natgillin/translations-raw huggingface dataset:
BOVIMEC B Ivermectin 10 mg/ml 
BOVIMEC B Ivermektin 10 mg/ml
Diapec R Ivermectin 10 mg/ml 
Diapec R Ivermektin 10 mg/ml
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET 
DOPOLNILA, KI SE VKLJUČIJO V USTREZNA POGLAVJA NAVODIL ZA UPORABO
Slovak Republic MERIAL 29 avenue Tony Garnier 69007 LYON 
Slovenija MERIAL 29 avenue Tony Garnier 69007 LYON France
WITHDRAWAL PERIOD Cattle: Meat and offal - 49 days. 
KARENCA Govedo: Meso in drobovina - 49 dni.
Subcutaneous Cattle, Sheep, Goats: 200 μg ivermectin/kg bw 
Subkutana Govedo, ovce, koze: 200 μg ivermektina/kg TM
FROMMECTIN Ivermectin 10 mg/ml 
FROMMECTIN Ivermektin 10 mg/ml
MAXIMEC Ivermectin 10 mg/ml 
MAXIMEC Ivermektin 10 mg/ml
Subcutaneous 200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw 
Subkutana 200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM
The Netherlands Cross Vetpharm Group Ltd, Broomhill Road 
Nizozemska Cross Vetpharm Group Ltd, Broomhill Road
PROMECTINE Ivermectin 10 mg/ml 
PROMECTINE Ivermektin 10 mg/ml
VETERMEC Ivermectin 10 mg/ml 
VETERMEC Ivermektin 10 mg/ml
VALANEQ Ivermectin 10 mg/ml 
VALANEQ Ivermektin 10 mg/ml
Ivotan LA Ivermectin 10 mg/ml 
Ivotan LA Ivermektin 10 mg/ml
TIZOVAL Ivermectin 10 mg/ml 
TIZOVAL Ivermektin 10 mg/ml
ECOMECTIN Ivermectin 10 mg/ml 
ECOMECTIN Ivermektin 10 mg/ml
Czech Republic MERIAL 29 avenue Tony Garnier 69007 LYON 
Romunija MERIAL 29 avenue Tony Garnier 69007 LYON France
Ivermektin S Ivermectin 10 mg/ml 
Ivermektin S Ivermektin 10 mg/ml
Euromec Injectie Ivermectin 10 mg/ml 
Euromec Injectie Ivermektin 10 mg/ml
Enovex Injection Ivermectin 10 mg/ml 
Enovex Injection Ivermektin 10 mg/ml
Paramectin 1% Ivermectin 10 mg/ml 
Paramectin 1% Ivermektin 10 mg/ml
Maximec Injectie Ivermectin 10 mg/ml 
Maximec Injectie Ivermektin 10 mg/ml
IVERTIN Ivermectin 10 mg/ml 
IVERTIN Ivermektin 10 mg/ml
Subcutaneous 200 μg ivermectin/kg bw, 5 mg closantel/kg bw 
Subkutana 200 μg ivermektina/kg TM, 5 mg klosantela/kg TM
Subcutaneous Cattle, Sheep, Reindeer: 200 μg ivermectin/kg bw 
Subkutana Govedo, ovce, jeleni: 200 μg ivermektina/kg TM
BOVECTIN Ivermectin 10 mg/ml 
BOVECTIN Ivermektin 10 mg/ml
VIRBAMEC Ivermectin 10 mg/ml 
VIRBAMEC Ivermektin 10 mg/ml
Ivermectin 10 mg/ml, Clorsulon 100 mg/ml 
Ivermektin 10 mg/ml, klorsulon 100 mg/ml
BIMECTIN Ivermectin 10 mg/ml 
BIMECTIN Ivermektin 10 mg/ml
Anisec Injection Ivermectin 10 mg/ml 
Anisec Injection Ivermektin 10 mg/ml
United Kingdom Cross Vetpharm Group Ltd, Broomhill Road 
Portugalska Cross Vetpharm Group Ltd, Broomhill Road
Alfamec 1 % Ivermectin 10 mg/ml 
Alfamec 1 % Ivermektin 10 mg/ml
The withdrawal period for the product will be the longer of the withdrawal periods derived for the individual components. 
Karenca za zdravilo je enaka daljši vrednosti od obeh karenc, sicer ugotovljeni za posamezni komponenti.
Ivomec 1% Ivermectin 10 mg/ml 
Ivomec 1% Ivermektin 10 mg/ml
Biomectin 1% Ivermectin 10 mg/ml 
Biomectin 1 % Ivermektin 10 mg/ml
Biomectin 1 % Ivermectin 10 mg/ml 
Biomectin 1% Ivermektin 10 mg/ml
Iverktin Injection Ivermectin 10 mg/ml 
Iverktin Injection Ivermektin 10 mg/ml
Virbamec F Ivermectin 10 mg/ml, Clorsulon 100 mg/ml 
Virbamec F Ivermektin 10 mg/ml, klorsulon 100 mg/ml
Pandex 1% Ivermectin 10 mg/ml 
Pandex 1% Ivermektin 10 mg/ml
The Netherlands Laboratorios Calier SA Barcelones 
Nizozemska Laboratorios Calier SA Barcelones
IVOMEC F Ivermectin 10 mg/ml, Clorsulon 100 mg/ml 
IVOMEC F Ivermektin 10 mg/ml, klorsulon 100 mg/ml
IVOMEC D Ivermectin 10 mg/ml, Clorsulon 100 mg/ml 
IVOMEC D Ivermektin 10 mg/ml, klorsulon 100 mg/ml
Animec Injection Ivermectin 10 mg/ml 
Animec Injection Ivermektin 10 mg/ml
Sumiject Injection Ivermectin 10 mg/ml 
Sumiject Injection Ivermektin 10 mg/ml
Cevamec 1% Ivermectin 10 mg/ml 
Cevamec 1% Ivermektin 10 mg/ml
Aniject Injection Ivermectin 10 mg/ml 
Aniject Injection Ivermektin 10 mg/ml
Topimec Injection Ivermectin 10 mg/ml 
Topimec Injection Ivermektin 10 mg/ml
Ecomectin 1% Ivermectin 10 mg/ml 
Ecomectin 1 % Ivermektin 10 mg/ml
Ecomectin 1 % Ivermectin 10 mg/ml 
Ecomectin 1% Ivermektin 10 mg/ml
Ivermectina 1% Ivermectin 10 mg/ml 
Ivermectina 1% Ivermektin 10 mg/ml
Subcutaneous Cattle, Reindeer: 200 μg ivermectin/kg bw 
Subkutana Govedo: 200 μg ivermektina/kg TM
Bimectin Injectie Ivermectin 10 mg/ml 
Bimectin Injectie Ivermektin 10 mg/ml
Ivodad 1% Ivermectin 10 mg/ml 
Ivodad 1% Ivermektin 10 mg/ml
Belgium Norbrook Laboratories Limited Station Works 
Portugalska Norbrook Laboratories Limited Station Works
The Netherlands ECO Animal Health Ltd 78 Coombe Road 
Nizozemska ECO Animal Health Ltd 78 Coombe Road
Belgium ECO Animal Health Ltd 78 Coombe Road 
Bolgarija ECO Animal Health Ltd 78 Coombe Road
IVERVETo 1 % Ivermectin 10 mg/ml 
IVERVETo 1 % Ivermektin 10 mg/ml
Av.Los Cerrilos 602 Santiago, 
Bolgarija Centrovet Ltd. Av.Los Cerrilos 602
Czech Republic ECO Animal Health Ltd 78 Coombe Road 
Madžarska ECO Animal Health Ltd 78 Coombe Road
The Netherlands Norbrook Laboratories Limited Station Works 
Nizozemska Norbrook Laboratories Limited Station Works
United Kingdom ECO Animal Health Ltd 78 Coombe Road 
Romunija ECO Animal Health Ltd 78 Coombe Road
Jylamvo received a marketing authorisation valid throughout the EU on 29 March 2017. 
