natgillin/translations-raw huggingface dataset:
Vimizim is an enzyme replacement therapy.
Vimizim je zdravilo za encimsko nadomestno zdravljenje.
Vimizim is a medicine that contains the active substance elosulfase alfa.
Vimizim je zdravilo, ki vsebuje zdravilno učinkovino elosulfazo alfa.
How does Vimizim work?
Kako zdravilo Vimizim deluje?
How is Vimizim used?
Kako se zdravilo Vimizim uporablja?
Bioavailability was shown to be approximately 70%.
Ugotovljeno je bilo, da je biološka razpoložljivost približno 70 %.
Plasma protein binding is high (~99%).
Vezava na plazemske beljakovine je visoka (~ 99 %).
ATCvet code: QP53BX03.
Oznaka ATCvet: QP53BX03
Do not use in dogs or cats under 14 weeks of age.
Ne uporabite pri psih in mačkah, mlajših od 14 tednov.
Administer with food.
Dajajte s hrano.
The duration of efficacy may be reduced if the dose is administered on an empty stomach.
Trajanje učinkovitosti se lahko skrajša, če se odmerek daje na prazen želodec.
These effects are caused primarily by activation of nicotinic acetylcholine receptors (nAChRs).
Te učinke povzroča večinoma aktivacija nikotinskih acetilholinskih receptorjev (nAChRs).
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Antidota ni.
Use with caution in dogs and cats with pre-existing epilepsy.
Previdno uporabljajte pri psih in mačkah z obstoječo epilepsijo.
Furthermore, a reduction of food intake was observed in females, however a significant reduction in their bodyweight was not observed.
Poleg tega so pri samicah opazili zmanjšan vnos hrane, vendar pa bistvenega zmanjšanja njihove telesne mase niso opazili.
In case of adverse clinical signs, the animal should be treated symptomatically.
V primeru neželenih kliničnih znakov je treba žival zdraviti simptomatsko.
Pharmacotherapeutic group: other ectoparasiticides for systemic use.
FARMAKOLOŠKE LASTNOSTI Farmakoterapevtska skupina: drugi ektoparazitiki za sistemsko uporabo.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/02/2011.
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 11/02/2011
In very rare cases, blindness, impaired vision and other eye disorders were observed.
V zelo redkih primerih so opazili slepoto, slabovidnost in ostala obolenja oči.
Keep the blister in the outer carton to protect from light.
Pretisni omot shranjujte v zunanji ovojnini, za zaščito pred svetlobo.
Children should not come into contact with the veterinary medicinal product.
Otroci ne smejo priti v stik s tem zdravilom za uporabo v veterinarski medicini.
The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
To zdravilo za uporabo v veterinarski medicini se lahko uporablja kot del strategije zdravljenja za obvladovanje alergijskega dermatitisa, ki ga povzročajo bolhe (flea allergy dermatitis - FAD).
Regular monthly treatments with Comfortis break the fleas' life cycle and may be needed to control the flea population in contaminated households.
Redna mesečna zdravljenja z zdravilom Comfortis prekinejo življenjski cikel bolhe in so morda potrebna za obvladovanje populacije bolh v kontaminiranem gospodinjstvu.
In the majority of cases, vomiting was transient, mild and did not require symptomatic treatment.
V večini primerov je bilo bruhanje prehodno in blago ter ga ni bilo treba simptomatsko zdraviti.
AUC and Cmax values were higher in fed than fasted cats.
Vrednosti AUC in Cmax so bile višje pri nahranjenih kot pa pri teščih mačkah.
Spinosad has been shown to be a substrate for P-glycoprotein (PgP).
Ugotovljeno je bilo, da je spinosad substrat za P-glikoprotein (PgP).
All dogs and cats within the household should be treated.
Zdraviti se mora vse pse in mačke v gospodinjstvu.
Spinosad could therefore interact with other PgP-substrates (for example, digoxin, doxorubicin) and possibly enhance adverse reactions from such molecules or compromise efficacy.
Spinosad bi lahko zato medsebojno deloval z drugimi PgP-substrati (na primer z digoksinom ali doksorubicinom) in morebiti okrepil neželene učinke teh molekul ali zmanjšal učinkovitost.
