natgillin/translations-raw huggingface dataset:
galdegangssygdomme, skade på leverceller og hepatitis, colestase og gulsot
bile duct disorders, hepatocellular damage and hepatitis, cholestasis and jaundice rare:
Sådan skal du tage Tacforius
How to take Tacforius
Overlevelsesraten efter 12 måneder var 96,9 % for tacrolimus depotkapsler og 97,5 % for tacrolimus kapsler med umiddelbar udløsning; i armen med tacrolimus depotkapsler døde 10 patienter (3 kvinder, 7 mænd), og i armen med tacrolimus kapsler med umiddelbar udløsning døde 8 patienter (3 kvinder, 5 mænd).
The 12-month patient survival rates were 96.9% for tacrolimus prolonged-release capsules and 97.5% for tacrolimus immediate release capsules; in the tacrolimus prolonged-release capsules arm 10 patients died (3 female, 7 male) and in the tacrolimus immediate release capsules arm 8 patients died (3 female, 5 male).
Det skal du vide, før du begynder at tage Tacforius
What you need to know before you take Tacforius Do not take Tacforius
Hjælpestof, som behandleren skal være opmærksom på Hver kapsel indeholder 53,725 mg lactose.
Each capsule contains 53.725 mg lactose.
Hjælpestof, som behandleren skal være opmærksom på Hver kapsel indeholder 107,45 mg lactose.
Each capsule contains 107.45 mg lactose.
lægemidler kendt som ”statiner” til behandling af forhøjet kolesterol og triglycerider fenytoin eller fenobarbital, til behandling af epilepsi kortikosteroiderne prednisolon og methylprednisolon, der anvendes til behandling af betændelsestilstande eller til at undertrykke immunsystemet (f.eks. ved afstødning af organ efter transplantation) nefazodon til behandling af depression naturmedicin, der indeholder perikon (Hypericum perforatum) eller ekstrakt af Schisandra sphenanthera.
- the corticosteroids prednisolone and methylprednisolone, belonging to the class of corticosteroids used to treat inflammations or suppress the immune system (e.g. in transplant rejection) - nefazodone, used to treat depression - Herbal preparations containing St. John's Wort (Hypericum perforatum) or extracts of Schisandra sphenanthera.
CYP3A4-hæmmere som potentielt kan øge tacrolimus' blodkoncentrationer
CYP3A4 inhibitors potentially leading to increased tacrolimus blood levels
Tacrolimus startede som kontinuerlig intravenøs infusion med doser på 0,05 mg/kg/dag, hvorefter oral tacrolimus blev administreret i doser på 0,1-0,3 mg/kg/dag med følgende dosisjustering for at nå dalkoncentrationer på 12-15 ng/ml.
Tacrolimus was started as continuous intravenous infusion at a dose of 0.05 mg/kg/day and oral tacrolimus was administered at a dose of 0.1 to 0.3 mg/kg/day with subsequent dose adjustments to target trough levels of 12 to 15 ng/ml.
Tacforius 0,5 mg/3 mg/5 mg depotkapsler, hårde Pakningsstørrelser: 30, 50 og 100 depotkapsler, hårde, i blisterkort eller 30x1, 50x1 og 100x1 depotkapsler, hårde, i perforeret enkeltdosisblisterkort.
Tacforius 0.5 mg / 3 mg / 5 mg prolonged-release hard capsules Pack sizes: 30, 50 and 100 prolonged-release hard capsules in blisters or 30x1, 50x1 and 100x1 prolonged-release hard capsules in perforated unit-dose blisters.
