natgillin/translations-raw huggingface dataset:
- This medicine has been prescribed for you personally.
- Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
A daily regimen of 150 mg of Wilzin in three administrations was shown to be effective in significantly reducing copper absorption and inducing a negative copper balance.
Izkazalo se je, da je dnevna shema odmerjanja 150 mg Wilzina v treh razdeljenih odmerkih učinkovita, saj je pomembno zmanjšala absorpcijo bakra in povzročila negativno bilanco bakra.
See the package leaflet for further information.
Za nadaljnje informacije glejte navodilo za uporabo.
This potentially leads to liver damage and neurological disorders.
To lahko povzroči okvaro jeter in nevrološke bolezni.
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.
Ker je mehanizem delovanja cinka vpliv na privzem bakra na ravni črevesne celice, farmakokinetične ocene na podlagi koncentracij cinka v krvi ne nudijo koristnih podatkov o biološki uporabnosti cinka na mestu delovanja.
The non-ceruloplasmin plasma copper is calculated by subtracting the ceruloplasmin-bound copper from the total plasma copper, given that each milligram of ceruloplasmin contains 3 micrograms of copper.
Neceruloplazminski plazemski baker izračunamo tako, da od celotnega plazemskega bakra odštejemo baker, vezan na ceruloplazmin, pri čemer upoštevamo, da vsak miligram ceruloplazmina vsebuje 3 mikrograme bakra.
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.
• Do not store above 25°C.
• Shranjujte pri temperaturi do 25 °C.
Please consult your doctor before taking any other medicines which may reduce the effectiveness of Wilzin, such as iron, calcium supplements, tetracyclines (antibiotics) or phosphorus.
Posvetujte se zdravnikom preden vzamete katerokoli zdravilo, ki bi lahko zmanjšalo učinkovitost zdravila Wilzin, na primer železo, dodatki kalcija, tetraciklini (antibiotiki) ali fosfor.
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).
Pri otrocih, ki ne morejo požirati kapsul, je treba kapsule odpreti in njihovo vsebino suspendirati v malo vode (ki je lahko oslajena s sladkorjem ali sirupom).
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.
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).
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., 4050 mikrogramov/24 ur).
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
Contains E110.
SEZNAM POMOŽNIH SNOVI Vsebuje E110.
If you have any further questions on the use of this medicine, ask your doctor.
Za morebitna nadaljnja vprašanja o uporabi tega zdravila se obrnite na svojega zdravnika.
6.1 List of excipients Capsule content maize starch magnesium stearate
6.1 Seznam pomožnih snovi Vsebina kapsule koruzni škrob magnezijev stearat
They may be early manifestations of copper deficiency and may recover rapidly following reduction of zinc dosage.
Ti utegnejo biti zgodnji znak pomanjkanja bakra in se utegnejo po zmanjšanju odmerjanja cinka hitro popraviti.
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
In this case you must ask your doctor for advice.
V tem primeru prosite za nasvet zdravnika.
It is very important to continue anti-copper therapy during pregnancy.
Zelo pomembno je, da med nosečnostjo še naprej jemljete zdravilo proti bakru.
Two patients of a series of 16 died from hepatic decompensation and advanced portal hypertension after being changed from penicillamine to zinc therapy.
Dva bolnika iz skupine 16 bolnikov sta umrla zaradi dekompenzacije jeter in napredovale portalne hipertenzije, potem ko sta prešla s penicilamina na zdravljenje s cinkom.
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).
• Periodic Safety Update Reports
• Redno posodobljena poročila o varnosti zdravila (PSUR)
Do not store above 25°C.
Shranjujte pri temperaturi do 25 °C.
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.
Če so vam Wilzin predpisali skupaj z drugim sredstvom proti bakru, na primer s penicilaminom, pazite, da bo presledek med obema zdraviloma vsaj 1 ura.
6.5 Nature and contents of container
6.5 Vrsta ovojnine in vsebina
If you are currently treated with another anti-copper agent, for example, penicillamine, your doctor may add Wilzin before stopping the initial treatment.
Če se trenutno zdravite z drugim sredstvom proti bakru, na primer s penicilaminom, vam bo mogoče zdravnik dodal Wilzin, še preden vam bo ukinil začetno zdravljenje.
Investigations common:
Preiskave pogosti:
Always take Wilzin on an empty stomach, at least one hour before or 2-3 hours after meals.
Wilzin vedno vzemite na prazen želodec, vsaj 1 uro pred obroki ali 2-3 ure po obrokih.
Therefore, breast-feeding should be avoided during Wilzin therapy.
Zato se je treba dojenju med zdravljenjem z Wilzinom izogibati.
As copper deficiency may also cause myeloneuropathy, physicians should be alert to sensory and motor symptoms and signs which may potentially indicate incipient neuropathy or myelopathy in patients treated with Wilzin.
Ker lahko pomanjkanje bakra povzroči mielonevropatijo, morajo biti zdravniki pozorni na senzorične in motorične simptome ter znake, ki bi lahko kazali na začetke nevropatije ali mielopatije pri bolnikih, ki se zdravijo z zdravilom Wilzin.
The most common undesirable effect is gastric irritation.
Najpogostejši neželeni učinek je draženje želodca.
It is available in packs of 250 hard capsules in a polyethylene bottle closed by a polypropylene and polyethylene closure.
Na voljo je v zloženkah s po 250 trdimi kapsulami v polietilenski plastenki, zaprti s pokrovčkom iz polipropilena in polietilena.
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.
Date of latest renewal: 13 October 2009
Datum zadnjega podaljšanja dovoljenja za promet: 13 oktober 2009
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 bolnike je treba v začetku zdraviti z enim od kelatorjev; ko koncentracije bakra padejo pod prag toksičnosti in se bolniki klinično stabilizirajo, pride v poštev vzdrževalno zdravljenje z Wilzinom.
The plasma elimination half-life of zinc in healthy subjects is around 1 hour after a dose of 45 mg.
Razpolovni čas odstranjevanja cinka iz plazme je pri zdravih osebah po odmerku 45 mg okrog 1 ura.
The weight of evidence, from in vitro and in vivo tests, suggests that zinc has no clinically relevant genotoxic activity.
Teža dokaznega materiala iz testov in vitro in in vivo kaže, da cink nima klinično pomembne genotoksične aktivnosti.
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.
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).
Wilzin date otroku, ki ne more pogoltniti kapsule, tako, da kapsulo odprete in prašek zmešate z malo vode (mogoče oslajene s sladkorjem ali sirupom).
4.9 Overdose
4.9 Preveliko odmerjanje
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 zdravljenja je vzdrževanje koncentracije prostega bakra v plazmi (ki je znan tudi kot neceruloplazminski plazemski baker) pod 250 mikrogramov/l (normalna koncentracija: 100-150 mikrogramov/l) in izločanje bakra z urinom pod 125 mikrogrami/24 ur (normalno: < 50 mikrogramov/24 ur).
Hypersensitivity to the active substance or to any of the excipients.
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
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.
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 Francija
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
Kaj je zdravilo Wilzin in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Wilzin Kako jemati zdravilo Wilzin Možni neželeni učinki
blood amylase, lipase and alkaline phosphatase increased
zvišanje amilaze, lipaze in alkalne fosfataze v krvi
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.
It may also be minimised by taking the first dose of Wilzin with a small amount of protein-containing food, such as meat (but not milk).
Še bolj ga lahko zmanjšate tako, da vzamete prvi odmerek Wilzina z majhno količino beljakovinske hrane, na primer z mesom (ne pa z mlekom).
This side effect may be reduced by postponing the first dose of the day until mid-morning (between breakfast and the midday meal).
Ta neželeni učinek lahko zmanjšate tako, da odložite prvi dnevni odmerek na sredino dopoldneva (med zajtrkom in kosilom).
What Wilzin looks like and contents of the pack
Izgled zdravila Wilzin in vsebina pakiranja
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).
Unabsorbed copper is then eliminated in the stool.
Neabsorbirani baker se nato izloči v blatu.
White HDPE bottle with a polypropylene and HDPE closure and contains a filler (cotton coil).
Plastenka iz belega HDPE s pokrovčkom iz polipropilena in HDPE in vsebuje polnilo (zvitek vate).
Important information about some of the ingredients of Wilzin Wilzin 50 mg hard capsules contains sunset yellow FCF (E110) which may cause allergic reactions.
Pomembne informacije o nekaterih sestavinah zdravila Wilzin Wilzin 50 mg trde kapsule vsebujejo sončno rumeno FCF (E110), ki lahko povzroča alergijske reakcije.
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).
Treatment of overdose should be with gastric lavage or induced emesis as quickly as possible to remove unabsorbed zinc.
Preveliko odmerjanje je treba zdraviti s čimprejšnjim izpiranjem želodca ali umetno sproženim bruhanjem, da odstranimo neabsorbirani cink.
The bottle also contains a cotton filler.
Plastenka vsebuje tudi polnilo iz vate.
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).
The capsule shell contains sunset yellow FCF (E110), which may cause allergic reactions.
Ovojnica kapsule vsebuje sončno rumeno FCF (E110), ki lahko povzroča alergijske reakcije.
Urinary copper levels are usually increased with chelation therapy such as penicillamine or trientine.
Raven bakra v urinu se pri zdravljenju s kelatorji, na primer s penicilaminom ali trientinom, navadno zviša.
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.
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).
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).
The urinary excretion of copper is an accurate reflection of body loading with excess copper only when patients are not on chelation therapy.
Izločanje bakra z urinom je natančen odsev obremenitve telesa z odvečnim bakrom samo takrat, ko se bolniki ne zdravijo s kelatorji.
Reported adverse reactions are listed below, by system organ class and by frequency.
Neželeni učinki, o katerih poročajo, so navedeni spodaj po organskih sistemih in po pogostosti.
In all cases, dose should be adjusted according to therapeutic monitoring (see section 4.4.
V vseh primerih je treba odmerek prilagoditi glede na terapevtsko spremljanje (glejte poglavje 4.4).
PHARMACEUTICAL FORM AND CONTENTS
FARMACEVTSKA OBLIKA IN VSEBINA
The level of hepatic copper cannot be used to manage therapy since it does not differentiate between potentially toxic free copper and metallothionein bound copper.
Raven bakra v jetrih ni uporabna za uravnavanje zdravljenja, ker ne razlikuje med potencialno toksičnim prostim bakrom in bakrom, vezanim na metalotionein.
Wilzin is indicated in the treatment of Wilson's disease, which is a rare inherited defect in copper excretion.
Wilzin se uporablja za zdravljenje Wilsonove bolezni, ki je redka dedna napaka v izločanju bakra.
MANUFACTURER'S BATCH NUMBER
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA
Preclinical studies have been conducted with zinc acetate and with other zinc salts.
Predklinične študije so opravili s cinkovim acetatom in z drugimi cinkovimi solmi.
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 absorpcijo bakra iz črevesa, s čimer prepreči njegov prenos v kri in njegovo nadaljnje kopičenje v telesu.
Please discuss with your doctor.
O tem se posvetujte s svojim zdravnikom.
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.
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.
- If you have any further questions, please ask your doctor or pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
4.4 Special warnings and special precautions for use
4.4 Posebna opozorila in previdnostni ukrepi
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.
A dose of 25 mg 3 times daily is usually effective but the dose should be adjusted to copper levels (see section 4.4 and section 4.6).
Navadno je učinkovit odmerek 25 mg trikrat na dan, vendar je treba odmerek prilagoditi koncentracijam bakra (glejte poglavje 4.4 in poglavje 4.6).
The usual dose is 50 mg 3 times daily with a maximum dose of 50 mg 5 times daily.
Običajen odmerek je 50 mg trikrat na dan, največji odmerek je 50 mg petkrat na dan.
The administration of the chelating treatment and Wilzin should be separated by at least 1 hour.
Med vzetjem kelatorja in Wilzina mora miniti vsaj 1 ura.
If you take more Wilzin than prescribed, you may experience nausea, vomiting and dizziness.
Če ste vzeli večji odmerek zdravila Wilzin od predpisanega, se bodo mogoče pojavili slabost s siljenjem na bruhanje, bruhanje in vrtoglavost.
4.1 Therapeutic indications
KLINIČNI PODATKI 4.1 Terapevtske indikacije
It is also possible to take Wilzin with a little protein, such as meat.
Wilzin lahko vzamete tudi z manjšo količino beljakovin, na primer mesa.
ANNEX II
DODATEK II
They showed no significant overall effect on copper balance although mild interaction of zinc with chelators (penicillamine and trientine) could be detected with decreased faecal but increased urinary copper excretion as compared with zinc alone.
Študije niso pokazale pomembnega neto učinka na ravnovesje bakra, čeprav je bilo možno odkriti blago interakcijo cinka s kelatorji (penicilaminom in trientinom) z zmanjšanim izločanjem bakra v blatu, a zvečanim izločanjem bakra v urinu kot pri cinku samem.
Zinc acetate dihydrate is not recommended for the initial therapy of symptomatic patients because of its slow onset of action.
Cinkov acetat dihidrat zaradi njegovega počasnega začetka delovanja ne priporočamo za začetno zdravljenje simptomatskih bolnikov.
250 hard capsules.
250 trdih kapsul
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 %.
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.
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.
Ko bolnik, ki se zdravi s kelatorjem, prehaja na zdravljenje z Wilzinom za vzdrževalno zdravljenje, je treba zdravljenje s kelatorjem vzdrževati in zdravili sočasno uporabljati še 2 do 3 tedne, ker traja toliko časa, da zdravljenje s cinkom inducira maksimalno indukcijo metalotioneina in popolno blokado absorpcije bakra.
Wilson's disease (hepatolenticular degeneration) is an autosomal recessive metabolic defect in hepatic excretion of copper in the bile.
Wilsonova bolezen (hepatolentikularna degeneracija) je avtosomna recesivna presnovna napaka v izločanju bakra iz jeter v žolč.
Ask your pharmacist how to dispose of medicines no longer required.
O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
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.
Bodite posebno pozorni pri uporabi/jemanju zdravila Wilzin Navadno Wilzina ne priporočajo za začetno zdravljenje bolnikov z znaki in simptomi Wilsonove bolezni zaradi njegovega počasnega nastopa delovanja.
Wilzin belongs to a group of medicines called Various Alimentary Tract and metabolism products.
Zdravilo Wilzin spada v skupino zdravil, ki jo imenujemo razna zdravila za bolezni prebavil in presnove.
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 sestavina cinkovega acetata dihidrata je cinkov kation, ki blokira črevesno absorpcijo bakra iz hrane in reabsorpcijo endogeno izločenega bakra.
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.
Kljub temu bi lahko, tačas ko čakamo, da se v dvanajstniku začne nastajanje metalotioneina, ki ga sproži cink in ki povzroči učinkovito inhibicijo absorpcije bakra, pri simptomatskih bolnikih v začetku uporabili cinkov acetat dihidrat v kombinaciji s kelatorjem.
ANNEX I
DODATEK I
Zinc is absorbed in the small intestine and its absorption kinetics suggest a tendency to saturation at increasing doses.
Cink se absorbira v tankem črevesu, kinetika njegove absorpcije pa kaže tendenco nasičenja pri naraščajočih odmerkih.
POSSIBLE SIDE EFFECTS Like all medicines, Wilzin can cause side effects, although not everybody gets them..
Kot vsa zdravila lahko tudi zdravilo Wilzin povzroča neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Fractional zinc absorption is negatively correlated with zinc intake.
Frakcijska absorpcija cinka je negativno korelirana z vnosom cinka.
Five miscarriages and 2 birth defects (microcephaly and correctable heart defect) were reported in 42 pregnancies.
Pri 42 nosečnostih so poročali o 5 splavih in 2 okvarah ploda (mikrocefalija in operabilne srčne hibe).
SUMMARY OF PRODUCT CHARACTERISTICS
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
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).
No conventional carcinogenicity study has been conducted with zinc acetate dihydrate.
Z cinkovega acetata dihidratom niso opravili konvencionalnih študij kancerogenosti.
6.6 Special precautions for disposal
6.6 Posebni varnostni ukrepi za odstranjevanje