natgillin/translations-raw huggingface dataset:
• The available information on colistimethate sodium has been reviewed and recommendations have been made on its safe use and appropriate dosage.
• Opravljen je bil pregled razpoložljivih podatkov o natrijevem kolistimetatu in podana priporočila o njegovi varni uporabi in ustreznem odmerjanju.
However, current experience has raised concerns that the existing product information, in particular relating to dosing and the way the medicine is handled in the body (pharmacokinetics), might need updating.
Vendar pa so trenutne izkušnje vzbudile skrbi, da bi bilo morda treba posodobiti obstoječe informacije o zdravilu, zlasti v zvezi z odmerjanjem in obnašanjem zdravila v telesu (farmakokinetika).
Products taken by mouth (which mainly contain colistin and are not absorbed into the body in significant amounts but act locally on the gut) and those applied externally were not covered in this review.
Zdravila, ki se jemljejo skozi usta (in ki v glavnem vsebujejo kolistin ter se v telesu ne absorbirajo v pomembnih količinah, temveč lokalno učinkujejo na črevesje), in zdravila za zunanjo uporabo v ta pregled niso bila vključena.
The medicine should be given with another suitable antibiotic where possible.
Če je mogoče, je zdravilo treba dajati sočasno z drugim ustreznim antibiotikom.
• Use of intravenous colistimethate sodium together with other medications that are potentially nephrotoxic or neurotoxic should be undertaken with great caution.
• Pri uporabi intravenskega natrijevega kolistimetata skupaj z drugimi zdravili, ki so lahko nefrotoksična ali nevrotoksična, je potrebna izjemna previdnost.
Products containing colistin are available for use by mouth or for external application but are not included in this review, as they are not considered to produce significant amounts of the active substance in the body.
Zdravila, ki vsebujejo kolistin, so na voljo za uporabo skozi usta ali zunanjo uporabo, vendar niso bila vključena v ta pregled, saj ne povzročijo pomembnih količin zdravilne učinkovine v telesu.
Where appropriate, adult doses of 125,000 IU for intraventricular administration and no more than this for intrathecal administration are recommended.
Kadar je to primerno, se za odrasle priporočajo odmerki 125.000 i.e. za intraventrikularno dajanje in največ tolikšni tudi za intratekalno dajanje.
A parallel review under Article 5(3) of Regulation (EC) No 726/2004 is currently also under way, looking at the quality of the products and the way the potency of colistimethate sodium is measured and tested, and may result in further changes to the product information once complete.
Trenutno poteka tudi vzporeden pregled v skladu s členom 5(3) Uredbe (ES) št. 726/2004, namenjen proučitvi kakovosti zdravil ter načina merjenja in preskušanja jakosti natrijevega kolistimetata, ob zaključku katerega se bodo morda v informacije o zdravilu vključile dodatne spremembe.
Consideration should be given to co-administration with another antibacterial agent whenever this is possible.
Razmisliti je treba o sočasni uporabi z drugim antibiotikom, kadar je to mogoče.
Colistin and its prodrug colistimethate sodium are the only polymyxins approved for clinical use in the EU, and the review was limited to products used by injection or inhalation (all formulated as colistimethate sodium).
Kolistin in njegovo predzdravilo natrijev kolistimetat sta edina polimiksina, ki sta odobrena za klinično uporabo v EU, pregled pa je bil omejen na zdravila, ki se uporabljajo z injiciranjem ali inhaliranjem (vsa v obliki natrijevega kolistimetata).
(Products for inhalation as a dry powder have a different dosage and distribution in the body, and were not affected by the conclusions of the review.)
(Zdravila v obliki suhega praška za inhaliranje se drugače odmerjajo in porazdelijo v telesu, zato zaključki pregleda zanje ne veljajo.)
Polymyxins are a group of antibiotics that includes colistin and colistimethate sodium (a ‘prodrug' that is converted to colistin in the body), which have been available in the EU since the 1960s for the treatment of susceptible infections.
