natgillin/translations-raw huggingface dataset:
Mild and short-lived signs relating to the nervous system such as ataxia (inability to co-ordinate muscle movements) or tremor (shaking) may occur in very rare cases. 
Prav tako se v zelo redkih primerih lahko pojavijo kratkotrajni neželeni učinki na živčni sistem, kot sta ataksija (nezmožnost usklajenega gibanja mišic) ali tresavica.
When giving Profender spot-on solution, skin contact with the pipette contents should be avoided and animals should not be stroked, groomed or allow to groom each other, until the application site is dry. 
Kot previdnostni ukrep je treba preprečiti stik kože z vsebino kapalke, živali pa se ne sme božati ali negovati, niti dovoliti, da se živali medsebojno negujejo, dokler se mesto nanosa ne posuši.
Profender is a medicine used to treat cats and dogs that have, or are at risk of catching, “mixed” (caused by more than one parasite) parasitic infections. 
Zdravilo Profender se uporablja za zdravljenje mačk in psov, ki imajo „mešano“ (ki jo povzroča več parazitov) parazitsko okužbo ali pri katerih obstaja tveganje za pojav takšne okužbe.
In each of the field studies, animals of various breeds, age groups and different weights that were naturally infected with roundworms or tapeworms in their guts, were treated either with Profender or another approved worming medicine (selamectin in cats, and milbemycin oxime and praziquantel in dogs). 
V vsaki od študij na terenu so bile živali različnih pasem, starosti in telesne mase, ki so bile okužene z gastrointestinalnimi glistami ali trakuljami, zdravljene bodisi z zdravilom Profender ali z drugim odobrenim protiparazitskim zdravilom (mačke s selamektinom, psi pa z milbemicin oksimom in prazikvantelom).
For lungworms in cats a laboratory study together with a field study showed Profender to reduce the number of larvae passed in the animal's faeces by more than 99%. 
Pri mačkah, okuženih s pljučnimi črvi, je laboratorijska študija skupaj s študijo na terenu pokazala, da zdravilo Profender zniža število ličink v izločkih za več kot 99 %.
In cats, in very rare cases, the cat might salivate or vomit after treatment. 
V zelo redkih primerih se lahko pri mačkah po zdravljenju pojavi slinjenje ali bruhanje.
The effectiveness of each of the products against the specified roundworms and tapeworms was investigated in both laboratory studies and in large field studies (one for the spot-on for cats and another for the tablets for dogs) carried out at several different places across Europe. 
Učinkovitost vsake učinkovine proti določenim vrstam glist in trakulj je bila proučena v različnih delih Evrope v laboratorijskih študijah in obsežnih študijah na terenu (ena za kožni nanos pri mačkah in druga za tablete pri psih).
Profender tablets are available in three different strengths to cover a range of dog weights (small, medium or large dogs). 
Tablete zdravila Profender so na voljo v treh različnih jakostih, ki ustrezajo različno težkim psom (majhnim, srednje velikim in velikim psom).
For more information about treatment with Profender, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za več informacij o zdravljenju z zdravilom Profender naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Profender works for infections caused by certain types of roundworms, tapeworms, as well as lungworms in cats. 
Zdravilo Profender deluje proti okužbam z določenimi vrstami glist in trakulj, pri mačkah pa tudi s pljučnimi črvi.
For practical information about using Profender, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za praktične informacije o uporabi zdravila Profender naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Praziquantel damages the skin-like outer layer of tapeworms, leading to their paralysis and death. 
Prazikvantel poškoduje povrhnjico trakulje, kar povzroči paralizo in pogin.
Profender solution is packed as spot-on pipettes, which are already filled with the correct amount of Profender needed to treat one cat (3 sizes of pipette for different cat weights) and as a multidose bottle for use only in a veterinary surgery, where the vet will measure the exact volume of Profender needed for each cat before application. 
Zdravilo Profender je pakirano v kapalkah za kožni nanos, ki so že napolnjene z ustrezno količino zdravila, potrebnega za zdravljenje ene mačke (tri različne velikosti kapalk za različno težke mačke), in v večodmernih stekleničkah za uporabo samo pri veterinarskih kirurških posegih, kjer veterinar pred posegom odmeri natančno količino zdravila Profender, ki je potrebna za posamezno mačko.
Profender is available as a solution for use on cats, and as modified release tablets for dogs. 
Profender je na voljo v obliki raztopine za uporabo pri mačkah in tablet s prilagojenim sproščanjem za uporabo pri psih.
Dogs are treated using Profender modified-release tablets, which are given by mouth when the dog is fasting. 
Za zdravljenje psov se uporabljajo tablete zdravila Profender s prilagojenim sproščanjem, ki jih psi zaužijejo peroralno, ko so tešči.
The appropriate quantity of Profender (either the contents of one full pipette or the volume measured by the vet) is applied onto the cat's skin, after parting the fur on the back of its neck at the base of its head. 
Ustrezno količino zdravila Profender (vsebino ene polne kapalke ali količino, ki jo odmeri veterinar) je treba nanesti mački na zatilje in sicer je treba razmakniti dlako, da je vidna koža.
As with other products of this type, Profender should be used on sick or ill cats or dogs only after a risk-benefit assessment by the vet. Profender should not be used for any other animal species. 
Kot pri drugih podobnih zdravilih se tudi zdravilo Profender pri bolnih in oslabljenih živalih uporablja le v skladu z veterinarjevo oceno razmerja med koristmi in tveganji.
How is Profender used? 
Kako se zdravilo Profender uporablja?
What is Profender? 
Kaj je zdravilo Profender?
How does Profender work? 
Kako zdravilo Profender deluje?
Profender is given as a single treatment for roundworms and tapeworms. 
Zdravilo Profender se za zdravljenje okužbe z glistami in trakuljami daje v enkratnem odmerku.
Users should also wash their hands after giving Profender as tablets to a dog. 
Tudi po dajanju tablet Profender psom si je treba temeljito umiti roke.
In very rare cases there might also be some temporary itchiness, inflammation or hair loss at the place where the product has been applied to the cat's skin. 
Zelo redko se lahko na mestu nanosa zdravila pri mački pojavi prehodno srbenje, vnetje ali izpadanje dlak.
Profender solution is packed as spot-on pipettes, which are already filled with the correct amount of Profender needed to treat one cat (3 sizes of pipette for different cat weights) and as a multidose 
Zdravilo Profender je pakirano v kapalkah za kožni nanos, ki so že napolnjene z ustrezno količino zdravila, potrebnega za zdravljenje ene mačke (tri različne velikosti kapalk za različno težke mačke), in v večodmernih stekleničkah za uporabo pri veterinarskih kirurških posegih, kjer veterinar pred posegom odmeri natančno količino zdravila Profender, ki je potrebna za posamezno mačko.
These effects are thought to occur as a result of the cat licking the application site straight after treatment. 
Domneva se, da se to zgodi, če mačka takoj po nanosu zdravila poliže mesto nanosa.
Cats are treated using the Profender spot-on solution range. 
Za zdravljenje mačk se uporablja serija raztopin zdravila Profender za kožni nanos.
Profender can only be obtained with a prescription. 
Izdaja zdravila je le na recept.
Instructions for Use 
Navodila za uporabo
The frequency of these types of events is not known (cannot be estimated from available data). 
Pogostost teh vrst dogodkov ni znana (je ni mogoče oceniti na podlagi razpoložljivih podatkov).
Adopted at the 30 November - 3 December 2015 PRAC 
Sprejeto na zasedanju odbora PRAC, ki je potekalo od 30. novembra do 3. decembra 2015
BEFORE YOU TAKE X 
PREDEN BOSTE VZELI ZDRAVILO X
Talk to your doctor if you have any concerns. 
Če imate kakršne koli skrbi, se posvetujte s svojim zdravnikom.
