FrancophonIA/ELRC3.0 huggingface dataset:
English: • A study in 320 patients not controlled with metformin and saxagliptin, showed that adding dapagliflozin to treatment with saxagliptin and metformin reduced HbA1c levels by 0.8 percentage points, compared with a reduction of 0.1 percentage points when placebo was added to saxagliptin and metformin.
Slovenian: • V študiji pri 320 bolnikih, pri katerih bolezen z metforminom in saksagliptinom ni bila uravnana, so ugotovili, da se je po dodajanju dapagliflozina zdravljenju s saksagliptinom in metforminom raven HbA1c znižala za 0,8 odstotne točke v primerjavi z znižanjem za 0,1 odstotne točke, ko so zdravljenju s saksagliptinom in metforminom dodajali placebo.
English: • in combination with other diabetes medicines, including insulin, in patients whose blood glucose is not adequately controlled by these medicines and metformin.
Slovenian: • v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni, vključno z insulinom, pri bolnikih,
English: 4.6 Adverse reactions (frequency and seriousness)
Slovenian: 4.6 Stranski učinki (pogostnost in resnost)
English: ATC vet code: QI09AB02.
Slovenian: Oznaka ATCvet: QI09AB02.
English: - Shake well before use.
Slovenian: − Pred uporabo dobro pretresite.
English: Pharmacotherapeutic group: inactivated bacterial vaccine.
Slovenian: Farmakoterapevtska skupina: inaktivirano bakterijsko cepivo.
English: Do not mix with any other vaccine or immunological product.
Slovenian: Ne mešajte z nobenim drugim cepivom ali imunoloških izdelkom.
English: It is therefore recommended that no other vaccine should be administered within 14 days before or after vaccination with this product.
Slovenian: Zato odsvetujemo uporabo katerega koli cepiva v obdobju 14 dni pred ali po cepljenju s tem izdelkom.
English: Swelling and redness at the injection site may occasionally last for at least 14 days.
Slovenian: Oteklina in rdečina na mestu injekcije lahko včasih trajata najmanj 14 dni.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of two ml:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA V odmerku po dva ml:
English: SPECIAL WARNING(S), IF NECESSARY Accidental injection is dangerous.
Slovenian: POSEBNA OPOZORILA, ČE SO POTREBNA Nenamerno injiciranje je nevarno.
English: For a full list of excipients, see section 6.1.
Slovenian: 150 mg Celoten seznam pomožnih snovi, glej razdelek 6.1.
English: 10 DATE OF REVISION OF THE TEXT {MM/YYYY} or <month YYYY>
Slovenian: DATUM REVIZIJE BESEDILA {MM/LLLL} ali <mesec LLLL>
English: Animal Species
Slovenian: Živalska vrsta
English: PHARMACEUTICAL FORM Suspension for injection.
Slovenian: FARMACEVTSKA OBLIKA Suspenzija za injiciranje
English: D. STATEMENT OF THE MRLs Annex II of Council Regulation (EEC) No 2377/90
Slovenian: D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Dodatek II Uredbe Sveta (EGS) No 2377/90
English: Store in a refrigerator (+2°C to +8°C).
Slovenian: Shranjujte v hladilniku (+2 °C do +8 °C).
English: Basic vaccination: Sows/gilts which have not yet been vaccinated with the product shall be given an injection preferably 6 to 8 weeks before the expected date of farrowing followed by a second injection 4 weeks later.
Slovenian: Osnovno cepljenje: svinjam in mladicam, ki z izdelkom še niso bile cepljene, je najbolje dati prvi odmerek 6 do 8 tednov pred pričakovano prasitvijo in drugi odmerek 4 tedne pozneje.
English: In the absence of incompatibility studies this vaccine must not be mixed with other veterinary medical products.
Slovenian: Ker ni študij inkompatibilnosti, cepiva ne smete mešati z drugimi zdravili za uporabo v veterinarski medicini.
English: The diameter of the swelling is in general below 5 cm, but in some cases a larger swelling may occur.
Slovenian: Premer otekline je večinoma manjši kot 5 cm, v nekaterih primerih pa je oteklina lahko večja.
English: - Before using the vaccine allow it to reach room temperature.
Slovenian: − Pred uporabo počakajte, da se cepivo ogreje na sobno temperaturo.
English: - LT toxoid
Slovenian: toksoid LT
English: No information is available on the safety and efficacy from concurrent use of this vaccine with any other.
Slovenian: Ni podatkov o varnosti ter učinkovitosti ob sočasni uporabi tega cepiva s katerim koli drugim cepivom.
English: Name and address of the manufacturer of the biological active substances
Slovenian: Ime in naslov izdelovalca bioloških zdravilnih učinkovin:
English: These immunogens are incorporated in an adjuvant in order to enhance a prolonged stimulation of immunity.
Slovenian: Imunogeni so vgrajeni v adjuvans, kar podaljša stimulativni učinek na razvoj imunosti.
English: 5830 AA Boxmeer, The Netherlands.
Slovenian: 5830 AA Boxmeer Nizozemska
English: 4.5 Special precautions for use
Slovenian: 4.5 Posebni previdnostni ukrepi za uporabo
English: - Use sterile syringes and needles.
Slovenian: − Uporabite sterilne brizge in igle.
English: Shelf-life after first opening: 3 hours.
Slovenian: Rok uporabnosti po prvem odpiranju: 3 ure
English: Reduced feed intake and listlessness may occur in approximately 10% of the animals on the day of vaccination, but returns to normal within 1-3 days.
Slovenian: Na dan cepljenja se lahko pojavita zmanjšan tek in ravnodušnost pri 10 do 20 % živali, kar se normalizira v 1-3 dneh.
English: Intramuscular injection in sows/gilts of 2 ml of the vaccine per animal in the neck in the area behind the ear.
Slovenian: Intramuskularno svinjam in mladicam po 2 ml cepiva za eno žival v vrat v predel za ušesom.
English: Revaccination: A single revaccination shall be carried out during the second half of each subsequent pregnancy, preferably 2 to 4 weeks before the expected date of farrowing.
Slovenian: Revakcinacija: en odmerek v drugi polovici vsake naslednje brejosti, najbolje 2 do 4 tedne pred pričakovano prasitvijo.
English: OJ No L290 of 5.12.95 g OJ No L290 of 5.12.95
Slovenian: f OJ št. L290 z dne 5.12.95 g OJ št. L290 z dne 5.12.95
English: STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
Slovenian: NAVEDBA ZDRAVILNE UČINKOVIN(E) IN DRUGE(IH) SESTAVIN(E)
English: Before using the vaccine allow it to reach room temperature (15-25 °C) and shake well before use.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Pred uporabo počakajte, da se cepivo ogreje na sobno temperaturo (15-25 ºC) in ga dobro pretresite.
English: DATE OF RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PODALJŠANJA DOVOLJENJA ZA PROMET
English: Each dose of two ml contains the F4ab (K88ab) fimbrial adhesin, the F4ac (K88ac) fimbrial adhesin, the F5 (K99) fimbrial adhesin, the F6 (987P) fimbrial adhesin and of LT toxoid, which induce a mean antibody titre of respectively ≥ 9.0 log2 Ab titre, ≥ 5.4 log2 Ab titre, ≥ 6.8 log2 Ab titre, ≥ 7.1 log2 Ab titre, and 6.8 log2 Ab titre after vaccination of mice with a 1/20 sow dose.
Slovenian: En odmerek po dva ml vsebuje fimbrijski adhezin F4ab (K88ab), fimbrijski adhezin F4ac (K88ac), fimbrijski adhezin F5 (K99), fimbrijski adhezin F6 (987P) in toksoid LT, ki spodbudijo srednji titer protiteles ≥ 9,0 log2 titra protiteles, ≥ 5,4 log2 titra protiteles, ≥ 6,8 log2 titra protiteles, ≥ 7,1 log2 titra protiteles in 6,8 log2 titra protiteles po cepljenju miši z 1/20 odmerka za svinje.
English: - Vaccinate only healthy animals.
Slovenian: − Cepite samo zdrave živali.
English: A transient swelling and redness at the injection site may be observed in approximately 5% of the animals.
Slovenian: Pri približno 5 % živali se lahko na mestu injiciranja pojavita prehodna oteklina in rdečina.
English: In the case of accidental self-injection, seek medical advice immediately and show the package insert or label to the physician.
Slovenian: V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
English: The antigens are adjuvanted with 150 mg dl-α-tocopherol acetate per dose.
Slovenian: En odmerek antigenov vsebuje 150 mg dl-α-tokoferol acetate kot adjuvans.
English: The fimbrial adhesins F4ab, F4ac, F5 and F6 are responsible for the adhesion and the virulence of E. coli strains, which cause neonatal enterotoxicosis in piglets.
Slovenian: Fimbrijski adhezini F4ab, F4ac, F5 in F6 povzročajo adhezijo in virulenco sevov E. coli, ki so povzročitelji neonatalne enterotoksikoze pujskov.
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
Slovenian: BESEDILO ''ZDRAVILO SHRANJUJTE IZVEN DOSEGA IN POGLEDA OTROK'' Zdravilo shranjujte izven dosega in pogleda otrok.
English: To be supplied only on veterinary prescription.
Slovenian: Izdaja zdravila za uporabo v veterinarski medicini je le na recept..
English: - Avoid introduction of contamination.
Slovenian: − Pazite, da ne bi prišlo do kontaminacije.
English: 4.7 Use during pregnancy, lactation or lay
Slovenian: 4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Lahko se uporablja v obdobju brejosti.
English: Vaccine to stimulate active immunity of sows/gilts in order to provide passive immunity to their progeny against E. coli strains that express the fimbrial adhesins F4ab, F4ac, F5 and F6.
Slovenian: Cepivo za spodbujanje aktivne imunosti svinj ali mladic za razvoj pasivne imunosti potomcev proti sevom E.coli, ki izločajo fimbrijske adhezine F4ab, F4ac, F5 in F6.
English: A mean transient increase in body temperature of about 1°C, in some pigs up to 3°C, may occur in the first 24 hours after vaccination.
Slovenian: Na splošno se lahko pri nekaterih prašičih prvih 24 ur po cepljenju dan prehodno povprečno za 1 °C, pri nekaterih prašičih do 3 °C, poveča telesna temperatura.
English: Cardboard box with 1 glass (hydrolytic type I) or 1 PET vial of 20, 50 or 100 ml with a halogenobutyl rubber stopper and a coded aluminium cap. Not all pack sizes may be marketed.
Slovenian: Zloženka z 1 stekleno vialo (hidrolitične skupine I) ali 1 vialo iz PET po 20, 50 ali 100 ml z zamaškom iz halogenobutilne gume in aluminijasto zaporko s šifro.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Porcoli Diluvac Forte suspension for injection
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Porcilis Porcoli Diluvac Forte suspenzija za injiciranje
English: SPECIAL STORAGE PRECAUTIONS Store in a refrigerator (+2°C to +8°C).
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi +2 - +8 ºC.
English: Other provisions dl-α-tocopherol acetatea
Slovenian: Druge določbe dl-α-tokoferol acetata (vitamin E)
English: - F5 (K99) fimbrial adhesin
Slovenian: fimbrijski adhezin F5 (K99)
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni) Niso zasledili nikakršnih drugačnih neželenih učinkov kot tistih, ki so navedeni v razdelku Stranski učinki.
English: Potassium Chloride Potassium Dihydrogen Phosphate Simethicone emulsion Sodium chloride
Slovenian: 6.1 Seznam pomožnih snovi polisorbat 80 kalijev klorid kalijev dihidrogen fosfat simetikon, emulzija natrijev klorid dinatrijev fosfat dihidrat DL-alfa-tokoferol acetat voda za injekcije
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of two ml: - F4ab (K88ab) fimbrial adhesin
Slovenian: NAVEDBA ZDRAVILNIH UČINKOVIN IN DRUGIH SNOVI V odmerku po dva ml: fimbrijski adhezin F4ab (K88ab)
English: MANUFACTURER'S BATCH NUMBER Batch: .......
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Serija: ……….
English: EXP {month/year} Once broached, use within 3 hours.
Slovenian: Načeto/odprto zdravilo uporabite v 3 urah.
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands.
Slovenian: Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Porcoli Diluvac Forte
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Porcilis Porcoli Diluvac Forte
English: BATCH NUMBER Batch: ......
Slovenian: ŠTEVILKA SERIJE Serija: ……….
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 20 ml (10 doses)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 20 ml (10 odmerkov)
English: (E508) All food-producing species
Slovenian: (E508) vse živali, namenjene za proizvodnjo živil kalijev dihidrogen fosfatc
English: PORCILIS PORCOLI DILUVAC FORTE
Slovenian: NAVODILO ZA UPORABO ZA PORCILIS PORCOLI DILUVAC FORTE
English: For the passive immunisation of piglets by active immunisation of sows/gilts to reduce mortality and clinical signs such as diarrhoea due to neonatal enterotoxicosis during the first days of life, caused by those E.coli strains, which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P).
Slovenian: S tem se zmanjša smrtnost in klinični znaki, kot je driska zaradi neonatalne enterotoksikoze prve dni po rojstvu, ki jo povzročajo sevi E. coli, ki izločajo fimbrijske adhezine F4ab (K88ab), F4ac (K88ac), F5 (K99) ali F6 (987P).
English: - F6 (987P) fimbrial adhesin
Slovenian: fimbrijski adhezin F6 (987P)
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Slovenian: POGOJI ALI OMEJITVE GLEDE NAČINA/REŽIMA IZDAJE IN UPORABE Zdravilo se izda le na recept.
English: Simethiconeg
Slovenian: KARENCA
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: MARKETING AUTHORISATION NUMBER(S) EU/2/96/001/003-008
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/96/001/003-008
English: - F4ac (K88ac) fimbrial adhesin
Slovenian: fimbrijski adhezin F4ac (K88ac)
English: Active substances: - F4ab (K88ab) fimbrial adhesin
Slovenian: Zdravilne učinkovine: fimbrijski adhezin F4ab (K88ab)
English: Intervet International B.V. Wim de Körverstraat 35, P.O.
Slovenian: Intervet International B.V.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ni podatkov o varnosti ter učinkovitosti ob sočasni uporabi tega cepiva s katerim koli drugim cepivom.
English: OJ No L272 of 25.10.96 c OJ No L272 of 25.10.96
Slovenian: (dimetikon) vse živali, namenjene za proizvodnjo živil a OJ št. L122 z dne 12.05.99 b OJ št L272 z dne 25.10.96 c OJ št. L272 z dne 25.10.96 d OJ št. L290 z dne 5.12.95 e OJ št. L272 z dne 25.10.96
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 20 ml & 50 ml (EU/2/96/001/003, EU/2/96/001/004, EU/2/97/001/006 & EU/2/96/001/007)
Slovenian: PODATKI NA ZUNANJI OVOJNINI 20 ml & 50 ml (EU/2/96/001/003, EU/2/96/001/006, EU/2/96/001/004 & EU/2/96/001/007)
English: PACKAGE SIZE 20 ml (10 doses) 50 ml (25 doses) 100 ml (50 doses)
Slovenian: VELIKOST PAKIRANJA 20 ml (10 odmerkov) 50 ml (25 odmerkov) 100 ml (50 odmerkov)
English: PACKAGE SIZE 100 ml (50 doses)
Slovenian: VELIKOST PAKIRANJA 100 ml (50 odmerkov)
English: In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.
Slovenian: Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 100 ml (EU/2/96/001/005 & EU/2/96/001/008)
Slovenian: PODATKI NA ZUNANJI OVOJNINI 100 ml (EU/2/96/001/005 & EU/2/96/001/008)
English: All food-producing species
Slovenian: vse živali, namenjene za proizvodnjo živil kalijev kloridb
English: PACKAGE SIZE 50 ml (25 doses) 100 ml (50 doses)
Slovenian: VELIKOST PAKIRANJA 50 ml (25 odmerkov) 100 ml (50 odmerkov)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 50 ml & 100 ml vial labels (EU/2/96/001/004, EU/2/96/001/005, EU/2/97/001/007 & EU/2/96/001/008 only)
Slovenian: PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Nalepke na vialah po 50 ml in 100 ml (samo za EU/2/96/001/004, EU/2/96/001/005, EU/2/97/001/0007 in EU/2/96/001/008)
English: IM injection of 2 ml
Slovenian: 2 ml i.m.
English: (E339ii) All food-producing species
Slovenian: (E339ii) vse živali, namenjene za proizvodnjo živil polisorbat 80f vse živali, namenjene za proizvodnjo živil simetikong
English: 1 Mean antibody titre (Ab) obtained after vaccination of mice with a 1/20 sow dose.
Slovenian: 1srednji titer protiteles po cepljenju miši z 1/20 odmerka za svinje dl-alfa-tokoferol acetat
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Slovenian: DATUM ZADNJE REVIZIJE NAVODIL ZA UPORABO
English: (E340i) All food-producing species
Slovenian: (E340i) vse živali, namenjene za proizvodnjo živil natrijev kloridd vse živali, namenjene za proizvodnjo živil dinatrijev hidrogen fosfate
English: Neonatal piglets derive passive immunity via ingestion of colostrum from vaccinated sows/gilts.
Slovenian: Pasivna imunizacija pujskov z aktivno imunizacijo svinj ali mladic.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 20 ml vial labels (EU/2/96/001/003 & EU/2/96/001/006 only)
Slovenian: Nalepke na vialah po 20 ml (samo za EU/2/96/001/003 in EU/2/96/001/006)
English: EU/2/96/001/008
Slovenian: EU/2/96/001/005 100 ml steklo EU/2/96/001/008 100 ml PET
English: EXPIRY DATE
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI EXP {mesec/leto}
English: NUMBERS IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/2/96/001/005
Slovenian: ŠTEVILKA V REGISTRU ZDRAVIL SKUPNOSTI EU/2/96/001/005 100 ml steklo EU/2/96/001/008 100 ml PET
English: PACKAGE SIZE 20 ml (10 doses) 50 ml (25 doses)
Slovenian: VELIKOST PAKIRANJA 20 ml (10 odmerkov)
English: Invented name Strength Pharmaceutical Form Route of administration Packaging
Slovenian: Farmacevtska oblika Pot uporabe Ovojnina
English: 1 vial + 1 ampoule
Slovenian: 1 viala + 1ampula
English: The European Commission issued a decision on this opinion on 28/04/2017.
Slovenian: Evropska komisija je sklep v zvezi s tem mnenjem izdala 28/04/2017.
English: 4.4 Special warnings and precautions
Slovenian: Posebna opozorila in previdnostni ukrepi
English: Haldol Decanoate and associated names (such as Aloperidin Decanoas, Haldol Decanoas, Haldol Decanoat, Haldol Decanoate, Haldol Decanoato, Haldol Depot, Serenase Dekanoat, and Serenase Depot) is marketed in Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Sweden and United Kingdom, and in Iceland and Norway.
Slovenian: Haldol Decanoate in povezana imena (kot so Aloperidin Decanoas, Haldol Decanoas, Haldol Decanoat, Haldol Decanoate, Haldol Decanoato, Haldol Depot, Serenase Dekanoat in Serenase Depot) se trži v Avstriji, Belgiji, Franciji, Nemčiji, Grčiji, Italiji, Luksemburgu, na Cipru, Danskem, Finskem, Irskem, Nizozemskem, Norveškem, Portugalskem, Švedskem in v Združenem kraljestvu ter na Islandiji in na Norveškem.
English: The companies that market these medicines include Janssen-Cilag Ltd and associated companies.
Slovenian: Ta zdravila tržijo družba Janssen-Cilag Ltd in povezana podjetja.
English: Low doses are recommended for elderly patients unless they have already been receiving higher doses of haloperidol and have not had unacceptable side effects.
Slovenian: Za starejše bolnike so priporočljivi majhni odmerki, razen če so že prejemali večje odmerke haloperidola in niso imeli nesprejemljivih neželenih učinkov.
English: Haldol Decanoate is authorised in the EU via national procedures.
Slovenian: Zdravilo Haldol Decanoate je bilo v EU odobreno po nacionalnih postopkih.
English: In particular, Haldol Decanoate must not be used in patients with heart disorders such as certain heart-rhythm problems, heart failure and recent heart attack, and with central nervous depression (reduced brain activity that slows down breathing and heart rate and reduces alertness).
Slovenian: Zdravilo Haldol Decanoate se še zlasti ne sme uporabljati pri bolnikih s srčnimi boleznimi, kot so določene težave s srčnim ritmom, srčnim popuščanjem in nedavnim srčnim infarktom, ter pri bolnikih z depresijo centralnega živčevja (zmanjšano aktivnostjo možganov, ki upočasni dihanje in srčni utrip ter zmanjša budnost).
English: On 23 February 2017, the European Medicines Agency completed a review of Haldol Decanoate.
Slovenian: Evropska agencija za zdravila je 23. februarja 2017 zaključila pregled zdravila Haldol Decanoate.
English: Why was Haldol Decanoate reviewed?
Slovenian: Zakaj je bilo zdravilo Haldol Decanoate pregledano?
English: It is also available in the EU as generic haloperidol decanoate.
Slovenian: V EU je na voljo tudi kot generični haloperidol dekanoat.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Haldol Decanoate in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti podatke o predpisovanju zdravila Haldol Decanoate v Evropski uniji (EU).
English: The CHMP harmonised other sections of the SmPC including interactions between Haldol Decanoate and other medicines (section 4.5), as well as information on pregnancy, lactation and fertility (section
Slovenian: Odbor CHMP je uskladil druga poglavja povzetka glavnih značilnosti zdravila, vključno z medsebojnim delovanjem med zdravilom Haldol Decanoate in drugimi zdravili (poglavje 4.5) ter informacijami o nosečnosti, dojenju in plodnosti (poglavje 4.6).
English: Haldol Decanoate is given by injection into the muscle usually every 4 weeks, to patients who have been taking haloperidol by mouth.
Slovenian: Zdravilo Haldol Decanoate se daje z injekcijo v mišico, običajno vsake 4 tedne, bolnikom, ki so pred tem jemali peroralni haloperidol.
English: What is Haldol Decanoate?
Slovenian: Kaj je zdravilo Haldol Decanoate?
English: The CHMP agreed to harmonisation of Haldol Decanoate's contra-indications.
Slovenian: Odbor CHMP je soglašal z uskladitvijo kontraindikacij za zdravilo Haldol Decanoate.
English: The CHMP agreed that Haldol Decanoate injection can be used for the continuing treatment of schizophrenia and schizoaffective disorder in adults who have been on a stable dose of haloperidol by mouth.
Slovenian: Odbor CHMP je soglašal, da se zdravilo Haldol Decanoate v obliki injekcij lahko uporablja za nadaljevalno zdravljenje shizofrenije in shizoafektivne motnje pri odraslih, ki so pred tem prejemali stabilni peroralni odmerek haloperidola.
English: The CHMP harmonised the SmPC to include information on when Haldol Decanoate's side effects on movement might appear, details on mortality in the elderly, and effects on the heart and the brain.
Slovenian: Odbor CHMP je uskladil povzetek glavnih značilnosti zdravila tako, da je vanj vključil informacije o tem, kdaj se lahko pojavijo neželeni učinki zdravila Haldol Decanoate, ki prizadenejo premikanje, podatke o smrtnosti pri starejših in učinke na možgane in srce.
English: It contains the active ingredient haloperidol decanoate.
Slovenian: Vsebuje zdravilno učinkovino haloperidol dekanoat.
English: The SmPC recommends caution in patients who have a high level of the hormone prolactin and in those who have tumours that are worsened by prolactin.
Slovenian: Povzetek glavnih značilnosti zdravila priporoča previdnost pri bolnikih z visokimi ravnmi hormona prolaktina in bolnikih s tumorji, ki jih prolaktin poslabša.