natgillin/translations-raw huggingface dataset:
If you see any bubbles, pull the plunger slightly back.
Če vidite mehurčke, počasi potegnite bat nazaj.
If you have the impression that the effect of Pegasys is too strong or too weak, talk to your doctor or pharmacist.
Če menite, da je učinek zdravila Pegasys premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
Prior to beginning Pegasys therapy, standard haematological and biochemical laboratory tests are recommended for all patients.
Pred začetkom zdravljenja z zdravilom Pegasys so za vse bolnike priporočljive standardne hematološke in biokemične laboratorijske preiskave.
Patients who initiate treatment prior to their 18th birthday should maintain paediatric dosing through the completion of therapy.
Bolniki, ki z zdravljenjem začnejo pred svojim 18. rojstnim dnevom, morajo odmerjanje za pediatrične bolnike ohraniti do zaključka zdravljenja.
1) Visually check the pre-filled pen 2) Allow the pre-filled pen to adjust to room temperature 3) Clean your hands
1) Vizualno preglejte napolnjeni injekcijski peresnik 2) Pustite, da se napolnjeni injekcijski peresnik ogreje na sobno temperaturo 3) Umijte si roke
The percentage of patients with cirrhosis who withdrew from treatment was similar to that of the overall population in each treatment group.
Delež bolnikov s cirozo, ki so prenehali z zdravljenjem, je bil podoben deležu pri celotni populaciji v vsaki zdravljeni skupini.
The study demonstrated that the post-treatment recovery in growth at 2 years post-treatment was maintained to 6 years post-treatment.
Študija je dokazala, da se je izboljšanje rasti dve leti po zdravljenju ohranilo tudi šest let po zdravljenju.
If ALT increase is progressive or persistent, the dose should be reduced initially to 135 micrograms.
Če je zvečanje koncentracij ALT progresivno ali vztrajno, odmerek v začetku zmanjšamo na 135 mikrogramov.
The duration of combination treatment varies from 4 to 18 months depending on the type of virus you are infected with, on treatment response and whether you have been treated before.
Kombinirano zdravljenje lahko traja od 4 do 18 mesecev, odvisno od tipa virusa, s katerim ste okuženi, odziva na zdravljenje in od tega, če ste se zdravili že prej.
With your other hand hold the syringe as you would a pencil.
Z drugo roko primite injekcijsko brizgo, kakor bi držali svinčnik.
None of these patients experienced unusual, serious or treatment-limiting events.
Pri teh bolnikih se ni pojavil nobeden od nenavadnih, resnih ali drugih učinkov, ki bi omejeval zdravljenje.
Pegasys has minor or moderate influence on the ability to drive and use machines.
Zdravilo Pegasys ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Keep the pre-filled pen pressed on the skin for 10 seconds for injection to complete.
Pustite napolnjeni injekcijski peresnik pritisnjen na kožo 10 sekund, da se injiciranje zaključi.
Excipient with known effect: Benzyl alcohol (10 mg/ 1 ml)
Pomožna snov z znanim učinkom: benzilalkohol (10 mg/1 ml)
The interaction between theophylline and Pegasys is likely to be maximal after more than 4 weeks of Pegasys therapy.
Interakcija med teofilinom in zdravilom Pegasys je verjetno največja po več kot 4 tednih zdravljenja z zdravilom Pegasys.
The mechanism behind these events is not known; thus, co-treatment with telbivudine and other interferons (pegylated or standard) may also entail an excess risk.
Mehanizem za razvoj le-te ni znan; sočasno zdravljenje s telbivudinom in drugimi interferoni (pegiliranimi ali standardnimi) torej lahko ravno tako predstavlja čezmerno tveganje.
● if you have advanced liver disease and your liver does not work properly (e.g. your skin has become yellow).
• imate napredovano jetrno bolezen in vaša jetra ne delujejo pravilno (npr. če je vaša koža postala rumena),
You should brush your teeth thoroughly twice daily and have regular dental examinations.
Zobe si morate temeljito umiti dvakrat na dan in redno hoditi na pregled k zobozdravniku.
Very rare Frequency not known
Zelo redki Pogostnost neznana
Patients and caregivers must not attempt to break the 200 mg tablets.
