FrancophonIA/ELRC3.0 huggingface dataset:
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.
Maltese: Sepsis* (ta' spiss imsejħa "avvelenament tad-demm", hi infezzjoni severa b'rispons infjammatorju mal-ġisem kollu li tista' twassal għal mewt), żieda f'ċerti ċelluli bojod tad-demm (eosinofilija), gGħadd baxx ta' plejtlits (tromboċitopenja), reazzjoni allerġika severa (reazzjoni anafilattika), reazzjoni allerġika (eż. raxx, ħakk, diffikultà biex tieħu n-nifs, tħarħir, nefħa tal-wiċċ jew pressjoni tad-demm baxxa), livelli baxxi ta' zokkor fid-demm (f'pazjenti dijabetiċi, tħossok ansjuż/a, ngħas, indeboliment fil-vista, rata mgħaġġla ta' taħbit tal-qalb (takikardija), ħalq xott, stonku mqalleb, disturb fit-togħma (tibdil fis-sens tat-togħma), funzjoni anormali tal-fwied (hemm aktar ċans li pazjenti Ġappuniżi jkollhom dawn l-effetti sekondarji), nefħa mgħaġġla tal-ġilda u tal-mukuża (anġjoedema), ekżema (disturb tal-ġilda), ħmura tal-ġilda, urtikarja (ħorriqija), raxx sever minħabba l-mediċina, ħmura tal-ġilda, nefħa b'mod mgħaġġel tal-ġilda u tal-mukuża (anġjodema), ekżema (disturb filġilda), uġigħ fil-gogi (artralġja), uġigħ fl-estremitajiet, uġigħ fit-tendini, mard li jixbah l-influwenza, tnaqqis fl-emoglobina (proteina fid-demm), żieda fil-livelli tal-uric acid, żieda fl-enzimi epatiċi jew ta'
English: White to off white, oval shaped tablet; one side of the tablet is debossed with the number "93".
Maltese: Pillola bajda sa abjad maħmuġ, b'għamla ovali; naħa waħda tal-pillola mnaqqxa bin-numru "93".
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Maltese: Meta t-tqala tkun iddijanjostikata, il-kura b'antagonisti tar-riċetturi ta' angiotensin II għandha titwaqqaf immedjatament, u, jekk ikun xieraq, għandha tinbeda kura alternattiva (ara sezzjonijiet 4.3 u 4.6).
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).
Maltese: • Dijuretiċi (‘pilloli tal-ilma'), speċjalment jekk jittieħdu f'dożi għoljin flimkien ma' Telmisartan Teva Pharma, jistgħu jwasslu għal telf eċċessiv ta' ilma u pressjoni tad-demm baxxa (ipotensjoni).
English: The use of angiotensin II receptor antagonists is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Maltese: L-użu ta' antagonisti tar-riċetturi ta' angiotensin II hu kontraindikat matul it-tieni u t-tielet trimestru tat-tqala (ara sezzjonijiet 4.3 u 4.4).
English: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting
Maltese: Anġjoedema, ekżema, eritema, urtikarja, eruzzjoni minħabba lmediċina, eruzzjoni tossika tal-ġilda
English: At the beginning of the preventive therapy with Telmisartan Teva 80 mg, blood pressure should be frequently monitored.
Maltese: 80mg, il-pressjoni tad-demm għandha tiġi mmonitorjata ta' spiss.
English: Telmisartan Teva Pharma belongs to a class of medicines known as angiotensin-II receptor antagonists.
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: EU/1/11/719/043 Cartons of 30x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Maltese: EU/1/11/719/033 Kaxxi tal-kartun ta' 30x1 pillola f'folji perforati ta' doża waħda magħmulin minn aluminju-aluminju
English: Non-steroidal anti-inflammatory medicinal products
Maltese: GĦAMLA FARMAĊEWTIKA
English: Telmisartan Teva Pharma is also provided in aluminium-aluminium blister packs of 28 tablets.
Maltese: Telmisartan Teva Pharma jiġi wkoll f'pakketti b'folji tal-aluminju-aluminju bi 28 pillola.
English: What Telmisartan Teva Pharma looks like and contents of the pack
Maltese: Kif jidher Telmisartan Teva Pharma u l-kontenut tal-pakkett
English: Your doctor will normally advise you to stop taking Telmisartan Teva Pharma before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Telmisartan Teva Pharma.
Maltese: Normalment, it-tabib tiegħek ser jagħtik parir biex twaqqaf Telmisartan Teva Pharma, qabel ma tinqabad tqila jew hekk kif tkun taf li inti tqila u jaghtik parir biex tiehu medicina ohra minnflok Telmisartan Teva Pharma.
English: EU/1/11/719/049 Cartons of 98x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Maltese: EU/1/11/719/019 Kaxxi tal-kartun ta' 98x1 pillola f'folji perforati ta' doża waħda magħmulin minn aluminju-aluminju
English: Chest pain, asthenia (weakness)
Maltese: - Dijabete mellitus, indeboliment renali, età (> 70 sena)
English: EU/1/11/719/042 Cartons of 28x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Maltese: EU/1/11/719/052 Kaxxi tal-kartun ta' 28x1 pillola f'folji perforati ta' doża waħda magħmulin minn aluminju-aluminju
English: Telmisartan Teva Pharma blocks this effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Maltese: Telmisartan Teva Pharma jimblokka dan l-effett ta' angiotensin II, sabiex il-vażi tad-demm tiegħek jistrieħu, u l-pressjoni tad demm tiegħek titbaxxa.
English: EU/1/11/719/011 Cartons of 14x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/012 Cartons of 28x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/013 Cartons of 30x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/014 Cartons of 40x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/015 Cartons of 56x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/016 Cartons of 60x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/017 Cartons of 84x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/018 Cartons of 90x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/019 Cartons of 98x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/020 Cartons of 100x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/063 Carton of 28 tablets in aluminium-aluminium blisters
Maltese: Kaxxi tal-kartun ta' 40x1 pillola f'folji perforati ta' doża waħda li jistgħu jitqaxxru magħmulin minn aluminju-aluminju EU/1/11/719/005 Kaxxi tal-kartun ta' 56x1 pillola f'folji perforati ta' doża waħda li jistgħu jitqaxxru magħmulin minn aluminju-aluminju EU/1/11/719/006 Kaxxi tal-kartun ta' 60x1 pillola f'folji perforati ta' doża waħda li jistgħu jitqaxxru magħmulin minn aluminju-aluminju EU/1/11/719/007 Kaxxi tal-kartun ta' 84x1 pillola f'folji perforati ta' doża waħda li jistgħu jitqaxxru magħmulin minn aluminju-aluminju EU/1/11/719/008 Kaxxi tal-kartun ta' 90x1 pillola f'folji perforati ta' doża waħda li jistgħu jitqaxxru magħmulin minn aluminju-aluminju EU/1/11/719/009 Kaxxi tal-kartun ta' 98x1 pillola f'folji perforati ta' doża waħda li jistgħu jitqaxxru magħmulin minn aluminju-aluminju EU/1/11/719/010
English: EU/1/11/719/041 Cartons of 14x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Maltese: EU/1/11/719/031 Kaxxi tal-kartun ta' 14x1 pillola f'folji perforati ta' doża waħda magħmulin minn aluminju-aluminju
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali wrew effett tossiku fuq is-sistema riproduttiva (ara 5.3).
English: EU/1/11/719/047 Cartons of 84x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Maltese: EU/1/11/719/037 Kaxxi tal-kartun ta' 84x1 pillola f'folji perforati ta' doża waħda magħmulin minn aluminju-aluminju
English: Each tablet contains 40 mg telmisartan
Maltese: Kull pillola fiha 40 mg telmisartan
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
Maltese: Sepsis* (ta' spiss imsejħa "avvelenament tad-demm", hi infezzjoni severa b'rispons infjammatorju mal-ġisem kollu li tista' twassal għal mewt), żieda f'ċerti ċelluli bojod tad-demm (eosinofilija), għadd baxx ta' plejtlits (tromboċitopenja), reazzjoni allerġika severa (reazzjoni anafilattika), reazzjoni allerġika (eż. raxx, ħakk, diffikultà biex tieħu n-nifs, tħarħir, nefħa tal-wiċċ jew pressjoni tad-demm baxxa), livelli baxxi ta' zokkor fid-demm (f'pazjenti dijabetiċi, tħossok ansjuż/a, ngħas, indeboliment fil-vista, rata mgħaġġla ta' taħbit tal-qalb (takikardija), ħalq xott, stonku mqalleb, disturb fit-togħma
English: EU/1/11/719/046 Cartons of 60x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Maltese: EU/1/11/719/016 Kaxxi tal-kartun ta' 60x1 pillola f'folji perforati ta' doża waħda magħmulin minn aluminju-aluminju
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".
Maltese: Il-pilloli ta' Telmisartan Teva Pharma 80 mg huma bojod għal ofwajt, f'għamla ovali; naħa minnhom hi intaljata bil-kodiċi, “93”.
English: Renovascular hypertension
Maltese: Disturbi psikjatriċi
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".
Maltese: Il-pilloli ta' Telmisartan Teva Pharma 40 mg huma bojod għal ofwajt, f'għamla ovali; naħa minnhom hi intaljata bil-kodiċi, “93”.
English: Alternatively, telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide, which have been shown to have an additive blood pressure lowering effect with telmisartan.
Maltese: Inkella, telmisartan jista' jintuża flimkien ma' tipi ta' dijuretiċi tat-tip thiazide bħal hydrochlorothiazide, li ntwerew li għandhom effett addizzjonali li jnaqqas il-pressjoni tad-demm b'telmisartan.
English: Telmisartan Teva Pharma 40 mg tablets Each tablet contains 40 mg telmisartan.
Maltese: Telmisartan Teva Pharma 40 mg pilloli Kull pillola fiha 40 mg telmisartan.
English: What Telmisartan Teva Pharma is and what it is used for What you need to know before you take Telmisartan Teva Pharma How to take Telmisartan Teva Pharma Possible side effects
Maltese: Kif għandek tieħu Telmisartan Teva Pharma Effetti sekondarji possibbli Kif taħżen Telmisartan Teva Pharma
English: EU/1/11/719/048 Cartons of 90x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Maltese: EU/1/11/719/038 Kaxxi tal-kartun ta' 90x1 pillola f'folji perforati ta' doża waħda magħmulin minn aluminju-aluminju
English: EU/1/11/719/003 Cartons of 30x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Maltese: EU/1/11/719/013 Kaxxi tal-kartun ta' 30x1 pillola f'folji perforati ta' doża waħda magħmulin minn aluminju-aluminju
English: In some of the investigated patients the doses used were higher than those recommended in the treatment of hypertension in the adult population, reaching a daily dose comparable to160 mg, which was tested in adults.
Maltese: F'xi wħud mill-pazjenti investigati, id-dożi użati kienu ogħla minn dawk rakkomandati fil-kura tal-pressjoni għolja fil-popolazzjoni adulta, fejn laħqu doża ta' kuljum komparabbli għal 160 mg, li ġiet ittestjata fl-adulti.
English: The effect of Telmisartan Teva Pharma may be reduced when you take NSAIDs (non steroidal antiinflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Maltese: L-effetti ta' Telmisartan Teva Pharma jistgħu jitnaqqsu meta tieħu NSAIDs (mediċini ta' kontra linfjammazzjoni mhux sterojdi) eż. aspirina jew ibuprofen) jew kortikosterojdi.
English: Other conditions with stimulation of the renin-angiotensin-aldosterone system In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system such as telmisartan has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
Maltese: Espożizzjoni għall-kura b'antagonisti tar-riċetturi ta' angiotensin II matul it-tieni u t-tielet trimestri hu magħruf li jinduċi fetotossiċità (tnaqqis fil-funzjoni renali, oligoidramnios, ittardjar fl-ossifikazzjoni tal-kranju) u tossiċità fit-trabi tat-twelid (insuffiċjenza renali, pressjoni baxxa, iperkalemija) (Ara sezzjoni 5.3).
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".
Maltese: Il-pilloli ta' Telmisartan Teva Pharma 20 mg huma bojod għal ofwajt, f'għamla ovali; naħa minnhom hi intaljata bil-kodiċi, “93”.
English: EU/1/11/719/007 Cartons of 84x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Maltese: EU/1/11/719/057 Kaxxi tal-kartun ta' 84x1 pillola f'folji perforati ta' doża waħda magħmulin minn aluminju-aluminju
English: No statistically significant difference in the incidence of the primary composite endpoint (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure) was found [15.7 % in the telmisartan and 17.0 % in the placebo groups with a hazard ratio of 0.92 (95 % CI 0.81 - 1.05, p = 0.22)].
Maltese: każijiet fatali ta' sepsis żdiedet għal pazjenti li kienu qed jieħdu telmisartan (0.33 %) kontra pazjenti li kienu qed jieħdu l-plaċebo (0.16 %) [RR 2.07 (95 % intervall ta' kunfidenza 1.14 - 3.76)].
English: Telmisartan Teva Pharma 80 mg tablets Each tablet contains 80 mg telmisartan.
Maltese: Telmisartan Teva Pharma 80 mg pilloli Kull pillola fiha 80 mg telmisartan.
English: How to take Telmisartan Teva Pharma
Maltese: Kif taħżen Telmisartan Teva Pharma
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.
Maltese: f'persuni kkurati għal pressjoni tad-demm għolja, sturdament meta wieħed iqum bilwieqfa (ipotensjoni ortostatika), qtugħ ta' nifs, sogħla, uġigħ ta' żaqq, dijarea, skonfort fiż-żaqq, nefħa fiż-żaqq, rimettar, ħakk, żieda fl-għaraq, ħakk, raxx minħabba l-mediċina, uġigħ fid-dahar, bugħawwieġ fil-muskoli, uġigħ fil-muskoli (majalġja), uġigħ fid-dahar, bugħawwieġ fil-muskoli, indeboliment fil-kliewi li jinkludi insuffiċjenza akuta tal-kliewi, uġigħ fis-sider, sensazzjoni ta' dgħufija, u żieda fil-livell ta'
English: EU/1/11/719/008 Cartons of 90x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Maltese: EU/1/11/719/018 Kaxxi tal-kartun ta' 90x1 pillola f'folji perforati ta' doża waħda magħmulin minn aluminju-aluminju
English: EU/1/11/719/045 Cartons of 56x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Maltese: EU/1/11/719/056 Kaxxi tal-kartun ta' 60x1 pillola f'folji perforati ta' doża waħda magħmulin minn aluminju-aluminju
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.
Maltese: Fil-bniedem, doża ta' 80 mg ta' telmisartan kważi tinibixxi kompletament iż-żieda fil-pressjoni tad-demm ikkawżata minn angiotensin II. Dan l-effett inibitorju jinżamm għal 24 siegħa u jista' jibqa'
English: Member State (EU/EEA)
Maltese: Stat Membru (EU / EEA)
English: Str. Chindiei nr. 5
Maltese: Chindiei nr. 5
English: Monograph 04/2013:1360.
Maltese: Monografija 04/2013:1360.
English: 03-715 Warszawa Poland
Maltese: 03-715 Warszawa Polonja
English: Ceva Hellas LLC 15, Agiou Nikolaou str.
Maltese: Il-Greċja Ceva Hellas LLC 15, Agiou Nikolaou str.
English: Farmacéuticos e Imunológicos, Lda.
Maltese: Imunológicos, Lda.
English: Monograph 1360.
Maltese: Eur. Monografija 1360.
English: Sofia -1113
Maltese: Sofia -1113Bulgaria
English: 831 53 Bratislava Slovakia
Maltese: 831 53 Bratislava
English: 17455 ALIMOS Greece
Maltese: 17455 ALIMOS IlGreċja
English: Pharmaceutical form
Maltese: Forma farmaċewtika
English: 40472 Düsseldorf Germany
Maltese: 40472 Düsseldorf IlĠermanja
English: 1130 Brussel
Maltese: 1130 Brussel Il
English: 1107 Budapest Hungary
Maltese: 1107 Budapest LUngerija
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.
Maltese: Għall-proċedura ta' rikonoxximent reċiproku (MRP), l-Ungerija aġixxiet bħala Stat Membru ta' referenza u l-Awstrija, il-Belġju, il-Bulgarija, il-Kroazja, Ċipru, ir-Repubblika Ċeka, l-Estonja, il-Finlandja, il-Ġermanja, il-Greċja, l-Iżlanda, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, il-Pajjiżi l-Baxxi, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, isSlovenja, l-Isvezja u r-Renju Unit kienu l-Istati Membri kkonċernati.
English: INDICATION(s)
Maltese: INDIKAZZJONI (i)
English: Viale Colleoni 15, 20864 Agrate Brianza (MB)
Maltese: Viale Colleoni 15, 20864
English: Bulgaria Ceva Animal Health Bulgaria ul.
Maltese: Il-Bulgaria Ceva Animal Health Bulgaria ul.
English: Romania Ceva Santé Animale Romania
Maltese: Ceva Santé Animale Romania
English: Having considered all data submitted the CVMP concluded that:
Maltese: Wara li kkunsidra d-data kollha sottomessa, is-CVMP ikkonkluda li:
English: ATCvet code: QI09AB07
Maltese: QI09AB07
English: The total quantity is 20 x 109 inactivated germs per dose.
Maltese: Il-kwantità totali huwa 20 x 109 mikrobi inattivati għal kull doża.
English: Unit 3, Anglo Office Park, White Lion Road Amersham, Bucks HP7 9FB
Maltese: Unit 3, Anglo Office Park, White Lion Road
English: Duration of immunity
Maltese: Tul ta' żmien tal-immunità
English: Poland Ceva Animal Health Polska Sp. z o.o.
Maltese: Il-Polonja Ceva Animal Health Polska Sp. z o.o. ul.
English: Specifically, the p-value is below 0.0001 which means that the probability of a false positive correlation is under 0.01%.
Maltese: B'mod speċifiku, il-valur-p huwa inqas minn 0.0001 li jfisser li l-probabbiltà ta' korrelazzjoni pożittiva falza hija inqas minn 0.01%.
English: Pharmacotherapeutic group: Actinobacillus/Haemophilus vaccine.
Maltese: Actinobacillus vaċċin/Haemophilus.
English: Tiendweg 8 c, 2670 AB Naaldwijk The Netherlands
Maltese: Tiendweg 8 c, 2670 AB
English: Germany Ceva Tiergesundheit GmbH
Maltese: Ceva Tiergesundheit GmbH
English: Belgium Ceva Santé Animale S.A/N.V.
Maltese: Il-Belġju Ceva Santé Animale S.A/N.V.
English: Onset of immunity: 21 days following second vaccination Duration of immunity: 16 weeks following second vaccination
Maltese: Bidu tal-immunità: 21 jum wara t-tieni vaċċinazzjoni Tul ta' żmien tal-immunità: 16-il ġimgħa wara t-tieni vaċċinazzjoni
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Maltese: Lista tal-ismijiet, forma farmaċewtika, punti sodi tal-prodott mediċinali tal-veterinarju, speċi ta' annimali, ir-rotta ta' amministrazzjoni, detentur ta' awtorizzazzjoni fl-Istati Membri
English: Onset of immunity is 21 days following second vaccination.
Maltese: Il-bidu tal-immunità huwa ta' 21 jum wara t-tieni vaċċinazzjoni.
English: Ceva Salute Animale S.p.A.
Maltese: L-Italja Ceva Salute Animale S.p.A.
English: Sweden Ceva Animal Health A.B.
Maltese: L-Isvezja Ceva Animal Health A.B.
English: OTHER INFORMATION
Maltese: INFORMAZZJONI OĦRA
English: Hungary CEVA-Phylaxia Veterinary Biologicals Co. Ltd
Maltese: L-Ungerija CEVA-Phylaxia Veterinary
English: A sentence is included in section 5 Immunological properties of the Summary of Product Characteristics to reflect the lack of data from field trials.
Maltese: Hija inkluża sentenza fis-sezzjoni 5 Proprjetajiet Immunoloġiċi tas-Sommarju tal-Karatteristiċi talProdott biex tirrifletti n-nuqqas ta' data mill-provi fuq il-post.
English: Rua Doutor António Loureiro Borges 9/9A - 9°A, Miraflores, 1495131 Algès Portugal
Maltese: Miraflores, 1495131 Algès
English: Efficacy was demonstrated under laboratory but not under field conditions.
Maltese: Effikaċja ntweriet taħt laboratorju iżda mhux taħt kundizzjonijiet reali.
English: The MAH confirmed that the batches were produced according to a consistent manufacturing process under EU Good Manufacturing Practice (GMP) standards and of adequate quality for use in the efficacy trials.
Maltese: Il-MAH ikkonferma li l-lottijiet kienu prodotti skont proċess ta' manifattura konsistenti skont standards ta' Prattika ta' Manifattura Tajba tal-UE (GMP) u ta' kwalità adegwata għall-użu fil-provi dwar l-effikaċja.
English: Coglapix suspension for injection for pigs (hereafter called ‘Coglapix') is an inactivated bacterial vaccine against porcine actinobacillosis.
Maltese: Coglapix sospensjoni għal injezzjoni għall-ħnieżer (minn hawn 'il quddiem "Coglapix") huwa vaċċin batterjali mhux attivat kontra l-antinobaċillożi tal-porċini.
English: During the MRP Italy, as a concerned Member State, considered that Coglapix may present a potential serious risk to animal health.
Maltese: Matul l-MRP, l-Italja bħala Stat Membru kkonċernat, ikkunsidrat li Coglapix jista' jippreżenta riskju potenzjali serju għall-annimali.
English: Correlation between the reduction of lung lesions and the reduction of clinical signs
Maltese: Il-korrelazzjoni bejn t-tnaqqis fil-leżjonijiet fil-pulmun u t-tnaqqis tas-sinjali kliniċi
English: The MAH clarified that inferential statistics was used for the data analysis and addressed the relevance of the method used.
Maltese: L-MAH iċċara li ntużat statistika inferenzjali għall-analiżi tad-data u indirizza r-rilevanza tal-metodu użat.
English: Ceva Saúde Animal Produtos
Maltese: Il-Portugall Ceva Saúde Animal Produtos