Za zdravilo Jylamvo je bilo 29. marca 2017 izdano dovoljenje za promet, veljavno po vsej EU.
For inflammatory conditions it is taken once a week, on the same day each week. 
Pri uporabi za vnetna stanja se jemlje enkrat tedensko, vedno na isti dan v tednu.
This especially affects fast-growing cells such as cancer cells. 
To še zlasti vpliva na hitro rastoče celice, kot na primer rakave celice.
The doctor may check with the patient or the patient's carer that the medicine can reliably be taken once a week. 
Zdravnik lahko pri bolniku ali njegovem skrbniku preveri, da se zdravilo zanesljivo jemlje enkrat tedensko.
Further information on Jylamvo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/jylamvo. 
Nadaljnje informacije za zdravilo Jylamvo so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/jylamvo.
What measures are being taken to ensure the safe and effective use of Jylamvo? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Jylamvo?
How often methotrexate is given depends on the other medicines it is used with. 
Pogostost dajanja metotreksata je odvisna od drugih zdravil, s katerimi se uporablja.
The company provided data from the published literature on the benefits and risks of methotrexate in the approved uses. 
Podjetje je predstavilo podatke iz objavljene literature o koristih in tveganjih metotreksata pri odobrenih uporabah.
It should be prescribed only by doctors with expertise in the use of methotrexate and a full understanding of the risks of methotrexate treatment. 
Predpisovati bi ga morali le zdravniki s strokovnim znanjem na področju uporabe metotreksata in popolnim razumevanjem tveganj zdravljenja z metotreksatom.
Jylamvo (methotrexate) 
Jylamvo (metotreksat)
What benefits of Jylamvo have been shown in studies? 
Kakšne koristi zdravila Jylamvo so se pokazale v študijah?
An overview of Jylamvo and why it is authorised in the EU 
Pregled zdravila Jylamvo in zakaj je odobreno v EU
In most cases, methotrexate medicines are used for long-term treatment. 
V večini primerov se zdravila, ki vsebujejo metotreksat, uporabljajo za dolgotrajno zdravljenje.
The dose that the patient takes each week depends on which inflammatory condition it is being used for, how well the treatment is working and, in the case of children, on the child's height and weight. 
Odmerek, ki ga bolnik jemlje vsak teden, je odvisen od vnetnih stanj, za katere se uporablja in učinkovitosti zdravljenja, pri otrocih pa od njihove višine in telesne mase.
Why is Jylamvo authorised in the EU? 
Zakaj je bilo zdravilo Jylamvo odobreno v EU?
What is Jylamvo and what is it used for? 
Kaj je zdravilo Jylamvo in za kaj se uporablja?
• acute lymphoblastic leukaemia (ALL), a cancer of white blood cells, in adults and children over the age of 3 years. 
• akutne limfoblastne levkemije (ALL), tj. raka belih krvnih celic, pri odraslih in otrocih, starejših od treh let.
The Agency therefore decided that Jylamvo's benefits are greater than its risks and it can be authorised for use in the EU. 
Agencija je zato zaključila, da so koristi zdravila Jylamvo večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The way methotrexate works in patients with arthritis and psoriasis is not completely understood, but the benefits of methotrexate are thought to be due to its ability to reduce inflammation and suppress an overactive immune system. 
Ni popolnoma znano, kako metotreksat učinkuje pri bolnikih z artritisom in psoriazo, domneva pa se, da so koristi metotreksata posledica njegove sposobnosti zmanjševanja vnetja in zaviranja čezmerno dejavnega imunskega sistema.
It must not be used if the patient is breastfeeding or is receiving live vaccines. 
Ne sme se uporabljati pri doječih materah ali pri osebah, ki so prejele živa cepiva.
This means that it is similar to a ‘reference medicine' containing the same active substance, but Jylamvo is given in a different way. 
To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje enako učinkovino, vendar se daje drugače.
The company that markets Jylamvo will supply a guide for healthcare professionals and a patient alert card, on how to use the medicine correctly and how to avoid medication errors. 
Podjetje, ki trži zdravilo Jylamvo bo zdravstvenim delavcem priskrbelo navodila, bolnikom pa opozorilno kartico o tem, kako pravilno uporabljati zdravilo in kako se izogniti napakam pri zdravljenju.
As for every medicine, the company provided studies on the quality of Jylamvo. 
Kot to velja za vsako zdravilo, je podjetje zagotovilo študije o kakovosti zdravila Jylamvo.
As for all medicines, data on the use of Jylamvo are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Jylamvo stalno spremljajo.
For more information about using Jylamvo, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Jylamvo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The company will also send out follow-up questionnaires for dosing errors that result in overdose. 
Podjetje bo razposlalo vprašalnike za nadaljnje spremljanje napak pri odmerjanju in s tem povezanih prevelikih odmerkov.
For acute lymphoblastic leukaemia, the dose of Jylamvo depends on the patient's height and weight. 
Pri akutni limfoblastni levkemiji je odmerek zdravila Jylamvo odvisen od bolnikove višine in telesne mase.
Side effects reported with Jylamvo are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Jylamvo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Jylamo must not be used in patients who abuse alcohol or those with liver or severe kidney problems, blood disorders, weakened immune system (body defences), severe or long-term infections such as tuberculosis and HIV infection, mouth ulcers, inflammation in the mouth, and ulcers in the digestive system. 
Zdravilo Jylamo se ne sme uporabljati pri bolnikih, ki prekomerno uživajo alkohol, ali pri tistih s hudimi težavami z jetri ali ledvicami, krvnimi motnjami, oslabljenim imunskim sistemom (obrambnimi mehanizmi telesa), resnimi ali dolgotrajnimi okužbami, kot so tuberkuloza in okužba z virusom HIV, razjedami v ustih, vnetji v ustih in razjedami v prebavnem sistemu.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jylamvo have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Jylamvo upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Jylamvo is an anti-inflammatory and cancer medicine used to treat the following conditions: 
Zdravilo Jylamvo je protivnetno zdravilo in zdravilo za zdravljenje raka, ki se uporablja za zdravljenje naslednjih bolezni:
Other information about Jylamvo 
Druge informacije o zdravilu Jylamvo
What are the risks associated with Jylamvo? 
Kakšna tveganja so povezana z zdravilom Jylamvo?
The most common side effects with Jylamvo (which may affect more than 1 in 10 people) are effects in the digestive system (such as inflammation of the lining of the mouth, indigestion, belly pain, feeling sick and loss of appetite) and blood tests showing changes in the liver. 
Najpogostejši neželeni učinki zdravila Jylamvo (ki se lahko pojavijo pri več kot 1 osebi od 10) so učinki v prebavnem sistemu (kot so vnetje ustne sluznice, prebavne motnje, bolečine v trebuhu, siljenje na bruhanje in izguba teka) in krvne preiskave, ki kažejo spremembe v jetrih.
The company also carried out studies that showed that it is bioequivalent to other methotrexate medicines used to treat inflammatory conditions and ALL (Methotrexat Lederle and Ebetrexat tablets). 
Podjetje je prav tako izvedlo študije, ki so pokazale, da je zdravilo Jylamvo bioekvivalentno drugim zdravilom, ki vsebujejo metotreksat in ki se uporabljajo za zdravljenje vnetnih stanj in akutne limfoblastne levkemije (zdravilo Metotreksat Lederle in tablete zdravila Ebetrexat).
