natgillin/translations-raw huggingface dataset:
At the dose of 50 mg/kg/day in rats (59 times the AUC0-24h of free plasma concentration at MRHD), delay in the ossification of the sacral and caudal vertebrae was observed.
Pri podganah so pri odmerku 50 mg/kg/dan (kar pomeni 59-krat večjo AUC0-24h koncentracije proste učinkovine v plazmi kot pri najvišjem priporočenem odmerku za človeka) opažali zakasnitev osifikacije križnih in repnih vretenc.
In patients receiving substances that are moderate CYP3A4 inhibitors, such as fluconazole, grapefruit juice and erythromycin, the recommended starting dose is 7.5 mg daily.
Pri bolnikih, ki prejemajo snovi, ki so zmerni zaviralci CYP3A4, na primer flukonazol, sok grenivke in eritromicin, je priporočeni začetni odmerek 7,5 mg na dan.
However, protein binding of darifenacin was affected by moderate hepatic impairment.
Vendar pa je zmerna jetrna okvara vplivala na vezavo darifenacina na proteine.
Titanium dioxide (E171)
Filmska obloga polietilenglikol hipromeloza titanov dioksid (E171) smukec
How to store Emselex 6.
Shranjevanje zdravila Emselex 6.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
In patients receiving substances that are potent CYP2D6 inhibitors (e.g. paroxetine, terbinafine, cimetidine and quinidine) the recommended starting dose should be 7.5 mg daily.
Pri bolnikih, ki dobivajo snovi, ki so močni zaviralci CYP2D6 (na primer paroksetin, terbinafin, cimetidin in kinidin), je priporočeni začetni odmerek 7,5 mg na dan.
How long to take Emselex
Kako dolgo je treba jemati zdravilo Emselex
Concomitant treatment with potent CYP2D6 inhibitors results in an increase in exposure (e.g. of 33% with 20 mg paroxetine at the 30 mg dose of darifenacin).
Če bolnik odmerek dobro prenaša, je za izboljšanje kliničnega odziva mogoče povečati odmerek do 15 mg na dan. Sočasno zdravljenje z močnimi zaviralci CYP2D6 povzroči zvečano izpostavljenost (na primer za 33 % pri 20-miligramskem odmerku paroksetina in 30-miligramskem odmerku darifenacina).
When co-administered with moderate CYP3A4 inhibitors such as erythromycin, clarithromycin, telithromycin, fluconazole and grapefruit juice, the recommended starting dose of darifenacin should be 7.5 mg daily.
Pri sočasni uporabi z zmernimi zaviralci CYP3A4, na primer z eritromicinom, s klaritromicinom, s telitromicinom, s flukonazolom in s sokom grenivke, je priporočeni začetni odmerek darifenacina 7,5 mg na dan.
Emselex is contraindicated in patients with severe hepatic impairment (Child Pugh C) (see section 4.3).
Pri bolnikih s hudo jetrno okvaro (Child Pugh C) je zdravilo Emselex kontraindicirano (glejte poglavje 4.3).
The effect of warfarin on prothrombin time was not altered when co-administered with darifenacin.
Pri sočasni uporabi z darifenacinom se učinek varfarina na protrombinski čas ni spremenil.
What Emselex looks like and contents of the pack Emselex 15 mg prolonged-release tablets are round, convex light peach tablets and are debossed with “DF” on one side and “15” on the other.
Emselex 15 mg tablete s podaljšanim sproščanjem so okrogle, konveksne tablete svetlo breskove barve z vtisnjenim napisom “DF” na eni strani in “15”na drugi
Darifenacin is a moderate inhibitor of the enzyme CYP2D6.
Darifenacin je zmeren zaviralec encima CYP2D6.
White round, convex tablet, debossed with “DF” on one side and “7.5” on the reverse.
Bela, okrogla, konveksna tableta, na eni strani je vtisnjen napis “DF”, na drugi pa “7.5”.
Therapy should be aimed at reversing the anticholinergic symptoms under careful medical supervision.
Zdravljenje mora biti usmerjeno v odpravljanje antiholinergičnih simptomov pod skrbnim medicinskim nadzorom, pri njihovem odpravljanju lahko pomagajo zdravila, kot je fizostigmin.
