natgillin/translations-raw huggingface dataset:
Docetaxel Mylan i kombination med doxorubicin er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystcancer, som ikke tidligere har fået kemoterapi mod denne tilstand.
Docetaxel Mylan in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Efter 10 års followup i GEICAM9805-studiet forekom akut leukæmi hos 1 ud af 532 (0,2%) patienter i TAC-armen.
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.
Det skal du vide, før du begynder at bruge Docetaxel Mylan 80 mg/4 ml Sådan skal du bruge Docetaxel Mylan 80 mg/4 ml Bivirkninger
What Docetaxel Mylan 80 mg/4 ml is and what it is used for What you need to know before you use Docetaxel Mylan 80 mg/4 ml How to use Docetaxel Mylan 80 mg/4 ml Possible side effects
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Docetaxel Mylan 20 mg/1 ml sterilt koncentrat docetaxel
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 20 mg/1 ml sterile concentrate docetaxel
Letargi (G3/4: 3,4%) Pyreksi (G3/4: 0,6%) Væskeretention Ødem
Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
I studiet GEICAM9805 persisterede alopeci ind i followup-perioden (median followup-tid var 10 år og 5 måneder) og blev fortsat observeret hos 49 patienter (9,2%) i TAC-armen og hos 35 patienter (6,7%) i FAC-armen.
In GEICAM 9805 study, alopecia persisted into the follow-up period (median follow-up time of 10 years and 5 months) and 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.
Anden episode: Reducer docetaxel-dosis med 20%.
Second episode: reduce docetaxel dose by 20%.
Sådan skal du bruge Docetaxel Mylan 80 mg/4 ml
How to use Docetaxel Mylan 80 mg/4 ml
Det skal du vide, før du begynder at bruge Docetaxel Mylan 20 mg/1 ml Sådan skal du bruge Docetaxel Mylan 20 mg/1 ml Bivirkninger
What Docetaxel Mylan 20 mg/1 ml is and what it is used for What you need to know before you use Docetaxel Mylan 20 mg/1 ml How to use Docetaxel Mylan 20 mg/1 ml Possible side effects
• 300 gastrisk adenokarcinoma-patienter (221 patienter i fase III-delen af studiet og 79 patienter i fase II-delen af studiet), som blev behandlet med docetaxel i kombination med cisplatin og 5-fluoruracil (klinisk relevante behandlingsrelaterede bivirkninger er nævnt).
• 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and
Indholdet i infusionsposen eller -flasken blandes ved at vippe posen/flasken.
Mix the infusion bag or bottle manually using a rocking motion.
Myalgi (G3/4: 0,6%)
Myalgia (G3/4: 0.6%)
Hvis Docetaxel Mylan-koncentratet eller infusionsvæsken kommer i kontakt med slimhinderne, skylles der straks grundigt med vand.
If Docetaxel Mylan concentrate or solution for infusion should come into contact with mucous membranes, wash immediately and thoroughly with water.
Det skal du vide, før du begynder at bruge Docetaxel Mylan 20 mg/1 ml
What you need to know before you use Docetaxel Mylan 20 mg/1 ml
Et hætteglas indeholder 80 mg docetaxel.
One vial contains 80 mg of docetaxel.
10,1 Hazard Ratio: 1,122 [97,2% CI: 0,937; 1,342]*
Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]* Treatment difference: 5.4% [95% CI: -1.1; 12.0]
Myalgi (G3/4: 0,4%)
Myalgia (G3/4: 0.4%)
Febril neuropeni (G3/4:
Peripheral sensory neuropathy (G3/4:
LÆGEMIDLETS NAVN Docetaxel Mylan 200 mg/10 ml koncentrat til infusionsvæske, opløsning
NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 200 mg/10 ml concentrate for solution for infusion
Metabolisme og ernæring Psykiske forstyrrelser Nervesystemet Øjne
Psychiatric disorders Nervous system disorders Eye disorders Cardiac disorders
Sådan skal du bruge Docetaxel Mylan 20 mg/1 ml
How to use Docetaxel Mylan 20 mg/1 ml
Et hætteglas indeholder 20 mg docetaxel.
One vial contains 20 mg of docetaxel.
Beskrivelse af udvalgte bivirkninger ved behandling af gastrisk adenokarcinom med Docetaxel 75 mg/m² i kombination med cisplatin og 5-fluoruracil
Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m in combination with cisplatin and 5-fluorouracil
Tabel over bivirkninger ved behandling af brystkræft med Docetaxel 100 mg/m² enkeltstof:
Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² single agent:
Perifer motorisk neuropati (G3/4: 0,4%)
Peripheral motor neuropathy (G3/4: 0.4%)
Medianvarighed af respons (måneder) (95% CI)
Median duration of response (months) (95% CI)
Docetaxel som monoterapi
Docetaxel as single agent
• muskelømhed og smerter, rygsmerter eller knoglesmerter
• muscle aches and pains; back pain or bone pain
Hvert hætteglas med 10 ml koncentrat indeholder 3,95 g vandfri ethanol Alle hjælpestoffer er anført under pkt.
One vial of 10 ml of concentrate contains 3,95 g of ethanol anhydrous.
Periferalt ødem (G3/4: 0,2%)
Oedema peripheral (G3/4: 0.2%)
• blodpropper
• blood clots.
Docetaxel i kombination med platinholdige stoffer hos patienter, der ikke tidligere er behandlet med kemoterapi
Docetaxel in combination with platinum agents in chemotherapy-naïve patients
Hos patienter med serumbilirubin > øvre normalværdi og/eller forhøjelse af ASAT/ALAT på > 3,5 gange øvre normalværdi og samtidig forhøjelse af basisk phosphatase på > 6 gange øvre normalværdi kan det ikke anbefales at reducere dosis.
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.
LÆGEMIDLETS NAVN Docetaxel Mylan 80 mg/4 ml koncentrat til infusionsvæske, opløsning
NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 80 mg/4 ml concentrate for solution for infusion
Kvalme (G3/4: 4%);
Nausea (G3/4: 4%);
Forhøjet lakrimation (G3/4: 0,6%)
Lacrimation increased (G3/4: 0.6%)
Vægtforøgelse (G3/4: 0%);
Epistaxis (G3/4: 0%);
Dyspnø (G3/4: 1%); Hoste (G3/4: < 1%); Epistaxis (G3/4: < 1%)
Dyspnoea (G3/4: 1%); Cough (G3/4: < 1%);
Inden for 7 dage udgjorde udskillelsen i urin og fæces henholdsvis ca. 6% og 75% af den indgivne radioaktivitet.
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.
Dette lægemiddel indeholder 50 vol% ethanol (alkohol), dvs. op til 1,58 g pr. hætteglas svarende til 40 ml øl eller 17 ml vin pr. hætteglas.
This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 1.58 g per vial, equivalent to 40 ml of beer or 17 ml wine per vial.
LÆGEMIDLETS NAVN Docetaxel Mylan 20 mg/1 ml koncentrat til infusionsvæske, opløsning
NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 20 mg/1 ml concentrate for solution for infusion
Kløende udslæt (G3/4: 0,7%); Neglesygdomme (G3/4: 0,7%); Hudeksfoliering (G3/4: 0%)
Rash pruritus (G3/4: 0.7%); Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
186 patienter blev randomiseret til docetaxel (100 mg/m²) med eller uden trastuzumab.
One hundred eighty six patients were randomized to receive docetaxel (100 mg/m²) with or without trastuzumab; 60% of patients received prior anthracycline-based adjuvant chemotherapy.
Docetaxel Mylan 200 mg/10 ml koncentrat til infusionsvæske, opløsning docetaxel
Docetaxel Mylan 200 mg/10 ml concentrate for solution for infusion Docetaxel
Følgende kan ske mellem Docetaxel Mylan-infusionerne.
Between infusions of Docetaxel Mylan the following may occur, and the frequency may vary with the combinations of medicines that are received.
Der er rapporteret sjældne tilfælde af dehydrering og lungeødem.
Dehydration and pulmonary oedema have rarely been reported.
Docetaxel Mylan monoterapi er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystcancer efter behandlingssvigt af kemoterapi.
Docetaxel Mylan monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Medianoverlevelse (måneder) (95% CI)
Median survival (months) (95% CI)
Diarre (G3/4: 4%); Kvalme (G3/4: 4%); Opkastning (G3/4: 3%)
Stomatitis (G3/4: 18%); Diarrhoea (G3/4: 14%); Nausea (G3/4: 6%);
Diarré (G3/4: 6,4%); Stomatitis (G3/4: 2%)
Vomiting (G3/4: 7.6%); Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%)
Arytmi (G3/4: 1,0%)
Arrhythmia (G3/4: 1.0%)
Nedsat hørelse (G3/4: 0%)
Hearing impaired (G3/4: 0%)
Docetaxel Mylan 20 mg/1 ml koncentrat til infusionsvæske, opløsning docetaxel
Docetaxel Mylan 20 mg/1 ml concentrate for solution for infusion Docetaxel
Hvert hætteglas med 1 ml koncentrat indeholder 395 mg vandfri ethanol Alle hjælpestoffer er anført under pkt.
One vial of 1 ml of concentrate contains 395 mg of ethanol anhydrous.
Justeret hazard ratio (95% CI) *p-værdi
Adjusted Hazard ratio (95% CI) *p-value
Erythematøst udslæt (G3/4: < 1%);
Epistaxis (G3/4: < 1%)
Docetaxel Mylan 80 mg/4 ml koncentrat til infusionsvæske, opløsning docetaxel
Docetaxel Mylan 80 mg/4 ml concentrate for solution for infusion Docetaxel
Hoste (G3/4: 0%)
Cough (G3/4: 0%)
Toksicitetsstudier hos gnavere har vist uønskede påvirkninger af testisfunktionen.
Undesirable effects on the testis observed in rodent toxicity studies suggest that docetaxel may impair male fertility
Asteni (G3/4: 10,0%); Feber (G3/4: NA);
Asthenia (G3/4: 10.0%); Pyrexia (G3/4: NA);
Opkastning (G3/4: 3%)
Vomiting (G3/4: 3%)
Epistaxis (G3/4: 0%); Dyspnø (G3/4: 0,6%); Hoste (G3/4: 0%)
Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
I de følgende tilfælde bør docetaxel-dosis reduceres til 65 mg/m² i efterfølgende behandlingsrunder: 1) hos patienter med en initialdosis på 75 mg/m² docetaxel i kombination med cisplatin, med en minimum blodpladeværdi under den tidligere behandlingsrunde på < 25.000 celler/mm
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.
Tabel over bivirkninger ved behandling af ikke-småcellet lungekræft med Docetaxel 75 mg/m² enkeltstof
Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² single agent MedDRA system organ classes
Dette lægemiddel indeholder 50 vol% ethanol (alkohol), dvs. op til 0,395 g pr. hætteglas svarende til 10 ml øl eller 4 ml vin pr. hætteglas.
This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 0.395 g per vial, equivalent to 10 ml of beer or 4 ml wine per vial.
Ødem (G3/4: 1,2%)
Hearing impaired (G3/4: 1.2%)
Dette lægemiddel indeholder 50 vol% ethanol (alkohol), dvs. op til 3,95 g pr. hætteglas svarende til 100 ml øl eller 40 ml vin pr. hætteglas.
This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 3.95 g per vial, equivalent to 100 ml of beer or 40 ml wine per vial.
Gastrointestinal hæmoragi (G3/4: 0,6%)
Gastrointestinal haemorrhage (G3/4:
Antal positive lymfeknuder Total
No of positive nodes Overall
Misfarvning af negle; Onycholysis (G3/4: 1%)
Onycholysis (G3/4: 1%)
Flebitis (G3/4: 0%)
Lymphoedema (G3/4: 0%)
Exfoliativt udslæt (G3/4: 0,3%)
Exfoliative rash (G3/4: 0.3%)
Cancersmerter (G3/4: 0,6%)
Vomiting (G3/4: 0.6%)
Denne medicin indeholder 50 vol% ethanol (alkohol), dvs. maksimalt 0,395 g pr. hætteglas svarende til 10 ml øl eller 4 ml vin pr. hætteglas.
This medicine contains 50 vol % ethanol (alcohol), i.e. up to 0.395 g per vial equivalent to 10 ml of beer or 4 ml wine per vial.
Hudeksfoliering (G3/4: 0,6%)
Skin exfoliative (G3/4: 0.6%)
Medmindre det er kontraindiceret, kan der til brystcancer og ikke-småcellet lungecancer gives et oralt kortikosteroid som præmedicinering, eksempelvis dexamethason 16 mg pr dag i 3 dage (f.eks. 8 mg 2 gange dagligt).
For breast and non-small cell lung cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.
Smerter i ekstremiteterne (G3/4: < 1%);
Pain in extremity (G3/4: < 1%); Back pain (G3/4: 1%)
Feber (G3/4: 1,2%)
(G3/4: 1.2%)
Kløende udslæt (G3/4: 0,7%);
Dysgeusia/Parosmia (G3/4: 0.4%);
Hazard ratio (95% CI) *p-værdi
Hazard ratio (95% CI) *p-value
Hazard ratio: (95% CI) **p-værdi
Hazard ratio: (95% CI) **p-value
Hvis du får nogle af disse bivirkninger, så fortæl det straks til hospitalspersonalet.
Tell them immediately if you notice any of these effects.
Kvalme (G3/4: 9,6%); Opkastning (G3/4: 7,6%);
Diarrhoea (G3/4: 19.7%); Nausea (G3/4: 16%);
Stomatitis (G3/4: 7,8%);
Nausea (G3/4: 5%); Stomatitis (G3/4: 7.8%);
Blod og lymfesystem Anæmi (G3/4: 3%); Neutropeni (G3/4: 59,2%);
Anaemia (G3/4: 3%); Neutropenia (G3/4:
Mavesmerter (G3/4: 0,4%)
Arrhythmia (G3/4: 0.2%)
Venøs lidelse (G3/4: 0,6%)
Venous disorder (G3/4: 0.6%)
Hætteglas til engangsbrug.
Single-use vial.
FREMSTILLINGSVEJLEDNING FOR DOCETAXEL MYLAN KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
The following information is intended for healthcare professionals only: PREPARATION GUIDE FOR USE WITH DOCETAXEL MYLAN CONCENTRATE FOR SOLUTION FOR INFUSION
Arytmi (G3/4: 0,7%)
Arrhythmia (G3/4: 0.7%)
Lægemidde l-form
Pharmaceutical form
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Protaphane den 7. oktober 2002.
The European Commission granted a marketing authorisation valid throughout the European Union for Protaphane on 7 October 2002.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Protaphane.
This is a summary of the European public assessment report (EPAR) for Protaphane.
Andre oplysninger om Protaphane
Other information about Protaphane
Der er udarbejdet en risikostyringsplan for at sikre, at Protaphane anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Protaphane is used as safely as possible.
Den fuldstændige EPAR for Protaphane findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Protaphane is available ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Protaphane.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Protaphane.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Protaphane?
What measures are being taken to ensure the safe and effective use of Protaphane?
Hvis du ønsker yderligere oplysninger om behandling med Protaphane, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Protaphane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Hvilken risiko er der forbundet med Protaphane?
What is the risk associated with Protaphane?
Det giver Protaphane en længerevarende virkning.
This gives Protaphane a longer duration of action.
Protaphane blev undersøgt i fire kliniske hovedundersøgelser med i alt 557 patienter med type 1diabetes, hvor bugspytkirtlen ikke kan producere insulin (to undersøgelser, som omfattede 81 patienter), eller type 2-diabetes, hvor kroppen ikke er i stand til at udnytte insulin effektivt (to undersøgelser, som omfattede 476 patienter).
Protaphane has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).
Det aktive stof i Protaphane, human insulin, produceres via en metode, der er kendt som "rekombinant teknologi": Det fremstilles af gærceller, der har fået indsat et gen (DNA), som gør dem i stand til at producere insulin.
The active substance in Protaphane, human insulin, is produced by a method known as ‘recombinant technology': it is made by yeast cells into which a gene (DNA) has been introduced which makes them able to produce insulin.
CHMP besluttede, at fordelene ved Protaphane opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Protaphane.
The CHMP decided that Protaphane's benefits are greater than its risks and recommended that it be given marketing authorisation.
Den hyppigste bivirkning ved Protaphane (som optræder hos flere end 1 ud af 10 patienter) er hypoglykæmi (lave blodsukkerniveauer).
The most common side effect with Protaphane (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Protaphane var effektivt ved såvel type 1- som type 2-diabetes og ved anvendelsen af en standardinjektion eller en af de fyldte penne.
Protaphane was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pre-filled pens.
Protaphane medførte et fald i HbA1c-niveauet, hvilket tyder på, at blodsukkeret var blevet holdt under kontrol på et niveau svarende til det, der var observeret for andre typer human insulin.
Protaphane led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulin.
Hos størstedelen af patienterne blev Protaphane sammenlignet med andre typer human insulin eller insulinanaloger.
In most patients, Protaphane was compared with other types of human insulin or insulin analogues.
Hvorfor blev Protaphane godkendt?
Why has Protaphane been approved?
Protaphane indeholder insulin blandet med et andet stof, protamin, i en form, der kaldes "isofan", som optages langsommere dagen igennem.
Protaphane contains insulin mixed with another substance, protamine, in an ‘isophane' form which is absorbed much more slowly during the day.
Protaphane er et langtidsvirkende insulin.
Protaphane is a long-acting insulin.
Der blev også gennemført yderligere undersøgelser af 225 patienter, hvor man sammenlignede injektion af Protaphane med kanyle eller med brug af en fyldt pen (InnoLet eller FlexPen).
Further studies were also carried out in 225 patients comparing injecting Protaphane using a syringe, or using a pre-filled pen (InnoLet or FlexPen).
Protaphane anvendes til behandling af diabetes (sukkersyge).
Protaphane is used to treat diabetes.
Protaphane gives som injektion under huden, sædvanligvis i låret, bugvæggen (maveskindet), sædemuskelregionen (ballerne) eller deltamuskelregionen (skulderen).
Protaphane is given by injection under the skin, usually in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder).
Protaphane er en injektionsvæske, suspension, som indeholder det aktive stof human insulin.
Protaphane is a suspension for injection that contains the active substance human insulin.
I undersøgelserne målte man blodsukkeret i fastende tilstand eller mængden af glykosyleret hæmoglobin (HbA1c, et hæmoglobin, som binder glukose til sig).
The studies measured the level of fasting blood glucose or glycosylated haemoglobin (HbA1c, the haemoglobin in the blood that has glucose attached).
Hvilke fordele viser undersøgelserne, at der er ved Protaphane?
What benefit has Protaphane shown during the studies?
Hvordan blev Protaphane undersøgt?
How has Protaphane been studied?
Protaphane er et erstatningsinsulin, der næsten er identisk med det insulin, som produceres af bugspytkirtlen.
Protaphane is a replacement insulin which is very similar to the insulin made by the pancreas.
Hvad er Protaphane?
What is Protaphane?
Protaphane, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Protaphane, including the appropriate precautions to be followed by healthcare professionals and patients.
Hvad anvendes Protaphane til?
What is Protaphane used for?
Hvordan anvendes Protaphane?
How is Protaphane used?
Hvordan virker Protaphane?
How does Protaphane work?
MT (EU)-nummer (Særnavn) Navn
MA (EU) number
Bristol-Myers Squibb GesmbH Rivergate / Gate 1 / 5.OG, Handelskai 92, 1200 Wien, Østrig
Bristol-Myers Squibb GesmbH Rivergate / Gate 1 / 5.OG, Handelskai 92, 1200 Vienna, Austria
Budějovická 778/3, Michle 140 00 Prague 4, Tjekkiet
Budějovická 778/3, Michle 140 00 Prague 4, Czech Republic
Orteliuslaan 1000, 3528 BD Utrecht, Holland
Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands
Orteliuslaan 1000, Utrecht, 3528 BD, Holland
Orteliuslaan 1000, Utrecht, 3528 BD, The Netherlands
Budějovická 778/3, Michle, 140 00 Prag, Tjekkiet
Budějovická 778/3, Michle, 140 00 Prague, Czech Republic
300 MBq/ml Injektionsvæske, opløsning
300 MBq/ml Solution for injection
1 ampul
1 vial
MF (EU)-nummer (Særnavn)
MA (EU) Number (Invented) name
Hvis du tager SOMAC Control i længere perioder, kan det medføre yderligere risici i form af:
If you take SOMAC Control for longer periods, this may cause additional risks, such as:
Nedenstående yderligere risici anses for relevante i forbindelse med langvarig anvendelse:
The following additional risks are considered relevant for long-term use
SOMAC Control kan medføre, at andre lægemidler ikke virker ordentligt.
SOMAC Control may stop certain other medicines from working properly.
SOMAC Control 20 mg enterotabletter bør ikke tygges eller knuses, men skal sluges hele med væske før et måltid.
SOMAC Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
SOMAC Control påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
SOMAC Control has no or negligible influence on the ability to drive and use machines.
For at undgå denne interferens bør SOMAC Control seponeres mindst 5 dage inden måling af CgA (se pkt.
To avoid this interference, SOMAC Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
- methotrexat (bruges til behandling af reumatoid artrit, psoriasis og cancer) - hvis du tager methotrexat, kan din læge midlertidigt stoppe din behandling med SOMAC Control, da SOMAC Control kan forøge niveauet af methotrexat i blodet.
- methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your SOMAC Control treatment because pantoprazole can increase levels of methotrexate in the blood.
Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}
This leaflet was last revised in {mm/yyyy}
Stop med at tage SOMAC Control, når du er symptomfri.
Stop taking SOMAC Control when you are completely symptom-free.
SOMAC Control må ikke bruges af børn og unge under 18 år pga. manglende dokumentation for sikkerhed i denne aldersgruppe.
SOMAC Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group.
SOMAC Control bør ikke anvendes til børn og unge under 18 år på grund af utilstrækkelige data vedrørende sikkerhed og virkning.
SOMAC Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.