natgillin/translations-raw huggingface dataset:
The results of the second study were insufficient to prove the long-term effectiveness of Mirapexin. 
Rezultati druge študije niso bili zadostni, da bi dokazali dolgoročno učinkovitost zdravila Mirapexin.
The European Commission granted a marketing authorisation valid throughout the European Union for Mirapexin on 23 February 1998. 
Evropska komisija je dovoljenje za promet z zdravilom Mirapexin, veljavno po vsej Evropski uniji, odobrila dne 23. februarja 1998.
The full EPAR for Mirapexin can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Mirapexin je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This document is a summary of the European Public Assessment Report (EPAR) for Mirapexin. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Mirapexin.
Mirapexin tablets should be swallowed with water. 
Tablete Mirapexin je treba pogoltniti z vodo.
For more information about treatment with Mirapexin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Mirapexin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Mirapexin is used when a specific cause for the disorder cannot be identified. 
Zdravilo Mirapexin se uporablja takrat, kadar točnega vzroka motnje ni mogoče ugotoviti.
Mirapexin must be given less often in patients who have problems with their kidneys. 
Zdravilo Mirapexin je treba dajati manj pogosto pri bolnikih, ki imajo težave z ledvicami.
Mirapexin is used to treat the symptoms of the following diseases: 
Zdravilo Mirapexin se uporablja za zdravljenje simptomov naslednjih bolezni:
Other information about Mirapexin: 
Druge informacije o zdravilu Mirapexin:
Mirapexin pramipexole 
Mirapexin pramipeksol
Mirapexin can be used either on its own or in combination with levodopa (another medicine for Parkinson's disease), at any stage of disease including the later stages when levodopa starts becoming less effective; 
Zdravilo Mirapexin se lahko uporablja bodisi samostojno ali v kombinaciji z levodopo (drugim zdravilom za zdravljenje Parkinsonove bolezni) v katerem koli stadiju bolezni, vključno s poznimi stadiji, ko začne učinek levodope popuščati;
Four studies compared Mirapexin with placebo (a dummy treatment): one study in 360 patients with advanced disease who were already taking levodopa that was starting to become less effective, and three studies in a total of 886 patients with early disease who were not receiving levodopa. 
V štirih študijah so zdravilo Mirapexin primerjali s placebom (zdravilom brez zdravilne učinkovine): v eni študiji s 360 bolniki z napredovalo boleznijo, ki so že jemali levodopo, katere učinkovitost je začela upadati, in v treh študijah s skupno 886 bolniki z boleznijo v zgodnjem stadiju, ki niso prejemali levodope.
For restless legs syndrome, Mirapexin immediate-release tablets should be taken once a day, two to three hours before going to bed. 
Pri sindromu nemirnih nog je treba tablete zdravila Mirapexin s takojšnjim sproščanjem vzeti enkrat na dan, dve do tri ure pred spanjem.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Mirapexin. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Mirapexin, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Mirapexin should not be used in people who may be hypersensitive (allergic) to pramipexole or any of the other ingredients. 
Zdravila Mirapexin ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) pramipeksol ali katero koli drugo sestavino zdravila.
Mirapexin was also more effective than levodopa at improving movement symptoms in early disease. 
Zdravilo Mirapexin je bilo tudi učinkovitejše od levodope pri izboljšanju motoričnih simptomov pri bolezni v zgodnjem stadiju.
The CHMP decided that Mirapexin's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Mirapexin večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The active substance in Mirapexin, pramipexole, is a dopamine agonist (a substance that imitates the action of dopamine). 
Zdravilna učinkovina zdravila Mirapexin, pramipeksol, je dopaminski agonist (snov, ki posnema delovanje dopamina).
The fifth study compared Mirapexin with levodopa in 300 patients with early disease, and measured the number of patients who had movement symptoms. 
V peti študiji so primerjali zdravilo Mirapexin z levodopo pri 300 bolnikih z boleznijo v zgodnjem stadiju in ugotavljali število bolnikov z motoričnimi simptomi.
