natgillin/translations-raw huggingface dataset:
The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daxas and the potential risk of suicide.
¾ Tveganje za psihiatrične motnje, npr. nespečnost, tesnobo, depresijo, pri bolnikih, ki jemljejo zdravilo Daxas in potencialno tveganje za samomor.
The limited or missing information in patients with liver impairment.
¾ Omejene ali pomanjkljive informacije o bolnikih z okvaro jeter.
The potential risk of infections: Daxas should not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
¾ Potencialno tveganje za okužbe: zdravila Daxas se ne sme uvajati oz. zdravljenje je treba prekiniti pri bolnikih z resnimi oblikami akutnih infekcijskih bolezni.
That Daxas may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Da zdravilo Daxas lahko povzroči izgubo telesne mase in, da se morajo redno tehtati ter beležiti svojo telesno maso na kartico za bolnike.
Clinical data are considered insufficient to recommend dose adjustment and caution should be observed in patients with mild liver impairment (child Pugh A).
Klinični podatki so nezadostni, da bi priporočali prilagajanje odmerkov, zato je pri bolnikih z blago okvaro jeter (Child Pugh A) potrebna previdnost.
• Summary of Product Characteristics and Patient Information Leaflet for Daxas
• Povzetek glavnih značilnosti zdravila in Navodilo za uporabo zdravila Daxas
That increased exposure might occur in certain populations and increase the risk of persistent intolerability: o Special populations who have increased PDE4 inhibition such as black non smoking females o Patients concomitantly treated with CYP1A2 inhibitors (such as fluvoxamine) or dual CYP3A4/1A2 inhibitors (such as enoxacin and cimetidine)
o Bolniki, sočasno zdravljeni z zaviralci CYP1A2 (npr. s fluvoksaminom) ali z dvojnimi zaviralci CYP3A4/1A2 (npr. z enoksacinom in cimetidinom).
That patients should tell their doctor if they develop symptoms indicative of:
• okužba s tuberkulozo, herpesom, hepatitisom, HIV Da morajo obvestiti svojega zdravnika, če opazijo simptome, ki so značilni za:
• infection with tuberculosis, herpes, hepatitis, HIV
• nespečnost, tesnobo, depresijo, samomorilne misli ali vedenje
A typical dose will range from 7.5 mg (3.75 ml) to 25 mg (12.5 ml) once a week.
Običajni odmerek znaša od 7,5 mg (3,75 ml) do 25 mg (12,5 ml) enkrat tedensko.
More information about Jylamvo can be found on the Agency's website: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003756/human_ med_002083.jsp
Več informacij o zdravilu Jylamvo je na voljo na spletni strani agencije: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003756/ human_med_002083.jsp
• If you have any questions about your treatment, speak to your doctor, nurse or pharmacist.
• Če imate kakršna koli vprašanja glede zdravljenja, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
Any mistakes in measuring the dose could lead to patients receiving too much or too little of the medicine potentially with serious consequences.
Vsaka napaka pri odmerjanju lahko pomeni, da bolniki prejmejo preveč ali premalo zdravila, kar ima lahko možne resne posledice.
• If you have any signs or symptoms of overdose contact your doctor immediately.
• Če imate kakršne koli znake ali simptome prevelikega odmerka, takoj obvestite svojega zdravnika.
You should follow your healthcare professional's instructions.
Upoštevajte navodila zdravstvenega delavca.
Guidance on the amount to withdraw for the different doses in mg is given in the table below:
Navodilo glede količine za različne odmerke v mg je navedeno v spodnji tabeli:
• Your doctor, nurse or pharmacist will explain you how to withdraw the required dose using the syringe provided.
• Vaš zdravnik, medicinska sestra ali farmacevt vam bo pojasnil, kako vzeti ustrezen odmerek z uporabo priložene brizge.
If the medicine is used for psoriasis or arthritis and is inadvertently taken once a day instead of once a week, this could lead to serious harm.
Če se zdravilo uporablja za zdravljenje psoriaze ali artritisa in se ga nehote vzame enkrat dnevno namesto enkrat tedensko, to lahko vodi do resnih negativnih posledic.
• Jylamvo (methotrexate 2mg/ml)
• Jylamvo (metotreksat 2 mg/ml)
Jylamvo is a medicine that is used for the treatment of the following inflammatory conditions:
Jylamvo je zdravilo, ki se uporablja za zdravljenje naslednjih vnetnih stanj:
The syringe is graduated in ml while the dose is expressed in mg.
Brizga je graduirana v ml, medtem ko je odmerek izražen v mg.
• Healthcare professionals should assess each patient to determine whether they are able to measure the dose correctly.
• Zdravstveni delavci morajo oceniti vsakega bolnika, da določijo, ali so zmožni pravilno odmeriti odmerek.
Healthcare professionals expected to prescribe and dispense Jylamvo will be given an educational guide to ensure that the medicine is used correctly.
Zdravstveni delavci, za katere se pričakuje, da bodo predpisovali ali izdajali zdravilo Jylamvo, bodo prejeli izobraževalno brošuro za zagotovitev pravilne uporabe zdravila.
Only for ALL, the medicine can be taken more frequently.
Zdravilo se lahko jemlje pogosteje samo za zdravljenje ALL.
Only after such an assessment should patients start to self-administer Jylamvo at home.
Šele po njihovi odobritvi si lahko bolniki zdravilo Jylamvo začnejo dajati sami doma.
When prescribing Jylamvo, doctors should always prescribe the dose in mg and ml.
Pri predpisovanju zdravila morajo zdravniki vedno predpisati odmerek v mg in ml.
It is also important that patients are carefully instructed on how to withdraw a dose from the bottle using the syringe provided.
Pomembno je, da bolniki prejmejo natančna navodila, kako vzeti odmerek iz stekleničke z uporabo priložene brizge.
Jylamvo is also used to treat adults and children over the age of 3 years who have acute lymphoblastic leukaemia (ALL), a cancer of white blood cells called lymphoblasts.
Zdravilo Jylamvo se prav tako uporablja za zdravljenje odraslih in otrok, starejših od treh let, ki imajo akutno limfoblastno levkemijo (ALL), raka belih krvnih celic, imenovanih limfoblasti.
• severe juvenile idiopathic arthritis (JIA), a joint disease in children;
• hudega juvenilnega idiopatičnega artritisa (JIA), bolezni sklepov pri otrocih;
• For acute lymphoblastic leukaemia (ALL), the dose is usually higher and you may need to take Jylamvo more frequently.
• Za zdravljenje akutne limfoblastne levkemije (ALL) je odmerek običajno višji in zdravilo Jylamvo boste morda morali jemati bolj pogosto.
• An oral syringe is provided with Jylamvo and it is important that only this syringe is used to withdraw the dose.
• Zdravilu Jylamvo je priložena peroralna brizga in pomembno je, da se za jemanje odmerka uporablja samo ta brizga.
• Patients should be monitored for signs and symptoms of overdose, such as bleeding, unusual feeling of weakness, ulcers in the mouth, feeling sick, vomiting, black or bloody stools, coughing up blood or vomiting blood and reduced urine output.
• Bolnike je treba spremljati zaradi pojava znakov in simptomov prevelikega odmerka, kot so krvavitve, nenavaden občutek šibkosti, razjede v ustih, siljenje na bruhanje, bruhanje, črno ali krvavo blato, izkašljevanje krvi ali bruhanje krvi in zmanjšano izločanje urina.
Dose in mg 5 mg
Odmerek v mg
• With every prescription patients should be reminded on how to measure the dose correctly.
• Pri izdaji vsakega recepta je treba bolnike opomniti, kako pravilno odmeriti odmerek.
• Patients should be counselled on taking the correct dose correctly: for arthritis and psoriasis, Jylamvo must be taken once a week only, on the same day each week.