Bolniki in njihovi skrbniki 200-mg tablet ne smejo prelamljati.
Disposal of the injection materials
Odstranjevanje injekcijskih materialov
As with other interferons, a higher incidence of neutralising antibodies was seen in CHB.
Kot pri drugih interferonih so pri CHB opazili višjo incidenco nevtralizirajočih protiteles.
Response Parameter
Parameter odziva
If there is bleeding, cover with an adhesive bandage.
Če pride do krvavitve, pokrijte z obližem.
Multiple regression and pooled group analyses evaluating the influence of treatment duration and use of induction dosing clearly identified treatment duration for 72 weeks as the primary driver for achieving a sustained virological response.
Multipla regresija in skupna analiza skupin, s katerima so ocenjevali vpliv trajanja zdravljenja in uporabe indukcijskega odmerjanja, je jasno pokazala, da je 72-tedensko zdravljenje primarno gonilo za dosego trajnega virološkega odziva.
All patients were followed up for 24 weeks post-treatment (groups A and C), or post-principal observation period (group B).
Vse bolnike so spremljali do 24 tednov po koncu zdravljenja (skupini A in C) ali po glavnem obdobju opazovanja (skupina B).
Patients with cirrhosis were not enrolled in this study.
Bolnikov s cirozo v to študijo niso vključili.
Dispose of the pre-filled pen and use another if:
Zavrzite napolnjeni injekcijski peresnik in uporabite drugega, če:
The probability for sustained virological response varied depending upon the previous treatment regimen; see Table 20.
Verjetnost trajnega virološkega odziva je bila različna glede na prejšnjo shemo zdravljenja (glejte preglednico 20).
For CHB patients, transient flares of ALT levels sometimes exceeding 10x ULN are not uncommon, and may reflect immune clearance.
Pri bolnikih s CHB prehodna nihanja vrednosti ALT, ki včasih presegajo 10-kratno ULN, niso redka in lahko odražajo imunsko čiščenje.
Overdoses involving between two injections on consecutive days (instead of weekly interval) up to daily injections for 1 week (i.e., 1260 micrograms/week) have been reported.
Poročali so o prevelikih odmerjanjih, ki so se pojavila med dvema injekcijama v zaporednih dnevih (namesto tedenskega intervala) in pri dnevnih injekcijah do 1 tedna (to je 1260 mikrogramov na teden).
A duration of therapy less than 48 weeks has not been adequately studied.
Zdravljenja, krajšega od 48 tednov, niso zadostno proučevali.
All HCV genotypes** HCV genotype 1
Vsi HCV genotipi** HCV genotipa 1
Although no teratogenic effects were seen in the offspring delivered at term, adverse effects in humans cannot be excluded.
Čeprav pri mladičih, ki so se skotili v normalnem času, niso opazili teratogenih učinkov, pri ljudeh neželenih učinkov ne moremo izključiti.
● Visually inspect the solution prior to administration: do not use if it is discoloured or if particles are present.
● Pred injiciranjem preglejte raztopino: ne uporabljajte raztopine, če je obarvana ali če so prisotni delci.
The terminal half-life after subcutaneous administration in patients is longer with a mean value of 160 hours (84 to 353 hours).
Končna razpolovna doba po subkutanem dajanju je pri bolnikih daljša, s srednjo vrednostjo 160 ur (84 do 353 ur).
In CHB, unlike CHC, disease exacerbations during therapy are not uncommon and are characterised by transient and potentially significant increases in serum ALT.
Pri CHB, v nasprotju s CHC, poslabšanja bolezni med zdravljenjem niso redka in so opisana kot prehodna in potencialno pomembna zvišanja ALT v serumu.
The negative predictive value for sustained response in patients treated with Pegasys in monotherapy was 98%.
Negativna napovedna vrednost trajnega odziva pri bolnikih, zdravljenih z zdravilom Pegasys pri samostojnem zdravljenju, je bila 98 %.
 The needle-shield will automatically move out and lock to prevent needle injuries.
 Ščitnik za iglo se bo avtomatsko pomaknil navzven in se zaklenil, da ne bi prišlo do poškodb.
Your doctor or his/her assistant will instruct you on how to give the injections.
