natgillin/translations-raw huggingface dataset:
Stalevo findes i seks forskellige pakningsstørrelser (10, 30, 100, 130, 175 eller 250 tabletter).
Stalevo comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets).
For at undgå bivirkninger skal der altid være mindst én time mellem Stalevo tabletterne.
Always leave at least an hour between Stalevo tablets, to avoid possible side effects.
Stalevo indeholder tre virksomme stoffer (levodopa, carbidopa og entacapon) i én filmovertrukket tablet.
Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet.
Der er ikke observeret interaktioner mellem entacapon og seligilin i studier med gentagen dosering hos patienter med Parkinsons sygdom, som blev behandlet med levodopa/DDC-hæmmer.
Interactions between entacapone and selegiline have been investigated in repeated dose studies in Parkinson's disease patients treated with levodopa/DDC inhibitor and no interaction was observed.
I henhold til denne daglige carbidopadosis, er den anbefalede daglige maksimale dosis for styrken 175 mg/43,75 mg/200 mg 8 tabletter pr. dag og for 200 mg/50 mg/200 mg 7 tabletter pr. dag.
According to this daily carbidopa dose, the maximum recommended daily dose of Stalevo 175 mg/43.75 mg/200 mg is 8 tablets per day and Stalevo 200 mg/50 mg/200 mg dose is 7 tablets per day.
b. Ved initiering af Stalevobehandling hos patienter, der allerede er i behandling med entacapon og levodopa/carbidopa i doser, der ikke findes i styrker tilsvarende Stalevo tabletter (50 mg/12,5 mg/200 mg eller 75 mg/18,75 mg/200 mg eller 100 mg/25 mg/200 mg eller 125 mg/31,25 mg/200 mg eller 150 mg/37,5 mg/200 mg eller 175 mg/43,75 mg/200 mg eller 200 mg/50 mg/200 mg), bør doseringen af Stalevo omhyggeligt titreres til et optimalt klinisk respons.
b. When initiating Stalevo therapy for patients currently treated with entacapone and levodopa/carbidopa in doses not equal to Stalevo tablets (50 mg/12.5 mg/200 mg or 75 mg/18.75 mg/200 mg or 100 mg/25 mg/200 mg or 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg or 175 mg/43.75 mg/200 mg or 200 mg/50 mg/200 mg), Stalevo dosing should be carefully titrated for optimal clinical response.
F.eks. kan en patient, der tager en tablet på 50 mg/12,5 mg levodopa/carbidopa samtidig med en tablet entacapon på 200 mg 4 gange dagligt, i stedet tage en 50 mg/12,5 mg/200 mg Stalevo-tablet 4 gange dagligt.
For example, a patient taking one tablet of 50 mg/12.5 mg of levodopa/carbidopa with one tablet of entacapone 200 mg four times daily can take one 50 mg/12.5 mg/200 mg Stalevo tablet four times daily in place of their usual levodopa/carbidopa and entacapone doses.
Sådan skal du tage Stalevo
How to take Stalevo
- Hvis du tager Stalevo 50 mg/12,5 mg/200 mg, 75 mg/18,75 mg/200 mg, 100 mg/25 mg/200 mg,
- If you are taking Stalevo 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg,
Da der er begrænset erfaring med brug af totale døgndoser større end 200 mg carbidopa, og den anbefalede maksimale daglige dosis af entacapon er 2000 mg, er den maksimale dosis derfor 10 tabletter pr. dag for Stalevostyrker på 50 mg/12,5 mg/200 mg, 75 mg/18,75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31,25 mg/200 mg og 150 mg/37,5 mg/200 mg. 10 Stalevo-tabletter med styrken
While the experience with total daily dose greater than 200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2,000 mg and therefore the maximum dose is 10 tablets per day for the Stalevo strengths of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg and 150 mg/37.5 mg/200 mg.
- problemer med leveren, da det i givet fald kan være nødvendigt at justere dosis - nyre- eller hormonrelaterede sygdomme - mavesår eller mavekramper - hvis du får længerevarende diarré Kontakt lægen, da det kan være tegn på betændelse i tyktarmen - en alvorlig mental lidelse, som f.eks. en psykose - kronisk åbenvinklet grøn stær, da det i givet fald kan være nødvendigt at justere dosis og kontrollere trykket i dine øjne.
- stomach ulcers or convulsions - if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon - any form of severe mental disorder like psychosis - chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in your eyes may need to be monitored.
Post-marketing data omfatter isolerede tilfælde af overdosis, hvor den største daglige dosis af levodopa og entacapon har været henholdsvis 10.000 mg og 40.000 mg. I disse tilfælde af en overdosis var de akutte symptomer og tegn: agitation, tilstand af forvirring, koma, bradykardi,
The post-marketing data includes isolated cases of overdose in which the reported highest daily doses of levodopa and entacapone have been at least 10,000 mg and 40,000 mg, respectively.
stalevo 125/31,25/200 mg [kun karton]
stalevo 125/31.25/200 mg [carton only]
stalevo 75/18,75/200 mg [kun karton]
stalevo 75/18.75/200 mg [carton only]
Det skal du vide, før du begynder at tage Stalevo Sådan skal du tage Stalevo Bivirkninger
What Stalevo is and what it is used for What you need to know before you take Stalevo How to take Stalevo
Det kan omfatte: - voldsom trang til at spille umådeholdent på trods af alvorlige personlige eller familiære konsekvenser - forandret eller øget seksuel lyst og adfærd, der giver betydelig bekymring for dig eller andre, for eksempel en øget sextrang - ukontrolleret og udtalt købelyst eller pengeforbrug - udtalt overspisning (at spise store mængder af mad i løbet af kort tid) eller tvangsspisning (at spise mere mad end normalt og mere end nødvendigt for at stille sulten).
You may experience the following side effects: - Inability to resist the impulse to perform an action that could be harmful, which may include: - strong impulse to gamble excessively despite serious personal or family consequences - altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive - uncontrollable excessive shopping or spending - binge eating (eating large amounts of food in a short time period) or compulsive eating
stalevo 175/43,75/200 mg [kun karton]
stalevo 175/43.75/200 mg [carton only]
125 mg/31,25 mg/200 mg eller 150 mg/37,5 mg/200 mg, må du ikke tage mere end 10 tabletter pr.
100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg tablets, do not take more than 10 tablets each day.
Brun eller grårøde, aflange ellipse-formede filmovertrukne tabletter uden delekærv præget med ”LCE 150” på den ene side.
Brownish or greyish red, elongated-ellipse shaped, unscored film-coated tablets marked with ‘LCE 150' on one side.
Du kan få følgende bivirkninger:
Possible side effects
125 mg/31,25 mg/200 mg eller150 mg/37,5 mg/200 mg, må du ikke tage mere end 10 tabletter pr.
100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg tablets, do not take more than 10 tablets per day.
stalevo 50/12,5/200 mg [kun karton]
stalevo 50/12.5/200 mg [carton only]
stalevo 150/37,5/200 mg [kun karton]
stalevo 150/37.5/200 mg [carton only]
stalevo 100/25/200 mg [kun karton]
stalevo 100/25/200 mg [carton only]
Kontakt lægen eller apotekspersonalet, før du tager Stalevo , hvis du har eller tidligere har haft: - et hjerteinfarkt eller anden sygdom i hjertet, herunder forstyrrelser i hjerterytmen, eller i blodårerne - asthma eller anden lungesygdom
Talk to your doctor or pharmacist before taking Stalevo if you have or have ever had: - a heart attack or any other diseases of the heart including cardiac arrhythmias, or of the blood vessels - asthma or any other disease of the lungs - a liver problem, because your dose may need to be adjusted - kidney or hormone-related diseases
Hvis du under behandling med Stalevo bemærker følgende symptomer, skal du kontakte din læge øjeblikkeligt:
If you have accidentally taken more Stalevo tablets than you should, talk to your doctor or pharmacist immediately.
Stalevo 150 mg/37,5 mg /200 mg: Brun- eller grårøde, aflange, ellipse-formede filmovertrukne tabletter uden delekærv mærket ”LCE 150” på den ene side.
Stalevo 150 mg/37.5 mg/200 mg: brownish or greyish red, elongated-ellipse shaped, unscored filmcoated tablets marked with ‘LCE 150' on one side.
150 mg/37,5 mg/200 mg svarer til 375 mg carbidopa pr. dag.
Ten tablets of Stalevo 150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day.
- voldsom trang til at spille umådeholdent på trods af alvorlige personlige eller familiære konsekvenser - forandret eller øget seksuel lyst og adfærd, der giver betydelig bekymring for dig eller andre, for eksempel en øget sextrang - ukontrolleret og udtalt købelyst eller pengeforbrug - udtalt overspisning (at spise store mængder af mad i løbet af kort tid) eller tvangsspisning (at spise mere mad end normalt og mere end nødvendigt for at stille sulten).
You may experience the following side effects: - Inability to resist the impulse to perform an action that could be harmful, which may include: - strong impulse to gamble excessively despite serious personal or family consequences - altered or increased sexual interest and behaviour of significant concern to you or to others for example, an increased sexual drive - uncontrollable excessive shopping or spending - binge eating (eating large amounts of food in a short time period) or compulsive eating
ventrikulær takykardi, Cheyne-Stokes respiration, misfarvning af hud, tunge og konjunktiva og kromaturi.
The acute symptoms and signs in these cases of overdose included agitation, confusional state, coma, bradycardia, ventricular tachycardia, Cheyne-Stokes respiration, discolourations of skin, tongue and conjunctiva, and chromaturia.
stalevo 200/50/200 mg [kun karton]
stalevo 200/50/200 mg [carton only]
- De øvrige indholdsstoffer i filmovertrækket: glycerol (85 procent) (E422), hypromellose, magnesiumstearat, polysorbat 80, rød jernoxid (E172), saccharose og titandioxid (E171).
- The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose and titanium dioxide (E171).
Stalevo indeholder saccharose (1,89 mg/tablet).
Stalevo contains sucrose (1.89 mg/tablet).
Stalevo indeholder saccharose (2,3 mg/tablet).
Stalevo contains sucrose (2.3 mg/tablet).
Stalevo 75 mg/18,75 mg/200 mg findes i fem forskellige pakningsstørrelser (10, 30, 100, 130 eller 175 tabletter).
Stalevo 75 mg/18.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Stalevo 125 mg/31,25 mg/200 mg: Lyse brunrøde, ovale, filmovertrukne tabletter mærket med ”LCE 125” på den ene side.
Stalevo 125 mg/31.25 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 125' on one side.
Stalevo 125 mg/31,25 mg/200 mg findes i fem forskellige pakningsstørrelser (10, 30, 100, 130 eller 175 tabletter).
Stalevo 125 mg/31.25 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Stalevo 50 mg/12,5 mg/200 mg: Brun- eller grårøde, runde, hvælvede filmovertrukne tabletter uden delekærv mærket med ”LCE 50” på den ene side.
Stalevo 50 mg/12.5 mg/200 mg: brownish or greyish red, round, convex unscored film-coated tablets marked with ‘LCE 50' on one side.
Stalevo 200 mg/50 mg/200 mg tabletter findes i fem forskellige pakningsstørrelser (10, 30, 100, 130 eller 175 tabletter).
Stalevo 200 mg/50 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175).
- Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
Talk to your doctor or pharmacist if you think the effect of Stalevo is too strong or too weak, or if you experience possible side effects.
Stalevo 75 mg/18,75 mg/200 mg: Lyse brunrøde, ovale, filmovertrukne tabletter mærket med ”LCE 75” på den ene side.
Stalevo 75 mg/18.75 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 75' on one side.
Stalevo 175 mg/43,75 mg/200 mg findes i fem forskellige pakningsstørrelser (10, 30, 100, 130 eller 175 tabletter).
Stalevo 175 mg/43.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Stalevo 175 mg/43,75 mg/200 mg: Lyse brunrøde, ovale, filmovertrukne tabletter uden delekærv mærket med ”LCE 175” på den ene side.
Stalevo 175 mg/43.75 mg/200 mg: light brownish red, oval, unscored film-coated tablets marked with ‘LCE 175' on one side.
- Hver Stalevo 125 mg/31,25 mg/200 mg tablet indeholder 125 mg levodopa, 31,25 mg carbidopa og 200 mg entacapon.
- Each Stalevo 125 mg/31.25 mg/200 mg tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
- Hver Stalevo 75 mg/18,75 mg/200 mg tablet indeholder 75 mg levodopa, 18,75 mg carbidopa og 200 mg entacapon.
- Each Stalevo 75 mg/18.75 mg/200 mg tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.
Stalevo 200 mg/50 mg/200 mg tabletter: Mørk brunrøde, ovale filmovertrukne tabletter uden delekærv mærket med ”LCE 200” på den ene side.
Stalevo 200 mg/50 mg/200 mg: dark brownish red, oval, unscored film-coated tablets marked with ‘LCE 200' on one side.
Stalevo indeholder saccharose (1,9 mg/tablet).
Stalevo contains sucrose (1.9 mg/tablet).
- Hver Stalevo 175 mg/43,75 mg/200 mg tablet indeholder 175 mg levodopa, 43,75 mg carbidopa og 200 mg entacapon.
- Each Stalevo 175 mg/43.75 mg/200 mg tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.
Stalevo 100 mg/25 mg/200 mg: Brun- eller grårøde, ovale filmovertrukne tabletter uden delekærv mærket med ”LCE 100” på den ene side.
Stalevo 100 mg/25 mg/200 mg: brownish or greyish red, oval, unscored film-coated tablets marked with ‘LCE 100' on one side.
- Hver Stalevo 150 mg/37,5 mg/200 mg tablet indeholder 150 mg levodopa, 37,5 mg carbidopa og 200 mg entacapon.
- Each Stalevo 150 mg/37.5 mg/200 mg tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
- Hver Stalevo 50 mg/12,5 mg/200 mg tablet indeholder 50 mg levodopa, 12,5 mg carbidopa og 200 mg entacapon.
- Each Stalevo 50 mg/12.5 mg/200 mg tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
- Hver Stalevo 100 mg/25 mg/200 mg tablet indeholder 100 mg levodopa, 25 mg carbidopa og 200 mg entacapon.
- Each Stalevo 100 mg/25 mg/200 mg tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
Stalevo indeholder saccharose (1,2 mg/tablet).
Stalevo contains sucrose (1.2 mg/tablet).
Stalevo 75 mg/18,75 mg/200 mg filmovertrukne tabletter Levodopa/carbidopa/entacapon
Stalevo 75 mg/18.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
- Hver Stalevo 200 mg/50 mg/200 mg tablet indeholder 200 mg levodopa, 50 mg carbidopa og 200 mg entacapon.
- Each Stalevo 200 mg/50 mg/200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
Stalevo indeholder saccharose (1,6 mg/tablet).
Stalevo contains sucrose (1.6 mg/tablet).
Stalevo indeholder saccharose (1,4 mg/tablet).
Stalevo contains sucrose (1.4 mg/tablet).
Hvis du har taget for mange Stalevo
If you take more Stalevo than you should
EU/1/03/260/024 10 filmovertrukne tabletter EU/1/03/260/025 30 filmovertrukne tabletter EU/1/03/260/026 100 filmovertrukne tabletter EU/1/03/260/027 130 filmovertrukne tabletter EU/1/03/260/028 175 filmovertrukne tabletter
EU/1/03/260/024 10 film-coated tablets EU/1/03/260/025 30 film-coated tablets EU/1/03/260/026 100 film-coated tablets EU/1/03/260/027 130 film-coated tablets EU/1/03/260/028 175 film-coated tablets
Stalevo 175 mg/43,75 mg/200 mg filmovertrukne tabletter levodopa/carbidopa/entacapon
Stalevo 175 mg/43.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Stalevo 175 mg/43,75 mg/200 mg filmovertrukne tabletter Levodopa/carbidopa/entacapon
Stalevo 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
EU/1/03/260/029 10 filmovertrukne tabletter EU/1/03/260/030 30 filmovertrukne tabletter EU/1/03/260/031 100 filmovertrukne tabletter EU/1/03/260/032 130 filmovertrukne tabletter EU/1/03/260/033 175 filmovertrukne tabletter
EU/1/03/260/029 10 film-coated tablets EU/1/03/260/030 30 film-coated tablets EU/1/03/260/031 100 film-coated tablets EU/1/03/260/032 130 film-coated tablets EU/1/03/260/033 175 film-coated tablets
EU/1/03/260/034 10 filmovertrukne tabletter EU/1/03/260/035 30 filmovertrukne tabletter EU/1/03/260/036 100 filmovertrukne tabletter EU/1/03/260/037 130 filmovertrukne tabletter EU/1/03/260/038 175 filmovertrukne tabletter
EU/1/03/260/034 10 film-coated tablets EU/1/03/260/035 30 film-coated tablets EU/1/03/260/036 100 film-coated tablets EU/1/03/260/037 130 film-coated tablets EU/1/03/260/038 175 film-coated tablets
Stalevo 150 mg/37,5 mg/200 mg filmovertrukne tabletter levodopa/carbidopa/entacapon
Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Stalevo 50 mg/12,5 mg/200 mg filmovertrukne tabletter levodopa/carbidopa/entacapon
Stalevo 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Stalevo 50 mg/12,5 mg/200 mg filmovertrukne tabletter Levodopa/carbidopa/entacapon
Stalevo 50 mg/12.5 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Stalevo 125 mg/31,25 mg/200 mg filmovertrukne tabletter Levodopa/carbidopa/entacapon
Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Stalevo 125 mg/31,25 mg/200 mg filmovertrukne tabletter levodopa/carbidopa/entacapon
Stalevo 125 mg/31.25 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
EU/1/03/260/009 10 filmovertrukne tabletter EU/1/03/260/010 30 filmovertrukne tabletter EU/1/03/260/011 100 filmovertrukne tabletter EU/1/03/260/012 250 filmovertrukne tabletter EU/1/03/260/015 175 filmovertrukne tabletter EU/1/03/260/018 130 filmovertrukne tabletter
EU/1/03/260/009 10 film-coated tablets EU/1/03/260/010 30 film-coated tablets EU/1/03/260/011 100 film-coated tablets EU/1/03/260/012 250 film-coated tablets EU/1/03/260/015 175 film-coated tablets EU/1/03/260/018 130 film-coated tablets
EU/1/03/260/005 10 filmovertrukne tabletter EU/1/03/260/006 30 filmovertrukne tabletter EU/1/03/260/007 100 filmovertrukne tabletter EU/1/03/260/008 250 filmovertrukne tabletter EU/1/03/260/014 175 filmovertrukne tabletter EU/1/03/260/017 130 filmovertrukne tabletter
EU/1/03/260/005 10 film-coated tablets EU/1/03/260/006 30 film-coated tablets EU/1/03/260/007 100 film-coated tablets EU/1/03/260/008 250 film-coated tablets EU/1/03/260/014 175 film-coated tablets EU/1/03/260/017 130 film-coated tablets
Stalevo 200 mg/50 mg/200 mg filmovertrukne tabletter Levodopa/carbidopa/entacapon
Stalevo 200 mg/50 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Stalevo 100 mg/25 mg/200 mg filmovertrukne tabletter levodopa/carbidopa/entacapon
Stalevo 100 mg/25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
EU/1/03/260/019 10 filmovertrukne tabletter EU/1/03/260/020 30 filmovertrukne tabletter EU/1/03/260/021 100 filmovertrukne tabletter EU/1/03/260/022 130 filmovertrukne tabletter EU/1/03/260/023 175 filmovertrukne tabletter
EU/1/03/260/019 10 film-coated tablets EU/1/03/260/020 30 film-coated tablets EU/1/03/260/021 100 film-coated tablets EU/1/03/260/022 130 film-coated tablets EU/1/03/260/023 175 film-coated tablets
EU/1/03/260/001 10 filmovertrukne tabletter EU/1/03/260/002 30 filmovertrukne tabletter EU/1/03/260/003 100 filmovertrukne tabletter EU/1/03/260/004 250 filmovertrukne tabletter EU/1/03/260/013 175 filmovertrukne tabletter EU/1/03/260/016 130 filmovertrukne tabletter
EU/1/03/260/001 10 film-coated tablets EU/1/03/260/002 30 film-coated tablets EU/1/03/260/003 100 film-coated tablets EU/1/03/260/004 250 film-coated tablets EU/1/03/260/013 175 film-coated tablets EU/1/03/260/016 130 film-coated tablets
Anæmi Ikke almindelig: Trombocytopeni
Thrombocytopenia
Det kan omfatte:
What is in this leaflet:
Der bør derfor udvises forsigtighed ved behandling af patienter med alvorlig nedsat nyrefunktion, inklusive dialysepatienter, med Stalevo (se pkt.
No particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with renal insufficiency, therefore Stalevo therapy should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy (see section 5.2).
London, den 11. juli 2007 EMEA/CHMP/75066/2007
London, 11 July 2007 EMEA/CHMP/75066/2007
Referencemedlemsstaten var Nederlandene, og de berørte medlemsstater var Østrig, Tyskland, Irland, Italien og Det Forenede Kongerige.
The Reference Member State was the Netherlands and the Concerned Member States were Austria, Germany, Ireland, Italy, and United Kingdom.
Den 24. januar 2007 blev der vedtaget en positiv udtalelse.
A positive opinion was adopted by on 24 January 2007.
Nederlandene indbragte grundene til uenigheden for EMEA den 7. juli 2006.
The Netherlands referred the reasons for disagreement to the EMEA on 7 July 2006.
Den gensidige anerkendelsesprocedure blev indledt den 28. januar 2006.
The Mutual Recognition Procedure started on 28 January 2006.
Der blev påpeget væsentlige forskelle vedrørende doseringen ved urinvejsinfektioner og vedrørende den maksimale daglige dosis til voksne.
Significant differences have been identified with regard to dose in urinary tract infections and of the maximum adult daily dose.
Dr. Ian Hudson var rapportør, og dr. Bengt Ljungberg var medrapportør.
The Rapporteur was Dr Ian Hudson and Co-Rapporteur was Dr Bengt Ljungberg.
Den endelige udtalelse blev den 11. juli 2007 omarbejdet til en beslutning af Europa-Kommissionen.
The final opinion was converted into a Decision by the European Commission on 11 July 2007.
Indehaveren af markedsføringstilladelsen indsendte skriftlige redegørelser den 20. oktober 2006.
The Marketing Authorisation Holder provided written explanations on 20 October 2006.
Voldgiftsproceduren blev indledt den 27. juli 2006 med vedtagelsen af en række spørgsmål.
The arbitration procedure started on 27 July 2006 with the adoption of a list of questions.
Listen over de berørte produktnavne findes i bilag I. De faglige konklusioner fremgår af bilag II, produktresuméet af bilag III.
The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
På sit møde i januar 2007 fandt CHMP på baggrund af alle de forelagte oplysninger og den faglige drøftelse i udvalget, at benefit-risk forholdet er gunstigt for Ciprofloxacin Hikma og tilknyttede navne, at de rejste indvendinger ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
During their January 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Ciprofloxacin Hikma and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
har indgivet ansøgninger om gensidig anerkendelse af Ciprofloxacin Hikma og tilknyttede navne, infusionsvæske, opløsning, 2 mg/ml, baseret på den markedsføringstilladelse, der blev udstedt af Nederlandene den 12. april 2005.
submitted applications for mutual recognition of Ciprofloxacin Hikma and associated names, 2 mg/ml solution for infusion on the basis of the marketing authorisation granted by the Netherlands on 12 April 2005.
5.1 burde medtage de organismer, der er anført i forbindelse med tærskelværdierne og i følsomhedstabellen for indikationerne, i overensstemmelse med "Note for Guidance on Evaluation of medicinal products indicated for treatment of bacterial infections" (CPMP/EWP/558/95 rev.1).
In addition, it was considered that the applicant should include in the Summary of Product Characteristics (point 5.1) the organisms listed in the breakpoints and susceptibility table relevant to the indications, as per the Note for Guidance on Evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev.1).