natgillin/translations-raw huggingface dataset:
For the prevention of flea infestations, the veterinary medicinal product should be administered at monthly intervals throughout the flea season, starting one month before fleas become active.
V sezoni razmnoževanja bolh je treba za preprečevanje infestacij z njimi zdravilo za uporabo v veterinarski medicini dajati v mesečnih intervalih, in sicer z začetkom mesec dni preden bolhe postanejo aktivne.
For complete elimination of the mites, a single dose of the veterinary medicinal product should be administered for two consecutive months.
Za popolno odpravo garij zadostuje en odmerek zdravila, ki se ga da dva meseca zapored.
When replacing another heartworm preventive product in a heartworm disease prevention programme, the first dose of the veterinary medicinal product must be given within a month of the last dose of the former medication.
Kadar s tem zdravilom za uporabo v veterinarski medicini nadomestimo druga zdravila za uporabo v veterinarski medicini v programih za preprečevanje infestacij s srčnimi glistami je treba prvi odmerek tega zdravila dati znotraj obdobja enega meseca po zadnjem odmerjanju prejšnjega zdravila.
Following spot on administration selamectin is absorbed from the skin reaching maximum plasma concentrations approximately 1 and 3 days after administration in cats and dogs respectively.
Po nanosu na kožo se selamektin resorbira in doseže maksimalno plazemsko koncentracijo približno v 1 dnevu po nanosu pri mačkah, oziroma 3 dneh po nanosu pri psih.
1 pipette 4 pipettes 24 pipettes x 0.25 ml x 0.5 ml x 1.0 ml x 2.0 ml x 3.0 ml
1 merilna kapalka 4 merilne kapalke 24 merilnih kapalk x 0,25 ml x 0,5 ml x 1,0 ml x 2,0 ml x 3,0 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON 30mg, 60mg, 120mg, 240mg, 360mg (1, 4 AND 24 PIPETTES)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA 30 mg, 60mg, 120mg, 240mg, 360mg (1, 4 IN 24 MERILNIH KAPALK)
• Treatment of biting lice infestations (Trichodectes canis)
• Zatiranje infestacij z ušmi, ki grizejo (Trichodectes canis)
Wash hands after use and wash off any product in contact with the skin immediately with soap and water.
Po uporabi si umijte roke in takoj sperite tiste dele kože, ki so prišli v stik z zdravilom z vodo in milom.
Administere d volume (nominal pipette size, ml)
Volumen odmerka (nominalna velikost merilne kapalke v ml)
This ensures that fleas infesting the animal are killed, no viable flea eggs are produced by these fleas, and larvae (found only in the environment) are also killed.
To zagotovi, da bolhe, ki so infestirale živali, odmrejo in ne proizvajajo več vitalnih jajčec prav tako pa pobije tudi larve, ki se nahajajo v okolju.
4.2 Indications for use, specifying the target species Cats and dogs:
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah
Following administration of the veterinary medicinal product, the adult fleas on the animal are killed, no viable eggs are produced, and larvae (found only in the environment) are also killed.
Po uporabi zdravila za uporabo v veterinarski medicini odrasle bolhe na živali odmrejo, produkcija vitalnih jajčec je ustavljena in tudi ličinke (prisotne le v okolju) odmrejo.
20.1-40.0 1 pipette of Evicto 240 mg for dogs 20.1-40.0 kg
20,1-40,0 1 merilna kapalka zdravila Evicto 240 mg za pse 20,1-40,0 kg
• Treatment of adult intestinal hookworms (Ancylostoma tubaeforme).
• Zatiranje odraslih črevesnih kavljastih črvov (Ancylostoma tubaeforme).
The product is available in packs of one, four and twenty-four pipettes (all pipette sizes).
Zdravilo se nahaja v ovojnini z eno, štirimi ali štiriindvajsetimi merilnimi kapalkami (vse velikosti merilnih kapalk).
Spot-on use
NAVODILO ZA UPORABO
EVICTO 45 mg for cats
Evicto 45 mg za mačke
Tel. : + 34-(0)93 470 79 40
España Tel. : + 34-(0)93 470 79 40
Treatment of roundworm infections (cats and dogs)
Zdravljenje infekcij z valjastimi črvi ( mačke in psi)
The product can be used in breeding, pregnant and lactating cats and dogs.
To zdravilo se lahko se uporablja v obdobju vzreje, brejosti in laktacije pri mačkah in psicah.
