natgillin/translations-raw huggingface dataset:
National Marketing Authorisations for injectable products containing ivermectin for use in cattle have been granted in all the Member States of the European Union via different authorisation procedures (mutual recognition procedures or national procedures) and under various legal bases.
Nacionalna dovoljenja za promet z zdravili za injiciranje, ki vsebujejo ivermektin za uporabo pri govedu, so bila odobrena v vseh državah članicah Evropske unije z različnimi postopki izdaje dovoljenj (postopki medsebojnega priznavanja ali nacionalnimi postopki) ali v skladu z različnimi pravnimi podlagami.
On 17 September 2008 the CVMP considered that there were still issues with regard to some products which needed further clarification and therefore the Committee requested the relevant Marketing Authorisation Holders to address the outstanding issues in writing.
17. septembra 2008 je CVMP menil, da nekatera vprašanja v zvezi z nekaterimi zdravili še ostajajo in zahtevajo nadaljnja pojasnila, zato je Odbor zadevne imetnike dovoljenj za promet zaprosil, naj pisno pojasnijo preostala vprašanja.
Based on the evaluation of the currently available data and the rapporteurs' assessment, the CVMP considered that its opinion of 11 February 2009 should be revised.
Na podlagi ovrednotenja trenutno razpoložljivih podatkov in poročevalčevih ocen je CVMP menil, da je treba mnenje z dne 11. februarja 2009 revidirati.
During its 10-12 March 2009 meeting, the CVMP, appointed Dr A. Holm as rapporteur and Dr M. Holzhauser-Alberti as co-rapporteur for the re-examination of the above mentioned opinion.
Na zasedanju CVMP od 10. do 12. marca 2009 je bil dr. A. Holm imenovan za poročevalca in dr. M. Holzhauser-Alberti za soporočevalca v postopku ponovne presoje zgoraj omenjenega mnenja.
On 25 February 2009, Norbrook Laboratories Ltd, notified the EMEA of its intention to request the reexamination of the CVMP opinion of 11 February 2009.
Dne 25. februarja 2009 je družba Norbrook Laboratories Ltd obvestila agencijo EMEA, da namerava zaprositi za ponovno presojo mnenja CVMP z dne 11. februarja 2009.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics, package leaflet and label in the Annex III.
Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj s spremenjenim povzetkom glavnih značilnosti zdravila, označevanjem in navodilom za uporabo v Dodatku III.
Due to concerns that the difference in withdrawal periods established across the European Union for injectable veterinary medicinal products containing ivermectin which are indicated for use in cattle and with a dose of 200µg ivermectin/kg bodyweight may present a potential serious risk to human health, the United Kingdom referred the matter to the EMEA on 14 December 2007, under Article 35 of Directive 2001/82/EC.
Zaradi zaskrbljenosti, da bi lahko razlike v karencah, določenih v različnih državah Evropske unije za veterinarska zdravila za injiciranje, ki vsebujejo ivermektin in so indicirana za uporabo pri govedu v odmerku 200µg ivermektina/kg telesne mase, utegnile predstavljati morebitno resno tveganje za zdravje ljudi, je Združeno kraljestvo zadevo napotilo na agencijo EMEA dne 14. decembra 2007, v skladu s členom 35 Direktive 2001/82/ES.
Eighteen Member States responded and submitted information concerning 103 of the outstanding 120 Marketing Authorisations.
Odgovorilo je 18 držav članic in predložilo informacije v zvezi s 103 od manjkajočih 120 dovoljenj za promet.
The Committee appointed Dr G. J. Schefferlie as rapporteur and Dr J. G. Beechinor, Prof C. Friis, Prof R. Kroker and Dr B. Urbain as co-rapporteurs.
Schefferlie je bil imenovan za poročevalca, dr. J. G. Beechinor, prof. C. Friis, prof. R. Kroker and dr. B. Urbain pa za soporočevalce.
On 21 May 2008 the EMEA received a total of 19 written explanations from the Marketing Authorisation Holders (either as a group of or individual Marketing Authorisation Holders).
21. maja 2008 je EMEA od imetnikov dovoljenj za promet z zdravilom (skupinskih ali posameznih imetnikov dovoljenj za promet) prejela skupaj 19 pisnih obrazložitev.
Written explanations were provided by the Marketing Authorisation Holders on 13 November 2008.
Imetniki dovoljenja za promet z zdravilom so pisna pojasnila predložili dne 13. novembra 2008.
Ivermectin belongs to the macrocyclic lactone class of endectocides with activity against a wide rage of internal and external parasites.
Ivermektin sodi v skupino makrocikličnih laktonov v okviru endektocitov, ki delujejo proti številnim vrstam notranjih in zunanjih parazitov.
Further to the resignation of Prof R. Kroker as CVMP member, Dr C. Ibrahim was appointed to replace him and took over the co-rapporteurship.
Ker je prof. R. Kroker odstopil z mesta člana odbora CVMP, je bil na njegovo mesto imenovan dr. C. Ibrahim, ki je prevzel soporočevalstvo.
Injectable veterinary medicinal products containing ivermectin, either as a single active substance or in combination with a second active substance are indicated for use in cattle for the treatment of endoparasitic and ectoparasitic infestations.
Veterinarska zdravila za injiciranje, ki vsebujejo ivermektin, bodisi kot samostojno zdravilno učinkovino ali v kombinaciji z drugo zdravilno učinkovino so indicirana za uporabo pri govedu za zdravljenje endoparazitskih in ektoparazitskih okužb.
OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR Injectable veterinary medicinal products containing ivermectin that are indicated for use in cattle at dose of 200 μg ivermectin per kg bodyweight
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 351 ZA zdravila za uporabo v veterinarski medicini za injiciranje, ki vsebujejo ivermektin in so indicirana za uporabo pri govedu v odmerku 200 μg ivermektina na kg telesne mase
Based on the evaluation of the currently available data and the rapporteurs' assessment, the CVMP considered that a single withdrawal period of 49 days should be established for all concerned injectable products for cattle containing ivermectin.
Na podlagi ovrednotenja trenutno razpoložljivih podatkov in ocene poročevalcev je CVMP menil, da bi morala biti za vsa zdravila za injiciranje za govedo, ki vsebujejo ivermektin, določena enotna karenca 49 dni.
Therefore, the Committee adopted an opinion on 11 February 2009 recommending the variation of the existing Marketing Authorisations in accordance with the recommended amendments to the Summary of Product Characteristics.
Zato je Odbor dne 11. februarja 2009 sprejel mnenje, v katerem je priporočil spremembo obstoječega dovoljenja za promet v skladu s predlaganimi dopolnitvami povzetka glavnih značilnosti zdravila.
Oral explanations were given on 12 May 2009.
Postopek se je začel 15. aprila 2009. 12. maja 2009 so bila podana ustna pojasnila.
Therefore, the Committee adopted by written procedure an opinion on 5 June 2009 recommending the variation the existing Marketing Authorisations in line with the proposed amendments of the Summary of Product Characteristics, labelling and package leaflet.
Zato je Odbor dne 5. junija 2009 s pisnim postopkom sprejel mnenje, v katerem je priporočil spremembo obstoječih dovoljenj za promet v skladu s predlaganimi dopolnitvami povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo.
With regard to the products containing ivermectin in combination with clorsulon as a second active substance a withdrawal period of 66 days for cattle was recommended.
Za zdravila, ki vsebujejo ivermektin v kombinaciji s klorsulonom kot drugo zdravilno učinkovino pa je bila za govedo priporočena karenca 66 dni.
The withdrawal period of 49 days for cattle would also apply to all concerned injectable products containing ivermectin in combination with closantel as a second active substance.
Enaka karenca 49 dni za govedo bi veljala tudi za vsa zadevna zdravila za injiciranje, ki vsebujejo ivermektin kombinaciji s klosantelom kot drugo zdravilno učinkovino.
The Committee confirmed that a withdrawal period of 49 days should be established for all concerned injectable products for cattle containing ivermectin as a single active substance.
Odbor je potrdil, da je treba določiti karenco 49 dni za vsa zadevna zdravila za govedo, ki vsebujejo ivermektin kot edino zdravilno učinkovino.
The detailed grounds for the re-examination were submitted by Norbrook Laboratories Ltd on 14 April 2009.
Družba Norbrook Laboratories Ltd je 14. aprila 2009 predložila podrobnosti, na podlagi katerih je zahtevala ponovno presojo.
The main measure of effectiveness was based on the reduction in the number of episodes of laughing or crying.
Glavno merilo učinkovitosti je temeljilo na zmanjšanju števila epizod smeha ali joka.
The CHMP also noted that there is currently no treatment available for this distressing condition.
Upošteval je tudi, da trenutno ni na voljo nobenega zdravljenja za to obremenjujočo bolezen.
The European Commission granted a marketing authorisation valid throughout the European Union for Nuedexta on 24 June 2013.
Evropska komisija je dovoljenje za promet z zdravilom Nuedexta, veljavno po vsej Evropski uniji, odobrila Dne 24. Junija 2013.
