FrancophonIA/ELRC3.0 huggingface dataset:
English: 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Slovenian: Druga je na 3 tedne (Tcis) dobivala docetaksel 75 mg/m2 v 1-urni infuziji v kombinaciji s karboplatinom (AUC 6 mg/ml•min) v 30-60 minutah, tretja pa na 4 tedne (Vcis) vinorelbin (V) 25 mg/m2 v 6-10 minutah
English: 15 ml clear glass Type I vial with a transparent colourless flip-off cap.
Slovenian: 15-ml viala iz prozornega stekla tipa I s prosojno, brezbarvno dvižno zaporko.
English: Dysgeusia/Parosmia; Peripheral sensory neuropathy (G3/4:
Slovenian: Bolezni živčevja disgevzija/parozmija, periferna senzorična nevropatija (S3/4:
English: The concentrate is supplied in a 7 ml clear colourless glass vial with a magenta aluminium seal and a magenta plastic flip-off cap.
Slovenian: Koncentrat je opremljen v 7-ml prozorni brezbarvni viali iz stekla tipa I z rdečo aluminijasto zaporko in s škrlatno dvižno zaporko.
English: As with all parenteral products, TAXOTERE infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Slovenian: Tako kot vsa zdravila za parenteralno uporabo je treba raztopino za infundiranje zdravila TAXOTERE pred uporabo pregledati; če vsebuje precipitat, jo je treba zavreči.
English: PREPARATION GUIDE FOR USE WITH TAXOTERE 20 mg/1 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Slovenian: Navodilo za uporabo TAXOTERE 20 mg/1ml koncentrat za raztopino za infundiranje docetaksel
English: Dizziness
Slovenian: izpuščaj
English: Alopecia (G3/4: 10.9%) Rash pruritic; Dry skin;
Slovenian: Bolezni kože in podkožja alopecija (S3/4: 10,9 %) pruritičen izpuščaj, suha koža, eksfoliacija kože (S3/4:
English: Constipation (G3/4: 1.0%); Gastrointestinal pain (G3/4:
Slovenian: bolečine v prebavilih (S3/4: 1,2 %), gastrointestinalna krvavitev (S3/4: 0,4 %)
English: 7 ml clear glass (type I) vial with a magenta aluminium seal and a magenta plastic flip-off cap containing 4 ml of concentrate.
Slovenian: 7 ml viala iz prozornega stekla tipa I s škrlatno aluminijasto zaporko in škrlatno dvižno zaporko z 1 ml koncentrata.
English: As with all parenteral products, TAXOTERE premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Slovenian: Tako kot vsa zdravila za parenteralno uporabo je treba tudi osnovno raztopino in raztopino za infundiranje zdravila TAXOTERE pred uporabo pregledati; če vsebuje precipitat, jo je treba zavreči.
English: Description of selected adverse reactions for adjuvant therapy with TAXOTERE 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 neželenih učinkov adjuvantnega zdravljenja z zdravilom TAXOTERE 75 mg/m2 v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah z rakom dojke s pozitivnimi bezgavkami (TAX 316) in negativnimi bezgavkami (GEICAM 9805)
English: Inject the required premix volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: Potrebno količino osnovne raztopine vbrizgajte v 250-ml infuzijsko vrečko ali steklenico, v kateri je 5 % raztopina glukoze ali raztopina za infundiranje 9 mg/ml (0,9%) natrijevega klorida.
English: Tabulated list of adverse reactions in breast cancer for TAXOTERE 100 mg/m² in combination with trastuzumab
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom TAXOTERE 100 mg/m2 pri raku dojke v kombinaciji s trastuzumabom
English: In some cases (frequency not known)
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
English: Dysgeusia (G3/4:
Slovenian: motnja solzenja (S3/4:
English: More than one premix vial may be necessary to obtain the required dose for the patient.
Slovenian: Za odmerek, ki ga potrebuje bolnik, utegne biti potrebna več kot ena viala z osnovno raztopino.
English: 3, 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: Bolnikom, ki uvodoma dobijo docetaksel v odmerku 75 mg/m2 v kombinaciji s cisplatinom in imajo v predhodnem ciklusu zdravljenja najmanjše število trombocitov < 25.000 celic/mm3, bolnikom, ki doživijo febrilno nevtropenijo, in bolnikom z resnimi nehematološkimi toksičnimi učinki je treba odmerek docetaksela v naslednjih ciklusih zmanjšati na 65 mg/m2.
English: Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%); Pain
Slovenian: zaprtje (hudo: 0,2 %), bolečine v trebuhu (hude: 1 %), gastrointestinalna krvavitev (huda: 0,3 %)
English: Tabulated list of adverse reactions for adjuvant therapy with TAXOTERE 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 neželenih učinkov adjuvantnega zdravljenja z zdravilom TAXOTERE 75 mg/m2 v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah z rakom dojke s pozitivnimi bezgavkami (TAX 316) in negativnimi bezgavkami (GEICAM 9805) - kumulativni podatki
English: Anaemia (G3/4: 8.9%); Febrile neutropenia
Slovenian: trombocitopenija, (S3/4: 0,6 %), febrilna nevtropenija
English: The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Slovenian: Dodatek celotne vsebine viale z vehiklom vsebini viale zdravila TAXOTERE 20 mg/0,5 ml koncentrat za raztopino za infundiranje zagotavlja koncentracijo docetaksela v osnovni raztopini 10 mg/ml.
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for TAXOTERE 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Slovenian: Opis izbranih neželenih učinkov zdravljenja z zdravilom TAXOTERE 75 mg/m2 v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
English: In TAXOTERE 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.
Slovenian: V zdravilu TAXOTERE 80 mg/4 ml vialah je koncentracija docetaksela 20 mg/ml.
English: PREPARATION GUIDE FOR USE WITH TAXOTERE 20 mg/0.5 ml CONCENTRATE FOR SOLUTION FOR INFUSION AND SOLVENT FOR TAXOTERE
Slovenian: Navodilo za uporabo TAXOTERE 20 mg/0,5 ml koncentrat in vehikel za raztopino za infundiranje docetaksel
English: • The solvent for TAXOTERE 80 mg/2 ml vial is a 15 ml clear glass vial with a transparent colourless flip-off cap.
Slovenian: • Viala z vehiklom za zdravilo TAXOTERE 80 mg/2 ml je 15-ml steklena viala iz prozornega stekla s prosojno, brezbarvno dvižno zaporko.
English: Hypertension; Haemorrhage
Slovenian: Bolezni jeter, žolčnika in žolčevodov
English: The viscous solution contains 40 mg/ml docetaxel (anhydrous).
Slovenian: Viskozna raztopina vsebuje 40 mg/ml brezvodnega docetaksela.
English: Tabulated list of adverse reactions in breast cancer for TAXOTERE 75 mg/m² in combination with doxorubicin
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom TAXOTERE 75 mg/m2 pri raku dojke v kombinaciji z doksorubicinom
English: Diarrhoea (G3/4: 1.2%);
Slovenian: bolečina zaradi raka (S3/4: 1,2 %)
English: Diarrhoea grade 3 First episode: reduce 5-FU dose by 20%.
Slovenian: Stomatitis/mukoziti Prvi pojav: zmanjšajte odmerek 5-FU za 20 %.
English: This medicinal product contains 13% (w/w) ethanol 95% v/v (alcohol), i.e. up to 252 mg ethanol 95% v/v per solvent vial, equivalent to 6 ml of beer or 2.6 ml wine.
Slovenian: Zdravilo vsebuje 13 % (m/m) 95 % (v/v) etanola (alkohola), tj. do 252 mg 95 % (v/v) etanola na vialo vehikla; kar ustreza 6 ml piva ali 2,6 ml vina.
English: TAXOTERE 20 mg/1 ml concentrate for solution for infusion
Slovenian: TAXOTERE 20 mg/1 ml koncentrat za raztopino za infundiranje docetaksel
English: FORMULATION
Slovenian: Κύπρος
English: This medicinal product contains 13% (w/w) ethanol 95% v/v (alcohol), i.e. up to 932 mg ethanol 95% v/v per solvent vial, equivalent to 23 ml of beer or 9.5 ml wine.
