natgillin/translations-raw huggingface dataset:
This means that Nemdatine is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Ebixa.
What is Nemdatine and what is it used for?
Kaj je zdravilo Nemdatine in za kaj se uporablja?
Nemdatine is a ‘generic medicine'.
Zdravilo Nemdatine je „generično zdravilo“.
It is not intended to provide practical advice on how to use Nemdatine.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
This is a summary of the European public assessment report (EPAR) for Nemdatine.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Nemdatine.
The Committee recommended that Nemdatine be approved for use in the EU.
Priporočil je, da se zdravilo Nemdatine odobri za uporabo v EU.
Memantine works by blocking special types of receptor called NMDA receptors to which the neurotransmitter glutamate normally attaches.
Memantin deluje tako, da zavira posebno vrsto receptorjev, imenovanih receptorji NMDA, na katere se živčni prenašalec glutamat navadno veže.
Nemdatine is available as 5 mg, 10 mg, 15 mg and 20 mg tablets and can only be obtained with a prescription.
Zdravilo Nemdatine je na voljo v obliki 5-, 10-, 15- in 20-miligramskih tablet in se izdaja le na recept.
Treatment should only be started if a caregiver is available who will regularly monitor the use of Nemdatine by the patient.
Zdravljenje se sme uvesti samo, če je na voljo negovalec, ki bo redno spremljal bolnikovo jemanje zdravila Nemdatine.
The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuing treatment with Nemdatine should be reassessed on a regular basis.
Prenašanje in odmerek zdravila je treba oceniti v 3 mesecih od začetka zdravljenja, od takrat naprej pa je treba koristi zdravljenja z zdravilom Nemdatine ponovno ocenjevati v rednih intervalih.
Because Nemdatine is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Nemdatine generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer's disease.
Memantin z zaviranjem receptorjev NMDA izboljšuje prenos signalov v možganih in zmanjšuje simptome Alzheimerjeve bolezni.
Other information about Nemdatine
Druge informacije o zdravilu Nemdatine
Why is Nemdatine approved?
Zakaj je bilo zdravilo Nemdatine odobreno?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Nemdatine has been shown to have comparable quality and to be bioequivalent to Ebixa.
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Nemdatine primerljivo raven kakovosti kot zdravilo Ebixa ter da mu je biološko enakovredno.
Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer's disease.
Spremembe načina, kako glutamat prenaša signale v možganih, se povezujejo z izgubo spomina, kakršno je opaziti pri Alzheimerjevi bolezni.
For more information about treatment with Nemdatine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Nemdatine preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For more information, see the package leaflet.
Za več informacij glejte navodilo za uporabo.
It contains the active substance memantine.
Vsebuje zdravilno učinkovino memantin.
Safety information has been included in the summary of product characteristics and the package leaflet for Nemdatine, including the appropriate precautions to be followed by healthcare professionals and patients.
V povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Nemdatine so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Because Nemdatine is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Ebixa.
Ker je zdravilo Nemdatine generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Ebixa.
For practical information about using Nemdatine, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Nemdatine naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The active substance in Nemdatine, memantine, is an antidementia medicine.
Zdravilna učinkovina zdravila Nemdatine, memantin, je zdravilo za zdravljenje demence.
Therefore, the CHMP's view was that, as for Ebixa, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi, tako kot pri zdravilu Ebixa, odtehtajo znana tveganja.
The dose may need to be reduced in patients who have moderate or severe problems with their kidneys.
Pri bolnikih, ki imajo zmerne ali hude težave z ledvicami, bo odmerek zdravila morda treba zmanjšati.
How is Nemdatine used?
Kako se zdravilo Nemdatine uporablja?
How has Nemdatine been studied?
Kako je bilo zdravilo Nemdatine raziskano?
How does Nemdatine work?
Kako zdravilo Nemdatine deluje?
fractures and heart failure).
zlome in srčno popuščanje).
The Prescriber Guide should highlight the following:
Priporočilo za zdravnike mora poudariti naslednje:
• Caution in use in the elderly in light of age related risks (in particular bladder cancer,
• Opozorilo o uporabi pri starejših glede na s starostjo povezana tveganja (zlasti za rak mehurja,
Prior to distribution of the prescriber guide in each Member State, the MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority.