Polimiksini so skupina antibiotikov, med katere spadata tudi kolistin in natrijev kolistimetat („predzdravilo“, ki se v telesu pretvori v kolistin) in ki so od šestdesetih let prejšnjega stoletja v EU na voljo za zdravljenje zanje občutljivih okužb.
Due in part to this limited use, colistimethate sodium has retained activity against a number of bacteria which have become resistant to commonly used antibiotics.
Natrijev kolistimetat je deloma tudi zaradi te omejene uporabe ohranil učinkovitost proti številnim bakterijam, ki so postale odporne proti pogosto uporabljanim antibiotikom.
• Doses should always be expressed in IU of colistimethate sodium.
• Odmerki morajo biti vedno izraženi v i.e. natrijevega kolistimetata.
• Intravenous colistimethate sodium does not cross the blood-brain barrier to a significant extent.
• Intravenski natrijev kolistimetat ne prehaja dovolj skozi krvno-možgansko pregrado.
• Colistin and colistimethate sodium are older antibiotics (belonging to the class called polymyxins) that are sometimes used for infections that have become resistant to newer treatments.
• Kolistin in natrijev kolistimetat sta starejša antibiotika (iz razreda zdravil, imenovanih polimiksini), ki se včasih uporabljata za okužbe, ki so postale odporne proti novejšim zdravilom.
Colistimethate sodium is given by injection or inhaled, and becomes colistin inside the body.
Natrijev kolistimetat se daje z injiciranjem ali inhaliranjem in se v telesu pretvori v kolistin.
• Injection or infusion (drip) of colistimethate sodium should only be used to treat serious infections in patients with few other treatment options, normally combined with another antibiotic.
• Natrijev kolistimetat se lahko z injiciranjem ali infundiranjem (kapalno infuzijo) daje samo za zdravljenje resnih okužb pri bolnikih, ki imajo malo drugih možnosti zdravljenja, običajno v kombinaciji z drugim antibiotikom.
Colistimethate sodium (mg)
Natrijev kolistimetat (mg)
• Intravenous colistimethate sodium is indicated in adults and children including neonates for the treatment of serious infections due to aerobic Gram-negative pathogens in patients with limited treatment options.
• Intravenski natrijev kolistimetat je indiciran pri odraslih in otrocih, vključno z novorojenčki, za zdravljenje resnih okužb, ki jih povzročajo aerobni gramnegativni patogeni, kadar imajo bolniki omejene možnosti zdravljenja.
A parallel review is currently underway, looking at the quality of the products and the way the potency of colistimethate sodium is measured and tested, and may result in further changes to the product information once complete.
Trenutno poteka vzporeden pregled, namenjen proučitvi kakovosti zdravil ter načina merjenja in preskušanja jakosti natrijevega kolistimetata, ob zaključku katerega se bodo morda v informacije o zdravilu vključile dodatne spremembe.
The review considered products given by injection or inhaled as a liquid into the lungs (systemic use) containing colistimethate sodium, which is converted to the active substance colistin in the body.
V pregled so bila vključena zdravila, ki se dajejo z injiciranjem ali se v obliki tekočine inhalirajo v pljuča (sistemska uporaba) in vsebujejo natrijev kolistimetat, ki se v telesu pretvori v zdravilno učinkovino kolistin.
Colistimethate sodium (IU)
Natrijev kolistimetat (i.e.)
• When given by inhalation, colistimethate sodium solutions may be used for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adults and children with cystic fibrosis.
• Raztopine natrijevega kolistimetata, ki se dajejo z inhaliranjem, se lahko uporabljajo za obvladovanje kroničnih pljučnih okužb, ki jih povzroča Pseudomonas aeruginosa, pri odraslih in otrocih s cistično fibrozo.
CHMP concluded that colistimethate sodium may also be given by inhalation or in a nebuliser to treat ongoing (chronic) infections with the bacterium Pseudomonas aeruginosa in patients with cystic fibrosis.