Vaš zdravnik ali njegov pomočnik vas bosta natančno poučila o tem.
Use of alfa interferons has been associated with exacerbation or provocation of psoriasis and sarcoidosis.
Uporaba interferonov alfa je bila povezana s poslabšanjem ali pojavom psoriaze in sarkoidoze.
In addition some patients may experience vomiting.
Pri nekaterih bolnikih se lahko pojavi tudi bruhanje.
● if you develop signs of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while on this medication, seek medical help immediately.
• če med prejemanjem tega zdravila opazite znake hude alergijske reakcije (kot so težave z dihanjem, hropenje ali izpuščaj), takoj poiščite zdravniško pomoč,
Body weight kg (lbs)
Telesna masa kg (lbs)
Transplantation
Presaditve
The device is for single use only and is then to be discarded.
Pripomoček je namenjen enkratni uporabi, potem pa ga je treba zavreči.
● if you are being treated with telbivudine, a medicine for hepatitis B infection (see “Other medicines and Pegasys”).
• se zdravite s telbivudinom, zdravilom za okužbo z virusom hepatitisa B (glejte “Druga zdravila in zdravilo Pegasys”).
Pegasys treatment was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Zdravljenje z zdravilom Pegasys je bilo povezano z zmanjšanjem absolutnega števila celic CD4+ v prvih 4 tednih zdravljenja, odstotek celic CD4+ pa ni bil zmanjšan.
Because of the potential for adverse reactions in breastfed infants, breastfeeding should be discontinued prior to initiation of treatment.
Zaradi možnih neželenih učinkov pri dojenih otrocih je treba pred začetkom zdravljenja dojenje prekiniti.
Physicians considering treatment in these patients should carefully weigh the risks versus the benefits of re-treatment.
Ko zdravniki razmišljajo o zdravljenju teh bolnikov, naj skrbno pretehtajo tveganja in koristi ponovnega zdravljenja.
● Press the injection site with a small bandage or sterile gauze if necessary for several seconds.
● Na mesto injiciranja pritisnite majhen ovoj ali sterilno gazo in jo, če je treba, držite nekaj sekund.
Do not touch the tip of the syringe.
Ne dotikajte se vrha brizge.
The duration of combination treatment in children with chronic hepatitis C varies from 6 to 12 months depending on the type of virus your child is infected with and their response to therapy.
Kombinirano zdravljenje pri otrocih s kroničnim hepatitisom C traja od 6 do 12 mesecev, odvisno od tipa virusa, s katerim je okužen vaš otrok, in njihovega odziva na zdravljenje.
In general, the safety profile observed in paediatric patients was similar to that seen in adults.
Na splošno je bil varnostni profil pri pediatričnih bolnikih podoben varnostnemu profilu pri odraslih.
The decision to treat should be made on a case by case basis (see section 4.4).
Odločitev za zdravljenje je potrebno sprejeti za vsak primer posebej (glejte poglavje 4.4).
● if you are infected with both the hepatitis C virus and the human immunodeficiency virus, and your liver does not work properly (e.g. your skin has become yellow).
• če ste okuženi z virusom hepatitisa C in virusom humane imunske pomanjkljivosti, vaša jetra pa ne delujejo pravilno (npr. če je vaša koža postala rumena),
You can save the swab to clean the skin area where you will inject Pegasys.
Krpico lahko shranite za čiščenje površine kože, kjer boste injicirali zdravilo Pegasys.
Reproductive toxicity studies have not been performed with Pegasys.
Študije reproduktivne toksičnosti z zdravilom Pegasys niso izvajali.
If you are injecting this medicine yourself, you will be instructed how to give the injection.
Če si boste zdravilo injicirali sami, vas bodo poučili o pravilnem postopku.
Let the skin dry for 10 seconds.
Počakajte 10 sekund, da se koža osuši.
Take the pre-filled pen out of the refrigerator.
Vzemite napolnjeni injekcijski peresnik iz hladilnika.
NPV Sensitivity Specificity HBeAg-positive(a)
NPV Občutljivost Specifičnost HBeAg-pozitivni
The “Instructions for the User”, provided in the carton, must be followed carefully by the patient.
Navodila za uporabnika, ki so dodana v škatli, mora bolnik skrbno upoštevati.
The frequency depends on the treatment duration and the dose of ribavirin (see section 4.8).
Pogostnost je odvisna od trajanja zdravljenja in od odmerka ribavirina (glejte poglavje 4.8).
Push the plunger up slowly to the correct dose.
Bat počasi potisnite do pravilnega odmerka.
4) Choose and prepare an injection site 5) Remove cap
4) Izberite in pripravite mesto vboda 5) Odstranite pokrovček
What Pegasys is and what it is used for
Kaj je zdravilo Pegasys in za kaj ga uporabljamo
Patients with advanced fibrosis were assigned to Pegasys treatment (group C, n=10).
Bolnike z napredovalo fibrozo so določili za zdravljenje z zdravilom Pegasys (skupina C, n = 10).
● Do not repeat the injection
• Ne ponavljajte injiciranja.
Body system Very common
Organski sistem zelo pogosti pogosti
● if you develop any signs of bleeding or unusual bruising, check with your doctor immediately.
• če opazite znake krvavitev ali nenavadne modrice, takoj obvestite svojega zdravnika,
Study NV15496 + NV15497 + NV15801
Študija NV15496 + NV15497 + NV15801
If necessary, an inter-disciplinary approach including a mental health care provider or addiction specialist should be considered to evaluate, treat and follow the patient.
Če je potrebno, je treba razmisliti o sodelovanju z drugimi specialisti kot so specialist za duševno zdravje ali specialist za zdravljenje odvisnosti, ter stanje oceniti, spremljati in bolnika zdraviti.
• Neonates and young children up to 3 years old, because of the excipient benzyl alcohol (see section 4.4 for benzyl alcohol)
• novorojenčki in otroci do tretjega leta starosti, zaradi pomožne snovi benzilalkohola (glejte poglavje 4.4 za benzilalkohol),
● a short needle for the subcutaneous injection
• kratka igla za podkožno injekcijo,
These patients had stable HIV disease and mean CD4 T-cell count was about 500 cells/µl.
Ti bolniki so imeli stabilno bolezen HIV, srednje število celic CD4+ pa je bilo približno 500 celic/μl.
● remove the cap until you are ready to inject.
• odstranite pokrovčka, dokler niste pripravljeni za injiciranje;
Do not use Pegasys if you are taking telbivudine (see “Do not use Pegasys”) because the combination of these medicines increases the risk of developing peripheral neuropathy (numbness, tingling, and/or burning sensations in the arms and/or legs).
Če jemljete telbivudin, ne uporabljajte zdravila Pegasys (glejte “Ne uporabljajte zdravila Pegasys, če”), ker kombinacija teh zdravil poveča tveganje za nastanek periferne nevropatije (otopelost, mravljinci in/ali pekoč občutek v rokah, nogah ali obojih).
This would be particularly important in patients with a known history of zidovudine induced anaemia.
To je še posebej pomembno pri bolnikih, pri katerih je znano, da je pri njih prišlo do anemije zaradi zidovudina.
Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
O poslabšanju anemije zaradi ribavirina so poročali, kadar je bil zidovudin del sheme zdravljenja HIV, čeprav natančen mehanizem ni znan.
Chronic Hepatitis B: Pegasys is usually used alone.
Kronični hepatitis B: zdravilo Pegasys se običajno uporablja samostojno.
A total of 55 patients received initial combination treatment of Pegasys plus ribavirin, of whom 51% were female, 82% were Caucasian, and 82% were infected with HCV genotype 1.
Skupno 55 bolnikov je prejelo začetno kombinacijo zdravljenja z zdravilom Pegasys in ribavirinom, od tega je bilo 51 % žensk, 82 % belcev in 82 % okuženih s HCV genotipa 1.
If your female partner is not pregnant now, but is of childbearing potential, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Če vaša partnerka ni noseča, vendar je v rodni dobi, mora vsak mesec v času zdravljenja in 7 mesecev po končanem zdravljenju opraviti test nosečnosti.
Odds Ratio (95% CI)
Razmerje obetov (95-% CI)
Appropriate antiinfective therapy should be started immediately and discontinuation of therapy should be considered.
Potrebno je takoj pričeti z ustreznim zdravljenjem proti okužbam in razmisliti o prekinitvi zdravljenja.
● if you have psoriasis, it may get worse during treatment with Pegasys.
• če imate psoriazo, ki se lahko med zdravljenjem z zdravilom Pegasys poslabša,
If treatment with alfa interferon is judged necessary in these patients, the presence of psychiatric co-morbidities and the potential for other substance use should be carefully assessed and adequately managed before initiating therapy.
Če je zdravljenje z interferoni alfa pri teh bolnikih nujno, je treba obstoječe simptome psihiatričnih motenj in možnost jemanja drugih substanc pazljivo oceniti in ustrezno obravnavati pred pričetkom zdravljenja.
In case of persistent or unexplained pulmonary infiltrates or pulmonary function impairment, treatment should be discontinued.
Pri dolgotrajnih ali nerazložljivih pljučnih infiltratih ali motenem pljučnem delovanju moramo zdravljenje prekiniti.
To calculate BSA, it is recommended to use Mosteller's equation:
Za izračun telesne površine je priporočljiva uporaba Mostellerjeve formule:
Your other hand will be free to move the plunger of the syringe.
Svojo drugo prosto roko uporabite za premikanje bata brizge.
Study NV15495 specifically recruited patients with a histological diagnosis of cirrhosis (about 80%) or transition to cirrhosis (about 20%).
Študija NV15495 je specifično vključevala bolnike s histološko diagnozo ciroze (okoli 80 %) ali prehoda v cirozo (okoli 20 %).
More frequent monitoring of hepatic function was recommended in all instances.
Pri vseh primerih so priporočali pogostejše spremljanje jetrne funkcije.
What Pegasys is and what it is used for What you need to know before you use Pegasys How to use Pegasys
Kaj je zdravilo Pegasys in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Pegasys Kako uporabljati zdravilo Pegasys
May cause toxic reactions and allergic reactions in infants and children up to 3 years old.
Lahko povzroči toksične in alergijske reakcije pri dojenčkih in otrocih do 3. leta starosti.
Patients in groups A and C (n=111) were treated with Pegasys once weekly for 48 weeks according to BSA categories, whereas patients in group B were observed for a period of 48 weeks (principal observation period).
Bolnike iz skupin A in C (n = 111) so zdravili z zdravilom Pegasys enkrat na teden 48 tednov glede na telesno površino, razdeljeno v kategorije, bolnike iz skupine B pa so opazovali 48 tednov (glavno obdobje opazovanja).
Keep the protective cap on the pre-filled pen until Step 5.
Pustite zaščitni pokrovček na napolnjenem injekcijskem peresniku do koraka 5.
Be sure not to touch the cleaned area prior to injection.
Ne dotikajte se očiščenega mesta, preden si date injekcijo.
p value
p-vrednost
In some cases, dose modification may be necessary (see section 4.2).
V nekaterih primerih je treba odmerek prilagoditi (glejte poglavje 4.2).
< 250 cells/mm3 (or febrile neutropenia): discontinue treatment.
< 250 celic/mm3 (ali febrilna nevtropenija): ukinitev zdravljenja.
24 weeks or 48 weeks
24 ali 48 tednov
● any part of the pre-filled pen appears to be damaged
• kateri koli del napolnjenega injekcijskega peresnika izgleda poškodovan;
The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials on a case by case basis (see sections 4.8 and 5.1).
Pričakovano korist zdravljenja je treba pri vsakem primeru posebej skrbno pretehtati glede na znane izsledke kliničnih preskušanj o varnosti pri otrocih in mladostnikih (glejte poglavji 4.8 in 5.1).
< 10 g/dl, and ≥ 8.5 g/dl
< 10 g/dl in ≥ 8,5 g/dl
Tell your doctor if you are taking medicines for asthma, because the dose for your asthma medicine may need to be changed.
Če jemljete zdravila proti astmi, to povejte svojemu zdravniku, ker bo zdravnik morda moral prilagoditi odmerek zdravila proti astmi.
Exposure to didanosine or its active metabolite (dideoxyadenosine 5'-triphosphate) is increased in vitro when didanosine is coadministered with ribavirin.