• Bolnikom je treba svetovati glede pravilnega jemanja pravilnega odmerka: za zdravljenje artritisa in psoriaze je treba zdravilo Jylamvo jemati samo enkrat tedensko, vedno na isti dan v tednu.
These include: bleeding, unusual feeling of weakness, ulcers in the mouth, feeling sick, vomiting, black or bloody stools, coughing up blood or vomiting blood and a reduced urine production.
Te vključujejo: krvavitve, nenavaden občutek šibkosti, razjede v ustih, siljenje na bruhanje, bruhanje, črno ali krvavo blato, izkašljevanje krvi ali bruhanje krvi in zmanjšano tvorbo urina.
• For arthritis and skin diseases, Jylamvo must be taken once a week only, on the same day each week.
• Za zdravljenje artritisa in kožnih bolezni je treba Jylamvo jemati samo enkrat tedensko in vedno na isti dan v tednu.
Healthcare professionals should carefully explain to patients when and how to take their dose
Zdravstveni delavci morajo bolnikom natančno pojasniti, kdaj in kako naj vzamejo odmerek
Amount in ml to be withdrawn
Količina, ki jo je treba vzeti, v ml
Jylamvo, an oral solution containing methotrexate, is used to treat arthritis and the skin disease psoriasis, as well as a type of blood cancer called acute lymphoblastic leukaemia (ALL).
Zdravilo Jylamvo, peroralna raztopina, ki vsebuje metotreksat, se uporablja za zdravljenje artritisa in kožne bolezni psoriaze ter vrste krvnega raka, imenovane akutna limfoblastna levkemija (ALL).
It is important that healthcare professionals carefully explain to patients when and how they should take their dose.
Pomembno je, da zdravstveni delavci bolnikom natančno pojasnijo, kako in kdaj naj vzamejo odmerek.
• severe disabling psoriasis, a disease causing red, scaly patches on the skin.
• hude neodzivne psoriaze, bolezni, ki povzroča nastajanje rdečih, luskastih zaplat na koži;
Methotrexate is never taken every day for arthritis or skin diseases.
Za zdravljenje artritisa in kožnih bolezni se metotreksata nikoli ne jemlje vsak dan.
• severe psoriatic arthritis, an inflammatory joint disease that occurs in patients with psoriasis.
• hudega psoriatičnega artritisa, vnetne bolezni sklepov, ki se pojavlja pri bolnikih s psoriazo.
• active rheumatoid arthritis, an inflammatory joint disease;
• aktivnega revmatoidnega artritisa, vnetne bolezni sklepov;
The educational guide will advise healthcare professionals that for arthritis and psoriasis Jylamvo must be taken once a week.
V izobraževalni brošuri za zdravstvene delavce bo navedeno, da je treba za zdravljenje artritisa in psoriaze zdravilo Jylamvo jemati enkrat tedensko.
• Jylamvo is available as an oral solution that contains 2 mg/ml of methotrexate.
• Zdravilo Jylamvo je na voljo v obliki peroralne raztopine, ki vsebuje 2 mg/ml metotreksata.
Only use the syringe provided with Jylamvo to withdraw your dose.
Za jemanje odmerka uporabljajte samo brizgo, ki je priložena zdravilu Jylamvo.
• Jylamvo is available as an oral solution that contains 2 mg of methotrexate per ml.
• Zdravilo Jylamvo je na voljo v obliki peroralne raztopine, ki vsebuje 2 mg metotreksata na mililiter.
For acute lymphoblastic leukaemia (ALL), the dose is usually higher and given more frequently.
Za zdravljenje artritisa in kožnih bolezni se metotreksata nikoli ne jemlje vsak dan. Za zdravljenje akutne limfoblastne levkemije (ALL) je odmerek običajno višji in se daje bolj pogosto.
29 May 2013 EMA/402567/2013 - Rev 1
29. maj 2013 EMA/402567/2013 - Rev 1
65 cases of SJS and TEN were reported.
Poročali so o 65 primerih SJS in TEN.
Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Tel.: +44 (0)20 7418 8427 E-naslov: press@ema.europa.eu
Contact our press officers Monika Benstetter or Martin Harvey Allchurch
Obrnite se na naše tiskovne predstavnike Monika Benstetter ali Martin Harvey Allchurch
Your doctor may also consider an appropriate alternative treatment for you.
Vaš zdravnik bo morda razmislil o ustreznem nadomestnem zdravljenju za vas.
The review of tetrazepam-containing medicines was initiated in January 2013 at the request of France, under Article 107i of Directive 2001/83/EC, also known as the urgent Union procedure.
Pregled zdravil, ki vsebujejo tetrazepam, se je začel januarja 2013 na zahtevo Francije, v skladu s členom 107i Direktive 2001/83/ES, znanim tudi kot nujni postopek Unije.
They are unpredictable and can occur at any stage during treatment, including after short-term treatment, and at recommended doses.
Te reakcije so nepredvidljive in se lahko pojavijo v kateri koli fazi zdravljenja, vključno s kratkotrajnim zdravljenjem, in pri zdravljenju s priporočenimi odmerki.
• In light of the unfavourable benefit-risk balance, doctors should review their patients' treatment at their next appointment, and may consider an appropriate alternative treatment.
• Ob upoštevanju neugodnega razmerja med tveganji in koristmi morajo zdravniki ob naslednjem obisku preveriti zdravljenje svojih bolnikov in morda razmisliti o ustreznem nadomestnem zdravljenju.
GABA decreases the excitability of many brain cells.
GABA zmanjšuje vzdraženost mnogih možganskih celic.
Tetrazepam-containing medicines have been approved since the 1960s via national procedures in several EU Member States (Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Latvia, Lithuania, Luxembourg, Poland, Romania, Slovakia and Spain), and are available on prescription under various trade names, including Epsipam, Miozepam, Musapam, Musaril, Myolastan, Myopam, Panos,
Zdravila, ki vsebujejo tetrazepam, so v več državah članicah EU odobrena od 60-ih let 20. stoletja na podlagi nacionalnih postopkov (v Avstriji, Belgiji, Bolgariji, Češki republiki, Franciji, Nemčiji, Latviji, Litvi, Luksemburgu, na Poljskem, v Romuniji, na Slovaškem in v Španiji) in se izdajajo na recept pod različnimi tržnimi imeni, vključno z imeni Epsipam, Miozepam, Musapam, Musaril, Myolastan, Myopam, Panos, Relaxam, Spasmorelax, Tetra-saar, Tetramdura in Tetraratio.
• Regarding its efficacy, four studies showed no difference between tetrazepam and other active medicines when used for spasticity.
• Glede učinkovitosti štiri študije niso pokazale nikakršne razlike med tetrazepamom in drugimi aktivnimi zdravili, ki so jih uporabljali proti spastičnosti.
• In the pharmacovigilance database of the originator product, Myolastan, a total of 513 cutaneous (or allergic) reactions were identified.
• V zbirki podatkov o farmakovigilanci originatorskega zdravila Myolastan so odkrili skupno 513 kožnih (ali alergijskih) reakcij.
You should make an appointment with your treating doctor to discuss your treatment.
Dogovorite se za obisk pri svojem lečečem zdravniku, da se boste dogovorili o zdravljenju.
Because the CMDh took this position by majority it was sent to the European Commission, which endorsed it and adopted a legally binding decision on 29 May 2013.
Ker je CMDh to stališče sprejela z večino, je bilo poslano Evropski Komisiji, ki ga je potrdila in dne 29. maja 2013 sprejela pravno zavezujočo odločbo.
The full list is available in Annex I on the EMA website, under the ‘All documents' tab.
Celoten seznam je na voljo v Prilogi I na spletni strani Evropske agencije za zdravila, v zavihku ‘All documents'.
The review was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Pregled je najprej opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC), torej odbor, ki je odgovoren za presojo varnostnih vprašanj o zdravilih za humano uporabo, in sestavil niz predlogov.
Tetrazepam belongs to a group of medicines called benzodiazepines.
Tetrazepam spada v skupino zdravil, imenovanih benzodiazepini.
• As a result of the risk of unpredictable, serious skin reactions identified, tetrazepam-containing medicines will no longer be available in the EU.
• Zaradi tveganja za ugotovljene nepredvidljive, resne kožne reakcije, zdravila, ki vsebujejo tetrazepam, v EU ne bodo več na voljo.
The suspension of the marketing authorisations can be lifted if the companies that market these medicines provide data identifying a specific group of patients for whom the benefits of tetrazepamcontaining medicines outweigh the risks.
Začasen umik dovoljenj za promet z zdravili je mogoče razveljaviti, če podjetja, ki tržijo ta zdravila, predložijo podatke, ki določajo specifično skupino bolnikov, pri katerih koristi zdravil, ki vsebujejo tetrazepam, odtehtajo z njimi povezana tveganja.
Although the majority of cases occurred in patients taking concomitant medications, the causal link with tetrazepam was strong in a high number of cases.
Čeprav je do večine teh primerov prišlo pri bolnikih, ki so sočasno jemali druga zdravila, je bila vzročna povezava s tetrazepamom v velikem številu primerov močna.
The review of tetrazepam was triggered by the French National Agency for the Safety of Medicine and Health Products (ANSM), following reports of serious skin reactions with this medicine in France.
Pregled tetrazepama je sprožila francoska nacionalna agencija za varnost zdravil in medicinskih pripomočkov (ANSM) zaradi poročil o resnih kožnih reakcijah ob uporabi tega zdravila v Franciji.
• The risk of skin reaction is higher with tetrazepam than with other benzodiazepines.
• Tveganje za kožne reakcije je pri tetrazepamu večje kot pri drugih benzodiazepinih.
• The review found that half of the reported reactions with tetrazepam are skin disorders, which are sometimes serious, life-threatening or fatal.
• Pri pregledu so ugotovili, da je polovica reakcij, o katerih so poročali pri uporabi tetrazepama, kožnih bolezni, ki so včasih resne, življenjsko nevarne ali smrtne.
This is possibly explained by a structural difference between tetrazepam and other benzodiazepines (i.e. the substituted cyclohexenyl ring of tetrazepam).
To je mogoče razložiti s strukturno razliko med tetrazepamom in drugimi benzodiazepini (torej s substituiranim cikloheksenilovim obročem tetrazepama).
The efficacy of tetrazepam for painful contractures is supported mainly by two small double-blind placebo-controlled clinical trials showing limited efficacy.
Učinkovitost tetrazepama za zdravljenje bolečih mišičnih krčev podpirata predvsem dve manjši dvojno slepi klinični preskušanji, nadzorovani s placebom, ki sta pokazali omejeno učinkovitost.
The CMDh agreed with the PRAC conclusion that the benefits of these medicines do not outweigh their risks, and adopted a final position that the marketing authorisations should be suspended throughout the EU.
CMDh se je strinjala s sklepom odbora PRAC, da koristi teh zdravil ne odtehtajo z njimi povezanih tveganj, ter sprejela dokončno stališče, da je treba dovoljenja za promet z zdravili po vsej Evropski uniji začasno umakniti.
Tetrazepam-containing medicines suspended across the EU
Zdravila, ki vsebujejo tetrazepam, začasno umaknjena v vsej EU
• Pharmacists should refer patients on a new or repeat prescription for tetrazepam to their treating physician.
• Farmacevti morajo bolnike, ki imajo nov ali obnovljiv recept za tetrazepam, napotiti k njihovim lečečim zdravnikom.
The Committee also noted that, in the light of the risks identified, the available data on the effectiveness of tetrazepam were not sufficiently robust to support its use in the authorised indications.
Odbor je opozoril tudi na to, da glede na ugotovljena tveganja razpoložljivi podatki o učinkovitosti tetrazepama niso dovolj zanesljivi, da bi lahko podprli uporabo zdravila za odobrene indikacije.
