natgillin/translations-raw huggingface dataset:
75 Dasatinib was not mutagenic in in vitro bacterial cell assays (Ames test) and was not genotoxic in an in vivo rat micronucleus study.
Pri in vitro testih na bakterijskih celicah (Amesov test) dasatinib ni deloval mutageno in tudi ni bil genotoksičen pri in vivo študiji s podganjimi mikronukleusi.
Alu/ Alu blisters (unit dose blisters) and high-density polyethylene (HDPE) bottle with child resistant closure of polypropylene.
Alu/ alu pretisni omoti (enoodmerni pretisni omoti) in plastenka iz polietilena visoke gostote (HDPE) z za otroke varno polipropilensko zaporko.
Cartons containing 30 film-coated tablets in perforated unit dose blisters.
Škatle s 30 filmsko obloženimi tabletami v perforiranih enoodmernih pretisnih omotih.
Cartons containing one bottle with 30 film-coated tablets.
Škatle z eno plastenko s 30 filmsko obloženimi tabletami.
76 Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
EU/ 1/ 06/ 363/ 011 - 30 x 1 film-coated tablets (unit-dose blisters) EU/ 1/ 06/ 363/ 010 - 30 film-coated tablets (bottle)
EU/ 1/ 06/ 363/ 011 - 30 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/ 1/ 06/ 363/ 010 - 30 filmsko obloženih tablet (plastenke)
77 ANNEX II
81 DODATEK II
The MAH must ensure that the system of pharmacovigilance, as described in version 2.5 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2. 5, predstavljeni v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 4. 0 načrta za obvladovanje tveganja (RMP – "Risk Management Plan"), predstavljenem v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernicami CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora imetnik dovoljenja za promet predložiti posodobljen RMP hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached At the request of the EMEA.
Poleg tega je treba posodobljen načrt za obvladovanje tveganja predložiti: kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki bi lahko vplivale na trenutne varnostne specifikacije zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja.
79 ANNEX III
84 DODATEK III
81 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
86 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
OUTER CARTON AND LABEL TEXT FOR BOTTLE PACK OUTER CARTON TEXT FOR BLISTER PACK
BESEDILO NA ŠKATLI IN NALEPKI ZA PLASTENKO BESEDILO NA ŠKATLI ZA PRETISNE OMOTE
SPRYCEL 20 mg film-coated tablets Dasatinib
SPRYCEL 20 mg filmsko obložene tablete dasatinib
EU/ 1/ 06/ 363/ 004 - 56 film-coated tablets (blisters) EU/ 1/ 06/ 363/ 007 - 60 x 1 film-coated tablets (unit-dose blisters) EU/ 1/ 06/ 363/ 001 - 60 film-coated tablets (bottle)
EU/ 1/ 06/ 363/ 004 - 56 filmsko obloženih tablet (pretisni omoti) EU/ 1/ 06/ 363/ 007 - 60 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/ 1/ 06/ 363/ 001 - 60 filmsko obloženih tablet (plastenka)
Outer Carton:
Škatla:
83 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
88 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
SPRYCEL 20 mg tablets Dasatinib
SPRYCEL 20 mg tablete dasatinib
Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Koledarsko pakiranje: ponedeljek torek sreda četrtek petek sobota nedelja
84 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
89 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
SPRYCEL 50 mg film-coated tablets Dasatinib
SPRYCEL 50 mg filmsko obložene tablete dasatinib
EU/ 1/ 06/ 363/ 005 - 56 film-coated tablets (blisters) EU/ 1/ 06/ 363/ 008 - 60 x 1 film-coated tablets (unit-dose blisters) EU/ 1/ 06/ 363/ 002 - 60 film-coated tablets (bottle)
EU/ 1/ 06/ 363/ 005 - 56 filmsko obloženih tablet (pretisni omoti) EU/ 1/ 06/ 363/ 008 - 60 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/ 1/ 06/ 363/ 002 - 60 filmsko obloženih tablet (plastenka)
86 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
91 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
SPRYCEL 50 mg tablets Dasatinib
SPRYCEL 50 mg tablete dasatinib
87 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
92 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
SPRYCEL 70 mg film-coated tablets Dasatinib
SPRYCEL 70 mg filmsko obložene tablete dasatinib
EU/ 1/ 06/ 363/ 006 - 56 film-coated tablets (blisters) EU/ 1/ 06/ 363/ 009 - 60 x 1 film-coated tablets (unit-dose blisters) EU/ 1/ 06/ 363/ 003 - 60 film-coated tablets (bottle)
