FrancophonIA/ELRC3.0 huggingface dataset:
English: DO NOT use other docetaxel medicine consisting of 2 vials (concentrate and solvent) with this medicine (DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
Icelandic: NOTIÐ EKKI önnur dócetaxel lyf sem samanstanda af 2 hettuglösum (innrennslisþykkni og leysir) með þessu lyfi (Docetaxel Kabi 20 mg/1 ml innrennslisþykkni, lausn sem er aðeins 1 hettuglas).
English: Somnolence (G3/4: 0%)
Icelandic: Heyrnarskerðing (G3/4: 0%)
English: DO NOT use other docetaxel medicine consisting of 2 vials (concentrate and solvent) with this medicine (DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
Icelandic: NOTIÐ EKKI önnur dócetaxel lyf sem samanstanda af 2 hettuglösum (innrennslisþykkni og leysir) með þessu lyfi (Docetaxel Kabi 80 mg/4 ml innrennslisþykkni, lausn sem er aðeins 1 hettuglas).
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 20 mg/1 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Icelandic: HEITI LYFS Docetaxel Kabi 20 mg/1 ml innrennslisþykkni, lausn
English: Paediatric population
Icelandic: Undirhópar Fjöldi sjúklinga
English: Nausea (G3/4: 5.0%); Stomatitis (G3/4: 6.0%); Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4: 0.5%)
Icelandic: Munnbólga (G3/4: 5,3%); Niðurgangur (G3/4: 4%); Ógleði (G3/4: 4%); Uppköst (G3/4: 3%)
English: From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately.
Icelandic: Frá örverufræðilegu sjónarmiði á að blanda/þynna lyfið við stýrðar aðstæður að viðhafðri smitgát og nota lyfið strax.
English: What DOCETAXEL KABI contains - The active substance is docetaxel anhydrous.
Icelandic: - Virka innihaldsefnið er vatnsfrítt dócetaxel.
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 180 mg/9 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Icelandic: HEITI LYFS Docetaxel Kabi 180 mg/9 ml innrennslisþykkni, lausn
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion
Icelandic: UM BLÖNDUN DOCETAXEL KABI 180 mg/9 ml, INNRENNSLISÞYKKNIS, LAUSNAR
English: Arrhythmia (G3/4: 0.7%)
Icelandic: Hjartsláttartruflanir (G3/4: 0,7%)
English: The benefit of resuming docetaxel treatment must be carefully evaluated.
Icelandic: Meta skal vandlega ávinning þess að hefja dócetaxel meðferð að nýju.
English: Vomiting (G3/4: 4%); Constipation (G3/4: 1%); Abdominal pain (G3/4: 2%); Dyspepsia
Icelandic: Ógleði (G3/4: 6%); Uppköst (G3/4: 4%); Hægðatregða (G3/4: 1%); Kviðverkir (G3/4: 2%); Meltingartruflanir
English: Pyrexia (G3/4: 3.6%);
Icelandic: Hiti (G3/4: 3,6%);
English: Hand-foot syndrome (G3/4: 24%);
Icelandic: Handa- og fótaheilkenni (G3/4: 24%); Hárlos (G3/4: 6%);
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Icelandic: HEITI LYFS Docetaxel Kabi 160 mg/8 ml innrennslisþykkni, lausn
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 80 mg/4 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Icelandic: HEITI LYFS Docetaxel Kabi 80 mg/4 ml innrennslisþykkni, lausn
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion
Icelandic: UM BLÖNDUN DOCETAXEL KABI 80 mg/4 ml, INNRENNSLISÞYKKNIS, LAUSNAR
English: Interruption of docetaxel therapy is recommended until diagnosis is available.
Icelandic: Mælt er með því að hætta meðhöndlun með dócetaxeli þar til sjúkdómsgreining liggur fyrir.
English: Dehydration (G3/4: 2%)
Icelandic: Breytingar á nöglum (G3/4: 2%)
English: Alopecia (G3/4: 4.0%)
Icelandic: Hárlos (G3/4: 4,0%)
English: DO NOT use other docetaxel medicine consisting of 2 vials (concentrate and solvent) with this medicine (DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion, which contains only 1 vial).
Icelandic: NOTIÐ EKKI önnur dócetaxel lyf sem samanstanda af 2 hettuglösum (innrennslisþykkni og leysir) með þessu lyfi (Docetaxel Kabi 120 mg/6 ml innrennslisþykkni, lausn sem er aðeins 1 hettuglas).
English: Peripheral sensory neuropathy (G3/4: 0.8%)
Icelandic: Útlægur skyntaugakvilli (G3/4: 0,8%)
English: Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 5.
Icelandic: á degi 1, fylgt eftir með gjöf 100 mg/m2 af císplatíni sem innrennsli á 30 mínútum til 3 klst. og síðan er 1000 mg/m2/sólarhring af 5-flúoróúrasíli gefið með stöðugu innrennsli frá degi 1 til 4.
English: Amenorrhoea (G3/4: NA)
Icelandic: Vessabjúgur (G3/4:
English: • oesophagitis
Icelandic: A. ÁLETRANIR
English: Hazard ratio: (95% CI) *p-value
Icelandic: Áhættuhlutfall: (95% CI) *p-gildi
English: The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin 75 mg/m2, as a 1- to 3- hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m2 per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Icelandic: Ráðlagður skammtur af dócetaxeli er 75 mg/m2 sem gefinn er með innrennsli á 1 klst. og í kjölfar þess eru 75 mg/m2 af cisplatíni gefin með innrennsli á 1 til 3 klst.
English: Constipation (severe: 0.2%); Abdominal pain (severe: 1%);
Icelandic: Hægðatregða (alvarleg tilvik: 0,2%);
English: • chest tightness; difficulty in breathing
Icelandic: Lágþrýstingur; Háþrýstingur; Blæðingar
English: Gastrointestinal haemorrhage (G3/4: 0.4%)
Icelandic: Útlægur hreyfitaugakvilli (G3/4: 0,4%)
English: Cough (G3/4: 0%)
Icelandic: Hósti (G3/4: 0%)
English: Esophagitis/dysphagia/ odynophagia (G3/4: 0.6%); Abdominal pain;
Icelandic: Efnaskipti og næring Lystarleysi (G3/4: 0,6%) Taugakerfi
English: Vomiting (G3/4: 4%);
Icelandic: Niðurgangur (G3/4: 14%);
English: DOCETAXEL KABI in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Icelandic: Docetaxel Kabi ásamt capecítabíni er ætlað til meðferðar á sjúklingum með langt gengið brjóstakrabbamein sem er staðbundið eða með meinvörpum þegar ekki hefur fengist svörun við annarri krabbameinslyfjameðferð.
English: For prostate cancer, the premedication is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.2).
Icelandic: Við blöðruhálskirtilskrabbameini er lyfjaforgjöf 8 mg af dexametasóni til inntöku 12 klst., 3 klst. og 1 klst.
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion
Icelandic: UM BLÖNDUN DOCETAXEL KABI 20 mg/1 ml, INNRENNSLISÞYKKNIS, LAUSNAR
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion
Icelandic: UM BLÖNDUN DOCETAXEL KABI 160 mg/8 ml, INNRENNSLISÞYKKNIS, LAUSNAR
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 120 mg/6 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Icelandic: HEITI LYFS Docetaxel Kabi 120 mg/6 ml innrennslisþykkni, lausn
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release
Icelandic: Heiti og heimilisfang framleiðenda sem eru ábyrgir fyrir lokasamþykkt
English: Acute myeloid leukemia and myelodysplastic syndrome have been reported (frequency uncommon) in pivotal clinical studies in breast cancer with TAC regimen.
Icelandic: Greint hefur verið frá bráðu kyrningahvítblæði og mergmisþroska (tíðni sjaldgæf) í lykilrannsóknum á brjóstakrabbameini með TAC samsettri meðferð.
English: Lethargy (G3/4: 4.0%);
Icelandic: Svefnhöfgi (G3/4: 4,0%);
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion
Icelandic: UM BLÖNDUN DOCETAXEL KABI 120 mg/6 ml, INNRENNSLISÞYKKNIS, LAUSNAR
English: Number of patients PSA** response rate (%) 95% CI p-value*
Icelandic: PSA**, hlutfall svörunar (%) 95% Cl p-gildi*
English: • Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour infusion followed by cisplatin 75 mg/m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m2 per day for five days.
Icelandic: Til upphafsmeðferðar hjá sjúklingum með óskurðtækt, staðbundið, langt gengið flöguþekjukrabbamein á höfði og hálsi (SCCHN) er ráðlagður skammtur af dócetaxeli 75 mg/m2 sem gefinn er með innrennsli á 1 klst. og síðan er gefið 75 mg/m2 af cisplatíni með innrennsli á 1 klst., á fyrsta degi.
English: In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
Icelandic: Í þessari rannsókn voru 255 sjúklingar, sem valdir voru með slembivali, meðhöndlaðir með dócetaxeli (75 mg/m2 voru gefin með innrennsli í bláæð á 1 klst.
English: Hearing impaired (G3/4: 0%)
Icelandic: Aukin táraseyting (G3/4: 0%)
English: Cardiac left ventricular function decrease (G3/4: 0.3%)
Icelandic: Minnkuð starfsemi vinstri slegils (G3/4: 0,3%)
English: Hazard ratio: (95% CI) **p-value
Icelandic: Áhættuhlutfall: (95% CI) **p-gildi
English: Asthenia (G3/4: 3%);
Icelandic: Þróttleysi (G3/4: 3%);
English: Skin reaction (G3/4: 5.9%);
Icelandic: Hárlos; Húðbreytingar (G3/4: 5,9%);
English: Anhydrous citric acid (pH adjustment)
Icelandic: Vatnsfrí sítrónusýra (til að stilla sýrustig)
English: Myalgia (G3/4: 0.6%)
Icelandic: Lystarleysi (G3/4: 0,6%)
English: • allergic reactions as described above
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á
English: Tabulated list of adverse reactions in non-small cell lung cancer for DOCETAXEL KABI 75 mg/m² in combination with cisplatin
Icelandic: Tafla yfir aukaverkanir við gjöf Docetaxel Kabi 75 mg/m² ásamt cisplatíni við lungnakrabbameini, sem er ekki af smáfrumugerð
English: Median duration of response (months) (95% CI)
Icelandic: Miðgildi þess tíma sem svörun varir (mánuðir) (95% CI)
English: In study TAX316 alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736FAC patients(87.6%).. At the end of the follow-up period actual median follow-up time of 8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Icelandic: Í TAX 316 rannsókninni var greint frá hármissi sem var viðvarandi eftir að eftirfylgnitímabilið hófst að lokinni krabbameinslyfjameðferð hjá 687 af 744 sjúklingum (92,3%) í TAC hópnum og 645 af 736 sjúklingum (87,6%) í FAC hópnum.
English: Stomatitis (G3/4: 23.7%);
Icelandic: Niðurgangur (G3/4: 19,7%);
English: Median progression free survival (months) (95% CI)
Icelandic: Miðgildi lifunar án versnunar sjúkdóms (mánuðir) (95% CI)
English: Peripheral motor neuropathy (G3/4: 0%)
Icelandic: Útlægur hreyfitaugakvilli (G3/4: 0%);
English: Lacrimation increased (G3/4: 0.6%)
Icelandic: Aukin táraseyting (G3/4: 0,6%)
English: For prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.4).
Icelandic: Við meðferð á blöðruhálskirtilskrabbameini, þar sem samtímis er gefið prednisón eða prednisólón, er mælt með lyfjaforgjöf með 8 mg af dexametasóni til inntöku 12 klst., 3 klst. og 1 klst.
English: The ORR was 59.3% (95% CI: 52.8 - 65.9) in AT arm versus 46.5% (95% CI: 39.8 - 53.2) in AC
Icelandic: ORR var 59,3 % (95 %CI :
English: Hazard ratio (95% CI) *p-value
Icelandic: Áhættuhlutfall (95% CI) *p-gildi
English: Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis; Dyspnoea;
Icelandic: - yfirlið - húðviðbrögð, bláæðabólga eða þroti á stungustað - blóðkekkir.
English: Docetaxel was eliminated in both the urine and faeces following cytochrome P450-mediated oxidative metabolism of the tert-butyl ester group, within seven days, the urinary and faecal excretion accounted for about 6% and 75% of the administered radioactivity, respectively.
Icelandic: Dócetaxel skildist bæði út í þvagi og hægðum eftir umbrot vegna óbeinnar ildingar tertbútýl-esterhóps fyrir tilstilli cýtókróm P450 ensímkerfisins.
English: Scleroderma-like changes usually preceded by peripheral lymphoedema have been reported with docetaxel.
Icelandic: Greint hefur verið frá herslishúðlíkum breytingum vegna dócetaxels venjulega að undangengnum útlægum vessabjúg.
English: Tabulated list of adverse reactions in gastric adenocarcinoma center for DOCETAXEL KABI 75 mg/m² in combination with cisplatin and 5-fluorouracil
Icelandic: Tafla yfir aukaverkanir við gjöf Docetaxel Kabi 75 mg/m² ásamt cisplatíni og 5-flúóroúrasíli við kirtilkrabbameini í maga
English: Stomatitis (G3/4: 6.0%); Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4: 0.5%)
Icelandic: Munnbólga (G3/4: 6,0%); Uppköst (G3/4: 4,2%); Niðurgangur (G3/4:
English: Diarrhoea (G3/4: 19.7%); Nausea (G3/4: 16%);
Icelandic: Munnbólga (G3/4: 20,7%); Uppköst (G3/4: 8,4%);
English: Syncope (G3/4: 0%); Neurotoxicity (G3/4: 0%);
Icelandic: Yfirlið (G3/4: 0%) Eiturverkanir á taugakerfi (G3/4: 0%); Svefnhöfgi (G3/4:0%)
English: In GEICAM 9805 study alopecia that started during the treatment period and persisted into the followup 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 followup 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.
Icelandic: Í GEICAM 9805 rannsókninni var hármissir sem hófst á meðferðartímanum og var viðvarandi eftir að eftirfylgnitímabilið hófst enn til staðar hjá 49 sjúklingum (9,2%) í TAC hópnum og 35 sjúklingum (6,7%) í FAC hópnum.
English: When patients are candidates for treatment with docetaxel in combination with trastuzumab, they should undergo baseline cardiac assessment.
Icelandic: Þegar meðhöndla á sjúklinga með dócetaxeli ásamt trastuzumabi, á að leggja mat á hjartastarfsemi þeirra áður en meðferð hefst.
English: Each ml of concentrate for solution for infusion contains 20 mg docetaxel.
Icelandic: Hvert hettuglas með 1 ml af innrennslisþykkni inniheldur 20 mg af dócetaxeli.
English: Stomatitis (G3/4: 18%); Diarrhoea (G3/4: 14%); Nausea (G3/4: 6%);
Icelandic: Blóðleysi (G3/4: 3%); Daufkyrningafæð (G3/4: 59,2%); Blóðflagnafæð (G3/4: 1,6%);
English: Endpoint
Icelandic: Sundl
English: In GEICAM 9805 study alopecia that started during the treatment period and persisted into the follow-up 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.
Icelandic: Í GEICAM 9805 rannsókninni var hármissir sem hófst á meðferðartímanum og viðvarandi eftir að eftirfylgnitímabilið hófst enn til staðar hjá 49 sjúklingum (9,2%) í TAC hópnum og 35 sjúklingum (6,7%) í FAC hópnum.
English: Median survival (months) (95% CI)
Icelandic: Miðgildi lifunar (mánuðir) (95% CI)
English: Fever (G3/4: 1.2%)
Icelandic: Vökvasöfnun (G3/4: 1,2%);
English: Hepatic impairment
Icelandic: Staða tíðablæðinga
English: p = Hazard ratio*
Icelandic: = Áhættuhlutfall*
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.
Icelandic: Í GEICAM 9805 rannsókninni var bjúgur á útlimum sem hófst á meðferðartímanum og hélst eftir að eftirfylgnitíminn hófst hjá 4 sjúklingum (0,8%) í TAC hópnum og hjá 2 sjúklingum (0,4%) í FAC hópnum.
English: Peripheral sensory neuropathy (G3/4: 1.2%);
Icelandic: Meltingaróþægindi (G3/4: 1,2%);
English: Rare cases of enterocolitis, including colitis, ischemic colitis, and neutropenic enterocolitis, have been reported with a potential fatal outcome (frequency not known).
Icelandic: Mjög sjaldan hefur verið greint frá garna- og ristilbólgu, þar á meðal ristilbólgu, ristilbólgu vegna blóðþurrðar og garna- og ristilbólgu af völdum daufkyrningafæðar, hugsanlega banvænni (tíðni ekki þekkt).
English: Neutropenia (G4: 51.5%); Anaemia (G3/4: 6.9%); Thrombocytopenia (G4: 0.5%)
Icelandic: Daufkyrningafæð (G4: 51,5%); Blóðleysi (G3/4: 6,9%);
English: Abdominal pain upper; Dry mouth
Icelandic: Kviðverkir í efri hluta kviðarhols; Munnþurrkur
English: Hazard ratio (95% CI) **p-value
Icelandic: Áhættuhlutfall (95% CI) **p-gildi
English: Arrhythmia (G3/4: 0.2%)
Icelandic: Hjartsláttaróregla (G3/4: 0,2%);
English: Myalgia (G3/4: 0.7%); Arthralgia (G3/4: 0.2%)
Icelandic: Sundl (G3/4: 2,0%); Útlægur hreyfitaugakvilli (G3/4: 0,4%)
English: Very common adverse reactions Common adverse reactions tissue disorders
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað
English: Reproductive system and breast disorders
Icelandic: Stoðkerfi og bandvefur
English: Cancer pain (G3/4: 0.6%)
Icelandic: Vöðvaþrautir (G3/4:0,6%)
English: Febrile neutropenia
Icelandic: Stærð æxlis
English: • fever or chills
Icelandic: Lifur og gall
English: Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Icelandic: Útlægur skyntaugakvilli (G3/4: 1,2%); Bragðtruflun (G3/4: 0%)
English: Nausea (G3/4: 13.9%); Stomatitis (G3/4: 20.7%); Vomiting (G3/4: 8.4%); Diarrhoea (G3/4: 6.8%); Esophagitis/dysphagia/ odynophagia (G3/4: 12.0%);
Icelandic: Niðurgangur (G3/4: 6,8%); Vélindisbólga/ kyngingartregða/ kyngingarsársauki (G3/4: 12,0%); Hægðatregða (G3/4:
English: Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection Neutropenic infection (Grade 3-4)
Icelandic: Daufkyrningafæð (gráða 4) Daufkyrningafæð með hita Daufkyrningafæð með sýkingu
English: Vascular disorders Hot flush (G3/4: 0.5%) Hypotension (G3/4: 0%);
Icelandic: Hitasteypur (G3/4: 0,5%) Lágþrýstingur (G3/4: 0%) Bláæðabólga (G3/4:0%)
English: Dysgeusia (G3/4: 0.6%); Peripheral sensory neuropathy (G3/4: < 0.1%)
Icelandic: Tárubólga (G3/4:<0,1%) Aukin táraseyting (G3/4: <0,1%);
English: Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Icelandic: Svefnhöfgi (G3/4: 3,4%) Hiti (G3/4: 0,6%); Vökvasöfnun; Bjúgur
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/005
Icelandic: MARKAÐSLEYFISNÚMER EU/1/12/770/005
English: BATCH NUMBER
Icelandic: Kennistærð
English: Aseptically withdraw the required amount of DOCETAXEL KABI concentrate for solution for infusion using a calibrated syringe.
Icelandic: Draga skal upp við smitgát það magn af Docetaxel Kabi innrennslisþykkni, lausn sem þarf með kvarðaðri sprautu.
English: Asthenia (severe: 8.1%); Fluid retention (severe: 1.2%); Pain
Icelandic: Vökvasöfnun (alvarleg tilvik: 1,2%);
English: Oedema
Icelandic: Tárubólga
English: It may harm them,
Icelandic: Hýprómellósa,
English: Sildenafil Actavis with food and drink and alcohol Sildenafil Actavis can be taken with or without food.
Icelandic: Notkun Sildenafil Actavis með mat, drykk og áfengi Sildenafil Actavis má taka með eða án matar.
English: Because not all adverse reactions are reported the frequencies of these reactions cannot be reliably determined.
Icelandic: Þar sem ekki allar aukaverkanir eru tilkynntar er ekki hægt að ákvarða tíðni þeirra nákvæmlega.
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á öskju á eftir EXP.
English: · Risk Management Plan (RMP) Not applicable.
Icelandic: Áætlun um áhættustjórnun Á ekki við.
English: You should not take Sildenafil Actavis if you are a woman.
Icelandic: Þú átt ekki að taka Sildenafil Actavis ef þú ert kona.
English: България Актавис ЕАД
Icelandic: България Актавис ЕАД Teл:
English: If you feel that the effect of Sildenafil Actavis is too strong or too weak, talk to your doctor or pharmacist.
Icelandic: Ef þér finnst, að áhrifin af Sildenafil Actavis séu of mikil eða of lítil skaltu ræða um það við lækninn eða lyfjafræðing.
English: Very common (may affect more than 1 in 10 people): headache.
Icelandic: Mjög algengar (geta komið fyrir hjá fleirum en 1 af hverjum 10 einstaklingum): höfuðverkur.
English: Its effect is more potent on PDE5 than on other known phosphodiesterases.
Icelandic: Áhrif þess á PDE5 eru meiri en á aðra þekkta fosfótvíesterasa.
English: Sildenafil Actavis should not be given to individuals under the age of 18.
Icelandic: Sildenafil Actavis er ekki ætlað einstaklingum yngri en 18 ára.
English: Do not use nitrates to treat your chest pain.
Icelandic: - Skaltu ekki nota nítröt til að fá bata við brjóstverknum.
English: - Chest pains - this occurs uncommonly If this occurs during or after intercourse Get in a semi-sitting position and try to relax.
Icelandic: - Brjóstverkur - þessi tilvik eru sjaldgæf Ef verkurinn kemur fram við eða eftir samfarir - Skaltu reisa þig upp í hálf-sitjandi stöðu og reyna að slaka á.
English: Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine.
Icelandic: Hafa skal í huga að flestir þeirra manna sem fundu fyrir þessum aukaverkunum, en þó ekki allir, voru með hjartasjúkdóma fyrir, áður en þeir tóku lyfið.
English: Reykjavíkurvegi 76-78 IS-220 Hafnarfjörður Iceland
Icelandic: Reykjavíkurvegi 76-78 IS-220 Hafnarfjörður Ísland
English: Elderly Dosage adjustments are not required in elderly patients (≥ 65 years old).
Icelandic: Ekki er þörf á að breyta skömmtum hjá öldruðum (≥ 65 ára).
English: If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking Sildenafil Actavis.
Icelandic: Ef læknirinn hefur sagt þér að þú hafir óþol fyrir sumum sykurtegundum, eins og laktósa, áttu að hafa samband við lækninn áður en byrjað er að nota Sildenafil Actavis.
English: If you experience any of the following serious side effects stop taking Sildenafil Actavis and seek medical help immediately:
Icelandic: Ef þú finnur fyrir einhverjum eftirtalinna alvarlegra aukaverkana áttu að hætta að taka Sildenafil Actavis og leita læknishjálpar tafarlaust:
English: A. Potamitis Medicare Ltd
Icelandic: A. Potamitis Medicare Ltd Τηλ:
English: In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken Sildenafil Actavis and when you did.
Icelandic: Ef alvarleg atvik henda verðurðu að segja lækninum, lyfjafræðingi eða hjúkrunarfræðingnum frá því að þú hafir notað Sildenafil Actavis og hvenær þú notaðir lyfið.
English: Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50>150 µM).
Icelandic: Síldenafíl hefur væga hamlandi verkun á cýtókróm P450 ísóensím 1A2, 2C9, 2C19, 2D6, 2E1 og 3A4 (IC50>150 µM).
English: Certain patients have experienced these symptoms when taking sildenafil with alpha-blockers.
Icelandic: Sumir sjúklingar hafa fundið fyrir þessum einkennum þegar þeir nota síldenafíl samtímis alfa-blokkum.
English: Date of latest renewal: 4 September 2014
Icelandic: 4. september 2014.
English: What Sildenafil Actavis is and what it is used for
Icelandic: Upplýsingar um Sildenafil Actavis og við hverju það er notað