FrancophonIA/ELRC3.0 huggingface dataset:
English: Xagrid received a marketing authorisation valid throughout the EU on 16 November 2004.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Xagrid na snazi u Europskoj uniji od 16. studenoga 2004.
English: The most common side effect with Xagrid (which may affect more than 1 in 10 people) is headache.
Croatian: Najčešća nuspojava lijeka Xagrid (uočena kod više od 1 na 10 bolesnika) je glavobolja.
English: What are the risks associated with Xagrid?
Croatian: Koji su rizici povezani s lijekom Xagrid?
English: In the other three studies, between 60 and 82% of patients had a complete response.
Croatian: U ostala tri ispitivanja postotak bolesnika s potpuno uspješnim odgovorom na lijek kretao se između 60 % i 82 %.
English: The European Medicines Agency decided that Xagrid's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) odlučio je da koristi od lijeka nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The active substance in Xagrid, anagrelide, blocks the development and growth of cells in the bone marrow called ‘megakaryocytes', which produce platelets.
Croatian: Djelatna tvar u lijeku Xagrid, anagrelid, zaustavlja razvoj i rast stanica u koštanoj srži koje se nazivaju „megakariociti”, koje proizvode trombocite.
English: This reduces the platelet count, helping to improve symptoms in patients with the disease.
Croatian: To smanjuje broj trombocita i pomaže u ublažavanju simptoma u bolesnika koji boluju od te bolesti.
English: Xagrid must not be used in patients with moderate or severe liver or kidney disease.
Croatian: Xagrid se ne smije primjenjivati u bolesnika koji boluju od bolesti jetre ili bubrega umjerenog ili teškog stupnja.
English: Xagrid was effective in lowering platelet counts in four main studies involving patients with various diseases in which the bone marrow produces too many cells.
Croatian: Xagrid se pokazao djelotvornim u smanjenju razina trombocita u četirima glavnim ispitivanjima na bolesnicima s raznim bolestima kod kojih koštana srž proizvodi previše stanica.
English: Almost 3,000 of the patients in the studies had essential thrombocythaemia, with a platelet count of more than 600 million/ml.
Croatian: Gotovo 3 000 bolesnika koji su sudjelovali u ispitivanjima imalo je esencijalnu trombocitemiju, utvrđenu na temelju razine trombocita veće od 600 milijuna/ml.
English: Xagrid can only be obtained with a prescription.
Croatian: Xagrid se izdaje samo na recept.
English: Treatment should only be started by a doctor who has experience in the treatment of essential thrombocythaemia.
Croatian: Liječenje lijekom Xagrid treba započeti isključivo liječnik s iskustvom u liječenju esencijalne trombocitemije.
English: Xagrid is used when patients do not respond to or do not tolerate their current treatment, and when they are ‘at risk' because of their age (over 60 years), very high platelet counts or previous clotting problems.
Croatian: Xagrid se koristi u slučaju izostanka odgovora na liječenje kod bolesnika ili u slučaju kada bolesnik ne podnosi postojeće liječenje te u slučaju kada bolesnik pripada „rizičnoj skupini” zbog svoje dobi (iznad 60 godina), ima jako visoku razinu trombocita ili je prethodno imao problema sa zgrušavanjem krvi.
English: Xagrid is a medicine used to reduce the number of platelets (components that help the blood to clot) in patients with essential thrombocythaemia (a disease in which there are too many platelets in the blood).
Croatian: Xagrid je lijek koji se koristi radi smanjivanja broja trombocita (sastavnica koje pomažu u zgrušavanju krvi) u bolesnika s esencijalnom trombocitemijom (bolesti kod koje u krvi cirkulira previše trombocita). „Esencijalna” znači da ne postoji očit uzrok bolesti.
English: Xagrid (anagrelide)
Croatian: Xagrid anagrelid
English: How is Xagrid used?
Croatian: Kako se Xagrid koristi?
English: Xagrid contains the active substance anagrelide.
Croatian: Xagrid sadrži djelatnu tvar anagrelid.
English: What benefits of Xagrid have been shown in studies?
Croatian: Koje su koristi lijeka Xagrid dokazane u ispitivanjima?
English: Why is Xagrid authorised in the EU?
Croatian: Zašto je lijek Xagrid odobren?
English: How does Xagrid work?
Croatian: Kako djeluje Xagrid?
English: For more information about using Xagrid, see the package leaflet or contact a doctor or a pharmacist.
Croatian: Više informacija o terapiji lijekom Xagrid pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: In essential thrombocythaemia the bone marrow produces too many platelets.
Croatian: Esencijalna trombocitemija je bolest kod koje koštana srž proizvodi previše trombocita.
English: This is because, as a result of the disease's rarity, it had not been possible to obtain full information about it. As the company has supplied the additional information requested, the ‘exceptional circumstances' ended on 11.07.2018.
Croatian: To znači da zbog rijetkosti bolesti nije bilo moguće dobiti potpune informacije o lijeku Xagrid.
English: For the full list of all side effects of Xagrid, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Xagrid potražite u uputi o lijeku.
English: As for all medicines, data on the use of Xagrid are continuously monitored.
Croatian: Budući da je lijek Xagrid odobren u iznimnim okolnostima, tvrtka koja stavlja u promet lijek Xagrid redovito će obavješćivati CHMP o svim objavljenim informacijama o djelotvornosti lijeka.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xagrid have been included in the summary of product characteristics and the package leaflet.
Croatian: Praktične informacije o primjeni lijeka Xagrid bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Talk to your doctor about the right methods of contraception for you and your partner.
Croatian: Razgovarajte sa svojim liječnikom o odgovarajućim metodama kontracepcije za Vas i Vašeg partnera.
English: ● and is advanced.
Croatian: ● i uznapredovao.
English: The median age was 54 years.
Croatian: Medijan dobi iznosio je 54 godine.
English: Do not give this medicine to children or adolescents under the age of 18 years.
Croatian: Nemojte davati ovaj lijek djeci ni adolescentima mlađima od 18 godina.
English: Contraception, pregnancy, and breast-feeding - information for women Contraception - information for women
Croatian: Kontracepcija, trudnoća i dojenje - informacije za žene Kontracepcija - informacije za žene
English: Alecensa with food and drink
Croatian: Alecensa s hranom i pićem
English: Effects of age, body weight, race and gender
Croatian: Učinci dobi, tjelesne težine, rase i spola
English: Extreme body weight (>130 kg)
Croatian: Ekstremna tjelesna težina (> 130 kg)
English: multiple sclerosis)
Croatian: multiple skleroze)
English: They must be taken with food (see section 5.2).
Croatian: Moraju se uzimati s hranom (vidjeti dio 5.2).
English: Grades 3-4
Croatian: Stupnjevi 3-4
English: Do not stop taking this medicine without talking to your doctor first.
Croatian: Nemojte prestati uzimati ovaj lijek bez prethodnog razgovora sa svojim liječnikom.
English: Do not open or dissolve the capsules.
Croatian: Kapsule nemojte otvarati niti rastapati.
English: It may also help to shrink your cancer.
Croatian: Također može pomoći smanjiti veličinu raka.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included
Croatian: JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
English: It is used if your lung cancer:
Croatian: Koristi se ako je rak pluća:
English: The hard capsules should be swallowed whole, and must not be opened or dissolved.
Croatian: Tvrde kapsule potrebno je progutati cijele i ne smiju se otvarati niti otapati.
English: The majority of these events occurred during the first 3 months of treatment.
Croatian: Većina tih događaja nastupila je tijekom prva 3 mjeseca liječenja.
English: Date of latest renewal: 1 December 2017
Croatian: Datum posljednje obnove odobrenja: 1. prosinca 2017.
English: ● The other ingredients are:
Croatian: Drugi sastojci su:
English: Alecensa may slow down or stop the growth of your cancer.
Croatian: Alecensa može usporiti ili zaustaviti rast raka.
English: A lower confidence limit for the estimated ORR above the pre-specified threshold of 35% would achieve a statistically significant result.
Croatian: Donja granična vrijednost intervala pouzdanosti za procijenjeni ORR iznad unaprijed određenog praga od 35% postigla bi statistički značajan rezultat.
English: ● alteration in sense of taste
Croatian: ● promjena osjeta okusa
English: Swallow each capsule whole.
Croatian: Svaku kapsulu progutajte cijelu.
English: ● Do not throw away any medicines via wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: ● You must take Alecensa with food.
Croatian: ● Lijek Alecensa morate uzimati s hranom.
English: Aluminium/aluminium (PA/Alu/PVC/Alu) blisters containing 8 hard capsules.
Croatian: Aluminij/aluminij (PA/Alu/PVC/Alu) blisteri koji sadrže 8 tvrdih kapsula.
English: It is important to take Alecensa twice a day for as long as your doctor prescribes it for you.
Croatian: Važno je da uzimate lijek Alecensa dvaput na dan onoliko dugo koliko Vam ga liječnik propisuje.
English: The corresponding values for M4 were 217 L/hour and 30.7 hours, respectively.
Croatian: Odgovarajuće vrijednosti za M4 iznosile su 217 l/h i 30,7 sati.
English: ● You should not become pregnant while taking this medicine.
Croatian: Ne smijete zatrudnjeti dok uzimate ovaj lijek.
English: Abnormal forms of this enzyme (due to fault in the gene that makes it) help encourage cancer cell growth.
Croatian: Abnormalni oblici tog enzima (zbog greške u genu koji je odgovoran za njegovo stvaranje) pomažu pospješiti rast stanica raka.
English: Patients who experience overdose should be closely supervised and general supportive care instituted.
Croatian: Bolesnike u kojih dođe do predoziranja treba pažljivo nadzirati i uvesti opću potpornu njegu.
English: Median duration of follow-up (months)
Croatian: Medijan trajanja praćenja (mjeseci)
English: ● if you are allergic to alectinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: ● ako ste alergični na alektinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Grade 2 or Grade 3 (symptomatic, may be severe and medically significant, medical intervention indicated)
Croatian: Bradikardijaa stupnja 2 ili stupnja 3 (simptomatska, može biti teška i medicinski značajna, indicirana je medicinska intervencija)
English: If you take more Alecensa than you should, talk to a doctor or go to hospital straight away.
Croatian: Ako uzmete više lijeka Alecensa nego što ste trebali, odmah se obratite svom liječniku ili otiđite u bolnicu.
English: There are no available data on patients over 80 years of age.
Croatian: Nema dostupnih podataka o primjeni u bolesnika starijih od 80 godina.
English: The safety and efficacy of Alecensa in children and adolescents below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Alecensa u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: ● medicines used to treat infections.
Croatian: ● lijekovi koji se koriste za liječenje infekcija.
English: If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite ili ne možete probaviti neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: Tell your doctor straight away if you notice any of the following side effects.
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koju od sljedećih nuspojava.
English: The capsules are also available in plastic bottles containing 240 hard capsules.
Croatian: Kapsule su dostupne i u plastičnim bocama koje sadrže 240 tvrdih kapsula.
English: The mechanism of micronucleus induction was abnormal chromosome segregation (aneugenicity), and not a clastogenic effect on chromosomes.
Croatian: Mehanizam mikronukleusne indukcije bila je abnormalna segregacija kromosoma (aneugenost), a ne klastogeni učinak na kromosome.
English: This is equivalent to 2.4% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 2,4% preporučenog maksimalnog dnevnog unosa natrija za odraslu osobu.
English: The signs may be similar to those from your lung cancer.
Croatian: Znakovi mogu biti slični onima koje uzrokuje rak pluća.
English: Alecensa can cause side effects that you need to tell your doctor about straight away.
Croatian: Alecensa može uzrokovati nuspojave o kojima odmah morate obavijestiti svog liječnika.
English: Dose modification advice is provided in Tables 1 and 2 below.
Croatian: Preporuke za prilagodbu doze navedene su u Tablicama 1 i 2 u nastavku.
English: Duration of treatment Treatment with Alecensa should be continued until disease progression or unacceptable toxicity.
Croatian: Trajanje liječenja Liječenje lijekom Alecensa treba nastaviti do progresije bolesti ili pojave neprihvatljive toksičnosti.
English: Frequency category (all grades)
Croatian: Kategorija učestalosti (svi stupnjevi)
English: There are no available data on patients with extreme body weight (>130 kg) (see section 4.2).
Croatian: Nema dostupnih podataka o bolesnicima ekstremne tjelesne težine (> 130 kg) (vidjeti dio 4.2).
English: The ADRs listed in Table 3 are presented by system organ class and frequency categories, defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000).
Croatian: Nuspojave navedene u Tablici 3 prikazane su prema klasifikaciji organskih sustava i kategorijama učestalosti definiranim kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000).
English: Alecensa has not been studied in children or adolescents.
Croatian: Alecensa se nije ispitivala u djece i adolescenata.
English: There are no available data on patients with body weight above 130 kg.
Croatian: Nema dostupnih podataka o bolesnicima tjelesne težine iznad 130 kg.
English: Alecensa contains lactose (a type of sugar).
Croatian: Alecensa sadrži laktozu (jednu vrstu šećera).
English: ● If you become pregnant when taking the medicine or during the 3 months after taking your last dose, tell your doctor straight away.
Croatian: Ako zatrudnite tijekom liječenja ovim lijekom ili unutar 3 mjeseca nakon uzimanja posljednje doze, odmah o tome obavijestite svog liječnika.
English: ● Do not take a double dose to make up for a missed dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili propuštenu dozu.
English: Do not take Alecensa:
Croatian: Nemojte uzimati lijek Alecensa:
English: If you take more Alecensa than you should
Croatian: Ako uzmete više lijeka Alecensa nego što ste trebali
English: ● swelling caused by fluid build-up in the body (oedema)
Croatian: ● oticanje uzrokovano nakupljanjem tekućine u tijelu (edem)
English: ● Fainting, dizziness and low blood pressure (potential signs of slow heart beat)
Croatian: ● nesvjestica, omaglica i nizak krvni tlak (mogući znakovi usporenih otkucaja srca)
English: Heart rate and blood pressure should be monitored as clinically indicated.
Croatian: Potrebno je kontrolirati srčanu frekvenciju i krvni tlak sukladno kliničkoj indikaciji.
English: ● liver injury (hepatotoxicity).
Croatian: ● oštećenje jetre (hepatotoksičnost).
English: Alecensa has minor influence on the ability to drive and use machines.
Croatian: Alecensa malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: You should use caution when drinking grapefruit juice or eating grapefruit or Seville oranges while on treatment with Alecensa as they may change the amount of Alecensa in your body.
Croatian: Potreban je oprez ako pijete sok od grejpa ili jedete grejp ili gorku naranču dok se liječite lijekom Alecensa jer oni mogu promijeniti količinu lijeka Alecensa u tijelu.
English: Other medicines and Alecensa
Croatian: Drugi lijekovi i Alecensa
English: Pharmacotherapeutic group: anti-neoplastic agents, protein kinase inhibitor; ATC code: L01XE36.
Croatian: Farmakoterapijska skupina: antineoplastici, inhibitor protein-kinaze; ATK oznaka: L01XE36.
English: The majority of patients had no history of smoking (62%).
Croatian: Većina bolesnika bili su nepušači (62%).
English: The range of body weights for patients enrolled in clinical studies is 36.9-123 kg.
Croatian: Raspon tjelesne težine bolesnika uključenih u klinička ispitivanja iznosio je 36,9 - 123 kg.
English: Talk to your doctor, pharmacist or nurse before taking Alecensa:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete lijek Alecensa:
English: Evaluate concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products.
Croatian: Procijeniti istodobno primijenjene lijekove za koje se zna da uzrokuju bradikardiju, kao i antihipertenzivne lijekove.
English: Alecensa blocks the action of an enzyme called ‘ALK tyrosine kinase'.
Croatian: Alecensa blokira djelovanje enzima koji se zove „tirozin kinaza ALK“.
English: Efficacy data are summarised in Table 4 and the Kaplan-Meier curve for investigator assessed PFS is shown in Figure 1.
Croatian: Podaci o djelotvornosti sažeto su prikazani u Tablici 4, a Kaplan-Meierova krivulja PFS-a prema ocjeni ispitivača prikazana je na Slici 1.
English: Patients should not take two doses at the same time to make up for a missed dose.
Croatian: Bolesnici ne smiju uzeti dvije doze odjednom kako bi nadoknadili propuštenu dozu.
English: Patients with rare hereditary problems of galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: Grade 4 (life-threatening consequences, urgent intervention indicated)
Croatian: Bradikardijaa stupnja 4 (posljedice opasne po život, indicirana je hitna intervencija)
English: If you take Alecensa whilst using oral contraceptives, the oral contraceptives may be less effective.
Croatian: Ako se liječite lijekom Alecensa dok uzimate oralne kontraceptive, oralni kontraceptivi će možda biti manje učinkoviti.
English: The effectiveness of concomitant administration of oral contraceptives may be reduced.
Croatian: Učinkovitost istodobno primijenjenih oralnih kontraceptiva može biti smanjena.
English: The majority of patients had no history of smoking (70%).
Croatian: Većina bolesnika bili su nepušači (70%).
English: Treatment with Alecensa should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Croatian: Liječenje lijekom Alecensa mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova za liječenje raka.
English: Alecensa treatment should be permanently discontinued if patients are unable to tolerate the 300 mg twice daily dose.
Croatian: Liječenje lijekom Alecensa treba trajno obustaviti ako bolesnici ne mogu podnijeti dozu od 300 mg dvaput na dan.
English: The limited data on the safety and efficacy of Alecensa in patients aged 65 years and older do not suggest that a dose adjustment is required in elderly patients (see section 5.2).
Croatian: Ograničeni podaci o sigurnosti i djelotvornosti lijeka Alecensa u bolesnika u dobi od 65 ili više godina ne ukazuju na potrebu za prilagođavanjem doze u starijih bolesnika (vidjeti dio 5.2).
English: The trial met its primary endpoint at the primary analysis, demonstrating a statistically significant improvement in PFS by investigator.
Croatian: Ispitivanje je postiglo primarnu mjeru ishoda u trenutku primarne analize te pokazalo statistički značajno poboljšanje PFS-a prema ocjeni ispitivača.
English: The events declined in frequency after the first month of treatment.
Croatian: Učestalost tih događaja smanjila se nakon prvog mjeseca liječenja.
English: If you are able to become pregnant, you must use highly effective contraception while on treatment and for at least 3 months after stopping treatment.
Croatian: Ako možete zatrudnjeti, morate koristiti visoko učinkovitu kontracepciju tijekom liječenja i još najmanje 3 mjeseca po njegovu završetku.
English: In particular tell your doctor or pharmacist if you are taking any of the following medicines:
Croatian: Osobito je važno da obavijestite liječnika ili ljekarnika ako uzimate neki od sljedećih lijekova:
English: ● blurred vision, loss of sight, black dots or white spots in your vision, and seeing double (problems with your eyes)
Croatian: ● zamagljen vid, gubitak vida, crne točkice ili bijele mrljice u vidnom polju i dvoslike (tegobe s očima)
English: The subjects in the Child Pugh B group however did in general not suffer from abnormal bilirubin, albumin or prothrombin time, indicating that they may not be fully representative of moderately hepatically impaired subjects with decreased metabolic capacity.
Croatian: Međutim, ispitanici u skupini s Child-Pugh stadijem B u načelu nisu imali odstupanja u vrijednostima bilirubina, albumina ni protrombinskog vremena, što ukazuje na to da oni možda nisu u potpunosti reprezentativni za ispitanike s umjerenim oštećenjem jetrene funkcije koji imaju smanjen metabolički kapacitet.
English: This is because it is not known if Alecensa can pass over into breast milk and could therefore harm your baby.
Croatian: Naime, nije poznato može li Alecensa prijeći u majčino mlijeko i stoga bi mogla naškoditi Vašem djetetu.
English: The geometric mean of the individual elimination half-life estimates for alectinib was 32.5 hours.
Croatian: Geometrijska srednja vrijednost pojedinačnih procijenjenih vrijednosti poluvijeka eliminacije alektiniba iznosila je 32,5 sati.
English: Multiple doses of 600 mg alectinib had no influence on the exposure of midazolam (2 mg), a sensitive CYP3A substrate.
Croatian: Višestruke doze alektiniba od 600 mg ne utječu na izloženost midazolamu (2 mg), osjetljivom supstratu CYP3A.
English: The events generally occurred during the first 3 months of treatment, were usually transient and the majority resolved upon dose modification.
Croatian: Ti su se događaji uglavnom javljali tijekom prva 3 mjeseca liječenja, obično su bili prolazne prirode te su se u većini slučajeva povukli nakon prilagodbe doze.
English: The incidence of Grade 3 elevations of CPK was 3.7%.
Croatian: Incidencija povišenih vrijednosti CPK-a stupnja 3 iznosila je 3,7%.
English: CPK levels should be assessed every two weeks for the first month of treatment and as clinically indicated in patients reporting symptoms.
Croatian: Razine CPK-a treba određivati svaka 2 tjedna tijekom prvog mjeseca liječenja, a zatim sukladno kliničkoj indikaciji u bolesnika koji prijave simptome.
English: Management of adverse events may require dose reduction, temporary interruption, or discontinuation of treatment with Alecensa.
Croatian: Zbrinjavanje štetnih događaja može zahtijevati smanjenje doze, privremeni prekid primjene ili trajnu obustavu liječenja lijekom Alecensa.
English: Severe myalgia has not been reported in the clinical trial BO28984.
Croatian: Teška mialgija nije prijavljena u kliničkom ispitivanju BO28984.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući one koje ste nabavili bez recepta i biljne lijekove.
English: Each hard capsule contains 33.7 mg lactose (as monohydrate) and 6 mg sodium (as sodium laurilsulfate).
Croatian: Jedna tvrda kapsula sadrži 33,7 mg laktoze (u obliku hidrata) i 6 mg natrija (u obliku natrijeva laurilsulfata).