Nuedexta must not be used in patients:
Zdravilo Nuedexta se ne sme uporabljati pri bolnikih:
The main safety issues were considered manageable and adequately addressed by risk minimisation measures.
Glavna varnostna tveganja naj bi bila obvladljiva in ustrezno nadzorovana z ukrepi za zmanjšanje tveganja.
The study also measured the change in the patients' symptoms, assessed in several ways including using a standard scale (called a CNS-LS score which ranges from 7 to 35).
V študiji so merili tudi spremembe simptomov pri bolnikih, ki so jih ocenjevali na več načinov, vključno s standardno lestvico (imenovano lestvica CNS-LS z rezultati od 7 do 35).
The full EPAR for Nuedexta 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 Nuedexta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
• who are taking or have taken within the last 14 days medicines for depression called monoamine oxidase inhibitors (MAOI).
• ki jemljejo ali so v zadnjih 14 dneh jemali zdravila proti depresiji, imenovana zaviralci monoaminoksidaze (MAOI).
This is a summary of the European public assessment report (EPAR) for Nuedexta.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Nuedexta.
Serious side effects reported include muscle spasticity (excessive stiffness of muscles), respiratory depression (inhibition of breathing) and decreased oxygen saturation (lower-than-normal levels of oxygen) in the blood.
Resni neželeni učinki, o katerih so poročali, vključujejo mišično spastičnost (prekomerna otrdelost mišic), respiratorno depresijo (ovirano dihanje) in zmanjšano nasičenost s kisikom (nižje ravni kisika od običajnih) v krvi.
• who are taking the medicine thioridazine used for mental illness;
• ki jemljejo tioridazin, ki se uporablja za zdravljenje duševnih bolezni;
• with ‘prolonged QT interval' (a disruption of the electrical activity of the heart);
• s „podaljšanim intervalom QT (motnjo električne aktivnosti srca);
In patients whose response is inadequate after four weeks, the higher strength capsule (23mg/9mg) may be used twice a day.
Bolniki, katerih odziv je po štirih tednih nezadosten, lahko jemljejo kapsulo večje jakosti (23 mg/9 mg) dvakrat na dan.
PBA is a condition where damage to certain areas of the brain results in sudden and uncontrollable episodes of crying or laughing that do not relate to the patient's real emotional state.
PBP je bolezen, pri kateri se zaradi poškodb nekaterih delov možganov pojavijo nenadne epizode joka ali smeha, ki jih ni mogoče nadzorovati in niso povezane z bolnikovim dejanskim čustvenim stanjem.
Other information about Nuedexta
Druge informacije o zdravilu Nuedexta
A decrease in the total score indicates an improvement in PBA symptoms.
Znižanje skupnega rezultata pomeni izboljšanje simptomov PBP.
Treatment should be started with one lower strength capsule (15mg/9mg) once a day (in the morning), which is increased after one week to twice a day (in the morning and evening, 12 hours apart).
Na začetku zdravljenja se jemlje eno kapsulo manjše jakosti (15 mg/9 mg) enkrat na dan (zjutraj), po enem tednu pa je treba odmerek povečati na dve kapsuli na dan (zjutraj in zvečer, z 12-urnim presledkom).
A risk management plan has been developed to ensure that Nuedexta is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Nuedexta je bil pripravljen načrt obvladovanja tveganj.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Nuedexta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Nuedexta večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The most common side effects with Nuedexta (which may affect up to 1 in 10 people) are diarrhoea, nausea (feeling sick), dizziness, headache, somnolence (sleepiness) and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Nuedexta (ki lahko prizadenejo največ 1 osebo od 10) so diareja, navzea (slabost), omotica, glavobol, somnolenca (zaspanost) in utrujenost.
Regarding its safety, the CHMP decided that dextromethorphan and quinidine have been marketed as medicines for a number of years and their safety and interactions with other medicines are relatively well known.
V zvezi z varnostjo je CHMP ugotovil, da se dekstrometorfan in kinidin kot zdravili tržita že vrsto let in da je glede njune varnosti in medsebojnega delovanja z drugimi zdravili znanega že relativno veliko.
For more information about treatment with Nuedexta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Nuedexta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Although the exact cause of PBA is unclear, it is believed that it affects the way signals are transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Čeprav natančen vzrok PBP ni znan, domnevno vpliva na način prenosa signalov med možganskimi celicami, ki poteka s pomočjo „živčnih prenašalcev , tj. kemičnih snovi, ki omogočajo medsebojno komunikacijo med živčnimi celicami.
After 12 weeks of treatment with Nuedexta, the CNS-LS score decreased by 8.2 points, compared with a decrease of 5.7 points for placebo.