Emselex 15 mg prolonged-release tablets Darifenacin
Emselex 15 mg tablete s podaljšanim sproščanjem darifenacin
The pharmacokinetics of darifenacin at steady state are dose-dependent, due to saturation of the CYP2D6 enzyme.
Farmakokinetika darifenacina v stanju dinamičnega ravnovesja je zaradi nasičenja encima s CYP2D6 odvisna od odmerka.
People who have taken an overdose may have dry mouth, constipation, headache, indigestion and nasal dryness.
Pri ljudjeh, ki so vzeli prevelik odmerek, lahko pride do suhih ust, zapeke, glavobola, prebavnih motenj in izsušenosti nosne sluznice.
Visual disturbance, including vision blurred
Očesne bolezni pogosti suhe oči občasni motnje vida vključno z zamegljenim vidom
Infections and infestations Uncommon
Infekcijske in parazitske bolezni občasni okužba sečil
The metabolism of darifenacin in CYP2D6 poor metabolisers is principally mediated by CYP3A4.
Presnovo darifenacina pri osebah z upočasnjeno presnovo CYP2D6 posreduje predvsem CYP3A4.
Effects of darifenacin on other medicinal products CYP2D6 substrates
Vpliv darifenacina na druga zdravila
Each tablet contains 15 mg darifenacin (as hydrobromide).
Vsaka tableta vsebuje 15 mg darifenacina (v obliki darifenacinijevega bromida).
• if you have a digestive motility disorder.
• če imate motnjo gibanja prebavne cevi (motilitete črevesja),
• if you suffer from urinary retention (inability to empty your bladder).
• če imate težave zaradi zastajanja seča (nezmožnosti praznjenja mehurja),
Each tablet contains 7.5 mg darifenacin (as hydrobromide).
Vsaka tableta vsebuje 7,5 mg darifenacina (v obliki darifenacinijevega bromida).
Urinary retention, urinary tract disorder, bladder pain
Bolezni sečil občasni zastoj urina, bolezni sečil, bolečina v sečnem mehurju
Darifenacin AUC24 and Cmax from 30 mg once daily dosing in subjects who are extensive metabolisers were 95% and 128% higher when erythromycin (moderate CYP3A4 inhibitor) was co-administered with darifenacin than when darifenacin was taken alone.
Če bolnik odmerek dobro prenaša, je za izboljšanje kliničnega odziva mogoče povečati odmerek do 15 mg na dan. AUC24 and Cmax darifenacina pri odmerku 30 mg enkrat dnevno pri osebah z obsežno presnovo sta bili za 95 % oziroma za 128 % večji, kadar so osebe dobivale sočasno z darifenacinom eritromicin (zmeren zaviralec CYP3A4), kot takrat, ko so dobivale samo darifenacin.
Yellow iron oxide (E172)
Filmska obloga polietilenglikol hipromeloza smukec titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172)
What Emselex can be used for
Za kaj lahko zdravilo Emselex uporabljamo
Emselex 7.5 mg prolonged-release tablets Darifenacin
Emselex 7,5 mg tablete s podaljšanim sproščanjem darifenacin
The dose may be titrated to 15 mg daily to obtain an improved clinical response provided the dose is well tolerated.
Če bolnik odmerek dobro prenaša, je za izboljšanje kliničnega odziva mogoče povečati odmerek do 15 mg na dan, vendar je pri tem potrebna previdnost.
How to take Emselex
Kako jemati zdravilo Emselex
Always take Emselex exactly as your doctor has told you.
Ne prenehajte jemati zdravila Emselex dokler vam tega ne naroči zdravnik.
Urinary retention.
Navodilo shranite.
What Emselex contains
Kaj vsebuje zdravilo Emselex
NAME OF THE MEDICINAL PRODUCT Emselex 7.5 mg prolonged-release tablets
IME ZDRAVILA Emselex 7,5 mg tablete s podaljšanim sproščanjem2.
Change from baseline (median)
sprememba od začetnega stanja (mediana)
Baseline (median)
začetno stanje (mediana)
You should not drive or use machines if you are affected by these symptoms.
Če imate navedene simptome, ne smete voziti ali upravljati strojev.
