FrancophonIA/ELRC3.0 huggingface dataset:
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for Taxespira 75 mg/m 2 in combination with cisplatin and 5-fluorouracil
Swedish: Beskrivning av utvalda biverkningar vid adenocarcinom i magsäcken för Taxespira 75 mg/m 2 i kombination med cisplatin och 5-fluorouracil
English: Stomatitis (G3/4: 5.3%); Diarrhoea
Swedish: Illamående(G3/4: 3,3 %); Stomatit
English: Taxespira 20 mg/1 ml concentrate for solution for infusion
Swedish: Taxespira 20 mg/1 ml koncentrat till infusionsvätska, lösning
English: Outer Carton
Swedish: Ytterkartong
English: Taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Swedish: Taxespira monoterapi är indicerat för behandling av patienter med lokalt avancerad eller metastaserande bröstcancer efter svikt på tidigare cytostatikabehandling.
English: Infection (G3/4: 3.3%)
Swedish: Infektion (G3/4: 3,6 %);
English: 80mg/4 ml One vial of 4 ml concentration contains 80 mg docetaxel.
Swedish: 80 mg/4 ml En injektionsflaska med 4 ml koncentrat innehåller 80 mg docetaxel.
English: Dizziness (G3/4: 2.0%); Peripheral motor neuropathy (G3/4: 0.4%)
Swedish: Yrsel (G3/4: 2,0 %); Perifer motorisk neuropati (G3/4:
English: Weight decreased
Swedish: Överkänslighetsreaktio ner
English: For example, a dose of 140 mg docetaxel would require 7 ml Taxespira 20 mg/1 ml concentrate for solution for infusion.
Swedish: Till exempel, en dos på 140 mg docetaxel kräver 7 ml Taxespira
English: After 10 years of follow-up in GEICAM 9805 study, acute leukaemia occurred in 1 of 532 (0.2%)patients in TAC arm. No cases were reported in patients in FAC arm. No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Swedish: Efter 10 års uppföljningsperiod i GEICAM 9805-studien utvecklades akut leukemi hos 1 av 532 (0,2 %) patienter i TAC-armen.
English: 120mg/6 ml One vial of 6 ml concentrate contains 120 mg docetaxel.
Swedish: 120 mg/6 ml En injektionsflaska med 6 ml koncentrat innehåller 120 mg docetaxel.
English: TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).At the median follow up time of 10 years and 5 months, TAC-treated patients had a 16.5% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.84, 95% CI (0.65-1.08), p=0.1646).
Swedish: TAC-behandlade patienter hade en 32 %-ig minskning av återfallsrisken jämfört med de som behandlades med FAC (hazard ratio =0,68; 95 % CI (0,49-0,93); p = 0,01).
English: Constipation (severe: 0.2%); Abdominal pain (severe: 1%);
Swedish: Förstoppning (svår 0,2 %); Buksmärta (svår 1 %); Gastrointestinal blödning (svår 0,3 %)
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per 1 ml, equivalent to 10 ml of beer or 4 ml wine.
Swedish: Detta läkemedel innehåller 50 vol% vattenfri etanol (alkohol) d.v.s. upp till 395 mg vattenfri etanol per 1 ml injektionsflaska, motsvararande 10 ml öl eller 4 ml vin.
English: Vials containing 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml and 160 mg/8 ml are available in packs containing a single vial.
Swedish: Varje kartong innehåller en injektionsflaska med 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml 140 mg/7 ml och 160 mg/8 ml.
English: Taxespira 140 mg/7 ml concentrate for solution for infusion.
Swedish: Taxespira 140 mg/7 ml koncentrat till infusionsvätska, lösning docetaxel
English: Taxespira 160 mg/8 ml concentrate for solution for infusion.
Swedish: Taxespira 160 mg/8 ml koncentrat till infusionsvätska, lösning docetaxel
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1580 mg ethanol anyhdrous per 4 ml vial, equivalent to 40 ml of beer or 17 ml wine.
Swedish: Detta läkemedel innehåller 50 vol% vattenfri etanol (alkohol) d.v.s. upp till 1580 mg vattenfri etanol per 4 ml injektionsflaska, motsvararande 40 ml öl eller 17 ml vin.