Po 12 tednih zdravljenja z zdravilom Nuedexta se je rezultat na lestvici CNS-LS znižal za 8,2 točke, medtem ko se je pri placebu znižal za 5,7 točke.
What measures are being taken to ensure the safe use of Nuedexta?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Nuedexta?
The company will also carry out a study on the use of Nuedexta and a study to monitor Nuedexta's safety including its effects on the heart and potential for interactions with other medicines.
Prav tako bo družba izvedla študijo uporabe zdravila Nuedexta in študijo, namenjeno spremljanju varnosti zdravila Nuedexta, vključno z njegovimi učinki na srce in možnostmi medsebojnega delovanja z drugimi zdravili.
• who are already being treated with the medicines quinidine, quinine or mefloquine or who have previously developed certain serious problems such as thrombocytopenia (low platelet counts) due to the use of these medicines;
• ki se že zdravijo s kinidinom, kininom ali meflokinom ali pri katerih so se v preteklosti že pojavile nekatere resne bolezni, na primer trombocitopenija (majhno število trombocitov), ki so bile posledica uporabe teh zdravil;
Since these neurotransmitters are involved in the control of emotions, dextromethorphan helps to normalise its activity in the brain, reducing the symptoms of PBA.
Ker ta živčna prenašalca sodelujeta pri uravnavanju čustev, dekstrometorfan pomaga normalizirati dejavnosti v možganih, s čimer se zmanjšajo simptomi PBP.
Nuedexta is available as capsules (15 mg or 23 mg dextromethorphan and 9 mg quinidine) and can only be obtained with a prescription.
Zdravilo Nuedexta je na voljo v obliki kapsul (15 mg ali 23 mg dekstrometorfana in 9 mg kinidina) in se izdaja le na recept.
In addition, the company that makes Nuedexta must ensure that all healthcare professionals who are expected to use Nuedexta receive an information pack and a patient alert card with key safety information.
Poleg tega mora družba, ki izdeluje zdravilo Nuedexta, zagotoviti, da bodo vsi zdravstveni delavci, ki naj bi uporabljali zdravilo Nuedexta, prejeli informativni paket ter opozorilno kartico za bolnike s ključnimi informacijami o varnosti.
It is used to treat the symptoms of pseudobulbar affect (PBA) in adults.
Uporablja se za zdravljenje simptomov psevdobulbarne paralize (PBP) pri odraslih.
Treatment with Nuedexta was effective in reducing patients' PBA episodes which were reduced by nearly 50% more than in patients treated with placebo.
Zdravljenje z zdravilom Nuedexta je bilo učinkovito pri zmanjšanju števila epizod PBP, ki so se zmanjšale za skoraj 50 % bolj kot pri bolnikih, zdravljenih s placebom.
Dextromethorphan / quinidine
Nuedexta dekstrometorfan/kinidin
What benefits of Nuedexta have been shown in studies?
Kakšne koristi je zdravilo Nuedexta izkazalo v študijah?
What is Nuedexta and what is it used for?
Kaj je zdravilo Nuedexta in za kaj se uporablja?
Although the exact way dextromethorphan works in PBA is unclear, it attaches to several different nerve cell receptors in the brain such as NMDA receptors and sigma-1 receptors for the neurotransmitter glutamate as well as receptors for the neurotransmitter serotonin.
Natančen način delovanja dekstrometorfana pri PBP ni znan, se pa veže na več različnih živčnih receptorjev v možganih, kot so receptorji NMDA in receptorji sigma-1 za živčni prenašalec glutamat ter receptorji za živčni prenašalec serotonin.
Nuedexta has been studied in one main study involving 326 patients with PBA due to multiple sclerosis or amyotrophic lateral sclerosis.
Zdravilo Nuedexta so raziskali v eni glavni študiji, v katero je bilo vključenih 326 bolnikov s PBP, ki je bila posledica multiple skleroze ali amiotrofične lateralne skleroze.
• with or at high risk of complete AV block (a type of heart rhythm disorder);
• ki imajo ali pri katerih obstaja veliko tveganje za kompletni AV-blok (vrsto motnje srčnega ritma);
The role of quinidine is to prevent dextromethorphan from being broken down early in the body and thereby it prolongs the action of dextromethorphan in the body.
Naloga kinidina je, da prepreči prehitro razgradnjo dekstrometorfana v telesu in tako podaljša čas njegovega delovanja.
Nuedexta is a medicine that contains two active substances, dextromethorphan and quinidine.
Nuedexta je zdravilo, ki vsebuje dve zdravilni učinkovini - dekstrometorfan in kinidin.
