natgillin/translations-raw huggingface dataset:
The powder should be mixed in the vial with a small amount of solution.
Te viale dobavljajo bolnišnicam na podstavkih s po desetimi vialami.
The vial should be gently swirled until the medicine is dissolved.
Vialo je treba nežno sukati, dokler se zdravilo ne raztopi.
Thereafter, the solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag or other suitable infusion container in the hospital.
Nato je treba raztopino takoj z brizgo posrkati iz viale in jo dodati 100- mililitrski vrečki za intravensko infundiranje ali kakšnemu drugemu primernemu infuzijskemu vsebniku v bolnišnici.
Wyeth Europa Ltd.
Wyeth Pharmaceuticals Wyeth Europa Ltd.
Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH United Kingdom
New Lane Huntercombe Lane South Havant Taplow, Maidenhead Hampshire PO9 2NG Berkshire, SL6 0PH Velika Britanija Velika Britanija
Wyeth Pharmaceuticals New Lane Havant Hampshire PO9 2NG United Kingdom
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
België/ Belgique/ Belgien Luxembourg/ Luxemburg
Malta V. J.
Malta Danmark V. J.
Tel: +35621 220174 Fax: +35621 243026
Wyeth Danmark Tel: +35621 220174 Tlf: +45 44 88 88 05 Fax: +35621 243026 Fax: +45 44 88 88 06
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Norge България/ Eesti/ Latvija/ Lietuva / Wyeth Österreich/ România/ Slovenija Tlf: +47 40 00 2340 Wyeth- Lederle Pharma GmbH Fax: +47 40 00 2341 Teл. / Tel/ Tãlr: +43 1 89 1140 Факс/ Faks/ Fakss/ Faksas/ Fax: +43 1 89 114600
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Tel: +354 540 8000 Fax: +354 540 8001
Tel: +46 8 470 3200 Tel: +354 540 8000 Fax: +46 8 730 0666 Fax: +354 540 8001
Italia Wyeth Lederle S. p. A.
United Kingdom Italia Wyeth Pharmaceuticals Wyeth Lederle S. p. A.
Tel: +39 06 927151 Fax: +39 06 23325555
Tel: +44 845 367 0098 Tel: +39 06 927151 Fax: +44 1628 414802 Fax: +39 06 23325555
26 Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
HOW TYGACIL IS GIVEN in this leaflet)
KAKO UPORABLJATI ZDRAVILO TYGACIL v tem navodilu za uporabo)
The lyophilised powder should be reconstituted with 5.3 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection or dextrose 50 mg/ ml (5%) solution for injection to achieve a concentration of 10 mg/ ml of tigecycline.
Liofilizirani prašek morate rekonstituirati s 5, 3 ml 0, 9- odstotne (9 mg/ ml) raztopine natrijevega klorida za injiciranje ali 5- odstotne (50 mg/ ml) raztopine glukoze za injiciranje, tako da dosežete koncentracijo 10 mg/ ml tigeciklina.
The vial should be gently swirled until the active substance is dissolved.
Vialo nežno sukajte, dokler se zdravilna učinkovina ne raztopi.
Thereafter, 5 ml of the reconstituted solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag for infusion or other suitable infusion container (e. g. glass bottle).
Takoj nato odvzemite 5 ml rekonstituirane raztopine iz viale in jo dodajte v 100- mililitrsko vrečko za intravensko infuzijo ali drug primeren vsebnik za infuzijo (na primer steklenico).
For a 100 mg dose, reconstitute using two vials into a 100 ml intravenous bag for infusion or other suitable infusion container (e. g. glass bottle).
Za 100- miligramski odmerek rekonstituirajte dve viali v 100- mililitrsko vrečko za intravensko infuzijo ali drug primeren vsebnik za infuzijo (na primer steklenico).
Parenteral products should be inspected visually for particulate matter and discolouration (e. g. green or black) prior to administration.
Zdravila za parenteralno uporabo morate s prostim očesom pregledati, da se prepričate, da ne vsebujejo delcev in da niso drugačne barve (na primer zelene ali črne), preden jih vbrizgate bolniku.
Tygacil may be administered intravenously through a dedicated line or through a Y-site.
25 Tygacil lahko dajete intravensko po posebni infuzijski cevki po ločenem infuzijskem kanalu ali skozi podaljšek Y.
Injection should be made with an infusion solution compatible with tigecycline and any other medicinal product(s) via this common line.
Injicirati morate z infuzijsko raztopino, ki je kompatibilna s tigeciklinom in morebitnim / - i drugim / - i zdravilom / – i, po tej skupni infuzijski cevki.
Compatible intravenous solutions include: sodium chloride 9 mg/ ml (0.9%) solution for injection and dextrose 50 mg/ ml (5%) solution for injection.
Med kompatibilnimi intravenskimi raztopinami sta raztopina natrijevega klorida v koncentraciji 9 mg/ ml (0, 9%) za injiciranje in raztopina glukoze v koncentraciji 50 mg/ ml (5%) za injiciranje.
When administered through a Y-site, compatibility of Tygacil diluted in sodium chloride 0.9% for injection is demonstrated with the following medicinal products or diluents: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidol, Lactated Ringer’ s, lidocaine HCl, morphine, norepinephrine, piperacillin/ tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine HCl, theophylline, and tobramycin.
Kompatibilnost Tygacila, razredčenega z 0, 9- odstotnim natrijevim kloridom za injiciranje, pri injiciranju v intravenski kanal so dokazali za naslednja zdravila in vehikle: amikacin, dobutamin, dopaminijev klorid, gentamicin, haloperidol, Ringerjev laktat, lidokainijev klorid, morfin, noradrenalin, piperacilin/ tazobaktam (pripravek z EDTA), kalijev klorid, propofol, ranitidinijev klorid, teofilin in tobramicin.
Once reconstituted and diluted in the bag or other suitable infusion container (e. g. glass bottle) tigecycline should be used immediately.
Ko je tigeciklin rekonstituiran in razredčen v vrečki ali drugem primernem vsebniku za infundiranje (na primer steklenici), ga morate uporabiti takoj.
For single use only, any unused solution should be discarded.
Samo za enkratno uporabo, morebitno neporabljeno raztopino morate zavreči.
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 • POGOJI ALI OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE ZDRAVILA, KI JIH MORAKO UVESTI DRŽAVE ČLANICE
The Member States shall ensure that:
Država članica mora zagotoviti, da:
The Marketing Authorisation Holder will implement nationally, prior to marketing, and as agreed with the competent authorities in the Member States that all physicians who intend to prescribe Tysabri are provided with a physician pack containing the following elements:
Imetnik dovoljenja za promet z zdravilom mora, pred prometom z zdravilom in skladno z dogovorom s pristojnimi organi v državah članicah, v nacionalnem okviru zagotoviti, da bodo vsi zdravniki, ki bodo predpisovali zdravilo, dobili zdravniško pakiranje, ki bo vsebovalo sledeče elemente:
• Product information • Physician information about Tysabri • Patient alert card
• Podatke o zdravilu • Informacije o zdravilu Tysabri za zdravnike • Kartico s posebnimi opozorili za bolnika
The physician information about Tysabri shall contain the following key elements: • Restricted indication • Atypical/ opportunistic infections in particular PML including: o Diagnosis of PML including differentiation between PML and MS relapse o PML management algorithm o Possibility of other opportunistic infections • Infusion reactions • Hypersensitivity reactions • Antibody formation • Need to inform patients about the benefits and risk of Tysabri and provide them with a patient alert card.
Diagnozo PML, vključno z diferenciacijo PML in recidiva multiple skleroze o Algoritem upravljanja PML o Možnost drugih oportunističnih okužb o • Reakcije na infuzijo • Preobčutljivostne reakcije • Nastajanje protiteles • Potreba, da se bolnike obvesti o koristih in tveganjih zdravljenja z zdravilom Tysabri in se jim da kartico s posebnimi opozorili.
Tysabri is a concentrate that is made up into a solution for infusion (drip into a vein).
Zdravilo Tysabri je koncentrat, ki se pripravi v raztopino za infundiranje (dajanje v veno po kapljicah).
It contains the active substance natalizumab.
Zdravilo Tysabri vsebuje 300 mg u inkovine natalizumab.
What is Tysabri used for?
Za kaj se zdravilo Tysabri uporablja?
Tysabri is used to treat adults with multiple sclerosis (MS).
Zdravilo Tysabri se uporablja za zdravljenje odraslih bolnikov z multiplo sklerozo (MS).
It is used in the type of MS known as ‘ relapsing-remitting’, when the patient has attacks (relapses) followed by periods with no symptoms (remissions).
Uporablja se pri tipu MS, ki je znan kot recidivno- remitentna multipla skleroza, ko ima bolnik napade (recidive), ki jim sledijo obdobja brez simptomov (remisija).
It is used when the disease is: • highly active despite treatment with a beta-interferon (another type of medicine used in MS), or; • severe and getting worse rapidly.
Uporablja se, e je bolezen: • zelo aktivna kljub zdravljenju z beta interferonom (drugo vrsto zdravila za zdravljenje MS) ali • resna in se hitro slabša.
Treatment with Tysabri should be started and supervised by a doctor who is experienced in treating diseases of the nervous system, and who has access to a type of scanning machine called a magnetic resonance imaging (MRI) machine.
Zdravljenje z zdravilom Tysabri mora za eti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem nevroloških bolezni in ki ima na voljo napravo za magnetnoresonan no slikanje (MRI).
This machine will enable the doctor to check for changes in the brain linked to MS or the rare brain infection called progressive multifocal leukoencephalopathy (PML).
Ta naprava omogo a zdravniku, da spremlja spremembe v možganih, povezane z MS, in opazi redko okužbo možganov, imenovano progresivna multifokalna levkoencefalopatija (PML).
Tysabri is given as one infusion lasting one hour every four weeks.
Zdravilo Tysabri se daje kot enourna infuzija vsake štiri tedne.
If there is no clear benefit for the patient after six months, the doctor will have to re-assess the treatment.
Ker lahko infuzija izzove alergijsko reakcijo, je treba bolnika opazovati med infundiranjem in do ene ure po njem. e po šestih mesecih zdravljenja pri bolniku ni vidnega izboljšanja stanja, mora zdravnik pretehtati nadaljevanje zdravljenja.
Patients who receive Tysabri must be given a special alert card that summarises the key safety information about the medicine.
Bolnik, ki dobiva zdravilo Tysabri, mora prejeti posebno opozorilno kartico, ki povzema klju ne informacije o varnosti zdravila.
Patients should show this card to their partner or carer, as well as to other doctors treating them, because they may notice symptoms of PML that the patient is not aware of, such as changes in mood, behaviour or speech.
Bolniki naj to kartico pokažejo partnerju ali skrbniku ali drugim zdravnikom, ki jih zdravijo, saj lahko ti opazijo simptome PML, ki se jih bolnik ne zaveda, kot so spremembe razpoloženja, vedenja ali govora.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged Kako zdravilo Tysabri deluje?
MS is a disease of the nerves, in which inflammation destroys the protective sheath surrounding the nerve cells.
Zdravilna u inkovina v zdravilu Tysabri, natalizumab, je monoklonsko protitelo.
By blocking the integrin, natalizumab stops the leucocytes from going from the blood into the brain.
Natalizumab je bil oblikovan, da se veže na specifi ni del integrina, imenovan „ integrin 4 1 “.
This reduces inflammation, and the nerve damage caused by MS.
MS je bolezen živcev, pri kateri vnetje uni i zaš itno ovojnico, ki obkroža živ ne celice.
The effects of Tysabri were first tested in experimental models before being studied in humans.
U inki zdravila Tysabri so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Two studies, both lasting two years, have looked at Tysabri in MS.
Uporabo zdravila Tysabri pri zdravljenju MS so prou evali v dveh študijah, obeh trajajo ih dve leti.
One study compared Tysabri on its own (monotherapy) with placebo (a dummy treatment) in 942 patients.
V okviru prve študije so pri 942 bolnikih zdravilo Tysabri kot monoterapijo primerjali s placebom (zdravilom brez zdravilne u inkovine).
The second study looked at the effect of adding Tysabri to interferon beta-1a (another medicine used in MS) in 1,171 patients.
V okviru druge študije so pri 1 171 bolnikih opazovali u inek dodajanja zdravila Tysabri interferonu beta- 1a (drugemu zdravilu, ki se uporablja pri MS).
The main measures of effectiveness were the number of relapses, and the changes in the patients’ level of disability, measured using a standard scale (the Expanded Disability Status Scale).
Glavno merilo u inkovitosti je bilo število recidivov in spremembe v bolnikovi invalidnosti, merjene z uporabo standardne lestvice (razširjena lestvica stanja prizadetosti (EDSS)).
In the monotherapy study, Tysabri was more effective than placebo in reducing the number of relapses.
Pri študiji, v kateri je bilo zdravilo Tysabri uporabljeno kot monoterapija, je bilo pri zmanjševanju števila recidivov bolj u inkovito od placeba. po enem letu je prišlo pri bolnikih, zdravljenih z zdravilom Tysabri, do približno dvotretjinskega zmanjšanja števila napadov MS v primerjavi z bolniki, ki so prejemali placebo.
After one year, there was a decrease of about two-thirds in the number of MS attacks in Tysabri-treated patients, in comparison with the patients who received placebo.
Prav tako se je zdravilo Tysabri izkazalo za u inkovitejše v primerjavi s placebom pri invalidnih u inkih MS.