BEFORE YOU TAKE DUVAVIVE 
PREDEN BOSTE VZELI ZDRAVILO DUVAVIVE
For tibolone containing products 
Za zdravila, ki vsebujejo tibolon
TACHOSIL (Human fibrinogen, human thrombin)Intestinal obstruction (EPITT no 18373) 
TACHOSIL (humani fibrinogen, humani trombin)obstrukcija črevesja (EPITT št. 18373)
What you need to know before TachoSil is used Warnings and precautions 
Kaj morate vedeti, preden boste uporabili zdravilo TachoSil Opozorila in previdnostni ukrepi
Hormone replacement therapy (HRT) medicinal products, which are not pharmaceutical forms for vaginal use, containing oestrogens or combined oestrogens-progestagens (tibolone containing products also concerned); DUAVIVE (bazedoxifene, oestrogens conjugated) - Increased risk of ovarian cancer (EPITT no 18258) 
Zdravila za hormonsko nadomestno zdravljenje (HNZ), ki niso v farmacevtski obliki za vaginalno uporabo, ki vsebujejo estrogene ali kombinacijo estrogenov in progestagenov (prav tako zdravila, ki vsebujejo tibolon); zdravilo DUAVIVE (bazedoksifen, konjugirani estrogeni) - povečano tveganje za raka jajčnikov (EPITT št. 18258)
Ovarian cancer is rare - much rarer than breast cancer. 
Rak jajčnikov je redek - bistveno redkejši od raka dojke.
Pressure is applied with moistened gloves or a moist pad. 
Pritisk vršite z navlaženimi rokavicami ali vlažno blazinico.
A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56). 
Pri metaanalizi 52 epidemioloških študij so poročali o povečanem tveganju za raka jajčnikov pri ženskah, ki trenutno uporabljajo HNZ, v primerjavi z ženskami, ki niso nikoli uporabljale HNZ (RR 1,43, 95 % CI 1,31-1,56).
To prevent the development of tissue adhesions at undesired sites, ensure tissue areas outside the desired application area are adequately cleansed before administration of TachoSil (see section 6.6). 
Za preprečevanje lepljenja tkiv na neželenih mestih se prepričajte, da so predeli tkiv zunaj želenega območja nanosa pred nanosom zdravila TachoSil primerno očiščeni (glejte poglavje 6.6).
Summary of product characteristics (SmPC) section 4.4: Special warnings and precautions for use 
Povzetek glavnih značilnosti zdravila, poglavje 4.4: Posebna opozorila in previdnostni ukrepi
After pressing TachoSil to the wound, the glove or the pad must be removed carefully. 
Po končanem pritiskanju zdravila TachoSil na rano morate rokavico ali blazinico pazljivo odstraniti.
Frequency ‘unknown': Intestinal obstruction (in abdominal surgeries) General disorders and administration site conditions: Frequency ‘unknown': Adhesions 
Neznana pogostnost: obstrukcija črevesja (pri abdominalnih operacijah) Splošne težave in spremembe na mestu aplikacije:
For DUAVIVE product 
Za zdravilo DUAVIVE
Due to the strong affinity of collagen to blood, TachoSil may also stick to surgical instruments, or gloves or adjacent tissues covered with blood. 
Zaradi močne afinitete kolagena do krvi, se lahko zdravilo TachoSil prime tudi na kirurške instrumente, ali rokavice ali sosednja tkiva, na katerih je kri.
After abdominal surgery and if TachoSil sticks to nearby tissues, it is possible that scar tissues can develop in the operated area. 
Če se po operaciji trebušne votline zdravilo TachoSil prilepi na bližnja tkiva, lahko na operiranem območju nastane zabrazgotinjeno tkivo.
To avoid TachoSil from being pulled loose it may be held in place at one end, e.g. with a pair of forceps. 
Da zdravila TachoSil ne potegnete z rane, ga lahko na enem koncu pritrdite na mestu, npr. s pinceto.
Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestagen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping. 
Epidemiološki podatki iz obširne metaanalize kažejo rahlo zvečano tveganje pri ženskah, ki uporabljajo samo estrogensko ali kombinacijo estrogenskega in progestagenskega HNZ, kar postane očitno po petih letih uporabe in se po prenehanju sčasoma počasi zmanjšuje.
Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only HRT, which becomes apparent within 5 years of use and diminishes over time after stopping. 
Epidemiološki podatki iz obširne metaanalize kažejo rahlo zvečano tveganje pri ženskah, ki uporabljajo samo estrogensko HNZ, kar postane očitno po petih letih uporabe in se po prenehanju sčasoma počasi zmanjšuje.
In the Million Women Study, taking 5 years of HRT tibolone resulted in 1 extra case per 2500 users (see Section 4.4). 
V študiji Million Women Study je 5-letna uporaba HRT tibolona povzročila en dodaten primer na 2 500 uporabnic (glej poglavje 4.4).
Events of adhesions to gastrointestinal tissues leading to gastrointestinal obstruction have been reported with use in abdominal surgery carried out in proximity to the bowel. 
Pri uporabi zdravila v abdominalni kirurgiji v bližini črevesa so poročali o primerih lepljenja na gastrointestinalna tkiva, kar je povzročilo gastrointestinalno obstrukcijo.
Your surgeon will make sure to clean the operating area when applying TachoSil to reduce this risk. 
Vaš kirurg bo za zmanjšanje tveganja pred nanosom zdravila TachoSil očistil območje, ki ga bo operiral.
Scar tissues can cause surfaces in your bowel to stick together, which can lead to blockage of the bowel. 
To lahko povzroči, da se površine v črevesu zlepijo skupaj, kar lahko privede do zapore črevesa.
In the Million Women Study, it was shown that the relative risk for ovarian cancer with use of tibolone was similar to the risk associated with use of other types of HRT. 
Študija Million Women Study je pokazala, da je relativno tveganje za raka jajčnikov pri uporabi tibolona podobno tveganju, povezanemu z uporabo drugih vrst HNZ.
This study showed that the relative risk for ovarian cancer with tibolone was similar to the risk with other types of HRT. 
Ta študija je pokazala, da je relativno tveganje za raka jajčnikov pri uporabi tibolona podobno tveganju, povezanemu z uporabo drugih vrst HNZ.
Scar tissues may develop in some patients after surgery and use of TachoSil. 
Pri nekaterih bolnikih lahko po operaciji in uporabi zdravila TachoSil nastane zabrazgotinjeno tkivo.
For oestrogen only and combined oestrogen-progestagen HRT products 
Za zdravila za HNZ s samo estrogenskim ali kombinacijo estrogenskega in progestagenskega zdravljenja
TachoSil may stick to surgical instruments, or gloves or adjacent tissues covered with blood. 
Zdravilo TachoSil se lahko prime na kirurške instrumente in, rokavice ali sosednja tkiva, na katerih je kri.
It is important to note that failure to adequately clean adjacent tissues may cause adhesions (see section 4.4). 
Upoštevajte, da lahko do lepljenja pride, če nezadostno očistite sosednja tkiva (glejte poglavje 4.4).
This can be avoided by cleansing surgical instruments, and gloves and adjacent tissues before application. 
Temu se lahko izognete tako, da očistite kirurške instrumente, rokavice in sosednja tkiva pred nanosom.
Long-term (at least 5-10 years) use of oestrogen-only HRT products has been associated with a slightly increased risk of ovarian cancer (see section 4.8). 
Dolgotrajna uporaba (vsaj 5-10 let) samo estrogenskega zdravljenja je povezana z rahlo zvečanim tveganjem za raka jajčnikov (glejte poglavje 4.8).
With use of X, the increased risk of ovarian cancer is similar to other types of HRT. 
Pri uporabi zdravila X je zvečano tveganje za raka jajčnikov podobno tveganju, povezanemu z uporabo drugih vrst HNZ.
The use of oestrogen-only HRT has been associated with a slightly increased risk of ovarian cancer. 
Uporaba samo estrogenskega HNZ zdravljenjem je bila povezana z rahlo zvečanim tveganjem za raka jajčnikov.
In the Million Women Study For women aged 50 to 54 years taking 5 years of HRT, this resultsed in about 1 extra case per 2,5000 users. 