• Treatment of adult roundworms (Toxocara cati)
• Zatiranje odraslih valjastih črvov (Toxocara cati)
Treatment of hookworm infections (cats)
Zdravljenje infekcij s kavljastimi črvi (mačke)
• Treatment of adult intestinal roundworms (Toxocara canis).
• Zatiranje infestacij odraslih intestinalnih valjastih črvov(Toxocara canis).
EVICTO 15 mg for cats and dogs 60 mg/ml solution Selamectin
EVICTO 15 mg mačke in pse 60 mg/ml raztopina selamektin
60 mg/ml solution Selamectin
60 mg/ml raztopina selamektin
120 mg/ml solution Selamectin
120 mg/ml raztopina selamektin
This stops flea reproduction, breaks the flea lifecycle and may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Tako se razmnoževanje ustavi in prekine se razvojni krog bolhe, kar lahko pomaga pri obvladovanju obstoječe infestacije okolja z bolhami na področjih, ki so dostopna živalim.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON 45mg, 60mg (1, 4 AND 24 PIPETTES)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA, 45 mg, 60mg (1, 4 IN 24 MERILNIH KAPALK)
for one month following a single administration.
- zdravilo deluje en mesec po enkratnem odmerku.
Flea treatment and prevention (cats and dogs)
Zdravljenje in preprečevanje infestacij z bolhami (mačke in psi)
Invert the cap and place other end back onto applicator tip.
Obrnite pokrovček in ga z nasprotnim koncem namestite nazaj na vrh merilne kapalke.
Remove the pipette from its protective package
Merilno kapalko z zdravilom vzemite iz zaščitnega ovoja.
1 pipette 4 pipettes 24 pipettes x 0.75 ml x 1.0 ml
1 merilna kapalka 4 merilne kapalke 24 merilnih kapalk x 0,75 ml x 1,0 ml
1 pipette of Evicto 15 mg for cats and dogs ≤2.5 kg
Evicto 15 mg kožni nanos, raztopina za mačke in pse ≤ 2,5 kg
Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will aid prevention of flea infestations in the litter up to seven weeks of age.
Preko zmanjševanja populacije bolh, mesečno zdravljenje brejih in doječih živali pripomore k preprečevanju infestacije z bolhami pri mladičih do sedmega tedna starosti.
2 - Remove the cap prior to treatment application.
2 - Pred nanašanjem pokrovček odstranite.
1 pipette of EVICTO 15 mg for cats and dogs contains 0.25 ml of 60 mg/ml solution 1 pipette of EVICTO 45 mg for cats contains 0.75 ml of 60 mg/ml solution 1 pipette of EVICTO 60 mg for cats contains 1.0 ml of 60 mg/ml solution 1 pipette of EVICTO 30 mg for dogs contains 0.25 ml of 120 mg/ml solution 1 pipette of EVICTO 60 mg for dogs contains 0.5 ml of 120 mg/ml solution 1 pipette of EVICTO 120 mg for dogs contains 1.0 ml of 120 mg/ml solution 1 pipette of EVICTO 240 mg for dogs contains 2.0 ml of 120 mg/ml solution 1 pipette of EVICTO 360 mg for dogs contains 3.0 ml of 120 mg/ml solution.
1 merilna kapalka zdravila EVICTO 30 mg za pse vsebuje 0,25 ml 120 mg/ml raztopine 1 merilna kapalka zdravila EVICTO 60 mg za pse vsebuje 0,5 ml 120 mg/ml raztopine 1 merilna kapalka zdravila EVICTO 120 mg za pse vsebuje 1,0 ml 120 mg/ml raztopine 1 merilna kapalka zdravila EVICTO 240 mg za pse vsebuje 2,0 ml 120 mg/ml raztopine 1 merilna kapalka zdravila EVICTO 360 mg za pse vsebuje 3,0 ml 120 mg/ml raztopine
Fertility: Can be used in breeding cats and dogs.
Lahko se uporablja pri vzrejnih mačkah in psih.
40.1-60.0 1 pipette of Evicto 360 mg for dogs 40.1-60.0 kg
40,1-60,0 1 merilna kapalka zdravila Evicto 360 mg za pse 40,1-60,0 kg > 60 Ustrezna kombinacija merilnih kapalk
1 pipette 4 pipettes 24 pipettes x 0.25 ml
1 merilna kapalka 4 merilne kapalke 24 merilnih kapalk x 0,25 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Sachets 15mg, 30mg, 45mg, 60mg, 120mg, 240mg, 360mg,
Vrečka 15mg, 30mg, 45mg, 60mg, 120mg, 240mg, 360mg
2.6-5.0 1 pipette of Evicto 30 mg for dogs 2.6-5.0 kg 5.1-10.0 1 pipette of Evicto 60 mg for dogs 5.1-10.0 kg 10.1-20.0 1 pipette of Evicto 120 mg for dogs 10.1-20.0 kg
2,6-5,0 1 merilna kapalka zdravila Evicto 30 mg za pse 2,6-5,0 kg 5,1-10,0 1 merilna kapalka zdravila Evicto 60 mg za pse 5,1-10,0 kg 10,1-20,0 1 merilna kapalka zdravila Evicto 120 mg za pse 10,1-20,0 kg
Remove the cap prior to treatment application.
Pred nanašanjem pokrovček odstranite.
PHARMACOLOGICAL PROPERTIES
FARMAKOLOŠKELASTNOSTI
EVICTO 240 mg for dogs
EVICTO 240 mg za pse
Treatment of biting lice (cats and dogs)
Zdravljenje infestacij z ušmi, ki grizejo (mačke in psi)
Excipient:
Učinkovina:
EVICTO 120 mg for dogs
Evicto 120 mg za pse
Prevention of heartworm disease (cats and dogs)
Preprečevanje obolenja, ki ga povzroča srčna glista (mačke in psi)
Mg of selamectin dispensed
Selamektin (selamectin)
Evicto 60 mg for cats
Evicto 60 mg za mačke
Pregnancy and lactation: Can be used in pregnant and lactating cats and dogs.
Lahko se uporablja pri brejih in doječih mačkah in psicah.
This product is a skin and eye irritant.Wash hands after use and wash off any product in contact with the skin immediately with soap and water.
Po uporabi si umijte roke in takoj sperite, tiste dele kože, ki so prišli v stik z zdravilom z vodo in milom.
EVICTO 360 mg for dogs
EVICTO 360 mg za pse
Evicto 30 mg for dogs
EVICTO 30 mg za pse
EVICTO 30 mg for dogs
Evicto 30 mg za pse
7.6-10.0 1 pipette of Evicto 60 mg for cats 7.6-10.0kg
7,6-10,0 1 merilna kapalka zdravila Evicto 60 mg za mačke 7,610,0kg > 10 Ustrezna kombinacija merilnih kapalk
Treatment of ear mites (cats)
Zdravljenje ušesnih garij (mačke)
≤ 2.5 1 pipette of Evicto 15 mg for cats and dogs ≤2.5 kg 2.6-7.5 1 pipette of Evicto 45 mg for cats 2.6-7.5 kg
2.6-7,5 1 merilna kapalka zdravila Evicto 45 mg za mačke 2,6-7,5 kg
AUTHORISATION
Selamectin
Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will aid prevention of flea infestation in the litter up to seven weeks of age.
Mesečno zdravljenje brejih in doječih živali zmanjša populacijo bolh in pomaga preprečiti infestacijo legla do sedmega tedna starosti.
EVICTO 60 mg for dogs
Evicto 60 mg za pse
Evicto 60 mg for dogs
EVICTO 60 mg za pse
5.1-10.0 1 pipette of Evicto 60 mg for dogs 5.1-10.0 kg 10.1-20.0 1 pipette of Evicto 120 mg for dogs 10.1-20.0 kg 20.1-40.0 1 pipette of Evicto 240 mg for dogs 20.1-40.0 kg 40.1-60.0 1 pipette of Evicto 360 mg for dogs 40.1-60.0 kg Appropriate combination of pipettes
Evicto 60 mg kožni nanos, raztopina za pse 5,1 - 10 kg Evicto 120 mg kožni nanos, raztopina za pse 10,1 - 20,0 kg Evicto 240 mg kožni nanos, raztopina za pse 20,1 - 40,0 kg Evicto 360 mg kožni nanos, raztopina za pse 40,1 - 60,0 kg
Evicto 30 mg spot-on solution for dogs 2.6-5.0 kg Evicto 60 mg spot-on solution for dogs 5.1-10.0 kg
Evicto v30 mg kožni nanos, raztopina za pse 2,6 - 5,0 kg
Evicto 45 mg spot-on solution for cats 2.6-7.5 kg Evicto 60 mg spot-on solution for cats 7.6-10.0 kg selamectin
EVICTO 45 mg kožni nanos, raztopina za mačke 2,6 - 7,5 kg EVICTO 60 mg kožni nanos, raztopina za mačke 7,6 - 10 kg
Evicto 15 mg spot-on solution for cats and dogs ≤2.5 kg selamectin
EVICTO 15 mg kožni nanos, raztopina za mačke in pse ≤ 2,5 kg
Spot-on use.