Spinosad therefore has a different mode of action to other flea control or insect control products.
Spinosad ima zato drugačen način delovanja kot druga sredstva za obvladovanje bolh ali izdelki za obvladovanje insektov.
The veterinary medicinal product may safely be given at monthly intervals at the recommended dose.
To zdravilo za uporabo v veterinarski medicini se lahko varno daje v mesečnih intervalih v priporočenem odmerku.
Do not use in case of known hypersensitivity to the active substance or to any of the excipients.
Ne uporabite v primeru preobčutljivosti na zdravilno učinkovino ali na katero koli pomožno snov.
The incidence of vomiting observed after the first and second treatments was higher (8%) in dogs dosed at the upper end of the dose band.
Pojavnost bruhanja, ki so jo opazili po prvem in drugem zdravljenju, je bila višja (8 %) pri psih, ki so prejeli odmerek na zgornji meji odmerjanja.
Fleas may persist for a period of time after administration of the product due to the emergence of adult fleas from pupae already in the environment.
Bolhe se lahko pojavijo tudi v obdobju po dajanju zdravila zaradi razvoja odraslih bolh iz ličink, ki so že v okolju.
It does not interact with known binding sites of other nicotinic or GABAergic insecticides such as neonicotinides (imidacloprid or nitenpyram), fiproles (fipronil), milbemycins, avermectins (e.g. selamectin) or cyclodienes, but through a novel insecticidal mechanism.
Ne deluje medsebojno z znanimi mesti vezave drugih nikotinskih ali GABA-ergičnih insekticidov, kot so neonikotinidi (imidakloprid ali nitenpiram), fiproli (fipronil), milbemicini, avermektini (npr. selamektin) ali ciklodieni, ampak s povsem novim insekticidnim mehanizmom.
The product starts killing fleas 30 minutes after administration; 100% of fleas are dead/moribund within 4 hours post-treatment in dogs, and in cats within 24 hours.
Zdravilo začne bolhe ubijati v 30 minutah po dajanju; 100 % bolh pogine/so v fazi poginjanja pri psih v 4 urah po dajanju zdravila, pri mačkah pa v 24 urah.
Seizures were rare adverse reactions.
Konvulzije so bile redek neželeni učinek.
If fleas reappear in the fourth week, the treatment interval can be shortened by up to 3 days in dogs.
Če se bolhe četrti teden ponovno pojavijo, lahko interval dajanja pri psih skrajšate za do 3 dni.
Treatment and prevention of flea infestations (Ctenocephalides felis).
Zdravljenje in preprečevanje infestacij z bolhami (Ctenocephalides felis).
The recommended dosage regimen should be followed.
Upoštevajte priporočeno tabelo odmerjanja.
However there was no evidence in the clinical observations and clinical chemistry parameters that indicated any loss in organ function.
Vendar klinična opažanja in klinični kemijski parametri niso pokazali slabšega delovanja organov.
The veterinary medicinal product should be administered with food or immediately after feeding.
Zdravilo za uporabo v veterinarski medicini se daje s hrano ali takoj po obroku.
As the safety of this for suckling puppies and kittens has not been established, the product should only be used during pregnancy and lactation according to the benefit/risk assessment by the responsible veterinarian.
Ker ni dokazov o varnosti za pasje in mačje mladiče, ki se dojijo, se lahko to zdravilo med brejostjo ali laktacijo uporablja le v skladu z oceno razmerja korist/tveganje odgovornega veterinarja.
At doses of approximately 2.5 times the recommended dose, spinosad caused vomiting in the vast majority of dogs.
Pri odmerkih, ki so približno 2,5-krat večji od priporočenega, je spinosad povzročil bruhanje pri veliki večini psov.
The use of the product in smaller dogs and smaller cats is therefore not recommended.
Zato uporaba tega zdravila pri manjših psih in mačkah ni priporočljiva.
Other commonly observed adverse reactions in cats were diarrhoea and anorexia.
Druga neželena učinka, ki so ju pri mačkah pogosto opazili, sta bili driska in anoreksija.
Cardboard box containing blister, each containing 3 or 6 chewable tablets.
Kartonska škatla vsebuje pretisni omot s 3 ali 6 žvečljivimi tabletami.
PACKAGE SIZE 3 tablets
VELIKOST PAKIRANJA 3 tablete
There is no antidote available.
Antidota ni.
In cats, the full 4 week gap between treatments should be maintained, even if fleas reappear (due to an occasional slightly reduced persistent efficacy) before the end of the 4 weeks.
Pri mačkah je treba upoštevati 4-tedenski razmik med zdravljenji, tudi če se bolhe znova pojavijo (zaradi občasne rahlo zmanjšane učinkovitosti) pred potekom 4 tednov.
The preventive effect against re-infestations is a result of the activity against adult fleas and the reduction in their production of eggs.
Preprečevalni učinek proti ponovnim infestacijam je rezultat delovanja proti odraslim bolham in manjšega nastajanja jajčec.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini, za oznako »EXP«.
Fleas from pets often infest the animal's basket, bedding and regular resting areas such as carpets and soft furnishings, which should be treated in case of massive infestation and at the beginning of the treatment with a suitable insecticide and vacuumed regularly.
Bolhe domačih živali pogosto infestirajo košaro, ležišče in prostore, kjer žival redno počiva, kot so preproge in oblazinjena pohištva; te morate v primeru hude infestacije in ob začetku zdravljenja obdelati z ustreznim insekticidom in jih redno sesati.
If vomiting occurs within an hour of administration and the tablet is visible, re-dose the animal with another full dose to ensure maximum effectiveness of the product.
Če v eni uri po dajanju zdravila pride do bruhanja in v njem opazite tableto, dajte živali še enkrat polni odmerek, da zagotovite največjo učinkovitost zdravila.
In lactating bitches, spinosad is excreted in the colostrum/milk.
Pri doječih psicah se spinosad izloča v kolostrum/mleko.
The recommended dosage regimen should be followed (see section 4.10 for information regarding overdose).
Upoštevajte priporočeno tabelo odmerjanja (za informacije o prekomernem odmerjanju glejte poglavje
Vomiting is most likely caused by a local effect on the small intestines.
Bruhanje najverjetneje povzroči lokalni učinek na tanko črevo.
Cat bodyweight (kg)
Telesna masa mačke (kg)
MANUFACTURER'S BATCH NUMBER Lot
IZDELOVALČEVA ŠTEVILKA SERIJE
In pregnant dogs (bitches), the safety of spinosad has not been sufficiently established.
Pri brejih psicah varnost spinosada ni bila dokazana v zadostni meri.
The preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the product.
Preprečevalni učinek proti ponovnim infestacijam je rezultat adulticidnega delovanja in manjšega nastajanja jajčec, ki traja še do 4 tedne po enkratni uporabi tega zdravila.
Insecticidal activity against new infestations persists for up to 4 weeks.
Insekticidna aktivnost pred ponovno infestacijo traja do 4 tedne.
The safety of the product in male dogs and male cats used for breeding has not been determined.
Varnost zdravila pri pasjih in mačjih samcih, namenjenih za vzrejo, ni bila ugotovljena.
Phospholipidosis (vacuolation of the cells of the liver, adrenal gland and lung) also occurred.
Pojavila se je tudi fosfolipidoza (vakuolizacija celic jeter, nadledvične žleze in pljuč).
Phospholipidosis (vacuolation of lymphoid tissue) also occurred; although this was not related to clinical signs in dogs treated up to 6 months.
Pojavila se je tudi fosfolipidoza (vakuolizacija limfoidnega tkiva), čeprav to ni bilo povezano s kliničnimi znaki pri psih,
In cats, the full 4 week gap between treatments should be maintained, even if fleas reappear before the end of the 4 weeks.
Pri mačkah je treba upoštevati 4-tedenski razmik med zdravljenji, tudi če se bolhe znova pojavijo pred potekom 4 tednov.
Spinosad comprises spinosyn A and spinosyn D. The insecticidal activity of spinosad is characterised by nervous excitation leading to muscle contractions and tremors, prostration, paralysis and rapid death of the flea.
Spinosad je sestavljen iz spinosina A in spinosina D. Za insekticidno aktivnost spinosada je značilno živčno vzdraženje, ki povzroči krčenje mišic in tremorje, izčrpanost, paralizo in hitro smrt bolh.
In adult cats, the AUC increased over 3 consecutive months of dosing with 75 mg spinosad/kg bodyweight, after which steady state was achieved; however, no clinical impact occurred as a result of this.
Pri odraslih mačkah se je vrednost AUC v treh zaporednih mesecih zdravljenja z odmerkom 75 mg/kg telesne mase povišala, potem pa stabilizirala, vendar to ni imelo nobenega kliničnega učinka.
MARKETING AUTHORISATION NUMBER(S) EU/2/10/115/016 (90 mg, 3 tablets)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10/115/016 (90 mg, 3 tablete) EU/2/10/115/017 (90 mg, 6 tablet)
6.5 Nature and composition of immediate packaging Clear PCTFE/PE/PVC blister sealed with aluminium foil containing 3 or 6 chewable tablets in cardboard box.
Prozoren PCTFE/PE/PVC pretisni omot, zatesnjen z aluminijasto folijo, ki vsebuje 3 ali 6 žvečljivih tablet, pakiran v kartonski škatli.
In dogs, spinosad is excreted in the colostrum and milk of lactating bitches and it is therefore assumed that spinosad is excreted in the colostrum and milk of lactating queens.
Pri psih se spinosad izloča v kolostrum in mleko doječih psic, zato se domneva, da se izloča tudi v kolostrum in mleko doječih mačk.
Laboratory studies in rats and rabbits have not produced any evidence of any effect on the reproductive capacity in males and females.
Z laboratorijskimi študijami na podganah in kuncih ni bil dokazan vpliv na sposobnost razmnoževanja pri samcih in samicah.
Accurate dosing is not possible in dogs weighing less than 1.3 kg and in cats weighing less than 1.2 kg.
Pri psih s telesno maso manj kot 1,3 kg in mačkah s telesno maso manj kot 1,2 kg natančno odmerjanje ni mogoče.
Therefore, it is recommended to treat cats with food as this maximises the opportunity for fleas to ingest lethal amounts of spinosad.
Zato se priporoča dajanje zdravila mački skupaj s hrano, saj to poveča možnost, da bolhe zaužijejo smrtne količine spinosada.
This activity persists for up to 4 weeks after a single administration of the product.
Ta učinek traja še do 4 tedne po enkratni uporabi tega zdravila.
Comfortis 1040 mg chewable tablets for dogs
Comfortis 1040 mg žvečljive tablete za pse
Mild elevations of ALT (alanine aminotransferase) occurred in all dogs treated with Comfortis, although values returned to their baseline by day 24.
Pri vseh psih, zdravljenih z zdravilom Comfortis, je prišlo do blagega dviga ALT (alanin aminotransferaze), čeprav so se vrednosti ALT vrnile na izhodiščne do 24. dne.
Microcrystalline cellulose Artificial beef flavour Hydroxypropylcellulose Colloidal silicon, anhydrous Croscarmellose sodium Magnesium stearate
Celuloza, mikrokristalna Umetna aroma govedine Hidroksipropilceluloza Silicijev dioksid, koloidni, brezvodni Natrijev karmelozat, premreženi Magnezijev stearat
Therefore, it is recommended to treat dogs with food as this maximises the opportunity for fleas to ingest lethal amounts of spinosad.
Zato se priporoča dajanje zdravila psu skupaj s hrano, saj to poveča možnost, da bolhe zaužijejo smrtne količine spinosada.
Post marketing reports, following the concomitant use of Comfortis with ‘off label' high dose ivermectin indicate that dogs have experienced trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation.
Poročila iz obdobja trženja zdravila kažejo, da je pri psih ob sočasni uporabi zdravila Comfortis in visokih odmerkov ivermektina, ki niso odobreni, prišlo do tresenja/trzanja, salivacije/slinjenja, konvulzij, ataksije, midriaze, slepote in dezorientacije.
Comfortis tablets are chewable and palatable for dogs.
Zdravilo Comfortis so žvečljive in okusne tablete za pse.
Seek veterinary advice regarding information on the optimal time to start treatment with this product.
Glede optimalnega časa uvedbe zdravljenja s tem zdravilom se posvetujte z veterinarjem.
Lethargy, loss of condition and salivation were uncommon.
Letargija, izguba kondicije in slinjenje so se pojavili občasno.
At doses in excess of the recommended dose vomiting becomes a very common event.
Pri odmerkih, ki so večji od priporočenega, je bruhanje zelo pogost pojav.
SPECIAL STORAGE CONDITIONS Keep the blister in the outer carton.
POSEBNA NAVODILA ZA SHRANJEVANJE Pretisni omot shranjujte v zunanji ovojnini.
On the day of, or the day following administration of spinosad at a dose of 45-70 mg/kg bodyweight, the observed incidence of vomiting in the field trial was 5.6%, 4.2% and 3.6% after the first, second and third monthly treatments respectively.
Na dan dajanja spinosada v odmerku 45-70 mg/kg telesne mase ali naslednji dan so v terenski študiji opazili 5,6 % pojavnost bruhanja po zdravljenju prvi mesec, 4,2 % po zdravljenju drugi mesec in 3,6 % po zdravljenju tretji mesec.
If a dose is missed, administer the veterinary medicinal product with the next offering of food and resume a monthly dosing schedule.
Če odmerek izpustite, dajte zdravilo za uporabo v veterinarski medicini z naslednjim obrokom hrane in nato ponovno vzpostavite režim mesečnega odmerjanja.
The frequency of adverse reactions is defined using the following convention:
Najpogostejši neželeni učinek je v skupini naveden prvi, po naslednjem dogovoru:
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Z laboratorijskimi študijami na podganah in kuncih niso bili dokazani teratogeni in fetotoksični učinki ter toksični učinki na mater.
Comfortis 1620 mg chewable tablets for dogs spinosad
Comfortis 1620 mg žvečljive tablete za pse
The residual insecticidal properties of the product persist for up to 4 weeks after a single administration.
Rezidualne insekticidne lastnosti zdravila se ohranijo še do 4 tedne po enkratnem dajanju.
If a dose is missed, administer the product with the next offering of food and resume a monthly dosing schedule.
Če odmerek izpustite, dajte zdravilo z naslednjim obrokom hrane in nato ponovno vzpostavite režim mesečnega odmerjanja.
Approximately 90% of spinosad is comprised of spinosyns A and D. Of that 90%, the ratio of spinosyn A to A+D is 0.85 when calculated as spinosyn A/spinosyn A+D.
Približno 90 % spinosada sestavljata spinosina A in D. Od teh 90 % je razmerje spinosina A in spinosina A in D 0,85, če se izračuna kot spinosin A/spinosin A in D. Doslednost te številke v farmakokinetičnih in drugih študijah kaže na primerljivost absorpcije, presnove in izločanja dveh glavnih spinosinov.
− very rare (less than 1 animal in 10,000 animals, including isolated reports).
- zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere)
In dogs, at doses up to 100 mg/kg bodyweight per day for 10 days, the only clinical symptom of overdose was vomiting, which occurred usually within 2.5 hours of dosing.
Pri dnevnih odmerkih do 100 mg/kg telesne mase, ki so jih psi dobivali 10 dni, je bil edini klinični znak prevelikega odmerjanja bruhanje, ki se je običajno pojavilo v roku 2,5 ure od dajanja zdravila.
On the day of, or the day following administration of spinosad at a dose of 50-75 mg/kg bodyweight, the observed incidence of vomiting in the global field trial was between 6% and 11% in the first three months of treatment.
Na dan dajanja spinosada v odmerku 50-75 mg/kg telesne mase ali naslednji dan so v terenski študiji opazili pojavnost bruhanja med 6 % in 11 % v prvih treh mesecih zdravljenja.
After a single acute overdose corresponding to 1.6 times the maximum label dose, spinosad caused vomiting in approximately half of the cats, and depression, pacing/panting and severe diarrhoea on rare occasions.
Pri enkratnem akutnem prevelikem odmerjanju, pri katerem je odmerek 1,6-krat večji od največjega priporočenega odmerka spinosada, se je pri približno polovici mačk pojavilo bruhanje; redko so se pojavili tudi depresija, nemirna hoja/sopenje in močna driska.
In cats, after a single acute overdose of 1.6 times the maximum label dose, spinosad caused vomiting in approximately half of the cats, and depression, pacing/panting and severe diarrhoea on rare occasions.
Pri mačkah se je pri enkratnem akutnem prevelikem odmerjanju, pri katerem je odmerek 1,6-krat večji od največjega priporočenega odmerka spinosada, pri približno polovici pojavilo bruhanje; redko so se pojavili tudi depresija, nemirna hoja/sopenje in močna driska.
In dogs, spinosyns A and D are rapidly absorbed and extensively distributed after oral administration.
Pri psih se po peroralni uporabi spinosina A in D hitro absorbirata in obsežno porazdelita.
In dogs lethargy, anorexia and diarrhoea were uncommon and muscle tremor, ataxia and seizures were rare.
Pri psih so se občasno pojavili letargija, anoreksija in driska ter redko tresenje mišic, ataksija in konvulzije.
The primary faecal and urinary metabolites in both the rat and the cat were identified as the glutathione conjugates of the parent compounds and N-demethylated spinosyns A and D. Excretion is primarily via the faeces, and also to a lesser extent in the urine.
Glavne presnovke v blatu in urinu pri podganah in mačkah so opredelili kot glutationske konjugate starševskih spojin in N-demetilirana spinosina A in D. Glavna pot izločanja je z blatom, v manjši meri pa tudi z urinom.
Marketing authorisation holder:
Datum podaljšanja dovoljenja za promet:
If the dog or cat does not accept the tablets directly they may be administered with food, or directly by opening the animal's mouth and placing the tablet onto the back of the tongue.
se jih lahko daje s hrano ali neposredno v gobec živali, na koren jezika.
In cats, spinosyns A and D are equally rapidly absorbed and extensively distributed after oral administration.
Pri mačkah se po peroralni uporabi spinosina A in D enakomerno hitro absorbirata in obsežno porazdelita.
In cats, at doses of 75 to 100 mg/kg bodyweight per day for 5 days, given monthly for a period of six months, the most commonly observed clinical sign was vomiting.
Pri dnevnih odmerkih od 75 do 100 mg/kg telesne mase, ki so jih mačke prejemale 5 dni vsak mesec v šestmesečnem obdobju, je bil najpogostejši klinični znak bruhanje.
The tablets are speckled tan to brown, round, flat and chewable.
Lisaste svetlorjave do rjave, okrogle, ploščate in žvečljive tablete.
In dogs, the incidence of vomiting on the day of, or the day after, dosing has been observed to increase as a function of dose.
Pri psih so opazili, da pojav bruhanja na dan dajanja zdravila ali dan po dajanju narašča z odmerkom.
EU/2/10/115/018 (140 mg, 3 tablets) EU/2/10/115/019 (140 mg, 6 tablets) EU/2/10/115/020 (180 mg, 3 tablets) EU/2/10/115/021 (180 mg, 6 tablets) EU/2/10/115/011 (270 mg, 3 tablets) EU/2/10/115/001 (270 mg, 6 tablets) EU/2/10/115/012 (425 mg, 3 tablets) EU/2/10/115/003 (425 mg, 6 tablets) EU/2/10/115/013 (665 mg, 3 tablets) EU/2/10/115/005 (665 mg, 6 tablets) EU/2/10/115/014 (1040 mg, 3 tablets) EU/2/10/115/007 (1040 mg, 6 tablets) EU/2/10/115/015 (1620 mg, 3 tablets) EU/2/10/115/009 (1620 mg, 6 tablets)
EU/2/10/115/018 (140 mg, 3 tablete) EU/2/10/115/019 (140 mg, 6 tablet) EU/2/10/115/020 (180 mg, 3 tablete) EU/2/10/115/021 (180 mg, 6 tablet) EU/2/10/115/011 (270 mg, 3 tablete) EU/2/10/115/001 (270 mg, 6 tablet) EU/2/10/115/012 (425 mg, 3 tablete) EU/2/10/115/003 (425 mg, 6 tablet) EU/2/10/115/013 (665 mg, 3 tablete) EU/2/10/115/005 (665 mg, 6 tablet) EU/2/10/115/014 (1040 mg, 3 tablete) EU/2/10/115/007 (1040 mg, 6 tablet) EU/2/10/115/015 (1620 mg, 3 tablete) EU/2/10/115/009 (1620 mg, 6 tablet)