natgillin/translations-raw huggingface dataset:
8 Some fatal cases of hepatic failure and of hepatic necrosis have been reported.
Poročali so o nekaj primerih odpovedi jeter in nekroze jeter s smrtnim izidom.
During treatment with Imatinib Teva, tell your doctor straight away if you put on weight very quickly.
Če med jemanjem zdravila Imatinib Teva začnete hitro pridobivati telesno maso, takoj obvestite zdravnika.
1200 mg to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache, decreased appetite.
Odrasla populacija Odmerki od 1200 mg do 1600 mg (trajanje zdravljenja od 1 do 10 dni): navzea, bruhanje, driska,
This change is not thought to be clinically significant.
Navedba smiselno ni potrebna.
- If you are being treated for CML: Depending on your condition the usual starting dose is either 400 mg or 600 mg: 400 mg to be taken as 1 capsule once a day, 600 mg to be taken as 1 capsule of 400 mg plus 2 capsules of 100 mg once a day.
- 400 mg vzamete kot 1 kapsulo enkrat na dan, 600 mg vzamete kot 1 kapsulo po 400 mg in še 2 kapsuli po 100 mg enkrat na dan.
Pack sizes of 60 or 120 film-coated tablets in blisters.
Škatle, ki vsebujejo po 30 ali 90 filmsko obloženih tablet v pretisnem omotu.
monthly for 13 months; Prednisolone 200 mg oral, 5 days per month for 13 months All treatment regimens include administration of steroids for CNS prophylaxis.
prednizolon 200 mg peroralno, 5 dni na mesec v obdobju 13 mesecev
ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3 G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir
in 3. dan G-CSF (5 μg/kg, s.c.): 4.-13. dan oziroma do ANC > 1500 po doseženem najnižjem številu
Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction
pruritus, edem obraza, suha koža, eritem,
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 400 mg film-coated tablets imatinib
NAVODILO ZA UPORABO Imatinib Teva 400 mg filmsko obložene tablete imatinib
Clinical studies in chronic myeloid leukaemia
Za otroke s kronično fazo KML
Daunorubicin 45 mg/m2 i.v., days 6-7, 13-14
daunorubicin 30 mg/m2 i.v., 1.-3., 15.-16. dan;
bone marrow, peripheral blood basophils < 20%, platelets > 100 x 10
< 30 %, blasti in promielociti skupaj ≥ 30 % v krvi ali kostnem mozgu (pogoj: blasti < 30 %), bazofilci v periferni krvi ≥ 20 %, trombociti < 100 x 10
Neutropenia, thrombocytopenia, anaemia
nevtropenija, trombocitopenija, anemija pogosti:
ANC < 0.5 x 10
Če se pojav/a ANC < 1,0 x
In CML, cytopenias, particularly neutropenia and thrombocytopenia, have been a consistent finding in all studies, with the suggestion of a higher frequency at high doses ≥ 750 mg (phase I study).
Podatki kažejo, da so lahko citopenije pogostejše pri velikih odmerkih ≥ 750 mg (študija prve faze),
Breast-feeding
propilenglikol
400 mg to be taken as 4 tablets once a day,
- 400 mg vzamete kot 4 tablete enkrat na dan, 600 mg vzamete kot 6 tablet enkrat na dan.
Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
(E172), smukec, titanov dioksid (E171), rdeči železov oksid (E172).
Imatinib Teva is also a treatment for adults for: - Myelodysplastic/myeloproliferative diseases (MDS/MPD).
- z mielodisplastičnimi/mieloproliferativnimi boleznimi (MDS/MPD).
CPM (300 mg/m2/day, IV): days 22-26
): 3. in 4. dan CPM (250 mg/m
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib until ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l, then resume treatment at 200 mg/m2.
dokler ni ANC ≥ 1 x 109/l in koncentracija trombocitov ≥ 20 x 109/l, nato spet začnite zdravljenje z odmerkom 200 mg/m2.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Ena filmsko obložena tableta vsebuje 100 mg imatiniba (v obliki mesilata).
G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir ARA-C (3 g/m2, q12h, IV): days 43, 44
G-CSF (5 μg/kg, s.c.): 27.-36. dan oziroma do ANC > 1500 po doseženem najnižjem številu
Pharmacokinetics in paediatric population
Posebne skupine bolnikov Uporaba v pediatriji
Hepatic failure8, hepatic necrosis Skin and subcutaneous tissue disorders Very common
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti:
In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 300 mg.
109/l in/ali koncentracija trombocitov < 50 x 109/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z imatinibom z zmanjšanim odmerkom 300 mg.
MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir
): 22.-26. dan G-CSF (5 μg/kg, s.c.):27.-36. dan oziroma do ANC > 1500 po doseženem najnižjem številu
VCR (1.5 mg/m2/day, IV): days 1, 8, and 15
VCR (1,5 mg/m2/dan, i.v.
MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
zdravljenje (prilagojeno na starost): 1. in 15. dan DEX (6 mg/m2/dan, peroralno): 1.-7. dan in 15.-21. dan 2. intenzifikacijski blok metotreksat (5 g/m2 v času 24 ur, i.v.
DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m i.v., days 3, 4, 5; MTX 12 mg intrathecal, day 1
daunorubicin 30 mg/m2 i.v., 1.-3., 15.-16. dan; VCR skupni odmerek 2 mg i.v., 1., 8., 15., 22. dan; CP 750 mg/m2 i.v., 1., 8. dan;
Ara-C 1,000 mg/m2/12 h i.v.
ARA-C (3 g/m2, vsakih 12 ur, i.v.
Weight increased
Preveliko odmerjanje
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Ena filmsko obložena tableta vsebuje 400 mg imatiniba (v obliki mesilata).
Frequency categories are defined using the following convention: very common
Splošne težave in spremembe na mestu aplikacije zelo pogosti:
If cytopenia persists for 2 weeks, reduce further to 300 mg.
Če citopenija traja 2 tedna,
Dyspnoea, epistaxis, cough
disfagija, pankreatitis redki:
CPM (250 mg/m2/dose q12h x 4 doses, iv): Days 3 and 4 PEG-ASP (2500 IUnits/m2, IM): day 4
): 1. in 2. dan CPM (250 mg/m2/odmerek vsakih 12 ur x 4 odmerki, i.v.
600 mg to be taken as 6 capsules once a day.
- 400 mg vzamete kot 4 kapsule enkrat na dan, 600 mg vzamete kot 6 kapsul enkrat na dan.
Name and address of the manufacturers responsible for batch release Teva Czech Industries s.r.o.
Ime in naslov izdelovalca, odgovornega za sproščanje serije
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 100 mg of imatinib (as mesilate).
Ena trda kapsula vsebuje 100 mg imatiniba (v obliki mesilata).
Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema
draženje očesa, bolečine v očesu, orbitalni edem, krvavitev v beločnico, krvavitev v mrežnico,
Tumour haemorrhage/tumour necrosis* Immune system disorders Not known
sindrom tumorske lize pogostnost neznana:
Reproductive system and breast disorders Uncommon
Infekcijske in parazitske bolezni občasni:
Methotrexate (5 g/m over 24 hours, IV): day 1 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6
): 1. in 15. dan levkovorin (75 mg/m2 36 ur po začetku, i.v.
Cardiac disorders Uncommon
glivične okužbe pogostnost neznana:
This summary was last updated on 22/04/2013.
Povzetek je bil nazadnje posodobljen dne 22/04/2013.
In very rare cases they may be serious or fatal.
V zelo redkih primerih so lahko resni ali smrtno nevarni.
The European Commission granted a marketing authorisation valid throughout the European Union, for Meloxidolor on 22/04/2013.