In particular, tetrazepam is used for its muscle relaxant effects.
Tetrazepam se zlasti uporablja zaradi svojih učinkov sproščanja mišic.
As tetrazepam-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Ker so vsa zdravil, ki vsebujejo tetrazepam, odobrena na nacionalni ravni, so bila priporočila odbora PRAC posredovana skupini za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončno stališče.
• If you are taking a tetrazepam-containing medicine, you should not suddenly stop taking tetrazepam without your doctor's advice.
• Če jemljete zdravila, ki vsebujejo tetrazepam, ne smete takoj prenehati z jemanjem tetrazepama, ne da bi se pred tem posvetovali z zdravnikom.
Having assessed all available data on the risk of skin reactions, including post-marketing data in the EU and the published literature, the PRAC concluded that tetrazepam is associated with a low but increased risk of serious skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS syndrome) compared with other benzodiazepines.
PRAC je po preučitvi vseh razpoložljivih podatkov o tveganju kožnih reakcij, vključno s podatki iz obdobja trženja v EU in iz objavljene literature, zaključil, da je tetrazepam povezan z nizkim, a povečanim tveganjem za resne kožne reakcije (vključno s Stevens-Johnsonovim sindromom, toksično epidermalno nekrolizo in sindromom DRESS) v primerjavi z drugimi benzodiazepini.
Serious skin reactions include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), erythema multiforme and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome.
Resne kožne reakcije vključujejo Stevens-Johnsonov sindrom (SJS), toksično epidermalno nekrolizo (TEN), multiformni eritem in kožni izpuščaj z eozinifilijo in sistematskimi simptomi (sindrom DRESS).
The CMDh position is based on the PRAC review of all available data on the risk of skin reactions with tetrazepam, including post-marketing data in the EU and the published literature, and the available information on efficacy in licensed indications:
Stališče CMDh temelji na pregledu vseh razpoložljivih podatkov o tveganju za kožne reakcije ob uporabi tetrazepama, ki ga je opravil odbor PRAC, vključno s podatki iz obdobja trženja v EU in iz objavljene literature, ter z razpoložljivimi informacijami o učinkovitosti pri indikacijah, za katere je zdravilo odobreno:
Benzodiazepines work by attaching to certain receptors in the brain, thereby increasing the activity of a substance called gamma-amino butyric acid (GABA).
Benzodiazepini delujejo tako, da se pritrdijo na določene receptorje v možganih in tako spodbujajo delovanje snovi, imenovane gama-aminomaslena kislina (GABA).
The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
CMDh, organ, ki zastopa države članice EU, je odgovoren za zagotavljanje usklajenih varnostnih standardov za zdravila, ki so bila odobrena prek nacionalnih postopkov v vsej Evropski uniji.
As the CMDh position was adopted by majority vote, the CMDh position was sent to the European Commission, which endorsed it and adopted an EU-wide legally binding decision.
Ker je bilo stališče CMDh sprejeto z večino glasov, je bilo poslano Evropski Komisiji, ki ga je potrdila in sprejela pravno zavezujočo odločbo, ki velja za celotno EU.
On 24 April 2013, following the recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh) endorsed by majority the PRAC recommendation to suspend the marketing authorisations of tetrazepam-containing medicines across the European Union (EU).
Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMDh) je po priporočilu Odbora za oceno tveganja na področju farmakovigilance (PRAC) dne 24. aprila 2013 z večino sprejela priporočilo PRAC, naj začasno umakne dovoljenja za promet z zdravili, ki vsebujejo tetrazepam, v vsej Evropski uniji (EU).
In view of the serious, potentially fatal, skin reactions and the limited efficacy of tetrazepam, the benefit-risk balance of tetrazepam-containing medicines is considered no longer favourable.
Zaradi resnih in potencialno smrtnih kožnih reakcij ter omejene učinkovitosti tetrazepama razmerja med tveganji in koristmi zdravil, ki vsebujejo tetrazepam, ni mogoče oceniti kot ugodnega.