Table 1: Adverse reactions with Emselex 7.5 mg and 15 mg prolonged-release tablets
Preglednica 1: Neželeni učinki 7,5-miligramskih in 15-miligramskih tablet s podaljšanim sproščanjem zdravila Emselex
• if you have liver problems.
• če imate težave z jetri,
(PVC/CTFE/alu blisters)
(PVC/CTFE/alu pretisni omoti)
NAME OF THE MEDICINAL PRODUCT Emselex 15 mg prolonged-release tablets
IME ZDRAVILA Emselex 15 mg tablete s podaljšanim sproščanjem2.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Merus Labs Luxco II S.à R.L.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Merus Labs Luxco II S.à R.L.
Grapefruit juice may interact with Emselex.
Grenivkin sok lahko medsebojno deluje z zdravilom Emselex, vendar prilagajanje odmerka zdravila Emselex ni potrebno.
Light peach round, convex tablet debossed with “DF” on one side and “15” on the reverse.
Svetlomarelična, okrogla, konveksna tableta, na eni strani je vtisnjen napis “DF”, na drugi pa “15”.
Emselex 7.5 mg and 15 mg were associated with statistically significant improvements over placebo in some aspects of quality of life as measured by the Kings Health Questionnaire including incontinence impact, role limitations, social limitations and severity measures.
V primerjavi s placebom je bil Emselex v odmerkih 7,5 mg in 15 mg povezan s statistično značilnim izboljšanjem nekaterih vidikov kakovosti življenja, izmerjenih s Kingsovim zdravstvenim vprašalnikom.
In patients receiving substances that are potent CYP2D6 inhibitors, such as paroxetine, terbinafine, quinidine and cimetidine, treatment should start with the 7.5 mg dose.
Bolniki, ki se sočasno zdravijo s snovmi, ki so močni zaviralci CYP2D6 ali zmerni zaviralci CYP3A4 Pri bolnikih, ki prejemajo snovi, ki so močni zaviralci CYP2D6, na primer paroksetin, terbinafin, kinidin in cimetidin, se mora zdravljenje začeti z odmerkom 7,5 mg.
• certain anticonvulsants (carbamazepine, barbiturates),
• določena zdravila za zdravljenje ali preprečevanje krčev - antikonvulzive (karbamazepin,
(PVC/PVDC/alu blisters)
(PVC/PVDC/alu pretisni omoti)
However, there was no association between the occurrence of adverse events related to the biliary system in darifenacin-treated patients and increasing age.
Vendar pri bolnikih, zdravljenih z darifenacinom, niso našli povezave med staranjem in pojavljanjem neželenih učinkov, povezanih z žolčnim sistemom.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Metabolism Darifenacin is extensively metabolised by the liver following oral administration.
Presnova Po peroralnem jemanju se darifenacin obsežno presnavlja v jetrih.
56 tablets (PVC/PVDC/alu blisters)
56 tablet (PVC/PVDC/ALU pretisni omoti)
Talk to your doctor before taking Emselex
Pred začetkom jemanja zdravila Emselex se posvetujte z zdravnikom
Food had no effect on darifenacin pharmacokinetics during multiple-dose administration of prolonged-release tablets.
Med jemanjem večkratnih odmerkov tablet s podaljšanim sproščanjem hrana ni vplivala na farmakokinetiko darifenacina.
56 tablets (PVC/CTFE/alu blisters)
56 tablet (PVC/CTFE/ALU pretisni omoti)
How to store Emselex
Shranjevanje zdravila Emselex
49 tablets (PVC/CTFE/alu blisters)
49 tablet (PVC/CTFE/ALU pretisni omoti)
• if you have heartburn and belching.
• če imate zgago in se vam spahuje,
7 tablets (PVC/CTFE/alu blisters)
7 tablet (PVC/CTFE/ALU pretisni omoti)
NAME OF THE MARKETING AUTHORISATION HOLDER Merus Labs Luxco II S.à R.L.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Merus Labs Luxco II S.à R.L.
7 tablets (PVC/PVDC/alu blisters)
7 tablet (PVC/PVDC/ALU pretisni omoti)
MARKETING AUTHORISATION NUMBER(S) EU/1/04/294/013
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/294/013
49 tablets (PVC/PVDC/alu blisters)
49 tablet (PVC/PVDC/ALU pretisni omoti)
98 tablets (PVC/CTFE/alu blisters)
98 tablet (PVC/CTFE/ALU pretisni omoti)
98 tablets (PVC/PVDC/alu blisters)
98 tablet (PVC/PVDC/ALU pretisni omoti)
28 tablets (PVC/CTFE/alu blisters)
28 tablet (PVC/CTFE/ALU pretisni omoti)
MARKETING AUTHORISATION NUMBER(S) EU/1/04/294/007
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/294/007
MARKETING AUTHORISATION NUMBER(S) EU/1/04/294/014
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/294/014
28 tablets (PVC/PVDC/alu blisters)
28 tablet (PVC/PVDC/ALU pretisni omoti)
MARKETING AUTHORISATION NUMBER(S) EU/1/04/294/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/294/001
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 7.5 mg darifenacin (as hydrobromide).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 7,5 mg darifenacina (v obliki darifenacinijevega bromida).
Respiratory, thoracic and mediastinal disorders Common
Žilne bolezni občasni hipertenzija
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Merus Labs Netherlands B.V.,
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
14 tablets (PVC/PVDC/alu blisters)
14 tablet (PVC/PVDC/ALU pretisni omoti)
Renal insufficiency
Ledvična odpoved
14 tablets (PVC/CTFE/alu blisters)
14 tablet (PVC/CTFE/ALU pretisni omoti)
Marketing Authorisation Holder Merus Labs Luxco II S.à R.L.
Imetnik dovoljenja za promet z zdravilom Merus Labs Luxco II S.à R.L.
It can therefore be concluded that darifenacin administration does not alter the pharmacokinetics of CYP3A4 substrates in vivo.
Razpoložljivi podatki pa ne kažejo, da bi darifenacin vplival na izločanje ali biološko uporabnost midazolama, zato je mogoče sklepati, da uporaba darifenacina in vivo ne vpliva na farmakokinetične lastnosti substratov CYP3A4.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 7.5 mg of darifenacin (as hydrobromide) For the full list of excipients, see section 6.1.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 7,5 mg darifenacina (v obliki darifenacinijevega bromida).
Rash, dry skin, pruritus, hyperhidrosis
Bolezni kože in podkožja občasni izpuščaj, suha koža, srbenje, čezmerno znojenje pogostnost neznana angioedem
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg darifenacin (as hydrobromide).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 15 mg darifenacina (v obliki darifenacinijevega bromida).
• if you are receiving treatment for narrow-angle glaucoma.
• če se zdravite zaradi glavkoma z zaprtim zakotjem,
Abdominal pain, nausea, dyspepsia
Psihiatrične motnje občasni nespečnost, motnje mišljenja
Effects of other medicinal products on darifenacin Darifenacin metabolism is primarily mediated by the cytochrome P450 enzymes CYP2D6 and CYP3A4.
Presnovo darifenacina omogočajo predvsem encimi s citokromoma P450 CYP2D6 in CYP3A4, zato bi zaviralci teh encimov lahko povečali izpostavljenost darifenacinu.
For Emselex, these side effects have been reported to be uncommon.
Našteti neželeni učinki so se pri zdravilu Emselex pojavljali občasno.
This is a summary of the European public assessment report.
To je povzetek evropskega javnega poročila o oceni zdravila.
The benefit-risk balance may be found in the scientific discussion 6 of this EPAR.
Razmerje med koristmi in tveganji najdete v znanstveni razpravi 6 tega povzetka EPAR.
When exposed to any of these viruses later in life, the cat will either not become infected or have a much less serious infection.
Pri izpostavitvi kateremu koli od teh virusov pozneje v življenju se mačka ne bo okužila ali pa bo okužba bistveno blažja.
The main measure of effectiveness was the level of antibodies in the blood against the viruses in the vaccine, with the exception of the FeLV component, whose effectiveness in preventing infection had already been demonstrated in other studies.
Glavno merilo učinkovitosti je bila raven protiteles v krvi proti virusom iz cepiva, razen sestavine FeLV, katere učinkovitost pri preprečevanju okužbe je bila že dokazana v drugih študijah.
It can also prevent death due to panleucopenia and prevent FeLV from remaining in the blood.
Hkrati pa lahko prepreči smrt zaradi panlevkopenije in zadrževanje virusa FeLV v krvi.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“ obrambe pred boleznijo.
The European Commission granted a marketing authorisation valid throughout the European Union, for Purevax RCP FeLV on 23 February 2005.
Evropska komisija je dovoljenje za promet z zdravilom Purevax RCP FeLV, veljavno po vsej Evropski uniji, izdala 23. februarja 2005.
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.
Če ima mucka visoke ravni protiteles, ki jih je prejela od matere, je treba s prvim cepljenjem počakati do starosti 12 tednov.
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.
Občasno se lahko pri mačkah pojavi začasna apatija (pomanjkanje zanimanja za okolico) in anoreksija (izguba teka) ter hipertermija (povišana telesna temperatura), ki trajajo dan ali dva.
The canarypox viruses do not spread or multiply in the cat but they do produce proteins from the FeLV genes.
Poksvirusi kanarčkov se v mački ne širijo ali množijo, vendar pa tvorijo beljakovine iz genov virusa FeLV.
The CVMP concluded that the benefits of Purevax RCP FeLV exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above approved indicationsand recommended that Purevax RCP FeLV be given a marketing authorisation.
Odbor CVMP je zaključil, da so koristi zdravila Purevax RCP FeLV za aktivno imunizacijo mačk, starih osem tednov ali več, proti zgoraj navedenim boleznim večje od z njimi povezanih tveganj, in priporočil, da se za zdravilo Purevax RCP FeLV izda dovoljenje za promet.
When a cat is given the vaccine, the immune system recognises the weakened or killed viruses and the FeLV proteins as ‘foreign' and makes antibodies against them.
Ko mačko cepimo, imunski sistem prepozna oslabljene ali uničene viruse in beljakovine virusa FeLV kot „tuje“ ter proti njim razvije protitelesa.
The cat should be revaccinated for all components one year after the first vaccination course, then every year for feline leukaemia, and every three years for rhinotracheitis, calicivirosis and panleucopenia.
Mačko je treba znova cepiti za vse sestavine cepiva eno leto po prvem cepljenju, nato pa vsako leto proti levkemiji mačk ter vsaka tri leta proti rinotraheitisu,
In laboratory conditions Purevax RCP FeLV was demonstrated to provide protection against the diseases listed above.
V laboratorijskih pogojih je bilo dokazano, da zdravilo Purevax RCP FeLV zagotavlja zaščito pred zgoraj navedenimi boleznimi.
To protect against feline leukaemia the vaccine contains two genes from the FeLV called env and gag, which have been inserted into another vector (carrier) virus called canarypox using ‘recombinant DNA technology'.
Za zaščito pred levkemijo mačk cepivo vsebuje dva gena virusa FeLV, imenovana env in gag, ki so ju s „tehnologijo rekombinantne DNK“ vstavili v drug virusni (prenašalni) vektor, imenovan poksvirus kanarčkov.
The effectiveness of Purevax RCP FeLV has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus, calicivirus, parvovirus or leukaemia virus.
Učinkovitost zdravila Purevax RCP FeLV so preučevali v več preskušanjih v laboratorijskih pogojih, kjer so mačke cepili in okužili s herpesvirusom, kalicivirusom, parvovirusom ali virusom levkemije.
For a full list of the side-effects reported with Purevax RCP FeLV, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Purevax RCP FeLV, glejte navodilo za uporabo.
In the field the studies of Purevax RCP FeLV looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination.
V terenskih študijah zdravila Purevax RCP FeLV so preučevali osnovno shemo cepljenja (dve injekciji z od tri- do štiritedenskim razmakom) in obnovitveno cepljenje.
Purevax RCP FeLV contains small amounts of weakened or killed viruses that cause feline viral rhinotracheitis, calicivirosis and panleucopenia.
Zdravilo Purevax RCP FeLV vsebuje majhne količine oslabljenih ali uničenih virusov, ki povzročajo virusni rinotraheitis, kalicivirozo in panlevkopenijo mačk.
Purevax RCP FeLV is a vaccine.
Zdravilo Purevax RCP FeLV je cepivo.
• feline leukaemia (an illness affecting the immune system caused by a retrovirus, feline leukaemia virus).
• levkemiji mačk (bolezni, ki prizadene imunski sistem in jo povzroča retrovirus, virus levkemije mačk).
Purevax RCP FeLV is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Zdravilo Purevax RCP FeLV je na voljo v obliki liofilizata (pelete, posušene v zamrznjenem stanju) in vehikla za pripravo suspenzije za injiciranje.
Purevax RCP FeLV is used to vaccinate cats from the age of 8 weeks against:
Zdravilo Purevax RCP FeLV se uporablja za cepljenje mačk, starih osem tednov ali več, proti:
Purevax RCP FeLV should not be used in pregnant cats.
Zdravilo Purevax RCP FeLV se ne sme uporabljati pri brejih mačkah.
In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection and feline panleucopenia remained stable at a high level or increased slightly.
V študiji obnovitvenega cepljenja je bilo ugotovljeno, da so ravni protiteles proti herpesvirusu rinotraheitisa, okužbam s kalicivirusi in panlevkopeniji mačk ostale stabilne na visoki ravni ali pa so se nekoliko zvišale.
Purevax RCP FeLV is a veterinary vaccine that contains:
Zdravilo Purevax RCP FeLV je cepivo za uporabo v veterinarski medicini, ki vsebuje:
What benefit has Purevax RCP FeLV shown during the studies?
Kakšne koristi je zdravilo Purevax PCP FeLV izkazalo v študijah?
What is the risk associated with Purevax RCP FeLV?
Kakšna tveganja so povezana z zdravilom Purevax RCP FeLV?
• feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97).
• rekombinantni poksvirus kanarčkov (vCP97), ki vsebuje antigen virusa levkemije mačk (FeLV).
Why has Purevax RCP FeLV been approved?
Zakaj je bilo zdravilo Purevax RCP FeLV odobreno?
Other information about Purevax RCP FeLV:
Druge informacije o zdravilu Purevax RCP FeLV
How has Purevax RCP FeLV been studied?
Kako je bilo zdravilo Purevax RCP FeLV raziskano?
Feline viral rhinotracheitis, feline panleucopenia (live attenuated), feline leukaemia and feline calicivirosis (inactivated) vaccine
Cepivo proti virusu rinotraheitisa mačk, (živo oslabljeno) cepivo proti panlevkopeniji mačk, cepivo proti levkemiji mačk in (inaktivirano) cepivo proti kalicivirozi mačk
What is Purevax RCP FeLV?
Kaj je zdravilo Purevax RCP FeLV?
What is Purevax RCP FeLV used for?
Za kaj se zdravilo Purevax RCP FeLV uporablja?
How does Purevax RCP FeLV work?
Kako zdravilo Purevax RCP FeLV deluje?
You and your doctor will decide if you can continue treatment or if you need to take another type of antibiotic.
Skupaj z zdravnikom se boste odločili, ali lahko nadaljujete zdravljenje ali morate jemati drugo vrsto antibiotika.
• If you have any questions or concerns about your medicines, speak to your doctor or pharmacist.
• Če imate kakršna koli vprašanja ali pomisleke glede svojih zdravil, se posvetujte z zdravnikom ali farmacevtom.
The review of fluoroquinolones and quinolones was initiated on 9 February 2017 at the request of the German medicines authority (BfArM), under Article 31 of Directive 2001/83/EC.
Pregled fluorokinolonov in kinolonov se je začel 9. februarja 2017 na zahtevo nemške agencije za zdravila (BfArM) v skladu s členom 31 Direktive 2001/83/ES.
The CHMP confirmed that the use of the remaining fluoroquinolone antibiotics should be restricted.
Odbor CHMP je potrdil, da je treba omejiti uporabo preostalih fluorokinolonskih antibiotikov.
• to treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used.
• zdravljenje blagih ali zmernih bakterijskih okužb, razen če ne bo mogoča uporaba drugih antibakterijskih zdravil, ki se običajno priporočajo za tovrstne okužbe.
The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.
Pregled je najprej opravil Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini.
Restrictions on the use of fluoroquinolone antibiotics will mean that they should not be used:
Omejitev uporabe fluorokinolonskih antibiotikov bo pomenila, da jih ne bo dovoljeno uporabljati za: