natgillin/translations-raw huggingface dataset:
There are no reproductive and developmental toxicology studies with Flucelvax Tetra. 
Študij vpliva na sposobnost razmnoževanja in razvoj s cepivom Flucelvax Tetra niso izvedli.
Extensive swelling of injected limb 
obsežna oteklina okončine, v katero je bilo injicirano cepivo
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) This medicine is subject to additional monitoring. 
Navodilo za uporabo Flucelvax Tetra, suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti gripi iz kulture celic, s površinskimi antigeni, inaktivirano Za to zdravilo se izvaja dodatno spremljanje varnosti.
Mild side effects 
Blagi neželeni učinki
Name and address of the manufacturer(s) responsible for batch release Seqirus Vaccines Ltd 
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
How to store Flucelvax Tetra 
Shranjevanje cepiva Flucelvax Tetra
Name and address of the manufacturer(s) of the biological active substance(s) Seqirus Inc. 
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin)
• Muscle pain 
• bolečine v mišicah,
HI data, egg-derived assay 
Podatki za HI, analiza na osnovi jajčnih celic.
Talk to your doctor, pharmacist or nurse before receiving Flucelvax Tetra. 
Preden prejmete cepivo Flucelvax Tetra, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Immunogenicity of TIVc in children 9 to less than 18 years of age was evaluated as part of a randomised, double-blind, controlled study (V58P12) that was performed in the paediatric population 3 to less than 18 years of age. 
nadzorovane študije (V58P12), ki je bila izvedena pri pediatrični populaciji starosti od 3 leta do manj kot 18 let, so ocenili imunogenost cepiva TIVc pri otrocih, starih od 9 let do manj kot 18 let.
Studies 301 and 202 
Študiji 301 in 202
What is MPS VII 
Kaj je MPS VII
Compatibility with other medicinal products has not been evaluated. 
Združljivosti z drugimi zdravili niso ocenili.
Currently available data are described in section 4.8 and section 5.1. 
Trenutno razpoložljivi podatki so opisani v poglavjih 4.8 in 5.1.
Appropriate clinical treatment should be immediately sought. 
Nemudoma je treba uvesti ustrezno klinično zdravljenje.
Reports to be submitted as part of the annual reassessment 
Poročila je treba predložiti kot del letne ponovne ocene.
- These sugars are re-cycled all the time - new ones are made and old ones are broken down. 
- Ti sladkorji se ves čas reciklirajo - nastajajo novi, medtem ko se stari razgrajujejo.
The posology in the paediatric population is the same as in adults. 
Pediatrična populacija Pri pediatrični populaciji je odmerjanje enako kot pri odraslih.
Dilution preparation should be done at room temperature. 
Raztopino je treba pripraviti pri sobni temperaturi.
From a microbiological safety point of view, the diluted product should be used immediately. 
Z vidika mikrobiološke varnosti je treba razredčeno zdravilo uporabiti takoj.
- Do not use this medicine if you notice particles. 
- Ne uporabljajte tega zdravila, če opazite prisotnost delcev.
Other symptoms to look out for 
Drugi simptomi, na katere morate biti pozorni
He or she will check that the correct dose has been given and take action as needed. 
Prepričal se bo, da ste dobili pravilen odmerek, in po potrebi ukrepal.
Tell your doctor if you are using, have recently used or might use any other medicines. 
Obvestite zdravnika, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
Colourless glass vial (Ph. Eur. 
Viala iz brezbarvnega stekla (Ph. Eur.
Nine patients were younger than 18 years of age. 
Devet bolnikov je bilo mlajših od 18 let.
They may include an allergic reaction (see section 4). 
Učinki lahko vključujejo alergijsko reakcijo (glejte poglavje 4).
Nineteen patients were younger than 18 years of age. 
Devetnajst bolnikov je bilo mlajših od 18 let.
These problems can be signs of the illness and may be caused by pressure on your spinal cord. 
Te težave so lahko znaki bolezni in so lahko posledica pritiska na hrbtenjačo.
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 using this medicine. 
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
In addition, uGAG response (% change from study week 0) shows a similar magnitude of reduction in uGAG in all groups after crossover to active treatment. 
Poleg tega odziv uGAG (% spremembe od študijskega tedna 0) kaže podoben obseg zmanjšanja ravni uGAG v vseh skupinah po prehodu na aktivno zdravljenje.
- The medicine has to be diluted before being given. 
- Zdravilo je treba pred dajanjem razredčiti.
- If you have ever had a severe allergic reaction to vestronidase alfa or any of the other ingredients of this medicine (listed in section 6). 
- če ste kdaj imeli hudo alergijsko reakcijo na vestronidazo alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica doseženja pomembnega mejnika (farmakovigilančnega ali povezanega z zmanjševanjem tveganja).
Side effects were mainly seen while patients were being given the medicine or within a day after the infusion (infusion reactions). 
Neželene učinke so v glavnem opažali, medtem ko so bolniki dobivali zdravilo ali v enem dnevu po infuziji (infuzijske reakcije).
Treatment with Mepsevii should be started and monitored by your doctor. 
Zdravljenje z zdravilom Mepsevii mora začeti in nadzorovati vaš zdravnik.
Take this into account if you are on a controlled sodium diet. 
To morate upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
Starting treatment early in children may stop the illness getting worse and reduce permanent damage. 
Pri otrocih lahko zgodnji začetek zdravljenja ustavi napredovanje bolezni in zmanjša trajno škodo.
No alternative dose regimen is recommended in these patients (see section 5.1). 
Pri teh bolnikih se ne priporoča drugačen režim odmerjanja (glejte poglavje 5.1).
- This enzyme helps to break down sugars in the body called mucopolysaccharides. 
- Ta encim pomaga razgraditi sladkorje v telesu, ki se imenujejo mukopolisaharidi.
- Treatment may improve various signs and symptoms of illness, like walking difficulties and tiredness. 
- Zdravljenje lahko izboljša različne znake in simptome bolezni, denimo oteženo hojo in utrujenost.
All 12 patients were responders, pre-specified as ≥ 50% reduction in uGAG on at least one visit during the first 24 weeks of treatment. 
Vseh 12 bolnikov je doseglo odziv, vnaprej določen kot ≥ 50-odstotno zmanjšanje uGAG ob najmanj enem obisku v prvih 24 tednih zdravljenja.
The extremely small population of patients with MPS VII globally necessitated the enrolment of all patients able to participate in this clinical trial, resulting in a highly variable group. 
Ker je populacija bolnikov z MPS VII po vsem svetu izjemno majhna, je bilo treba v to klinično preskušanje sprejeti vse bolnike, ki so bili zmožni sodelovati; to je povzročilo visoko variabilno skupino.
Patients should be informed of the signs and symptoms of hypersensitivity reactions and instructed to seek immediate medical care should such signs and symptoms occur. 
Bolnike seznanite z znaki in simptomi preobčutljivostnih reakcij in jim naročite, naj ob morebitnem pojavu takšnih znakov in simptomov takoj poiščejo zdravniško pomoč.
What you need to know before you are given Mepsevii 3. 
Kaj morate vedeti, preden boste dobili zdravilo Mepsevii 3.
Total Infusion Volume (infused over 4 hours) (mL) 
Celotni volumen infuzije (infundiran v 4 urah) (ml)
If you have an infusion reaction, tell your doctor straight away. 
Če imate infuzijsko reakcijo, o tem takoj obvestite svojega zdravnika.
Do not infuse Mepsevii with other medicinal products in the infusion tubing. 
Ne mešajte zdravila Mepsevii z drugimi zdravili v istih infuzijskih cevkah.
The effects of treatment with vestronidase alfa should be periodically evaluated and discontinuation of treatment should be considered in cases where clear benefits (including stabilisation of disease manifestations) are not observed. 
Učinke zdravljenja z vestronidazo alfa je treba občasno oceniti in razmisliti o prekinitvi zdravljenja v primerih, ko ni videti jasnih koristi (vključno s stabilizacijo manifestacij bolezni).
The 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 nadaljnje sprejetih posodobitvah RMP.
The safety and efficacy of vestronidase alfa in patients older than 65 years have not been established. 
Varnost in učinkovitost vestronidaze alfa pri bolnikih, starejših od 65 let, nista dokazani.
It is not known whether Mepsevii passes into breast milk, but transfer of the medication to your baby is not expected. 
Ni znano, ali zdravilo Mepsevii prehaja v materino mleko, vendar ni pričakovati, da se bo zdravilo preneslo na vašega otroka.
In order to obtain long-term data on effectiveness and safety of treatment with Mepsevii and to characterize the entire mucopolysaccharidosis VII, including variability of clinical manifestation, progression and natural history, the MAH is requested to submit the results of a study based on adequate source of data deriving from a Disease Monitoring Program of patients with mucopolysaccharidosis VII. 
Za pridobitev dolgoročnih podatkov o učinkovitosti in varnosti zdravljenja z zdravilom Mepsevii in za določitev značilnosti celotne mukopolisaharidoze tipa VII, vključno z razlikami v klinični izraženosti, napredovanju in naravni zgodovini, mora imetnik z dovoljenjem za promet predložiti rezultate študije na podlagi ustreznih virov podatkov, pridobljenih iz programa spremljanja bolezni pri bolnikih z mukopolisaharidozo tipa VII.
These side effects are called infusion reactions because they are caused by the infusion (drip) of the medicine. 
Ti neželeni učinki se imenujejo »infuzijske reakcije«, ker jih povzroča infuzija zdravila.
Each vial of Mepsevii is intended for single use only. 
Vsaka viala zdravila Mepsevii je samo za enkratno uporabo.
**One adverse reaction of Peripheral swelling is included within the frequency of Infusion site swelling as the event is classified as intravenous catheter issue. 
** Neželeni učinek »periferna oteklina« je vključen v pogostnost »otekline na mestu infundiranja«, ker je dogodek razvrščen med težave, povezane z intravenskim katetrom.
What Mepsevii is and what it is used for 2. 
Kaj je zdravilo Mepsevii in za kaj ga uporabljamo 2.
- If you have an allergic reaction during your infusion your doctor may slow down, or stop your infusion. 
- Če se med infundiranjem pri vas pojavi alergijska reakcija, lahko zdravnik upočasni ali ustavi infuzijo.
For each vial dosed, including the corresponding diluent volume, the sodium intake is 35.5 mg sodium. 
Pri vsaki odmerjeni viali, vključno z ustreznim volumnom razredčila, je vnos natrija 35,5 mg.
- The recommended dose is 4 mg for each kg of body weight. 
- Priporočeni odmerek je 4 mg na vsak kg telesne mase.
Administration of vestronidase alfa should be carried out by an appropriately trained healthcare professional with the ability to manage medical emergencies. 
Vestronidazo alfa smejo dajati samo ustrezno usposobljeni zdravstveni delavci z zmožnostjo obvladovanja nujnih zdravstvenih primerov.
Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes, ATC code: A16AB18 
Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, encimi; oznaka ATC: A16AB18
The dose you will receive is based on how much you weigh. 
Odmerek, ki ga boste dobili, bo izračunan na podlagi vaše telesne mase.
You will not be given Mepsevii if you are pregnant unless treatment is clearly necessary. 
Če ste noseči, ne boste dobili zdravila Mepsevii, razen če je zdravljenje nedvomno nujno.
Treatment should be supervised by a healthcare professional experienced in the management of patients with MPS VII or other inherited metabolic disorders. 
Zdravljenje mora nadzorovati zdravnik z izkušnjami z zdravljenjem bolnikov z MPS VII ali drugimi dednimi presnovnimi boleznimi.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare (< 1/10,000). 
(od ≥ 1/100 do < 1/10), občasni (od ≥ 1/1.000 do < 1/100), redki (od ≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
It is important to administer vestronidase alfa according to the recommended infusion rate schedule (see Table 2 in section 6.6). 
Pomembno je, da se vestronidaza alfa daje skladno s priporočenim razporedom infundiranja (glejte preglednico 2 v poglavju 6.6).
- The dose is given every two weeks through a drip into a vein (intra-venous infusion). 
- Zdravilo se daje vsaka dva tedna neposredno v veno (intravenska infuzija).
Sixteen out of 23 patients (70%) from 4 clinical trials developed anti-recombinant human betaglucuronidase (rhGUS) antibodies (ADA), nine of whom further developed neutralizing antibodies (NAb) on at least one occasion, but not consistently over time. 
Šestnajst od 23 bolnikov (70 %) v 4 kliničnih preskušanjih je razvilo protitelesa proti humani rekombinantni beta-glukuronidazi (rhGUS) (ADA), od katerih jih je devet razvilo nevtralizirajoča protitelesa (NAb) vsaj enkrat, vendar ne časovno dosledno.
Block-7, City North Business Campus Stamullen, Co. Meath, Ireland 
Millmount Healthcare Ltd. Block-7, City North Business Campus Stamullen, Co. Meath, Irska
If severe hypersensitivity reactions occur, immediately stop the infusion of vestronidase alfa and initiate appropriate treatment. 
Če se pojavijo hude preobčutljivostne reakcije, takoj ustavite infundiranje vestronidaze alfa in uvedite ustrezno zdravljenje.
Most adverse reactions were mild to moderate in severity. 
Neželeni učinki so bili večinoma blagi do zmerni.
This should be taken into consideration during dilution of the medicinal product for patients on a controlled sodium diet or for those patients with congestive heart failure needing to restrict sodium and total water intake. 
To je treba upoštevati pri redčenju zdravila za bolnike, ki so na dieti z nadzorovanim vnosom natrija, ali za bolnike s kongestivnim srčnim popuščanjem, ki morajo omejevati vnos natrija in skupni vnos vode.
During enzyme replacement therapy, spinal cord injury can occur due to improved neck and spine mobility. 
Med nadomestnim encimskim zdravljenjem lahko zaradi izboljšane mobilnosti vratu in hrbtenice pride do poškodb hrbtenjače.
Anaphylactoid reaction Very common 
Anafilaktoidna reakcija Zelo pogosti
Round to the next whole vial and remove the required number of vials (refer to Table 2) from the refrigerator to allow them to reach room temperature up to a maximum of 25°C. 
Število zaokrožite na naslednjo celo vialo in vzemite potrebno število vial (glejte preglednico 2) iz hladilnika, da dosežejo sobno temperaturo, največ 25 °C.
No alternative dose regimen is recommended in these patients. 
Pri teh bolnikih se ne priporoča drugačen režim odmerjanja.
- Each infusion will be given over about 4 hours. 
- Posamezna infuzija traja približno 4 ure.
Each vial dosed is therefore equivalent to 1.8% of the recommended maximum daily dietary intake of sodium for an adult. 
Vsaka odmerjena viala torej ustreza 1,8 % priporočenega največjega dnevnega vnosa natrija za odrasle.
Adverse reactions are presented by System Organ Class and frequency. 
Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti.
Clinical endpoints were not assessable in some patients due to their extent of disease, age or level of cognition (23 out of 72 assessments [~32%] in 6 domains for 12 patients were non-assessable at baseline). 
Kliničnih opazovanih dogodkov pri nekaterih bolnikih ni bilo mogoče oceniti zaradi obsežnosti bolezni, starosti ali ravni kognicije (ob izhodišču ni bilo mogoče izvesti 23 od 72 ocen [~32 %] iz 6 domen pri 12 bolnikih).
Infusion Rate for Subsequent 3 Hours 
Hitrost infuzije v naslednjih 3 urah
Mepsevii has no or negligible influence on the ability to drive and use machines. 
Zdravilo Mepsevii nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
In most patients, a pattern of attenuated immunogenicity with chronic exposure was suggested by declining antibody titres over time on continuous treatment. 
Pri večini bolnikov je bil navidez prisoten vzorec oslabljene imunogenosti ob kronični izpostavljenosti, pri čemer so se titri protiteles ob nadaljevanju zdravljenja sčasoma zmanjšali.
Spinal or cervical cord compression is a known and serious complication of MPS VII. 
Kompresija (vratne) hrbtenjače je znan in resen zaplet pri MPS VII.
Gently rock the infusion bag to ensure proper distribution of Mepsevii. 
Infuzijsko vrečko previdno obračajte, da zagotovite pravilno porazdelitev zdravila Mepsevii.
This belongs to a group of medicines called enzyme replacement therapies. 
Ta spada v skupino zdravil, namenjenih »nadomestnemu encimskemu zdravljenju«.
This medicine replaces beta-glucuronidase - this helps to break down the sugars that collect in the tissues of people with MPS VII. 
To zdravilo nadomešča beta-glukuronidazo, s čimer pomaga razgraditi sladkorje, ki se kopičijo v tkivih ljudi z MPS VII.
The presence of ADA (non-NAb and NAb) does not appear to affect reduction in the pharmacodynamic marker, urinary glycosaminoglycans (uGAGs). 
Zdi se, da prisotnost ADA (ne-NAb in NAb) ne vpliva na zmanjšanje ravni farmakodinamičnega označevalca, urinarnih glikozaminoglikanov (uGAG).
The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary. 
Evropska agencija za zdravila bo vsako leto pregledala vse nove podatke, ki bodo na voljo.
The lowest rate administered to a patient in the clinical development program was 0.5 mL/hour during the first 30 minutes of infusion, followed by 1 mL/hour over the next 30 minutes, equalling 0.75 mL as the lowest total volume infused during the first hour. 
Najnižja hitrost infundiranja, ki je bila uporabljena pri bolniku v programu kliničnega razvoja, je bila 0,5 ml/h v prvih 30 minutah infuzije in 1 ml/h v naslednjih 30 minutah, kar ustreza 0,75 ml kot najmanjši skupni količini, infundirani v prvi uri.
Patients with MPS VII who received Hematopoietic Stem Cell Transplant therapy were excluded in this study. 
Bolniki z MPS VII, ki so se zdravili s presaditvijo krvotvornih matičnih celic, niso mogli sodelovati v tej študiji.
- Mucopolysaccharides are made in the body and they help build bones, cartilage, skin, and tendons. 
- Mukopolisaharidi nastajajo v telesu ter so gradniki kosti, hrustanca, kože in kit.
- The other ingredients are: sodium dihydrogen phosphate dihydrate, sodium chloride, histidine, polysorbate 20, and water for injections (for sodium, see section 2 under “Mepsevii contains sodium”). 
- Druge sestavine so: natrijev dihidrogenfosfat dihidrat, natrijev klorid, histidin, polisorbat 20 in voda za injekcije (za informacije o natriju glejte poglavje 2 »Zdravilo Mepsevii vsebuje natrij«).
As end organ damage progresses over time, it is more difficult for the treatment to reverse the damage or to show improvements. 
Ker poškodbe tarčnih organov sčasoma napredujejo, je s poznejšim zdravljenjem težje odpraviti poškodbe ali doseči izboljšanje stanja.
Vestronidase alfa, at the exposure observed in humans, is not expected to cross the blood-brain-barrier and therefore it is not likely to impact the neurological manifestations of the disease. 
Ni pričakovati, da bo vestronidaza alfa pri izpostavljenosti, opaženi pri ljudeh, prehajala skozi krvno možgansko pregrado, zato verjetno ne bo vplivala na nevrološke manifestacije bolezni.
Table 1 lists the adverse reactions reported from 4 clinical trials in 23 patients treated with Mepsevii. 
V preglednici 1 so našteti neželeni učinki, o katerih so poročali v 4 kliničnih preskušanjih pri 23 bolnikih, zdravljenih z zdravilom Mepsevii.
Contents of the pack and other information What Mepsevii contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Mepsevii
Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake »Uporabno do:«.
No excretion studies have been conducted in humans. 
Pri ljudeh niso opravili nobenih študij izločanja.
Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment: 
Če opazite katerega od naslednjih neželenih učinkov, nemudoma povejte zdravniku - morda boste potrebovali nujno zdravniško pomoč:
MPS VII is an illness that runs in families, where the body does not produce enough of an enzyme called beta-glucuronidase. 
MPS VII je dedna bolezen, pri kateri telo ne proizvaja dovolj encima beta-glukuronidaze.
Do not flush the line containing vestronidase alfa to avoid a rapid bolus of infused enzyme. 
Ne izpirajte linije, ki vsebuje vestronidazo alfa, da ne pride do hitrega bolusa infundiranega encima.
Mepsevii is not likely to affect you being able to drive or use machines. 
Ni verjetno, da bi zdravilo Mepsevii vplivalo na vašo sposobnost za vožnjo ali uporabo strojev.
It is used in adults and children of all ages with MPS VII to treat nonneurological manifestations of the disease (mucopolysaccharidosis VII, also known as Sly Syndrome). 
Uporablja se pri odraslih in otrocih vseh starosti z MPS VII za zdravljenje nenevroloških manifestacij bolezni (mukopolisaharidoza VII, imenovana tudi Slyev sindrom).
Discuss with your doctor if the benefits of using Mepsevii are greater than the possible risks to your unborn baby. 
Pogovorite se z zdravnikom, ali so koristi uporabe zdravila Mepsevii večje od možnih tveganj za vašega nerojenega otroka.
After 120 weeks of exposure to vestronidase alfa, one patient demonstrated a 21% improvement over baseline in forced vital capacity (FVC% predicted) on pulmonary function testing in addition to a 105 meter improvement in the 6MWT. 
Po 120 tednih izpostavljenosti vestronidazi alfa je en bolnik pri testiranju delovanja pljuč pokazal 21-odstotno izboljšanje forsirane vitalne kapacitete (predvideni % FVC) glede na izhodiščno vrednost in izboljšanje 6MWT za 105 metrov.
There was a single adverse reaction of febrile convulsion observed in one patient (4.3%); the patient recovered without sequelae. 
Opazili so en sam primer vročinskih krčev, ki so se kot neželeni učinek pojavili pri enem bolniku (4,3 %); bolnik je okreval brez posledic.
What you need to know before you are given Mepsevii You must not be given Mepsevii: 
Kaj morate vedeti, preden boste dobili zdravilo Mepsevii Zdravila Mepsevii ne smete dobiti:
Life-threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1 (see section 4.4). 
Življenjsko nevarna preobčutljivost (anafilaktična reakcija) na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte poglavje 4.4).