natgillin/translations-raw huggingface dataset:
Vizarsin 100 mg smeltetabletter Hver smeltetablet indeholder 1,5 mg aspartam (E951) og 0,035 mg sorbitol (E420).
Vizarsin 100 mg orodispersible tablets Each orodispersible tablet contains 1.5 mg aspartame (E951) and 0.035 mg sorbitol (E420).
Da sildenafil clearance er nedsat hos patienter med alvorligt nedsat nyrefunktion (kreatininclearance <30 ml/min.)
Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 ml/min) a 25 mg dose should be considered.
neohesperidin-dihydrochalcon (E959), mynteolie, pebermynteolie (indeholder sorbitol (E420)),
neohesperidin-dihydrochalcone (E959), spearmint oil, peppermint oil (containing sorbitol
Vizarsin 50 mg smeltetabletter Hver smeltetablet indeholder 0,75 mg aspartam (E951) og 0,0175 mg sorbitol (E420).
Vizarsin 50 mg orodispersible tablets Each orodispersible tablet contains 0.75 mg aspartame (E951) and 0.0175 mg sorbitol (E420).
I et dobbelt-blind, placebo-kontrolleret motionsstressstudie, hvori 144 patienter med erektil dysfunktion og stabil angina tog deres sædvanlige medicin mod angina pectoris (undtaget nitrater), blev der ikke set klinisk relevante forskelle i tiden indtil angina blev en begrænsende faktor for sildenafil sammenlignet med placebo.
A double-blind, placebo-controlled exercise stress trial evaluated 144 patients with erectile dysfunction and chronic stable angina, who regularly received anti-anginal medicinal products (except nitrates).
Vizarsin indeholder aspartam (E951), en fenylalaninkilde.
Vizarsin contains aspartame (E951), a source of phenylalanine which may be harmful for people with phenylketonuria.
Ikke almindelig (kan ses hos op til 1 ud af 100 personer): opkastning, hududslæt, øjenirritation, blodsprængte øjne/røde øjne, smerte i øjet, forskellige lysfornemmelser, f.eks. lysflimren og lysglimt, lysfølsomhed, rindende øjne, uregelmæssig eller hurtig puls, forhøjet blodtryk, lavt blodtryk, muskelsmerter, føle sig søvnig, nedsat følelse ved berøring, svimmelhed, susen for ørerne (tinnitus),, mundtørhed, blokerede eller tilstoppede bihuler, irritation i næseslimhinden (symptomerne omfatter løbende næse, nysen og tilstoppet næse), mavesmerter lige over navlen, gastroøsofageal reflukssyndrom (tilbageløb af syre fra mavesækken til spiserøret - symptomerne omfatter halsbrand), blod i urinen, smerter i arme og ben, næseblod, varmefølelse og træthed.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes /red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.
Almindelig (kan ses hos op til 1 ud af 10 personer): kvalme, ansigtsrødme i ansigtet, hedeture (symptomerne omfatter en pludselig varmefølelse i overkroppen), dårlig fordøjelse, farvesyn, sløret syn, synsforstyrrelser, tilstoppet næse og svimmelhed.
Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.
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Vizarsin indeholder lactose
Vizarsin contains lactose
Vizarsin 25 mg smeltetabletter Vizarsin 50 mg smeltetabletter Vizarsin 100 mg smeltetabletter
Vizarsin 25 mg orodispersible tablets Vizarsin 50 mg orodispersible tablets Vizarsin 100 mg orodispersible tablets
Samtidig indgift af HIV-proteasehæmmeren, ritonavir, som er en meget potent CYP-hæmmer, ved steady state (500 mg 2 gange dagligt) og enkeltdosis af sildenafil (100 mg) gav en stigning i sildenafils Cmax på 300% (4 gange) og en stigning i sildenafils plasma AUC på 1.000% (11 gange).
Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma AUC.
Vizarsin er kontraindiceret til patienter, som på grund af non-arteritis anterior iskæmisk opticus-neuropati (NAION) har nedsættelse af synet på det ene øje.
Vizarsin is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
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Samtidig indgift af HIV-proteasehæmmeren saquinavir, en CYP3A4-hæmmer, ved steady state (1200 mg 3 gange dagligt) og enkeltdosis sildenafil (100 mg) gav en stigning i sildenafils Cmax på 140% og en stigning i sildenafils plasma AUC på 210%.
Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.
Du bør være på en regelmæssig daglig dosis af alfa-blokkeren, før du tager Vizarsin, for at nedsætte risikoen for at disse symptomer opstår.
To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start Vizarsin.
- hvis du bruger præparater, som kaldes nitrogenoxiddonorer som amylnitrit (“poppers”), da samtidig brug også kan medføre potentielt farligt blodtryksfald.
- If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.
Hver filmovertrukket tablet indeholder sildenafilcitrat svarende til 25 mg, 50 mg eller 100 mg sildenafil.
Each film-coated tablet contains sildenafil citrate equivalent to 25 mg, 50 mg or 100 mg sildenafil.
- De andre indholdsstoffer er: Tabletkernen: Mikrokrystallinsk cellulose (E460), vandfri calciumhydrogenphosphat, natriumcroscarmellose, hypromellose (E464), magnesiumstearat (E572).
microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate, croscarmellose sodium, hypromellose (E464), magnesium stearate (E572).
Ingen særlige forholdsregler ved bortskaffelse
6.6 Special precautions for disposal
Vizarsin 25 mg smeltetabletter 2 år
Vizarsin 25 mg orodispersible tablets 2 years
Vizarsin indeholder aspartam (E591) og sorbitol (E420) Aspartam er en fenylalaninkilde.
Vizarsin contains aspartame (E951) and sorbitol (E420) Aspartame is a source of phenylalanine which may be harmful for people with a disorder called phenylketonuria.
Vizarsin indeholder lactose.
Vizarsin contains lactose.
Vizarsin 50 mg, 100 mg smeltetabletter
Vizarsin 50 mg, 100 mg orodispersible tablets
Blisterpakning (peel-open perforeret enkeltdosisblister, Orienteret Polyamid/Aluminium/PVC//PET/Aluminium): 2 x 1, 4 x 1, 8 x 1 eller 12 x 1 smeltetablet i en æske.
Blister (peel open perforated unit dose blister, Oriented Polyamide/Aluminium/PVC//PET/Aluminium): 2 x 1, 4 x 1, 8 x 1, 12 x 1 or 24 x 1 orodispersible tablet, in a carton.
ÆSKE med tre sprog
CARTON for trilingual packaging
Riociguat
Deafness
- hvis du tager medicin, som kaldes nitrater, da samtidig brug kan medføre potentielt farligt blodtryksfald.
- If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure.
Blisterpakning (perforeret enkeltdosisblister PVC/alu-folie) 4 x 1, 8 x 1 eller 12 x 1 filmovertrukket tablet i en æske.
Blister (perforated unit dose blister, PVC-foil/Alu-foil): 4 x 1, 8 x 1 or 12 x 1 film-coated tablet, in a carton.
Blødning fra penis, priapisme*, hæmatospermi,
Penile haemorrhage, Priapism
4.4), bør en startdosis på 25 mg overvejes til patienter i samtidig behandling med andre CYP3A4-hæmmere (se pkt.
With the exception of ritonavir for which co-administration with sildenafil is not advised (see section 4.4) a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5).
Vizarsin 25 mg filmovertrukne tabletter Vizarsin 50 mg filmovertrukne tabletter Vizarsin 100 mg filmovertrukne tabletter
Vizarsin 25 mg film-coated tablets Vizarsin 50 mg film-coated tablets Vizarsin 100 mg film-coated tablets
Vizarsin 100 mg filmovertrukne tabletter: Hvide, aflange tabletter, mærket med ”100” på den ene side.
Vizarsin 100 mg film-coated tablets: White, oblong tablets, marked “100” on one side.
Det skal du vide, før du begynder at tage Vizarsin Sådan skal du tage Vizarsin Bivirkninger
What Vizarsin is and what it is used for What you need to know before you take Vizarsin How to take Vizarsin
Vizarsin 25 mg filmovertrukne tabletter: Hvide, aflange tabletter, mærket med ”25” på den ene side.
Vizarsin 25 mg film-coated tablets: White, oblong tablets, marked “25” on one side.
1 smeltetablet 2 x 1 smeltetablet 4 x 1 smeltetablet 8 x 1 smeltetablet 12 x 1 smeltetablet 24 x 1 smeltetablet
1 orodispersible tablet 2 x 1 orodispersible tablet 4 x 1 orodispersible tablet 8 x 1 orodispersible tablet 12 x 1 orodispersible tablet 24 x 1 orodispersible tablet
Vizarsin 100 mg filmovertrukne tabletter 1 filmovertrukket tablet: EU/1/09/551/009
Vizarsin 100 mg film-coated tablets 1 film-coated tablet: EU/1/09/551/009
Hver smeltetablet indeholder 25 mg sildenafil.
Each orodispersible tablet contains 25 mg sildenafil.
Vizarsin 25 mg smeltetabletter: Hvide til næsten hvide, runde, let hvælvede tabletter evt. med mørkere pletter.
Vizarsin 25 mg orodispersible tablets: White to almost white, round, slightly biconvex tablets, with possible darker spots.
1 smeltetablet: EU/1/09/551/023
1 orodispersible tablet: EU/1/09/551/023
Vizarsin 50 mg filmovertrukne tabletter: Hvide, aflange tabletter, mærket med ”50” på den ene side.
Vizarsin 50 mg film-coated tablets: White, oblong tablets, marked “50” on one side.
Nedsat leverfunktion:
Visual acuity reduced,
Vizarsin er til behandling af voksne mænd med erektil dysfunktion, også kendt som impotens, hvilket er manglende evne til at opnå og/eller opretholde erektion tilstrækkelig til at gennemføre tilfredsstillende seksuel aktivitet.
Vizarsin is a treatment for adult men with erectile dysfunction, sometimes known as impotence.
Vizarsin 100 mg smeltetabletter: Hvide til næsten hvide, runde, let hvælvede tabletter evt. med mørkere pletter.
Vizarsin 100 mg orodispersible tablets: White to almost white, round, slightly biconvex tablets, with possible darker spots.
Hver smeltetablet indeholder 100 mg sildenafil.
Each orodispersible tablet contains 100 mg sildenafil.
Vizarsin 25 mg filmovertrukne tabletter 1 filmovertrukket tablet: EU/1/09/551/001
Vizarsin 25 mg film-coated tablets 1 film-coated tablet: EU/1/09/551/001
lyskilder, øjenødem, hævede øjne, øjenlidelse, konjunktival hyperæmi, øjenirritation, unormal følelse i øjet, øjenlågsødem, tørre øjne, skleral misfarvning
Iris disorder, Mydriasis, Halo vision, Eye oedema, Eye swelling, Eye disorder, Conjunctival hyperaemia Eye irritation, Abnormal sensation in eye,
1 smeltetablet 2 x 1 smeltetablet 4 x 1 smeltetablet 8 x 1 smeltetablet 12 x 1 smeltetablet
1 orodispersible tablet 2 x 1 orodispersible tablet 4 x 1 orodispersible tablet 8 x 1 orodispersible tablet 12 x 1 orodispersible tablet
1 smeltetablet: EU/1/09/551/018
1 orodispersible tablet: EU/1/09/551/018
Er du i tvivl, så spørg lægen eller på apotekspersonalet.
- If you have any further questions, ask your doctor or pharmacist.
Vizarsin 50 mg filmovertrukne tabletter 1 filmovertrukket tablet: EU/1/09/551/005
Vizarsin 50 mg film-coated tablets 1 film-coated tablet: EU/1/09/551/005
Vizarsin 50 mg smeltetabletter: Hvide til næsten hvide, runde, let hvælvede tabletter evt. med mørkere pletter.
Vizarsin 50 mg orodispersible tablets: White to almost white, round, slightly biconvex tablets, with possible darker spots.
Hver smeltetablet indeholder 50 mg sildenafil.
Each orodispersible tablet contains 50 mg sildenafil.
Hver filmovertrukket tablet indeholder sildenafilcitrat svarende til 100 mg sildenafil.
Each film-coated tablet contains sildenafil citrate equivalent to 100 mg sildenafil.
Vizarsin bør ikke anvendes af kvinder.
You should not take Vizarsin if you are a woman.
4 x 1 filmovertrukket tablet: EU/1/09/551/010 8 x 1 filmovertrukket tablet: EU/1/09/551/011 12 x 1 filmovertrukket tablet: EU/1/09/551/012
4 x 1 film-coated tablet: EU/1/09/551/010 8 x 1 film-coated tablet: EU/1/09/551/011 12 x 1 film-coated tablet: EU/1/09/551/012
Vizarsin smeltetabletter findes i æsker med 1 smeltetablet i blisterpakning og i æsker med 2 x 1, 4 x 1, 8 x 1, 12 x 1 eller 24 x 1 smeltetablet i en perforeret enkeltdosisblister.
Vizarsin orodispersible tablets are available in boxes of 1 orodispersible tablet in blisters and also in boxes of 2 x 1, 4 x 1, 8 x 1, 12 x 1 or 24 x 1 orodispersible tablet in a perforated unit dose blisters.
Hver filmovertrukket tablet indeholder sildenafilcitrat svarende til 25 mg sildenafil.
Each film-coated tablet contains sildenafil citrate equivalent to 25 mg sildenafil.
4 x 1 filmovertrukket tablet: EU/1/09/551/006 8 x 1 filmovertrukket tablet: EU/1/09/551/007 12 x 1 filmovertrukket tablet: EU/1/09/551/008
4 x 1 film-coated tablet: EU/1/09/551/006 8 x 1 film-coated tablet: EU/1/09/551/007 12 x 1 film-coated tablet: EU/1/09/551/008
1 filmovertrukket tablet: EU/1/09/551/001
1 film-coated tablet: EU/1/09/551/001
Vizarsin 25 mg filmovertrukne tabletter Sildenafil
Vizarsin 25 mg film-coated tablets Sildenafil
Hver filmovertrukket tablet indeholder sildenafilcitrat svarende til 50 mg sildenafil.
Each film-coated tablet contains sildenafil citrate equivalent to 50 mg sildenafil.
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4 x 1 filmovertrukket tablet: EU/1/09/551/002 8 x 1 filmovertrukket tablet: EU/1/09/551/003 12 x 1 filmovertrukket tablet: EU/1/09/551/004
4 x 1 film-coated tablet: EU/1/09/551/002 8 x 1 film-coated tablet: EU/1/09/551/003 12 x 1 film-coated tablet: EU/1/09/551/004
1 filmovertrukket tablet: EU/1/09/551/005
1 film-coated tablet: EU/1/09/551/005
1 filmovertrukket tablet: EU/1/09/551/009
1 film-coated tablet: EU/1/09/551/009
Vizarsin 25 mg filmovertrukne tabletter findes i æsker med 1 filmovertrukket tablet som blisterpakning og ligeledes i æsker med 4 x 1, 8 x 1 eller 12 x 1 filmovertrukket tablet som perforerede enkeltdosis-blisterpakninger.
Vizarsin 25 mg film-coated tablets are available in boxes of 1 film-coated tablet in blisters and also in boxes of 4 x 1, 8 x 1 or 12 x 1 film-coated tablet in a perforated unit dose blisters.
Vizarsin 100 mg filmovertrukne tabletter findes i æsker med 1 filmovertrukket tablet som blisterpakning og ligeledes i æsker med 4 x 1, 8 x 1 eller 12 x 1 filmovertrukket tablet som perforerede enkeltdosis-blisterpakninger.
Vizarsin 100 mg film-coated tablets are available in boxes of 1 film-coated tablet in blisters and also in boxes of 4 x 1, 8 x 1 or 12 x 1 film-coated tablet in a perforated unit dose blisters.
Non-arteritis anterior iskæmisk opticusneuropati (NAION)*, vaskulær okklusion i retina*, blødning i retina, arteriosklerotisk retinopati, retinal sygdom, glaukom, synsfeltdefekt,
Retinal haemorrhage, Arteriosclerotic retinopathy, Retinal disorder, Glaucoma, Visual field defect, Diplopia,
Udseende og pakningsstørrelser Hvide til næsten hvide, runde, let hvælvede tabletter evt. med mørkere pletter.
What Vizarsin looks like and contents of the pack White to almost white, round, slightly biconvex tablets, with possible darker spots.
Vizarsin 100 mg filmovertrukne tabletter Sildenafil
Vizarsin 100 mg film-coated tablets Sildenafil
Vizarsin 50 mg filmovertrukne tabletter findes i æsker med 1 filmovertrukket tablet som blisterpakning og ligeledes i æsker med 4 x 1, 8 x 1 eller 12 x 1 filmovertrukket tablet som perforerede enkeltdosis-blisterpakninger.
Vizarsin 50 mg film-coated tablets are available in boxes of 1 film-coated tablet in blisters and also in boxes of 4 x 1, 8 x 1 or 12 x 1 film-coated tablet in a perforated unit dose blisters.
Vizarsin 25 mg smeltetabletter Sildenafil
Vizarsin 25 mg orodispersible tablets Sildenafil
Vizarsin 50 mg filmovertrukne tabletter Sildenafil
Vizarsin 50 mg film-coated tablets Sildenafil
Vizarsin smeltetabletter findes i æsker med 1 smeltetablet i blisterpakning og i æsker med 2 x 1, 4 x 1, 8 x 1 eller 12 x 1 smeltetablet i en perforeret enkeltdosisblister.
Vizarsin orodispersible tablets are available in boxes of 1 orodispersible tablet in blisters and also in boxes of 2 x 1, 4 x 1, 8 x 1 or 12 x 1 orodispersible tablet in a perforated unit dose blisters.
Vizarsin 100 mg smeltetabletter Sildenafil
Vizarsin 100 mg orodispersible tablets Sildenafil
1 smeltetablet: EU/1/09/551/013 2 x 1 smeltetablet: EU/1/09/551/014 4 x 1 smeltetablet: EU/1/09/551/015 8 x 1 smeltetablet: EU/1/09/551/016 12 x 1 smeltetablet: EU/1/09/551/017
1 orodispersible tablet: EU/1/09/551/013 2 x 1 orodispersible tablet: EU/1/09/551/014 4 x 1 orodispersible tablet: EU/1/09/551/015 8 x 1 orodispersible tablet: EU/1/09/551/016 12 x 1 orodispersible tablet: EU/1/09/551/017
Vizarsin 50 mg smeltetabletter Sildenafil
Vizarsin 50 mg orodispersible tablets Sildenafil
2 x 1 smeltetablet: EU/1/09/551/019 4 x 1 smeltetablet: EU/1/09/551/020 8 x 1 smeltetablet: EU/1/09/551/021 12 x 1 smeltetablet: EU/1/09/551/022 24 x 1 smeltetablet: EU/1/09/551/028
2 x 1 orodispersible tablet: EU/1/09/551/019 4 x 1 orodispersible tablet: EU/1/09/551/020 8 x 1 orodispersible tablet: EU/1/09/551/021 12 x 1 orodispersible tablet: EU/1/09/551/022 24 x 1 orodispersible tablet: EU/1/09/551/028
2 x 1 smeltetablet: EU/1/09/551/024 4 x 1 smeltetablet: EU/1/09/551/025 8 x 1 smeltetablet: EU/1/09/551/026 12 x 1 smeltetablet: EU/1/09/551/027 24 x 1 smeltetablet: EU/1/09/551/029
2 x 1 orodispersible tablet: EU/1/09/551/024 4 x 1 orodispersible tablet: EU/1/09/551/025 8 x 1 orodispersible tablet: EU/1/09/551/026 12 x 1 orodispersible tablet: EU/1/09/551/027 24 x 1 orodispersible tablet: EU/1/09/551/029
Vizarsin 100 mg smeltetabletter
Vizarsin 100 mg orodispersible tablets
2 x 1 smeltetablet: EU/1/09/551/014 4 x 1 smeltetablet: EU/1/09/551/015 8 x 1 smeltetablet: EU/1/09/551/016 12 x 1 smeltetablet: EU/1/09/551/017
2 x 1 orodispersible tablet: EU/1/09/551/014 4 x 1 orodispersible tablet: EU/1/09/551/015 8 x 1 orodispersible tablet: EU/1/09/551/016 12 x 1 orodispersible tablet: EU/1/09/551/017
Vizarsin 25 mg smeltetabletter
Vizarsin 25 mg orodispersible tablets
Vizarsin 50 mg smeltetabletter
Vizarsin 50 mg orodispersible tablets
forlænget erektion
Nasal congestion
Vizarsin 100 mg filmovertrukne tabletter er hvide, aflange tabletter og mærket med ”100” på den ene side.
What Vizarsin looks like and contents of the pack Vizarsin 100 mg film-coated tablets are white, oblong and marked “100” on one side.
Samtidig anvendelse af nitrogenoxiddonorer eller nitrater i en hvilken som helst form er derfor kontraindiceret (se pkt.
Consistent with its known effects on the nitric oxide/cGMP pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see section 4.3).
Vizarsin 25 mg filmovertrukne tabletter er hvide, aflange tabletter og mærket med ”25” på den ene side.
What Vizarsin looks like and contents of the pack Vizarsin 25 mg film-coated tablets are white, oblong and marked “25” on one side.
Bilag I Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, administrationsveje og indehavere af markedsføringstilladelser i medlemsstaterne
Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
28703 San Sebastian de los Reyes (Madrid) Spanien
28703 San Sebastian de los Reyes (Madrid) Spain
747 70 Opava-Komárov Tjekkiet
747 70 Opava-Komárov Czech Republic
0,10 g/0,80 g oral opløsning
0.10 g / 0.80 g oral solution
Ferraz 80, 5º 28008 Madrid Spanien
Ferraz 80, 5º 28008 Madrid Spain
ERGODAVUR GOTAS 1 mg (enkeltdosis suchet)
ERGODAVUR GOTAS 1 mg (monodose suchet)
TEVA Czech Industries s.r.o.
Czech Republic TEVA Czech Industries s.r.o.
Arzneimittelvertriebs GmbH, Anton Anderer Platz 6/1, A-1210 Wien Østrig
Arzneimittelvertriebs GmbH, Anton Anderer Platz 6/1, A-1210 Vienna Austria
pulver til oral opløsning som enkeltdosis
powder for oral solution for single dose
ARKOLEON 11, KATO PATISSIA, 10445
ARKOLEON 11, KATO PATISSIA, 10445 Greece
FINIXFARM EPE DERVENAKION 38 & SAHINI, GERAKAS, 15344 Grækenland
FINIXFARM EPE DERVENAKION 38 & SAHINI, GERAKAS, 15344 Greece
ANTOR LTD P. MAVROMIHALI 1 VRILISSIA 15235 Grækenland
ANTOR LTD P. MAVROMIHALI 1 VRILISSIA 15235 Greece
ARGONAFTWN 22, ARGYROUPOLI, 16452 Grækenland
ARGONAFTWN 22, ARGYROUPOLI, 16452 Greece
6 mg/ENKELT DOSIS
6MG/SINGLE DOSE
ISKEDYL FORT, tablet 2,40 mg/19,20 mg
ISKEDYL, comprimé 0.60 mg / 4.80 mg
Iskedyl Fort
ISKEDYL FORT, comprimé
Ergomed - depotkapsler 2,5 mg (1:1:1) depotkapsler, blød oral anvendelse
2.5 mg (1:1:1) prolonged-release capsule, soft
ISKEDYL, oral opløsning i hætteglas
ISKEDYL, solution buvable en flacon
3 mg/kap.
3 mg
ISKEDYL, injektionsvæske ampul injektionsvæske
ISKEDYL, solution injectable en ampoule solution for injection IV/IM
3 mg hård kapsel
Capsule hard
ISKEDYL, tablet
Iskedyl Fort tablets
Dette sammendrag blev sidst ajourført i november 2016.
This summary was last updated in November 2016.
Bakteriestammerne i vaccinen har disse proteiner, men producerer ikke de toksiner, der forårsager sygdommen.
The strains of bacteria in the vaccine have these proteins but do not produce the toxins that cause the disease.
To undersøgelser anvendte F4-stammen, mens de to øvrige anvendte F18-stammen.
Two studies used the F4 strain while the other two used the F18 strain.
Dette vil hjælpe svinene med at bekæmpe infektionen og reducere sygdomsrisikoen.
This will help protect the pigs against the infection and reduce the risk of disease.
Vaccinen reducerede antallet af svin med moderat til svær diarré sammenholdt med ikke-vaccinerede svin.
The vaccine reduced the number of pigs with moderate to severe diarrhoea compared to non-vaccinated pigs.
E. coli O8:K87/O141:K94-vaccine (levende)
E. coli O8:K87 / O141:K94 vaccine (live)
Dette er mere sandsynligt ved fravænning, hvor smågrisene ikke længere får beskyttende antistoffer gennem soens modermælk.
This is more likely to occur at weaning time when the piglet no longer receives protecting antibodies through the sow's milk.
Den fuldstændige EPAR for Coliprotec F4/F18 findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The full EPAR for Coliprotec F4/F18 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Der skal anvendes personligt sikkerhedsudstyr bestående af engangsbeskyttelseshandsker og sikkerhedsbriller ved håndtering af vaccinen.
Personal protective equipment consisting of protective disposable gloves and safety glasses should be worn when handling the vaccine.
Vaccinens virkning er blevet undersøgt i fire laboratorieundersøgelser hos svin, der primært så på forekomsten, sværhedsgraden og varigheden af diarréen samt tilstedeværelsen af sygdomsfremkaldende E. coli i dyrenes afføring.
The effectiveness of the vaccine was studied in four laboratory studies in pigs that looked chiefly at the incidence, severity and duration of diarrhoea as well as the presence of disease-causing E. coli in the animals' excrement.
Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Coliprotec F4/F18 opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Coliprotec F4/F18's benefits are greater than its risks and recommended that it be approved for use in the EU.