FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER EU/1/10/662/002
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/10/662/002
English: Dizziness (G3/4: 2.0%); Peripheral motor neuropathy (G3/4: 0.4%)
Slovenian: omotica (S3/4: 2,0 %), periferna motorična nevropatija (S3/4: 0,4 %)
English: What Docetaxel Teva Pharma concentrate vial contains: - The active substance is docetaxel.
Slovenian: Kaj vsebuje viala koncentrata Docetaxel Teva Pharma - Zdravilna učinkovina je docetaksel.
English: • Induction chemotherapy followed by radiotherapy (TAX 323) MedDRA system organ classes
Slovenian: Indukcijska kemoterapija in nato obsevanje (TAX 323) Organski sistemi po
English: This overfill ensures that after dilution with the entire contents of the accompanying solvent for docetaxel vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 20 mg per vial.
Slovenian: Po razredčenju s celotno vsebino spremljajoče viale z vehiklom za vialo docetaksela to prepolnjenje zagotavlja, da je mogoče izvleči najmanj 2 ml osnovne raztopine z 10 mg/ml docetaksela, kar ustreza označeni količini 20 mg na vialo.
English: For patients with serum bilirubin levels >ULN and/or ALT and AST >3.5 times the ULN concurrent with serum alkaline phosphatase levels >6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Slovenian: Pri bolnikih, ki imajo serumski bilirubin > ZMNO in/ali ALT in AST > 3,5-kratno ZMRO ter hkrati alkalno fosfatazo > 6-kratno ZMRO, ni mogoče priporočiti zmanjšanja odmerka; pri teh bolnikih se docetaksel ne sme uporabljati, če ni izrecno indiciran.
English: Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe
Slovenian: Bolezni ţivčevja periferna senzorična nevropatija (S 3: 4,1 %), periferna motorična nevropatija (S3/4: 4 %), disgevzija (huda:
English: Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Slovenian: Pri bolnikih je med terapijo in v obdobju spremljanja po terapiji treba opazovati morebitne simptome zastojnega srčnega popuščanja.
English: This overfill ensures that after dilution with the entire contents of the accompanying solvent for docetaxel vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 80 mg per vial.
Slovenian: Po razredčenju s celotno vsebino spremljajoče viale z vehiklom za vialo docetaksela to prepolnjenje zagotavlja, da je mogoče izvleči najmanj 8 ml osnovne raztopine z 10 mg/ml docetaksela, kar ustreza označeni količini 80 mg na vialo.
English: • Infusion solution: Chemical and physical in-use stability has been demonstrated for 4 hours at room temperature (below 25°C).
Slovenian: Raztopina za infundiranje: dokazano je, da je kemijsko in fizikalno stabilna 4 ure, če je shranjena pri sobni temperaturi (do 25°C).
English: 2.1 Docetaxel 20 mg vial:
Slovenian: 2.1 Viala z 20 mg docetaksela
English: Clinical cases consistent with an increase in docetaxel toxicity were reported when it was combined with ritonavir.
Slovenian: Med uporabo docetaksela skupaj z ritonavirjem so bili opisani klinični primeri, ki se skladajo s povečano toksičnostjo docetaksela.
English: Anaemia (G3/4: 20.9%); Neutropenia (G3/4: 83.2%); Thrombocytopenia (G3/4: 8.8%);
Slovenian: Bolezni krvi in limfatičnega sistema anemija (S3/4: 20,9 %), nevtropenija (S3/4: 83,2 %), trombocitopenija (S3/4: 8,8 %), febrilna nevtropenija
English: Breast Cancer
Slovenian: Rak dojke
English: [95% CI: 0.7; 13.5] *: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
Slovenian: *: korigirano za več primerjav in prilagojeno za stratifikacijske faktorje (stadij bolezni in predel zdravljenja) na podlagi ocenljive populacije bolnikov.
English: Peripheral sensory neuropathy
Slovenian: Bolezni ţivčevja periferna senzorična nevropatija (S
English: Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe 0.07%)
Slovenian: Občasni neželeni učinki nevropatija (S3/4: 4 %), disgevzija (huda: 0,07 %)
English: 1.28 ml (Fill: 1.71 ml)
Slovenian: voda za injekcije 1,28 ml (napolnjena: 1,71 ml)
English: In combination with cisplatin For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is < 25,000 cells/mm3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m2.
Slovenian: V kombinaciji s cisplatinom Bolnikom, ki uvodoma dobijo docetaksel v odmerku 75 mg/m v kombinaciji s cisplatinom in imajo v predhodnem krogu zdravljenja najmanjše število trombocitov < 25.000 celic/mm
English: 4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Teva Pharma vial by partially inverting the vial.
Slovenian: 4.1.2 Uporabite injekcijsko brizgo z nameščeno iglo in aseptično izvlecite celotno količino vehikla za zdravilo Docetaxel Teva Pharma iz viale tako, da vialo delno obrnete.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg
Slovenian: KARTONSKA ŠKATLA - 80 mg
English: Hypotension; Hypertension Haemorrhage
Slovenian: Ţilne bolezni hipotenzija
English: General disorders and administration site conditions
Slovenian: Splošne teţave in spremembe na mestu aplikacije
English: You must not breast-feed while you are treated with Docetaxel Teva Pharma.
Slovenian: V obdobju zdravljenja z zdravilom Docetaxel Teva Pharma NE smete dojiti.
English: Neutropenia (Grade 4) Febrile neutropenia
Slovenian: Nevtropenija (4. stopnje)
English: Ask your doctor for advice before being given any medicine.
Slovenian: Nosečnost, dojenje in plodnost Posvetujte se z zdravnikom, preden vzamete katerokoli zdravilo.
English: The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their coadministration.
Slovenian: Docetaksel, doksorubicin in ciklofosfamid pri sočasni aplikaciji ne vplivajo na farmakokinetiko drug drugega.
English: • pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)
Slovenian: ); pljučnica (okuţba pljuč); pljučna fibroza (brazgotinjenje in zadebelitve v pljučih s teţkim dihanjem); zamegljen vid zaradi oteklosti očesne mreţnice (cistoidni makularni edem); zniţanje natrija v krvi.
English: Docetaxel Teva Pharma is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Slovenian: Zdravilo Docetaxel Teva Pharma je indicirano za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
English: Neurotoxicity(G3/4: 0%); Somnolence (G3/4: 0%)
Slovenian: sinkopa (S3/4: 0 %) nevrotoksični (S3/4: 0 %), somnolenca (S3/4: 0 %)
English: • 258 patients who received docetaxel in combination with doxorubicin.
Slovenian: 75 mg/m258 bolnikih, ki so dobivali docetaksel v kombinaciji z doksorubicinom; 406 bolnikih, ki so dobivali docetaksel v kombinaciji s cisplatinom;
English: Dyspnoea (G3/4: 1%); Cough (G3/4: <1%);
Slovenian: dispneja (S3/4: 1 %), kašelj (S3/4: < 1 %), epistaksa (S3/4: < 1 %)
English: Lethargy (G3/4: 4.0%); Pyrexia (G3/4: 3.6%); Fluid retention (G3/4: 1.2%);
Slovenian: Splošne teţave in spremembe na mestu aplikacije letargija (S3/4: 4,0 %), pireksija (S3/4: 3,6 %), zastajanje tekočine (S3/4: 1,2 %), edem (S3/4: 1,2 %)
English: Neutropenic infection; Infection (G3/4: 11.7%)
Slovenian: Infekcijske in parazitske bolezni nevtropenična okuţba, okuţba (S3/4: 11,7 %)
English: Cardiac failure;
Slovenian: Srčne bolezni srčno popuščanje,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 20 mg
Slovenian: KARTONSKA ŠKATLA - 20 mg
English: • The Docetaxel 80 mg vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml.
Slovenian: Viala z 80 mg docetaksela vsebuje raztopino docetaksela v polisorbatu 80 s koncentracijo 27,73 mg/ml.
English: 2.1 Docetaxel 80 mg vial:
Slovenian: 2.1 Viala z 80 mg docetaksela
English: Lacrimation increased (G3/4: <0.1%)
Slovenian: povečanje solzenja (S3/4: <0,1 %)
English: • The Docetaxel 20 mg vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml.
Slovenian: Viala z 20 mg docetaksela vsebuje raztopino docetaksela v polisorbatu 80 v koncentraciji 27,73 mg/ml.
English: Patients should be retreated with docetaxel when neutrophils recover to a level ≥1,500 cells/mm3 (see section 4.2).
Slovenian: Bolniki smejo docetaksel spet dobiti šele, ko se število nevtrofilcev znova poveča na vrednost ≥ 1500 celic/mm
English: Each vial of concentrate contains 80 mg of docetaxel.
Slovenian: Ena viala koncentrata zdravila vsebuje 80 mg docetaksela.
English: You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Teva Pharma administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Teva Pharma in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Slovenian: Namen tega je zmanjšanje nekaterih neţelenih učinkov, ki se lahko pojavijo po infuziji zdravila Docetaxel Teva Pharma, zlasti alergijskih reakcij in zastajanja tekočine (otekanje dlani, stopal, nog ali povečanje telesne mase).
English: Peripheral sensory neuropathy (G3: 3.7%); Peripheral motor neuropathy (G3/4: 2%)
Slovenian: Bolezni ţivčevja periferna senzorična nevropatija (S 3: 3,7 %), periferna motorična nevropatija (S3/4: 2 %)
English: Hypersensitivity (no severe)
Slovenian: Bolezni imunskega sistema preobčutljivost (ne huda)
English: Docetaxel Teva Pharma monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Slovenian: Zdravilo Docetaxel Teva Pharma v monoterapiji je indicirano za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, pri katerih citotoksična terapija ni bila uspešna.
English: However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between +2°C and +8°C or at room temperature (below 25°C).
Slovenian: Vendar je osnovna raztopina dokazano kemijsko in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med +2 in +8°C ali pri sobni temperaturi (do 25°C).
English: • 1312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively.
Slovenian: 1312 bolnikih, ki so v monoterapiji dobivali 100 mg/m docetaksela, 121 pa jih je dobivalo
English: If Docetaxel Teva Pharma concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Slovenian: Če pride koncentrat, osnovna raztopina ali raztopina za infundiranje zdravila Docetaxel Teva Pharma v stik s sluznicami, jih je treba takoj in temeljito umiti z vodo.
English: Cases of cystoid macular oedema (CMO) have been reported in patients treated with docetaxel.
Slovenian: Pri bolnikih zdravljenih z docetakselom je bil opisan cistoidni makularni edem (CMO).
English: Rare cases of ileus and intestinal obstruction have been reported.
Slovenian: Opisali so redke primere ileusa in zapore črevesa.
English: Description of selected adverse reactions for adjuvant therapy with Docetaxel 75 mg/m2 in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
Slovenian: Opis izbranih neţelenih učinkov adjuvantnega zdravljenja z zdravilom Docetaxel Teva Pharma 75 mg/m v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah z rakom dojke s pozitivnimi bezgavkami (TAX 316) in negativnimi bezgavkami (GEICAM 9805)
English: Docetaxel increased response rate (33% vs. 12%, p<0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p=0.0004) and prolonged overall survival (11 months vs. 9 months, p=0.01).
Slovenian: z 11 tedni, p = 0,0004) in podaljšal celotno preţivetje (11 mesecev v prim.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 21st January 2011
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each single dose vial of Docetaxel Teva Pharma concentrate contains 80 mg docetaxel (anhydrous).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka enoodmerna viala koncentrata Docetaxel Teva Pharma vsebuje 80 mg docetaksela (brezvodnega).
English: Each vial of concentrate contains 20 mg of docetaxel.
Slovenian: Ena viala koncentrata zdravila vsebuje 20 mg docetaksela.
English: Alopecia (G3/4: 6%); Nail disorders (G3/4: 2%)
Slovenian: alopecija (S3/4: 6 %), spremembe nohtov (S3/4: 2 %)
English: The increase in survival seen in the docetaxel weekly arm was not statistically significant compared to the mitoxantrone control arm. Efficacy endpoints for the docetaxel arms versus the control arm are summarized in the following table:
Slovenian: Podaljšanje preţivetja, opaţeno v kraku s tedenskim odmerjanjem docetaksela, ni bilo statistično značilno v primerjavi s kontrolnim krakom z mitoksantronom.
English: In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined.
Slovenian: Če imate teţave z vidom, morate to povedati zdravniku, bolnišničnemu farmacevtu ali medicinski sestri.V primeru teţav z vidom, zlasti zamegljenega vida, morate takoj opraviti pregled oči in vida.
English: Localised skin erythema of the extremities (palms of the hands and soles of the feet) with oedema followed by desquamation has been observed.
Slovenian: Na okončinah (dlaneh in podplatih) so opaţali lokalen koţni eritem z edemi in poznejše luščenje.
English: Keep this medicine out of the sight and reach of children.
Slovenian: ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM!
English: Tabulated list of adverse reactions for adjuvant therapy with Docetaxel 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Slovenian: Tabelarični prikaz neţelenih učinkov adjuvantnega zdravljenja z zdravilom Docetaxel Teva Pharma 75 mg/m v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah z rakom dojke s pozitivnimi bezgavkami (TAX 316) in negativnimi bezgavkami (GEICAM 9805) - kumulativni podatki
English: The Docetaxel Teva Pharma infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.
Slovenian: Aplicirati jo je treba aseptično v enourni infuziji, pri sobni temperaturi (do 25°C) in običajnih svetlobnih pogojih.
English: How to store Docetaxel Teva Pharma
Slovenian: Shranjevanje zdravila Docetaxel Teva Pharma
English: G3/4 Blood bilirubin increased (< 5%);
Slovenian: Preiskave povišanje ravni bilirubina v krvi S3/4 (< 2 %)
English: If Docetaxel Teva Pharma concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Slovenian: Če pride koncentrat, osnovna raztopina ali raztopina za infundiranje zdravila Docetaxel Teva Pharma v stik s koţo, površino takoj in temeljito umijte z milom in vodo.
English: • 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
Slovenian: fazi študije), ki so dobivali docetaksel v kombinaciji s cisplatinom in 5 -fluorouracilom (navedeni so klinično pomembni, z zdravljenjem povezani, neţeleni učinki); 174 in 251 bolnikih z rakom glave in vratu, ki so dobivali docetaksel v kombinaciji s cisplatinom in 5-fluorouracilom (navedeni so klinično pomembni, z zdravljenjem povezani, neţeleni učinki).
English: Hypersensitivity (G3/4:
Slovenian: eksfoliacijski izpuščaj (S3/4:
English: Pain in extremity (G3/4: <1%); Back pain (G3/4: 1%)
Slovenian: bolečine v okončinah (S3/4: < bolečine v hrbtu (S3/4: 1 %)
English: • interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing.
Slovenian: Neznana pogostnost (pogostnosti iz razpoloţljivih podatkov ni mogoče oceniti): intersticijska bolezen pljuč (vnetje pljuč, ki povzroča kašljanje in teţave z dihanjem.
English: • one 6 ml clear glass vial with a flip-off cap containing 1.28 ml of solvent.
Slovenian: Vsaka kartonska škatla vsebuje: eno 6 ml vialo iz prozornega stekla s pokrovčkom Flip Off, ki vsebuje 0,72 ml koncentrata in eno 6 ml vialo iz prozornega stekla s pokrovčkom Flip Off, ki vsebuje 1,28 ml vehikla.
English: There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Slovenian: Podatkov o uporabi docetaksela v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah, starejših od 70 let je malo.
English: If Docetaxel concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Slovenian: Če pride koncentrat docetaksela, osnovna raztopina ali raztopina za infundiranje v stik s sluznicami, jih takoj in temeljito sperite z vodo.
English: Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Slovenian: Splošne teţave in spremembe na mestu aplikacije letargija (S3/4: 3,4 %), pireksija (S3/4: 0,6 %), zastajanje tekočine, edem
English: Each vial contains 80 mg/2.88 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 94.4 mg/3.40 ml).
Slovenian: Ena viala vsebuje 80 mg/2,88 ml raztopine docetaksela 27,73 mg/ml v polisorbatu 80 (polnilni volumen: 94,4 mg/3,40 ml).
English: 5.12 ml (Fill: 6.29 ml)
Slovenian: voda za injekcije 5,12 ml (napolnjena: 6,29 ml)
English: Rare cases of convulsion or transient loss of consciousness have been observed with docetaxel administration.
Slovenian: Ob uporabi docetaksela so opaţali redke primere konvulzij ali prehodne izgube zavesti.
English: Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Slovenian: Splošne teţave in spremembe na mestu aplikacije astenija, periferni edemi, pireksija, utrujenost, vnetje sluznice, bolečine, gripi podobna bolezen, bolečine v prsih, mrzlica letargija
English: Neutropenia is the most frequent adverse reaction of docetaxel.
Slovenian: Najpogostejši neţeleni učinek docetaksela je nevtropenija.
English: • one 15 ml clear glass vial with a flip-off cap containing 5.12 ml of solvent.
Slovenian: Vsaka kartonska škatla vsebuje: eno 15 ml vialo iz prozornega stekla s pokrovčkom Flip Off, ki vsebuje 2,88 ml koncentrata in eno 15 ml vialo iz prozornega stekla s pokrovčkom Flip Off, ki vsebuje 5,12 ml vehikla.
English: Dysgeusia/Parosmia; Peripheral sensory neuropathy (G3/4: 0.6%)
Slovenian: Bolezni ţivčevja disgevzija / parozmija, periferna senzorična nevropatija (S3/4: 0,6 %)
English: Infection (G3/4: 6.3%); Neutropenic infection
Slovenian: Infekcijske in parazitske bolezni okuţba (S3/4: 6,3 %), nevtropenična okuţba
English: • redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body)
Slovenian: pordelost in otekanje dlani ali podplatov, ki lahko povzroči lupljenje koţe (to se lahko pojavi tudi na rokah, obrazu ali telesu); sprememba barve nohtov, ki lahko odstopijo; bolečine v mišicah, bolečine v hrbtu ali kosteh; spremembe ali izostanek menstruacije; otekanje dlani, stopal, nog; utrujenost ali gripi podobni simptomi; povečanje ali zmanjšanje telesne mase.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - CONCENTRATE 80 mg
Slovenian: NALEPKA NA VIALI - KONCENTRAT 80 mg
English: Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija (S3/4: 32 %), anemija (S3/4: 4,9 %)
English: • Premix solution: Chemical and physical in-use stability has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
Slovenian: Osnovna raztopina: dokazano je, da je osnovna raztopina kemijsko in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med 2 in 8°C ali pri sobni temperaturi (do 25°C).
English: However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
Slovenian: Vendar je osnovna raztopina dokazano kemijsko in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med 2 in 8°C ali pri sobni temperaturi (do 25°C).
English: • 1276 patients (744 and 532 in TAX 316 and GEICAM 9805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
Slovenian: 92 bolnicah, ki so dobivale docetaksel v kombinaciji s trastuzumabom; 255 bolnikih, ki so dobivali docetaksel v kombinaciji s kapecitabinom; 332 bolnikih, ki so dobivali docetaksel v kombinaciji s prednizonom ali prednizolonom (predstavljeni so klinično pomembni, z zdravljenjem povezani, neţeleni učinki); 1276 bolnikih (744 pri TAX 316 in 532 GEICAM 9805), ki so dobivali docetaksel v kombinaciji z doksorubicinom in ciklofosfamidom (predstavljeni so klinično pomembni, z zdravljenjem povezani, neţeleni učinki);
English: Stomatitis (G3/4: 5.3%); Diarrhoea (G3/4: 4%);
Slovenian: Bolezni prebavil stomatitis (S3/4: 5,3 %), driska (S3/4: 4 %), navzeja (S3/4: 4 %), bruhanje (S3/4: 3 %)
English: Tel: +44 1977 628 500
Slovenian: United Kingdom Teva UK Limited Tel: +44 1977 628 500
English: You must NOT be given Docetaxel Teva Pharma if
Slovenian: Zdravila Docetaxel Teva Pharma NE smete dobiti, razen če je to nujno potrebno.
English: Nail disorders (severe 0.7%); Skin reaction (G3/4: 0.2%)
Slovenian: podkoţja spremembe nohtov (hude: 0,7 %), koţna reakcija (S3/4:
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² in combination with trastuzumab
Slovenian: Tabelarični prikaz neţelenih učinkov zdravljenja z zdravilom Docetaxel Teva Pharma 100 mg/m pri raku dojke v kombinaciji s trastuzumabom
English: Infection (G3/4: 3.6%) Neutropenic infection
Slovenian: Infekcijske in parazitske bolezni okuţba (S3/4: 3,6 %) nevtropenična okuţba
English: Conjunctivitis (G3/4: <0.1%)
Slovenian: Očesne bolezni konjunktivitis (S3/4: <0,1 %)
English: Docetaxel Teva Pharma is supplied as single-dose vials.
Slovenian: PAKIRANJE Docetaxel Teva Pharma je na voljo v vialah z enim odmerkom.
English: Each single dose vial of Docetaxel Teva Pharma concentrate contains 80 mg docetaxel (anhydrous).
Slovenian: Vsaka enoodmerna viala koncentrata Docetaxel Teva Pharma vsebuje 80 mg docetaksela (brezvodnega).
English: G3/4 Blood bilirubin increased
Slovenian: Preiskave povišanje ravni bilirubina v krvi S3/4
English: Solvent for Docetaxel Teva Pharma 20 mg vial 6 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
Slovenian: Docetaxel Teva Pharma 20 mg viala 6 ml viala tipa I iz prozornega stekla z zaporko iz brombutilne gume in pokrovčkom Flip Off.
English: Lymphoedema (G3/4: 0%)
Slovenian: limfedem (S3/4: 0 %)
English: Febrile neutropenia (G3/4: NA)
Slovenian: Motnje reprodukcije in Amenoreja (S3/4: ni na
English: This vial contains 0.72 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.88 ml).
Slovenian: Ta viala vsebuje 0,72 ml raztopine docetaksela 27,73 mg/ml v polisorbatu 80 (polnilni volumen: 24,4 mg/0,88 ml).
English: Arrhythmia (G3/4: 2.0%)
Slovenian: Srčne bolezni aritmija (S3/4: 2,0 %)
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with prednisone or prednisolone
Slovenian: Tabelarični prikaz neţelenih učinkov zdravljenja z zdravilom Docetaxel Teva Pharma 75 mg/m pri raku dojke v kombinaciji s prednizonom ali prednizolonom