Slovenian: Zdravilo vsebuje 13 % (m/m) 95 % (v/v) etanola (alkohola), tj. do 932 mg 95 % (v/v) etanola na vialo vehikla; kar ustreza 23 ml piva ali 9,5 ml vina.
English: The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 80 mg/2 ml vial ensures a premix concentration of 10 mg/ml docetaxel.
Slovenian: Dodatek celotne vsebine viale z vehiklom vsebini viale zdravila TAXOTERE 80 mg/2 ml zagotavlja koncentracijo 10 mg/ml docetaksela v osnovni raztopini.
English: The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 80 mg/2 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Slovenian: Dodatek celotne vsebine viale z vehiklom vsebini viale zdravila TAXOTERE 80 mg/2 ml koncentrat za raztopino za infundiranje zagotavlja koncentracijo docetaksela v osnovni raztopini 10 mg/ml.
English: Arrhythmia (G3/4:
Slovenian: Žilne bolezni hipotenzija (S3/4:
English: 0.5 ml (Fill 0.61 ml)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 0,5 ml (polnitev 0,61 ml)
English: Infection (G3/4: 5.7%)
Slovenian: Infekcijske in parazitske okužba (S3/4: 5,7 %)
English: TAXOTERE monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Slovenian: Zdravilo TAXOTERE v monoterapiji je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, pri katerih predhodna citotoksična terapija ni bila uspešna.
English: Hypersensitivity (G3-4: 1%)
Slovenian: Bolezni imunskega sistema preobčutljivost (3.-4. st.: 1 %)
English: If TAXOTERE concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Slovenian: Če pride koncentrat ali raztopina za infundiranje zdravilo TAXOTERE v stik s kožo, jo je treba takoj in temeljito umiti z milom in vodo.
English: OUTER CARTON / TAXOTERE 80 mg/4 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA/TAXOTERE 80 mg/4 ml
English: Oral candidiasis (G3/4: < 1%)
Slovenian: Infekcijske in parazitske bolezni oralna kandidoza (S3/4): <1 %)
English: In TAXOTERE 20 mg /1 ml vial the concentration of docetaxel is 20 mg/ml.
Slovenian: V zdravilu TAXOTERE 20 mg/1 ml vialah je koncentracija docetaksela 20 mg/ml.
English: 7 ml clear glass Type I vial with a green flip-off cap.
Slovenian: 7-ml viala iz prozornega stekla tipa I z zeleno dvižno zaporko.
English: This medicinal product contains 13 % (w/w) ethanol 95% v/v (alcohol), i.e. up to 252 mg ethanol 95% v/v per solvent vial, equivalent to 6 ml of beer or 2.6 ml wine.
Slovenian: Zdravilo vsebuje 13 % (m/m) 95 % (v/v) etanola (alkohola), tj. do 252 mg 95 % v/v etanola na vialo vehikla; kar ustreza 6 ml piva ali 2,6 ml vina.
English: PREPARATION GUIDE FOR USE WITH TAXOTERE 80 mg/2 ml CONCENTRATE FOR SOLUTION FOR INFUSION AND SOLVENT FOR TAXOTERE
Slovenian: Navodilo za uporabo TAXOTERE 80 mg/2 ml koncentrat in vehikel za raztopino za infundiranje docetaksel
English: 13% (w/w) ethanol 95% in water for injections Fill: 1.98 ml
Slovenian: 13 % (m/m) 95 % etanol v vodi za injekcije
English: SOLVENT for TAXOTERE 20 mg/0.5 ml
Slovenian: KONCENTRAT IN VEHIKEL TAXOTERE 20 mg/0,5 ml
English: Tabulated list of adverse reactions in breast cancer for TAXOTERE 75 mg/m² in combination with capecitabine
Slovenian: Tabelarični prikaz neželenih učinkov tzdravljenja z zdravilom TAXOTERE 75 mg/m2 pri raku dojke v kombinaciji s kapecitabinom
English: Anaemia (G3/4: 9.2%); Thrombocytopenia (G3/4: 5.2%)
Slovenian: anemija (S3/4: 12,4 %), trombocitopenija (S3/4: 4,0 %), febrilna nevtropenija
English: Elderly
Slovenian: Prednizon
English: TAXOTERE 160 mg/8 ml concentrate for solution for infusion.
Slovenian: IME ZDRAVILA TAXOTERE 160 mg/8 ml koncentrat za raztopino za infundiranje
English: G3/4 Blood bilirubin increased (< 2.5%);
Slovenian: S 3/4 zvišanje bilirubina v krvi (< 2,5 %) S3/4 zvišanje alkalne fosfataze v krvi (< 2,5
English: TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion
Slovenian: TAXOTERE 20 mg/0,5 ml koncentrat in vehikel za raztopino za infundiranje
English: TAXOTERE should not be used after the expiry date shown on the carton, blister pack and vials.
Slovenian: zdravila TAXOTERE 20 mg ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, pretisnem omotu in vialah.
English: Insomnia (G3: 1%)
Slovenian: Psihiatrične motnje nespečnost (3. st.: 1 %)
English: TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion
Slovenian: TAXOTERE 80 mg/2 ml koncentrat in vehikel za raztopino za infundiranje
English: TAXOTERE 80 mg/4 ml concentrate for solution for infusion docetaxel
Slovenian: TAXOTERE 80 mg/4 ml koncentrat za raztopino za infundiranje docetaksel
English: OUTER CARTON / TAXOTERE 20 mg/1 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA/TAXOTERE 20 mg /1ml
English: TAXOTERE 80 mg/4 ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA TAXOTERE 80 mg/ 4 ml koncentrat za raztopino za infundiranje
English: Hypotension (G3: 0%)
Slovenian: Srčne bolezni hipotenzija (3. st.: 0 %)
English: Esophagitis/dysphagia/ odynophagia (G3/4:
Slovenian: Bolezni živčevja dizgevzija/parozmija, periferna senzorična nevropatija (S3/4: 0,6
English: In GEICAM 9805 study alopecia that started during the treatment period and persisted into the followup period was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Slovenian: V študiji GEICAM 9805 so nadaljnjo prisotnost alopecije, ki se je začela med obdobjem zdravljenja in je trajala v obdobje spremljanja , zabeležili pri 49 bolnicah (9,2 %) v kraku TAC in pri 35 bolnicah (6,7 %) v kraku FAC.
English: Anorexia (G3/4:
Slovenian: Presnovne in prehranske motnje anoreksija (S3/4:
English: If TAXOTERE concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Slovenian: Če pride koncentrat ali raztopina za infundiranje zdravilo TAXOTERE v stik s sluznicami, jih je treba takoj in temeljito umiti z vodo.
English: Hypocalcaemia (G3: 0%) Hypophosphataemia (G3-4: 1%) Hypokalaemia (G3: 0%)
Slovenian: sinkopa (S3/4: 0 %) nevrotoksičnost (S3/4: somnolenca (S3/4; 0 %)
English: TAXOTERE 20 mg/1 ml sterile concentrate docetaxel
Slovenian: TAXOTERE 20 mg/1 ml sterilni koncentrat docetaksel intravenska uporaba
English: Respiratory disorders
Slovenian: eksfoliacijski izpuščaj
English: The concentrate is a pale yellow to brownish-yellow solution.
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) Koncentrat je bledorumena do rjavkastoo-rumena raztopina.
English: Weight decreased; G3/4 Blood bilirubin increased
Slovenian: Zmanjšanje telesne mase, S3/4 zvišanje bilirubina v krvi (9 %)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: Izgled zdravila in vsebina pakiranja
English: TAXOTERE 80 mg/4 ml sterile concentrate docetaxel
Slovenian: TAXOTERE 80 mg/4 ml sterilni koncentrat docetaksel intravenska uporaba
English: SOLVENT for TAXOTERE 80 mg/2 ml
Slovenian: KONCENTRAT IN VEHIKEL TAXOTERE 80 mg/2 ml
English: Epistaxis (G3/4: < 1%)
Slovenian: S3/4 zvišanje AST (< 1
English: If TAXOTERE 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 TAXOTERE v stik s kožo, jo je treba takoj in temeljito umiti z milom in vodo.
English: In TAXOTERE 80 mg /4 ml vial the concentration of docetaxel is 20 mg/ml.
Slovenian: V viali, ki vsebuje zdravilo Taxotere 80 mg/4 ml, je koncentracija docetaksela 20 mg/ml.
English: Docetaxel every 3 weeks
Slovenian: Končna točka docetaksel vsake 3 tedne docetaksel vsak teden
English: • weight gain or loss
Slovenian: • povečanje ali zmanjšanje telesne mase
English: What TAXOTERE looks like and contents of the pack TAXOTERE concentrate for solution for infusion is a pale yellow to brownish-yellow solution.
Slovenian: Zdravilo TAXOTERE koncentrat za raztopino za infundiranje je bledorumena do rjavo-rumena raztopina.
English: Hypersensitivity (G3/4: 1.7%)
Slovenian: Bolezni imunskega sistema preobčutljivost (S3/4: 1,7)
English: If TAXOTERE 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 TAXOTERE v stik s sluznicami, jih je treba takoj in temeljito umiti z vodo.
English: Tabulated list of adverse reactions in high-risk locally advanced or metastatic hormone-sensitive prostate cancer for TAXOTERE 75 mg/m² in combination with prednisone or prednisolone and ADT (STAMPEDE study)
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost (S3/4: 3,9 %), zastajanje tekočine (hudo 0,6 %) Za bolnike z lokalno napredovalim ali metastatskim hormonsko občutljivim rakom prostate z velikim tveganjem so v preglednici prikazani neželeni učinki za zdravilo TAXOTERE 75 mg/m2 v kombinaciji s prednizonom ali prednizolonom in ADT (študija STAMPEDE) Organski sistemi po MedDRA
English: Hand-foot syndrome (G3/4:
Slovenian: Očesne bolezni konjunktivitis (S3/4:
English: Each ml of docetaxel solution contains 40 mg of docetaxel (anhydrous).
Slovenian: En ml raztopine docetaksela vsebuje 40 mg brezvodnega docetaksela.
English: Tabulated list of adverse reactions in breast cancer for TAXOTERE 100 mg/m² single agent
Slovenian: Tabelarični prikaz neželenih učinkov monoterapije z zdravilom TAXOTERE 100 mg/m2 pri raku dojke
English: Hot flush (G3/4: 0.5%) Hypotension (G3/4:
Slovenian: hipotenzija (S3/4: 0 %) flebitis (S3/4: 0 %)
English: Peripheral sensory neuropathy (G3/4: 0.8%)
Slovenian: periferna motorična nevropatija (S3/4: 0,4 %)
English: TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion docetaxel
Slovenian: TAXOTERE 80 mg/2 ml koncentrat in vehikel za raztopino za infundiranje docetaksel
English: Pyrexia (G3/4: NA); Oedema peripheral (G3/4: 0.2%)
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija (S3/4: 10,0 %), zvišana telesna temperatura (S3/4: NA), periferni edemi (S3/4: 0,2 %)
English: Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Slovenian: hipotenzija (S3/4: 0 %) vnetje žile (S 3/4: 0 %)
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for TAXOTERE 75 mg/m² in combination with cisplatin and 5-fluorouracil
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom TAXOTERE 75 mg/m2 v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
English: Febrile neutropenia (G3/4: NA)
Slovenian: Amenoreja (S3/4: NA)
English: Description of selected adverse reactions in breast cancer for TAXOTERE 100 mg/m² single agent
Slovenian: Opis izbranih neželenih učinkov monoterapije z zdravilom TAXOTERE 100 mg/m2 pri raku dojke
English: Tabulated list of adverse reactions in non-small cell lung cancer for TAXOTERE 75 mg/m² single agent
Slovenian: Tabelarični prikaz neželenih učinkov monoterapije z zdravilom TAXOTERE 75 mg/m2 pri nedrobnoceličnem pljučnem raku
English: Lethargy (G3-4: 2%) Flu-like symptoms (G3: 0%) Asthenia (G3: 0%) Fluid retention
Slovenian: Srčne bolezni aritmija (S3/4: 2, 0 %) ishemija miokarda
English: Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Slovenian: febrilna nevtropenija, trombocitopenija (S4: 0,8 %)
English: PREPARATION GUIDE FOR USE WITH TAXOTERE 80 mg/4 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Slovenian: NAVODILA ZA UPORABO GLEDE PRIPRAVE KONCENTRATA ZA RAZTOPINO ZA INFUNDIRANJE ZDRAVILA TAXOTERE 80 mg/ 4 ml
English: Alopecia (G3/4: 4.0%); Rash pruritic
Slovenian: Srčne bolezni aritmija (S3/4: 2,0 %) ishemija miokarda
English: Dysgeusia/Parosmia (G3/4: 0.4%);
Slovenian: bolečine v trebuhu (S3/4: 0,4 %)
English: Oesophagitis/dysphagia/odynop hagia (G3/4: 0.7%)
Slovenian: Bolezni živčevja disgevzija/parozmija, periferna senzorična nevropatija (S3/4:0,6 %)
English: Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Slovenian: Infekcijske in parazitske bolezni okužba (S3/4): 3,3 %) Bolezni krvi in limfatičnega sistema nevtropenija (S3/4: 32 %), anemija (S3/4: 4,9 %)
English: Skin reaction (no severe)
Slovenian: Pogosti neželeni učinki spremembe nohtov (nobenih hudih)
English: The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 20 mg/0.5 ml vial ensures a premix concentration of 10 mg/ml docetaxel.
Slovenian: Dodatek celotne vsebine viale z vehiklom vsebini viale zdravila TAXOTERE 20 mg zagotavlja koncentracijo 10 mg/ml docetaksela v osnovni raztopini.
English: 24.4 mg/0.61 ml).
Slovenian: z 9 meseci, p = 0,01).
English: Diarrhoea (G3/4: 2.9%); Vomiting (G3/4: 0.6%)
Slovenian: Bolezni prebavil navzea (S3/4: 0,6 %), stomatitis (S3/4: 4,0 %), driska (S3/4: 2,9 %), bruhanje (S3/4: 0,6 %)
English: 2.1 TAXOTERE 80 mg/2 ml vial
Slovenian: 2.1 Viala zdravila TAXOTERE 80 mg/2 ml:
English: Tabulated list of adverse reactions in non-small cell lung cancer for TAXOTERE 75 mg/m² in combination with cisplatin
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom TAXOTERE 75 mg/m2 pri nedrobnoceličnem pljučnem raku v kombinaciji s cisplatinom Organski sistemi po
English: 60 mg/m².
Slovenian: stopnje, moramo odmerek zmanjšati na 60 mg/m2.
English: Diabetes (G3-4: 1%)
Slovenian: Bolezni endokrinega sistema sladkorna bolezen (3.-4. st.: 1 %)
English: Dehydration (G3/4: 2%)
Slovenian: Srčne bolezni aritmija (S3/4: 0,2 %)
English: ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IZMIŠLJENIH IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POT UPORABE IN IMETNIKI DOVOLJENJ ZA PROMET
English: Member State Marketing Authorisation Holder Invented Name
Slovenian: Imetnik dovoljenja za promet
English: 2 bottles of 240
Slovenian: 2 plastenki po 240
English: 240 ml (15 mg/ml) 1 bottle + 20 ml measuring cup
Slovenian: 1 plastenka + 20 ml odmerni lonček
English: Package size
Slovenian: Vsebnost (koncentracija) Velikost pakiranja
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Slovenian: Farmacevtska oblika Način uporabe Ovojnina
English: 15 mg/ml Oral solution
Slovenian: EU/1/00/148/004 AGENERASE 15 mg/ml Peroralna raztopina Peroralna uporaba Plastenka (HDPE) 240 ml (15 mg/ml)
English: Locomotor disorders:
Slovenian: Lokomotorne motnje:
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
English: Cattle and pigs
Slovenian: Goveda in prašiči
English: Novem alone will not provide adequate pain relief during the dehorning procedure.
Slovenian: Samo zdravilo Novem ne zagotavlja ustreznega lajšanja bolečine med postopkom odstranjevanja rogov.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the relase of the concerned batch.
Slovenian: V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov proizvajalca, odgovornega za sproščanje zadevne serije.