FrancophonIA/ELRC3.0 huggingface dataset:
English: Telmisartan Teva Pharma 20 mg tablets This medicine contains 21.4 mg sorbitol in each tablet.
Swedish: Telmisartan Teva Pharma 20 mg tabletter Detta läkemedel innehåller 21,4 mg sorbitol per tablett.
English: Telmisartan Teva Pharma 80 mg tablets This medicine contains 85.6 mg sorbitol in each tablet.
Swedish: Telmisartan Teva Pharma 80 mg tabletter Detta läkemedel innehåller 85,6 mg sorbitol per tablett.
English: Package leaflet: Information for the user Telmisartan Teva Pharma 20 mg Tablets
Swedish: Bipacksedel: Information till användaren Telmisartan Teva Pharma 20 mg tabletter telmisartan
English: Package leaflet: Information for the user Telmisartan Teva Pharma 40 mg Tablets
Swedish: Bipacksedel: Information till användaren Telmisartan Teva Pharma 40 mg tabletter telmisartan
English: Talk to your doctor before taking Telmisartan Teva Pharma: - if you are taking digoxin.
Swedish: Tala med din läkare innan du använder Telmisartan Teva Pharma:
English: Telmisartan Teva Pharma 40 mg tablets This medicine contains 42.8 mg sorbitol in each tablet.
Swedish: Telmisartan Teva Pharma 40 mg tabletter Detta läkemedel innehåller 42,8 mg sorbitol per tablett.
English: Package leaflet: Information for the user Telmisartan Teva Pharma 80 mg Tablets
Swedish: Bipacksedel: Information till användaren Telmisartan Teva Pharma 80 mg tabletter telmisartan
English: Urinary tract infections, upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.
Swedish: Mindre vanliga biverkningar (kan förekomma hos upp till 1 av 100 användare): Urinvägsinfektioner, övre luftvägsinfektion (t ex halsont, inflammerade bihålor, vanlig förkylning), brist på röda blodkroppar (anemi), höga kaliumnivåer, svårighet att somna, nedstämdhet (depression), svimning (synkope), en känsla av yrsel (vertigo), långsam hjärtrytm (bradykardi), lågt blodtryck (hypotension) hos användare som behandlas för högt blodtryck, yrsel när man reser sig upp (ortostatisk hypotension), andfåddhet, hosta, magsmärtor, diarré, obehag från magtrakten, uppblåsthet, kräkningar, klåda, svettning, hudutslag pga läkemedel, ryggsmärta, muskelkramp, muskelsmärta (myalgi), nedsatt njurfunktion inklusive akut njursvikt, bröstsmärta, svaghet och ökad halt kreatinin i blodet.
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effects), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Swedish: Sepsis* (som ofta kallas ”blodförgiftning”, är en svår infektion med inflammatoriska reaktioner i hela kroppen, som kan leda till döden), ökat antal av vissa vita blodkroppar (eosinifili), få blodplättar (trombocytopeni), svåra allergiska reaktioner (anafylaktisk reaktion), allergiska reaktioner (t ex hudutslag, klåda, svårighet att andas, väsande andning, svullnad i ansiktet eller lågt blodtryck), låg blodsockerhalt (hos patienter med diabetes), oro, somnolens, försämrad syn, snabb hjärtrytm (takykardi), muntorrhet, orolig mage, förändrad smakupplevelse (dysgeusi), avvikande leverfunktion (japanska patienter löper större risk att få denna biverkan), hastig svullnad av hud och slemhinnor som kan leda till döden (angioödem även med dödlig utgång), eksem (en hudsjukdom), hudrodnad, nässelutslag (urtikaria), svåra hudutslag pga läkemedel, ledsmärta (artralgi), smärta i extremiteterna, smärta i senor, influensaliknande sjukdom, minskade halter av hemoglobin (ett blodprotein), ökade nivåer urinsyra, ökad halt av leverenzymer eller kreatinfosfokinas i blodet.
English: You can take Telmisartan Teva Pharma with or without food.
Swedish: Du kan ta Telmisartan Teva Pharma med eller utan mat. Du ska svälja tabletterna med ett glas vatten eller någon annan alkoholfri dryck.
English: - The other ingredients are microcrystalline cellulose (Avicel PH 102), sodium starch glycolate (Type
Swedish: - Övriga innehållsämnen är mikrokristallin cellulosa (Avicel PH 102), natriumstärkelseglykolat (typ A), poloxamerer, meglumin, povidon, sorbitol (E420) och magnesiumstearat.
English: Each tablet contains 40 mg telmisartan
Swedish: Varje tablett innehåller 40 mg telmisartan.
English: Telmisartan Teva Pharma 40 mg tablets
Swedish: Telmisartan Teva Pharma 40 mg tabletter
English: If you have the impression that the effect of Telmisartan Teva Pharma is too strong or too weak, talk to your doctor or pharmacist.
Swedish: Det är viktigt att ta Telmisartan Teva Pharma varje dag tills läkaren ger andra instruktioner.Vänd dig till din läkare eller apotekspersonal om du upplever att effekten av Telmisartan Teva Pharma är för stark eller för svag.
English: Each tablet contains 80 mg telmisartan
Swedish: Varje tablett innehåller 80 mg telmisartan.
English: HU-4042 Debrecen
Swedish: TEVA Pharmaceutical Works Private Limited Company HU-4042 Debrecen
English: Telmisartan Teva Pharma 20 mg tablets telmisartan
Swedish: Telmisartan Teva Pharma 20 mg tabletter telmisartan
English: Each Telmisartan Teva Pharma tablet contains 40 mg telmisartan.
Swedish: Varje Telmisartan Teva Pharma tablett innehåller 40 mg telmisartan.
English: Telmisartan Teva Pharma 80 mg tablets
Swedish: Telmisartan Teva Pharma 80 mg tabletter
English: Each Telmisartan Teva Pharma tablet contains 80 mg telmisartan.
Swedish: Varje Telmisartan Teva Pharma tablett innehållerer 80 mg telmisartan.
English: Telmisartan Teva Pharma 20 mg tablets
Swedish: Telmisartan Teva Pharma 20 mg tabletter
English: Each Telmisartan Teva Pharma tablet contains 20 mg telmisartan.
Swedish: Varje Telmisartan Teva Pharma tablett innehåller 20 mg telmisartan.
English: Each tablet contains 20 mg telmisartan
Swedish: Varje tablett innehåller 20 mg telmisartan.
English: • Diuretics (‘water tablets'), especially if taken in high doses together with Telmisartan Teva Pharma, may lead to excessive loss of body water and low blood pressure (hypotension).
Swedish: Telmisartan Teva Pharma leda till alltför stor vätskeförlust och lågt blodtryck (hypotension).
English: Pharma.
Swedish: Тел.
English: Telmisartan Teva Pharma 40 mg tablets telmisartan
Swedish: Telmisartan Teva Pharma 40 mg tabletter telmisartan.
English: 14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 30 tablets 28 tablets
Swedish: 14x1 tabletter 28x1 tabletter 30x1 tabletter 40x1 tabletter 56x1 tabletter 60x1 tabletter 84x1 tabletter 90x1 tabletter 98x1 tabletter 100x1 tabletter 30 tabletter 28 tabletter
English: Telmisartan Teva Pharma 20 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Swedish: Telmisartan Teva Pharma 20 mg tabletter är vita till benvita, ovala tabletter.
English: How to store Telmisartan Teva Pharma
Swedish: Hur Telmisartan Teva Pharma ska förvaras
English: 14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 28 tablets
Swedish: 14x1 tabletter 28x1 tabletter 30x1 tabletter 40x1 tabletter 56x1 tabletter 60x1 tabletter 84x1 tabletter 90x1 tabletter 98x1 tabletter 100x1 tabletter 28 tabletter
English: If you take more Telmisartan Teva Pharma than you should
Swedish: Om du har tagit för stor mängd av Telmisartan Teva Pharma
English: EU/1/11/719/005 Cartons of 56x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/005 Kartonger med 56x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: EU/1/11/719/006 Cartons of 60x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/006 Kartonger med 60x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: EU/1/11/719/044 Cartons of 40x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/044 Kartonger med 40x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: Telmisartan Teva Pharma 80 mg tablets telmisartan
Swedish: Telmisartan Teva Pharma 80 mg tabletter telmisartan.
English: EU/1/11/719/007 Cartons of 84x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/007 Kartonger med 84x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: EU/1/11/719/003 Cartons of 30x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/003 Kartonger med 30x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: EU/1/11/719/004 Cartons of 40x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/004 Kartonger med 40x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: EU/1/11/719/009 Cartons of 98x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/009 Kartonger med 98x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: EU/1/11/719/001 Cartons of 14x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/001 Kartonger med 14x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: EU/1/11/719/049 Cartons of 98x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/049 Kartonger med 98x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: EU/1/11/719/045 Cartons of 56x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/045 Kartonger med 56x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: EU/1/11/719/047 Cartons of 84x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/047 Kartonger med 84x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: EU/1/11/719/046 Cartons of 60x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/046 Kartonger med 60x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: EU/1/11/719/041 14x1 tablets EU/1/11/719/042 28x1 tablets EU/1/11/719/043 30x1 tablets EU/1/11/719/044 40x1 tablets EU/1/11/719/045 56x1 tablets EU/1/11/719/046 60x1 tablets EU/1/11/719/047 84x1 tablets EU/1/11/719/048 90x1 tablets EU/1/11/719/049 98x1 tablets EU/1/11/719/050 100x1 tablets
Swedish: EU/1/11/719/041 14x1 tabletter EU/1/11/719/042 28x1 tabletter EU/1/11/719/043 30x1 tabletter EU/1/11/719/044 40x1 tabletter EU/1/11/719/045 56x1 tabletter EU/1/11/719/046 60x1 tabletter EU/1/11/719/047 84x1 tabletter EU/1/11/719/048 90x1 tabletter EU/1/11/719/049 98x1 tabletter EU/1/11/719/050 100x1 tabletter
English: Telmisartan Teva Pharma 80 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Swedish: Telmisartan Teva Pharma 80 mg tabletter är vita till benvita, ovalformade tabletter.
English: EU/1/11/719/043 Cartons of 30x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/043 Kartonger med 30x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: EU/1/11/719/048 Cartons of 90x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/048 Kartonger med 90x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: EU/1/11/719/042 Cartons of 28x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/042 Kartonger med 28x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: EU/1/11/719/002 Cartons of 28x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/002 Kartonger med 28x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: EU/1/11/719/041 Cartons of 14x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/041 Kartonger med 14x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: Telmisartan Teva Pharma 40 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Swedish: Telmisartan Teva Pharma 40 mg tabletter är vita till benvita, ovalformade tabletter.
English: EU/1/11/719/001 14x1 tablets EU/1/11/719/002 28x1 tablets EU/1/11/719/003 30x1 tablets EU/1/11/719/004 40x1 tablets EU/1/11/719/005 56x1 tablets EU/1/11/719/006 60x1 tablets EU/1/11/719/007 84x1 tablets EU/1/11/719/008 90x1 tablets EU/1/11/719/009 98x1 tablets EU/1/11/719/010 100x1 tablets
Swedish: EU/1/11/719/001 14x1 tabletter EU/1/11/719/002 28x1 tabletter EU/1/11/719/003 30x1 tabletter EU/1/11/719/004 40x1 tabletter EU/1/11/719/005 56x1 tabletter EU/1/11/719/006 60x1 tabletter EU/1/11/719/007 84x1 tabletter EU/1/11/719/008 90x1 tabletter EU/1/11/719/009 98x1 tabletter EU/1/11/719/010 100x1 tabletter
English: EU/1/11/719/021 14x1 tablets EU/1/11/719/022 28x1 tablets EU/1/11/719/023 30x1 tablets EU/1/11/719/024 40x1 tablets EU/1/11/719/025 56x1 tablets EU/1/11/719/026 60x1 tablets EU/1/11/719/027 84x1 tablets EU/1/11/719/028 90x1 tablets EU/1/11/719/029 98x1 tablets EU/1/11/719/030 100x1 tablets
Swedish: EU/1/11/719/021 14x1 tabletter EU/1/11/719/022 28x1 tabletter EU/1/11/719/023 30x1 tabletter EU/1/11/719/024 40x1 tabletter EU/1/11/719/025 56x1 tabletter EU/1/11/719/026 60x1 tabletter EU/1/11/719/027 84x1 tabletter EU/1/11/719/028 90x1 tabletter EU/1/11/719/029 98x1 tabletter EU/1/11/719/030 100x1 tabletter
English: EU/1/11/719/031 14x1 tablets EU/1/11/719/032 28x1 tablets EU/1/11/719/033 30x1 tablets EU/1/11/719/034 40x1 tablets EU/1/11/719/035 56x1 tablets EU/1/11/719/036 60x1 tablets EU/1/11/719/037 84x1 tablets EU/1/11/719/038 90x1 tablets EU/1/11/719/039 98x1 tablets EU/1/11/719/040 100x1 tablets EU/1/11/719/061 30 tablets EU/1/11/719/064 28 tablets
Swedish: EU/1/11/719/031 14x1 tabletter EU/1/11/719/032 28x1 tabletter EU/1/11/719/033 30x1 tabletter EU/1/11/719/034 40x1 tabletter EU/1/11/719/035 56x1 tabletter EU/1/11/719/036 60x1 tabletter EU/1/11/719/037 84x1 tabletter EU/1/11/719/038 90x1 tabletter EU/1/11/719/039 98x1 tabletter EU/1/11/719/040 100x1 tabletter EU/1/11/719/061 30 tabletter EU/1/11/719/064 28 tabletter
English: EU/1/11/719/008 Cartons of 90x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Swedish: EU/1/11/719/008 Kartonger med 90x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: Excipients with known effect Telmisartan Teva Pharma 20 mg tablets Each tablet contains 21.4 mg sorbitol (E420) Telmisartan Teva Pharma 40 mg tablets Each tablet contains 42.8 mg sorbitol (E420) Telmisartan Teva Pharma 80 mg tablets Each tablet contains 85.6 mg sorbitol (E420) For the full list of excipients, see section 6.1.
Swedish: Telmisartan Teva Pharma 40 mg tabletter Varje tablett innehåller 40 mg telmisartan Telmisartan Teva Pharma 80 mg tabletter Varje tablett innehåller 80 mg telmisartan Hjälpämnen med känd effekt
English: EU/1/11/719/051 14x1 tablets EU/1/11/719/052 28x1 tablets EU/1/11/719/053 30x1 tablets EU/1/11/719/054 40x1 tablets EU/1/11/719/055 56x1 tablets EU/1/11/719/056 60x1 tablets EU/1/11/719/057 84x1 tablets EU/1/11/719/058 90x1 tablets EU/1/11/719/059 98x1 tablets EU/1/11/719/060 100x1 tablets EU/1/11/719/062 30 tablets EU/1/11/719/065 28 tablets
Swedish: EU/1/11/719/051 14x1 tabletter EU/1/11/719/052 28x1 tabletter EU/1/11/719/053 30x1 tabletter EU/1/11/719/054 40x1 tabletter EU/1/11/719/055 56x1 tabletter EU/1/11/719/056 60x1 tabletter EU/1/11/719/057 84x1 tabletter EU/1/11/719/058 90x1 tabletter EU/1/11/719/059 98x1 tabletter EU/1/11/719/060 100x1 tabletter EU/1/11/719/062 30 tabletter EU/1/11/719/065 28 tabletter
English: EU/1/11/719/010 Cartons of 100x1 tablets in peelable perforated unit-dose aluminium aluminium blisters
Swedish: EU/1/11/719/010 Kartonger med 100x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: EU/1/11/719/011 14x1 tablets EU/1/11/719/012 28x1 tablets EU/1/11/719/013 30x1 tablets EU/1/11/719/014 40x1 tablets EU/1/11/719/015 56x1 tablets EU/1/11/719/016 60x1 tablets EU/1/11/719/017 84x1 tablets EU/1/11/719/018 90x1 tablets EU/1/11/719/019 98x1 tablets EU/1/11/719/020 100x1 tablets EU/1/11/719/063 28 tablets
Swedish: EU/1/11/719/011 14x1 tabletter EU/1/11/719/012 28x1 tabletter EU/1/11/719/013 30x1 tabletter EU/1/11/719/014 40x1 tabletter EU/1/11/719/015 56x1 tabletter EU/1/11/719/016 60x1 tabletter EU/1/11/719/017 84x1 tabletter EU/1/11/719/018 90x1 tabletter EU/1/11/719/019 98x1 tabletter EU/1/11/719/020 100x1 tabletter EU/1/11/719/063 28 tabletter
English: EU/1/11/719/050 Cartons of 100x1 tablets in peelable perforated unit-dose aluminium aluminium blisters
Swedish: EU/1/11/719/050 Kartonger med 100x1 tabletter i avdragbara perforerade aluminium-aluminium endosblister.
English: White to off white, oval shaped tablet; one side of the tablet is debossed with the number "93".
Swedish: Ena sidan av tabletten är präglad med ”93” och den andra sidan med
English: Member State (EU/EEA)
Swedish: Medlemsstat (EU/EEA)
English: Furthermore, it was confirmed that standardisation of variables was applied.
Swedish: Dessutom bekräftades det att standardisering av variabler tillämpades.
English: Add the following text in the relevant sections of the product information:
Swedish: Lägg till följande text i de relevanta avsnitten i produktinformationen:
English: For the mutual recognition procedure (MRP), Hungary acted as a reference Member State and Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden and the United Kingdom were concerned Member States.
Swedish: Vid förfarandet för ömsesidigt erkännande agerade Ungern referensmedlemsstat och Belgien, Bulgarien, Cypern, Estland, Finland, Grekland, Irland, Island, Italien, Kroatien, Lettland, Litauen, Nederländerna, Polen, Portugal, Rumänien, Slovakien, Slovenien, Storbritannien, Sverige, Tjeckien, Tyskland och Österrike var berörda medlemsstater.
English: Quality and safety were not assessed in this referral procedure, as no concern was notified by the reference Member State.
Swedish: Kvalitet och säkerhet bedömdes inte i detta hänskjutningsförfarande, eftersom inga betänkligheter anmäldes av referensmedlemsstaten.
English: Specifically, the p-value is below 0.0001 which means that the probability of a false positive correlation is under 0.01%.
Swedish: I synnerhet underskrider p-värdet 0,0001 vilket innebär att sannolikheten för ett falskt positivt samband underskrider 0,01 procent.
English: Furthermore, the formulation of the finished product, either in terms of antigen content or of additional components, was questioned.
Swedish: Vidare ifrågasattes beredningen av den färdiga produkten, antingen vad gällde innehållet av antigen eller av ytterligare komponenter.
English: Monograph 1360.
Swedish: Monografi 1360.
English: Efficacy of the vaccine under practical conditions of use
Swedish: Vaccinets effekt under praktiska användningsförhållanden
English: The total quantity is 20 x 109 inactivated germs per dose.
Swedish: Den totala mängden är 20 x 109 inaktiverade bakterier per dos.
English: These batches had been tested according to the requirements when the product was first authorised in Hungary.
Swedish: Dessa tillverkningssatser hade testats i enlighet med de gällande kraven när produkten först godkändes i Ungern.
English: Healthier vaccinated pigs are expected to give better growth rates, although this was not demonstrated under field conditions.
Swedish: Friskare vaccinerade svin förväntas ge bättre tillväxttakt, även om detta inte påvisades under fältförhållanden.
English: ATCvet code: QI09AB07
Swedish: ATCvet-kod: QI09AB07
English: Ceva Hellas LLC 15, Agiou Nikolaou str.
Swedish: Grekland Ceva Hellas LLC 15, Agiou Nikolaou str.
English: Details of statistics were provided for each serotype in order to support the magnitude of the positive relationship between the two concerned measures.
Swedish: Utförlig statistik tillhandahölls för varje serotyp till stöd för storleken på det positiva förhållandet mellan de två berörda måtten.
English: Non-significant results have been obtained in 3 out of 5 studies carried out for both serotypes 1 and 2.
Swedish: Icke-signifikanta resultat erhölls i 3 av 5 studier som utfördes för både serotyp 1 och 2.
English: The vaccination schedule is 2 doses administered to animals from 7 weeks of age with an interval of 3 weeks between doses.
Swedish: Vaccinationsprogrammet består av 2 doser som ges till djur från 7 veckors ålder med ett intervall av 3 veckor mellan doserna.
English: Furthermore, the information gathered from Periodic Safety Update Reports was similarly considered to be only supportive and did not substantiate the claims.
Swedish: På samma sätt ansågs informationen som samlats in från periodiska säkerhetsrapporter dessutom bara vara understödjande utan att styrka påståendena.
English: It is also considered that the indication is acceptable taking account of the intended use of the vaccine and the existing data from the laboratory studies.
Swedish: Indikationen anses även vara godtagbar vid beaktande av vaccinets avsedda användning och de befintliga uppgifterna från laboratoriestudierna.
English: Monograph 04/2013:1360.
Swedish: Monografi 04/2013:1360.
English: Viale Colleoni 15, 20864 Agrate Brianza (MB)
Swedish: Viale Colleoni 15, 20864 Agrate Brianza (MB) Italien
English: Six additional laboratory studies were also provided, but these studies were carried out for the marketing authorisation of Coglapix in a country outside the EU and in some elements did not meet the criteria of Ph. Eur.
Swedish: Sex ytterligare laboratoriestudier lämnades även in, men dessa studier utfördes för godkännandet för försäljning av Coglapix i ett land utanför EU och uppfyllde i vissa delar inte kriterierna i Ph. Eur.
English: 40472 Düsseldorf Germany
Swedish: 40472 Düsseldorf Tyskland
English: Since the issues raised by Italy remained unresolved, the Member States concerned failed to reach agreement regarding the efficacy of Coglapix and consequently the matter was referred to the CVMP on 24 October 2014 under Article 33(4) of Directive 2001/82/EC.
Swedish: Eftersom de frågor som tagits upp av Italien förblev olösta lyckades inte de berörda medlemsstaterna nå en överenskommelse beträffande effekten av Coglapix, och ärendet hänsköts därför till CVMP den 24 oktober 2014 i enlighet med artikel 33.4 i direktiv 2001/82/EG.
English: Duration of immunity
Swedish: Immunitetens längd: