FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Med drugim in tretjim trimesečjem nosečnosti so antagonisti receptorjev angiotenzina II kontraindicirani (glejte poglavji 4.3 in 4.4).
English: Telmisartan Actavis should be used only with caution in patients with mild to moderate hepatic impairment.
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter se sme zdravilo Telmisartan Actavis uporabljati le previdno.
English: The incidence of dry cough was significantly lower in patients treated with telmisartan than in those given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two antihypertensive treatments.
Slovenian: V kliničnih preskušanjih, ki so neposredno primerjala dve antihipertenzivni zdravljenji, je bila incidenca suhega kašlja med prejemniki telmisartana značilno manjša kot med prejemniki zaviralcev angiotenzinske konvertaze.
English: Always take this medicine exactly as your doctor has told you.
Slovenian: Pomembno je, da uporabljate odmerek, ki vam ga je predpisal zdravnik.
English: - if you are taking any of the following medicines used to treat high blood pressure: an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Slovenian: - zaviralec ACE (na primer enalapril, lizinopril ali ramipril), zlasti če imate kakšne težave z ledvicami, ki so povezane s sladkorno boleznijo - aliskiren
English: Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC code: C09CA07.
Slovenian: Oznaka ATC: C09CA07.
English: Hepatobiliary disorders Rare:
Slovenian: Pshiatrične motnje Občasni:
English: Magnesium stearate Croscarmellose sodium Mannitol
Slovenian: 6.1 Seznam pomožnih snovi magnezijev stearat premreženi natrijev karmelozat manitol povidon kroglice kalijevega hidroksida
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).
Slovenian: Pri takšnih bolnikih so uporabo zdravil, ki vplivajo na ta sistem, npr. telmisartana, spremljale akutna hipotenzija, hiperazotemija, oligurija ali, redko, akutna odpoved ledvic (glejte poglavje 4.8).
English: Somnolence
Slovenian: vrtoglavica
English: Take Telmisartan Actavis every day for as long as your doctor prescribes it in order to keep your blood pressure controlled.
Slovenian: Da boste vzdrževali urejen krvni tlak, jemljite zdravilo Telmisartan Actavis vsak dan, kolikor časa vam ga zdravnik predpiše.
English: PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING Carton for tablet container
Slovenian: PODATKI NA ZUNANJI IN NA PRIMARNI OVOJNINI Škatla za vsebnik za tablete
English: How to store Telmisartan Actavis
Slovenian: Shranjevanje zdravila Telmisartan Actavis
English: Symptomatic hypotension, especially after the first dose of Telmisartan Actavis, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Slovenian: Bolnikom, ki so zaradi intenzivnega zdravljenja z diuretiki, prehranskega omejevanja soli, driske ali bruhanja hipovolemični ali hiponatriemični, se lahko pojavi simptomatska hipotenzija, še zlasti po prvem odmerku zdravila Telmisartan Actavis.
English: Povidone
Slovenian: Actavis.
English: The mean steady state apparent volume of distribution (Vdss) is approximately 500 l.
Slovenian: Povprečni navidezni volumen porazdelitve v stanju dinamičnega ravnovesja (Vdss)
English: Chest pain, asthenia (weakness) Influenza-like illness
Slovenian: bolečina v prsih, astenija (šibkost)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/639/029 (30 tablets container) EU/1/10/639/030 (250 tablets container)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/10/639/029 (vsebnik 30 tablet) EU/1/10/639/030 (vsebnik 250 tablet)
English: Angioedema (also with fatal outcome), eczema, erythema, urticaria, drug eruption, toxic skin eruption
Slovenian: srbenje, hiperhidroza, izpuščaj angioedem (lahko tudi smrtni izid), ekcem, eritem, utikarija,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/639/009 (30 tablets container) EU/1/10/639/010 (250 tablets container)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/10/639/009 (vsebnik 30 tablet) EU/1/10/639/010 (vsebnik 250 tablet)
English: Elderly
Slovenian: tahikardija
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/639/019 (30 tablets container) EU/1/10/639/020 (250 tablets container)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/10/639/019 (vsebnik 30 tablet) EU/1/10/639/020 (vsebnik 250 tablet)
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 40 mg tablets telmisartan
Slovenian: IME ZDRAVILA Telmisartan Actavis 40 mg tablete telmisartan
English: 6.5 Nature and contents of container
Slovenian: 6.5 Vrsta ovojnine in vsebina Al/Al pretisni omoti:
English: Diuretics (thiazide or loop diuretics)
Slovenian: heparina, imunosupresivov (ciklosporin ali takrolimus) ali trimetoprima).
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor antagonists, including telmisartan.
Slovenian: Med sočasno uporabo litija z zaviralci angiotenzinske konvertaze in z antagonisti receptorjev angiotenzina II, vključno s telmisartanom, sta bila opisana reverzibilen porast koncentracije litija v serumu in povečanje njegovih toksičnih učinkov.
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 80 mg tablets telmisartan
Slovenian: IME ZDRAVILA Telmisartan Actavis 80 mg tablete telmisartan
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 40 mg tablets
Slovenian: IME ZDRAVILA Telmisartan Actavis 40 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 20 mg tablets
Slovenian: IME ZDRAVILA Telmisartan Actavis 20 mg tablete
English: Because no information is available regarding the use of Telmisartan Actavis during breast-feeding, Telmisartan Actavis is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Slovenian: Dojenje Ker informacij o uporabi zdravila Telmisartan Actavis med obdobjem dojenja ni, njegova uporaba med tem obdobjem ni priporočljiva.
English: What Telmisartan Actavis looks like and contents of the pack 80 mg tablets are white, oval, biconvex with logo T1 on one side
Slovenian: 80 mg tablete so bele, ovalne, bikonveksne tablete z oznako T1 na eni strani.
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 20 mg tablets telmisartan
Slovenian: IME ZDRAVILA Telmisartan Actavis 20 mg tablete 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,
Slovenian: Sepsa* (pogosto poimenovana tudi "zastrupitev krvi", je huda okužba, pri kateri pride v vsem telesu do vnetnega odziva in je lahko usodna), povečanje določenih belih krvničk (eozinofilija), majhno število trombocitov (trombocitopenija), huda alergijska reakcija (anafilaktična reakcija), alergijska reakcija (npr. izpuščaj, srbež, oteženo dihanje, piskanje, otekanje obraza ali nizek krvni tlak), nizka raven krvnega sladkorja (pri bolnikih s sladkorno boleznijo), občutek tesnobe, zaspanost, motnje vida,
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 80 mg tablets
Slovenian: IME ZDRAVILA Telmisartan Actavis 80 mg tablete
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for blister
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla za pretisni omot
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.
Slovenian: Okužbe sečil, okužbe zgornjih dihal (npr. bolečine v grlu, vneti sinusi, prehlad), pomanjkanje rdečih krvničk (anemija), visoka raven kalija, težave z uspavanjem, občutek žalosti (depresija), omedlevica (sinkopa), vrtoglavica, počasen srčni utrip (bradikardija), nizek krvni tlak (hipotenzija) pri osebah, ki se zdravijo zaradi visokega krvnega tlaka, omotica pri vstajanju (ortostatska hipotenzija), zasoplost,
English: Telmisartan Actavis 40 mg tablets Telmisartan
Slovenian: Navodilo za uporabo Telmisartan Actavis 40 mg tablete telmisartan
English: There is no experience regarding the administration of Telmisartan Actavis in patients with recent kidney transplantation.
Slovenian: Actavis pri bolnikih, ki jim je bila pred kratkim presajena ledvica, ni.
English: Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased
Slovenian: (artralgija), bolečina v okončini, bolečina v kitah, gripi podobna bolezen, znižan hemoglobin (krvna beljakovina), zvišana raven sečne kisline, zvišana raven jetrnih encimov ali kreatin fosfokinaze v krvi.
English: The blood pressure lowering effect of telmisartan can be increased by concomitant use of other antihypertensive medicinal products.
Slovenian: Sočasna uporaba drugih antihipertenzivnih zdravil lahko poveča učinek telmisartana na znižanje krvnega tlaka.
English: Telmisartan Actavis 80 mg tablets Telmisartan
Slovenian: Navodilo za uporabo Telmisartan Actavis 80 mg tablete telmisartan
English: Telmisartan Actavis 20 mg tablets Telmisartan
Slovenian: Navodilo za uporabo Telmisartan Actavis 20 mg tablete telmisartan
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Second and third trimesters of pregnancy (see sections 4.4 and 4.6) - Biliary obstructive disorders - Severe hepatic impairment
Slovenian: - Drugo in tretje trimesečje nosečnosti (glejte poglavji 4.4 in 4.6).
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)
Slovenian: EU/1/10/639/021 (pretisni omot 14 tablet) EU/1/10/639/022 (pretisni omot 28 tablet) EU/1/10/639/023 (pretisni omot 30 tablet) EU/1/10/639/024 (pretisni omot 56 tablet) EU/1/10/639/025 (pretisni omot 84 tablet) EU/1/10/639/026 (pretisni omot 90 tablet) EU/1/10/639/027 (pretisni omot 98 tablet) EU/1/10/639/028 (pretisni omot 100 tablet)
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)
Slovenian: EU/1/10/639/011 (pretisni omot 14 tablet) EU/1/10/639/012 (pretisni omot 28 tablet) EU/1/10/639/013 (pretisni omot 30 tablet) EU/1/10/639/014 (pretisni omot 56 tablet) EU/1/10/639/015 (pretisni omot 84 tablet) EU/1/10/639/016 (pretisni omot 90 tablet) EU/1/10/639/017 (pretisni omot 98 tablet) EU/1/10/639/018 (pretisni omot 100 tablet)
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)
Slovenian: EU/1/10/639/001 (pretisni omot 14 tablet) EU/1/10/639/002 (pretisni omot 28 tablet) EU/1/10/639/003 (pretisni omot 30 tablet) EU/1/10/639/004 (pretisni omot 56 tablet) EU/1/10/639/005 (pretisni omot 84 tablet) EU/1/10/639/006 (pretisni omot 90 tablet) EU/1/10/639/007 (pretisni omot 98 tablet) EU/1/10/639/008 (pretisni omot 100 tablet)
English: It is not known whether doses lower than 80 mg of telmisartan are effective in reducing cardiovascular morbidity.
Slovenian: Priporočeni odmerek je 80 mg enkrat na dan. Ni znano, ali so odmerki, manjši od 80 mg telmisartana,
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)
Slovenian: EU/1/10/639/021 (pretisni omot 14 tablet) EU/1/10/639/022 (pretisni omot 28 tablet) EU/1/10/639/023 (pretisni omot 30 tablet) EU/1/10/639/024 (pretisni omot 56 tablet) EU/1/10/639/024 (pretisni omot 84 tablet) EU/1/10/639/026 (pretisni omot 90 tablet) EU/1/10/639/027 (pretisni omot 98 tablet) EU/1/10/639/028 (pretisni omot 100 tablet) EU/1/10/639/029 (vsebnik 30 tablet)
English: What Telmisartan Actavis looks like and contents of the pack 20 mg tablets are white, round, flat with logo T on one side
Slovenian: 20 mg tablete so bele, okrogle, ploščate tablete z oznako T na eni strani.
English: HDPE container with LDPE lid and desiccant Pack sizes: 30 or 250 tablets
Slovenian: Velikosti pakiranj: 30 ali 250 tablet
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)
Slovenian: EU/1/10/639/001 (pretisni omot 14 tablet) EU/1/10/639/002 (pretisni omot 28 tablet) EU/1/10/639/003 (pretisni omot 30 tablet) EU/1/10/639/004 (pretisni omot 56 tablet) EU/1/10/639/005 (pretisni omot 84 tablet) EU/1/10/639/006 (pretisni omot 90 tablet) EU/1/10/639/007 (pretisni omot 98 tablet) EU/1/10/639/008 (pretisni omot 100 tablet) EU/1/10/639/009 (vsebnik 30 tablet)
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) EU/1/10/639/019 (30 tablets container) EU/1/10/639/020 (250 tablets container)
Slovenian: EU/1/10/639/011 (pretisni omot 14 tablet) EU/1/10/639/012 (pretisni omot 28 tablet) EU/1/10/639/013 (pretisni omot 30 tablet) EU/1/10/639/014 (pretisni omot 56 tablet) EU/1/10/639/015 (pretisni omot 84 tablet) EU/1/10/639/016 (pretisni omot 90 tablet) EU/1/10/639/017 (pretisni omot 98 tablet) EU/1/10/639/018 (pretisni omot 100 tablet) EU/1/10/639/019 (vsebnik 30 tablet)
English: Medicinal products or therapeutic class of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Slovenian: ACE, antagonisti receptorjev angiotenzina II, nesteroidna protivnetna zdravila (NSAID, vključno s selektivnimi zaviralci CO-2), heparin, imunosupresivi (ciklosporin ali takrolimus) in trimetoprim.
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.
Slovenian: (ortostatska hipotenzija), zasoplost, kašelj, trebušne bolečine, driska, nelagodje v trebuhu, napenjanje, bruhanje, srbež, povečano znojenje, medikamentni izpuščaj, bolečine v hrbtu, mišični krči, mišična bolečina (mialgija), ledvična okvara, tudi akutna ledvična odpoved, bolečina v prsnem košu, občutek oslabelosti in zvišana raven kreatinina v krvi.
English: Muscoloskeletal and connective tissue disorders Uncommon:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: Blood and the lymphatic system disorders Uncommon:
Slovenian: sepsa, vključno s smrtnim izidom1 Bolezni krvi in limfatičnega sistema Občasni:
English: Hypotension
Slovenian: Plodnost
English: Anaphylactic reaction , hypersensitivity Metabolism and nutrition disorders Uncommon:
Slovenian: Stenoza aortne in mitralne zaklopke, obstruktivna hipertrofična kardiomiopatija
English: Inventedname Strength Pharmaceutical Form
Slovenian: Jakost Farmacevtska oblika Pot uporabe
English: The application for Mutual Recognition for Adartrel were submitted to Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom.
Slovenian: Prošnja za medsebojno priznanje za Adartrel je bila predložena Avstriji, Belgiji, Cipru, Češki republiki, Danski, Estoniji, Finski, Nemčiji, Grčiji, Madžarski, Irski, Italiji, Latviji, Litvi, Luksemburgu, Malti, Nizozemski, Norveški, Poljski, Portugalski, Slovaški republiki, Sloveniji, Španiji, Švedski in Združenem kraljestvu.
English: London, 3 April 2006 EMEA/CHMP/416317/2005
Slovenian: London, 3. aprila 2006 EMEA/CHMP/416317/2005
English: The final opinion was converted into a Decision by the European Commission on 3 April 2006.
Slovenian: Končno mnenje je bilo v Odločbo Evropske komisije spremenjeno dne 3. aprila 2006.
English: A positive opinion was therefore adopted on 15 September 2005.
Slovenian: Pozitivno mnenje je bilo tako sprejeto 15. septembra 2005.
English: Adartrel is a selective dopamine agonist at the D2- and D3-dopamine receptor subtypes and is active both centrally and peripherally.
Slovenian: Adartrel je selektivni agonist dopamina na podvrstah dopaminskih receptorjev D2- in D3 in deluje centralno in periferno.
English: The Mutual Recognition Procedure started in September 2004.
Slovenian: Postopek medsebojnega priznavanja se je začel septembra
English: The referral procedure was triggered by Spain and The Netherlands, who were of the opinion that this medicinal product might present a risk to public health since the safety and efficacy in long-term treatment of ropinirole in restless legs syndrome had not been demonstrated.
Slovenian: Napotitveni postopek sta sprožili Španija in Nizozemska, ki sta menili da bi lahko to zdravilo pomenilo tveganje za javno zdravje, saj varnost in učinkovitost ropinirola pri dolgotrajnem zdravljenju sindroma nemirnih nog nista bili dokazani.
English: The arbitration procedure started on 15 December 2004.
Slovenian: Arbitražni postopek se je začel 15. decembra 2004.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2) REFERRAL Adartrel International Non-Proprietary Name (INN): Ropinirole
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 29(2) Adartrel Mednarodno nelastniško ime (INN): Ropinirol
English: Supplementary information was provided by the Marketing Authorisation Holder on 18 March 2005.
Slovenian: Dodatne informacije je imetnik dovoljenja za promet z zdravilom predložil dne 18. marca 2005.
English: A Marketing Authorisation for Adartrel was granted to GlaxoSmithKline by France on 30 June 2004.
Slovenian: Dovoljenje za promet z zdravilom Adartrel je Francija odobrila družbi GlaxoSmithKline dne 30. junija 2004.
English: During its 12-15 September 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee was of the opinion that a marketing authorisation should be granted subject to certain conditions considered essential for the safe and effective use of the medicinal product.
Slovenian: Na svojem zasedanju od 12. do 15. septembra 2005 je CHMP glede na celotne predložene podatke in znanstveno razpravo znotraj Odbora menil, da se dovoljenje za promet z zdravilom lahko podeli pod posebnimi pogoji, za katere je mnenja, da so bistvenega pomena za varno in učinkovito rabo zdravila.
English: The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the Summary of Product Characteristics in the Annex III.
Slovenian: Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III.
English: Conditions of the Marketing Authorisation are set out in Annex IV.
Slovenian: Pogoji dovoljenja za promet z zdravilom so navedeni v Dodatku IV.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RC on 23 February 2005.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Purevax RC, veljavno po vsej Evropski uniji, izdala 23. februarja 2005.
English: They included young and adult cats of various breeds, but not young kittens.
Slovenian: Vanje so bile vključene mlade in odrasle mačke različnih pasem, mladiči pa ne.
English: The cat should be revaccinated for all components one year after the first vaccination course, then every three years.
Slovenian: Mačko je treba ponovno cepiti za vse sestavine cepiva eno leto po prvem cepljenju in nato na vsaka tri leta.
English: The vaccine helps to reduce the symptoms of the diseases and also helps to reduce viral excretion in case of calicivirus infection for one year after vaccination.
Slovenian: Cepivo pomaga zmanjševati simptome bolezni in tudi prispeva k zmanjšanju izločanja virusa pri okužbi s kalicivirusom eno leto po cepljenju.
English: If the kitten has high levels of antibodies received from the mother in the womb and in the milk, the first vaccination should be delayed until 12 weeks of age.
Slovenian: Če ima mačka visoke ravni protiteles, ki jih je prejela v maternici od matere in z mlekom, je treba prvo cepljenje odložiti do 12. tedna starosti.
English: The antibodies will help to protect against the diseases caused by these viruses.
Slovenian: To prispeva k obrambi pred boleznimi, ki jih ti virusi povzročajo.
English: The main measure of effectiveness was the level of antibodies in the blood against the viruses in the vaccine.
Slovenian: Glavno merilo učinkovitosti je bila raven protiteles v krvi proti virusom v cepivu.
English: The first injection should be given in kittens aged at least eight weeks, with a second injection three to four weeks later.
Slovenian: Prvo cepivo je treba dati mladim mačkam, starim vsaj osem tednov, drugo injekcijo pa tri do štiri tedne pozneje.