EU/ 1/ 06/ 363/ 006 - 56 filmsko obloženih tablet (pretisni omoti) EU/ 1/ 06/ 363/ 009 - 60 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/ 1/ 06/ 363/ 003 - 60 filmsko obloženih tablet (plastenka)
89 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
94 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
SPRYCEL 70 mg tablets Dasatinib
SPRYCEL 70 mg tablete dasatinib
90 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
95 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
SPRYCEL 100 mg film-coated tablets Dasatinib
SPRYCEL 100 mg filmsko obložene tablete dasatinib
30 x 1 film-coated tablets 30 film-coated tablets
30 x 1 filmsko obložena tableta 30 filmsko obloženih tablet
EU/ 1/ 06/ 363/ 011 - 30 x 1 film-coated tablets (unit-dose blisters) EU/ 1/ 06/ 363/ 010 - 30 film-coated tablets (bottle)
EU/ 1/ 06/ 363/ 011 - 30 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/ 1/ 06/ 363/ 010 - 30 filmsko obloženih tablet (plastenka)
92 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
97 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
SPRYCEL 100 mg tablets Dasatinib
SPRYCEL 100 mg tablete dasatinib
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 100 mg film-coated tablets
SPRYCEL 20 mg filmsko obložene tablete SPRYCEL 50 mg filmsko obložene tablete SPRYCEL 70 mg filmsko obložene tablete SPRYCEL 100 mg filmsko obložene tablete
Dasatinib
dasatinib
Before you take SPRYCEL 3.
Kaj morate vedeti, preden boste vzeli zdravilo SPRYCEL 3.
WHAT SPRYCEL IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO SPRYCEL IN ZA KAJ GA UPORABLJAMO
SPRYCEL is a leukaemia treatment for adults with chronic myeloid leukaemia (CML) who are not benefiting from imatinib therapy.
Zdravilo SPRYCEL uporabljamo za zdravljenje levkemije pri odraslih s kronično mieloično levkemijo (KML), pri katerih zdravljenje z imatinibom ni bilo uspešno.
SPRYCEL is also a treatment for adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL), and lymphoid blast CML who are not benefiting from prior therapies.
Zdravilo SPRYCEL uporabljamo tudi za zdravljenje odraslih z akutno limfoblastno levkemijo (ALL) s prisotnostjo kromosoma Philadelphia (Ph+) in odraslih s KML v obdobju limfoblastne preobrazbe, pri katerih so bila predhodna zdravljenja neuspešna.
If you have any questions about how SPRYCEL works or why this medicine has been prescribed for you, ask your doctor.
Če imate o delovanju zdravila SPRYCEL kakršno koli vprašanje, ali če vas zanima, zakaj vam je bilo to zdravilo predpisano, se posvetujte s svojim zdravnikom.
BEFORE YOU TAKE SPRYCEL
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO SPRYCEL
SPRYCEL will only be prescribed to you by a doctor with experience in medicines to treat leukaemia.
Zdravilo SPRYCEL vam sme predpisati le zdravnik z izkušnjami pri zdravljenju levkemij.
Do not take SPRYCEL if you are allergic (hypersensitive) to dasatinib or any of the other ingredients of SPRYCEL.
Ne jemljite zdravila SPRYCEL če ste alergični na (preobčutljivi za) dasatinib ali katero koli sestavino zdravila SPRYCEL.
If you could be allergic, ask your doctor for advice.
Če mislite, da bi lahko bili alergični, se posvetujte s svojim zdravnikom.
Take special care with SPRYCEL if you are taking medicines to thin the blood or prevent clots (see Using other medicines) if you have a liver or heart problem, or used to have one if you start having difficulty breathing, chest pain, or a cough when taking SPRYCEL: this may be a sign of fluid retention in the lungs or chest (which can be more common in patients aged 65 years and older).
100 če med jemanjem zdravila SPRYCEL začnete težko dihati, začutite bolečino v prsih ali začnete kašljati, je to lahko znak zastajanja tekočine v pljučih ali prsnem košu (kar je lahko pogostejše pri bolnikih, starih 65 let ali starejših).
95 If any of these affects you, tell your doctor.
Če se karkoli od navedenega nanaša na vas, obvestite svojega zdravnika.
Children, adolescents and SPRYCEL SPRYCEL is not recommended in patients below 18 years of age.
Otroci, mladostniki in zdravilo SPRYCEL Uporaba zdravila SPRYCEL pri bolnikih, mlajših od 18 let ni priporočljiva.
Older people and SPRYCEL SPRYCEL can be used by people over 65 at the same doses as other adults.
Starostniki in zdravilo SPRYCEL Bolniki, starejši od 65 let, lahko jemljejo enake odmerke zdravila SPRYCEL kot ostali odrasli bolniki.
Using other medicines SPRYCEL is mainly handled by the liver.
Uporaba drugih zdravil Zdravilo SPRYCEL se v glavnem presnavlja v jetrih.
John’ s wort - a herbal preparation obtained without a prescription used to treat depression and other conditions (also known as Hypericum perforatum)
Zdravila, ki jih ne smete uporabljati skupaj z zdravilom SPRYCEL so: ketokonazol, itrakonazol - antimikotika, eritromicin, klaritromicin, telitromicin - antibiotiki, ritonavir - protivirusno zdravilo, deksametazon - kortikosteroid, fenitoin, karbamazepin, fenobarbital - zdravila za zdravljenje epilepsije, rifampicin - zdravilo za zdravljenje tuberkuloze, famotidin, omeprazol – zdravili za zaviranje izločanja želodčne kisline, šentjanževka – zdravilo rastlinskega izvora za zdravljenje depresije in drugih stanj (znana tudi kot Hypericum perforatum), ki ga lahko dobite brez recepta.
Medicines that neutralise stomach acids (antacids such as aluminium hydroxide/ magnesium hydroxide) may be taken up to 2 hours before or 2 hours after taking SPRYCEL.
Zdravila, ki nevtralizirajo želodčno kislino (antacidi, kot sta aluminijev hidroksid in magnezijev hidroksid), lahko vzamete do 2 uri pred ali 2 uri po jemanju zdravila SPRYCEL.
You should tell your doctor if you are taking medicines to thin the blood or prevent clots.
Svojega zdravnika morate obvestiti, če jemljete zdravila za redčenje krvi ali preprečevanje nastanka krvnih strdkov.
Pregnancy and breast-feeding If you are pregnant or think you may be, tell your doctor immediately.
Nosečnost in dojenje Če ste noseči ali mislite, da ste noseči, to nemudoma povejte svojemu zdravniku.
Breast-feeding should be stopped if you are taking SPRYCEL.
Med jemanjem zdravila SPRYCEL morate z dojenjem prenehati.
Driving and using machines Take special care when driving or using machines in case you experience side effects such as dizziness and blurred vision.
Vpliv na sposobnost upravljanja vozil in strojev V primeru pojava neželenih učinkov, kot sta omotica ali zamegljen vid, bodite pri upravljanju vozil in strojev še posebej previdni.
Important information about some of the ingredients of SPRYCEL SPRYCEL contains lactose.
Pomembne informacije o nekaterih sestavinah zdravila SPRYCEL Zdravilo SPRYCEL vsebuje laktozo.
If you have been diagnosed with an intolerance to some sugars, talk to your doctor before taking this medicine.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte z zdravnikom.
HOW TO TAKE SPRYCEL
KAKO JEMATI ZDRAVILO SPRYCEL
Always take SPRYCEL exactly as your doctor has told you.
Pri jemanju zdravila SPRYCEL natančno upoštevajte zdravnikova navodila.
96 The starting dose recommended for patients with chronic phase CML is 100 mg once a day, taken at the same time every day.
Priporočeni začetni odmerek za bolnike s KML v kroničnem obdobju je 100 mg enkrat na dan, vsak dan ob istem času.
The starting dose recommended for patients with accelerated or blast crisis CML or Ph+ALL is 70 mg twice daily: one tablet in the morning one tablet in the evening
Priporočeni začetni odmerek za bolnike s KML v obdobju pospešenega poteka ali blastne krize in bolnikih s Ph+ ALL je 70 mg dvakrat na dan: ena tableta zjutraj, ena tableta zvečer.
For higher or lower doses use of combinations of the different tablet strengths may be necessary.
Če vam zdravnik predpiše večji ali manjši odmerek, boste morda morali jemati kombinacijo tablet različnih jakosti.
The tablets may come in calendar packs.
Tablete se lahko nahajajo v koledarskem pakiranju.
These are blister packs showing the days of the week.
To so pretisni omoti, na katerih so označeni dnevi v tednu.
If you have been recommended to take the tablet once daily, take it at the same time every day.
Če vam je zdravnik predpisal jemanje tablet enkrat na dan, vzemite tableto vsak dan ob istem času.
If you have been recommended to take the tablets twice daily, this will help you remember to take a tablet every day in the morning and in the evening.
Če vam je zdravnik predpisal jemanje tablet dvakrat na dan, vam bo takšno pakiranje pomagalo, da se boste lažje spomnili, da morate tableto vzeti vsak dan zjutraj in zvečer.
This is important for an effective treatment.
To je pomembno za učinkovitost zdravljenja.
How to take SPRYCEL The tablets must be swallowed whole, not crushed.
Kako jemati zdravilo SPRYCEL Tablete morate pogoltniti cele, ne smete jih drobiti.
Special handling instructions for SPRYCEL In the unlikely event of the tablets being broken, persons other than the patient are recommended to use gloves when handling SPRYCEL.
Posebna navodila za ravnanje z zdravilom SPRYCEL Verjetnost, da bi se tablete zdrobile je sicer majhna, vendar pa osebam, ki niso bolniki, kljub temu pri rokovanju z zdravilom SPRYCEL priporočamo uporabo rokavic.
How long to take SPRYCEL You should take SPRYCEL daily until your doctor tells you to stop.
Kako dolgo jemati zdravilo SPRYCEL Zdravilo SPRYCEL morate jemati vsak dan dokler vam zdravnik ne naroči, da prenehajte z jemanjem zdravila.
If you take more SPRYCEL than you should If you have accidentally taken too many tablets, talk to your doctor immediately.
Če ste vzeli večji odmerek zdravila SPRYCEL, kot bi smeli Če ste slučajno vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.
If you forget to take SPRYCEL Do not take a double dose to make up for a forgotten tablet.
Če ste pozabili vzeti zdravilo SPRYCEL Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo tableto.
Like all medicines, SPRYCEL can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo SPRYCEL neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Tell your doctor immediately if you notice any of the following: if you have chest pain, difficulty breathing, coughing and fainting if you experience unexpected bleeding or bruising without having an injury if you find blood in your vomit, stools or urine, or have black stools if you get signs of infections such as fever, severe chills These can all be signs of serious side effects.
Če opazite kar koli od naslednjega, o tem nemudoma obvestite svojega zdravnika: če začutite bolečino v prsih, začnete oteženo dihati, kašljati ali omedlite če opazite nepojasnjeno krvavitev ali nastanek modrice brez predhodne poškodbe
97 Frequencies are defined as follows:
Pogostnost je navedena na naslednji način:
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data
pojavijo se pri več kot 1 od 10 bolnikov pojavijo se pri 1 do 10 bolnikih od 100 bolnikov pojavijo se pri 1 do 10 bolnikih od 1. 000 bolnikov pojavijo se pri 1 do 10 bolnikih od 10. 000 bolnikov pojavijo se pri manj kot 1 bolniku od 10. 000 bolnikov pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
Very common side effects Infections (including bacterial, viral and fungal) Heart and lungs: shortness of breath, cough Digestive problems: diarrhoea, feeling or being sick (nausea, vomiting) Skin, hair, eye, general: skin rash, fever, swelling around hands and feet, headache, feeling tired or weak, bleeding Pain: pain in the muscles, abdominal (tummy) pain Tests may show: low blood platelet count, low white blood cells count (neutropenia), anaemia, fluid around the lungs
Preiskave lahko pokažejo: zmanjšano število trombocitov, zmanjšano število belih krvnih celic (nevtropenija), anemijo in tekočino okrog pljuč.
Common side effects Infections: pneumonia, herpes viral infection, upper respiratory infection, serious infection of the blood or tissues (including fatal outcome) Heart and lungs: palpitations, flushing, dizziness, congestive heart failure, cardiac dysfunction, high blood pressure Digestive problems: appetite disturbances, taste disturbance, bloated or distended tummy (abdomen), inflammation of the colon, constipation, heartburn, mouth ulceration, weight increase, weight decrease, gastritis Skin, hair, eye, general: skin tingling, itching, dry skin, acne, inflamation of the skin, persistant noise in ears, hair loss, excessive perspiration, visual disorder (including blurred vision and disturbed vision), dry eye, haematoma, depression, insomnia, contusion, anorexia, somnolence, generalised oedema Pain: pain in joints, muscle inflammation, muscular weakness, chest pain, pain around hands and feet, chills Tests may show: fluid around the heart, fluid in the lungs, arrhythmia, febrile neutropenia, deficiency in all blood cells, gastrointestinal bleeding
Preiskave lahko pokažejo: tekočino okrog srca, tekočino v pljučih, motnje srčnega ritma, febrilno nevtropenijo, zmanjšanje števila vseh krvnih celic in krvavitve v prebavilih.
HOW TO STORE SPRYCEL
SHRANJEVANJE ZDRAVILA SPRYCEL
Do not use SPRYCEL after the expiry date which is stated on the label, blister or carton after EXP.
Zdravila SPRYCEL ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki, pretisnem omotu ali škatli poleg oznake “ Uporabno do ”.
Medicines should not be disposed of via wastewater or household waste.
103 Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
What SPRYCEL contains The active substance is dasatinib.
Kaj vsebuje zdravilo SPRYCEL Zdravilna učinkovina je dasatinib.
Each film-coated tablet contains 20 mg, 50 mg, 70 mg or 100 mg dasatinib (as monohydrate).
Ena filmsko obložena tableta vsebuje 20 mg, 50 mg, 70 mg ali 100 mg dasatiniba (v obliki monohidrata).
Tablet core: lactose monohydrate; cellulose, microcrystalline; croscarmellose sodium; hydroxypropyl cellulose; magnesium stearate Film-coating: hypromellose; titanium dioxide; macrogol 400
Jedro tablete: laktoza monohidrat, mikrokristalna celuloza, premreženi natrijev karmelozat, hidroksipropilceluloza in magnezijev stearat Filmska obloga: hipromeloza, titanov dioksid in makrogol 400
What SPRYCEL looks like and contents of the pack SPRYCEL 20 mg: the film-coated tablet is white to off-white, biconvex, round with “ BMS ” debossed on one side and “ 527” on the other side.
Izgled zdravila SPRYCEL in vsebina pakiranja SPRYCEL 20 mg: bele do sivobele, bikonveksne in okrogle filmsko obložene tablete z oznako “ BMS ” na eni in “ 527 ” na drugi strani.
SPRYCEL 50 mg: the film-coated tablet is white to off-white, biconvex, oval with “ BMS ” debossed on one side and “ 528” on the other side.
SPRYCEL 50 mg: bele do sivobele, bikonveksne in ovalne filmsko obložene tablete z oznako “ BMS ” na eni in “ 528 ” na drugi strani.
SPRYCEL 70 mg: the film-coated tablet is white to off-white, biconvex, round with “ BMS ” debossed on one side and “ 524” on the other side.
SPRYCEL 70 mg: bele do sivobele, bikonveksne in okrogle filmsko obložene tablete z oznako “ BMS ” na eni in “ 524 ” na drugi strani.
SPRYCEL 100 mg: the film-coated tablet is white to off-white, biconvex, oval with “ BMS 100 ” debossed on one side and “ 852” on the other side.
SPRYCEL 100 mg: bele do sivobele, bikonveksne in ovalne filmsko obložene tablete z oznako “ BMS 100 ” na eni in “ 852 ” na drugi strani.
SPRYCEL 20 mg, 50 mg or 70 mg film-coated tablets are available in cartons containing 56 film-coated tablets in 4 blisters of 14 film-coated tablets each, and in cartons containing 60 film-coated tablets in perforated unit dose blisters. They are also available in bottles with child resistant closure containing 60 film-coated tablets.
Na voljo je tudi v plastenkah z za otroke varnimi zaporkami, ki vsebujejo 60 filmsko obloženih tablet.
SPRYCEL 100 mg film-coated tablets are available in cartons containing 30 film-coated tablets in perforated unit dose blisters.
Zdravilo SPRYCEL 100 mg filmsko obložene tablete je na voljo v škatlah s 30 filmsko obloženimi tabletami v perforiranih enoodmernih pretisnih omotih.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Velika Britanija
Manufacturer Bristol-Myers Squibb Rue du Docteur André Gilles 28230 Epernon France
Bristol- Myers Squibb Rue du Docteur André Gilles 28230 Epernon Francija
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu There are also links to other websites about rare diseases and treatments.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
It is available as a range of brown oval tablets containing levodopa and carbidopa in four doses (50 mg levodopa and 12.5 mg carbidopa, 100 mg levodopa and 25 mg carbidopa, 150 mg levodopa and 37.5 mg carbidopa, or 200 mg levodopa and 50 mg carbidopa).
Zdravilo je na voljo v obliki rjavih ovalnih tablet, ki vsebujejo levodopo in karbidopo v štirih različnih odmerkih (50 mg levodope in 12, 5 mg karbidope, 100 mg levodope in 25 mg karbidope, 150 mg levodope in 37, 5 mg karbidope ali 200 mg levodope in 50 mg kardidope).
All of the tablets contain the same dose of entacapone (200 mg).
Vse tablete vsebujejo enak odmerek entakapona (200 mg).
Stalevo is used to treat patients with Parkinson’ s disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Zdravilo Stalevo se uporablja za zdravljenje bolnikov s Parkinsonovo boleznijo, napredujoče bolezni možganov, ki povzroči tresenje, počasno gibanje in okorelost mišic.