natgillin/translations-raw huggingface dataset:
The Insulin Human Winthrop range is comprised of fast-acting insulin solutions (Insulin Human Winthrop Rapid and Insulin Human Winthrop Infusat) that contain soluble insulin, an intermediate-acting insulin suspension (Insulin Human Winthrop Basal) that contains isophane insulin, and combinations of fast- and intermediateacting in various proportions (Insulin Human Winthrop Comb):
Paleta izdelkov Insulin Human Winthrop vključuje raztopine insulinov s hitrim delovanjem (Insulin Human Winthrop Rapid in Insulin Human Winthrop Infusat), ki vsebujejo topni insulin, suspenzije insulinov s srednje dolgim delovanjem (Insulin Human Winthrop Basal), ki vsebujejo insulin izofan, ter kombinacije insulina s hitrim in srednje dolgim delovanjem v različnih razmerjih (Insulin Human Winthrop Comb):
The desired blood glucose levels, the type of Insulin Human Winthrop to be used, and the dose and timing of injections are determined by the doctor for each patient individually, and are adjusted to suit the patient's diet, physical activity and lifestyle.
Zdravnik za vsakega posameznika posebej določi zaželene koncentracije glukoze v krvi, vrsti zdravila Insulin Human Winthrop , ki ga je treba uporabiti, in čas uporabe injekcij ter jih prilagodi, da kar najbolje ustrezajo prehrani, telesni aktivnosti in življenjskemu slogu bolnika.
Other information about Insulin Human Winthrop:
Druge informacije o zdravilu Insulin Human Winthrop:
For the full list of all side effects reported with Insulin Human Winthrop, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Insulin Human Winthrop, glejte navodilo za uporabo.
In one of the studies, Insulin Human Winthrop was used in an insulin pump.
V eni od teh študij je bilo zdravilo Insulin Human Winthrop uporabljeno v insulinski črpalki.
Insulin Human Winthrop is given by injection under the skin, generally in the abdominal wall (tummy) or the thigh, according to the doctor's recommendations.
Zdravilo Insulin Human Winthrop se daje z injekcijo pod kožo, običajno v trebušno steno ali stegno v skladu s priporočilom zdravnika.
Insulin Human Winthrop led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with semi-synthetic human insulin.
Zdravilo Insulin Human Winthrop je povzročilo znižanje koncentracije HbA1c, kar kaže, da so bile koncentracije glukoze v krvi vzdrževane na podobni ravni kot pri polsinteznem humanem insulinu.
Insulin Human Winthrop can cause hypoglycaemia.
Zdravilo Insulin Human Winthrop lahko povzroči hipoglikemijo.
In the other study, Insulin Human Winthrop Comb 25 was compared with semi-synthetic human insulin.
V drugi študiji pa so zdravilo Insulin Human Winthrop Comb 25 primerjali s polsinteznim humanim insulinom.
Insulin Human Winthrop is a replacement insulin that is identical to the insulin made by the body.
Zdravilo Insulin Human Winthrop je nadomestni insulin, ki je identičen insulinu, ki ga tvori telo.
The Committee recommended that Insulin Human Winthrop be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Insulin Human Winthrop odobri dovoljenje za promet.
What benefit has Insulin Human Winthrop shown during the studies?
Kakšne koristi je zdravilo Insulin Human Winthrop izkazalo med študijami?
The full EPAR for Insulin Human Winthrop is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Insulin Human Winthrop je na voljo tukaj.
Insulin Human Winthrop contains the active substance insulin human.
Zdravilo Insulin Human Winthrop vsebuje zdravilno učinkovino humani insulin.
Insulin Human Winthrop is a range of insulin solutions and suspensions for injection.
Zdravilo Insulin Human Winthrop obsega različne raztopine in suspenzije insulina za injiciranje.
Why has Insulin Human Winthrop been approved?
Zakaj je bilo zdravilo Insulin Human Winthrop odobreno?
What is the risk associated with Insulin Human Winthrop?
Kakšna tveganja so povezana z zdravilom Insulin Human Winthrop?
See the Package Leaflet for exact timings.
Natančen čas uporabe najdete v navodilu za uporabo.
How is Insulin Human Winthrop used?
Kako se Insulin Human Winthrop uporablja?
How has Insulin Human Winthrop been studied?
Kako je bilo zdravilo Insulin Human Winthrop raziskano?
What is Insulin Human Winthrop?
Kaj je zdravilo Insulin Human Winthrop?
What is Insulin Human Winthrop used for?
Za kaj se zdravilo Insulin Human Winthrop uporablja?
How does Insulin Human Winthrop work?
Kako zdravilo Insulin Human Winthrop deluje?
The safety profile of the medicine is considered acceptable.
Varnostni profil zdravila je ocenjen kot sprejemljiv.
As a result, it prevents the growth of tumour cells and eventually kills them.
Tako preprečuje rast tumorskih celic in jih sčasoma uniči.
Further information on Xeloda can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Xeloda.
Nadaljnje informacije za zdravilo Xeloda so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Xeloda.
Xeloda is available as tablets (150 and 500 mg).
Na voljo je v obliki tablet (150 in 500 mg).
The European Medicines Agency therefore decided that Xeloda's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Xeloda večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The tablets are given twice daily for 14 days followed by a 7-day gap before the next course.
Jemljejo se 14 dni dvakrat na dan, čemur sledi enotedenski premor pred naslednjim ciklom.
Fluorouracil is very similar to pyrimidine.
Fluorouracil je zelo podoben pirimidinu.
What measures are being taken to ensure the safe and effective use of Xeloda?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xeloda?
• pregnant or breastfeeding women;
• nosečnicah ali ženskah, ki dojijo;
Xeloda received a marketing authorisation valid throughout the EU on 2 February 2001.
Za zdravilo Xeloda je bilo 2. februarja 2001 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
For other types of cancer, treatment is stopped if the disease gets worse or the side effects are unacceptable.
Pri drugih oblikah raka je treba zdravljenje prekiniti, če se bolezen poslabša ali so neželeni učinki nesprejemljivi.
Xeloda tablets should be taken within 30 minutes after a meal.
Tablete zdravila Xeloda je treba vzeti z vodo v 30 minutah po obroku.
The disease responded in 19 to 25% of patients treated with Xeloda, compared with 12 to 15% with the comparator combination.
Bolezen se je odzvala pri 19 do 25 % bolnikov, zdravljenih z zdravilom Xeloda, v primerjavi z 12 do 15 % bolnikov, ki so jemali primerjalno kombinacijo.
Other information about Xeloda
Druge informacije o zdravilu Xeloda
Treatment is continued for 6 months after colon surgery.
Zdravljenje se nadaljuje šest mesecev po operaciji debelega črevesa.
As for all medicines, data on the use of Xeloda are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Xeloda stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xeloda have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Xeloda upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The most common side effects with Xeloda are diarrhoea, nausea (feeling sick), vomiting, abdominal (belly) pain, stomatitis (sores in the mouth), palmar-plantar erythrodysaesthesia (hand-foot syndrome, a skin reaction with rash and pain on the hands and feet), tiredness, weakness, loss of appetite, problems due to formation of blood clots in the blood vessels, heart problems and kidney problems in patients who already have reduced kidney function.
Najpogostejši neželeni učinki zdravila Xeloda so driska, navzeja (siljenje na bruhanje), bruhanje, bolečina v trebuhu, stomatitis (razjede v ustih), palmarno-plantarna eritrodisestezija (sindrom rokanoga, kožne reakcije z izpuščaji in bolečinami v rokah in nogah), utrujenost, šibkost, izguba teka, težave zaradi nastajanja krvnih strdkov v krvnih žilah, težave s srcem in ledvicami pri bolnikih, ki so že imeli okvaro delovanja ledvic.
Side effects reported with Xeloda are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Xeloda, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
• patients taking brivudine (an antiviral medicine for treating shingles or chickenpox) or who have taken it in the last 4 weeks.
• bolnikih, ki jemljejo brivudin (protivirusno zdravilo za zdravljenje pasovca ali noric) ali ki so ga prejeli v zadnjih štirih tednih.
Xeloda is taken as tablets, while fluorouracil normally needs to be injected.
Zdravilo Xeloda se jemlje v obliki tablet, medtem ko je treba fluorouracil navadno injicirati.
What benefits of Xeloda have been shown in studies?
Kakšne koristi zdravila Xeloda so se pokazale v študijah?
• patients with severe leucopenia, neutropenia, or thrombocytopenia (low levels of white cells or platelets in the blood);
• bolnikih s hudo levkopenijo, nevtropenijo ali trombocitopenijo (nizkimi ravnmi belih krvnih celic ali trombocitov v krvi);
An overview of Xeloda and why it is authorised in the EU
Pregled zdravila Xeloda in zakaj je odobreno v EU
For more information about using Xeloda, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Xeloda glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Why is Xeloda authorised in the EU?
Zakaj je bilo zdravilo Xeloda odobreno v EU?
• patients who have had severe and unexpected reactions to fluoropyrimidine therapy;
• bolnikih, ki so imeli hudo in nepričakovano reakcijo na zdravljenje s fluoropirimidinom;
About two-thirds of the patients taking Xeloda or the combination remained disease-free throughout the 3.8 years of the study.
Približno dve tretjini bolnikov, ki so jemali zdravilo Xeloda ali kombinacijo, v vseh 3,8 letih študije ni kazalo znakov bolezni.
• locally advanced or metastatic breast cancer (breast cancer that has begun to spread to other parts of the body).
• lokalno napredovalega ali metastatskega raka dojk (ki se je začel širiti na druge dele telesa).
It can also be used on its own when treatment with both anthracyclines and taxanes (another type of cancer medicine) has failed or when further treatment with anthracyclines is not suitable for the patient.
Lahko se uporablja tudi samostojno, če je bilo zdravljenje z antraciklini in taksani (drugimi vrstami zdravil za zdravljenje raka) neuspešno ali če nadaljnje zdravljenje z antraciklini za bolnika ni primerno.
In the body, fluorouracil takes the place of pyrimidine and interferes with the enzymes involved in making new DNA.
Fluorouracil v telesu zavzame mesto pirimidina in ovira encime, ki sodelujejo pri tvorjenju nove DNK.
What are the risks associated with Xeloda?
Kakšna tveganja so povezana z zdravilom Xeloda?
Xeloda is a cancer medicine that is used to treat:
Xeloda je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje:
What is Xeloda and what is it used for?
Kaj je zdravilo Xeloda in za kaj se uporablja?
Xeloda must not be used in people who may be hypersensitive (allergic) to capecitabine, to any of the other ingredients, or to fluorouracil.
Zdravila Xeloda ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) kapecitabin, katero koli drugo sestavino zdravila ali fluorouracil.
• patients with complete absence of activity of the dihydropyrimidine dehydrogenase enzyme;
• bolnikih s popolnim pomanjkanjem dejavnosti encima dihidropirimidin dehidrogenaze;
The dose depends on the patient's height and weight and the type of cancer being treated.
Odmerek je odvisen od bolnikove telesne višine in telesne mase ter vrste raka, ki se zdravi.
Two smaller studies (238 patients) showed that Xeloda was effective after treatment with taxanes and anthracyclines did not work.
Dve manjši študiji (238 bolnikov) sta pokazali, da je bilo zdravilo Xeloda učinkovito, kadar zdravljenje s taksani in antraciklini ni delovalo.
Xeloda should only be prescribed by a doctor who is experienced in the use of cancer medicines.
Zdravilo Xeloda lahko predpiše le zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
Xeloda has been shown to be effective in treating colon, colorectal, gastric and breast cancer.
Zdravilo Xeloda se je izkazalo za učinkovito pri zdravljenju raka debelega črevesa, kolorektalnega raka, raka želodca in raka dojk.
Patients taking Xeloda with docetaxel had a longer time before the disease got worse compared with patients taking docetaxel on its own (186 days compared with 128 days).
Pri bolnikih, ki so jemali zdravilo Xeloda z docetakselom, je trajalo dlje, da se je bolezen poslabšala v primerjavi s bolniki, ki so jemali docetaksel kot samostojno zdravilo (186 dni v primerjavi s 128 dnevi).
Capecitabine is a ‘prodrug' that is converted to the medicine fluorouracil in the body, but more is converted in tumour cells than in normal tissues.
Kapecitabin je „predzdravilo“, ki se v telesu pretvori v florouracil, in sicer v večji meri v tumorskih celicah kot v normalnem tkivu.
Also, the results of a published study involving 1,002 patients showed that patients taking combinations of medicines that included Xeloda survived for a similar period as those taking combinations that included fluorouracil.
Poleg tega so rezultati objavljene študije, ki je vključevala 1 002 bolnika, pokazali, da so bolniki, ki so jemali kombinacije zdravil, ki so vključevale zdravilo Xeloda, preživeli podobno obdobje kot tisti, ki so jemali kombinacije, ki so vključevale fluorouracil.
Xeloda contains the active substance capecitabine.
Zdravilo Xeloda vsebuje učinkovino kapecitabin.
Xeloda is used on its own or with other cancer medicines;
Zdravilo Xeloda se uporablja samostojno ali z drugimi zdravili za zdravljenje raka;
Xeloda is used with other cancer medicines, including a platinum-containing cancer medicine such as cisplatin;
Zdravilo Xeloda se uporablja z drugimi zdravili za zdravljenje raka, vključno z zdravilom proti raku, ki vsebuje platino, kot na primer cisplatin;
Xeloda is used on its own or with other cancer medicines in patients who have had surgery for stage III or Dukes' stage C colon cancer;
Uporablja se z drugimi zdravili za zdravljenje raka ali samostojno pri bolnikih po operaciji raka kolona stadija III ali stadija Dukes C;
Xeloda is used with docetaxel (another cancer medicine) after treatment with anthracyclines (another type of cancer medicine) has failed.
Zdravilo Xeloda se uporablja z docetakselom (drugim zdravilom za zdravljenje raka), potem ko zdravljenje z antraciklini (drugo vrsto zdravila za zdravljenje raka) ni bilo uspešno.
The active substance in Xeloda, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Učinkovina zdravila Xeloda, kapecitabin, je citotoksik (zdravilo, ki uničuje celice, ki se delijo, kot na primer rakave celice) iz skupine „antimetabolitov“.
Another study involving 1,886 patients who had had surgery showed that Xeloda together with oxaliplatin (another cancer medicine) was more effective than the combination of fluorouracil and folinic acid: patients taking Xeloda and oxaliplatin had 20% lower risk of getting cancer again or death compared with patients taking fluorouracil and folinic acid.
V drugi študiji, v katero je bilo vključenih 1 886 bolnikov, ki so prestali kirurški poseg, je bilo ugotovljeno, da je zdravilo Xeloda skupaj s oksaliplatinom (drugim zdravilom za zdravljenje raka) učinkovitejše od kombinacije fluorouracila in folinske kisline: bolniki, ki so prejemali zdravilo Xeloda in oksaliplatin, so imeli 20 % manjše možnosti, da se rak ponovno pojavi ali da umrejo, v primerjavi z bolniki, ki so jemali fluorouracil in folinsko kislino.
Results showed that when either Xeloda or fluorouracil and folinic acid were used with oxaliplatin, it took an average of 8 months for the disease to get worse in patients who had not been treated before, and 5 months in patients whose previous treatment had not worked.
Rezultati so pokazali, da je ob jemanju zdravila Xeloda ali kombinacije fluorouracila in folinske kisline v kombinaciji z oksaliplatinom, pri bolnikih, ki pred tem še niso bili zdravljeni, trajalo v povprečju osem mesecev, da se je bolezen poslabšala, pri bolnikih, pri katerih predhodno zdravljenje ni bilo uspešno, pa je do poslabšanja bolezni v povprečju prišlo v petih mesecih.
It took 5.6 months for the disease to get worse in patients taking Xeloda and cisplatin, and 5.0 months in patients receiving fluorouracil and cisplatin.
Pri bolnikih, ki so jemali zdravilo Xeloda in cisplatin, je trajalo 5,6 meseca, da se je bolezen poslabšala, pri bolnikih, ki so jemali fluorouracil in cisplatin pa 5,0 meseca.
• patients with severe liver or kidney disease;
• bolnikih s hudimi obolenji jeter ali ledvic;
For the full list of side effects reported with Xeloda, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Xeloda, glejte navodilo za uporabo.
How does Xeloda work?
Kako zdravilo Xeloda deluje?
How is Xeloda used?
Kako se zdravilo Xeloda uporablja?
In locally advanced or metastatic breast cancer, Xeloda with docetaxel was more effective than docetaxel on its own in a study involving 511 women.
Študija, ki je vključevala 511 žensk z lokalno napredovalim ali metastatskim rakom dojk, je pokazala, da je bilo zdravilo Xeloda v kombinaciji z docetakselom učinkovitejše od docetaksela kot samostojnega zdravila.
Xeloda has also been compared with the combination of fluorouracil and folinic acid, both used in combination with oxaliplatin, in 2 studies: the first involved 2,035 patients who had not been treated before, and the second involved 627 patients in whom previous treatment with irinotecan and a fluoropyrimidine (a group of cancer medicines that includes fluorouracil) had not worked.
V prvo študijo je bilo vključenih 2 035 bolnikov, ki predhodno niso bili zdravljeni, v drugo pa 627 bolnikov, pri katerih predhodno zdravljenje z irinotekanom in fluoropirimidinom (skupino zdravil za zdravljenje raka, ki vključuje tudi fluorouracil) ni bilo uspešno.
Xeloda must also not be used in the following groups:
Zdravilo se ne sme uporabljati pri:
In colon cancer, Xeloda on its own has been shown to be as effective as the combination of fluorouracil and folinic acid (a medicine that enhances the effects of fluorouracil) in a main study involving 1,987 patients who had had surgery for their cancer.
Pri raku kolona se je zdravilo Xeloda, uporabljeno kot samostojno zdravilo, v eni glavni študiji, v katero je bilo vključenih 1 987 bolnikov, ki so bili predhodno operirani zaradi raka, izkazalo za enako učinkovito kot kombinacija fluorouracila in folinske kisline (zdravila, ki poveča učinke fluorouracila).
In advanced gastric cancer, Xeloda with cisplatin was as effective as a combination of fluorouracil and cisplatin in slowing down the disease in a study involving 316 patients.
Študija, ki je vključevala 316 bolnikov, je pokazala, da je pri napredovalem raku želodca zdravilo Xeloda skupaj s cisplatinom enako učinkovito kot kombinacija fluorouracila in cisplatina pri upočasnitvi bolezni.
Colon cancer
Rak kolona
Breast cancer
Rak želodca
In metastatic colorectal cancer, Xeloda taken on its own was as effective as the combination of fluorouracil and folinic acid in 2 studies involving 1,207 patients.
Dve študiji, ki sta vključevali 1 207 bolnikov, sta pokazali, da je pri metastatski obliki kolorektalnega raka zdravilo Xeloda, vzeto samostojno, enako učinkovito kot kombinacija fluorouracila in folinske kisline.
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They may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Družbi lahko zahtevata ponovno presojo mnenja v 15 dneh od prejema obvestila o negativnem mnenju.
London, 23 October 2008 Doc.
London, 23. oktober 2008 Sklic dok.
Ref. EMEA/551181/2008
: EMEA/599109/2008
It is used for the treatment of adults with the following diseases:
Uporablja se za zdravljenje odraslih z naslednjimi boleznimi:
These were measured using standard scales and questionnaires.
Te so merili s standardnimi lestvicami in vprašalniki.
• episodes of major depression;
• epizod hude depresije,
International non-proprietary name (INN): duloxetine
Mednarodno nelastniško ime (INN): duloksetin
What documentation was presented to support this application?
Katero dokumentacijo je družba predložila v podporo svoji vlogi ?
In all of the studies, the main measures of effectiveness were based on changes in the patients' symptoms, particularly pain levels, and their overall state of health.
V vseh študijah so glavna merila učinkovitosti temeljila na spremembah bolnikovih simptomov, še posebej jakosti bolečine in njihovemu splošnemu zdravstvenemu stanju.
• generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
• generalizirana motnja anksioznosti (dolgotrajne anksioznosti ali živčnosti zaradi vsakodnevnih zadev).
What is happening for duloxetine used for the treatment of other diseases?
Kakšne so posledice za duloksetin, ki se uporablja za zdravljenje drugih bolezni?
It is available as gastroresistant capsules.
Zdravilo je na voljo v obliki gastrorezistentnih kapsul.
‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Izraz „gastrorezistentno“ pomeni, da vsebina kapsul potuje skozi želodec, ne da bi se razgradila, dokler ne doseže črevesja.
The change concerned an extension of indication to add the treatment of fibromyalgia.
Sprememba se je nanašala na razširitev indikacije za zdravljenje fibromialgije.
Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Živčni prenašalci so kemične spojine, ki živčnim celicam omogočajo medsebojno komunikacijo.
• pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
• bolečin zaradi diabetične periferne nevropatije (poškodb živcev v okončinah, do katerih pride pri bolnikih s sladkorno boleznijo),
Duloxetine, under the names Ariclaim and Yentreve, is also authorised for use in stress urinary incontinence.
Duloksetin je pod imeni Ariclaim in Yentreve odobren tudi za uporabo pri stresni urinarni inkontinenci.
There are no consequences on the use of Cymbalta/Xeristar, Ariclaim or Yentreve in their authorised indications, for which the balance of benefits and risks remains unchanged.
Zavrnitev nima nobenih posledic za uporabo zdravil Cymbalta/Xeristar, Ariclaim ali Yentreve pri odobrenih indikacijah, pri katerih ostaja razmerje med koristmi in tveganji nespremenjeno.
By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Duloksetin z zaviranjem ponovnega privzemanja poveča količino teh živčnih prenašalcev v prostorih med omenjenimi živčnimi celicami, zaradi česar se poveča raven komunikacije med celicami.
It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Deluje tako, da preprečuje ponovno privzemanje živčnih prenašalcev 5hidroksitriptamina (imenovanega tudi serotonin) in noradrenalina v možganske celice in hrbtenjačo.
The fifth, a long-term study, compared the effects of two doses of Cymbalta/Xeristar over a year in 307 patients.
V peti, dolgoročni študiji so učinke dveh odmerkov zdravila Cymbalta/Xeristar v trajanju enega leta primerjali pri 307 bolnikih.
Cymbalta/Xeristar has been authorised since December 2004.
Zdravilo Cymbalta/Xeristar ima dovoljenje za promet z zdravilom od decembra 2004.