleko).
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.
Podatki, zbrani pri omejenem številu izpostavljenih nosečnosti pri bolnicah z Wilsonovo boleznijo ne kažejo na možnost škodljivih vplivov cinka na zarodek/ plod in mater.
Animal studies conducted with different zinc salts do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih, opravljene z različnimi cinkovimi solmi, niso pokazale neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
It is extremely important that pregnant Wilson’ s disease patients continue their therapy during pregnancy.
Izredno pomembno je, da nosečnice z Wilsonovo boleznijo med nosečnostjo nadaljujejo z zdravljenjem.
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).
Potrebne so prilagoditve odmerka, ki bodo zagotovile, da plodu ne bo manjkalo bakra, in obvezno je skrbno spremljanje bolnice (glejte poglavje 4. 4).
Clinical experience of more than 1 000 patient-years with zinc (more than 500 with zinc acetate dihydrate) as well as post-marketing surveillance with zinc acetate dihydrate of more than 1 000 patient-years showed that the most common undesirable effect is gastric irritation.
Klinične izkušnje več kot 1000 bolniških let s cinkom (od tega več kot 500 s cinkovim acetatom dihidratom), pa tudi več kot 1000 bolniških let nadzora po prihodu cinkovega acetata dihidrata na trg so pokazali, da je najpogostejši neželeni učinek draženje želodca.
Frequencies are defined as: very common (> 1/ 10), common (> 1/ 100 ,< 1/10) and uncommon (> 1/1 ,000, < 1/100):
Pogostost je opredeljena kot: zelo pogoste (> 1/ 10), pogoste (> 1/ 100, < 1/ 10) in občasne (> 1/ 1. 000, < 1/ 100):
Blood and lymphatic system disorders Gastrointestinal disorders Laboratory investigations
Bolezni krvi in limfatičnega sistema Bolezni prebavil Laboratorijske preiskave
uncommon: common: common:
občasne: pogoste: pogoste:
sideroblastic anaemia; leukopenia gastric irritation blood amylase, lipase and alkaline phosphatase increased
sideroblastna anemija; levkopenija draženje želodca zvišanje amilaze, lipaze in alkalne fosfataze v krvi
Bone marrow examination usually reveals characteristic "ringed sideroblasts" (i. e. developing red blood cells containing iron-engorged paranuclear mitochondria).
Preiskava kostnega mozga navadno pokaže značilne “ obročaste sideroblaste ” (t. j., razvijajoče se rdeče krvničke, ki vsebujejo z železom nabite paranuklearne mitohondrije).
However, they must be distinguished from haemolytic anaemia which commonly occurs where there is elevated serum free copper in uncontrolled Wilson’ s disease.
Razlikovati pa jih moramo od hemolitične anemije, ki se pogosto pojavi, kadar je pri neobvladani Wilsonovi bolezni zvišan prosti baker v serumu.
Three cases of acute oral overdosage with zinc salts (sulphate or gluconate) have been reported in the literature.
V literaturi so poročali o treh primerih akutnega peroralnega prevelikega odmerjanja cinkovih soli (sulfata ali glukonata).
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.
Petintridesetletna ženska je umrla petega dne po zaužitju 6 g cinka (40- kratni predlagani terapevtski odmerek), smrt so pripisali ledvični odpovedi in hemoragičnemu pankreatitisu s hiperglikemično komo.
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.
Drug mladostnik, ki je zaužil 4 g cinka, je imel 5 ur pozneje koncentracijo cinka v serumu okrog 50 mg/ l, od simptomov in znakov pa samo hudo navzeo, bruhanje in vrtoglavost.
Heavy metal chelation therapy should be considered if plasma zinc levels are markedly elevated (> 10 mg/ l).
Zdravljenje s keliranjem težkih kovin pride v poštev, če je koncentracija cinka v plazmi močno zvišana (> 10 mg/ l).
Pharmacotherapeutic group: various alimentary tract and metabolism product, ATC code:
Farmakoterapevtska skupina: razna zdravila za bolezni prebavil in presnove, Oznaka ATC:
Copper accumulation in the liver leads to hepatocellular injury and eventual cirrhosis.
Ko je kapaciteta jeter za shranjevanje bakra presežena, se začne baker sproščati v kri in ga privzemajo mesta zunaj jeter, na primer možgani, kjer povzroča gibalne motnje in duševne znake.
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
Bolniki lahko klinično kažejo prevladujoče jetrne, nevrološke ali psihiatrične simptome.
5 psychiatric manifestations.
5 Aktivna sestavina cinkovega acetata dihidrata je cinkov kation, ki blokira črevesno absorpcijo bakra iz hrane in reabsorpcijo endogeno izločenega bakra.
Patients may present clinically with predominantly hepatic, neurologic, or psychiatric symptoms.
Cink v enterocitu sproži nastajanje metalotioneina, beljakovine, ki veže baker in s tem prepreči njegov prenos v kri.
Pharmacodynamic investigations of copper metabolism in patients with Wilson’ s disease included determinations of net copper balance and radiolabelled copper uptake.
Farmakodinamične raziskave presnove bakra pri bolnikih z Wilsonovo boleznijo so obsegale tudi določanje neto ravnovesja bakra in privzema radioaktivno označenega bakra.
It ranges from 30 to 60% with usual dietary intake (7-15 mg/ d) and decreases to 7% with pharmacological doses of 100 mg/ d.
Pri običajnem vnosu s hrano (7- 15 mg/ dan), sega od 30 do 60%, pri farmakoloških odmerkih po 100 mg/ dan pa se zmanjša na 7%.
In the blood, about 80% of absorbed zinc is distributed to erythrocytes, with most of the remainder being bound to albumin and other plasma proteins.
V krvi se okrog 80% absorbiranega cinka porazdeli v eritrocite, večina preostalega cinka pa se veže na albumine in druge plazemske beljakovine.
The oral LD50 is approximately 300 mg zinc/ kg body weight (about 100 to 150 times the human therapeutic dose).
Peroralna LD50 je približno 300 mg cinka/ kg telesne teže (okrog 100 do 150- krat več od terapevtskega odmerka za človeka).
Repeat-dose toxicity studies have established that the NOEL (No Observed Effect Level) is about 95 mg zinc/ kg body weight (about 48 times the human therapeutic dose).
Študije toksičnosti ponavljajočih se odmerkov so pokazale, da je NOEL (raven, pri kateri ni opaznega učinka) okrog 95 mg cinka/ kg telesne teže (okrog 48- krat več od terapevtskega odmerka za človeka).
Capsule content: maize starch magnesium stearate Capsule shell: gelatin titanium dioxide (E171) brilliant blue FCF (E133) Printing ink: black iron oxide (E172) shellac
Vsebina kapsule: koruzni škrob magnezijev stearat Ovoj kapsule: želatina titanov dioksid (E171) briljantno modro FCF (E133)
White HDPE bottle which is equipped with a polypropylene and HDPE closure and contains a filler (cotton coil).
Plastenka iz belega HDPE, ki je opremljena s pokrovčkom iz polipropilena in HDPE in vsebuje polnilo (zvitek vate).
Orphan Europe SARL Immeuble “ Le Wilson” F-92058 Paris-La-Défense - France
Orphan Europe SARL Immeuble “ Le Wilson ” F- 92058 Paris- La- Défense - Francija
Each hard capsule contains 50 mg of zinc (corresponding to 167.84 mg of zinc acetate dihydrate).
Ena trda kapsula vsebuje 50 mg cinka (kar ustreza 167, 84 mg cinkovega acetata dihidrata).
Size 1 hard capsule with orange opaque cap and body, imprinted "93-377”.
1 z oranžnim neprozornim pokrovom in telesom, z napisom "93- 377 ”.
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 8 the zinc treatment to induce maximum metallothionein induction and full blockade of copper absorption.
Kadar bolniku, ki se zdravi s kelatorji, zamenjujemo kelatorje z Wilzinom za vzdrževalno zdravljenje, je treba zdravljenje s kelatorji vzdrževati in nadaljevati skupaj z Wilzinom še 2 do 3 tedne, ker toliko 8 časa traja, da zdravljenje s cinkom povzroči maksimalno indukcijo metalotioneina in popolno blokado absorpcije bakra.
In case of gastric intolerance, often occurring with the morning dose, this dose may be delayed to mid- morning, between breakfast and lunch.
Če bolnikov želodec ne prenaša zdravila, kar se pogosto dogaja pri jutranjem odmerku, lahko bolnik ta odmerek preloži na sredino dopoldneva, na čas med zajtrkom in kosilom.
The capsule shell includes sunset yellow FCF (E110) which may cause allergic reactions.
9 Ovojnica kapsule vsebuje sončno rumeno FCF (E110), ki lahko povzroča alergijske reakcije.
Zinc induces the 11 production of metallothionein in the enterocyte, a protein that binds copper thereby preventing its transfer into the blood.
11 Aktivna sestavina cinkovega acetata dihidrata je cinkov kation, ki blokira črevesno absorpcijo bakra iz hrane in reabsorpcijo endogeno izločenega bakra.
The bound copper is then eliminated in the stool following desquamation of the intestinal cells.
Cink v enterocitu sproži nastajanje metalotioneina, beljakovine, ki veže baker in s tem prepreči njegov prenos v kri.
Capsule content: maize starch magnesium stearate Capsule shell: gelatin titanium dioxide (E171) sunset yellow FCF (E110) Printing ink: black iron oxide (E172)
Vsebina kapsule: koruzni škrob magnezijev stearat Ovoj kapsule: želatina titanov dioksid (E171) sončno rumena FCF (E110)
12 shellac
12 Tiskarsko črnilo: črni železov oksid (E172) šelak
Orphan Europe SARL Immeuble "Le Wilson" 70 avenue du Général de Gaulle F-92800 Puteaux France
Orphan Europe SARL Immeuble “ Le Wilson ” 70 avenue du Général de Gaulle F- 92800 Puteaux Francija
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI
Wilzin 25 mg hard capsules Zinc acetate dihydrate
Wilzin 25 mg trde kapsule cinkovega acetata dihidrat
Each hard capsule contains 25 mg of zinc (corresponding to 83.92 mg of zinc acetate dihydrate)
Ena trda kapsula vsebuje 25 mg cinka (kar ustreza 83, 92 mg cinkovega acetata dihidrata).
Do not store above 25°C
Shranjujte pri temperaturi do 25 °C
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI
Wilzin 50 mg hard capsules Zinc acetate dihydrate
Wilzin 50 mg trde kapsule cinkovega acetata dihidrat
Each hard capsule contains 50 mg of zinc (corresponding to 167.84 mg of zinc acetate dihydrate)
Ena trda kapsula vsebuje 50 mg cinka (kar ustreza 167, 84 mg cinkovega acetata dihidrata).
Wilzin 50 mg hard capsules Includes E110.
Vsebuje E110.
22 PACKAGE LEAFLET
22 NAVODILO ZA UPORABO
What Wilzin is and what it is used for 2.
Kaj je zdravilo Wilzin in za kaj ga uporabljamo 2.
Before you take Wilzin 3.
Kaj morate vedeti, preden boste vzeli zdravilo Wilzin 3.
How to take Wilzin 4.
Kako jemati zdravilo Wilzin 4.
Possible side effects 5 Storing Wilzin 6.
Možni neželeni učinki 5 Shranjevanje zdravila Wilzin 6.
Wilzin 25 mg hard capsules Wilzin 50 mg hard capsules zinc acetate dihydrate
Wilzin 25 mg trde kapsule Wilzin 50 mg trde kapsule cinkovega acetata dihidrat
• The active substance is zinc acetate dihydrate.
• Zdravilna učinkovina je cinkovega acetata dihidrat.
Each hard capsule contains 25 mg of zinc (corresponding to 83.92 mg of zinc acetate dihydrate) or 50 mg of zinc (corresponding to 167.84 mg of zinc acetate dihydrate). • The other ingredients are maize starch and magnesium stearate.
Ena trda kapsula vsebuje 25 mg cinka (kar ustreza 83, 92 mg cinkovega acetata dihidrata) ali 50 mg cinka (kar ustreza 167, 84 mg cinkovega acetata dihidrata). • Pomožni snovi sta koruzni škrob in magnezijev stearat.
The capsule shells 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 vsebuje želatino, titanov dioksid (E171) in bodisi briljantno modro FCF (E133) pri Wilzinu 25 mg ali sončno rumeno FCF (E110) pri Wilzinu 50 mg.
Wilzin 25 mg is an aqua blue hard capsule imprinted "93-376”.
Wilzin 25 mg je pariško modra trda kapsula z napisom "93- 376 ”.
Wilzin 50 mg is a orange opaque hard capsule imprinted “ 93-377”.
Wilzin 50 mg je oranžna neprozorna trda kapsula z napisom "93- 377 ”.
The bottle also contains a cotton filler.
Steklenica vsebuje tudi polnilo iz vate.
Wilzin is prescribed for the treatment of Wilson’ s disease, which is a rare inherited defect in copper excretion.
Wilzin predpisujemo za zdravljenje Wilsonove bolezni, ki je redka dedna napaka v izločanju bakra.
Wilson’ s disease will persist during the entire lifetime of the patient and therefore the need for this treatment is life-long.
Wilsonova bolezen traja vse bolnikovo življenje, zato je tudi zdravljenje potrebno vse življenje.
Do not take Wilzin:
Ne jemljite zdravila Wilzin:
If you are hypersensitive (allergic) to zinc or any of the other ingredients of Wilzin.
Če ste preobčutljivi za (alergični na) cink ali katerokoli sestavino zdravila Wilzin.
Take special care with Wilzin:
23 Bodite posebno pozorni pri uporabi/ jemanju zdravila Wilzin:
Wilzin is usually not recommended for initial therapy of patients with signs and symptoms of Wilson’ s disease because of its slow onset of action.
Navadno Wilzina ne priporočajo za začetno zdravljenje bolnikov z znaki in simptomi Wilsonove bolezni zaradi njegovega počasnega nastopa delovanja.
Monitoring may detect evidence of insufficient treatment (copper excess) or excessive treatment (copper deficiency), both of which can be harmful, particularly to growing children and pregnant women.
Oboje utegne biti škodljivo, posebno za otroke, ki rastejo, in nosečnice.
Taking Wilzin with food and drink:
Jemanje zdravila Wilzin skupaj s hrano in pijačo:
Please discuss the matter with your Wilson’ s disease physician if this affects you.
Če to velja za vas, so pogovorite o tem s svojim zdravnikom – specialistom za Wilsonovo bolezen.