• with a history suggestive of torsades de pointes ventricular tachycardia (abnormal heart rhythms);
• z anamnezo, ki kaže na ventrikularno tahikardijo tipa torsades de pointes (nenormalen srčni ritem);
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 Nuedexta.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Nuedexta, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What is the risk associated with Nuedexta?
Kakšna tveganja so povezana z zdravilom Nuedexta?
Why has Nuedexta been approved?
Zakaj je bilo zdravilo Nuedexta odobreno?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nuedexta, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Nuedexta vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Nuedexta was compared with placebo (a dummy treatment) for 12 weeks.
Zdravilo Nuedexta so 12 tednov primerjali s placebom (zdravilom brez zdravilne učinkovine).
For the full list of all side effects reported with Nuedexta, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Nuedexta, glejte navodilo za uporabo.
How does Nuedexta work?
Kako zdravilo Nuedexta deluje?
How is Nuedexta used?
Kako se zdravilo Nuedexta uporablja?
The CHMP concluded that Nuedexta is effective in treating the symptoms of PBA based on the studies in patients with PBA caused by multiple sclerosis and amyotrophic lateral sclerosis.
Na podlagi študij pri bolnikih s PBP, ki je bila posledica multiple skleroze in amiotrofične lateralne skleroze, je zaključil, da je zdravilo Nuedexta učinkovito pri zdravljenju simptomov PBP.
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
Arquiparque-Miraflores 1495-131 Algés Portugal
Arquiparque-Miraflores 1495-131 Algés Portugalska
266 Kifisias Avenue 152 32 Halandri Greece
266 Kifisias Avenue 152 32 Halandri Grčija
GlaxoSmithKline Latvia SIA Duntes iela 11
GlaxoSmithKline Latvija SIA Duntes iela 11
GlaxoSmithKline, S.A. PTM- Severo Ochoa, 2 28760-Tres Cantos (Madrid) Spain
GlaxoSmithKline, S.A. PTM- Severo Ochoa, 2 28760-Tres Cantos (Madrid) Španija
1 g/vial
1 g/viala
Intramuscular
Intramuskularno
Powder for oral suspension (sachet)
Prašek za peroralno suspenzijo (vrečica)
Intravenous/ Intramuscular
Intravensko/Intramuskul arno
Intramuscular Use 1 g/vial
Intramuskularna uporaba 1 g/viala
Amoxil Vials 500mg, powder for solution for injection or infusion
Amoxil Vials 500mg, powder for solution for injection or infusion powder for solution for injection or infusion
Dispersible tablet
Disperzibilna Tableta Peroralna uporaba
Amoxil Paediatric 125mg/1.25ml Powder for Oral Suspension
Paediatric 125mg/1.25m l Powder for Oral
Amoxil 3g Powder for Oral Suspension Sachets
Amoxil 3g Powder for Oral
Intravenous
Intravensko
500 mg Capsule
500 mg Kapsula
500 mg Capsule, hard
500 mg Kapsula, trda
Stonemasons Way Rathfarnham Dublin 16
GlaxoSmithKline (Irska) Ltd Stonemasons Way Rathfarnham
Powder for solution for injection
Prašek za raztopino za injiciranje
Amoxil Capsules 500mg 500 mg Capsule
Amoxil Kapsulas 500mg
Powder and solvent for solution for injection
Prašek in topilo za raztopino za injiciranje
United Kingdom250 mg Capsule
250 mg Kapsula
Apo B decreased by 12%.
Koncentracija Apo B se je znižala za 12 %.
Very rare: Pancreatitis
Zelo redko: pankreatitis
The safety and efficacy in children (below the age of 18 years) has not been studied.
Varnost in učinkovitost tega zdravila pri otrocih (mlajših od 18 let) ni bila preučevana.
Other forms of interaction
Druge oblike medsebojnega delovanja
Without the recycling process, your liver has to make additional bile acids.
Brez postopka ponovne uporabe morajo vaša jetra ustvariti dodatne žolčne kisline.
Date of first authorisation: 10 March 2004 Date of latest renewal: 12 March 2009
Datum zadnjega podaljšanja: 12. marec 2009
Doses in excess of the maximum recommended dose (4.5 g per day (7 tablets)) have not been tested.
Odmerkov, večjih od najvišjega priporočenega odmerka (4,5 g dnevno (7 tablet)), niso preizkusili.
You may take your dose with a later meal, but never take in one day more than the total number of tablets that your doctor has prescribed to you in a single day.
Lahko vzamete odmerek ob kasnejšem obroku, vendar nikoli ne vzemite več od skupnega števila tablet, ki vam jih je zdravnik predpisal za en dan.