FrancophonIA/ELRC3.0 huggingface dataset:
English: • One mL Iblias 3000 IU contains approximately 600 IU (3000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Slovenian: • 1 ml zdravila Iblias 3000 i.e. vsebuje približno 600 i.e. (3000 i.e./5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa) po rekonstituciji z vodo za injekcije.
English: 28 IU/kg 39 IU/kg)
Slovenian: 28 i.e./kg 39 i.e./kg)
English: 31 IU/kg 49 IU/kg)
Slovenian: 31 i.e./kg 49 i.e./kg)
English: • One mL Iblias 1000 IU contains approximately 400 IU (1000 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Slovenian: • 1 ml zdravila Iblias 1000 i.e. vsebuje približno 400 i.e. (1000 i.e./2,5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa) po rekonstituciji z vodo za injekcije.
English: 30 IU/kg 34 IU/kg)
Slovenian: 30 i.e./kg 34 i.e./kg)
English: 32 IU/kg 58 IU/kg)
Slovenian: 32 i.e./kg 58 i.e./kg)
English: • One mL Iblias 2000 IU contains approximately 400 IU (2000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Slovenian: • 1 ml zdravila Iblias 2000 i.e. vsebuje približno 400 i.e. (2000 i.e./5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa) po rekonstituciji z vodo za injekcije.
English: 31 IU/kg 43 IU/kg)
Slovenian: 31 i.e./kg 43 i.e./kg)
English: 31 IU/kg 72 IU/kg)
Slovenian: 39 i.e./kg 72 i.e./kg)
English: • nausea
Slovenian: • nespečnost
English: • where the bleed is and how serious it is
Slovenian: • mesto in obseg krvavitve
English: If you store this medicine at ambient room temperature it expires after 12 months or at the expiry date if this is earlier.
Slovenian: V tem primeru se rok uporabnosti zdravila izteče ob koncu 12-mesečnega obdobja ali z datumom izteka roka uporabnosti, odvisno kaj nastopi prej.
English: Headache, dizziness common
Slovenian: Bolezni živčevja glavobol, omotica pogosti disgevzija občasni
English: Cardiac disorders
Slovenian: • hiter srčni utrip
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size EU/1/08/499/002 Valdoxan
Slovenian: Jakost Farmacevtska oblika Pot uporabe
English: The specific indication approved.
Slovenian: ¾ Odobrena specifična indikacija.
English: Patient Card
Slovenian: Kartica za bolnike
English: • Prior to launch of the product in the Member State, the national competent authority shall agree the content and format of the educational material with the Marketing Authorisation Holder
Slovenian: • Pred uvajanjem zdravila na tržišče vsake države članice se pristojni organi države članice dogovorijo glede vsebine in oblike izobraževalnega gradiva z imetnikom dovoljenja za promet z zdravilom.
English: That patients should tell their doctor if they are taking any other medicines.
Slovenian: Bolniki morajo svojemu zdravniku povedati, če jemljejo katerakoli druga zdravila.
English: The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented in their national territory:
Slovenian: Države članice morajo zagotoviti, da se vsi spodaj opisani pogoji ali omejitve glede varne in učinkovite uporabe zdravila uveljavijo na njihovem državnem ozemlju:
English: The need to inform patients about the risks of Daxas and the precautions for safe use.
Slovenian: ¾ Obveznost informiranja bolnikov o tveganjih zdravila Daxas in previdnostnih ukrepih za varno uporabo.
English: The lack of clinical data to support the combination with theophylline and that such combination is not recommended.
Slovenian: ¾ Pomanjkanje kliničnih podatkov, ki bi podpirali kombinacijo s teofilinom, zato takšna kombinacija ni priporočljiva.
English: The limited experience in patients with latent infections such as tuberculosis, viral hepatitis or herpes infections.
Slovenian: Omejene izkušnje pri bolnikih z latentnimi okužbami, npr. tuberkulozo, virusnim hepatitisom ali herpetičnimi okužbami
English: The potential risk of malignant tumours and the lack of experience in patients with past history of cancer.
Slovenian: ¾ Potencialno tveganje za maligne tumorje in pomanjkanje izkušenj pri bolnikih z anamnezo raka v preteklosti.
English: Daxas is not recommended in patients with a history of depression associated with suicidal ideation or behaviour.
Slovenian: Daxas ni priporočljiv za bolnike z anamnezo depresije, ki je bila povezana s samomorilnimi mislimi ali vedenjem.
English: Daxas is contraindicated in patients with moderate or severe liver impairment (Child Pugh B or C).
Slovenian: Daxas je kontraindiciran pri bolnikih z zmerno ali hudo okvaro jeter (Child Pugh B ali C).
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: DODATEK POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI BO UVEDENO V DRŽAVAH ČLANICAH
English: Hence, the need to carefully assess the benefit risk balance of this treatment in patients with existing psychiatric symptoms or with history of depression and to inform patients to report any changes in behaviour, mood and any suicidal ideation.
Slovenian: Zato potreba po skrbnem pretehtanju koristi in tveganja ob zdravljenju bolnikov s prisotnimi psihiatričnimi simptomi ali z anamnezo depresije ter potreba po informiranju bolnikov, naj sporočijo kakršnekoli spremembe v vedenju, razpoloženju ali kakršnekoli samomorilne misli.
English: That they should tell their doctor if they have a history of any of the following conditions
Slovenian: Da opozorijo zdravnika, če imajo v anamnezi katerokoli od naslednjih stanj
English: The patient card should include an area where patients can record their weight and the date they weighed themselves and they should be asked to bring the patient card with them at each visit.
Slovenian: Kartica za bolnike mora vsebovati prostor, kamor bolniki lahko zabeležijo svojo telesno maso in datum tehtanja, bolnikom pa je treba naročiti, da kartico za bolnike ob vsakem obisku prinesejo s seboj.
English: The fact that Daxas is not indicated for the treatment of COPD patients other than those covered by the approved indication, nor for use in patients with asthma or alpha 1 anti trypsine deficiency.
Slovenian: Dejstvo, da zdravilo Daxas ni indicirano za zdravljenje bolnikov s KOPB, razen tistih, ki ustrezajo odobreni indikaciji, ni primeren za uporabo pri bolnikih z astmo ali pomanjkanjem alfa-1-antitripsina.
English: The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g. multiple sclerosis, lupus erythematous, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Daxas should not be initiated or should be stopped in these patients.
Slovenian: ¾ Pomanjkanje izkušenj pri bolnikih z okužbo HIV ali aktivnim hepatitisom, z resnimi imunološkimi boleznimi (npr. multiplo sklerozo, eritematoznim lupusom, multifokalno leukoencefalopatijo) ali na zdravljenju z imunosupresivnimi zdravili (razen kratkotrajnega zdravljenja s sistemskimi kortikosteroidi) in zdravila Daxas se pri teh bolnikih ne sme uvajati oz. ga je treba ukiniti.
English: The risk of weight decrease in underweight patients and the need to monitor the body weight at each visit and to stop the treatment in the event of an unexplained and clinically concerning weight decrease.
Slovenian: ¾ Tveganje za zmanjšanje telesne mase pri podhranjenih bolnikih, potreba po spremljanju telesne mase ob vsakem obisku in potreba po prekinitvi zdravljenja v primeru nepojasnjenega ali klinično zaskrbljujočega zmanjšanja telesne mase.
English: The potential cardiac risk: Daxas has not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.
Slovenian: ¾ Potencialno tveganje za srce: zdravilo Daxas ni bilo raziskano pri bolnikih s kongestivnim srčnim popuščanjem (NYHA stopnje 3 in 4); za to populacijo ni priporočljiv.
English: • The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Daxas are provided with an Educational pack.
Slovenian: • Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo imeli ob uvajanju vsi zdravniki, ki bodo predpisovali zdravilo Daxas, na razpolago izobraževalno gradivo.
English: The patient card should contain the following key elements:
Slovenian: Kartica za bolnike mora vsebovati naslednje ključne informacije:
English: • Copies of the patient card to be given to patients before they receive Daxas
Slovenian: • Kopije kartic za bolnike, ki naj bi jih bolniki prejeli pred začetkom jemanja zdravila Daxas
English: Daxas should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma).
Slovenian: Zdravila Daxas se ne sme uvajati oz. ga je treba ukiniti pri bolnikih z rakom (z izjemo bazalnoceličnega karcinoma).
English: The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daxas and the potential risk of suicide.
Slovenian: ¾ Tveganje za psihiatrične motnje, npr. nespečnost, tesnobo, depresijo, pri bolnikih, ki jemljejo zdravilo Daxas in potencialno tveganje za samomor.
English: The limited or missing information in patients with liver impairment.
Slovenian: ¾ Omejene ali pomanjkljive informacije o bolnikih z okvaro jeter.
English: The potential risk of infections: Daxas should not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
Slovenian: ¾ Potencialno tveganje za okužbe: zdravila Daxas se ne sme uvajati oz. zdravljenje je treba prekiniti pri bolnikih z resnimi oblikami akutnih infekcijskih bolezni.
English: That Daxas may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Slovenian: Da zdravilo Daxas lahko povzroči izgubo telesne mase in, da se morajo redno tehtati ter beležiti svojo telesno maso na kartico za bolnike.
English: Clinical data are considered insufficient to recommend dose adjustment and caution should be observed in patients with mild liver impairment (child Pugh A).
Slovenian: Klinični podatki so nezadostni, da bi priporočali prilagajanje odmerkov, zato je pri bolnikih z blago okvaro jeter (Child Pugh A) potrebna previdnost.
English: • Summary of Product Characteristics and Patient Information Leaflet for Daxas
Slovenian: • Povzetek glavnih značilnosti zdravila in Navodilo za uporabo zdravila Daxas
English: 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)
Slovenian: o Bolniki, sočasno zdravljeni z zaviralci CYP1A2 (npr. s fluvoksaminom) ali z dvojnimi zaviralci CYP3A4/1A2 (npr. z enoksacinom in cimetidinom).
English: That patients should tell their doctor if they develop symptoms indicative of:
Slovenian: • okužba s tuberkulozo, herpesom, hepatitisom, HIV Da morajo obvestiti svojega zdravnika, če opazijo simptome, ki so značilni za:
English: • infection with tuberculosis, herpes, hepatitis, HIV
Slovenian: • nespečnost, tesnobo, depresijo, samomorilne misli ali vedenje
English: A typical dose will range from 7.5 mg (3.75 ml) to 25 mg (12.5 ml) once a week.
Slovenian: Običajni odmerek znaša od 7,5 mg (3,75 ml) do 25 mg (12,5 ml) enkrat tedensko.
English: 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
Slovenian: 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
English: • If you have any questions about your treatment, speak to your doctor, nurse or pharmacist.
Slovenian: • Če imate kakršna koli vprašanja glede zdravljenja, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: Any mistakes in measuring the dose could lead to patients receiving too much or too little of the medicine potentially with serious consequences.
Slovenian: Vsaka napaka pri odmerjanju lahko pomeni, da bolniki prejmejo preveč ali premalo zdravila, kar ima lahko možne resne posledice.
English: • If you have any signs or symptoms of overdose contact your doctor immediately.
Slovenian: • Če imate kakršne koli znake ali simptome prevelikega odmerka, takoj obvestite svojega zdravnika.
English: You should follow your healthcare professional's instructions.
Slovenian: Upoštevajte navodila zdravstvenega delavca.
English: Guidance on the amount to withdraw for the different doses in mg is given in the table below:
Slovenian: Navodilo glede količine za različne odmerke v mg je navedeno v spodnji tabeli:
English: • Your doctor, nurse or pharmacist will explain you how to withdraw the required dose using the syringe provided.
Slovenian: • Vaš zdravnik, medicinska sestra ali farmacevt vam bo pojasnil, kako vzeti ustrezen odmerek z uporabo priložene brizge.
English: 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.
Slovenian: 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.
English: • Jylamvo (methotrexate 2mg/ml)
Slovenian: • Jylamvo (metotreksat 2 mg/ml)
English: Jylamvo is a medicine that is used for the treatment of the following inflammatory conditions:
Slovenian: Jylamvo je zdravilo, ki se uporablja za zdravljenje naslednjih vnetnih stanj:
English: The syringe is graduated in ml while the dose is expressed in mg.
Slovenian: Brizga je graduirana v ml, medtem ko je odmerek izražen v mg.
English: • Healthcare professionals should assess each patient to determine whether they are able to measure the dose correctly.
Slovenian: • Zdravstveni delavci morajo oceniti vsakega bolnika, da določijo, ali so zmožni pravilno odmeriti odmerek.
English: Healthcare professionals expected to prescribe and dispense Jylamvo will be given an educational guide to ensure that the medicine is used correctly.
Slovenian: Zdravstveni delavci, za katere se pričakuje, da bodo predpisovali ali izdajali zdravilo Jylamvo, bodo prejeli izobraževalno brošuro za zagotovitev pravilne uporabe zdravila.
English: Only for ALL, the medicine can be taken more frequently.
Slovenian: Zdravilo se lahko jemlje pogosteje samo za zdravljenje ALL.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom29 March 2017 EMA/81869/2017
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Only after such an assessment should patients start to self-administer Jylamvo at home.
Slovenian: Šele po njihovi odobritvi si lahko bolniki zdravilo Jylamvo začnejo dajati sami doma.
English: When prescribing Jylamvo, doctors should always prescribe the dose in mg and ml.
Slovenian: Pri predpisovanju zdravila morajo zdravniki vedno predpisati odmerek v mg in ml.
English: It is also important that patients are carefully instructed on how to withdraw a dose from the bottle using the syringe provided.
Slovenian: Pomembno je, da bolniki prejmejo natančna navodila, kako vzeti odmerek iz stekleničke z uporabo priložene brizge.
English: 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.
Slovenian: 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.
English: • severe juvenile idiopathic arthritis (JIA), a joint disease in children;
Slovenian: • hudega juvenilnega idiopatičnega artritisa (JIA), bolezni sklepov pri otrocih;
English: • For acute lymphoblastic leukaemia (ALL), the dose is usually higher and you may need to take Jylamvo more frequently.
Slovenian: • Za zdravljenje akutne limfoblastne levkemije (ALL) je odmerek običajno višji in zdravilo Jylamvo boste morda morali jemati bolj pogosto.
English: • An oral syringe is provided with Jylamvo and it is important that only this syringe is used to withdraw the dose.
Slovenian: • Zdravilu Jylamvo je priložena peroralna brizga in pomembno je, da se za jemanje odmerka uporablja samo ta brizga.
English: • 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.
Slovenian: • 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.
English: Dose in mg 5 mg
Slovenian: Odmerek v mg
English: • With every prescription patients should be reminded on how to measure the dose correctly.
Slovenian: • Pri izdaji vsakega recepta je treba bolnike opomniti, kako pravilno odmeriti odmerek.
English: • 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.
Slovenian: • 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.
English: 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.
Slovenian: 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.
English: • For arthritis and skin diseases, Jylamvo must be taken once a week only, on the same day each week.
Slovenian: • Za zdravljenje artritisa in kožnih bolezni je treba Jylamvo jemati samo enkrat tedensko in vedno na isti dan v tednu.
English: Healthcare professionals should carefully explain to patients when and how to take their dose
Slovenian: Zdravstveni delavci morajo bolnikom natančno pojasniti, kdaj in kako naj vzamejo odmerek
English: Amount in ml to be withdrawn
Slovenian: Količina, ki jo je treba vzeti, v ml
English: 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).
Slovenian: 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).
English: It is important that healthcare professionals carefully explain to patients when and how they should take their dose.
Slovenian: Pomembno je, da zdravstveni delavci bolnikom natančno pojasnijo, kako in kdaj naj vzamejo odmerek.
English: • severe disabling psoriasis, a disease causing red, scaly patches on the skin.
Slovenian: • hude neodzivne psoriaze, bolezni, ki povzroča nastajanje rdečih, luskastih zaplat na koži;
English: Methotrexate is never taken every day for arthritis or skin diseases.
Slovenian: Za zdravljenje artritisa in kožnih bolezni se metotreksata nikoli ne jemlje vsak dan.
English: • severe psoriatic arthritis, an inflammatory joint disease that occurs in patients with psoriasis.
Slovenian: • hudega psoriatičnega artritisa, vnetne bolezni sklepov, ki se pojavlja pri bolnikih s psoriazo.
English: • active rheumatoid arthritis, an inflammatory joint disease;
Slovenian: • aktivnega revmatoidnega artritisa, vnetne bolezni sklepov;
English: The educational guide will advise healthcare professionals that for arthritis and psoriasis Jylamvo must be taken once a week.
Slovenian: V izobraževalni brošuri za zdravstvene delavce bo navedeno, da je treba za zdravljenje artritisa in psoriaze zdravilo Jylamvo jemati enkrat tedensko.
English: • Jylamvo is available as an oral solution that contains 2 mg/ml of methotrexate.
Slovenian: • Zdravilo Jylamvo je na voljo v obliki peroralne raztopine, ki vsebuje 2 mg/ml metotreksata.
English: Only use the syringe provided with Jylamvo to withdraw your dose.
Slovenian: Za jemanje odmerka uporabljajte samo brizgo, ki je priložena zdravilu Jylamvo.
English: • Jylamvo is available as an oral solution that contains 2 mg of methotrexate per ml.
Slovenian: • Zdravilo Jylamvo je na voljo v obliki peroralne raztopine, ki vsebuje 2 mg metotreksata na mililiter.
English: For acute lymphoblastic leukaemia (ALL), the dose is usually higher and given more frequently.
Slovenian: 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.
English: 29 May 2013 EMA/402567/2013 - Rev 1
Slovenian: 29. maj 2013 EMA/402567/2013 - Rev 1
English: 65 cases of SJS and TEN were reported.
Slovenian: Poročali so o 65 primerih SJS in TEN.
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Slovenian: Tel.: +44 (0)20 7418 8427 E-naslov: press@ema.europa.eu
English: Contact our press officers Monika Benstetter or Martin Harvey Allchurch
Slovenian: Obrnite se na naše tiskovne predstavnike Monika Benstetter ali Martin Harvey Allchurch
English: Your doctor may also consider an appropriate alternative treatment for you.
Slovenian: Vaš zdravnik bo morda razmislil o ustreznem nadomestnem zdravljenju za vas.
English: 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.
Slovenian: 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.
English: They are unpredictable and can occur at any stage during treatment, including after short-term treatment, and at recommended doses.
Slovenian: Te reakcije so nepredvidljive in se lahko pojavijo v kateri koli fazi zdravljenja, vključno s kratkotrajnim zdravljenjem, in pri zdravljenju s priporočenimi odmerki.
English: • 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.
Slovenian: • Ob upoštevanju neugodnega razmerja med tveganji in koristmi morajo zdravniki ob naslednjem obisku preveriti zdravljenje svojih bolnikov in morda razmisliti o ustreznem nadomestnem zdravljenju.
English: GABA decreases the excitability of many brain cells.
Slovenian: GABA zmanjšuje vzdraženost mnogih možganskih celic.
English: 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,
Slovenian: 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.