Pred distribucijo priporočila za zdravnike v vsaki državi članici, se mora imetnik dovoljenja za promet glede vsebine in oblike izobraževalnega gradiva, vključno z načrtom obveščanja, dogovoriti z nacionalnim pristojnim organom.
ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
DODATEK POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH IZVAJAJO DRŽAVE ČLANICE
Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the member states.
Pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, ki jih izvajajo države članice.
• Patient selection criteria including that Pioglitazone should not be used as first line therapy and emphasising the need for regular review of treatment benefit.
• Merila za izbiro bolnika, ki vključujejo, da se pioglitazona ne sme uporabljati kot zdravilo prvega izbora in poudarijo potrebo po redni oceni koristi zdravljenja.
The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use Pioglitazone.
Imetnik dovoljenja za promet mora zagotoviti izobraževalno gradivo, namenjeno vsem zdravnikom, za katere se pričakuje, da bodo predpisovali/uporabljali pioglitazon.
• This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the benefit-risk margin at the patient level.
• To izobraževalno gradivo je namenjeno ozaveščanju o pomembnih ugotovljenih tveganjih za rak mehurja in srčno popuščanje ter o splošnih priporočilih, da bi dosegli najboljše razmerje med koristjo in tveganjem na ravni bolnika.
• The physician educational pack should contain: The Summary of Product Characteristics, package leaflet, and a Prescriber Guide.
• Izobraževalno gradivo za zdravnike mora vsebovati: Povzetek glavnih značilnosti zdravila, navodilo za uporabo in priporočilo za zdravnike.
• The risk of heart failure and relevant risk minimisation advice.
• Tveganje za srčno popuščanje in ustrezen nasvet za zmanjšanje tveganja.
• The risk of bladder cancer and relevant risk minimisation advice.
• Tveganje za nastanek raka mehurja in ustrezen nasvet za zmanjšanje tveganja.
Package size l t o r
Velikost pakiranja l t o r
Strength Pharmaceutical Form Route of Administration
Farmacevtska oblika
Date of first authorisation: 23 March 2015 Date of latest renewal:
Datum prve odobritve: 23. marec 2015 Datum zadnjega podaljšanja:
The recommended dose is:
Priporočeni odmerek je:
- If you have uncontrolled very high blood pressure.
- če imate nenadzorovan zelo visok krvni tlak.
• severe allergic reactions,
• hude alergijske reakcije;
A risk to the newborns/infants cannot be excluded.
Tveganja za dojenega novorojenca/otroka ne moremo izključiti.
• You suffer from breathing difficulties such as asthma.
• imate težave z dihanjem, kot je astma.
Tell your doctor immediately if you notice any of the following:
Zdravniku takoj povejte, če opazite kaj od naslednjega:
The doctor will decide if you will need to be treated for longer periods.
Zdravnik se bo odločil, ali vas bo treba zdraviti dlje časa.
Sorbitol is a source of fructose.
Sorbitol je vir fruktoze.
Use with other anticoagulant agents
Uporaba z drugimi antikoagulanti
In clinical studies, healthy volunteers received up to two times the proposed daily dose.
V kliničnih študijah so zdravi prostovoljci prejemali do dvakratni priporočeni dnevni odmerek.
Mean clearance was approximately 43.2 L/kg.
Povprečni očistek je bil približno 43,2 l/kg.
In this study, semen analysis was conducted after 8 weeks of continuous treatment.
V tej študiji so analizo semenske tekočine izvedli po 8 tednih stalnega dovajanja zdravila.
Carcinogenicity studies have not been performed.
Študij kancerogenosti niso izvajali.
Initial excretion was rapid, such that approximately 50% of the administered radioactivity was recovered in the first 24 hours, and 75% was recovered by 48 hours.
Začetno izločanje je bilo hitro, tako da so približno 50 % uporabljene radioaktivnosti izmerili v prvih 24 urah in 75 % so izmerili po 48 urah.
GP IIb/IIIa inhibitors were permitted for bailout use only and were used in 2.9% of patients.
Zaviralci GPIIb/IIIa so bili dovoljeni le za reševalno uporabo in so bili uporabljeni pri 2,9 % bolnikov.
This medicine will be given to you by a healthcare professional.
Zdravilo vam bo dal zdravstveni delavec.
Do not use without dilution.
Ne uporabite brez redčenja.
The bolus and infusion should be initiated prior to the procedure and continued for at least two hours or for the duration of the procedure, whichever is longer.
Bolus in infuzijo je treba uvesti pred postopkom in nadaljevati vsaj dve uri ali ves čas trajanja postopka, kar traja dlje.
Your doctor will decide how to treat you, including stopping the medicine and monitoring for signs of side effects.
Zdravnik se bo odločil o tem, kako vas bo zdravil, vključno s prenehanjem dajanja zdravila in spremljanjem znakov neželenih učinkov.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
V primeru pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
• Bleeding from anywhere in the body.
• Krvavitev iz katerega koli dela telesa.
Bleeding is the most likely pharmacological effect of overdose.
Krvavitev je najverjetnejši farmakološki učinek prevelikega odmerjanja.
Table 1 depicts adverse reactions that have been identified based upon a pooling of combined data from all CHAMPION studies.
V preglednici 1 so navedeni neželeni učinki, ugotovljeni na podlagi združevanja kombiniranih podatkov iz vseh študij CHAMPION.
Swirl gently until all material is dissolved.
Nežno obračajte tako dolgo, da se raztopi ves material.
Data from the CHAMPION pooled population of over 25,000 PCI patients provide additional clinical support for safety.
Podatki za združeno populacijo CHAMPION za več kot 25.000 bolnikov s PKI dodatno klinično podpirajo podatke o varnosti.
These effects were not apparent at lower doses and were reversible following cessation of dosing.
Ti učinki niso bili vidni pri nižjih odmerkih in so bili po prenehanju odmerjanja reverzibilni.
** Transfusion was uncommon 101/12,565 (0.8%).
** transfuzija je bila občasna 101/12.565 (0,8 %)
No dose adjustment is needed for these populations.
Pri teh populacijah ni treba prilagajati odmerka.
• You have been told by your doctor that you have an intolerance to some sugars.
• vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev.
- If you are allergic to cangrelor or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na kangrelor ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
very rare (<1/10,000).
<1/1.000); zelo redki (<1/10.000).
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom,
The median duration of cangrelor infusion was 129 minutes.
Mediano trajanje infundiranja kangrelorja je bilo 129 minut.
Multiple related adverse reaction terms have been grouped together in the table and include medical terms as described below: a.
V preglednici je združenih več povezanih zadevnih izrazov, ki vključujejo medicinske pojme, kot je opisano zgoraj: a.
The doctor will decide how much Kengrexal you receive, and will prepare the medicine.
Vaš zdravnik se bo odločil, koliko zdravila Kengrexal boste prejeli, in pripravil zdravilo.
The dose given depends on your weight.
Uporabljeni odmerek je odvisen od vaše telesne mase.
• Minor bruising can occur anywhere in the body (including small red bruises on the skin or at the site of an injection under the skin causing swelling),
• manjše modrice se lahko pojavijo kjer koli po telesu (vključno z majhnimi rdečimi modricami na koži ali na mestu injiciranja pod kožo, ki povzročajo oteklino);
Risk of bleeding
Tveganje za krvavitve
No dose adjustment is needed in elderly (≥75 years) patients.
Pri starejših bolnikih (≥ 75 let) odmerka ni treba prilagajati.
Breast cancer resistance protein (BCRP)
Protein odpornosti pri raku dojke (BCRP-breast cancer resistance protein)
These included cases of anaphylactic reactions/shock and angioedema (see section 4.8).
To vključuje primere anafilaktičnih reakcij/šoka in angioedema (glejte poglavje 4.8).
• You have ever suffered from an allergic reaction to Kengrexal or any of its constituents.
• ste kadar koli imeli alergijsko reakcijo na zdravilo Kengrexal ali katero od njegovih sestavin.
48155 Münster GERMANY
48155 Münster
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Če se ne uporabi takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik.
Mild a
Blaga a
The safety and efficacy of cangrelor in children aged less than 18 years has not been established.
Varnost in učinkovitost kangrelorja pri otrocih, starih manj kot 18 let, nista bili dokazani.
At the discretion of the physician, the infusion may be continued for a total duration of four hours, see section 5.1.
Po presoji zdravnika se lahko infuzija nadaljuje, skupaj štiri ure, glejte poglavje 5.1.
• increased levels of creatinine in the blood (identified by blood tests), indicating reduced kidney function,
• povečana raven kreatinina v krvi (ugotovljena s krvnimi testi), kar kaže na zmanjšano delovanje ledvic;
• Allergic reaction (a rash, itching, throat tightening/swelling, swelling of the tongue or lips, difficulty breathing).
• Alergijska reakcija (izpuščaj, srbenje, zoženje/oteklost žrela, oteklost jezika ali ustnic, težave z dihanjem).
The bioavailability of cangrelor is complete and immediate.
Absorpcija Biološka uporabnost kangrelorja je popolna in takojšnja.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
Kengrexal is not recommended for children and adolescents under 18 years.
Zdravilo Kengrexal se ne priporoča za otroke in mladostnike, stare manj kot 18 let.
Kengrexal is available in packs of 10 vials.
Zdravilo Kengrexal je na voljo v pakiranjih po 10 vial.
During this procedure you may have a stent inserted in your blood vessel to help to keep it open.
Med tem postopkom vam bodo morda v krvno žilo vstavili žilno opornico, ki bo žilo pomagala ohranjati odprto.
Mix the bag thoroughly.
Vrečo temeljito premešajte.
Fructose intolerance
Intoleranca za fruktozo
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
This medicinal product contains 52.2 mg sorbitol in each vial.
To zdravilo vsebuje 52,2 mg sorbitola v en viali.
If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine.
Če imate dedno intoleranco za fruktozo, redko genetsko bolezen, vi ne smete dobiti tega zdravila.
IDR a Primary endpoint from logistic regression adjusted for loading dose and patient status.
a Primarni opazovani dogodek z logistične regresije, prilagojen za začetni odmerek in status bolnika.
Your treatment with Kengrexal will be supervised by a doctor experienced in caring for patients with heart disease.
Vaše zdravljenje z zdravilom Kengrexal bo nadziral zdravnik z izkušnjami v oskrbi bolnikov z boleznijo srca.
Of the recovered material, 58% was found in urine and the remaining 35% was found in faeces, presumably following biliary excretion.
58 % snovi so izmerili v urinu, preostalih 35 % pa v blatu, verjetno po izločanju skozi žolč.
If bleeding occurs appropriate supportive measures should be taken, which may include stopping the medicinal product so platelet function can return.
Če se pojavi krvavitev, je treba uvesti ustrezne podporne ukrepe, ki lahko vključujejo ukinitev uporabe zdravila, da se lahko povrne delovanje trombocitov.
Severe/life-threatening
Huda/življenjsko nevarna
The pharmacokinetic properties of cangrelor have been evaluated and found to be linear in patients and healthy volunteers.
Ocenili so farmakokinetične lastnosti kangrelorja in ugotovili, da so pri bolnikih in zdravih prostovoljcih linearne.
Possible implications for the in vivo situation have not been investigated, but caution is advised when cangrelor is to be combined with a BCRP substrate.
Možnih implikacij za situacijo in vivo niso preučili, vendar pa se pri kombiniranju kangrelorja s substratom BCRP priporoča previdnost.
Any unexplained fall in blood pressure or haematocrit should lead to the serious consideration of a haemorrhagic event and the cessation of cangrelor administration.
Vsak nepojasnjeni upad krvnega tlaka ali hematokrita mora biti povod za skrben razmislek o hemoragičnem dogodku in prekinitev dajanja kangrelorja.
p-values for secondary endpoints based on Chi-squared test.
Vrednosti p za sekundarne opazovane dogodke na podlagi testa hi-kvadrata.
Platelets are very small cells in the blood that can clump together and help the blood to clot.
Trombociti so zelo majhne celice v krvi, ki se zlepljajo in pomagajo pri strjevanju krvi.
• balloon-like swelling in an artery or wall of the heart, which involves only a few layers of the vessel walls,
• balonu podobno otekanje v arteriji ali steni srca, ki vključuje le nekaj slojev stene žil;
This dilution will generate a concentration of 200 micrograms/mL and should be sufficient for at least two hours of dosing as required.
S to razredčitvijo dobite koncentracijo 200 mikrogramov/ml, kar mora zadoščati za vsaj dveurno odmerjanje, kot je potrebno.
- If you have ever had a stroke, or a ‘mini-stroke' (also known as a transient ischaemic attack, TIA) caused by the temporary interruption of the blood supply to the brain.
- če ste kadar koli imeli »mini kap« (imenovana tudi tranzitorna ishemična ataka, TIA) zaradi začasne prekinitve oskrbe možganov s krvjo.
No baseline demographic factor altered the relative risk of bleeding with cangrelor.
Izhodiščni demografski dejavniki niso vplivali na relativno tveganje za krvavitev s kangrelorjem.
There is no antidote to Kengrexal, however, the pharmacokinetic half-life of Kengrexal is three to six minutes.
Antidota za zdravilo Kengrexal ni, vendar pa je farmakokinetični razpolovni čas zdravila Kengrexal tri do šest minut.
Transfusion and GUSTO severe/life-threatening bleeding rates were similar.
Pogotnosti transfuzij in hudih/življenjsko nevarnih krvavitev po lestvici GUSTO so bile podobne.
Anatomical changes correlated with increased plasma creatinine and urea, and increased albumin and blood cells in urine.
Anatomske spremembe so korelirale s povečanjem kreatinina in sečnine v plazmi ter povečanimi ravnmi albumina in krvnih celic v urinu.
• variations in blood pressure,
• spremembe krvnega tlaka;
Alternatively, a loading dose of ticagrelor or prasugrel, but not clopidogrel, may be administered up to 30 minutes before the end of the infusion, see section 4.5.
Alternativno se lahko uporabi polnilni odmerek tikagrelorja ali prasugrela, ne pa klopidogrela, do 30 minut pred koncem infuzije, glejte poglavje 4.5.
Powder in 10 mL glass vials (Type 1) closed with a Flurotec coated butyl rubber stopper and sealed with crimped aluminium seal.
Prašek v 10 ml steklenih vialah (tip 1), zaprt z zamaškom Flurotec iz butilne gume in zapečaten z aluminijasto zaporko.
Adverse reactions are classified according to frequency and system organ class.
Neželeni učinki so opredeljeni po pogostnosti in glede na organske sisteme.
Cangrelor has a volume of distribution of 3.9 L. Cangrelor is 97-98% plasma-protein bound.
Volumen porazdelitve kangrelorja je 3,9 l. Kangrelor se veže na beljakovine v plazmi 97-98 %.
• Active bleeding or increased risk of bleeding, because of impaired haemostasis and/or irreversible coagulation disorders or due to recent major surgery/trauma or uncontrolled severe hypertension.
• Aktivna krvavitev ali večje tveganje za krvavitev zaradi okvare hemostaze in/ali ireverzibilne motnje koagulacije ali zaradi nedavne velike operacije/poškodbe ali neobvladane hude hipertenzije.
Instructions for preparation
Navodilo za pripravo
It is unknown whether Kengrexal is excreted in human milk.
Ni znano, ali se zdravilo Kengrexal izloča v materino mleko.
Patients with hereditary fructose intolerance (HFI) must not be given this medicine unless strictly necessary.
Bolniki z dedno intoleranco za fruktozo ne smejo prejeti tega zdravila, razen če je nujno potrebno.
If you use more Kengrexal than you should
Če ste uporabili večji odmerek zdravila Kengrexal, kot bi smeli
Patients 100 kg and over will require a minimum of two bags.
Bolniki s telesno maso 100 kg ali več potrebujejo vsaj dve vreči.
What Kengrexal is and what it is used for
Kaj je zdravilo Kengrexal in za kaj ga uporabljamo
Sometimes clots can form within a damaged blood vessel such as in an artery in the heart and this can be very dangerous as the clot can cut off the blood supply (a thrombotic event), causing a heart attack (myocardial infarction).
Včasih lahko v poškodovanih krvnih žilah, kot so arterije v srcu, nastajajo strdki, kar je lahko zelo nevarno, saj lahko strdek prekine oskrbo s krvjo (trombotični dogodek), kar povzroči srčno kap (miokardni infarkt).
The other ingredients are mannitol, sorbitol and sodium hydroxide for pH-adjustment.
Druge sestavine zdravila so manitol, sorbitol in natrijev hidroksid za uravnavanje pH.