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2765 mg ethanol anhydrous per 7 ml vial, equivalent to 70 ml of beer or 29 ml wine.
Swedish: Detta läkemedel innehåller 50 vol% vattenfri etanol (alkohol) d.v.s. upp till 2765 mg vattenfri etanol per 7 ml injektionsflaska, motsvararande 70 ml öl eller 29 ml vin.
English: EU/1/15/1017/005 160 mg/8 ml vial x 1 vial
Swedish: EU/1/15/1017/005 160 mg/8 ml injektionsflaska x 1 injektionsflaska
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2370 mg ethanol anhydrous per 6 ml vial, equivalent to 60 ml of beer or 25 ml wine.
Swedish: Detta läkemedel innehåller 50 vol% vattenfri etanol (alkohol) d.v.s. upp till 2370 mg vattenfri etanol per 6 ml injektionsflaska, motsvararande 60 ml öl eller 25 ml vin.
English: Tabulated list of adverse reactions in breast cancer for Taxespira 75 mg/m² in combination with doxorubicin
Swedish: Tabell över biverkningar vid bröstcancer för Taxespira 75 mg/m 2 i kombination med doxorubicin
English: In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST >1.5 × ULN
Swedish: I den pivotala kliniska prövningen där man kombineradecisplatin och 5-fluorouracil för behandling av patienter med adenocarcinom i magsäcken, exkluderades patienter med ALAT och/eller ASAT > 1,5 x ULN i kombination med alkaliska fosfataser > 2,5 x ULN, och bilirubin > 1 x ULN.
English: EU/1/15/1017/004 140 mg/7 ml vial x 1 vial
Swedish: EU/1/15/1017/004 140 mg/7 ml injektionsflaska x 1 injektionsflaska
English: In the case of severe neutropenia (<500 cells/mm
Swedish: Hos patienter med uttalad neutropeni (< 0,5 x 10
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2370 mg ethanol anhydrous per 6 ml vial.
Swedish: Detta läkemedel innehåller 50 vol% vattenfri etanol (alkohol), d.v.s. upp till 2370 mg vattenfri etanol per injektionsflaska med 6 ml.
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2765 mg ethanol anhydrous per 7 ml vial.
Swedish: Detta läkemedel innehåller 50 vol% vattenfri etanol (alkohol), d.v.s. upp till 2765 mg vattenfri etanol per injektionsflaska med 7 ml.
English: 1,000 mg/m2 per day for 5 days.
Swedish: fluorouracil (F) (1000 mg/m2 per dag under 5 dagar).
English: Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/mm
Swedish: Ny behandlingskur skall ges när antalet neutrofila granulocyter återgått till en nivå ≥ 1,5 x 10
English: Tabulated list of adverse reactions in breast cancer for Taxespira 100 mg/m² in combination with trastuzumab
Swedish: Tabell över biverkningar vid bröstcancer för Taxespira 100 mg/m 2 i kombination med trastuzumab
English: Hypersensitivity (G3/4: 0.6%)
Swedish: Överkänslighetsreaktioner (G3/4: 0,6 %)
English: Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F)
Swedish: Patienter i den jämförande armen erhöll cisplatin (P) 100 mg/m2 följt av 5-fluorouracil (F) 1000 mg/m2 dagligen i 5 dagar.
English: Weight decreased; G3/4 Blood bilirubin increased
Swedish: Viktminskning; G3/4 bilirubinstegring (9 %)
English: Taxespira is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Swedish: Taxespira är indicerat för behandling av patienter med lokalt avancerad eller metastaserad ickesmåcellig lungcancer, efter behandlingssvikt på tidigare kemoterapi.
English: EU/1/15/1017/003 120 mg/6 ml vial x 1 vial
Swedish: EU/1/15/1017/003 120 mg/6 ml injektionsflaska x 1 injektionsflaska
English: In GEICAM 9805 study, peripheral sensory neuropathy that started during the treatment period persisted into the follow-up period in 10 patients (1.9%) in TAC arm and 4 patients (0.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), peripheral sensory neuropathy was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Swedish: I studien GEICAM 9805 uppkom perifer sensorisk neuropati under behandlingen och kvarstod under uppföljningsperioden hos 10 patienter (1,9 %) i TAC-armen och 4 patienter (0,8 %) i FAC-armen.
English: Description of selected adverse reactions in breast cancer for Taxespira 100 mg/m 2 single agent
Swedish: Beskrivning av utvalda biverkningar vid bröstcancer för Taxespira 100 mg/m 2 monoterapi
English: Taxespira 120 mg/6 ml concentrate for solution for infusion.
Swedish: Taxespira 120 mg/6 ml koncentrat till infusionsvätska, lösning docetaxel
English: This is equivalent to 40 ml of beer or17 ml of wine.
Swedish: Det här motsvarar 40 ml öl eller 17 ml vin.
English: In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every
Swedish: I denna kliniska studie randomiserades 255 patienter till behandling med docetaxel (75 mg/m2 som en intravenös infusion under en timme var tredje vecka) och capecitabin (1250 mg/m2 2 gånger dagligen i två veckor följt av en veckas viloperiod).
English: Nausea (G3/4: 2.4%); Diarrhoea (G3/4: 1.2%);
Swedish: Stomatit (G3/4: 5,3 %); Diarré (G3/4: 4 %);
English: Exfoliative rash (G3/4: 0.3%)
Swedish: Exfoliativt utslag (G3/4: 0,3 %)
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per 1 ml vial.
Swedish: Detta läkemedel innehåller 50 vol% vattenfri etanol (alkohol), d.v.s. upp till 395 mg vattenfri etanol per injektionsflaska med 1 ml.
English: Constipation
Swedish: Konjunktivit
English: Lacrimation increased (G3/4: 0%)
Swedish: Ökat tårflöde (G3/4: 0 %)
English: Lacrimation increased (G3/4:
Swedish: Ökat tårflödet (G3/4:
English: Hearing impaired (G3/4: 0%)
Swedish: Nedsatt hörsel (G3/4: 0 %)
English: Immune system disorders Metabolism and nutrition disorders Nervous system disorders
Swedish: Metabolism och nutrition Psykiska störningar Centrala och perifera nervsystemet Ögon
English: In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period and was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
Swedish: I GEICAM 9805-studien observerades att amenorré som uppkom under behandlingsperioden kvarstod i uppföljningsperioden hos 18 patienter (3,4 %) i TAC-armen och 5 patienter (1,0 %) i FAC-armen.
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3160 mg ethanol anhydrous per 8 ml vial.
Swedish: Detta läkemedel innehåller 50 vol% vattenfri etanol (alkohol), d.v.s. upp till 3160 mg vattenfri etanol per injektionsflaska med 8 ml.
English: Arrhythmia (G3/4: 1.0%)
Swedish: Arytmi (G3/4: 1,0 %)
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1580 mg ethanol anhydrous per 4 ml vial.
Swedish: Detta läkemedel innehåller 50 vol% vattenfri etanol (alkohol), d.v.s. upp till 1580 mg vattenfri etanol per injektionsflaska med 4 ml.
English: Hot flush (G3/4: 0.5%) Hypotension (G3/4: 0%); Phlebitis (G3/4:
Swedish: Hypotoni (G3/4: 0 %); Flebit (G3/4:
English: Number of patients in TAC group
Swedish: Patientundergrupp Antalet patienter
English: Hypotension (G3/4:
Swedish: Hypotoni (G3/4:
English: Taxespira as single agent
Swedish: Taxespira som monoterapi
English: Taxespira 80 mg/4 ml concentrate for solution for infusion.
Swedish: Taxespira 80 mg/4 ml koncentrat till infusionsvätska, lösning docetaxel
English: Syncope (G3/4: 0%); Neurotoxicity (G3/4: 0%); Somnolence (G3/4: 0%)
Swedish: Epistaxis (G3/4: 0 %); Dyspné (G3/4: 0,6 %); Hosta (G3/4: 0 %)
English: Dose adjustments during treatment
Swedish: Dosjustering under behandling:
English: 1.2%); Oedema (G3/4:
Swedish: 1,2 %); Ödem (G3/4: 1,2 %)
English: Rash pruritus (G3/4: 0.7%); Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Swedish: Utslag/klåda (G3/4: 0,7 %); Nagelförändringar (G3/4: 0,7 %); Hudexfoliering (G3/4: 0 %)
English: Tabulated list of adverse reactions in non-small cell lung cancer for Taxespira 75 mg/m² in combination with cisplatin
Swedish: Tabell över biverkningar vid småcellig lungcancer för Taxespira 75 mg/m 2 i kombination med cisplatin
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 140 mg/7 ml concentrate for solution for infusion, which contains only 1 vial).
Swedish: ANVÄND INTE andra läkemedel som innehåller docetaxel bestående av 2 injektionsflaskor (koncentrat och spädningsvätska) med detta läkemedel (Taxespira 140 mg/7 ml koncentrat till infusionsvätska, lösning, vilket endast innehåller 1 injektionsflaska).
English: EU/1/15/1017/001 20 mg/1 ml vial x 1 vial
Swedish: EU/1/15/1017/001 20 mg/1 ml injektionsflaska x 1 injektionsflaska
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Taxespira 75 mg/m² in combination with cisplatin and 5-fluorouracil
Swedish: Tabell över biverkningar vid adenocarcinom i magsäcken för Taxespira 75 mg/m 2 i kombination med cisplatin och 5-fluorouracil
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.
Swedish: I GEICAM 9805-studien hade alopeci som uppkommit under behandlingsperioden och kvarstod i uppföljningsperioden observerats för 49 patienter (9,2 %) i TAC-armen och 35 patienter (6,7 %) i FAC-armen.
English: EU/1/15/1017/002 80 mg/4 ml vial x 1 vial
Swedish: EU/1/15/1017/002 80 mg/4 ml injektionsflaska x 1 injektionsflaska
English: Cough (G3/4: 0%)
Swedish: Hosta (G3/4: 0 %)
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
Swedish: ANVÄND INTE andra läkemedel som innehåller docetaxel bestående av 2 injektionsflaskor (koncentrat och spädningsvätska) med detta läkemedel (Taxespira 160 mg/8 ml koncentrat till infusionsvätska, lösning, vilket endast innehåller 1 injektionsflaska).
English: Gastrointestinal pain (G3/4: 1.0%); Oesophagitis/dysphagia/odynophagia (G3/4: 0.7%)
Swedish: Esofagit/dysfagit/odynofagi (G3/4: 0,7 %)
English: Anorexia (G3/4: 0.6%)
Swedish: Cancersmärta (G3/4:0,6 %)
English: Venous disorder (G3/4:
Swedish: Venösa sjukdomar (G3/4:
English: Number of patients Median survival (months) 95% CI
Swedish: Överlevnad i median (månader) 95 % CI
English: 50 mg/m2 (TAC arm), or doxorubicin 50 mg/m 2 followed by fluorouracil 500 mg/m2 (FAC arm).
Swedish: 500 mg/m2 (FAC-armen).
English: G-CSF was administered as secondary prophylaxis to patients who experienced complicated neutropenia (febrile neutropenia, prolonged neutropenia, or infection).
Swedish: Docetaxel administrerades som en 1-timmes infusion, övriga läkemedel gavs som intravenös bolusdos dag ett. G-CSF administrerades som en sekundär profylax till patienter som fick svår neutropeni (febril neutropeni, förlängd neutropeni eller infektion).
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
Swedish: ANVÄND INTE andra läkemedel som innehåller docetaxel bestående av 2 injektionsflaskor (koncentrat och spädningsvätska) med detta läkemedel (Taxespira 20 mg/1 ml koncentrat till infusionsvätska, lösning, vilket endast innehåller 1 injektionsflaska).
English: 7.8%); Diarrhoea (G3/4: 6.2%);
Swedish: 6,4 %); Stomatit (G3/4: 2 %)
English: Tabulated list of adverse reactions in breast cancer for Taxespira 75 mg/m² in combination with capecitabine
Swedish: Tabell över biverkningar vid bröstcancer för Taxespira 75 mg/m 2 i kombination med capecitabin
English: ALT and AST >3.5 times the ULN associated with alkaline phosphatase >6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Swedish: Till patienter med serumbilirubin högre än normalvärdesgränsen och/eller ASAT/ALAT-värden på mer än 3,5 gånger den övre normalvärdesgränsen som samtidigt har alkaliska fosfataser högre än 6 gånger övre normalvärdesgränsen, kan ingen rekommendation angående dosreduktion ges och docetaxel bör ej användas om inte strikt indikation föreligger.
English: Tabulated list of adverse reactions in head and neck cancer for Taxespira 75 mg/m² in combination with cisplatin and 5-fluorouracil
Swedish: Tabell över biverkningar vid huvud- halscancer för Taxespira 75 mg/m 2 i kombination med cisplatin och 5-fluorouracil
English: Peripheral sensory neuropathy (G3: 0.4%)
Swedish: Perifer sensorisk neuropati (G3:
English: Arrhythmia (G3/4:
Swedish: Vätskeretention (G3/4:
English: Nausea (G3/4: 9.6%); Vomiting (G3/4:
Swedish: Illamående (G3/4: 9,6 %); Kräkning (G3/4: 7,6 %);
English: Lacrimation increased Conjunctivitis
Swedish: Ökat tårflöde
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 120 mg/6 ml concentrate for solution for infusion, which contains only 1 vial).
Swedish: ANVÄND INTE andra läkemedel som innehåller docetaxel bestående av 2 injektionsflaskor (koncentrat och spädningsvätska) med detta läkemedel (Taxespira 120 mg/6 ml koncentrat till infusionsvätska, lösning, vilket endast innehåller 1 injektionsflaska).
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
Swedish: ANVÄND INTE andra läkemedel som innehåller docetaxel bestående av 2 injektionsflaskor (koncentrat och spädningsvätska) med detta läkemedel (Taxespira 80 mg/4 ml koncentrat till infusionsvätska, lösning, vilket endast innehåller 1 injektionsflaska).
English: Neutropenia (G3/4:
Swedish: Viktökning (G3/4:
English: Stomatitis (G3/4: 2%)
Swedish: Nagelförändringar (G3/4: 2 %).
English: Pain
Swedish: Hud
English: G3/4 Blood alkaline phosphatase increased
Swedish: G3/4 bilirubin stegring
English: Taxespira 20 mg/1 ml concentrate for solution for infusion.
Swedish: Taxespira 20 mg/1 ml koncentrat till infusionsvätska, lösning docetaxel i.v.
English: Peripheral sensory neuropathy (G3/4: 0.8%)
Swedish: Perifer motorisk neuropati (G3/4: 0 %)
English: Nausea (G3/4: 5%); Stomatitis (G3/4:
Swedish: Anemi (G3/4: 3 %); Neutropeni (G3/4:
English: Vomiting (G3/4: 5%);
Swedish: Illamående (G3/4: 4 %);
English: Tabulated list of adverse reactions in non-small cell lung cancer for Taxespira 75 mg/m² single agent
Swedish: Tabell över biverkningar vid småcellig lungcancer för Taxespira 75 mg/m 2 monoterapi
English: Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle.
Swedish: • Dra aseptiskt upp den mängd koncentrat till infusionsvätska, lösning som behövs med en
English: Hypersensitivity (G3/4:
Swedish: Överkänslighetsreaktioner (G3/4:
English: • dizziness
Swedish: • ryggvärk
English: Frequency of administration
Swedish: Administreringsintervall
English: Hazard ratio: (95% CI) **p-value
Swedish: Hazard ratio: (95 % CI) **p-värde
English: Lymphoedema (G3/4:
Swedish: Arytmi (G3/4:
English: Constipation (G3/4: 1.0%);
Swedish: Letargi (G3/4: 4,0 %);
English: Thrombocytopenia (G4: 0.2%)
Swedish: Trombocytopeni (G3/4: 3 %)
English: Hazard ratio: (95% CI) *p-value
Swedish: Hazard ratio: (95 % CI) *p-värde
English: 3 (see section 4.2).
Swedish: (anges i avsnitt 6).
English: Hazard ratio (95% CI) *p-value
Swedish: Hazard ratio (95 % CI) *p-värde
English: Hazard ratio (95% CI) **p-value
Swedish: Hazard ratio (95 % CI) **p-värde
English: • at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling
Swedish: • hudreaktioner, kärlväggsinflammation eller svullnad vid insticksstället
English: Lethargy (G3/4: 4.0%); Pyrexia (G3/4: 3.6%);
Swedish: Pyrexi (G3/4: 3,6 %);
English: Epistaxis (G3/4: 0%);
Swedish: Neurotoxicitet (G3/4: 0 %);
English: Myalgia (G3/4: 0.4%)
Swedish: Arytmi (G3/4: 0,2 %)
English: Adjusted hazard ratio (95% CI) *p-value
Swedish: Justerad hazard ratio (95 % CI) *p-värde
English: In study GEICAM 9805 peripheral oedema that started during the treatment period persisted into the follow-up period in 4 patients (0.8%) in TAC arm and in 2 patients (0.4%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), no patients (0%) in TAC arm had peripheral oedema and it was observed to be ongoing in 1 patient (0.2%) in FAC arm. Lymphoedema that started during the treatment period persisted into the follow-up period in 5 patients (0.9%) in TAC arm and 2 patients (0.4 %) in FAC arm. At the end of the follow-up period, lymphoedema was observed to be ongoing in 4 patients (0.8%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Swedish: I studie GEICAM 9805 uppkom perifert ödem under behandlingsperioden och kvarstod i uppföljningsperioden hos 4 patienter (0,8 %) i TAC-armen och hos 2 patienter (0,4 %) i FAC-armen.
English: Tabulated list of adverse reactions in breast cancer for Taxespira 100 mg/m² single agent
Swedish: Tabell över biverkningar vid bröstcancer för Taxespira 100 mg/m 2 monoterapi
English: Myocardial ischemia (G3/4:1.7%)
Swedish: Hjärtmuskelischemi (G3/4: 1,7 %)
English: Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4:
Swedish: Dyspné (G3/4: 1 %); Hosta (G3/4: < 1 %); Epistaxis (G3/4:
English: • feeling of numbness or pins and needles
Swedish: • domningskänsla eller myrkrypningar
English: • alteration in sense of taste
Swedish: • smakförändring
English: Constipation;
Swedish: Förstoppning;
English: Pharyngolaryngeal pain (G3/4: 2%) Dyspnoea (G3/4: 1%); Cough (G3/4: <1%);
Swedish: Asteni (G3/4: 3 %); Pyrexi (G3/4: 1 %); Trötthet/svaghet (G3/4: 5 %), Perifert ödem (G3/4: 1 %)
English: Vial label
Swedish: Injektionsflaskans etikett
English: Cardiac left ventricular function decrease (G3/4:
Swedish: Öron och balansorgan Nedsatt hörsel (G3/4:
English: Alopecia; Nail disorders (severe:
Swedish: Alopeci; erytem; hudutslag; nagelförändringar
English: Nail disorders (severe: 0.8%)
Swedish: Esofagit (svår 0,4 %)
English: However, the number of abortions increased.
Swedish: Antalet aborter ökade dock.
English: This reaction may be delayed.
Swedish: Reaktionen kan vara fördröjd.
English: (Possible mechanism)
Swedish: (Möjlig mekanism)
English: (Study conducted in 8 patients)
Swedish: (Studien genomförd på 8 patienter)
English: In this case close monitoring is required.
Swedish: I sådana fall krävs noggrann övervakning
English: Let them dry completely before you use them again.
Swedish: Låt dem torka innan du använder dem igen.
English: Mechanism unknown.
Swedish: Okänd mekanism.
English: 79 % of subjects received greater than 48 weeks of exposure.
Swedish: 79% av individerna fick mer än 48 veckors exponering.
English: • if they have been taking combination therapy for a long time
Swedish: • om de har fått kombinationsbehandling under lång tid
English: • if their immune systems are very weak
Swedish: • om deras immunförsvar är mycket svagt
English: Date of renewal of authorisation: 15 May 2009.
Swedish: Datum för förnyat godkännande: 15 maj 2009
English: For this reason, it is very important to talk to your doctor about any changes in your health.
Swedish: Av denna anledning är det mycket viktigt att du informerar din läkare om alla förändringar i ditt hälsotillstånd.