Tysabri was also more effective than placebo on the disabling effects of MS: over two years, the risk of disability getting worse was reduced by 42% in comparison with placebo.
V dveletnem obdobju je bilo tveganje poslabšanja invalidnosti v primerjavi s placebom manjše za 42%.
However, the way the study was designed did not allow the clear identification of whether these results were due to Tysabri only, or to the combination.
V dodatni študiji z interferonom beta- 1a sta bila zmanjšana tako tveganje za poslabšanje invalidnosti kot število recidivov, vendar pa zaradi zasnove študije ni bilo mogo e jasno opredeliti, ali so ti rezultati posledica zdravila Tysabri samega ali kombinacije.
Patients, carers and doctors need to be aware that Tysabri can be associated with infections, including PML.
Bolniki, njihovi skrbniki in zdravniki se morajo zavedati, da je zdravilo Tysabri možno povezati z okužbami, vklju no z redko okužbo možganov, imenovano PML (progresivna multifokalna levkoencefalopatija).
PML has symptoms that are similar to those of an MS attack, and usually leads to severe disability or death.
PML ima simptome, ki so podobni simptomom napada MS.
If PML is suspected, the doctor must stop treatment until it is certain that the patient does not have the infection.
PML po navadi vodi do resne invalidnosti ali smrti. e obstaja sum na PML, mora zdravnik prekiniti zdravljenje, dokler ni jasno, da bolnik nima okužbe.
In the studies, the most common side effects with Tysabri (seen in between 1 and 10 patients in 100) were urinary tract infection (infections of the structures that carry urine), nasopharyngitis (inflammation of the nose and throat), urticaria (rash), headache, dizziness, vomiting, nausea (feeling sick), arthralgia (joint pain), rigors (shaking chills), pyrexia (fever) and fatigue (tiredness).
V študijah so bili najpogostejši neželeni u inki zdravila Tysabri (opaženi pri 1 do 10 bolnikih od 100) okužbe se il, okužbe nosu in žrela, urtikarija (izpuš aji), glavobol, omotica, bruhanje, navzeja (ob utek slabosti), artralgija (bole ine v sklepih), rigor (tresavica), pireksija (povišana telesna temperatura) in utrujenost.
For the full list of all side effects reported with Tysabri, see the Package Leaflet.
Za celoten seznam neželenih u inkov, o katerih so poro ali pri uporabi zdravila Tysabri, glejte navodilo za uporabo.
This led to a decrease in the effectiveness of the medicine.
Pri približno 6% bolnikov so se razvila trdovratna (obstojna) protitelesa proti natalizumabu, kar je privedlo do zmanjšanja u inkovitosti zdravila.
Tysabri should not be used in people who may be hypersensitive (allergic) to natalizumab or any of the other ingredients.
Zdravila Tysabri ne smejo uporabljati osebe, ki utegnejo biti preob utljive za (alergi ne na) natalizumab ali katero koli drugo sestavino zdravila.
It must not be given to patients who have PML or who are at risk of getting an infection, including patients whose immune systems are weakened because of disease or other medicines they are receiving or may have received before.
Zdravilo se ne sme dajati bolnikom, ki imajo PML ali pri katerih obstaja nevarnost okužbe, kot so npr. bolniki z oslabljenim imunskim sistemom kot posledico bolezni ali zdravil, ki jih prejemajo ali so jih prejemali v preteklosti.
Tysabri must not be given with beta-interferon or glatiramer acetate (other long-term medicines for MS).
Zdravilo Tysabri se ne sme dajati z interferonom beta ali glatiramer acetatom (drugi vrsti zdravil za dolgotrajno zdravljenje MS).
It also must not be given to patients who have cancer (unless it is a type of skin cancer called basal cell carcinoma) or to people under 18 years of age.
Ne sme se dajati bolnikom, ki imajo raka (razen e gre za kožni rak, imenovan bazocelularni karcinom kože) ali mlajšim od 18 let.
However, because of its safety profile, the medicine should only be used in patients who have a real need for the medicine.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da je bila u inkovitost zdravila Tysabri pri zdravljenju MS tako z vidika recidivov kot napredovanja invalidnosti nedvoumno dokazana, vendar pa ga je zaradi njegovega varnostnega profila dopustno uporabljati le pri bolnikih, ki zdravilo resni no potrebujejo.
The Committee decided that Tysabri’ s benefits are greater than its risks as single disease modifying therapy in highly active relapsing remitting MS for patients with high disease activity despite treatment with a beta-interferon, or with rapidly evolving severe relapsing remitting MS.
Odbor je odlo il, da so koristi zdravila Tysabri za zdravljenje, ki vpliva 2/ 3 na eno bolezen, pri visoko aktivni recidivno- remitentni MS pri bolnikih, katerih bolezen je zelo aktivna kljub zdravljenju z beta interferonom ali pri hitro napredujo i hudi recidivno- reminentni MS, ve je od z njim povezanih tveganj.
The Committee recommended that Tysabri be given marketing authorisation.
Odbor je priporo il, da se za zdravilo Tysabri odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of Tysabri?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Tysabri?
The company that makes Tysabri will ensure that all doctors who prescribe Tysabri are supplied with an educational pack that gives them all the information they need to ensure that the medicine is used appropriately, and that the patients are closely monitored.
Družba, ki izdeluje zdravilo Tysabri, bo poskrbela, da bodo vsi zdravniki, ki predpisujejo zdravilo Tysabri, prejeli paket za usposabljanje z vsemi informacijami, potrebnimi za zagotovitev pravilne uporabe zdravila in skrbnega spremljanja bolnikov.
2/ 3 Other information about Tysabri:
Druge informacije o zdravilu Tysabri:
The European Commission granted a marketing authorisation valid throughout the European Union for Tysabri to Elan Pharma International Ltd on 27 June 2006.
Evropska komisija je dovoljenje za promet z zdravilom Tysabri, veljavno po vsej Evropski uniji, odobrila družbi Elan Pharma International Ltd dne 27. junija 2006.
The full EPAR for Tysabri can be found here.
Celotno evropsko javno poro ilo o oceni zdravila (EPAR) za zdravilo Tysabri je na voljo tukaj.
TYSABRI 300 mg concentrate for solution for infusion.
TYSABRI 300 mg koncentrat za raztopino za infundiranje.
Each ml of concentrate contains 20 mg of natalizumab.
Vsak ml koncentrata vsebuje 20 mg natalizumaba.
Natalizumab is a recombinant humanised anti-α 4-integrin antibody produced in a murine cell line by recombinant DNA technology.
Natalizumab je rekombinantno humanizirano anti- α4- integrin protitelo, proizvedeno na celični liniji miši in podgan z uporabo tehnologije rekombinantne DNA.
When diluted (see section 6.6), the solution for infusion contains approximately 2.6 mg/ ml of natalizumab.
Razredčena raztopina za infundiranje (glejte poglavje 6. 6) vsebuje približno 2, 6 mg/ ml natalizumaba.
TYSABRI is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following patient groups:
Zdravilo TYSABRI je indicirano kot terapija, ki spreminja potek bolezni pri zelo aktivni recidivni remitentni multipli sklerozi, za sledeči skupini bolnikov:
• Patients with high disease activity despite treatment with a beta-interferon (see section 5.1);
• Bolniki z zelo aktivno boleznijo, kljub zdravljenju z interferonom beta (glejte poglavje 5. 1);
• Patients with rapidly evolving severe relapsing remitting multiple sclerosis (see section 5.1).
• bolniki s hitro razvijajočo se hudo recidivno remitentno multiplo sklerozo (glejte poglavje 5. 1).
TYSABRI therapy is to be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI.
Zdravljenje z zdravilom TYSABRI mora začeti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju nevroloških bolezni, v centrih s pravočasnim dostopom do MRT (slikanja z magnetno resonanco).
Patients treated with TYSABRI must be given the patient alert card.
Bolnikom, ki se zdravijo z zdravilom TYSABRI, je treba izročiti bolnikovo varnostno kartico.
Resources for the management of hypersensitivity reactions and access to MRI should be available.
Na voljo morajo biti viri za upravljanje s preobčutljivostnimi reakcijami in dostop do MRT.
If there are signs of
Bolniki lahko direktno preidejo iz interferona beta ali glatiramer acetata na natalizumab, če ne kažejo znakov pomembnih bolezenskih sprememb, povezanih z zdravljenjem, npr. nevtropenije.
2 treatment-related abnormalities these must return to normal before treatment with natalizumab is started.
2 Nekateri bolniki so bili morda zdravljeni z zaviralci imunskega odziva (npr. mitoksantron, ciklofosfamid, azatioprin).
These drugs have the potential to cause prolonged immunosuppression, even after dosing is discontinued.
Ta zdravila lahko podaljšajo imunosupresijo tudi po prekinitvi zdravljenja.
Therefore the physician must confirm that such patients are not immunocompromised before starting treatment with TYSABRI.
Zdravnik mora potrditi ustrezno odpornost pri bolnikih, preden začnejo zdravljenje z zdravilom TYSABRI.