FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common symptoms of telmisartan overdose are low blood pressure (hypotension) and fast heart beat (tachycardia).
Maltese: Is-sintomi l-aktar komuni ta' overdose ta' telmisartan, huma pressjoni baxxa (ipotensjoni) u rata ta' taħbit tal-qalb għolja (takikardija).
English: The pharmacokinetics of two doses of telmisartan were assessed as a secondary objective in hypertensive patients (n = 57) aged 6 to < 18 years after taking telmisartan 1 mg/kg or 2 mg/kg over a four-week treatment period.
Maltese: Il-farmakokinetika ta' żewġ dożi ta' telmisartan ġiet evalwata bħala objettiv sekondarju f'pazjenti bi pressjoni tad-demm għolja (n = 57) li kellhom minn 6 sa < 18-il sena wara li ħadu telmisartan 1 mg/kg jew
English: Telmisartan Actavis is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: Pazjenti b'indeboliment tal-fwied Telmisartan Actavis hu kontraindikat f'pazjenti b'indeboliment serju tal-fwied (ara sezzjoni 4.3).
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: Kundizzjonijiet oħrajn bl-istimulazzjoni tas-sistema renin-angiotensin-aldosterone F'pazjenti fejn it-ton vaskulari u l-funzjoni renali jiddependu b'mod predominanti mill-attività tas-sistema renin-angiotensin-aldosterone (eż. pazjenti b'insuffiċjenza konġestiva severa tal-qalb jew li għandhom mard prinċipali renali, li jinkludi stenosi ta' l-arterja renali), il-kura bi prodotti mediċinali oħrajn li jaffettwaw din is-sistema bħal telmisartan, kienet assoċjata ma' pressjoni baxxa ħafna akuta, iperażotemija, oligurja, jew b'mod rari ma' insuffiċjenza renali akuta (ara sezzjoni 4.8).
English: In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium in normotensive animals.
Maltese: emoglobina, ematokrit), bidliet fl-emodinamiċi renali (żieda fin-nitrogen ta' l-urea u l-krejatinina fiddemm), kif ukoll żieda fil-potassium fis-serum f'annimali normotensivi.
English: Angioedema (also with fatal outcome), eczema, erythema, urticaria, drug eruption, toxic skin eruption
Maltese: Anġjoedema (wkoll b'riżultat fatali), ekżema, eritema, urtikarja, eruzzjoni minħabba l-mediċina, eruzzjoni tossika tal-ġilda
English: HDPE tablet container:
Maltese: Tikketta għall-kontenitur tal-pillloli
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 this side effect), 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* (ħafna drabi msejħa “demm avvelenat”, hija infezzjoni severa b'rispons infjammatorju tal-ġisem kollu li jistgħu jwasslu għall-mewt), żieda f'ċerti ċelluli bojod tad-demm (eosinofilja), għadd baxx ta' plejtlits (tromboċitopenja), reazzjoni allerġika (eż. raxx, ħakk, diffikulta biex tieħu nifs, tħarħir, nefħa talwiċċ jew pressjoni tad-demm baxa), livelli baxxi ta' zokkor fid-dem (f'pazjenti dijabetiċi), tħossok ansjuż/a, ngħas, indeboliment fil-vista, rata mgħaġġla ta' taħbit tal-qalb (takikardija), ħalq xott, stonku mqalleb, tibdil fis-sens tat-togħma (disgewżja), funzjoni anormali tal-fwied**, (hemm aktar ċans li pazjenti Ġappuniżi jkollhom dawn l-effetti sekondarji), nefħa b'mod mgħaġġel tal-ġilda u tal-mukoża li jistgħu wkoll iwasslu għall-mewt (anġjoedema wkoll fatali), ekżema (disturb tal-ġilda), ħmura tal-ġilda, ħorriqija (urtikarja), raxx sever għall-mediċina, 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, ta' enzimi epatiċi jew ta' creatine phosphokinase fid-demm.
English: EU/1/10/639/011 (14 tablets blister) EU/1/10/639/012 (28 tablets blister) EU/1/10/639/013 (30 tablets blister) EU/1/10/639/014 (56 tablets blister) EU/1/10/639/015 (84 tablets blister) EU/1/10/639/016 (90 tablets blister) EU/1/10/639/017 (98 tablets blister) EU/1/10/639/018 (100 tablets blister)
Maltese: EU/1/10/639/011 (14 -il pillola f‘folji) EU/1/10/639/012 (28 pillola f‘folja) EU/1/10/639/013 (30 pillola f‘folja) EU/1/10/639/014 (56 pillola f‘folja) EU/1/10/639/015 (84 pillola f‘folja) EU/1/10/639/016 (90 pillola f‘folja) EU/1/10/639/017 (98 pillola f‘folja) EU/1/10/639/018 (100 pillola f‘folja)
English: The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal antiinflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
Maltese: Ir-riskju jista' jiżdied f'każ li l-kura tingħata flimkien ma' prodotti mediċinali oħra li jistgħu jikkawżaw ukoll l-iperkalemija (sostituti tal-melħ li fihom il-potassium, dijuretiċi li ma jneħħux potassium, inibituri ta' ACE, antagonisti tar-riċettur ta' angiotensin II, prodotti mediċinali mhux sterojdi kontra l-infjammazzjoni (NSAIDs, li jinkludu inibituri COX-2 selettivi), eparina, immunosoppressuri (cyclosporin jew tacrolimus), u trimethoprim).
English: In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat.
Maltese: AUC0-24 u s-Cmax ta' ramipril u ramiprilat.
English: Al/Al blisters:
Maltese: Puh/Tel:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 40 mg telmisartan.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 80 mg telmisartan.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Actavis logo
Maltese: Actavis logo
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/639/029 (30 tablets container) EU/1/10/639/030 (250 tablets container)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/639/029 (30 pillola f‘kontenitur)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/639/009 (30 tablets container) EU/1/10/639/010 (250 tablets container)
Maltese: FIS-SUQ EU/1/10/639/009 (30 pillola f‘kontenitur)
English: Telmisartan Actavis may also be used in combination with diuretics (‘water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with telmisartan.
Maltese: Telmisartan Actavis jista' jintuża flimkien ma' dijuretiċi (‘pilloli tal-awrina') bħal hydrochlorothiazide, li ntwera li għandu effett addizzjonali li jnaqqas il-pressjoni tad-demm b'Telmisartan Actavis.
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 40 mg tablets
Maltese: Telmisartan Actavis 40 mg pilloli
English: The elimination half-life is not changed in patients with renal impairment.
Maltese: Il-half-life ta' l-eliminazzjoni ma tinbidilx f'pazjenti b'indeboliment renali.
English: EU/1/10/639/021 (14 tablets blister) EU/1/10/639/022 (28 tablets blister) EU/1/10/639/023 (30 tablets blister) EU/1/10/639/024 (56 tablets blister) EU/1/10/639/025 (84 tablets blister) EU/1/10/639/026 (90 tablets blister) EU/1/10/639/027 (98 tablets blister) EU/1/10/639/028 (100 tablets blister) EU/1/10/639/029 (30 tablets container) EU/1/10/639/030 (250 tablets container)
Maltese: EU/1/10/639/021 (14 -il pillola f'folji) EU/1/10/639/022 (28 pillola f'folji) EU/1/10/639/023 (30 pillola f'folji) EU/1/10/639/024 (56 pillola f'folji) EU/1/10/639/025 (84 pillola f'folji) EU/1/10/639/026 (90 pillola f'folji) EU/1/10/639/027 (98 pillola f'folji) EU/1/10/639/028 (100 pillola f'folji) EU/1/10/639/029 (30 pillola f‘kontenitur)
English: The use of angiotensin II receptor antagonists is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Maltese: L-użu ta' antagonisti tar-riċetturi ta' angiotensin II hu kontra-indikat matul it-tieni u t-tielet trimestru tat-tqala (ara sezzjonijiet 4.3 u 4.4).
English: EU/1/10/639/021 (14 tablets blister) EU/1/10/639/022 (28 tablets blister) EU/1/10/639/023 (30 tablets blister) EU/1/10/639/024 (56 tablets blister) EU/1/10/639/025 (84 tablets blister) EU/1/10/639/026 (90 tablets blister) EU/1/10/639/027 (98 tablets blister) EU/1/10/639/028 (100 tablets blister)
Maltese: EU/1/10/639/021 (14 -il pillola f‘folji) EU/1/10/639/022 (28 pillola f‘folji) EU/1/10/639/023 (30 pillola f‘folji) EU/1/10/639/024 (56 pillola f‘folji) EU/1/10/639/025 (84 pillola f‘folji) EU/1/10/639/026 (90 pillola f‘folji) EU/1/10/639/027 (98 pillola f‘folji) EU/1/10/639/028 (100 pillola f‘folji)
English: EU/1/10/639/001 (14 tablets blister) EU/1/10/639/002 (28 tablets blister) EU/1/10/639/003 (30 tablets blister) EU/1/10/639/004 (56 tablets blister) EU/1/10/639/005 (84 tablets blister) EU/1/10/639/006 (90 tablets blister) EU/1/10/639/007 (98 tablets blister) EU/1/10/639/008 (100 tablets blister)
Maltese: EU/1/10/639/001 (14 -il pillola f'folji) EU/1/10/639/002 (28 pillola f'folji) EU/1/10/639/003 (30 pillola f'folji) EU/1/10/639/004 (56 pillola f'folji) EU/1/10/639/005 (84 pillola f'folji) EU/1/10/639/006 (90 pillola f'folji) EU/1/10/639/007 (98 pillola f'folji) EU/1/10/639/008 (100 pillola f'folji)
English: EU/1/10/639/001 (14 tablets blister) EU/1/10/639/002 (28 tablets blister) EU/1/10/639/003 (30 tablets blister) EU/1/10/639/004 (56 tablets blister) EU/1/10/639/005 (84 tablets blister) EU/1/10/639/006 (90 tablets blister) EU/1/10/639/007 (98 tablets blister) EU/1/10/639/008 (100 tablets blister) EU/1/10/639/009 (30 tablets container) EU/1/10/639/010 (250 tablets container)
Maltese: EU/1/10/639/001 (14 -il pillola f'folji) EU/1/10/639/002 (28 pillola f'folji) EU/1/10/639/003 (30 pillola f'folji) EU/1/10/639/004 (56 pillola f'folji) EU/1/10/639/005 (84 pillola f'folji) EU/1/10/639/006 (90 pillola f'folji) EU/1/10/639/007 (98 pillola f'folji) EU/1/10/639/008 (100 pillola f'folji) EU/1/10/639/009 (30 pillola f‘kontenitur)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/639/019 (30 tablets container) EU/1/10/639/020 (250 tablets container)
Maltese: FIS-SUQ EU/1/10/639/019 (30 pillola f‘kontenitur)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg telmisartan.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 20 mg telmisartan.
English: There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Maltese: Hemm evidenza li l-użu konkomitanti ta' inibituri ta' ACE, imblokkaturi tar-riċettur ta' angiotensin II jew aliskiren iżid ir-riskju ta' pressjoni baxxa, iperkalemija u tnaqqis fil-funzjoni renali (li jinkludi insuffiċjenza akuta renali).
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 20 mg tablets
Maltese: Telmisartan Actavis 20 mg pilloli
English: Rare: Psychiatric disorders
Maltese: Disturbi psikjatriċi
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 ta' pressjoni għolja fil-popolazzjoni adulta, u laħqu doża ta' kuljum komparabbli għal 160 mg, li ġiet ittestjata fl-adulti.
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,
Maltese: Sepsis* (ħafna drabi msejħa “demm avvelenat”, hija infezzjoni severa b'rispons infjammatorju tal-ġisem kollu li jistgħu jwasslu għall-mewt), żieda f'ċerti ċelluli bojod tad-demm (eosinofilja), għadd baxx ta'
English: Potassium sparing diuretics or potassium supplements Angiotensin II receptor antagonists such as telmisartan attenuate diuretic induced potassium loss.
Maltese: Meta Telmisartan Actavis jintuża f'pazjenti li għandhom indeboliment fil-funzjoni renali, monitoraġġ perjodiku tal-livelli tal-potassium u tal-krejatinina tas-serum hu rakkomandat.
English: Angiotensin II receptor antagonists should not be initiated during pregnancy.
Maltese: angiotensin II, li jinkludu telmisartan.
English: - Lithium containing medicines to treat some types of depression.
Maltese: • Mediċini li fihom il-lithium għall-kura ta' xi tipi ta' dipressjoni.
English: Hyperkalaemia Hypoglycaemia (in diabetic patients)
Maltese: hydrochlorothiazide, u lisinopril).
English: Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
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 talkranju) u tossiċità fit-trabi tat-twelid (insuffiċjenza renali, pressjoni baxxa, iperkalemija).
English: The maximum plasma concentration (Cmax) and, to a smaller extent, the area under the plasma concentration-time curve (AUC) increase disproportionately with dose.
Maltese: L-ogħla konċentrazzjoni fil-plażma (Cmax) u, fi grad anqas, iż-żona taħt il-kurva ta' konċentrazzjoni fil-plażma-ħin (AUC), jiżdiedu b'mod sproporzjonat mad-doża.
English: Urinary tract infections, upper respiratory tract infections (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: “demm avvelenat”, hija infezzjoni severa b'rispons infjammatorju tal-ġisem kollu li jistgħu jwasslu għall mewt), żieda f'ċerti ċelluli bojod tad-demm (eosinofilja), għadd baxx ta' plejtlits (tromboċitopenja), reazzjoni allerġika severa (anaphylactic reaction), reazzjoni allerġika (eż. raxx, ħakk, diffikulta biex tieħu nifs, tħarħir, nefħa tal-wiċċ jew pressjoni tad-demm baxa), livelli baxxi ta' zokkor fid-demm (f'pazjenti dijabetiċi), tħossok ansjuż/a, ngħas, indeboliment fil-vista, rata mgħaġġla ta' taħbit tal-qalb (takikardija),
English: Hepatobiliary disorders Rare:
Maltese: Disturbi fil-fwied u fil-marrara Rari:
English: For reduction of cardiovascular events, the usual dose of Telmisartan Actavis is one 80 mg tablet once a day.
Maltese: Għal tnaqqis ta' avvenimenti kardjovaskulari, id-doża tas-soltu ta' Telmisartan Actavis hi ta' pillola waħda ta' 80 mg darba kuljum.
English: Gender differences in plasma concentrations were observed, Cmax and AUC being approximately 3-and 2-fold higher, respectively, in females compared to males.
Maltese: Effetti tas-sess Differenzi relatati mas-sess fil-konċentrazzjonijiet fil-plażma kienu osservati, bis-Cmax u l-AUC li kienu madwar 3 darbiet u darbtejn ogħla, rispettivament, fin-nisa meta mqabbla mal-irġiel.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg telmisartan For the full list of excipients, see section 6.1.
Maltese: Hg fil-grupp ta' telmisartan 1 mg/kg, u -6.0 (2.4) fil-grupp tal-plaċebo.
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 80 mg tablets
Maltese: Telmisartan Actavis 80 mg pilloli
English: Inventedname Strength Pharmaceutical Form
Maltese: Numru tal-EU Isem (ivvintat) Qawwa Għamla farmaċewtika
English: • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains).
Maltese: • antiġeni mhux attivati (maqtula) tal-kaliċivirożi (razez FCV 431 u G1).
English: Other information about Purevax RC:
Maltese: Informazzjoni oħra dwar Purevax RC:
English: Purevax RC is a veterinary vaccine that contains:
Maltese: Purevax RC huwa vaċċin veterinarju li fih:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RC on 23 February 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Purevax RC fit-23 ta' Frar 2005.
English: Occasionally, cats will develop temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as hyperthermia (elevated body temperature) lasting for one or two days.
Maltese: Xi drabi, il-qtates jiżviluppaw apatija temporanja (nuqqas ta' interess fl-ambjent ta' madwarhom) u anoressija (nuqqas ta' aptit) kif ukoll ipertermija (temperatura għolja tal-ġisem) li ddum ġurnata jew tnejn.
English: The effectiveness of Purevax RC has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus and calicivirus.
Maltese: L-effikaċja ta' Purevax RC ġiet studjata f'bosta provi f'kundizzjonijiet tal-laboratorju fejn il-qtates ġew imlaqqma u infettati bil-virus tal-erpete u bil-kaliċivirus.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RC exceed the risks for the approved indications and recommended that Purevax RC be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Purevax RC huma akbar mir-riskji għall-kura tal-indikazzjoni approvata u rrakkomanda li Purevax RC jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: What is Purevax RC?
Maltese: X'inhu Purevax RC?
English: For a full list of the side-effects reported with Purevax RC, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrappurtati b'Purevax RC, ara l-fuljett ta' tagħrif.
English: In the field, the studies of Purevax RC looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination.
Maltese: Fuq il-post, l-istudji dwar Purevax RC osservaw l-iskeda bażika tat-tilqim (2 injezzjonijiet bi 3 jew 4 ġimgħat bejniethom) u t-tilqima tal-booster.
English: • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus).
Maltese: • il-kaliċivirożi fil-qtates (marda li tixbah lill-influwenza b'infjammazzjoni tal-ħalq ikkawżata minn kaliċivirus).
English: Feline viral rhinotracheitis (live attenuated) and feline calicivirosis (inactivated) vaccine
Maltese: Vaċċin (ħaj attenwat) tar-rinotrakeite virali fil-qtates u vaċċin (mhux attivat) tal-kaliċivirożi fil-qtates
English: Why has Purevax RC been approved?
Maltese: Għaliex ġie approvat Purevax RC?
English: In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus and calicivirus infection.
Maltese: Fl-istudju fuq il-post tat-tilqima bażika kien hemm żieda fl-antikorpi kontra l-virus tal-erpete tar-rinotrakeite u l-infezzjoni mill-kaliċivirus fil-qtates.
English: Purevax RC is a vaccine.
Maltese: Purevax RC huwa vaċċin.
English: Purevax RC is used to vaccinate cats from the age of 8 weeks against:
Maltese: Purevax RC jintuża għat-tilqim tal-qtates mill-età ta' 8 ġimgħat kontra:
English: In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus and calicivirus infection remained stable at a high level or increased slightly.
Maltese: Fl-istudju dwar it-tilqima tal-booster, il-livelli ta' antikorpi kontra l-virus tal-erpete tar-rinotrakeite u l-infezzjoni mill-kaliċivirus baqgħu stabbli f'livell għoli jew żdiedu xi ftit.
English: What is the risk associated with Purevax RC?
Maltese: X'inhuwa r-riskji assoċjati ma' Purevax RC?
English: They included young and adult cats of various breeds, but not young kittens.
Maltese: Dawn kienu jinkludu qtates frieħ u adulti ta' diversi razez, iżda mhux frieħ żgħar.
English: Purevax RC contains small amounts of weakened or killed viruses that cause feline rhinotracheitis and calicivirosis.
Maltese: Fil-kundizzjonijiet tal-laboratorju Purevax RC intwera li jipprovdi protezzjoni kontra l-mard elenkat hawn fuq.
English: EMEA Number
Maltese: Numru tal-proċedura talEMEA
English: A/Switzerland/9715293/2013 (H3N2) - like strain (A/South Australia/55/2014, wild type)
Maltese: A/Switzerland/9715293/2013 (H3N2) - razza simili (A/South Australia/55/2014, wild type) 15-il mikrogramma HA** B/Phuket/3073/2013 - razza simili (B/Utah/9/2014, wild type)
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains: A/California/7/2009 (H1N1)pdm09- like strain (A/Brisbane/10/2010, wild type)
Maltese: A/California/7/2009 (H1N1)pdm09 - razza simili (A/Brisbane/10/2010, wild type)
English: 2 x 10 pre-filled syringes (Luer Cone) + 20 needles
Maltese: 2 x 10 siringi mimlijin għallest (Luer Cone) + 20 labra
English: 2 x 10 pre-filled syringes (Luer Lock)
Maltese: 2 x 10 siringi mimlijin għallest (Luer Lock)
English: 10 pre-filled syringe (Luer Lock) + 10 needles l t o r
Maltese: 10 siringi mimlijin għal-lest (Luer Lock) + 10 labriet t x
English: 10 pre-filled syringes (Luer Cone) + 10 needles
Maltese: 10 siringi mimlijin għal-lest (Luer Cone) + 10 labriet
English: 10 pre-filled syringes (Luer Lock)
Maltese: 10 siringi mimlijin għal-lest (Luer Lock)
English: 2 x 10 pre-filled syringes (Luer Cone)
Maltese: 2 x 10 siringi mimlijin għallest (Luer Cone)
English: 10 pre-filled syringes (Luer Cone)
Maltese: 10 siringi mimlijin għal-lest (Luer Cone)
English: 1 pre-filled syringe (Luer Lock) + 1 needle
Maltese: Siringa 1 mimlija għal-lest (Luer Lock) + labra 1
English: 1 pre-filled syringe (Luer Cone) + 1 needle
Maltese: Siringa 1 mimlija għal-lest (Luer Cone) + labra 1
English: 1 pre-filled syringe (Luer Cone)
Maltese: Siringa 1 mimlija għal-lest (Luer Cone)
English: 1 pre-filled syringe (Luer Lock)
Maltese: Siringa 1 mimlija għal-lest (Luer Lock)
English: EU numbers
Maltese: Numri tal-EU
English: Following the European Commission Decision the Risk Management Plan should be submitted with any new application for extending the indication regarding the treatment of mania in bipolar disorder, as relevant.
Maltese: Skont id-Deċiżjoni tal-Kummissjoni Ewropea, il-Pjan tal-Ġestjoni tar-Riskji għandu jiġi sottomess ma' kwalunkwe applikazzjoni ġdida għall-estensjoni tal-indikazzjoni rigward it-trattament tal-manija fid-disturb bipolari, kif relevanti.