UPORABE, ČE JE SMISELNO
Evicto 120 mg spot-on solution for dogs 10.1-20.0 kg Evicto 240 mg spot-on solution for dogs 20.1-40.0 kg Evicto 360 mg spot-on solution for dogs 40.1-60.0 kg selamectin
EVICTO 60 mg kožni nanos, raztopina za pse 5,1 - 10 kg EVICTO 120 mg kožni nanos, raztopina za pse 10,1 - 20,0 kg EVICTO 240 mg kožni nanos, raztopina za pse 20,1 - 40,0 kg EVICTO 360 mg kožni nanos, raztopina za pse 40,1 - 60,0 kg
Why was Syner-Kinase reviewed?
Zakaj je bilo zdravilo Syner-Kinase pregledano?
The review of Syner-Kinase was initiated on 26 July 2018 at the request of the United Kingdom, under Article 29(4) of Directive 2001/83/EC.
Pregled zdravila Syner-Kinase se je začel 26. julija 2018 na zahtevo Združenega kraljestva v skladu s členom 29(4) Direktive 2001/83/ES.
What is Syner-Kinase?
Kaj je zdravilo Syner-Kinase?
A European Commission decision valid throughout the EU was issued on 16/05/2019.
Sklep Evropske komisije, ki velja po vsej EU, je bil izdan 16. maja 2019.
The Agency also considered that the data provided by the company show that the purification process is suitable for the removal of possible viral and prion impurities.
Agencija je menila tudi, da podatki, ki jih je predložilo podjetje, dokazujejo, da je postopek čiščenja primeren za odstranjevanje morebitnih virusnih in prionskih nečistot.
Syner-Kinase is a medicine used to dissolve blood clots in the lungs, in deep veins, in arteries in the arms, hands, legs and feet, or in catheters or cannulae (surgical tubes) placed in a vein.
Syner-Kinase je zdravilo, ki se uporablja za raztapljanje krvnih strdkov v pljučih, globokih venah, arterijah v rokah, dlaneh, nogah in stopalih ali v katetrih ali kanilah (kirurških cevkah), nameščenih v veni.
The marketing authorisation holder, Syner-Medica Ltd, requested that the marketing authorisation for Syner-Kinase granted in the UK on 29 September 2006 be recognised in France, Germany, the Netherlands and Spain (the ‘concerned Member States').
Imetnik dovoljenja za promet z zdravilom, podjetje Syner-Medica Ltd, je zaprosil, da se dovoljenje za promet z zdravilom za zdravilo Syner-Kinase, izdano v Združenem kraljestvu dne 29. septembra 2006, prizna tudi v Franciji, Nemčiji, na Nizozemskem in v Španiji („zadevnih državah članicah“).
Syner-Kinase contains the active substance urokinase, a natural enzyme that helps to dissolve blood clots in the body.
Zdravilo Syner-Kinase vsebuje učinkovino urokinazo, naravni encim, ki pomaga raztapljati krvne strdke v telesu.
Concerns were also raised regarding the manufacturing and purification processes for the active substance urokinase, which is extracted from human urine.
Pojavili so se tudi pomisleki o postopku proizvodnje in čiščenja učinkovine urokinaze, ki se ekstrahira iz človeškega urina.
demonstrated that the production of the semi-purified urokinase (an intermediate step in the production of the active substance) is adequately controlled, and that this intermediate is manufactured at a site that complies with the principles and guidelines of Good Manufacturing Practice (GMP).
Končno je podjetje dokazalo tudi, da je proizvodnja delno očiščene urokinaze (vmesna faza pri proizvodnji učinkovine) primerno nadzorovana in da je intermediat izdelan na lokaciji, ki deluje v skladu z načeli in smernicami dobre proizvodne prakse (GMP).
The grounds for the referral were concerns that the data provided by the company, which included published data on other urokinase-containing medicines, were not sufficient to demonstrate that the benefits of Syner-Kinase outweigh its risks.
Razlogi za napotitev so bili pomisleki, da podatki, ki jih je predložilo podjetje in so vključevali objavljene podatke o drugih zdravilih, ki vsebujejo urokinazo, niso zadoščali za dokaz, da koristi zdravila Syner-Kinase odtehtajo z njim povezana tveganja.
On 28 February 2019, the European Medicines Agency completed a review of Syner-Kinase and associated names following a disagreement among EU Member States regarding its authorisation.
Evropska agencija za zdravila je 28. februarja 2019 zaključila pregled v zvezi z izdajo dovoljenja za promet z zdravilom Syner-Kinase in povezanimi imeni po nesoglasju med državami članicami EU.
However, the Member States were not able to reach an agreement and the UK medicines agency referred the matter to EMA for arbitration on 5 July
Ker pa države članice niso dosegle soglasja, je britanska agencija za zdravila 5. julija 2018 zadevo napotila na Evropsko agencijo za zdravila v arbitražo.
The Agency concluded that the benefits of Syner-Kinase outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation.
Agencija je zaključila, da koristi zdravila Syner-Kinase odtehtajo z njim povezana tveganja in da se dovoljenje za promet z njim, izdano v Združenem kraljestvu, lahko prizna tudi v drugih državah članicah EU, v katerih je podjetje zanj zaprosilo.
EMA recommends authorisation of Syner-Kinase (urokinase) in the EU
Evropska agencija za zdravila priporoča izdajo dovoljenja za promet z zdravilom Syner-Kinase (urokinaza) v EU
Having reviewed the available data, EMA considered that Syner-Kinase is comparable to the urokinase products mentioned in the published literature, and that the data are adequate to support its proposed use.
Po pregledu razpoložljivih podatkov je agencija EMA ocenila, da je zdravilo Syner-Kinase primerljivo z zdravili, ki vsebujejo urokinazo, iz objavljene literature, in da razpoložljivi podatki ustrezno podpirajo
EMA recommends authorisation of Syner-Kinase (urokinase) in the EU EMA/299749/2019
Kinase (urokinaza) v EU EMA/446079/2019
Therefore, based on the evaluation of the available data, the Agency concluded that the benefits of Syner-Kinase outweigh its risks, and that the marketing authorisation for Syner-Kinase should be granted in all concerned Member States.
Zato je agencija na podlagi vrednotenja razpoložljivih podatkov zaključila, da koristi zdravila SynerKinase odtehtajo z njim povezana tveganja in da se dovoljenje za promet s tem zdravilom izda v vseh zadevnih državah članicah.
For publication with complete documentation after commission decision: The European Commission issued a decision on 16 February 2009.
Za objavo s celotno dokumentacijo po odločitvi Komisije: Evropska komisija je odločbo izdala dne 16. februarja 2009.
Ref. EMEA/CHMP/137577/2009 EMEA/H/A-30/998
EMEA/150579/2009 EMEA/H/A-30/998
Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Člen 30 Direktive 2001/83/ES, kakor je bila spremenjena, napotitev na podlagi različnih odločitev, ki so jih sprejele države članice.
London, 18 February 2009 Doc.
London, 18. februarja 2009 Sklic dok.
Dr Alar Irs (Estonia)
dr Alar Irs (Estonija)
The company that markets it is Novartis.
Družba, ki zdravilo trži, je Novartis.
The review was carried out under an ‘Article 30' referral1.
Pregled je bil izveden v skladu z napotitvenim postopkom1 po členu 30.
Dr Liv Mathison (Norway)
dr Liv Mathison (Norveška)
• how to manage dose increases,
• kako voditi večanje odmerkov,
Why was Diovan reviewed?
Zakaj je bilo zdravilo Diovan pregledano?
However the Committee agreed that such a combination should still not be recommended until there is more evidence to support its positive benefit-risk balance.
Vendar pa se je Odbor strinjal, da se tovrstna kombinacija ne sme priporočati, dokler ni več dokazov, ki podpirajo njegovo pozitivno ravnotežje med koristmi in tveganji.
The 320 mg strength was not available in all markets.
Jakost v odmerku 320 mg ni bila na voljo na vseh trgih.
Consideration should be given to reducing the dose of concomitant diuretics.
Razmisliti je treba o zmanjšanju odmerka sočasnih diuretikov.
As a result, blood vessels relax and blood pressure is lowered.
Posledično se sprostijo krvne žile, krvni tlak pa zniža.
Questions and answers on the referral for Diovan film coated tablets and hard capsules containing valsartan 40, 80, 160 or 320 mg
Vprašanja in odgovori v zvezi z napotitvenim postopkom za zdravilo Diovan filmsko obložene tablete in trde kapsule, ki vsebujejo valsartan 40, 80, 160 ali 320 mg
The CHMP discussed three areas where there was a divergence:
CHMP je razpravljal o treh področjih, na katerih je bilo neskladje:
Diovan can also be available in the EU and the EEA under other trade names: Angiosan, Cordinate, Dalzad, Diovane, Kalpress, Miten, Novacard, Provas, Rixil, Tareg, and Varexan.
