FrancophonIA/ELRC3.0 huggingface dataset:
English: If you or your child get(s) any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: - Keep this leaflet.
Slovenian: Pred uporabo pretresite.
English: • diarrhoea
Slovenian: • nespečnost;
English: Common: upper respiratory tract infection Uncommon: otitis media
Slovenian: Infekcijske in parazitske bolezni: Pogosti: okužba zgornjih dihal Občasni: vnetje srednjega ušesa
English:  Common (these may occur with up to 1 in 10 doses of the vaccine):
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 odmerkov cepiva):
English: NAME OF THE MEDICINAL PRODUCT See Annex I - To be completed nationally
Slovenian: IME ZDRAVILA [glejte Prilogo I - izpolni država članica]
English:  Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 odmerkov cepiva):
English: PRIORIX is for subcutaneous injection, although it can also be given by intramuscular injection.
Slovenian: Cepivo PRIORIX injicirajte subkutano.
English: What you need to know before you or your child receive(s) Priorix Priorix should not be given
Slovenian: Cepiva Priorix vi ali vaš otrok ne smete prejeti
English: Marketing Authorisation Holder and Manufacturer <See Annex I - To be completed nationally>
Slovenian: Imetnik dovoljenja za promet s cepivom [glejte Prilogo I - izpolni država članica]
English: Package leaflet: information for the user See Annex I - To be completed nationally
Slovenian: Navodilo za uporabo [glejte Prilogo I - izpolni država članica]
English: MARKETING AUTHORISATION HOLDER
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Gastrointestinal disorders: Uncommon: parotid gland enlargement, diarrhoea, vomiting
Slovenian: Bolezni prebavil: Občasni: oteklina obušesne slinavke, driska, bruhanje
English: 4 (4 x 1) vials (multipack)
Slovenian: Škatla s 4 (4 x 1) vialami (skupno pakiranje)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Slovenian: (Izmišljeno) Ime Jakost
English: 1 vial
Slovenian: Škatla z 1 vialo
English: ATCvet code: QI09AL01.
Slovenian: Oznaka ATC vet: QI09AL01.
English: Date of first authorisation: 08/07/2014 Date of latest renewal:
Slovenian: Datum pridobitve dovoljenja za promet: 08/07/2014 Datum zadnjega podaljšanja dovoljenja za promet:
English: Each dose of 2 ml contains:
Slovenian: Vsak 2-mililitrski odmerek vsebuje:
English: E. rhusiopathiae: three weeks after completion of the basic vaccination scheme.
Slovenian: E. rhusiopathiae: tri tedne po zaključku osnovne sheme cepljenja.
English: Basic vaccination:
Slovenian: Osnovno cepljenje:
English: Revaccination should be performed prior to each gestation, see section 4.9.
Slovenian: Revakcinacijo je treba izvesti pred vsako brejostjo, glejte poglavje 4.9.
English: Pigs from 6 months of age which have not been previously vaccinated with the product should be given two injections with an interval of 3-4 weeks.
Slovenian: Pri prašičih, starih 6 mesecev ali več, ki še niso bili cepljeni s tem cepivom, je treba dati dve injekciji z razmikom 3-4 tednov.
English: A single injection should be given 2-3 weeks prior to each subsequent mating (approximately every 6 months).
Slovenian: Eno injekcijo je treba dati 2-3 tedne pred vsakim naslednjim parjenjem (približno vsakih 6 mesecev).
English: Porcine parvovirus: from the beginning of the gestation period.
Slovenian: Prašičji parvovirus: od začetka brejosti.
English: LABORATORIOS HIPRA, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) SPAIN
Slovenian: Carretera C-63, km 48.300, Polígono Industrial El Rieral17170 Amer (Girona) Španija
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Slovenian: Zdravila za uporabo v veterinarski medicini po datumu izteka roka uporabnosti, navedenega na etiketi poleg oznake EXP, ne smete uporabljati.
English: ERYSENG PARVO suspension for injection for pigs
Slovenian: ERYSENG PARVO suspenzija za injiciranje za prašiče
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Slovenian: Ni podatkov o varnosti in učinkovitosti tega cepiva, če ga uporabljate s katerim drugim veterinarskim izdelkom, razen za zgoraj omenjeno cepivo.
English: Shelf life after mixing with UNISTRAIN PRRS: 2 hours.
Slovenian: Rok trajanja po tem, ko ga zmešate z UNISTRAIN PRRS: 2 uri.
English: The second injection should be administered 3-4 weeks before mating.
Slovenian: Drugo injekcijo je treba dati 3-4 tedne pred parjenjem.
English: Pharmacotherapeutic group: Immunologicals for suidae, Inactivated viral and bacterial vaccines.
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila za prašiče, inaktivirana virusna in bakterijska cepiva.
English: Special precautions for use in animals: None.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih: Jih ni.
English: For the active immunisation of male and female pigs to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by Erysipelothrix rhusiopathiae, serotype 1 and serotype 2.
Slovenian: Za aktivno imunizacijo merjascev in plemenskih svinj za zmanjšanje kliničnih znakov (kožnih lezij in vročine) rdečice, ki jo povzroča bakterija Erysipelothrix rhusiopathiae, serotip 1 in serotip 2.
English: Store and transport refrigerated (2 °C - 8 °C).
Slovenian: Shranjujte in prevažajte pri temperaturi (2 °C - 8 °C).
English: Adjuvants:
Slovenian: Ddodatki:
English: Porcine parvovirus: vaccination provides foetal protection for the duration of gestation.
Slovenian: Prašičji parvovirus: cepljenje zagotavlja zaščito ploda v času trajanja brejosti.
English: Major incompatibilities: Do not mix with any other veterinary medicinal product except with UNISTRAIN PRRS.
Slovenian: Inkompatibilnosti: Ne mešajte z nobenim drugim zdravilom razen pri UNISTRAIN PRRS.
English: Administer one dose of 2 ml by intramuscular injection in the neck muscles according to the following schedule:
Slovenian: En 2-mililitrski odmerek aplicirajte z intramuskularno injekcijo v vratno mišičevje po naslednjem razporedu:
English: A single dose (2 ml) of the mixed vaccines should be injected within a period of 2 hours via intramuscular use.
Slovenian: 2-mililitrski odmerek mešanega cepiva morate injicirati v roku dveh ur preko intramuskularne uporabe.
English: Do not use in case of hypersensitivity to the active substances, to the adjuvants or to any of the excipients.
Slovenian: Ne uporabite v primeru preobčutljivosti na zdravilne učinkovine, na dodatke ali na katero koli pomožno snov.
English: In case of adverse reactions following accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: Če se po nenamernem samoinjiciranju pojavijo neželeni učinki, se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
English: Revaccination should be performed prior to each gestation, refer to section “Dosage for each species, route(s) and method of administration”.
Slovenian: Revakcinacijo je treba izvesti pred vsako brejostjo, glejte poglavje »Odmerki za posamezne živalske vrste ter pot(i) in način uporabe zdravila« .
English: For the active immunisation of female pigs for the protection of progeny against transplacental infection caused by porcine parvovirus.
Slovenian: Za aktivno imunizacijo plemenskih svinj za zaščito potomstva pred transplacentarno okužbo, ki jo povzroča prašičji parvovirus.
English: E. rhusiopathiae: vaccination protects against swine erysipelas until the time of the recommended revaccination (approximately six months after the basic vaccination scheme), see section 4.9.
Slovenian: E. rhusiopathiae: cepljenje varuje pred rdečico do takrat, ko je priporočena revakcinacija (približno šest mesecev po osnovni shemi cepljenja), glejte poglavje 4.9.
English: Do not mix with any other veterinary medicinal product, except with UNISTRAIN PRRS.
Slovenian: Ne mešajte z nobenim drugim zdravilom, razen z UNISTRAIN PRRS.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
English: Very common adverse reactions: - Mild to moderate inflammation at the injection site that typically resolves within four days but in some cases may persist for up to 12 days post-vaccination was observed in safety studies.
Slovenian: - v varnostnih študijah je bilo opaženo blago do zmerno vnetje na mestu injiciranja, ki ponavadi izzveni v roku štirih dni, v nekaterih primerih pa lahko vztraja do 12 dni po cepljenju.
English: Name and address of the manufacturers of the biological active substances:
Slovenian: Ime in naslov izdelovalca(izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin).
English: The following instructions should be used: the contents of a single vial of UNISTRAIN PRRS should be reconstituted with the contents of a single vial of ERYSENG PARVO.
Slovenian: Upoštevajte naslednje navodilo: vsebino ene viale UNISTRAIN PRRS zmešajte z vsebino ene viale ERYSENG PARVO.
English: Common adverse reactions: - A transient increase in body temperature within the first 6 hours after vaccination, which spontaneously resolves within 24 hours was observed in safety studies.
Slovenian: - v varnostnih študijah je bilo opaženo prehodno povišanje telesne temperature v prvih 6 urah po cepljenju, ki spontano izzveni v 24 urah.
English: E. rhusiopathiae: vaccination protects against swine erysipelas until the time of the recommended revaccination (approximately six months after the basic vaccination scheme), refer to section “Dosage for each species, route(s) and method of administration”.
Slovenian: E. rhusiopathiae: cepljenje varuje pred rdečico do takrat, ko je priporočena revakcinacija (približno šest mesecev po osnovni shemi cepljenja), glejte poglavje »Odmerki za posamezne živalske vrste ter pot(i) in način uporabe zdravila«.
English: However, the duration of immunity of the Erysipelas component following mixed use has not been investigated.
Slovenian: Trajanje imunosti komponente rdečice pri uporabi mešanega cepiva ni raziskana.
English: EXP {month/year} Once broached use immediately.
Slovenian: EXP {mesec/leto} Po odprtju uporabite takoj.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: To stimulate active immunisation against porcine parvovirus and swine erysipelas.
Slovenian: Za stimulacijo aktivne imunizacije proti prašičjemu parvovirusu in rdečici.
English: Polyethylene (PET) bottles of 20, 50, 100 and 250 ml.
Slovenian: Polietilenske (PET) plastenke z vsebino 20, 50, 100 in 250 ml.
English: Aluminium hydroxide .............................................................................. 5.29 mg (aluminium) DEAE-Dextran
Slovenian: aluminijev hidroksid ............................................................................................. 5,29 mg (aluminij) DEAE-dekstran korenina pravega ženšena (ginsenga)
English: For simultaneous use with UNISTRAIN PRRS in sows for reproduction from 6 months of age, the mixed administration of ERYSENG PARVO and UNISTRAIN PRRS should only be used when vaccinating animals prior to mating.
Slovenian: Pri hkratni uporabi UNISTRAIN PRRS pri šest mesecev starih svinjah, namenjenih za razplod, mešanico cepiva ERYSENG PARVO in UNISTRAIN PRRS uporabite samo, če živali cepite pred paritvijo.
English: Potassium chloride Potassium dihydrogen phosphate Simethicone
Slovenian: Seznam pomožnih snovi aluminijev hidroksid DEAE-dekstran dinatrijev fosfat dodekahidrat korenina pravega ženšena (ginsenga) kalijev klorid kalijev dihidrogenfosfat simetikon natrijev klorid natrijev hidroksid voda za injekcije
English: Special precautions for use in animals
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Jih ni.
English: 10 doses (20 ml) 25 doses (50 ml) 50 doses (100 ml) 125 doses (250 ml)
Slovenian: 10 odmerkov (20 ml) 25 odmerkov (50 ml) 50 odmerkov (100 ml) 125 odmerkov (250 ml)
English: For mixed use, the onset and duration of immunity of the parvovirus component and the onset of immunity of the Erysipelas component have been demonstrated to be equivalent to those determined for ERYSENG PARVO when used alone.
Slovenian: Dokazali so, da so pri uporabi mešanice cepiv nastop in trajanje imunosti pri komponenti rdečice in nastop imunosti pri parvovirusni komponenti enaki, kot če uporabimo samo cepivo ERYSENG PARVO.
English: Interaction with other medicinal products and other forms of interaction: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with UNISTRAIN PRRS (where this vaccine is authorised) and administered at one injection site.
Slovenian: Na voljo so podatki o varnosti in učinkovitosti, ki dokazujejo, da to cepivo lahko mešamo s cepivom
English: No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a 2-fold vaccine dose.
Slovenian: Po dajanju dvojnega odmerka cepiva niso opazili neželenih učinkov razen tistih, ki so navedeni v poglavju 4.6.
English: 10 doses (20 ml) 25 doses (50 ml)
Slovenian: 10 odmerkov (20 ml) 25 odmerkov (50 ml)
English: The mixed administration of UNISTRAIN PRRS and ERYSENG PARVO should only be used when vaccinating animals prior to mating.
Slovenian: Mešanico UNISTRAIN PRRS in ERYSENG PARVO injiciramo samo, ko cepimo živali pred paritvijo.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with UNISTRAIN PRRS (where this vaccine is authorised) and administered at one injection site.
Slovenian: UNISTRAIN PRRS (kjer je to cepivo registrirano) in ga lahko damo na enem mestu injiciranja.
English: Suspension for injection Whitish suspension
Slovenian: Suspenzija za injiciranje Suspenzija belkaste barve
English: Aluminium hydroxide ..................................................................................... 5.29 mg (aluminium) DEAE-Dextran
Slovenian: ................................................... 5,29 mg (aluminij) DEAE-dekstran korenina pravega ženšena (ginsenga)
English: Cardboard box, (20 ml, 50 ml, 100ml, and 250ml) Bottles (100 ml, 250 ml) and vials (100 ml)
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN STIČNI OZ. PRIMARNI OVOJNINI KARTONSKA ŠKATLA, (20 ml, 50 ml, 100ml in 250ml) plastenke (100 ml, 250 ml) in viale (100 ml)
English: No adverse reactions other than already mentioned under section “Adverse reactions” can be expected after the administration of a 2-fold vaccine dose.
Slovenian: Po dajanju dvojnega odmerka cepiva neželeni učinki razen tistih, ki so navedeni v poglavju »Neželeni učinki«, ni pričakovati.
English: Cardboard box with 1 PET bottle of 125 doses (250 ml).
Slovenian: Kartonska škatla z 1 PET-plastenko s 125 odmerki (250 ml).
English: Inactivated porcine parvovirus, strain NADL-2, ..................................................... RP > 1.15 * Inactivated Erysipelothrix rhusiopathiae, strain R32E11, .............. ELISA > 3.34 log2 IE50%** * RP - relative potency (ELISA).
Slovenian: inaktiviran prašičji parvovirus, sev NADL-2 .......................................................... RP > 1,15* inaktivirana bakterija Erysipelothrix rhusiopathiae, sev R32E11,…ELISA > 3,34 log2 IE50 %** *RP - relativna potenca (ELISA) ** IE50 % - inhibicija ELISA 50%
English: Cardboard box with 1 glass vial of 10 doses (20 ml).
Slovenian: Kartonska škatla z 1 stekleno vialo z 10 odmerki (20 ml).
English: Very rare adverse reactions: - Anaphylactic-type reactions have been reported in spontaneous reports and appropriate symptomatic treatment is recommended.
Slovenian: - Spontano so poročali o primerih reakcij anafilaktičnega tipa.
English: Inactivated porcine parvovirus, strain NADL-2, ....................................................... RP > 1.15, inactivated Erysipelothrix rhusiopathiae, strain R32E11, ................. ELISA > 3.34 log2 IE50%.
Slovenian: Inaktiviran prašičji parvovirus, sev NADL-2 ............................................................ RP > 1,15 inaktivirana bakterija Erysipelothrix rhusiopathiae, sev R32E11,…ELISA > 3,34 log2 IE50 % * * IE50 % - inhibicija ELISA 50%
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Slovenian: Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem Zdravilo odstranite na okolju prijazen način.
English: Cardboard box with 1 glass vial of 25 doses (50 ml).
Slovenian: Kartonska škatla z 1 stekleno vialo s 25 odmerki (50 ml).
English: Type I colourless glass vials of 20, 50 and 100 ml.
Slovenian: Brezbarvne viale iz stekla tipa I z vsebino 20, 50 in 100 ml. Viale so zaprte z gumijastim zamaškom in aluminijasto zaporko.
English: Cardboard box with 1 PET bottle of 10 doses (20 ml).
Slovenian: Kartonska škatla z 1 PET-plastenko z 10 odmerki (20 ml).
English: Cardboard box with 1 glass vial of 50 doses (100 ml).
Slovenian: Kartonska škatla z 1 stekleno vialo s 50 odmerki (100 ml).
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne pasivne imunosti, ni vključena v
English: Cardboard box with 1 PET bottle of 50 doses (100 ml).
Slovenian: Kartonska škatla z 1 PET-plastenko s 50 odmerki (100 ml).
English: Cardboard box with 1 PET bottle of 25 doses (50 ml).
Slovenian: Kartonska škatla z 1 PET-plastenko s 25 odmerki (50 ml).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottles, (20 ml, 50 ml) and vials (20 ml, 50 ml)
Slovenian: Plastenke (20 ml, 50 ml), in viale (20 ml, 50 ml)
English: Name and address of the manufacturer responsible for batch release:
Slovenian: Ime in naslov izdelovalca (izdelovalcev) zdravila, odgovornega (odgovornih) za sprostitev serije
English: Avda.
Slovenian: OVOJNINAH
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
Slovenian: PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI)
English: Ginseng.
Slovenian: Rp-Vet.
English: Conditions for lifting the suspension
Slovenian: Pogoji za preklic začasnega umika
English: The PRAC issued a recommendation to the CHMP on 10 January 2013.
Slovenian: PRAC je izdal priporočilo odboru CHMP dne 10. januarja 2013.
English: Scientific conclusions and grounds for suspension of the marketing authorisation presented by the European Medicines Agency
Slovenian: Znanstveni zaključki in podlaga za začasni umik dovoljenja za promet z zdravilom, ki jih je predstavila Evropska agencija za zdravila
English: With regards to the risks observed, there were also strong new unfavourable safety signals.
Slovenian: V zvezi z ugotovljenimi tveganji so bili opaženi tudi izraziti novi neugodni znaki, povezani z varnostjo.
English: Grounds for CHMP opinion Whereas,
Slovenian: Razlogi za mnenje odbora CHMP Ob upoštevanju:
English: • The CHMP noted that no additional risk minimisation measures could be recommended at this point in time,
Slovenian: • da je CHMP ugotovil, da trenutno ni mogoče priporočiti nobenih dodatnih ukrepov za zmanjšanje tveganja;
English: 1 HPS2-THRIVE: Hearth Protection Study 2 - Treatment of HDL (high density lipoprotein) to Reduce the Incidence of Vascular Events.
Slovenian: 1 HPS2-THRIVE: Študija zaščite srca 2 - zdravljenje HDL (lipoproteina velike gostote) za zmanjšanje pojavnosti vaskularnih dogodkov.
English: The available evidence provided by the MAH in writing and at an oral explanation was reviewed by the Pharmacovigilance Risk Assessment Committee (PRAC).
Slovenian: Razpoložljive podatke, ki jih je imetnik dovoljenja za promet z zdravilom podal v obliki pisne dokumentacije in ustnih obrazložitev, je pregledal Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC).
English: Overall summary of the scientific evaluation of nicotinic acid/laropiprant
Slovenian: Splošni povzetek znanstvene ocene nikotinske kisline/laropipranta
English: Preliminary results of this study became available and were submitted by the MAH for review end of December 2012.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predhodne rezultate študije objavil in predložil v pregled konec decembra 2012.
English: The HSP2-THRIVE study was a very large randomised trial, enrolling 25,673 patients considered to be at high risk of cardiovascular events.
Slovenian: Študija HSP2-THRIVE je bila zelo obsežno randomizirano preskušanje, ki je vključevalo 25 673 bolnikov, pri katerih naj bi obstajalo visoko tveganje za kardiovaskularne dogodke.
English: The product is authorised as modified release tablets containing 1000mg of nicotinic acid and 20mg of laropiprant.
Slovenian: Zdravilo je odobreno v obliki tablet s prirejenim sproščanjem, ki vsebujejo 1 000 mg nikotinske kisline in 20 mg laropipranta.
English: It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated.
Slovenian: Kot monoterapija se lahko uporabi samo pri bolnikih, za katere zaviralci reduktaze HMG-CoA niso primerni ali ki jih bolniki ne prenašajo.
English: The HPS2-THRIVE study was conducted by the Clinical Trial Service Unit at the University of Oxford and funded by the MAH.
Slovenian: Študijo HPS2-THRIVE je izvedla enota službe za klinična preskušanja Univerze v Oxfordu, financiral pa jo je imetnik dovoljenja za promet z zdravilom.
English: Nicotinic acid/laropiprant (authorised in the EU as Tredaptive, Trevaclyn and Pelzont) is indicated for the treatment of dyslipidaemia, particularly in adult patients with combined mixed dyslipidaemia and in adult patients with primary hypercholesterolaemia in combination with HMG-CoA reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate.
Slovenian: Nikotinska kislina in laropiprant (odobrena v EU kot zdravila Tredaptive, Trevaclyn in Pelzont) sta indicirana za zdravljenje dislipidemije, zlasti pri odraslih bolnikih s kombinirano mešano dislipidemijo in pri odraslih bolnikih s primarno hiperholesterolemijo, v kombinaciji z zaviralci reduktaze HMG-CoA (statini), če monoterapija z zaviralci reduktaze HMG-CoA holesterola ne zniža v zadostni meri.
English: Previously available data on laropiprant/nicotinic acid included nine studies where a total of 5,782 patients were exposed to the medicine.
Slovenian: Podatki, ki so bili predhodno na voljo o laropiprantu/nikotinski kislini, so bili iz devetih študij, v katerih je zdravilo prejemalo skupno 5 782 bolnikov.
English: • The CHMP considered the notification under Article 20 of Regulation (EC) No 726/2004 for nicotinic acid/laropiprant (approved in the EU as Tredaptive, Trevaclyn and Pelzont) initiated by the European Commission,
Slovenian: • da je CHMP upošteval obvestilo v skladu s členom 20 Uredbe (ES) št. 726/2004 v zvezi z nikotinsko kislino in laropiprantom (odobrenih v EU kot zdravila Tredaptive, Trevaclyn in Pelzont), ki ga je izdala Evropska komisija;
English: Furthermore, no additional risk minimisation measures were identified or proposed by the marketing authorisation holder to minimise the newly identified safety concerns.
Slovenian: Poleg tega imetnik dovoljenja za promet z zdravilom ni razkril ali predlagal nobenih dodatnih ukrepov za zmanjšanje tveganja, s katerimi bi zmanjšali nove pomisleke glede varnosti.