Mirapexin is a medicine that contains the active substance pramipexole. 
Mirapexin je zdravilo, ki vsebuje zdravilno učinkovino pramipeksol.
In the study of patients with advanced Parkinson's disease, patients taking Mirapexin immediaterelease tablets had larger improvements after 24 weeks of steady-dose treatment than those taking placebo. 
V študiji z bolniki z napredovalo Parkinsonovo boleznijo je bilo pri bolnikih, ki so jemali tablete Mirapexin s podaljšanim sproščanjem, po 24 tednih zdravljenja s stalnim odmerkom doseženo večje izboljšanje kot pri bolnikih, ki so jemali placebo.
In restless legs syndrome, Mirapexin immediate-release tablets were more effective than placebo at reducing symptoms over 12 weeks, but the difference between placebo and Mirapexin was greatest after four weeks before getting smaller. 
Pri sindromu nemirnih nog so bile tablete Mirapexin s takojšnjim sproščanjem pri zmanjševanju simptomov po 12 tednih učinkovitejše od placeba, razlika med zdravilom Mirapexin in placebom pa je bila največja po štirih tednih, nato se je začela zmanjševati.
What benefit has Mirapexin shown during the studies? 
Kakšne koristi je zdravilo Mirapexin izkazalo med študijami?
The most common side effect with Mirapexin (seen in more than 1 patient in 10) is nausea (feeling sick). 
Najpogostejši neželeni učinek zdravila Mirapexin (opažen pri 1 bolniku izmed 10) je navzeja (slabost).
The second included 150 patients who took Mirapexin for six months, and compared the effects of remaining on Mirapexin with switching to placebo. 
V drugo študijo je bilo vključenih 150 bolnikov, ki so zdravilo Mirapexin jemali šest mesecev, v njej pa so učinke nadaljevanja jemanja zdravila Mirapexin primerjali z učinki prehoda na placebo.
In Parkinson's disease, Mirapexin immediate-release tablets have been studied in five main studies. 
Pri Parkinsonovi bolezni so tablete Mirapexin s takojšnjim sproščanjem proučevali v petih glavnih študijah.
What is the risk associated with Mirapexin? 
Kakšna tveganja so povezana z zdravilom Mirapexin?
For the full list of all side effects reported with Mirapexin, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Mirapexin, glejte navodilo za uporabo.
In restless legs syndrome, Mirapexin immediate-release tablets have been studied in two main studies. 
Pri sindromu nemirnih nog so tablete zdravila Mirapexin s takojšnjim sproščanjem proučevali tudi v dveh glavnih študijah.
Why has Mirapexin been approved? 
Zakaj je bilo zdravilo Mirapexin odobreno?
The first compared Mirapexin with placebo over 12 weeks in 344 patients and measured the improvement in symptoms. 
V prvi so več kot 12 tednov primerjali zdravilo Mirapexin s placebom pri 344
How does Mirapexin work? 
Kako zdravilo Mirapexin deluje?
What is Mirapexin used for? 
Za kaj se zdravilo Mirapexin uporablja?
How has Mirapexin been studied? 
Kako je bilo zdravilo Mirapexin raziskano?
What is Mirapexin? 
Kaj je zdravilo Mirapexin?
How is Mirapexin used? 
Kako se zdravilo Mirapexin uporablja?
The MAH should submit a revised risk management plan including proposals for evaluating the effectiveness of the risk minimisation measures. 
Imetnik dovoljenja za promet z zdravilom mora predložiti posodobljen načrt obvladovanja tveganja, vključno s predlogi za vrednotenje učinkovitosti ukrepov za zmanjševanje tveganja.
Conditions to the marketing authorisations for Numeta G16%E and associated names 
Pogoji dovoljenj za promet z zdravilom Numeta G16%E in povezanimi imeni
The MAH should conduct a prospective non-interventional postauthorisation safety study to further evaluate magnesium levels observed in term newborn infants and children up to two years of age treated with Numeta G16%E in routine clinical practice. 