The most serious side effects include reduced production of blood cells, damage to the lung, liver, kidneys and nerves, thromboembolism (problems caused by clots in blood vessels), and severe allergic and skin reactions. 
Najresnejši neželeni učinki vključujejo zmanjšano proizvodnjo krvnih celic, poškodbe pljuč, jeter, ledvic in živcev, tromboembolijo (težave, ki jih povzročajo strdki v krvnih žilah) ter hude alergijske in kožne reakcije.
• severe juvenile idiopathic arthritis (inflammation of joints in children) in patients from 3 years of age when NSAIDs (non-steroidal anti-inflammatory drugs) have not worked well enough; 
• hudega juvenilnega idiopatičnega artritisa (vnetja sklepov pri otrocih) pri bolnikih, starih tri leta ali več, ko nesteroidna protivnetna zdravila (NSAID) ne delujejo dovolj dobro;
Jylamvo is a ‘hybrid medicine'. 
Zdravilo Jylamvo je „hibridno zdravilo“.
For the full list of side effects and restrictions of Jylamvo, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Jylamvo glejte navodilo za uporabo.
The reference medicine for Jylamvo is Methotrexat Lederle injection. 
Referenčno zdravilo za zdravilo Jylamvo je zdravilo Metotreksat Lederle za injiciranje.
• active rheumatoid arthritis (a disease causing inflammation in joints) in adults; 
• aktivnega revmatoidnega artritisa (bolezni, ki povzroča vnetje sklepov) pri odraslih;
The European Medicines Agency decided that Jylamvo was of comparable quality and was bioequivalent to the methotrexate-containing medicines Methotrexat Lederle and Ebetrexat. 
Evropska agencija za zdravila je zaključila, da je zdravilo Jylamvo primerljive kakovosti kot zdravili Metotreksat Lederle in Ebetrexat, ki vsebujeta metotreksat, ter jima je bioekvivalentno.
How does Jylamvo work? 
Kako zdravilo Jylamvo deluje?
The active substance in Jylamvo, methotrexate, stops cells from growing by interfering with the production of DNA. 
Učinkovina v zdravilu Jylamvo, metotreksat, z oviranjem tvorbe DNK ustavi rast celic.
• severe psoriatic arthritis (inflammation of joints that occurs in patients with psoriasis) in adults; 
• hudega psoriatičnega artritisa (vnetja sklepov, ki se pojavlja pri bolnikih s psoriazo) pri odraslih;
Jylamvo is available as a liquid to be taken by mouth and it can only be obtained with a prescription. 
Zdravilo Jylamvo je na voljo v obliki raztopine, ki se daje peroralno, njegovo predpisovanje in izdaja pa je le na recept.
Jylamvo contains the active substance methotrexate. 
Zdravilo Jylamvo vsebuje učinkovino metotreksat.
How is Jylamvo used? 
Kako se zdravilo Jylamvo uporablja?
• severe disabling psoriasis (an inflammatory disease causing red, scaly patches on the skin) in adults when other treatments have not worked well enough; 
• hude neodzivne psoriaze (vnetne bolezni, ki povzroča rdeče, luskaste zaplate na koži) pri odraslih,
National Competent Authorities (NCAs) of Member State(s) or Reference Member State(s) (RMS) where applicable, shall ensure that the following conditions are fulfilled by the MAH(s): 
Pristojne nacionalne agencije ene ali več držav članic ali referenčnih držav članic bodo zagotovile, kjer je to ustrezno, da imetnik(i) dovoljenja za promet z zdravilom izpolnjuje(jo) naslednje pogoje:
Condition to the marketing authorisations 
Pogoj dovoljenja za promet z zdravilom
Annex IV Condition to the marketing authorisations 
Priloga IV Pogoj dovoljenja za promet z zdravilom
Elderly patients (over 65 years) 
Starejši bolniki (nad 65 let)
The potential risk for humans is unknown. 
Potencialna nevarnost za človeka ni znana.
Submission of the protocol by 31 March 
Predložitev protokola do 31. marca 2015
The study protocol, including key aspects of the DMC charter, has to be agreed before initiation of the study. 
O protokolu študije, vključno z bistvenimi vidiki listine DMC, se je treba dogovoriti pred začetkom študije.
Changes in mean blood pressure are described in Section 4.4. 
Spremembe povprečnega krvnega tlaka so opisane v poglavju 4.4.
These symptoms may resemble serum sickness. 
Ti simptomi so lahko podobni serumski bolezni.
Someone who has had a fit may be confused afterwards and may not remember what has happened. 
Oseba, pri kateri so se pojavili krči, je lahko po tem zmedena in se ne spomni, kaj se je zgodilo.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 March 2015 
Datum prve odobritve: 26 marec 2015
• medicines used to prevent malaria; 
• zdravila, ki se uporabljajo za preprečevanje malarije;
The study is to be monitored regularly by a Data Monitoring Committee (DMC). 
Študijo mora redno nadzorovati odbor za spremljanje podatkov
Effect on body composition 
Učinki na sestavo telesa
Food effect: 
Vpliv hrane:
• if you have had a serious head injury or head trauma; 
• če ste imeli hudo poškodbo ali travmo glave;
(see sections 4.2 and 5.2). 
(glejte poglavji 4.7 in 4.8).
** The incidence of seizures is approximately 0.1% (1/1,000). 
** Pojavnost epileptičnih napadov znaša približno 0,1 % (1/1.000).
If you do drink a lot now, do not just stop suddenly, because that may put you at risk of having a fit. 
Če zdaj zaužijete veliko alkohola, ne prenehajte kar naenkrat, saj se s tem pojavi tveganje za krče.
• medicines for depression and other mental health problems; 
• zdravila za zdravljenje depresije in drugih duševnih težav;
Bupropion is indicated for the treatment of depression in some countries. 
Bupropion je v nekaterih državah indiciran za zdravljenje depresije.
28-Week Data 
28-tedenski podatki
Suite 2 Stafford House, Strand Road, Portmarnock, Co. Dublin, Ireland 
Suite 2 Stafford House, Strand Road, Portmarnock, Co. Dublin, Irska
Patients who did not meet the early response criterion were not found to have increased tolerability or safety issues relative to patients who did have a favourable early response. 
Pri bolnikih, ki niso izpolnjevali merila zgodnjega odziva, niso ugotovili večje tolerance ali težav glede varnosti v primerjavi z bolniki, ki so imeli ugoden zgodnji odziv.
Your doctor may carry out a blood test to ensure that your body has cleared these medicines before starting your treatment. 
Zdravnik bo morda opravil krvni test, da se prepriča, da je vaše telo izločilo ta zdravila pred začetkom zdravljenja.
56-Week Data 
56-tedenski podatki
Do not delay, contact your doctor or your nearest hospital emergency department immediately. 
Ne čakajte, temveč se nemudoma obrnite na svojega zdravnika ali oddelek za nujno pomoč v najbližji bolnišnici.
Activated charcoal should be administered. 
Uporabiti je treba aktivno oglje.
Cardiac rhythm and vital signs should be monitored. 
Spremljati je treba srčni ritem in vitalne znake.
The dose will be gradually adapted as follows: 
Odmerek se prilagaja postopoma:
• you have a history of mania (feeling elated or over-excited, which causes unusual behaviour). 
• če ste že imeli manijo (občutek vznesenosti ali prekomernega razburjenja, ki povzroči neobičajno vedenje).
An adequate airway, oxygenation, and ventilation should be ensured. 
Zagotoviti je treba ustrezno stanje dihalnih poti, oksigenacijo in ventilacijo.
EEG monitoring is also recommended for the first 48 hours post-ingestion. 
V prvih 48 urah po zaužitju se priporoča tudi spremljanje zapisov EEG.
Mouse and rat studies confirm the absence of carcinogenicity in these species. 
Študije na miših in podganah potrjujejo odsotnost kancerogenih učinkov pri teh vrstah.
Similarly, efavirenz 600 mg once daily for two weeks reduced the exposure of bupropion by approximately 55% in healthy volunteers. 
Podobno se je z uporabo efavirenza 600 mg enkrat dnevno dva tedna zmanjšala izpostavljenost bupropiona pri zdravih prostovoljcih za približno 55 %.
Your doctor will closely monitor you for side effects and/or may need to adjust the dose of the other medicines or Mysimba. 
Zdravnik vas bo natančno spremljal zaradi neželenih učinkov in/ali bo morda prilagodil odmerek drugih zdravil ali zdravila Mysimba.
Upon initiating treatment, the dose should be escalated over a 4-week period as follows: 
Ob uvedbi zdravljenja je treba odmerek stopnjevati v 4-tedenskem obdobju:
Events were generally self-limited; the majority of events resolved within 4 weeks and almost all resolved by Week 24. 
Dogodki so večinoma minili sami od sebe; večina dogodkov je minila v roku 4 tednov, skoraj vsi pa so minili do 24. tedna.
- Coldness of extremities (hands, feet) 
- hladne okončine (dlani, stopala).
The enzyme responsible for the main elimination pathway is not known. 
Encim, ki je odgovoren za glavno pot izločanja, ni znan.
Pack sizes: 28, 112 tablets. 
Velikost pakiranja: 28, 112 tablet.
The need for continued treatment should be evaluated after 16 weeks (see section 4.1) and reevaluated annually. 
Po 16 tednih je treba oceniti, ali je potrebno nadaljnje zdravljenje (glejte poglavje 4.1), nato pa je treba vsako leto to ponovno oceniti.
No dosage adjustment is necessary based on gender or race. 
Odmerkov ni treba prilagajati glede na spol ali raso.
Based on studies in animals, it is recommended that seizures be treated with intravenous benzodiazepine administration and other supportive measures, as appropriate. 
Na podlagi študij na živalih je priporočeno, da se epileptični napadi zdravijo z intravenskim dajanjem benzodiazepina in drugimi podpornimi ukrepi, kot je to ustrezno.
Results are based on last-observation-carriedforward (LOCF). 
Rezultati temeljijo na metodi prenosa zadnjega opazovanja naprej (LOCF).
Electrocardiogram change (N) 
Pogosti spremembe v elektrokardiogramu (N)
• if you are taking medicines that may increase the risk of fits (see “Other medicines and 
• če jemljete zdravila, ki lahko povečajo tveganje za krče (glejte “Druga zdravila in zdravilo
The tablets should be swallowed whole with some water. 
Cele tablete je treba pogoltniti s požirkom vode.
• if you regularly drink alcohol (see “Mysimba with alcohol”); 
• če redno uživate alkohol (glejte “Zdravilo Mysimba skupaj z alkoholom”);
Uncommon Oral herpes (N), Tinea pedis (N) 
Občasni ustni herpes (N), tinea pedis (N)
Tell your doctor if you are taking any of the following medicines, as your doctor will closely monitor you for side effects: 
Obvestite svojega zdravnika, če jemljete katero koli izmed naslednjih zdravil, kajti zdravnik vas bo natančno spremljal zaradi neželenih učinkov:
HbA1c, % Not applicable 
HbA1c, % Ni podatka.
Treatment was initiated with a dose escalation period. 
Zdravljenje je bilo uvedeno z obdobjem povečevanja odmerkov.
You may need to take Mysimba for at least 16 weeks to have its full effect. 
Zdravilo Mysimba boste morali jemati vsaj 16 tednov, da boste dosegli poln učinek.
The clinical relevance of these equivocal findings is unknown. 
Klinični pomen teh dvoumnih ugotovitev ni znan.