Odbor CHMP je zaključil, da se natrijev kolistimetat lahko daje tudi z inhaliranjem ali z nebulatorjem za zdravljenje obstoječih (kroničnih) okužb z bakterijo Pseudomonas aeruginosa pri bolnikih s cistično fibrozo.
Doses should be reduced according to creatinine clearance in patients with renal impairment.
Pri bolnikih z okvaro ledvic je treba odmerke zmanjšati glede na očistek kreatinina.
The CHMP concluded that injection or infusion (drip) of colistimethate sodium should be reserved for the treatment of serious infections due to susceptible bacteria, in patients whose other treatment options are limited.
Odbor CHMP je zaključil, da se lahko natrijev kolistimetat z injiciranjem ali infundiranjem (kapalno infuzijo) daje samo za zdravljenje resnih okužb, ki jih povzročajo občutljive bakterije, pri bolnikih, pri katerih so druge možnosti zdravljenja omejene.
Colistimethate sodium may also be inhaled as a liquid vapour to treat lung infection in patients with cystic fibrosis.
Prav tako se natrijev kolistimetat lahko inhalira v obliki tekočinske pare za zdravljenje pljučne okužbe pri bolnikih s cistično fibrozo.
• adults and children from 6 years of age with chronic (long-term) kidney disease.
• odraslih in otrocih, starih šest let in več, s kronično (dolgotrajno) boleznijo ledvic.
• adult patients on dialysis (a technique to remove unwanted substances from the blood);
• odraslih bolnikih na dializi (tehniki odstranjevanja neželenih snovi iz krvi);
This authorisation was based on the authorisation granted to Renvela in 2009 (‘informed consent').
Izdaja tega dovoljenja je temeljila na dovoljenju za promet z zdravilom Renvela, ki je bilo izdano leta 2009 (uporaba dokumentacije s soglasjem).
Further information on Sevelamer carbonate Winthrop can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/sevelamer-carbonate-winthrop.
Nadaljnje informacije za zdravilo Sevelamer carbonate Winthrop so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/sevelamer-carbonate-winthrop.
The European Medicines Agency therefore decided that Sevelamer carbonate Winthrop's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Sevelamer carbonate Winthrop večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Sevelamer carbonate Winthrop is available as tablets (800 mg) and as powder (800 mg and 2.4 g) to be taken 3 times a day with meals.
Zdravilo Sevelamer carbonate Winthrop je na voljo v obliki tablet (800 mg) ali praška (800 mg in 2,4 g) in se jemlje trikrat na dan z obroki.
When taken with meals, it attaches in the gut to phosphate from the food, thereby preventing the phosphate from being absorbed into the body and helping to reduce phosphate levels in the blood.
Ko se vzame s hrano, se v črevesju veže na fosfat iz hrane, kar preprečuje njegovo absorpcijo v telo in prispeva k zmanjšanju njegovih ravni v krvi.
Sevelamer carbonate Winthrop received a marketing authorisation valid throughout the EU on 15 January 2015.
Za zdravilo Sevelamer carbonate Winthrop je bilo 15. januarja 2015 izdano dovoljenje za promet, veljavno po vsej EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sevelamer carbonate Winthrop have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Sevelamer carbonate Winthrop upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Sevelamer carbonate Winthrop must not be taken on an empty stomach and patients should keep to their prescribed diets.
Zdravilo Sevelamer carbonate Winthrop se ne sme jemati na prazen želodec, bolniki pa morajo upoštevati predpisano dieto.
The dose to take depends on the patient's level of blood phosphate and, for children, their height and weight.
Odmerek je odvisen od bolnikove ravni fosfata v krvi, pri otrocih pa od telesne višine in mase.
The most common side effects with Sevelamer carbonate Winthrop (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, upper abdominal (belly) pain and constipation.