Evropska komisija je dovoljenje za promet z zdravilom Meloxidolor, veljavno po vsej Evropski uniji, odobrila dne 22/04/2013.
It must not be used in cats weighing less than 2 kg.
Zdravilo se ne sme uporabljati pri mačkah, lažjih od 2 kg.
If someone accidentally injects themselves with the medicine, the advice of a doctor should be sought immediately.
Če si kdo po nesreči injicira to zdravilo, naj se takoj posvetuje z zdravnikom.
For meat the withdrawal period is 15 days and for milk it is five days.
Za meso je obdobje karence 15 dni, za mleko pa pet dni.
In dogs, these generally occur within the first week of treatment and usually disappear once treatment has stopped.
Pri psih se ti neželeni učinki v splošnem pojavijo v prvem tednu zdravljenja in po končanem zdravljenju običajno minejo.
For meat the withdrawal period is five days.
Za meso je obdobje karence pet dni.
The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Meloxidolor has been considered to be bioequivalent to Metacam.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je menil, da je v skladu z zahtevami Evropske unije zdravilo Meloxidolor biološko enakovredno zdravilu Metacam.
As Meloxidolor is considered to be bioequivalent to the reference medicine, its benefit is taken as being the same as that of the reference medicine.
Ker je zdravilo Meloxidolor biološko enakovredno referenčnemu zdravilu, se njegove koristi obravnavajo kot enake koristim referenčnega zdravila.
Other information about Meloxidolor:
Druge informacije o zdravilu Meloxidolor:
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Meloxidolor.
Osebe, ki so preobčutljive za (alergične na) nesteroidna protivnetna zdravila, naj se izogibajo stiku z zdravilom Meloxidolor.
Pregnant women and women of child-bearing potential should not administer Meloxidolor as meloxicam may be harmful for the foetus and unborn child.
Noseče ženske in ženske, ki bi lahko zanosile, naj zdravila Meloxidolor ne dajejo, ker je meloksikam lahko škodljiv za plod ali nerojenega otroka.
It is available as a solution for injection (5 mg/ml, 20 mg/ml and 40 mg/ml).
Na voljo je kot raztopina za injiciranje (5 mg/ml, 20 mg/ml in 40 mg/ml).
What benefit has Meloxidolor shown during the studies?
Kakšne koristi je zdravilo Meloxidolor izkazalo med študijami?
It is also the time allowed after administration of the medicine before the milk can be used for human consumption.
To je tudi čas, ki mora preteči po dajanju zdravila, preden se lahko mleko uporabi za prehrano ljudi.
In horses, a temporary swelling at the injection site can occur but resolves without intervention.
Pri konjih se lahko na mestu vboda pojavi začasna oteklina, ki mine brez intervencije.
It must not be used in animals which are hypersensitive (allergic) to the active substance or to any of the other ingredients.
Zdravilo se ne sme uporabljati pri živalih, ki so preobčutljive za (alergične na) zdravilno učinkovino ali katero koli drugo sestavino zdravila.
Meloxidolor meloxicam
Meloxidolor meloksikam
Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Meloksikam zavira encime, imenovane ciklooksigenaza, ki sodelujejo pri nastajanju prostaglandinov.
In very rare cases, potentially serious or fatal anaphylactoid reactions (similar to severe allergic reactions) may occur following administration of the solution for injection and should be treated symptomatically.
Zelo redko se lahko po dajanju raztopine za injiciranje pojavijo potencialno resne ali smrtno nevarne anafilaktoidne reakcije (podobne hudim alergičnim reakcijam), ki jih je treba zdraviti simptomatsko.
The product is not authorised for use in horses producing milk for human consumption.
Zdravilo ni dovoljeno za uporabo pri konjih v laktaciji, katerih mleko je namenjeno prehrani ljudi.
This means that Meloxidolor is similar to a ‘reference veterinary medicine' containing the same active substance, but it is also available at a higher strength.
To pomeni, da je podobno referenčnemu zdravilu za uporabo v veterinarski medicini, saj vsebuje enako zdravilno učinkovino, vendar je na voljo tudi v večji jakosti.
For intravenous use no studies in animals were needed as Meloxidolor contains the same active substance as the reference medicine Metacam.
Za intravenozno uporabo pri živalih niso bile potrebne nobene študije, saj zdravilo Meloxidolor vsebuje enako zdravilno učinkovino kot referenčno zdravilo Metacam.
As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Ker so prostaglandini snovi, ki sprožajo vnetje, bolečino, izločanje tekočine (ki med vnetjem uhaja iz krvnih žil) in zvišano telesno temperaturo, meloksikam te bolezenske znake zmanjšuje.
Therefore the CVMP's view was that, as for Metacam, Meloxidolor's benefits are greater than its risks when used for the approved indications and the Committee recommended that Meloxidolor be given a marketing authorisation.
Zato je menil, da so njegove koristi, kot pri zdravilu Metacam, večje od z njim povezanih tveganj pri uporabi za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
What is the risk associated with Meloxidolor?
Kakšna tveganja so povezana z zdravilom Meloxidolor?
Meloxidolor contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Zdravilo Meloxidolor vsebuje meloksikam, ki spada v skupino nesteroidnih protivnetnih zdravil (NSAID).
Meloxidolor must not be used in dogs, in cats or horses less than six weeks of age, in cattle less than one week of age when used in the treatment of diarrhoea or in pigs less than two days old.
Zdravilo Meloxidolor se ne sme uporabljati pri psih, mačkah ali konjih, mlajših od šest tednov, pri govedu, mlajšem od enega tedna, za zdravljenje driske, ali pri prašičih, mlajših od dveh dni.
It can be used in combination with oral re-hydration therapy for diarrhoea (medicines given by mouth to restore water levels in the body) in calves of over one week of age and in young, non-lactating cattle.
V kombinaciji s peroralnim rehidracijskim zdravljenjem driske (zdravili, ki se dajejo v usta za obnovitev ravni vode v telesu) se lahko uporablja pri teletih, starejših od enega tedna, in mladem govedu, ki ni v obdobju laktacije.
Meloxidolor is a medicine that contains the active substance meloxicam.
Meloxidolor je zdravilo, ki vsebuje zdravilno učinkovino meloksikam.
For subcutaneous and intramuscular use no studies were need for the 5 mg/ml and 20 mg/ml strengths as they contain the same concentration of active substance and have a similar composition to the reference product Metacam.
Za podkožno in intramuskularno uporabo za jakosti 5 mg/ml in 20 mg/ml niso bile potrebne nobene študije, saj vsebujejo enako koncentracijo zdravilne učinkovine in imajo podobno sestavo kot referenčno zdravilo Metacam.
Meloxidolor is a 'generic'.
Meloxidolor je generično zdravilo.
Meloxidolor must not be used in animals with liver, heart or kidney problems, bleeding disorders, or suffering from irritation or ulcers of the digestive tract.
Zdravila Meloxidolor ni dovoljeno uporabljati pri živalih s težavami z jetri, srcem ali ledvicami, krvavitvenimi motnjami ali pri živalih s težavami z draženjem ali razjedami prebavnega trakta.
Why has Meloxidolor been approved?
Zakaj je bilo zdravilo Meloxidolor odobreno?
While the reference medicine, Metacam, is available as 5 mg/ml and 20 mg/ml solutions for injection, Meloxidolor is also available as a 40 mg/ml solution for injection.
Medtem ko je referenčno zdravilo Metacam na voljo kot raztopina za injiciranje v jakosti 5 mg/ml in 20 mg/ml, je zdravilo Meloxidolor na voljo tudi kot raztopina za injiciranje v jakosti 40 mg/ml.
The 5 mg/ml solution for injection can also be used for the relief of post-operative pain associated with minor soft tissue surgery such as castration (surgical removal of the testicles) and the 20 mg/ml solution for injection can be used together with appropriate antibiotic therapy for the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia (bacteria present in blood) and toxaemia (a toxic state) (mastitis-metritis-agalactia syndrome).
Raztopina za injiciranje v jakosti 5 mg/ml se lahko uporablja tudi za lajšanje postoperativnih bolečin, povezanih z manjšimi operacijami mehkega tkiva (kirurško odstranitvijo mod), raztopina za injiciranje v jakosti 20 mg/ml pa se lahko ob ustreznem antibiotičnem zdravljenju uporablja za zdravljenje bolezni, ki nastanejo po prasitvi (kotitvi), na primer puerperalna septikemija (bakterija, ki je prisotna v krvi) in toksemija (toksično stanje) (sindrom mastitisa, metritisa in agalaktije).
Meloxidolor should not be used in pregnant or lactating dogs, cats and horses, but it can be used during pregnancy and lactation for cattle and pigs.
Zdravilo Meloxidolor se ne sme uporabljati pri psih, mačkah ali konjih v obdobju brejosti ali laktacije, lahko pa se v obdobju brejosti ali laktacije uporablja pri govedu in prašičih.
Meloxidolor solution for injection (5 mg/ml and 20 mg/ml) is used in pigs to reduce the symptoms of lameness (inability to walk normally) and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move).
Meloxidolor raztopina za injiciranje (5 mg/ml in 20 mg/ml) se uporablja pri prašičih za ublažitev simptomov ohromelosti (nezmožnosti normalne hoje) in vnetja pri neinfekcijskih lokomotornih motnjah (boleznih, ki vplivajo na sposobnost premikanja).
Meloxidolor solution for injection (5 mg/ml) can be used to relieve inflammation and pain in dogs following surgery involving the bones or soft tissue (tissue just below the skin), and in cats following ovariohysterectomy (spaying) and minor soft tissue surgery.
Meloxidolor raztopina za injiciranje (5 mg/ml) se lahko uporablja pri psih za lajšanje vnetja in bolečin po operacijah kosti ali mehkega tkiva (tkivo tik pod kožo) ter pri mačkah po ovariohisterektomiji (steriliziranju) in manjših operacijah mehkega tkiva.
Meloxidolor solution for injection (20 mg/ml and 40 mg/ml) is used in horses to relieve colic (abdominal pain) and the inflammation and pain in musculo-skeletal disorders.
Meloxidolor raztopina za injiciranje (20 mg/ml in 40 mg/ml) se uporablja pri konjih za lajšanje kolik (bolečin v trebuhu) ter vnetja in bolečin pri kostno-mišično obolenjih.
Meloxidolor solution for injection (5 mg/ml, 20 mg/ml and 40 mg/ml) is used in cattle, together with appropriate antibiotic therapy, to reduce signs of disease in acute respiratory infections (infection of the lungs and airways).
Meloxidolor raztopina za injiciranje (5 mg/ml, 20 mg/ml in 40 mg/ml) se pri govedu ob ustreznem antibiotičnem zdravljenju uporablja za umirjanje znakov bolezni pri akutnih okužbah dihal (okužbah pljuč in dihalnih poti).
How has Meloxidolor been studied?
Kako je bilo zdravilo Meloxidolor raziskano?
What is Meloxidolor used for?
Za kaj se zdravilo Meloxidolor uporablja?
How does Meloxidolor work?
Kako zdravilo Meloxidolor deluje?
Side effects sometimes seen with other NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools, renal (kidney) failure and apathy (lack of vitality) are occasionally seen with Meloxidolor in dogs and cats.
Pri uporabi zdravila Meloxidolor pri prsih in mačkah se občasno pojavijo neželeni učinki, ki so včasih opaženi pri drugih nesteroidnih protivnetnih zdravilih, kot so izguba teka, bruhanje, driska, kri v blatu, ledvična odpoved in apatija (pomanjkanje vitalnosti).
What is Meloxidolor?
Kaj je zdravilo Meloxidolor?
A slight temporary swelling at the injection site following injection under the skin was observed in cattle and pigs.
Pri govedu in prašičih je bila opažena blaga začasna oteklina na mestu vboda pod kožo.
The 20 mg/ml and 40/mg/ml solutions for injection are also used in combination with antibiotic therapy to treat acute mastitis (inflammation of the udder).
Raztopina za injiciranje v jakosti 20 mg/ml in 40 mg/ml se lahko v kombinaciji z antibiotičnim zdravljenjem prav tako uporablja za zdravljenje akutnega mastitisa (vnetja vimena).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 November 2015
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 27. november 2015
− infection including sepsis
− okužba, vključno s sepso
The results of these analyses of efficacy are summarised in the table below.
Izsledki teh analiz učinkovitosti so povzeti v spodnji preglednici.
− thirst and increased water consumption
− žeja in povečano pitje vode
Any diarrhoea requiring hospitalisation (irrespective of grade) or grade 3 or 4 diarrhoea
Kakršnakoli diareja, ki potrebuje hospitalizacijo (ne glede na stopnjo) ali diareja stopnje 3 ali 4
PFS data were partially confirmed by an independent review (400/1,725 patients were randomly selected for review).
PBN podatki so bili delno potrjeni z neodvisnim pregledom (400/1725 bolnikov je bilo naključno izbranih za pregled).
Gently swirl each vial until the powder is completely dissolved.
Vsako vialo narahlo sukajte, dokler se prašek popolnoma ne raztopi.
− if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
− če ste alergični na pemetreksed ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
− increased skin pigmentation
− povečana pigmentiranost kože
Further dilution is required.
Potrebno je dodatno redčenje.
22880 Wedel
22880 Wedel Nemčija
The pH of the reconstituted solution is between 6.6 and 7.8.
Vrednost pH pripravljene raztopine je med 6,6 in 7,8.
Survival Time (months)
Čas preživetja (meseci)
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP.
< 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) and not known (cannot be estimated from available data).
do < 1/100), redko (≥ 1/10.000 do < 1/1.000), zelo redko (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness
V vsaki skupini pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Based on the planned date of your infusion of Pemetrexed medac and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Na podlagi načrtovanega datuma vaše infuzije zdravila Pemetreksed medac in/ali glede na delovanje vaših ledvic vam mora zdravnik svetovati, katera zdravila lahko jemljete in kdaj jih lahko jemljete.
The European Medicines Agency has waived the obligation to submit the results of studies with Pemetrexed in all subsets of the paediatric population in the granted indications (see section 4.2).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij s pemetreksedom za vse podskupine pediatrične populacije za odobrene indikacije (glejte poglavje 4.2).
− low white blood cells
− nizko število belih krvnih celic
It is a white to light yellow powder.
Je bel do svetlo rumen prašek.
Brnĕnská 32/čp.
Brnenská 32/čp.
Calculate the dose and the number of Pemetrexed medac vials needed.
Izračunajte odmerek in število potrebnih vial zdravila Pemetreksed medac.
If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
Če niste prepričani, vprašajte zdravnika ali farmacevta, ali je katero od vaših zdravil vrste NSAID.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2 °C to 8 °C.
Če zdravila, pripravljenega za uporabo, ne uporabimo takoj, je za čase shranjevanja in pogoje pred uporabo odgovoren uporabnik, in naj bi ne presegali 24 ur pri 2 do 8 °C.
100 % of previous dose
100 % predhodnega odmerka
Driving and using machines Pemetrexed medac may make you feel tired.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Pemetreksed medac lahko povzroči, da se boste počutili utrujene.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Nosečnost Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
− increased urine output
− povečano izločanje urina