natgillin/translations-raw huggingface dataset:
Kinzalmono may also be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Kinzalmono.
Zdravilo Kinzalmono lahko jemljete tudi v kombinaciji z diuretiki, kot je hidroklorotiazid, za katerega se je pokazalo, da pri sočasnem jemanju z zdravilom Kinzalmono dodatno znižuje krvni tlak.
Kinzalmono 20 mg tablets 3 years
Kinzalmono 20 mg tablete 3 leta
Such conditions should be corrected before the administration of Kinzalmono.
Tovrstna stanja moramo uravnati pred zdravljenjem z zdravilom Kinzalmono.
INFORMATION IN BRAILLE Kinzalmono 80 mg
PODATKI V BRAILLOVI PISAVI Kinzalmono 80 mg
Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Znano je, da izpostavljenost antagonistom angiotenzina II v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnij, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (ledvična odpoved, hipotenzija, hiperkaliemija) (glejte poglavje 5.3).
Volume and/or sodium depletion should be corrected prior to administration of Kinzalmono.
Pomanjkanje volumna ali natrija ali obe stanji moramo uravnati pred začetkom zdravljenja z zdravilom Kinzalmono.
The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal antiinflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
Tveganje je lahko povečano pri kombiniranem zdravljenju z drugimi zdravili, ki lahko povzročijo hiperkaliemijo (nadomestki soli s kalijem, diuretiki, ki zadržujejo kalij, zaviralci ACE, antagonisti receptorjev angiotenzina II, nesteroidna protivnetna zdravila (tudi selektivni zaviralci ciklooksigenaze 2), heparin, imunosupresivi (ciklosporin ali takrolimus) in trimetoprim).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister (28 x 1 tablets pack)
Pretisni omot za enkratni odmerek (28 x 1 tableta)
The overall incidence of adverse reactions reported with telmisartan (was usually comparable to placebo (41.4 % vs 43.9 %) in controlled trials in patients treated for hypertension.
V s placebom nadzorovanih kliničnih preskušanjih pri bolnikih, ki so se zdravili zaradi hipertenzije, je bila skupna pogostnost neželenih dogodkov podobna pri telmisartanu in placebu (41,4 % v primerjavi s 43,9 %).
Eye disorders: Rare:
Očesne bolezni Redki:
Kinzalmono 40 mg tablets White oblong tablets of 3.8 mm engraved with the code number '51H' on one side.
Bele, 3,8 mm podolgovate tablete z vtisnjeno kodno številko 51H na eni strani.
You must tell your doctor if you think you are (or might become) pregnant.
Obvestite zdravnika, če menite, da ste noseči ali načrtujete zanositev.
Kinzalmono 20 mg tablets EU/1/98/091/009 (14 tablets) EU/1/98/091/010 (28 tablets) EU/1/98/091/011 (56 tablets) EU/1/98/091/012 (98 tablets)
Kinzalmono 20 mg tablete EU/1/98/091/009 (14 tablet) EU/1/98/091/010 (28 tablet) EU/1/98/091/011 (56 tablet) EU/1/98/091/012 (98 tablet)
Kinzalmono is available in blister packs containing 14, 28, 56 or 98 tablets.
Zdravilo Kinzalmono je na voljo v pretisnih omotih po 14, 28, 56 ali 98 tablet.
There is no experience regarding the administration of Kinzalmono in patients with recent kidney transplantation.
Pri bolnikih z nedavno presajeno ledvico ni izkušenj z uporabo zdravila Kinzalmono.
Kinzalmono 40 mg tablets EU/1/98/091/001 (14 tablets) EU/1/98/091/002 (28 tablets) EU/1/98/091/003 (56 tablets) EU/1/98/091/004 (98 tablets) EU/1/98/091/013 (28 x 1 tablets)
Kinzalmono 40 mg tablete EU/1/98/091/001 (14 tablet) EU/1/98/091/002 (28 tablet) EU/1/98/091/003 (56 tablet) EU/1/98/091/004 (98 tablet) EU/1/98/091/013 (28 x 1 tableta)
What Kinzalmono looks like and contents of the pack Kinzalmono 40 mg tablets are white, oblong-shaped and engraved with the code number '51H' on one side.
Izgled zdravila Kinzalmono in vsebina pakiranja Tablete Kinzalmono 40 mg so bele, podolgovate tablete z vtisnjenim logom podjetja in oznako 51H..
Kinzalmono 80 mg tablets White oblong tablets of 4.6 mm engraved with the code number '52H' on one side.
Bele, 4,6 mm podolgovate tablete z vtisnjeno kodno številko 52H na eni strani.
Kinzalmono 80 mg tablets EU/1/98/091/005 (14 tablets) EU/1/98/091/006 (28 tablets) EU/1/98/091/007 (56 tablets) EU/1/98/091/008 (98 tablets) EU/1/98/091/014 (28 x 1 tablets)
Kinzalmono 80 mg tablete EU/1/98/091/005 (14 tablet) EU/1/98/091/006 (28 tablet) EU/1/98/091/007 (56 tablet) EU/1/98/091/008 (98 tablet) EU/1/98/091/014 (28 x 1 tableta)
NAME OF THE MEDICINAL PRODUCT Kinzalmono 40 mg tablets telmisartan
IME ZDRAVILA Kinzalmono 40 mg tablete telmisartan
What Kinzalmono looks like and contents of the pack Kinzalmono 20 mg tablets are white, round and engraved with the code number '50H' on one side and the company logo on the other side.
Izgled zdravila Kinzalmono in vsebina pakiranja Tablete Kinzalmono 20 mg so bele, okrogle tablete z vtisnjenim logom podjetja in oznako 50H .
How to store Kinzalmono
Shranjevanje zdravila Kinzalmono
NAME OF THE MEDICINAL PRODUCT Kinzalmono 80 mg tablets telmisartan
IME ZDRAVILA Kinzalmono 80 mg tablete telmisartan
At the beginning of the preventive therapy with Kinzalmono 80 mg, blood pressure should be frequently monitored.
Za zmanjševanje srčnožilnih dogodkov je običajni odmerek zdravila Kinzalmono ena tableta po 80 mg na dan. Na začetku preventivnega zdravljenja z zdravilom Kinzalmono 80 mg je treba pogosto izmeriti krvni tlak.
Symptomatic hypotension, especially after the first dose of Kinzalmono, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting.
Pri bolnikih z zmanjšanim volumnom krvi in/ali zmanjšano količino natrija zaradi intenzivnega diuretičnega zdravljenja, omejitve količine soli v hrani, driske ali bruhanja, se zlasti po prvem odmerku zdravila Kinzalmono lahko pojavi simptomatska hipotenzija.
NAME OF THE MEDICINAL PRODUCT Kinzalmono 20 mg tablets telmisartan
IME ZDRAVILA Kinzalmono 20 mg tablete telmisartan
What Kinzalmono looks like and contents of the pack Kinzalmono 80 mg tablets are white, oblong-shaped and engraved with the code number '52H' on one side.
Izgled zdravila Kinzalmono in vsebina pakiranja Tablete Kinzalmono so bele, podolgovate tablete z vtisnjenim logom podjetja in oznako 52H.
Kinzalmono 40 mg and 80 mg tablets Pack sizes: Blister with 14, 28, 56 or 98 tablets or perforated unit dose blisters with 28 x 1 tablets.
Velikost pakiranja: pretisni omot po 14, 28, 56 ali 98 tablet ali perforirani pretisni omoti za enkratni odmerek po 28 x 1 tableta.
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.
Občasni neželeni učinki (pojavijo se pri največ 1 od 100 bolnikov): okužbe sečil, okužbe zgornjih dihal (npr. bolečine v grlu, vneti sinusi, prehlad), pomanjkanje rdečih krvničk (anemija), visoka raven kalija, težave z uspavanjem, občutek žalosti (depresija), omedlevica (sinkopa), vrtoglavica, počasen srčni utrip (bradikardija), nizek krvni tlak (hipotenzija) pri osebah, ki se zdravijo zaradi visokega krvnega tlaka, omotica pri vstajanju (ortostatska hipotenzija), zasoplost, kašelj, trebušne bolečine, driska, nelagodje v trebuhu, napenjanje, bruhanje, srbež, povečano znojenje, medikamentni izpuščaj, bolečine v hrbtu, mišični krči, mišična bolečina (mialgija), ledvična okvara, tudi akutna ledvična odpoved, bolečina v prsnem košu, občutek oslabelosti in zvišana raven kreatinina v krvi.
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), severe allergic reaction (anaphylactic reaction), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), upset stomach, dry mouth, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): sepsa* (pogosto poimenovana tudi zastrupitev krvi, je huda okužba, pri kateri pride v vsem telesu do vnetnega odziva in je lahko usodna), povečanje določenih belih krvničk (eozinofilija), majhno število trombocitov (trombocitopenija), huda alergijska reakcija (anafilaktična reakcija), alergijska reakcija (npr. izpuščaj, srbež, oteženo dihanje, piskanje, otekanje obraza ali nizek krvni tlak), nizka raven krvnega sladkorja (pri bolnikih s sladkorno boleznijo), občutek tesnobe, zaspanost, motnje vida, hitro bitje srca (tahikardija), suha usta, želodčne težave, motnje okusa (disgevzija), motnje v delovanju jeter (pri japonskih bolnikih obstaja večja verjetnost pojavljanja tega neželenega učinka), hitro otekanje kože in sluznice, ki lahko povzroči tudi smrt (angioedem tudi s smrtnim izidom), ekcem (kožno obolenje), kožna rdečica, izpuščaji (urtikarija), hud medikamentni izpuščaj, bolečina v sklepih (artralgija), bolečina v okončini, bolečina v kitah, gripi podobna bolezen, znižan hemoglobin (krvna beljakovina), zvišana raven sečne kisline, zvišana raven jetrnih encimov ali kreatin fosfokinaze v krvi.
Progressive scarring of lung tissue (interstitial lung disease)**.
Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): Progresivno brazgotinjenje pljučnega tkiva (intersticijska pljučna bolezen)**
Kinzalmono is available in blister packs containing 14, 28, 56 or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.
Kinzalmono je na voljo v pretisnih omotih po 14, 28, 28 x 1, 56 ali 98 tablet.
It must not be given to patients with active cancers.
Ne sme se dajati bolnikom z aktivnim rakom.
This treatment course is repeated one year later.
Ta cikel zdravljenja se ponovi čez eno leto.
The first year, patients take one to two tablets a day for 4 or 5 days; after one month, they again take one to two tablets a day for 4 or 5 days, adding up to a total dose of 1.75 mg per kg body weight over the two periods.
Prvo leto bolniki 4 do 5 dni zaporedoma jemljejo eno do dve tableti na dan; po enem mesecu ponovno 4 do 5 dni jemljejo eno do dve tableti na dan, tako da skupni odmerek znaša 1,75 mg na kg telesne mase v dveh obdobjih.
The full EPAR for Mavenclad 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 Mavenclad je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Mavenclad.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Mavenclad.
What measures are being taken to ensure the safe and effective use of Mavenclad?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Mavenclad?
The European Medicines Agency therefore decided that Mavenclad's benefits are greater than its risks and recommended that it be approved for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Mavenclad večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
Mavenclad is used in patients whose disease is highly active.
Zdravilo Mavenclad se uporablja pri bolnikih, pri katerih je bolezen zelo aktivna.
Cladribine is already approved in the EU for the treatment of certain leukaemias (cancers affecting lymphocytes).
Kladribin je v EU že odobren za zdravljenje nekaterih levkemij (rakov, ki prizadenejo limfocite).
In addition, the fact that Mavenclad is given by mouth, and requires only 2 short courses 12 months apart, offers an advantage to patients.
Poleg tega tudi to, da se zdravilo Mavenclad daje peroralno in sta potrebna le dva kratka cikla v razmiku 12 mesecev, predstavlja prednost za bolnike.
The results suggested that the effects were greatest in patients with highly active disease and that benefit might be expected in other relapsing forms of multiple sclerosis.
Rezultati so nakazali, da so bili učinki največji pri bolnikih z visoko aktivno boleznijo in da bi korist lahko pričakovali tudi pri drugih recidivnih oblikah multiple skleroze.
In a follow-up study for up to a further 2 years, benefit of the original treatment was maintained but there seemed no additional benefit from giving more than 2 courses of Mavenclad treatment.
V kontrolni študiji, ki je trajala največ nadaljnji dve leti, so se koristi prvotnega zdravljenja ohranile, ni pa kazalo na dodatno korist več kot dveh ciklov zdravljenja z zdravilom Mavenclad.
Relapsing means that the patient has repeated flare-ups of the symptoms.
Recidivna pomeni, da imajo bolniki ponavljajoče se izbruhe simptomov.
Rashes, hair loss and lowered counts of another type of white blood cell, neutrophils, may also affect up to 1 patient in 10.
Izpuščaji, izpadanje las in dlak ter znižano število druge vrste belih krvnih celic, nevtrofilcev, se lahko pojavijo pri največ 1 bolniku od 10.
This appeared to be most marked in patients with highly active disease, in whom the clinical benefits were considered to outweigh the risks of a severe long-term lowering in lymphocyte numbers, which increases the risk of infection and possibly of cancer.
To se je najizraziteje pokazalo pri bolnikih z zelo aktivno boleznijo, pri katerih je bilo ocenjeno, da klinične koristi odtehtajo tveganja dolgotrajnega znižanja števila limfocitov, zaradi katerega se poveča tveganje za okužbo in morda za rak.
Treatment must also be avoided in patients whose kidney function is moderately or severely reduced, and in women who are pregnant or breast feeding.
Izogibati se mu je treba tudi pri bolnikih z zmerno ali hudo okvaro delovanja ledvic in pri ženskah, ki so noseče ali dojijo.
The active substance in Mavenclad, cladribine, has a similar chemical structure to purine, one of the substances needed to make up the DNA.
Zdravilna učinkovina v zdravilu Mavenclad, kladribin, ima podobno kemično strukturo kot purin, ena od snovi, ki so potrebne za izgradnjo DNK.
Effects on lymphocytes reduce the body's immune defence against infections and cancer: Mavenclad must not be given to patients with active long-term infections such as tuberculosis or hepatitis, nor to patients with HIV infection or whose immune defences are weakened for other reasons such as treatment with medicines that suppress the immune system.
Učinki na limfocite zmanjšujejo imunsko obrambo telesa pred okužbami in rakom: zdravila Mavenclad se ne sme dajati bolnikom z aktivnimi dolgotrajnimi okužbami, kot je tuberkuloza ali hepatitis, ali bolnikom, okuženim z virusom HIV ali pri katerih je imunski odziv oslabljen iz drugih razlogov, npr. zaradi zdravljenja z zdravili, ki zavirajo imunski sistem.
Other information about Mavenclad
Druge informacije o zdravilu Mavenclad
The company that markets Mavenclad will provide information on the medicine for healthcare professionals and patients, including advice on the side effects and safety concerns, the need for monitoring before and during treatment, and on pregnancy prevention and effective contraception in both female and male patients.
Družba, ki trži zdravilo Mavenclad, bo zagotovila informacije o zdravilu za zdravstvene delavce in bolnike, vključno z nasveti o neželenih učinkih in zadržkih glede varnosti, potrebi po spremljanju pred in med zdravljenjem ter o preprečevanju nosečnosti in učinkoviti kontracepciji pri bolnicah in bolnikih.
The study compared the effect of Mavenclad and placebo (a dummy treatment) in reducing the relapse rate 96 weeks after the start of treatment.
V študiji so primerjali učinek zdravila Mavenclad in placeba (zdravila brez zdravilne učinkovine) pri zmanjševanju stopnje ponovitve 96 tednov po začetku zdravljenja.
Patients treated with Mavenclad had a relapse rate of 0.14 per year on average, compared with 0.33 for patients given placebo; at the end of 96 weeks, around 8 out 10 patients given standard doses of Mavenclad and 6 out of 10 given placebo had not had a relapse.
Pri bolnikih, zdravljenih z zdravilom Mavenclad, je bila stopnja ponovitve povprečno 0,14 na leto, v primerjavi z 0,33 pri bolnikih, ki so prejemali placebo; po preteku 96 tednov do ponovitve ni prišlo pri 8 bolnikih od 10, ki so prejemali standardne odmerke zdravila Mavenclad, in 6 bolnikih od 10, ki so prejemali placebo.
The dose depends on patients' body weight and treatment consists of two courses spread over 2 years.
Odmerek je odvisen od telesne mase bolnika, zdravljenje pa je sestavljeno iz dveh ciklov v času dveh let.
Mavenclad has been shown to be effective in one main study involving 1,326 patients with relapsingremitting multiple sclerosis.
Zdravilo Mavenclad se je kot učinkovito pokazalo v eni glavni študiji, v katero je bilo vključenih 1 326 bolnikov z recidivno-remitentno multiplo sklerozo.
In multiple sclerosis, the body's immune (defence) system attacks and damages the protective sheath around the nerve cells in the central nervous system (the brain and spinal cord).
Pri multipli sklerozi imunski (obrambni) sistem telesa napade in poškoduje zaščitno ovojnico okoli živčnih celic v osrednjem živčevju (možganih in hrbtenjači).
In addition, patients given Mavenclad were nearly 50% less likely to have disease progression (indicated as an increase in disability that lasted for at least 6 months).
Poleg tega je bilo napredovanje bolezni skoraj 50 % manj verjetno pri bolnikih, ki so prejemali zdravilo Mavenclad (opredeljeno kot povečanje nezmožnosti, ki je trajalo vsaj 6 mesecev).
For more information about treatment with Mavenclad, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Mavenclad preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mavenclad 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 Mavenclad upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Mavenclad can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in treating multiple sclerosis.
Predpisovanje in izdaja zdravila Mavenclad je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje multiple skleroze.
What is Mavenclad and what is it used for?
Kaj je zdravilo Mavenclad in za kaj se uporablja?
The most common side effects with Mavenclad are lymphopenia (reduction in lymphocytes, which may affect more than 1 in 10 people) and infections with herpes zoster virus, in up to 1 patient in 10.
Najpogostejši neželeni učinki zdravila Mavenclad so limfopenija (zmanjšanje števila limfocitov, ki lahko prizadene več kot 1 bolnika od 10) in okužbe z virusom herpesa zostra pri največ 1 bolniku od 10.
Mavenclad is a medicine used to treat adults with the relapsing forms of multiple sclerosis, a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord.
Mavenclad je zdravilo, ki se uporablja za zdravljenje odraslih z recidivno obliko multiple skleroze (bolezni, pri kateri vnetje poškoduje zaščitno ovojnico okrog živčnih celic v možganih in hrbtenjači).
This brings about the death of the lymphocytes, slowing down the progression of multiple sclerosis.
To povzroči odmiranje limfocitov in s tem upočasnitev napredovanja multiple skleroze.
What are the risks associated with Mavenclad?
Kakšna tveganja so povezana z zdravilom Mavenclad?
What benefits of Mavenclad have been shown in studies?
Kakšne koristi je zdravilo Mavenclad izkazalo v študijah?
Why is Mavenclad approved?
Zakaj je bilo zdravilo Mavenclad odobreno?
For practical information about using Mavenclad, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Mavenclad naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
For the full list of all side effects reported with Mavenclad, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Mavenclad, glejte navodilo za uporabo.
It is not intended to provide practical advice on how to use Mavenclad.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
It contains the active substance cladribine.
Vsebuje zdravilno učinkovino kladribin.
The immune cells called lymphocytes play a key role in this process.
V tem procesu imajo osrednjo vlogo imunske celice, imenovane limfociti.
No other medicines should be taken within 3 hours of a Mavenclad tablet.
Tri ure po zaužitju tablete zdravila Mavenclad se ne sme vzeti nobeno drugo zdravilo.
In the body, cladribine is taken up by cells such as lymphocytes and interferes with the production of new DNA.
V telesu kladribin privzamejo celice, kot so limfociti, kar ovira tvorbo nove DNK.
Mavenclad has been shown to reduce relapse rates and delay disease progression in patients with relapsing multiple sclerosis.
Dokazano je bilo, da zdravilo Mavenclad pri bolnikih z recidivno multiplo sklerozo zmanjšuje stopnjo ponovitve in upočasnjuje napredovanje bolezni.
How is Mavenclad used?
Kako se zdravilo Mavenclad uporablja?
How does Mavenclad work?
Kako zdravilo Mavenclad deluje?
This new oral formulation has not been submitted for approval in any of the EU member states.
Ta nova peroralna formulacija ni bila predložena v odobritev v nobeni od držav članic EU.
Grounds for re-examination were received on 22 September 2012.
Razlogi za ponovno presojo so bili sprejeti 22. septembra 2012.
A Commission Decision for this previous referral procedure was issued on 12 June 2003.
Komisija je odločbo za ta prejšnji napotitveni postopek izdala 12. junija 2003.
Pharmacovigilance
Farmakovigilanca
Calcitonin is currently authorised in most European member states.
Kalcitonin je trenutno odobren v večini evropskih držav članic.
Statistical issues (meta-analysis)
Statistična vprašanja (metaanaliza)
Treatment duration is recommended to be 2 weeks and not exceeding 4 weeks in any case.
Priporočeno trajanje zdravljenja je 2 tedna in ne sme v nobenem primeru preseči 4 tednov.