V študiji Million Women Study Pri ženskah, starih od 50 do 54 let, ki uporabljajo HNZ pet let, to povzroča je to povzročilo približno en dodaten primer na 2 5000 uporabnic.
For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users. 
Pri ženskah, starih od 50 do 54 let, je 5-letna uporaba HNZ povzročila približno en dodaten primer na 2 000 uporabnic.
Cleanse surgical instruments, or gloves and adjacent tissues, if necessary. 
Po potrebi očistite kirurške instrumente, ali rokavice in sosednja tkiva.
Some other studies, including the Women's Health Initiative (WHI) trial, suggest that the longterm use of combined HRTs may confer be associated with a similar, or slightly smaller risk (see Section 4.8). 
Nekatere druge študije, vključno s preskušanjem Women's Health Initiative (WHI), kažejo, da je dolgotrajna uporaba kombiniranih HNZ lahko pomeni povezana s podobnim ali rahlo manjšim tveganjem (glejte poglavje 4.8).
In the Million Women Study 5 years of HRT resulted in 1 extra case per 2500 users. 
V študiji Million Women Study je 5-letna uporaba HNZ povzročila en dodatni primer na 2 500 uporabnic.
The use of oestrogen-only or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of ovarian cancer. 
Uporaba HNZ, ki vsebuje samo estrogen ali kombinacijo estrogena in progestagena, je bila povezana z rahlo zvečanim tveganjem za raka jajčnikov.
Some other studies, including the WHI trial, suggest that use of combined HRTs may be associated with a similar or slightly smaller risk (see Section 4.8). 
Nekatere druge študije, vključno s preskušanjem WHI, kažejo, da je uporaba kombiniranih HNZ lahko povezana s podobnim ali rahlo manjšim tveganjem (glejte poglavje 4.8).
In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period. 
Pri ženskah, starih od 50 do 54 let, ki ne uporabljajo HNZ, bodo v 5-letnem obdobju diagnosticirali raka jajčnikov pri približno dveh ženskah od 2 000.
Bowel obstruction and pain following abdominal surgeries can also occur. 
Prav tako lahko pride do zapore črevesa in bolečin v trebuhu.
Some other studies, including the WHI trial, suggest that the long-term use of combined HRTs may confer be associated with a similar, or slightly smaller risk (see Section 4.8). 
Nekatere druge študije, vključno s preskušanjem WHI, kažejo, da je dolgotrajna uporaba kombiniranih HNZ lahko pomeni povezana s podobnim ali rahlo manjšim tveganjem (glejte poglavje 4.8).
A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years. 
Pri ženskah, ki uporabljajo HNZ vsaj 5 do 10 let, so poročali o rahlo zvečanem tveganju za raka jajčnikov.
For women who have been taking HRT for 5 years, there will be between 2 and about 3 cases per 21000 users (i.e. up to about 1 extra case). 
Pri ženskah, ki uporabljajo HNZ pet let, bodo raka jajčnikov odkrili pri približno med 2 in treh izmed 2 1000 uporabnic (tj. do približno en primer več).
For women who have been taking HRT for 5 years, there will be between 2 and about 3 cases per 21,000 users (i.e. about up to 1 extra case). 
Pri ženskah, ki uporabljajo HNZ pet let, bodo raka jajčnikov odkrili pri približno med 2 in treh zmed 2 1000 uporabnic (tj. do približno en primer več).
Gastrointestinal disorders: 
Bolezni prebavil:
Long term uUse of estrogen-only and or combined estrogen-progestogen HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see Section 4.4). 
Dolgotrajna uUporaba samo estrogenskega in ali kombinacije estrogenskega in progestagenskega HNZ je povezana z rahlo zvečanim tveganjem za diagnosticiranje raka jajčnikov (glejte poglavje 4.4).
Long-term uUse of oestrogen-only and or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see Section 4.4). 
Dolgotrajna uUporaba samo estrogenskega zdravljenjem in ali kombinacije estrogenskega in progestogenskega HNZ je povezana z rahlo zvečanim tveganjem za diagnosticiranje raka jajčnikov (glejte poglavje 4.4).
SmPC section 4.4: Special warnings and precautions for use Ovarian cancer 
Povzetek glavnih značilnosti zdravila, poglavje 4.8: Neželeni učinki Rak jajčnikov
For example, in women aged 50 to 5469 who are not taking HRT, on average about 2 women in 21,000 will be diagnosed with ovarian cancer over a 5year period. 
Na primer pri ženskah, starih od 50 do 5469 let, ki ne uporabljajo HNZ, bodo v obdobju petih let v povprečju pri približno dveh ženskah izmed 21 000 odkrili raka jajčnikov.
For example, in Wwomen aged 50 to 5469 who are not taking HRT, on average about 2 women in 21000 will be diagnosed with ovarian cancer over a 5year period. 
Na primer pri Žženskah, starih od 50 do 5469 let, ki ne uporabljajo HNZ, bodo v obdobju 5 let v povprečju pri približno dveh ženskah izmed 2 1000 odkrili raka jajčnikov.
Other adverse reactions have been reported in association with oestrogen and oestrogenprogestogen treatment: 
Povzetek glavnih značilnosti zdravila, poglavje 4.8: Neželeni učinki V zvezi z zdravljenjem z estrogenom in kombinacijo estrogena in progestogena so poročali tudi o drugih neželenih učinkih:
Long-term uUse of oestrogen-only HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see Section 4.4). 
Dolgotrajna uUporaba HNZ s samo estrogenskim zdravljenjem estrogenskega HNZ je povezana z zvečanim tveganjem za diagnosticiranje raka jajčnikov (glejte poglavje 4.4).
It is important to note that failure to adequately clean adjacent tissues may cause adhesions. 
Upoštevajte, da lahko do lepljenja pride, če nezadostno očistite sosednja tkiva.
Inactivated Rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037: ≥70% cELISA40* (*) ≥=70% of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40. 
--1 Inaktivirani virus hemoragične bolezni kuncev tipa 2 (RHDV2), sev V-1037 ≥70 % cELISA40* (*) ≥ 70 % cepljenih kuncev bo imelo titer protiteles cELISA 40 ali več.
Vial (glass) 0.5 ml (1 dose) 
0,5 ml
EU (MA) Number 
EU (MA) številka Izmišljeno ime Jakost
10 vials Zero days 
(1 odmerek vialami
Typically, such reactions have been observed within the first few weeks or months of initiation of CART. 
Po navadi so takšne reakcije opažali v prvih nekaj tednih ali mesecih po začetku CART.
50 to <200 200 to <350 
od 50 do < 200 od 200 do < 350
Date of latest renewal: 21 September 2018 
Datum zadnjega podaljšanja: 21. september 2018
Keep the bottle tightly closed. 
Vsebnik shranjujte tesno zaprt.
→ Read the information in Section 4 of this leaflet. 
→ Preberite informacije v poglavju 4 tega navodila.
CD4 cells are a type of white blood cells that are important in helping your body to fight infection. 
Celice CD4 so vrsta belih krvnih celic, ki so pomembna pomoč telesu v boju proti okužbi.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 January 2014 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 20. januar 2014
To control your HIV infection, and to stop your illness from getting worse, you must keep taking all your medicines, unless your doctor tells you to stop taking any. 
Za obvladovanje okužbe s HIV in preprečevanje poslabšanja bolezni morate nadaljevati z jemanjem vseh vaših zdravil, razen če vam zdravnik ne naroči, da katerega prenehate jemati.
Extremadura 3, 09400 Aranda De Duero, Burgos, Spain OR 
Extremadura 3, 09400 Aranda De Duero, Burgos, Španija ALI
40 or greater 
40 ali več
The mechanism for the decrease is unknown. 
Mehanizem tega zmanjšanja ni pojasnjen.
Please refer to section 4.5. 
Prosimo glejte poglavje 4.5.
After the functional monotherapy phase, subjects had the opportunity to re-optimize their background regimen when possible. 
Po fazi funkcionalne monoterapije so imele osebe možnost ponovne optimizacije njihove osnovne sheme, kadar je bilo to mogoče.