Najpogostejši neželeni učinki zdravila Sevelamer carbonate Winthrop (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so navzeja (siljenje na bruhanje), bruhanje, bolečine v zgornjem predelu trebuha in zaprtje.
In a third main study in 49 adults who were not on dialysis, Sevelamer carbonate Winthrop reduced phosphate levels from 2.0 mmol/l to 1.6 mmol/l.
V tretji glavni študiji pri 49 odraslih, ki niso bili na dializi, je zdravilo Sevelamer carbonate Winthrop znižalo ravni fosfata z 2,0 mmol/l na 1,6 mmol/l.
Sevelamer carbonate Winthrop should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Zdravilo Sevelamer carbonate Winthrop je treba uporabljati sočasno z drugimi zdravili, na primer z dodatki kalcija in vitamina D, za preprečevanje razvoja bolezni kosti.
For more information about using Sevelamer carbonate Winthrop, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Sevelamer carbonate Winthrop glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
In two main studies in 110 adults with kidney disease who were on dialysis, Sevelamer carbonate Winthrop brought phosphate levels down to around 1.5-1.6 mmol/l (which is within or close to the normal range) and was as effective as another approved medicine Renagel.
V dveh glavnih študijah pri 110 odraslih z obolenjem ledvic, ki so bili na dializi, je zdravilo Sevelamer carbonate Winthrop znižalo ravni fosfata na približno 1,5-1,6 mmol/l (kar je znotraj oziroma blizu normalnega razpona) in je bilo enako učinkovito kot drugo, že odobreno zdravilo, in sicer zdravilo Renagel.
Side effects reported with Sevelamer carbonate Winthrop are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Sevelamer carbonate Winthrop, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
1 Previously known as Sevelamer carbonate Zentiva.
1 Prej znano pod imenom Sevelamer carbonate Zentiva.
What measures are being taken to ensure the safe and effective use of Sevelamer carbonate Winthrop?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Sevelamer carbonate Winthrop?
As for all medicines, data on the use of Sevelamer carbonate Winthrop are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Sevelamer carbonate Winthrop stalno spremljajo.
An overview of Sevelamer carbonate Winthrop and why it is authorised in the EU
Pregled zdravila Sevelamer carbonate Winthrop in zakaj je odobreno v EU
Finally, a main study also showed that Sevelamer carbonate Winthrop was effective at lowering phosphate levels in 100 children: children who took Sevelamer carbonate Winthrop had a greater reduction in phosphorous (0.87 mg/dl) than those taking placebo (a dummy treatment) who had a rise in phosphorous of 0.04 mg/dl.
V še eni glavni študiji pri 100 otrocih so ugotovili, da je zdravilo Sevelamer carbonate Winthrop učinkovito pri zniževanju ravni fosfata, saj se je raven fosforja pri otrocih, ki so jemali to zdravilo, zmanjšala bolj (0,87 mg/dl) kot pri bolnikih, ki so jemali placebo (zdravilo brez učinkovine), pri katerih se je vrednost fosforja zvišala za 0,04 mg/dl.
Sevelamer carbonate Winthrop is a medicine used to control hyperphosphataemia (high blood phosphate levels) in:
Sevelamer carbonate Winthrop je zdravilo, ki se uporablja za obvladovanje hiperfosfatemije (visoke ravni fosfata v krvi) pri:
The active substance in Sevelamer carbonate Winthrop, sevelamer carbonate, is a phosphate binder.
Učinkovina v zdravilu Sevelamer carbonate Winthrop, sevelamerijev karbonat, je vezalec fosfata.
Studies show that Sevelamer carbonate Winthrop is effective at reducing levels of blood phosphate in patients with hyperphosphataemia, and its side effects are considered manageable.
V študijah so ugotovili, da je zdravilo Sevelamer carbonate Winthrop učinkovito pri zniževanju ravni fosfata v krvi pri bolnikih s hiperfosfatemijo, njegovi neželeni učinki pa se štejejo za obvladljive.
What benefits of Sevelamer carbonate Winthrop have been shown in studies?
Kakšne koristi zdravila Sevelamer carbonate Winthrop so se pokazale v študijah?
Sevelamer carbonate Winthrop must not be used in people with low blood phosphate levels or with bowel obstruction (a blockage in the gut).
Zdravilo Sevelamer carbonate Winthrop se ne sme uporabljati pri osebah z nizko ravnjo fosfata v krvi ali obstrukcijo (zaporo) črevesa.
What is Sevelamer carbonate Winthrop and what is it used for?
Kaj je zdravilo Sevelamer carbonate Winthrop in za kaj se uporablja?
It contains the active substance sevelamer carbonate.
Vsebuje učinkovino sevelamerijev karbonat.
Why is Sevelamer carbonate Winthrop approved?
Zakaj je bilo zdravilo Sevelamer carbonate Winthrop odobreno?
Other information about Sevelamer carbonate Winthrop
Druge informacije o zdravilu Sevelamer carbonate Winthrop
(sevelamer carbonate)
(sevelamerijev karbonat)
For the full list of side effects of Sevelamer carbonate Winthrop, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Sevelamer carbonate Winthrop, glejte navodilo za uporabo.
What are the risks associated with Sevelamer carbonate Winthrop?
Kakšna tveganja so povezana z zdravilom Sevelamer carbonate Winthrop?
Sevelamer carbonate Winthrop has been shown in studies to be effective at lowering levels of blood phosphate in patients with hyperphosphataemia.
V študijah so dokazali, da je zdravilo Sevelamer carbonate Winthrop učinkovito pri zniževanju ravni fosfata v krvi pri bolnikih s hiperfosfatemijo.
How does Sevelamer carbonate Winthrop work?
Kako zdravilo Sevelamer carbonate Winthrop deluje?
How is Sevelamer carbonate Winthrop used?
Kako se zdravilo Sevelamer carbonate Winthrop uporablja?
Date of first authorisation: 21 April 2016
Datum prve odobritve: 21. april 2016
Effect is unknown.
Učinek ni znan.
ATC code: J05AR17.
Oznaka ATC: J05AR17.
Keep the tablet bottle with you so that you can show what you have taken.
S seboj imejte plastenko tablet, da boste pokazali, kaj ste zaužili.
None of the changes was considered clinically relevant.
Nobena od sprememb ni bila ocenjena za klinično pomembno.
Adults: one tablet each day, with or without food
Odrasli: ena tableta vsak dan s hrano ali brez nje
This is because one of the active substances in this medicine passes into breast milk.
To je zato, ker ena učinkovina tega zdravila prehaja v mleko.
Other types of medicine:
Druge vrste zdravil:
Descovy therefore reduces the amount of HIV in your body.
Zdravilo Descovy zato zmanjša količino virusa HIV v vašem telesu.
The film-coated tablet should not be chewed, crushed, or split.
Filmsko obložene tablete se ne sme žvečiti, zdrobiti ali razdeliti.
If you have taken Descovy during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Če ste zdravilo Descovy jemali med nosečnostjo, vas lahko zdravnik naroči na redne preiskave krvi in druge diagnostične preiskave, da bo spremljal razvoj vašega otroka.
Talk to your doctor if you are taking:
Obvestite svojega zdravnika, če jemljete:
Treatment difference
Razlika zdravljenja
No emergent resistance to E/C/F/TAF was detected through Week 48.
Pojava rezistence proti E/C/F/TAF do vključno 48. tedna niso odkrili.
If you feel dizzy when taking Descovy, do not drive and do not use any tools or machines.
Če se vam med zdravljenjem z zdravilom Descovy pojavlja omotičnost, ne vozite avtomobila in ne upravljajte orodij ali strojev.
Race Black Non-black
Črnci Ne črnci
Descovy should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Zdravilo Descovy se sme med nosečnostjo uporabljati samo, če možne koristi upravičujejo možno tveganje za plod.
• Your doctor may not prescribe Descovy to you if the virus has a K65R mutation.
• Zdravnik vam morda ne bo predpisal zdravila Descovy, če ima virus mutacijo K65R.
• antibiotics, used to treat bacterial infections including tuberculosis, containing:
• antibiotike, ki se uporabljajo za zdravljenje bakterijskih okužb, vključno s tuberkulozo, ki vsebujejo:
Treatment of overdose with Descovy consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Zdravljenje prevelikega odmerka z zdravilom Descovy načeloma predstavljajo podporni ukrepi, vključno s spremljanjem vitalnih znakov in opazovanjem kliničnega stanja bolnika.
Therefore, the same problems may be seen if Descovy is administered with a third nucleoside analogue.
Zato je mogoče, da se bodo enake težave pojavile pri zdravilu Descovy, če se bo uporabilo s tretjim nukleozidnim analogom.
Stopping Descovy can seriously affect how well future treatment works.
Prenehanje jemanja zdravila Descovy lahko resno vpliva na to, kako dobro bo delovalo prihodnje zdravljenje.
2 When data are available from drug-drug interaction studies.
2 Ko so razpoložljivi podatki iz študij medsebojnega delovanja zdravil.
What Descovy is and what it is used for
Kaj je zdravilo Descovy in za kaj ga uporabljamo
Descovy contains two active substances:
Zdravilo Descovy vsebuje dve učinkovini:
In animal studies it has been shown that tenofovir is excreted in milk.
Študije na živalih so pokazale, da se tenofovir izloča v mleko.
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Nosečnost in dojenje • Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Descovy should be taken orally, once daily with or without food (see section 5.2).
Zdravilo Descovy se jemlje enkrat dnevno, peroralno s hrano ali brez nje (glejte poglavje 5.2).
5 Study conducted with Descovy.
5 Študija je bila opravljena z zdravilom Descovy.
As a result, the amounts of Descovy or other medicines in your blood may change.
To lahko posledično spremeni količino zdravila Descovy ali drugih zdravil v vaši krvi.
If you have both HIV infection and hepatitis B, it is very important not to stop taking Descovy without talking to your doctor first.
Če ste okuženi tako z virusom HIV kot s hepatitisom B, je zelo pomembno, da ne prenehate jemati zdravila Descovy, ne da bi se prej posvetovali z zdravnikom.
The 50% effective concentration (EC50) values for emtricitabine were in the range of 0.0013 to 0.64 μM.
Vrednosti 50-odstotno učinkovite koncentracije (EC50) za emtricitabin so bile v razponu od 0,0013 do 0,64 µM.
Descovy may interact with other medicines.
Zdravilo Descovy lahko medsebojno deluje z drugimi zdravili.
The use of Descovy in children aged 11 years or under has not yet been studied.
Uporabe zdravila Descovy pri otrocih, starih 11 let ali manj, še niso preučili.
If Descovy is stopped for any reason, speak to your doctor before you restart taking Descovy tablets.
Če zaradi katerega koli razloga prenehate jemati zdravilo Descovy, se pogovorite s svojim zdravnikom, preden začnete ponovno jemati tablete zdravila Descovy.
7 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposurers expected in HCV-infected patients.
7 Študija je bila opravljena z dodatnim voksilaprevirjem 100 mg za doseganje izpostavljenosti voksilaprevirju, pričakovane pri bolnikih, okuženih s HCV.
There are no adequate and well-controlled studies of Descovy or its components in pregnant women.
Ni ustreznih, dobro kontroliranih študij z zdravilom Descovy ali njegovimi učinkovinami pri nosečnicah.
Ethinylestradiol:
etinilestradiol:
If you have hepatitis B liver problems may become worse after you stop taking Descovy.
Če imate hepatitis B, se lahko težave z jetri poslabšajo, ko prenehate jemati zdravilo Descovy.
Iron oxide black (E172)
smukec črni železov oksid (E172)