Imetnik dovoljenja za promet z zdravilom mora opraviti prospektivno, neintervencijsko študijo varnosti po pridobitvi dovoljenja za promet z zdravilom, s katero bo nadalje ocenil ravni magnezija, opažene pri donošenčkih in otrocih, starih do dveh let, ki se zdravijo z zdravilom Numeta G16%E v rutinski klinični praksi.
National competent authorities of Member States or reference Member State if applicable, shall ensure that the following conditions are fulfilled by the MAH for Numeta G16%E: 
Pristojne nacionalne agencije držav članic ali referenčne države članice, če je primerno, zagotovijo, da imetnik(i) dovoljenja za promet z zdravilom Numeta G16%E izpolnjuje(jo) naslednje pogoje:
By the end of Q3 2015 Within 3 months after CMDh agreement 
Do konca 3. četrtine leta
Within 3 months after CMDh agreement 
Priloga V Pogoji dovoljenj za promet z zdravili
This will help to protect against the disease. 
To bo pripomoglo k zaščiti pred boleznijo.
In very rare cases a higher temperature may occur for up to 2 days. 
V zelo redkih primerih se lahko pojavi povišana telesna temperatura, ki traja do 2 dni.
As with any vaccine rare, occasional allergic reactions may occur. 
Tako kot pri vseh cepivih se lahko pojavijo redke občasne alergijske reakcije.
It is sometimes associated with pain and very rarely with mild depression. 
Včasih jih spremljata bolečina in zelo redko blaga depresija.
The first is given from six month of age and the second is given three to five weeks later. 
Prva injekcija se da od šestega meseca starosti naprej, druga pa tri do pet tednov pozneje.
The European Commission granted a marketing authorisation valid throughout the European Union for Equip WNV on 21 November 2008. 
Evropska komisija je dovoljenje za promet z zdravilom Equip WNV, veljavno po vsej Evropski uniji, odobrila dne 21. novembra 2008.
In the future, if the animals are exposed to West Nile virus the immune system will be able to respond more quickly. 
Če bodo živali v prihodnosti izpostavljene virusu West Nile, se bo njihov imunski sistem nanj hitreje odzval.
It is available as an emulsion for injection. 
Na voljo je v obliki emulzije za injiciranje.
The vaccine is initially given as two injections into the muscles in the neck. 
Cepivo se najprej dvakrat injicira v mišice na predelu vratu.
The vaccine also contains an ‘adjuvant' to enhance the immune response. 
Cepivo vsebuje tudi „adjuvans“ za spodbuditev imunskega odziva.
A number of field trials were also conducted involving vaccinated and non-vaccinated horses. 
Opravili so tudi številne študije na terenu, v katere so bili vključeni cepljeni in necepljeni konji.
The laboratory studies showed that horses developed protection three weeks after the primary vaccination course. 
Laboratorijske študije so pokazale, da so konji razvili zaščito tri tedne po osnovnem cepljenju.
West Nile virus strain VM-2 
sev VM-2 virusa West Nile
Other information about Equip WNV: 
Druge informacije o zdravilu Equip WNV:
Equip WNV is a vaccine that contains inactivated (killed) West Nile virus. 
Zdravilo Equip WNV je cepivo, ki vsebuje inaktivirani (uničeni) virus West Nile.
West Nile virus is an infection that is transmitted by mosquitoes and can cause severe disease and fatal brain infections in infected horses. 
Virus West Nile je okužba, ki jo prenašajo komarji in lahko pri okuženih konjih povzroči hudo obolenje ter smrtne okužbe možganov.
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or milk used for human consumption. 
Karenca je časovno obdobje, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje ter meso uporabi za prehrano ljudi ali mleko uporabi za prehrano ljudi.
What benefit has Equip WNV shown during the studies? 
Kakšne koristi je zdravilo Equip WNV izkazalo med študijami?
The main measure of effectiveness was reduction of virus in the blood and the frequency and duration of clinical signs. 
Glavno merilo učinkovitosti je bilo zmanjšanje količine virusa v krvi ter zmanjšanje pogostosti pojavljanja in skrajšanje trajanja kliničnih znakov.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equip WNV outweigh the risks for the approved indication and recommended that Equip WNV be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da koristi zdravila Equip WNV pri odobreni indikaciji odtehtajo z njim povezana tveganja, in priporočil, da se zanj odobri dovoljenje za promet.
Outbreaks of West Nile virus in Europe have been caused by two strains of the virus called lineage 1 and lineage 2. 
Izbruhe virusa West Nile v Evropi povzročata dva seva virusa, imenovana linija 1 in linija 2.
The effectiveness of Equip WNV was studied in a number of laboratory studies that examined how long it took to achieve protection after vaccination and how long protection lasted in horses injected with West Nile virus lineage 1. 
Učinkovitost zdravila Equip WNV so raziskali v več laboratorijskih študijah, v katerih so proučevali, koliko časa je trajalo, da se je po cepljenju razvila zaščita, in kako dolgo je zaščita trajala pri konjih, ki so jim injicirali virus West Nile linije 1.
When Equip WNV is given to horses, their immune system recognises the virus contained in the vaccine as ‘foreign' and makes antibodies to defend against it. 
Ko konji prejmejo cepivo Equip WNV, njihov imunski sistem prepozna virus v cepivu kot „tujek“ in začne proti njim tvoriti protitelesa.
If the product is accidentally self-injected, ingested or spilled onto skin medical advice should be sought immediately and the package leaflet or label shown to the doctor. 
V primeru nenamernega samoinjiciranja, zaužitja ali razlitja po koži se je treba nemudoma posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali ovojnino zdravila.
A small number of animals may show temporary local reactions, in the form of a mild, local swelling at the injection site post vaccination (maximum 1 cm in diameter), that resolve by themselves within 1 to 2 days. 
Manjše število živali ima lahko po cepljenju prehodne lokalne reakcije v obliki blage lokalne otekline na mestu injiciranja (največ 1 cm v premeru), ki izginejo spontano v 1 do 2 dneh.
In addition a laboratory study was performed in which vaccinated and non-vaccinated horses were injected with West Nile virus lineage 2 directly into the central nervous system three weeks after initial vaccination. 
Poleg tega so opravili tudi laboratorijsko študijo, v kateri so cepljenim in necepljenim konjem tri tedne po osnovnem cepljenju injicirali virus West Nile linije 2 neposredno v osrednje živčevje.
What is the risk associated with Equip WNV? 
Kakšna tveganja so povezana z zdravilom Equip WNV?
Equip WNV is used to vaccinate horses from six months of age against West Nile virus. 
Zdravilo Equip WNV se uporablja za cepljenje konjev, starih šest mesecev ali več, proti virusu West Nile.
The vaccine is used to reduce the number of horses with the West Nile virus lineage 1 or 2 in their blood (viraemia) and to reduce the severity and duration of clinical signs of West Nile virus disease caused by lineage 2 strains. 
Cepivo se uporablja za zmanjšanje števila konjev, ki imajo v krvi virus West Nile linije 1 ali 2 (viremija), ter za ublažitev in skrajšanje trajanja kliničnih znakov bolezni, ki jo povzročajo sevi virusa West Nile iz linije 2.
The duration of protection was 12 months after the primary vaccination course for lineage 1 strains but was not established for lineage 2 strains. 
Zaščita pred sevi iz linije 1 je trajala 12 mesecev po osnovnem cepljenju, trajanja zaščite pred sevi iz linije 2 pa niso ugotovili.
The field studies showed that Equip WNV protects horses from West Nile virus by reducing the number of viraemic horses after infection with West Nile virus lineage 1 or 2 strains and by reducing the duration and severity of clinical signs against lineage 2 strains. 