symptomer fra mave-tarmkanalen, opkastning, abdominale og gastrointestinale smerter, inflammatoriske lidelser i mave-tarm-kanalen, blødning i mave-tarm-kanalen, ulceration og perforation i mave-tarm-kanalen, ascites, ulcerøs stomatitis, obstipation, dyspepsi, flatulens, oppustethed, tynd afføring
gastrointestinal signs and symptoms, vomiting, gastrointestinal and abdominal pains, gastrointestinal inflammatory conditions, gastrointestinal haemorrhages, gastrointestinal ulceration and perforation, ascites, stomatitis and ulceration, constipation, dyspeptic signs and symptoms, flatulence, bloating and distension, loose stools uncommon:
Alvorlig sygdom med blærer i huden, munden, øjnene og kønsorganerne, øget behåring Tørst, øget tendens til at falde, trykken for brystet, nedsat bevægelighed, sår
- Cyst formation in your pancreas - Problems with blood flow in the liver - Serious illness with blistering of skin, mouth, eyes and genitals; increased hairiness - Thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer
Tacforius 0,5 mg/1 mg/3 mg depotkapsler, hårde Rød jernoxid (E 172)
Tacforius 0.5 mg / 1 mg / 3 mg prolonged-release hard capsules Red iron oxide (E172)
Nervesystemet Meget almindelig:
deafness neurosensory very rare:
lidelse i lungeparenkymet, dyspnø, pleura-effusion, hoste, faryngitis, tilstopning og inflammation i næsen
parenchymal lung disorders, dyspnoea, pleural effusion, cough, pharyngitis, nasal congestion and inflammations uncommon:
Tacforius 0,5 mg/1 mg depotkapsler, hårde 2 år
Tacforius 0.5 mg / 1 mg prolonged-release hard capsules 2 years
Du skal i særdeleshed oplyse det til lægen, hvis du tager eller for nylig har taget medicin såsom: svampemidler og antibiotika, især såkaldte makrolide antibiotika til behandling af infektioner f.eks. ketoconazol, fluconazol, itraconazol, voriconazol, clotrimazol og isavuconazol, erythromycin, clarithromycin, josamycin og rifampicin hiv-proteasehæmmere (f.eks. ritonavir, nelfinavir, saquinavir), boostermedicinen cobicitstat og kombinationstabletter, som bruges ved behandling af hiv-infektion HCV-proteasehæmmere (f.eks. telaprevir, boceprevir og kombinationen ombitasvir/paritaprevir/ritonavir med eller uden dasabuvir), som bruges til behandling af hepatitis C-infektion nilotinib og imatinib (bruges til behandling af visse typer cancer) mycophenolsyre, som bruges til at undertrykke immunsystemet for at forhindre afstødning af et transplantat medicin til forebyggelse og behandling af mavesår og spiserørskatar (f.eks. omeprazol, lansoprazol eller cimetidin) antiemetika, der anvendes til behandling af kvalme og opkastning (f.eks. metoclopramid) cisaprid eller det syreneutraliserende middel magnesium-aluminium-hydroxid, der anvendes til behandling af halsbrand p-piller eller anden hormonbehandling med ethinylestradiol, hormonbehandling med danazol medicin mod forhøjet blodtryk eller hjerteproblemer (f.eks. nifedipin, nicardipin, diltiazem og verapamil) antiarytmika (amiodaron), som bruges til behandling af arytmier (uregelmæssig hjerterytme)
and combination tablets, used to treat HIV infection - HCV protease inhibitors (e.g. telaprevir, boceprevir and the combination ombitasvir/paritaprevir/ritonavir with or without dasabuvir), used to treat hepatitis C infection - nilotinib and imatinib (used to treat certain cancers) - mycophenolic acid, used to suppress the immune system to prevent transplant rejection - medicines for stomach ulcer and acid reflux (e.g. omeprazole, lansoprazole or cimetidine) - antiemetics, used to treat nausea and vomiting (e.g. metoclopramide) - cisapride or the antacid magnesium-aluminium-hydroxide, used to treat heartburn - the contraceptive pill or other hormone treatments with ethinylestradiol, hormone treatments with danazol - medicines used to treat high blood pressure or heart problems (e.g. nifedipine, nicardipine,
Sort jernoxid (E 172)
Black iron oxide (E172)
Tacforius 5 mg depotkapsler, hårde Rød jernoxid (E 172)
Tacforius 5 mg prolonged-release hard capsules Red iron oxide (E172)
30 depotkapsler, hårde 30x1 depotkapsler, hårde 50 depotkapsler, hårde 50x1 depotkapsler, hårde 60 depotkapsler, hårde 60x1 depotkapsler, hårde 100 depotkapsler, hårde 100x1 depotkapsler, hårde
30 prolonged-release hard capsules 30x1 prolonged-release hard capsules 50 prolonged-release hard capsules 50x1 prolonged-release hard capsules 60 prolonged-release hard capsules 60x1 prolonged-release hard capsules 100 prolonged-release hard capsules 100x1 prolonged-release hard capsules
feber, smerter og ubehag, asteni, ødem, ændret opfattelse af kropstemperatur
febrile disorders, pain and discomfort, asthenic conditions, oedema, body temperature, perception disturbed uncommon:
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) Nedsat antal blodceller (plader, røde eller hvide blodlegemer), stigning af hvide blodlegemer, ændret antal røde blodlegemer (ses i blodprøver) Nedsat indhold af magnesium, fosfat, kalium, calcium eller natrium i blodet, væskeoverbelastning, stigning af urinsyre eller fedt i blodet, nedsat appetit, øget surhed af blodet, andre ændringer i blodets salte (ses i blodprøver) Angstsymptomer, forvirring og desorientering, depression, humørsvingninger, mareridt, hallucinationer, forstyrret sindstilstand
Common side effects (may affect up to 1 in 10 people) - Reduction in blood cell counts (platelets, red or white blood cells), increase in white blood cell counts, changes in red blood cell counts (seen in blood tests) - Reduced magnesium, phosphate, potassium, calcium or sodium in the blood, fluid overload,
Sjældne bivirkninger (kan forekomme hos op til 1ud af 1.000 personer) Små blødninger i huden på grund af blodpropper Øget muskelstivhed
Rare side effects (may affect up to 1 in 1,000 people) - Small bleedings in your skin due to blood clots - Increased muscle stiffness - Blindness, deafness - Collection of fluid around the heart - Acute breathlessness
Der er endnu ingen kliniske data tilgængelige for depotformulering af tacrolimus ved profylaktisk behandling mod transplantatafstødning hos hjertetransplanterede voksne.
For prophylaxis of transplant rejection in adult heart allograft recipients clinical data are not yet available for the prolonged-release formulation of tacrolimus.
artralgi, rygsmerter, muskelspasmer, smerter i ekstremiteterne
arthralgia, back pain, muscle spasms, pain in extremity uncommon:
Tacforius 0,5 mg depotkapsler, hårde Hver depotkapsel, hård, indeholder 0,5 mg tacrolimus (som monohydrat).
Tacforius 0.5 mg prolonged-release hard capsules Each prolonged-release hard capsule contains 0.5 mg tacrolimus (as monohydrate).
iskæmiske koronararteriesygdomme, takykardi
ischaemic coronary artery disorders, tachycardia uncommon:
diabetes mellitus, hyperglykæmi, hyperkaliæmi
Metabolism and nutrition disorders very common: diabetes mellitus, hyperglycaemic conditions, hyperkalaemia common:
Smerter i led, lemmer, ryg og fødder, muskelspasmer Utilstrækkelig nyrefunktion, nedsat urindannelse, forringet eller smertefuld vandladning Generel svaghed, feber, væskeansamling i kroppen, smerter og ubehag, øget indhold af enzymet basisk fosfatase i blodet, vægtstigning, ændret opfattelse af kropstemperatur Utilstrækkelig funktion af det transplanterede organ.
abdominal pain, indigestion, constipation, passing wind, bloating, loose stools - Bile duct disorders, yellowing of the skin due to liver problems, liver tissue damage and inflammation of the liver - Itching, rash, hair loss, acne, increased sweating - Pain in joints, limbs, back and feet, muscle spasms - Insufficient function of the kidneys, reduced production of urine, impaired or painful urination - General weakness, fever, collection of fluid in your body, pain and discomfort, increase of the enzyme alkaline phosphatase in your blood, weight gain, feeling of temperature disturbed - Insufficient function of your transplanted organ
Vaskulære sygdomme Meget almindelig:
Torsades de Pointes Vascular disorders very common: hypertension common:
Indholdet af Tacforius i blodet kan påvirkes af anden medicin, og Tacforius kan påvirke indholdet af anden medicin i blodet.
Tacforius blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Tacforius, which may require interruption, an increase or a decrease in Tacforius dose.
dehydrering, hypoglykæmi, hypoproteinæmi, hyperfosfatæmi
dehydration, hypoglycaemia, hypoproteinaemia, hyperphosphataemia Psychiatric disorders very common: insomnia common:
Hver kapsel Tacforius 0,5 mg indeholder 0,5 mg tacrolimus (som monohydrat).
Each capsule of Tacforius 0.5 mg contains 0.5 mg of tacrolimus (as monohydrate).
Pakningsstørrelser: 30, 50, 60 og 100 depotkapsler, hårde, i blisterkort eller 30x1, 50x1, 60x1 og 100x1 depotkapsler, hårde, i perforeret enkeltdosisblisterkort.
Pack sizes: 30, 50, 60 and 100 prolonged-release hard capsules in blisters or 30x1, 50x1, 60x1 and 100x1 prolonged-release hard capsules in perforated unit-dose blisters.
Hver kapsel Tacforius 1 mg indeholder 1 mg tacrolimus (som monohydrat).
Each capsule of Tacforius 1 mg contains 1 mg of tacrolimus (as monohydrate).
Tacforius 5 mg kapsler indeholder ponceau 4R Tacforius 5 mg kapsler indeholder ponceau 4R, som kan medføre allergiske reaktioner.
Tacforius 5 mg capsules contains ponceau 4R
Blodkoncentrationerne af ciclosporin og patientens tilstand skal tages i betragtning, før man indleder behandling med Tacforius.
Tacforius therapy should be initiated after considering ciclosporin blood concentrations and the clinical condition of the patient.
Tacforius 1 mg depotkapsler, hårde EU/1/17/1244/007
Tacforius 1 mg prolonged-release hard capsules EU/1/17/1244/007
Hver kapsel Tacforius 3 mg indeholder 3 mg tacrolimus (som monohydrat).
Each capsule of Tacforius 3 mg contains 3 mg of tacrolimus (as monohydrate).
Tacforius 0,5 mg depotkapsler Tacforius 1 mg depotkapsler Tacforius 3 mg depotkapsler Tacforius 5 mg depotkapsler tacrolimus
Tacforius 0.5 mg prolonged-release capsules Tacforius 1 mg prolonged-release capsules Tacforius 3 mg prolonged-release capsules Tacforius 5 mg prolonged-release capsules tacrolimus
Tacforius 3 mg hårde depotkapsler
Tacforius 3 mg prolonged-release hard capsules
Gelatinekapsler præget med ”TR” på den grå-røde kapseltop og med ”5 mg” på den lysorange kapselbund.
Gelatin capsules imprinted with “TR” on the greyish red capsule cap and “5 mg” on the light orange capsule body.
Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) Forhøjet blodsukker, sukkersyge, øget kaliumindhold i blodet Søvnløshed
Very common side effects (may affect more than 1 in 10 people) - Increased blood sugar, diabetes mellitus, increased potassium in the blood - Difficulty in sleeping - Trembling, headache - Increased blood pressure - Liver function tests abnormal - Diarrhoea, nausea - Kidney problems
Hver kapsel Tacforius 5 mg indeholder 5 mg tacrolimus (som monohydrat).
Each capsule of Tacforius 5 mg contains 5 mg of tacrolimus (as monohydrate).
Tacforius 1 mg hårde depotkapsler
Tacforius 1 mg prolonged-release hard capsules
Tacforius 3 mg depotkapsler, hårde EU/1/17/1244/015
Tacforius 3 mg prolonged-release hard capsules EU/1/17/1244/015
Tacforius 5 mg depotkapsler, hårde EU/1/17/1244/021
Tacforius 5 mg prolonged-release hard capsules EU/1/17/1244/021
Depotkapsel, hård
Prolonged-release hard capsule
Gelatinekapsler præget med ”TR” på den lysegule kapseltop og med ”0.5 mg” på den lysorange kapselbund.
Gelatin capsules imprinted with “TR” on the light yellow capsule cap and “0.5 mg” on the light orange capsule body.
Tacrolimus blev startet som kontinuerlig intravenøs infusion i doser på 0,01 mg0,03 mg/kg/dag.
Tacrolimus was started as continuous intravenous infusion at a dose of 0.01 to 0.03 mg/kg/day and oral tacrolimus was administered at a dose of 0.05 to 0.3 mg/kg/day.
Nyre og urinveje Meget almindelig:
mobility decreased Renal and urinary disorders very common: renal impairment common:
Tacforius 0,5 mg hårde depotkapsler
Tacforius 0.5 mg prolonged-release hard capsules
Nedsat nyrefunktion
primary graft dysfunction
Smertefuld vandladning med blod i urinen Øget fedtvæv
increased uric acid or lipids in the blood, decreased appetite, increased acidity of the blood,
Gelatinekapsler præget med ”TR” på den hvide kapseltop og med ”1 mg” på den lysorange kapselbund.
Gelatin capsules imprinted with “TR” on the white capsule cap and “1 mg” on the light orange capsule body.
Hårde gelatinekapsler præget med “TR” på den hvide kapseltop og “1 mg” på den lysorange kapselbund.
Hard gelatin capsules imprinted with “TR” on the white capsule cap and “1 mg” on the light orange capsule body.
Overlevelsesraten efter 12 måneder var 89,2 % for armen med tacrolimus depotkapsler og 90,8 % for armen med tacrolimus kapsler med umiddelbar udløsning; i armen med tacrolimus depotkapsler døde 25 patienter (14 kvinder, 11 mænd), og i armen med tacrolimus kapsler med umiddelbar udløsning døde 24 patienter (5 kvinder, 19 mænd).
The treatment difference (tacrolimus prolonged-release capsules - tacrolimus immediate release capsules) was 3.3% (95% confidence interval [-5.7%, 12.3%]).The 12-month patient survival rates were 89.2% for tacrolimus prolongedrelease capsules and 90.8% for tacrolimus immediate release capsules; in the tacrolimus prolongedrelease capsules arm 25 patients died (14 female, 11 male) and in the tacrolimus immediate release capsules arm 24 patients died (5 female, 19 male).
Ved tegn på toksicitet såsom alvorlige hændelser (se pkt.
If signs of toxicity such as severe adverse reactions are noted (see section 4.8), the dose of Tacforius may need to be reduced.
Pakningsstørrelser på 30, 50, 60 eller 100 depotkapsler fås i blistere og pakningsstørrelser på 30×1, 50×1, 60×1 eller 100×1 depotkapsler fås i perforerede enkeltdosisblistere.
Packs of 30, 50, 60 and 100 prolonged-release capsules are available in blisters and packs of 30x1, 50x1, 60x1 and 100x1 prolonged-release capsules are available in perforated unit-dose blisters.
Tacforius 0,5 mg depotkapsler, hårde EU/1/17/1244/001
Tacforius 0.5 mg prolonged-release hard capsules EU/1/17/1244/001
Tacforius 5 mg hårde depotkapsler
Tacforius 5 mg prolonged-release hard capsules
Tacforius indeholder:
tinnitus uncommon:
Pakningsstørrelser på 30, 50 og 100 hårde depotkapsler fås i blistere og pakningsstørrelser på 30×1, 50×1 og 100×1 depotkapsler fås i perforerede enkeltdosisblistere.
Packs of 30, 50 and 100 prolonged-release hard capsules are available in blisters and packs of 30x1, 50x1 and 100x1 prolonged-release capsules are available in perforated unit-dose blisters.
Hårde gelatinekapsler præget med “TR” på den lysorange kapseltop og “3 mg” på den lysorange kapselbund.
Hard gelatin capsules imprinted with “TR” on the light orange capsule cap and “3 mg” on the light orange capsule body.
Gelatinekapsler præget med ”TR” på den lysorange kapseltop og med ”3 mg” på den lysorange kapselbund.
Gelatin capsules imprinted with “TR” on the light orange capsule cap and “3 mg” on the light orange capsule body.
Unormal hjerteundersøgelse
Cardiac disorders
Gul jernoxid (E 172)
Yellow iron oxide (E172)
veneokklusiv leversygdom, trombose i leverarterie
veno-occlusive liver disease, hepatitic artery thrombosis very rare:
Tacforius 0,5 mg depotkapsler, hårde Tacforius 1 mg depotkapsler, hårde Tacforius 3 mg depotkapsler, hårde Tacforius 5 mg depotkapsler, hårde tacrolimus
Tacforius 0.5 mg prolonged-release hard capsules Tacforius 1 mg prolonged-release hard capsules Tacforius 3 mg prolonged-release hard capsules Tacforius 5 mg prolonged-release hard capsules tacrolimus
Psykiske forstyrrelser Meget almindelig:
joint disorders rare:
udslæt, pruritus, alopeci, akne, svedudbrud
rash, pruritus, alopecias, acne, sweating increased uncommon:
Hårde gelatinekapsler præget med “TR” på den grårøde kapseltop og “5 mg” på den lysorange kapselbund.
Hard gelatin capsules imprinted with “TR” on the greyish red capsule cap and “5 mg” on the light orange capsule body.
Akut åndenød
hepatic failure
Maveproblemer såsom betændelse eller mavesår som giver mavesmerter eller diarré, maveblødning, betændelse eller sår i munden, væskeansamling i bughulen, opkastning, mavesmerter, fordøjelsesbesvær, forstoppelse, luftafgang fra tarmen, oppustethed, løs afføring Galdegangssygdomme, gulsot på grund af leverproblemer, ødelæggelse af levervæv og leverbetændelse
hallucination, mental disorders - Fits, disturbances in consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, nervous system disorders - Blurred vision, increased sensitivity to light, eye disorders - Ringing sound in your ears - Reduced blood flow in the heart vessels, faster heartbeat - Bleeding, partial or complete blocking of blood vessels, reduced blood pressure - Shortness in breath, disorders of the respiratory tissues in the lung, collection of liquid around the lung, inflammation of the pharynx, cough, flu-like symptoms - Stomach problems such as inflammation or ulcer causing abdominal pain or diarrhoea, bleeding in the stomach, inflammation or ulcer in the mouth, collection of fluid in the belly, vomiting,
Mave-tarm-kanalen Meget almindelig:
haemolytic uraemic syndrome, anuria very rare:
Undersøgelser Meget almindelig:
Investigations very common: liver function tests abnormal common:
Hvis du har taget for meget Tacforius
If you take more Tacforius than you should
Den initiale orale dosis på 0,15 mg/kg/dag bør gives én gang daglig om morgenen til patienter, som er blevet overført til Tacforius.
Treatment of allograft rejection after heart transplantation In adult patients converted to Tacforius, an initial oral dose of 0.15 mg/kg/day should be administered once daily in the morning.
Hårde gelatinekapsler præget med “TR” på den lysegule kapseltop og “0.5 mg” på den lysorange kapselbund.
Tacforius 0.5 mg prolonged-release hard capsules Hard gelatin capsules imprinted with “TR” on the light yellow capsule cap and “0.5 mg” on the light orange capsule body.
Tacforius 0,5 mg depotkapsler, hårde Tacforius 1 mg depotkapsler, hårde Tacforius 3 mg depotkapsler, hårde Tacforius 5 mg depotkapsler, hårde
Tacforius 0.5 mg prolonged-release hard capsules Tacforius 1 mg prolonged-release hard capsules Tacforius 3 mg prolonged-release hard capsules Tacforius 5 mg prolonged-release hard capsules
fald (kortvarig tab af balance), ulcus, trykken for brystet, tørst
fall, ulcer, chest tightness, thirst very rare:
Det er vigtigt at opdage og behandle dette så hurtigt som muligt.
It is important to identify and treat these as soon as possible.
Jo flere injektioner, du får, jo hyppigere kan disse virkninger optræde.
The more injections you have the more these effects can occur.
Hver pakke indeholder:
Each pack contains:
Følg disse anvisninger omhyggeligt.
Please follow these instructions carefully.
Børn og unge (under 18 år)
Children and adolescent (below 18 years of age)
Visualiseringen er mulig i de fleste tilfælde.
Visualisation is possible in the large majority of cases.
[Vedlægges i pakningen]
[To be provided in the carton]
Systemisk absorption er minimal, og der forventes ingen interaktioner.
Systemic absorption is minimal and no interactions are anticipated.
Der skal altid anvendes korrekte aseptiske injektionsteknikker.
Proper aseptic injection techniques must always be used.
Hver applikator må kun bruges til behandling af et enkelt øje.
Each applicator can only be used for the treatment of a single eye.
Dato for første markedsføringstilladelse: 27/07/2010 Dato for seneste fornyelse: 23 marts 2015
Date of first authorisation: 27/07/2010 Date of latest renewal: 23/03/2015
Før lancering i den enkelte medlemsstat skal indehaveren af markedsføringstilladelsen (MAH) aftale det endelige uddannelsesmateriale med den relevante nationale myndighed.
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational material with the National Competent Authority.
Westport, Co Mayo Irland
Westport, Co Mayo Ireland
1 implantat.
1 implant
Spørg din læge til råds, før du tager nogen form for medicin.
Ask your doctor for advice before taking any medicine.
Det er en kraftig promotor for vaskulær permeabilitet.
It is a potent promoter of vascular permeability.
DME er en lidelse, der rammer nogle mennesker med sukkersyge.
DME is a condition that affects some people with diabetes.
Din læge vil hjælpe dig med at beslutte, hvornår det er bedst at udføre denne operation, men du skal være klar over, at indtil du er parat til operationen, kan dit syn være lige så dårligt eller dårligere, end før du begyndte at få OZURDEX-injektioner.
Your doctor will help you to decide when is the most appropriate time to perform this operation, but you should be aware that until you are ready for your operation your vision may be as bad or worse than it was before you started receiving your OZURDEX injections.
Implantatet er ca. 0,46 mm i diameter og 6 mm langt.
The implant is approximately 0.46 mm in diameter and 6 mm in length.
Læs denne indlægsseddel grundigt, inden du får medicinen, da den indeholder vigtige oplysninger.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.