Izpostavljenost didanozinu ali njegovemu aktivnemu presnovku (dideoksiadenozin 5`- trifosfat) je povečana in vitro, če didanozin jemljemo sočasno z ribavirinom.
● Hold the vial and syringe in one hand and turn the vial and the syringe upside down (4).
● Vialo in brizgo primite v eno roko in ju obrnite navzgor (4).
You should inject your regularly scheduled dose immediately on Friday and take your next injection on Wednesday (5 days after your Friday dose).
V petek si takoj injicirajte priporočeni odmerek, naslednji odmerek pa si injicirajte v sredo (5 dni po petkovem odmerku).
No dose adjustment is required for adult patients with mild or moderate renal impairment.
Prilagoditev odmerka pri odraslih bolnikih z blago ali zmerno ledvično okvaro ni potrebna.
Dose adjustment for adverse reactions in adult patients
Prilagajanje odmerkov zaradi neželenih učinkov pri odraslih bolnikih
● Do not touch the tip of the pre-filled pen, since needlestick injuries may occur.
• Ne dotikajte se konice napolnjenega injekcijskega peresnika, ker lahko pride do poškodb (vboda z iglo).
Adjustments in the recommended dosage of 180 micrograms once weekly are not necessary when instituting Pegasys therapy in elderly patients (see section 5.2).
Prilagoditve priporočenega odmerka 180 mikrogramov enkrat na teden pri uvajanju zdravljenja z zdravilom Pegasys pri starejših bolnikih niso potrebne (glejte poglavje 5.2).
The pharmacokinetics of Pegasys after single subcutaneous injections was comparable between male and female healthy subjects.
Farmakokinetika zdravila Pegasys je bila po enkratni podkožni injekciji med zdravimi moškimi in ženskami primerljiva.
The side effect may develop at various time points during treatment, typically several months after starting treatment with Pegasys.
Neželeni učinek se lahko pojavi ob različnih časovnih točkah zdravljenja, običajno nekaj mesecev po začetku zdravljenja z zdravilom Pegasys.
Do not exceed the recommended dose.
Priporočenega odmerka ne smete prekoračiti.
Unless otherwise noted, the management of all other toxicities should follow the adult recommendations.
Pri obravnavi vseh ostalih toksičnostih je treba slediti priporočilom za odrasle, razen če ni navedeno drugače.
● Check for air bubbles in the syringe.
● Preverite, če so v brizgi zračni mehurčki.
● if you have a problem with your liver other than hepatitis B or C.
• če imate težave z jetri in vzrok ni hepatitis B ali C,
Patients should be closely monitored during therapy and even after treatment discontinuation.
Bolnike je treba skrbno spremljati med zdravljenjem in tudi po njegovem zaključku.
16 weeks(a) or 24 weeks
16 tednov(a) ali
Use Pegasys exactly as described by your doctor, for as long as prescribed by your doctor.
Zdravilo Pegasys uporabljajte natančno po zdravnikovih navodilih in tako dolgo, kot vam je predpisal zdravnik.
If it is not used within 5 minutes, the pre-filled pen should be disposed and a new pre-filled pen should be used.
Če ga ne uporabite v 5 minutah, je treba napolnjeni injekcijski peresnik zavreči in uporabiti novega.
Pegasys treatment may be initiated or continued if TSH levels can be maintained in the normal range by pharmaceutical means.
Zdravljenje z zdravilom Pegasys lahko začnemo ali nadaljujemo, če lahko z zdravilom vzdržujemo koncentracije TSH v normalnih mejah.
● if you have thyroid disease that is not well controlled with medicines.
• če imate bolezen ščitnice, ki ni popolnoma nadzorovana z zdravili,
Needle-shield (only visible once cap is removed in Step 5)
Ščitnik za iglo (viden samo, ko je pokrovček odstranjen v koraku 5)
SI unit = µmol/l)
SI-enote (µmol/l)
Excipient with known effect: Benzyl alcohol (10 mg/ 1 ml) For the full list of excipients, see section 6.1.
Pomožna snovi z znanim učinkom: benzilalkohol (10 mg/1 ml) Za celoten seznam pomožnih snovi glejte poglavje 6.1.