Študije na terenu so pokazale, da cepivo Equip WNV zaščiti konje pred virusom West Nile z zmanjšanjem števila viremičnih konjev po okužbi s sevi virusa West Nile iz linije 1 ali 2 in s skrajšanjem trajanja ter ublažitvijo kliničnih znakov okužbe s sevi iz linije 2.
Why has Equip WNV been approved? 
Zakaj je bilo zdravilo Equip WNV odobreno?
The withdrawal period for Equip WNV is zero days. 
Karenca po uporabi zdravila Equip WNV je nič dni.
How has Equip WNV been studied? 
Kako je bilo zdravilo Equip WNV raziskano?
What is Equip WNV used for? 
Za kaj se zdravilo Equip WNV uporablja?
What is Equip WNV? 
Kaj je zdravilo Equip WNV?
How does Equip WNV work? 
Kako zdravilo Equip WNV deluje?
19 August 2005 CHMP/297837/2005 
19. avgust 2005 CHMP/297837/2005
The Member States competent authorities will continue to keep the product under regular review. 
Pristojni organi držav članic bodo nadaljevali z rednim nadziranjem izdelka.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE OPINION FOLLOWING AN ARTICLE 31 REFERRAL 
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 31
The final opinion was converted into a Decision by the European Commission on 19 August 2005. 
Končno mnenje je Evropska komisija dne 19. avgusta 2005 spremenila v odločbo.
The referral procedure started on 20 January 2005. 
Postopek obravnave se je pričel 20. januarja 2005.
For more information see: http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con2018037.pdf 
Za dodatne informacije glejte: http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con2018037.pdf
The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II. 
Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so navedeni v Dodatku II.
Dr Barbara van Zwieten-Boot was appointed Rapporteur and Dr Gonzalo Calvo Rojas, Dr Eric Abadie, Dr Karl Broich and Dr Julia Dunne were appointed Co-Rapporteurs. 
Za poročevalca je bila imenovana dr. Barbara van Zwieten-Boot, za soporočevalce pa dr. Gonzalo Calvo Rojas, dr. Eric Abadie, dr. Karl Broich in dr. Julia Dunne.
Notes: The information given in this document and Annexes reflect only the CHMP Opinion dated 21 April 2005. 
Opombe: Informacije v tem dokumentu in Dodatkih odražajo zgolj mnenje CHMP z dne 21. aprila 2005.
Following the adoption of the CHMP, further data have become available on Atomoxetine. 
Po sprejetju mnenja CHMP so bili dani na razpolago nadaljnji podatki o atomoksetinu.
Written explanations were provided by the Marketing Authorisation Holders by 22 February 2005. 
Pisna pojasnila je imetnik dovoljenja za promet z zdravilom posredoval 22. februarja 2005.
Based on the evaluation of the available data and the Rapporteurs' assessment reports, the CHMP adopted and opinion on 21 April 2005. 
Na podlagi ovrednotenja razpoložljivih podatkov in poročevalčevih poročil o oceni je CHMP dne 21. aprila 2005 sprejel svoje mnenje.
On 17 December 2004 the European Commission referred the matter to the EMEA under Article 31 of Directive 2001/83/EC, as amended, for medicinal products containing atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine. 
Dne 17. decembra 2004 je Evropska komisija na EMEA posredovala napotitev za izvedbo postopka v skladu s členom 31 Direktive 2001/83/ES, kot je bila spremenjena, za zdravila, vsebujoča atomoksetin, citalopram, escitalopram, fluoksetin, fluvoksamin, mianserin, milnacipran, mirtazapin, paroksetin, reboksetin, sertralin in venlafaksin.
Most of the above mentioned medicinal products are approved for the treatment of depression and anxiety in adults, but are not licensed Europe-wide for the treatment of these conditions in children or adolescents. 