Zdravilo Diovan je v EU in EGP lahko na voljo tudi pod drugimi imeni: Angiosan, Cordinate, Dalzad, Diovane, Kalpress, Miten, Novacard, Provas, Rixil, Tareg in Varexan.
Diovan is authorised in the European Union (EU) via national procedures.
Zdravilo Diovan je v Evropski uniji (EU) odobreno z nacionalnimi postopki.
What is Diovan?
Kaj je zdravilo Diovan?
All strengths can be used in these diseases, except the lowest (40 mg) strength, which cannot be used to treat hypertension.
Za te bolezni se lahko uporabijo vse jakosti, razen najmanjše jakosti (40 mg), ki je ne moremo uporabiti za zdravljenje hipertenzije.
The CHMP also updated other parts of the products information to put it in line with the new data available.
CHMP je prav tako posodobil druge dele informacij o zdravilu, da bodo v skladu z novo dostopnimi podatki.
• concomitant use of other medicinal products containing, or raising the level of, potassium.
• sočasna uporaba drugih zdravil, ki vsebujejo kalij ali zvišajo njegovo raven.
The European Medicines Agency (EMEA) has completed a review of Diovan (and associated names).
Evropska agencija za zdravila (EMEA) je zaključila pregled zdravila Diovan (in z njim povezanih imen).
The maximum daily dose administered in clinical trials is 320 mg in divided doses.
Največji dnevni odmerek v kliničnih preskušanjih je 320 mg v razdeljenih odmerkih.
Evaluation of patients with heart failure should always include assessment of renal function.”
V ocenjevanje bolnikov s srčnim popuščanjem mora biti vedno vključevana ocena ledvične funkcije.“
The Committee also concluded that the 320 mg dose provides a modest, but statistically significant additional reduction in blood pressure compared to 160 mg and a similarly modest increase in the rate of blood pressure control.
Odbor je prav tako zaključil, da 320-miligramski odmerek v primerjavi s 160-miligramskim zagotavlja zmerno, a statistično pomembno dodatno znižanje krvnega tlaka in podobno zmerno povečan obseg nadzora krvnega tlaka.
Having assessed the data available, the CHMP agreed that valsartan 80 mg can be used as a starting dose in patients with reduced kidney function.
Po oceni razpoložljivih podatkov se je CHMP strinjal, da se valsartan v odmerku 80 mg lahko uporablja kot začetni odmerek pri bolnikih z zmanjšano ledvično funkcijo.
However, the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended (see sections 4.4 and 5.1).
Vendar pa trojna kombinacija zaviralca angiotenzinske konvertaze, zaviralca beta receptorjev in valsartana ni priporočljiva (glejte poglavji 4.4 in 5.1).
The CHMP considered the need to harmonise a number of precautions for use:
CHMP je razpravljal o potrebi uskladitve številnih previdnostnih ukrepov:
This has led to divergences across member states on the way the medicine can be used, as seen in the differences observed in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed.
To je v državah članicah vodilo v razhajanja glede uporabe zdravila, kot je razvidno iz povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo v državah, v katerih je zdravilo na trgu.
Angiotensin II is a substance in the body that causes vessels to tighten, thus causing blood pressure to increase.
Angiotenzin II je snov v telesu, ki povzroči zoženje žil in s tem poviša krvni tlak.
The CHMP endorsed the following text: “If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, monitoring of potassium plasma levels is advised”.
CHMP je podprl naslednje besedilo: „Če se meni, da je zdravilo, ki vpliva na raven kalija, potrebno v kombinaciji z valsartanom, se priporoča spremljanje ravni kalija v plazmi.“;
The CHMP endorsed the use of Diovan in the “treatment of essential hypertension”.
CHMP je odobril uporabo zdravila Diovan za „zdravljenje esencialne hipertenzije“.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Diovan in the European Union (EU) and the European Economic Area (EEA).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba v Evropski uniji (EU) in v Evropskem gospodarskem prostoru (EGP) uskladiti podatke o predpisovanju zdravila Diovan.
However, the dose of valsartan should not exceed 80 mg in patients with cholestasis and should be used with caution.
Vendar pa odmerek valsartana pri bolnikih s holestazo ne sme presegati 80 mg in ga je treba uporabljati previdno.