natgillin/translations-raw huggingface dataset:
Ciprofloxacin Bayer 250 mg filmovertrukne tabletter er indiceret til behandling af følgende infektioner (se pkt.
Ciprofloxacin Bayer 250 mg film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1).
YDERLIGERE OPLYSNINGER Ciprofloxacin Bayer indeholder: [Udfyldes nationalt] Udseende og pakningstørrelser Infusionsvæske, opløsning [Udfyldes nationalt]
What Ciprofloxacin Bayer looks like and contents of the pack Solution for infusion [To be completed nationally]
500 mg/5 ml suspension oral anvendelse
500 mg/5 ml oral suspension oral use
• Urethritis og cervicitis forårsaget af gonokokker
• Gonococcal uretritis and cervicitis
Du må ikke tage Ciprofloxacin Bayer, hvis du er gravid.
Do not take Ciprofloxacin Bayer if you are:
Ciprofloxacin Bayer 200 mg/100 ml infusionsvæske, opløsning er indiceret til behandling af følgende infektioner (se pkt.
Ciprofloxacin Bayer 200 mg/100 mL solution for infusion is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Ciprobay XR 500 mg tabletter med modificeret udløsning oral anvendelse
Ciprobay XR 500 mg modified release tablets oral use
Belgien
Belgium:
5 ml to gange dagligt (én 5 ml måleske to gange dagligt)
5 mL twice daily (one 5-mL measuring spoonful twice daily)
MINDSTEKRAV TIL MÆRKNING DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SINGLE DOSE SACHETS 250 MG
SÅDAN SKAL DU TAGE CIPROFLOXACIN BAYER
HOW TO TAKE CIPROFLOXACIN BAYER
Du må dog ikke tage Ciprofloxacin Bayertabletterne sammen med mælkeprodukter, som f.eks. mælk eller yoghurt, eller sammen med beriget frugtjuice (f.eks. calciumberiget orangejuice).
However, do not take Ciprofloxacin Bayer tablets with dairy products such as milk or yoghurt or with fortified fruit-juices (e.g. calcium-fortified orange juice).
- hvis du tager tizanidin (se pkt.
• taking tizanidine (see Section 2: Taking other medicines)
Ciproxina OD 500 mg tabletter med modificeret udløsning oral anvendelse
Ciproxina OD 500 mg modified release tablets oral use
Gastrointestinale og intraabdorminale infektioner
• gastro-intestinal tract infections and intra-abdominal infections
CIPROXIN 1000 mg tabletter med modificeret udløsning oral anvendelse
CIPROXIN 1000 mg modified release tablets oral use
• Akut exacerbation af kronisk sinusitis, især hvis infektionerne skyldes gramnegative bakterier, herunder Pseudomonas aeruginosa
• Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria
250 mg filmovertrukne tabletter oral anvendelse
250 mg film-coated tablets oral use
CIPROBAY 400 mg/200 ml infusionsvæske, opløsning intravenøs anvendelse 2 mg/ml
CIPROBAY 400 mg/200 ml solution for infusion intravenous use
Den behandlende læge skal rådføre sig med nationale og/eller internationale konsensusdokumenter vedrørende behandling af miltbrand.
The treating physician should refer to national and/or international consensus documents regarding treatment of anthrax.
Hvis din behandling med Ciprofloxacin Bayer stoppes
If you stop your course of Ciprofloxacin Bayer
Spørg din læge eller apotek til råds, før du tager nogen form for medicin.
Ask your pharmacist how to dispose of any medicines no longer required.
CIPROBAY 200 mg/100 ml infusionsvæske, opløsning intravenøs anvendelse 2 mg/ml
CIPROBAY 200 mg/100 ml solution for infusion intravenous use
Tubulointerstitiel nephritis
Renal failure Haematuria Crystalluria (see section 4.4) Tubulointerstitial nephritis
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 750 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt]
Ciprofloxacin Bayer and associated names (see Annex I) 750 mg film-coated tablets [See Annex I - To be completed nationally]
CIPROXIN 400 mg/200 ml infusionsvæske, opløsning intravenøs anvendelse 2 mg / ml
CIPROXIN 400 mg/200 ml solution for infusion intravenous use
Nerve
Neutropenia
CIPROXIN 200 mg/100 ml infusionsvæske, opløsning intravenøs anvendelse 2 mg / ml
CIPROXIN 200 mg/100 ml solution for infusion intravenous use
750 mg filmovertrukne tabletter oral anvendelse
750 mg film-coated tablets oral use
20 mg/kg legemsvægt to gange dagligt, maksimalt 750 mg pr. dosis, svarende til 0,2 ml/kg legemsvægt to gange dagligt, maksimalt 7,5 ml pr. dosis
20 mg/kg body weight twice daily with a maximum of 750 mg per dose, corresponding to a 0.2 mL/kg body weight twice daily with a maximum of 7.5 mL per dose
CIPROXIN 500 mg tabletter med modificeret udløsning oral anvendelse
CIPROXIN 500 mg modified release tablets oral use
Bayer HealthCare AG D-51368 Leverkusen, Tyskland
Bayer Healthcare AG D-51368 Leverkusen, Germany
2 Vær ekstra forsigtig med at tage Ciprofloxacin Bayer) - migræne, besvær med at styre bevægelser, usikker gang, forøget følsomhed over for lugte (olfaktorisk sygdom), tryk på hjernen (forhøjet intrakranielt tryk) - forvrænget farvesyn - betændelse i blodkarrenes væg (vasculitis) - betændelse i bugspytkirtlen - levercelledød (levernekrose), som lejlighedsvis kan medføre livsfarligt leversvigt - små punktformede blødninger under huden (petekkier), forskellige hududbrud eller udslæt (f.eks. det potentielt dødelige Stevens-Johnson syndrom eller toksisk epidermal nekrolyse) - muskelsvaghed, betændelse i en sene (inflammation), senebrud - især i den store sene på bagsiden af anklen (akillessenen) (se pkt.
- a special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis ); a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal; and bone marrow depression, which may also be fatal (see Section 2: Take special care with Ciprofloxacin Bayer) - severe allergic reactions (anaphylactic reaction or anaphylactic shock, which can be fatalserum sickness) (see Section 2: Take special care with Ciprofloxacin Bayer) - mental disturbances (psychotic reactions) (see Section 2: Take special care with Ciprofloxacin Bayer) - migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure) - visual colour distortions - inflammation of the wall of the blood vessels (vasculitis) - pancreatitis - death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure - small, pin-point bleeding under the skin (petechiae); various skin eruptions or rashes (for example, the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis) - muscle weakness, tendon inflammation, tendon rupture - especially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Take special care with Ciprofloxacin Bayer); worsening of the symptoms of myasthenia gravis (see Section 2: Take special care with Ciprofloxacin Bayer)
CIPROBAY 100 mg/50 ml infusionsvæske, opløsning intravenøs anvendelse 2 mg/ml
CIPROBAY 100 mg/50 ml solution for infusion intravenous use
Teofyllin
Lactation
Bayer HealthCare AG 51368 Leverkusen, Tyskland
Bayer HealthCare AG 51368 Leverkusen, Germany
- en speciel situation med et nedsat antal røde blodlegemer (hæmolytisk anæmi), et farligt fald i antallet af en speciel type hvide blodlegemer (agranulocytose), et fald i antallet af røde og hvide blodlegemer samt blodplader (pancytopeni), som kan være dødelig, og en hæmning af knoglemarven (knoglemarvsdepression), som også kan være dødelig (se pkt.
Section 2: Take special care with Ciprofloxacin Bayer) - changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal, bone marrow depression which may also be fatal (see Section 2: Take special care with Ciprofloxacin
2,5 ml to gange dagligt op til 50 ml to gange dagligt (en halv 5 ml måleske to gange dagligt op til én 5 ml måleske to gange dagligt)
2.5 mL twice daily to 5 mL twice daily (half 5-mL measuring spoonful twice daily up to one 5-mL measuring spoonful twice daily)
20 mg/kg legemsvægt to gange dagligt, maksimalt 750 mg pr. dosis, svarende til 0,4 ml/kg legemsvægt to gange dagligt, maksimalt 15 ml pr. dosis
20 mg/kg body weight twice daily with a maximum of 750 mg per dose, corresponding to a 0.4 mL/kg body weight twice daily with a maximum of 15-mL per dose
CIPROXIN XR 500 mg tabletter med modificeret udløsning oral anvendelse
CIPROXIN XR 500 mg modified release tablets oral use
CIPROXIN 100 mg/50 ml infusionsvæske, opløsning intravenøs anvendelse 2 mg / ml
CIPROXIN 100 mg/50 ml solution for infusion intravenous use
100 mg filmovertrukne tabletter oral anvendelse
100 mg film-coated tablets oral use
Ciprofloxacin Bayer 100 mg filmovertrukne tabletter er indiceret til behandling af følgende infektioner (se pkt.
Ciprofloxacin Bayer 100 mg film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1).
500 mg filmovertrukne tabletter oral anvendelse
500 mg film-coated tablets oral use
5 ml to gange dagligt op til 10 ml to gange dagligt (én 5 ml måleske to gange dagligt op til to 5 ml måleskeer to gange dagligt)
5-mL twice daily to 10 mL twice daily (one 5-mL measuring spoonful twice daily up to two 5-mL measuring spoonfuls twice daily)
Du må dog ikke tage ciprofloxacin-suspension sammen med mælkeprodukter, som f.eks. mælk eller yoghurt, eller sammen med beriget frugtjuice (f.eks. calciumberiget orangejuice).
However, do not take Ciprofloxacin Bayer suspension with dairy products such as milk or yoghurt or with fortified fruit-juice (e.g. calcium-fortified orange-juice).
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 250 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt]
Ciprofloxacin Bayer and associated names (see Annex I) 250 mg film-coated tablets [See Annex I - To be completed nationally]
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 100 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt]
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg film-coated tablets [See Annex I - To be completed nationally]
400 mg/ 200 ml infusionsvæske, opløsning intravenøs anvendelse 2 mg/ml
400 mg/200 ml solution for infusion intravenous use
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt] {Navn og adresse} <{Tlf}>
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Ciprofloxacin Bayer 500 mg filmovertrukne tabletter er indiceret til behandling af følgende infektioner (se pkt.
Ciprofloxacin Bayer 500 mg film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1).
(se pkt 2 Vær ekstra forsigtig med at tage Ciprofloxacin Bayer) - ændringer i blodtal (leukopeni, leukocytose, neutropeni, anæmi), øget eller nedsat mængde af en bestemt blodstørkningsfaktor (trombocytter) - allergisk reaktion, hævelser (ødemer) eller hurtig hævelse i hud og slimhinder (angioødem) - øget blodsukker (hyperglykæmi) - forvirring, desorientering, angst, mærkelige drømme, depression eller hallucinationer
Section 2: Take special care with Ciprofloxacin Bayer) - changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased amounts of a blood clotting factor (thrombocytes) - allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes
Indhold af sukrose
• sucralfate
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 500 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt]
Ciprofloxacin Bayer and associated names (see Annex I) 500 mg film-coated tablets [See Annex I - To be completed nationally]
YDRE BESKYTTELSESPOSE (indeholder 1 infusionspose med 400 mg /200 ml infusionsvæske, opløsning)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAP (containing 1 infusion bag of 400 mg / 200 mL solution for infusion)
Bare slug det.
• Keep this leaflet.
4.4) Serumsygdomslignende reaktion
Serum sickness-like reaction
2 Vær ekstra forsigtig med at tage Ciprofloxacin Bayer) - besvær med at styre bevægelser, usikker gang, tryk på hjernen (forhøjet intrakranielt tryk) - forvrænget farvesyn - forskellige hududbrud eller udslæt (f.eks. det potentielt dødelige Stevens-Johnson syndrom eller toksisk epidermal nekrolyse) - muskelsvaghed, betændelse i en sene (inflammation), forværring af symptomer på myasthenia gravis (se pkt.
- a special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis ) - severe allergic reaction (anaphylactic reaction, anaphylactic shock, serum sickness) which can be fatal (see Section 2: Take special care with Ciprofloxacin Bayer) - disturbed coordination, unsteady walk (gait disturbance), pressure on the brain (intracranial pressure) - visual colour distortions - various skin eruptions or rashes (e.g. the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis) - muscle weakness, tendon inflammation, worsening of the symptoms of myasthenia gravis (see Section 2: Take special care with Ciprofloxacin Bayer)
YDRE BESKYTTELSESPOSE (indeholder 1 infusionspose med 200 mg / 100 ml infusionsvæske, opløsning)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAP (containing 1 infusion bag of 200 mg / 100 mL solution for infusion)
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 100 mg / 50 ml infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg / 50 mL solution for infusion [See Annex I - To be completed nationally]
100 mg/50 ml infusionsvæske, opløsning intravenøs anvendelse 2 mg/ml
100 mg/50 ml solution for infusion intravenous use
2 Vær ekstra forsigtig med Ciprofloxacin Bayer), små nåleformede blødninger under huden (petekkier) - muskelsmerter, betændelse i leddene (inflammation), øget spænding i en muskel, kramper, senebrud - specielt i den store sene på bagsiden af anklen (Achilles-senen)(se pkt.
- sensitivity to light (see Section 2: Take special care with Ciprofloxacin Bayer), small, pin-point bleeding under the skin (petechiae) - muscle pain, inflammation of the joints, increased muscle tone, cramping, tendon ruptureespecially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Take special care with Ciprofloxacin Bayer) - blood or crystals in the urine (see Section 2: Take special care with Ciprofloxacin Bayer), urinary tract inflammation - excessive sweating - abnormal levels of a clotting factor (prothromibin) increased levels of the enzyme amylase
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 400 mg / 200 ml infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
Ciprofloxacin Bayer and associated names (see Annex I) 400 mg/200 mL solution for infusion [See Annex I - To be completed nationally]
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 200 mg/100 ml infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
Ciprofloxacin Bayer and associated names (see Annex I) 200 mg/100 mL solution for infusion [See Annex I - To be completed nationally]
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 200 mg / 100 ml infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
Ciprofloxacin Bayer and associated names (see Annex I) 200 mg / 100 mL solution for infusion [See Annex I - To be completed nationally]
Urethritis og cervicitis, som skyldes gonokokker
Gonococcal uretritis and cervicitis
• Underlivsbetændelse, herunder tilfælde forårsaget af Neisseria gonorrhoeae
• Pelvic inflammatory disease including cases due to Neisseria gonorrhoeae
Olfaktoriske nervesygdomme Intrakraniel hypertension neuropati (se pkt.
Hepatic impairment Cholestatic icterus Hepatitis
200 mg/100 ml infusionsvæske, opløsning intravenøs anvendelse 2 mg/ml
200 mg/100 ml solution for infusion intravenous use
Eosinofili
Leukocytosis
Udseende og pakningstørrelser
Package Leaflet and Labelling
ANGIVELSE AF AKTIVT STOF [Udfyldes nationalt] LISTE OVER HJÆLPESTOFFER [Udfyldes nationalt] LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) [Udfyldes nationalt] ANVENDELSESMÅDE OG INDGIFTSVEJ Til intravenøs anvendelse.
[To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container [To be completed nationally] 6.6 Special precautions for disposal No special requirements.
Hjertesygdomme
Cardiac Disorders
DET SKAL DU VIDE, FØR DU FÅR CIPROFLOXACIN BAYER
BEFORE YOU ARE GIVEN CIPROFLOXACIN BAYER
Forvrænget farvesyn
Renal impairment
• Knogle- og ledinfektioner
• bone and joint infections
Agranulocytose
Theophylline
Tacrolimus er blevet anvendt siden midten af 1990'erne.
Tacrolimus has been used since the mid-1990's.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Advagraf den 23. april 2007.
The European Commission granted a marketing authorisation valid throughout the EU for Advagraf on 23 April 2007.
Indehaveren af markedsføringstilladelsen er Astellas Pharma Europe B.V.
The marketing authorisation holder is Astellas Pharma Europe B.V.
Advagraf gives én gang dagligt om morgenen mindst én time før eller to-tre timer efter fødeindtagelse.
Advagraf is given once a day, in the morning, at least one hour before or two to three hours after food.
Andre oplysninger om Advagraf:
Other information about Advagraf:
Det vil sige, at det dæmper aktiviteten af immunsystemet (kroppens naturlige forsvar).
This means that it reduces the activity of the immune system (the body's natural defences).
Advagraf var lige så effektivt som begge de lægemidler, det blev sammenlignet med.
Advagraf was as effective as both comparator medicines.
I Den Europæiske Union (EU) har det været markedsført som kapsler under navnet Prograf eller Prograft (afhængigt af land).
In the European Union (EU), it has been available as capsules under the name Prograf or Prograft (depending on the country).
Efter ét år havde 14 % af de patienter, der fik Advagraf, fået organsvigt.
After one year, 14% of the patients receiving Advagraf had experienced organ failure.
Den fuldstændige EPAR for Advagraf findes her.
The full EPAR for Advagraf can be found here.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Advagraf.
The Committee recommended that Advagraf be given marketing authorisation.
EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) ADVAGRAF EPAR - sammendrag for offentligheden
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ADVAGRAF EPAR summary for the public
Det leveres som depotkapsler indeholdende tacrolimus (0,5 mg: gule og orange, 1 mg: hvide og orange, 5 mg: rødgrå og orange).
It is available as prolongedreleased capsules containing tacrolimus (0.5 mg: yellow and orange; 1 mg: white and orange; 5 mg: greyish-red and orange).
Advagraf er et lægemiddel, der indeholder det aktive stof tacrolimus.
Advagraf is a medicine containing the active substance tacrolimus.
Da tacrolimus og Prograf/Prograft allerede har været anvendt i EU, fremlagde firmaet resultaterne af de undersøgelser, der tidligere var udført med Prograf/Prograft, foruden oplysninger fra den offentliggjorte litteratur.
Because tacrolimus and Prograf/Prograft have already been used in the EU, the company presented the results of studies that had been carried out with Prograf/Prograft previously, as well as data from the published literature.
Derfor behøver Advagraf kun tages én gang dagligt, hvorimod Prograf/Prograft skal tages to gange dagligt.
This allows Advagraf to be given once a day, whereas Prograf/Prograft is given twice a day.
Tacrolimus virker på nogle særlige celler i immunsystemet, T-cellerne, som primært er ansvarlige for, at det transplanterede organ angribes (organafstødning).
Tacrolimus acts on some special cells in the immune system called T-cells that are primarily responsible for attacking the transplanted organ (organ rejection).
Patienter og læger bør udvise forsigtighed, når andre lægemidler (bl.a. visse naturlægemidler) anvendes sammen med Advagraf, da det kan være nødvendigt at justere dosis af Advagraf eller af det lægemiddel, det anvendes sammen med.
Patients and doctors must be careful when other medicines (including some herbal remedies) are taken at the same time as Advagraf, as there may be a need to adjust the dose of Advagraf or the dose of the medicine it is taken with.
Patienterne fik desuden mycophenolatmofetil (et andet lægemiddel, der anvendes til forebyggelse af afstødning).
Patients also received mycophenolate mofetil (another medicine used in the prevention of rejection).
Virkningen blev hovedsagelig bedømt ud fra antallet af patienter, hos hvem transplantationen mislykkedes (f.eks. vurderet efter, om det var nødvendigt at gentage transplantationen eller genoptage dialysen) efter et års behandling.
The main measure of effectiveness was the number of patients in whom the transplant failed (as measured by looking at, for example, the need for a repeat transplant or a return to dialysis) after one year's treatment.
Den tilsvarende procentdel var 15,1 % hos de patienter, der havde fået Prograf/Prograft, og 17 % hos dem, der havde fået ciclosporin.
The percentages were 15% in the patients treated with Prograf/Prograft, and 17% in those treated with ciclosporin.
At kapslerne er depotkapsler, betyder, at tacrolimus frigives langsomt fra kapslen i løbet af få timer.
‘Prolonged-release' means that tacrolimus is released slowly from the capsule over a few hours.
Advagraf bør kun ordineres af en læge med erfaring i behandling af transplantationspatienter.
Treatment with Advagraf should only be prescribed by doctors who have experience in the management of transplant patients.
Tacrolimus, det aktive stof i Advagraf, er et immundæmpende middel.
Tacrolimus, the active substance in Advagraf, is an immunosuppressive agent.
Advagraf er næsten identisk med Prograf/Prograft, dog fremstilles kapslerne på en anden måde, så det aktive stof frigives langsommere fra kapslen end i Prograf/Prograft.
Advagraf is very similar to Prograf/Prograft, but the way the medicine is made has been changed so that the active substance is released more slowly from the capsule than it is in Prograf/Prograft.
Advagraf kan også anvendes til at behandle afstødning af organer hos voksne patienter, når anden immundæmpende medicin ikke virker.
Advagraf can also be used to treat organ rejection in adult patients when other immunosuppressive medicines are not effective.
Advagraf bør ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for tacrolimus, makrolidantibiotika (som f.eks. erythromycin) eller nogen af indholdsstofferne.
Advagraf should not be used in people who may be hypersensitive (allergic) to tacrolimus, to macrolide antibiotics (such as erythromycin) or to any of the other ingredients.
Dette kan gøre det lettere for patienterne at overholde ordinationen.
This can help the patients stick to their treatment.
Hvilken risiko er der forbundet med Advagraf?
What is the risk associated with Advagraf?
Advagraf anvendes til voksne patienter, der har fået foretaget en nyre- eller levertransplantation, til at forhindre organafstødning (når immunsystemet angriber det transplanterede organ).
Advagraf is used in adult patients who have had a kidney or liver transplant, to prevent rejection (when the immune system attacks the transplanted organ).
De hyppigste bivirkninger af Advagraf (der ses hos flere end 1 ud af 10 patienter) er rysten, hovedpine, kvalme, diarré, nyreproblemer, for højt blodsukker, sukkersyge, for højt kaliumindhold i blodet, for højt blodtryk og søvnbesvær.
The most common side effects with Advagraf (seen in more than 1 patient in 10) are tremor (shaking), headache, nausea (feeling sick), diarrhoea, kidney problems, hyperglycaemia (raised blood glucose levels), diabetes, hyperkalaemia (raised blood potassium levels), hypertension (high blood pressure) and insomnia (difficulty sleeping).
Desuden blev der udført kortvarige undersøgelser hos 119 nyretransplantationspatienter og 129 levertransplantationspatienter, hvor det blev undersøgt, hvordan Advagraf optages af kroppen sammenlignet med Prograf/Prograft.
Further shorter studies were also carried out in 119 kidney transplant patients and 129 liver transplant patients, looking at how Advagraf is absorbed by the body in comparison to Prograf/Prograft.