Večina zgoraj navedenih medicinskih izdelkov je odobrena za zdravljenje depresije in tesnobe pri odraslih, vendar pa ni odobrena po vsej Evropi za zdravljenje teh stanj pri otrocih ali mladostnikih.
These data have been evaluated by the Reference Member State (MHRA) and has identified an increased risk of suicidal thoughts and behaviour in children treated with Atomoxetine. 
Te podatke je referenčna država članica (MHRA) ovrednotila in identificirala povečano tveganje za samomorilno razmišljanje in vedenje pri otrocih, zdravljenih z atomoksetinom.
The reasons for referral concerned the risk of suicidal behaviour, including suicide attempts and suicidal ideation and/or related behaviour like self-harm, hostility and mood lability in children and adolescents treated with the above mentioned active substances. 
Razlogi za napotitev so zadevali tveganje za samomorilno vedenje, vključno s poskusi samomora in samomorilnim razmišljanjem in/ali povezanim vedenjem, kot so samopoškodovanje, sovražnost in čustvena labilnost, pri otrocih in mladostnikih, zdravljenih z zgoraj navedenimi učinkovinami.
ATOMOXETINE, CITALOPRAM, ESCITALOPRAM, FLUOXETINE, FLUVOXAMINE, MIANSERINE, MILNACIPRAN, MIRTAZAPINE, PAROXETINE, REBOXETINE, SERTRALINE AND VENLAFAXINE 
ATOMOKSETIN, CITALOPRAM, ESCITALOPRAM, FLUOKSETIN, FLUVOKSAMIN, MIANSERIN, MILNACIPRAN, MIRTAZAPIN, PAROKSETIN, REBOKSETIN, SERTRALIN IN VENLAFAKSIN
This Opinion recommended the maintenance of the Marketing Authorisations in accordance with the amendments to the relevant sections of the Summaries of Product Characteristics and Package Leaflets as set out in Annexes III and IV. 
Mnenje je priporočilo vzdrževanje dovoljenj za promet v skladu z dopolnitvami ustreznih poglavij Povzetkov glavnih značilnosti zdravila in Navodil za uporabo, kot je navedeno v Dodatkih III in IV.
Only some of these medicines are authorised for the treatment of obsessive-compulsive disorder (OCD) in children and adolescents and atomoxetine is authorised for the treatment of attention deficit/hyperactivity disorder (ADHD) in children and adolescents. 
Le nekatera od teh zdravil so odobrena za zdravljenje obsesivno-kompulzivne motnje (OCD) pri otrocih in mladostnikih, atomoksetin pa je odobren za zdravljenje motnje pomanjkljive pozornosti s hiperaktivnostjo (ADHD) pri otrocih in mladostnikih.
Updated warnings will be put on the Product Information for Atomoxetine about the risk of suicidal thoughts and behaviour. 
Za atomoksetin bodo v informacije o zdravilu vključena posodobljena opozorila glede tveganja za samomorilno razmišljanje in vedenje.
Diagnosis should be made according to current guidelines. 
Diagnozo je treba postaviti v skladu z veljavnimi smernicami.
The volume of distribution is around 10 l/kg. 
Volumen porazdelitve je okoli 10°l/kg.
Children and adolescents Nemdatine is not recommended for children and adolescents under the age of 18 years. 
Zdravila Nemdatine ne priporočajo otrokom in mladostnikom, mlajšim od 18 let.
Your doctor will tell you whether your illness allows you to drive and to use machines safely. 
Vaš zdravnik vam bo povedal, če zaradi vaše bolezni lahko varno vozite in varno upravljate stroje.
Use within 100 days after opening. 
Uporabite v 100 dneh po odprtju.
Some factors that may raise urine pH (see section 5.2 ‘Elimination') may necessitate careful monitoring of the patient. 
Kadar so prisotni nekateri dejavniki, ki lahko zvišajo pH urina (glejte poglavje 5.2 ‘Izločanje'), je potreben skrben nadzor bolnika.