natgillin/translations-raw huggingface dataset:
For a vial of diluent: Transfer a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) to a vial of sodium chloride 9 mg/mL (0.9 %) solution for a final concentration of 20 mg/mL or less.
Za redčenje v viali topila: v vialo raztopine natrijevega klorida 9 mg/ml (0,9 %) prenesite količino, ki ustreza 15 mg/kg telesne teže (ne sme preseči 1 g/dan); končna koncentracija naj bo 20 mg/ml ali manj.
• Burning, itching, redness and warmth at infusion site, redness at injection site
• pekoč občutek, srbenje, rdečina in občutek toplote na mestu infuzije, rdečina na vbodnem mestu,
An additional 476 patients received ertapenem as a single 1 g dose prior to surgery in a clinical study for the prophylaxis of surgical site infections following colorectal surgery.
Dodatno je v klinični študiji o preventivi pred okužbami po kirurškem posegu v kolorektalnem področju ertapenem v obliki enojnega 1-gramskega odmerka pred kirurškim posegom prejelo 476 bolnikov.
For patients who received only INVANZ, the most common adverse reactions reported during therapy plus follow-up for 14 days after treatment was stopped were: diarrhoea (4.8 %), infused vein complication (4.5 %) and nausea (2.8 %).
Pri bolnikih, ki so se zdravili samo z zdravilom INVANZ, so bili najpogosteje poročani neželeni učinki med zdravljenjem in v 14-dnevnem obdobju spremljanja po koncu zdravljenja naslednji: driska (4,8 %), zapleti v zvezi z veno, v katero je bila nameščena infuzija (4,5 %) in navzea (2,8 %).
• Streptococcus pneumoniae: S ≤ 0.5 mg/L and R > 0.5 mg/L
• Streptococcus pneumoniae: S ≤ 0,5 mg/l in R > 0,5 mg/l
• Miscarriage, genital bleeding
• splav, krvavitev iz rodil,
Decreases in valproic acid levels that may fall below the therapeutic range have been reported when valproic acid was co-administered with carbapenem agents.
Pri sočasni uporabi valprojske kisline in karbapenemskih antibiotikov so poročali o znižanju koncentracij valprojske kisline, pri čemer lahko le te padejo pod terapevtsko območje.
Seizures
Redčenje
For patients who received only INVANZ, the most common adverse reactions reported during therapy plus follow-up for 14 days after treatment was stopped were: diarrhoea (5.2 %) and infusion site pain
Pri bolnikih, ki so se zdravili samo z zdravilom INVANZ, so bili najpogosteje poročani neželeni učinki med zdravljenjem in v 14-dnevnem obdobju spremljanja po koncu zdravljenja naslednji: driska (5,2 %) in bolečina na vbodnem mestu infuzije (6,1 %).
Uncommon: Constipation, acid regurgitation, dry mouth, dyspepsia, abdominal pain Rare: Dysphagia, faecal incontinence, pelvic peritonitis Not known: teeth staining
Pogosti: driska, navzea, bruhanje Občasni: zaprtje, regurgitacija kisline, suha usta, dispepsija, bolečina v trebuhu Redki: disfagija, inkontinenca blata, peritonitis v medenici Neznana: obarvanje zob
What INVANZ contains
Kaj vsebuje zdravilo INVANZ
INVANZ 1 g powder for concentrate for solution for infusion Ertapenem
INVANZ 1 g prašek za koncentrat za raztopino za infundiranje ertapenem
Transfer the contents of the reconstituted 1 g vial of INVANZ to the 50 mL vial of sodium chloride 9 mg/mL (0.9 %) solution.
Pripravljeni koncentrat iz 1 g viale zdravila INVANZ prenesite v 50 ml vialo z raztopino natrijevega klorida 9 mg/ml (0,9 %).
Plasma concentrations of ertapenem are comparable in paediatric patients 13 to 17 years of age and adults following a 1 g once daily intravenous dose.
Plazemske koncentracije ertapenema po intravenskem odmerku 1 g enkrat dnevno pri otrocih, starih 13 do 17 let, in pri odraslih so primerljive.
For a 50 mL bag of diluent: For a 1 g dose, immediately transfer contents of the reconstituted vial to a 50 mL bag of sodium chloride 9 mg/mL (0.9 %) solution; or
Za redčenje v 50 ml vrečki topila: za pripravo 1 g odmerka koncentrat takoj prenesite v 50 ml vrečko raztopine natrijevega klorida 9 mg/ml (0,9 %); ali
Anaerobes:
Anaerobne bakterije:
• Haemophilus influenzae: S ≤ 0.5 mg/L and R > 0.5 mg/L
• Haemophilus influenzae: S ≤ 0,5 mg/l in R > 0,5 mg/l
Do not use INVANZ - if you are allergic to the active substance (ertapenem) or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to antibiotics such as penicillins, cephalosporins or carbapenems (which are used to treat various infections).
• če ste alergični na antibiotike, kot so penicilini, cefalosporini ali karbapenemi (uporabljajo se za zdravljenje različnih okužb).
Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 20 mg/kg (up to a maximum dose of 1 g) dose in patients 13 to 17 years of age were 170.4 micrograms/mL (Cmax) at 0.5 hour postdose (end of infusion), 7.0 micrograms/mL at 12 hour postdose, and 1.1 microgram/mL at 24 hour postdose.
Povprečne plazemske koncentracije ertapenema po eni 30-minutni intravenski infuziji odmerka 20 mg/kg (do največjega odmerka 1 g) pri bolnikih, starih od 13 do 17 let, so znašale: 170,4 mikrogramov/ml (Cmax) 0,5 ure po odmerku (ob koncu infuzije), 7,0 mikrogramov/ml 12 ur po odmerku in 1,1 mikrograma/ml 24 ur po odmerku.
• teeth staining
• obarvanje zob.
• M. catarrhalis: S ≤ 0.5 mg/L and R > 0.5 mg/L
• M. catarrhalis: S ≤ 0,5 mg/l in R > 0,5 mg/l
• Enterobacterales: S ≤ 0.5 mg/L and R > 0.5 mg/L
• Enterobacterales: S ≤ 0,5 mg/l in R > 0,5 mg/l
Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 1 g dose in healthy young adults (25 to 45 years of age) were 155 micrograms/mL (Cmax) at 0.5 hour postdose (end of infusion), 9 micrograms/mL at 12 hour postdose, and 1 microgram/mL at 24 hour postdose.
Po eni 30-minutni intravenski infuziji 1-gramskega odmerka so bile povprečne plazemske koncentracije ertapenema pri zdravih mladih odraslih (starih 25 do 45 let) naslednje: 155 mikrogramov/ml (Cmax) 0,5 ure po odmerku (ob koncu infuzije), 9 mikrogramov/ml 12 ur po odmerku in 1 mikrogram/ml 24 ur po odmerku.
• Abdominal pain, fatigue, fungal infection, fever, oedema/swelling, chest pain, abnormal taste
• bolečina v trebuhu, utrujenost, glivna okužba, zvišana telesna temperatura, edem/otekanje,
Rare: Pneumonia, dermatomycosis, postoperative wound infection, urinary tract infection
Občasni: kandidoza v ustni votlini, kandidoza, glivična okužba, pseudomembranski enterokolitis, vaginitis Redki: pljučnica, dermatomikoze, postoperativne okužbe ran, okužba sečil
For a 50 mL vial of diluent: For a 1 g dose, withdraw 10 mL from a 50 mL vial of sodium chloride 9 mg/mL (0.9 %) solution and discard.
Za redčenje v 50 ml viali topila: za pripravo 1 g odmerka iz 50 ml viale z raztopino natrijevega klorida 9 mg/ml (0,9 %) odvzemite 10 ml raztopine in jo zavrzite.
How to store INVANZ
Shranjevanje zdravila INVANZ
• Gram positive anaerobes: S ≤ 0.5 mg/L and R > 0.5 mg/L
• Gram pozitivni anaerobi: S ≤ 0,5 mg/l in R > 0,5 mg/l
Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 15 mg/kg (up to a maximum dose of 1 g) dose in patients 3 to 23 months of age were 103.8 micrograms/mL (Cmax) at 0.5 hour postdose (end of infusion), 13.5 micrograms/mL at 6 hour postdose, and 2.5 micrograms/mL at 12 hour postdose.
Povprečne plazemske koncentracije ertapenema po eni 30-minutni intravenski infuziji odmerka 15 mg/kg (do največjega odmerka 1 g) pri bolnikih, starih od 3 do 23 mesecev, so znašale: 103,8 mikrogramov/ml (Cmax) 0,5 ure po odmerku (ob koncu infuzije), 13,5 mikrogramov/ml 6 ur po odmerku in 2,5 mikrograma/ml 12 ur po odmerku.
The reconstituted solutions should be inspected visually for particulate matter and discolouration prior to administration, whenever the container permits.
Pripravljeno raztopino je treba, če ovojnina to dovoljuje, pred infundiranjem vizualno pregledati, da ne vsebuje vidnih delcev in da ni spremenila barve.
Common: Diarrhoea Uncommon: Faeces discoloured, melaena
Pogosti: driska Občasni: spremenjena barva blata, melena
• Gram negative anaerobes: S ≤ 0.5 mg/L and R > 0.5 mg/L
• Gram negativni anaerobi: S ≤ 0,5 mg/l in R > 0,5 mg/l
• Viridans group streptococci: S ≤ 0.5 mg/L and R > 0.5 mg/L
• Streptokoki skupine viridans: S ≤ 0,5 mg/l in R > 0,5 mg/l
Not known: Altered mental status (including aggression, delirium, disorientation, mental status changes)
Občasni: nespečnost, zmedenost Redki: vznemirjenost, anksioznost, depresija Neznana: spremenjeno duševno stanje (vključno z agresivnostjo, delirijem, dezorientiranostjo, spremembami duševnega stanja)
• Shortness of breath, sore throat
• kratka sapa, vneto žrelo,
Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 1 g dose in three patients 13 to 17 years of age were 155.9 micrograms/mL (Cmax) at 0.5 hour postdose (end of infusion), and 6.2 micrograms/mL at 12 hour postdose.
Povprečne plazemske koncentracije ertapenema po eni 30-minutni intravenski infuziji odmerka 1 g pri treh prostovoljcih, starih od 13 do 17 let, so znašale: 155,9 mikrogramov/ml (Cmax) 0,5 ure po odmerku (ob koncu infuzije), 12 ur po odmerku pa 6,2 mikrogramov/ml.
• Urinary tract infection, kidney impairment
• okužba sečil, okvara ledvic,
• Skin redness, skin rash
• rdečica kože, izpuščaj po koži,
Disease Stratum
Žilne bolezni
Common: Infusion site pain Uncommon: Infusion site burning, infusion site pruritus, infusion site erythema, injection site erythema, infusion site warmth
Občasni: pekoč občutek, srbenje in eritem na mestu infuzije, eritem na mestu vboda, občutek toplote na mestu infuzije
• Constipation, yeast infection of the mouth, antibiotic-associated diarrhoea, acid regurgitation,
• zaprtje, kandidoza v ustih, z antibiotiki povzročena driska, zgaga, suha usta, slaba prebava,
• muscle weakness
• šibkost mišic,
Not known: Anaphylaxis including anaphylactoid reactions
Bolezni imunskega sistema Redki: alergija Neznana: anafilaksija vključno z anafilaktoidnimi reakcijami
It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving INVANZ.
Pomembno je, da preden prejmete zdravilo INVANZ, zdravniku poveste, če dojite ali nameravate dojiti.
Common: Elevation in platelet count
Pogosti: povečanje števila trombocitov
The change in binding was < 12 % at peak plasma ertapenem concentration following a 1 g dose.
Pri maksimalni plazemski koncentraciji ertapenema po 1-gramskem odmerku je bila sprememba vezave manjša od 12 %.
Uncommon: Oral candidiasis, candidiasis, fungal infection, pseudomembranous enterocolitis, vaginitis
Redki: kongestija nosne sluznice, kašelj, krvavitev iz nosu, poki/hropci, piskanje
Ertapenem
Mešane
Adults 18 years of age and older Children and adolescents (3 months to 17 years of age)
Otroci in mladostniki (stari od 3 mesecev do 17 let)
The recommended dose for adults and adolescents (12 years of age and over) is one tablet once a day.
Priporočeni odmerek za odrasle in mladostnike (stare 12 let in več) je ena tableta enkrat na dan.
The full EPAR for Desloratadine Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Desloratadine Teva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Desloratadine Teva on 24 November 2011.
Evropska komisija je dovoljenje za promet z zdravilom Desloratadine Teva, veljavno po vsej Evropski uniji, odobrila dne 24. novembra 2011.
For more information about treatment with Desloratadine Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Desloratadine Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
This means that Desloratadine Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aerius.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Aerius.
What are the benefits and risks of Desloratadine Teva?
Kakšne so koristi in tveganja, povezani z zdravilom Desloratadine Teva?
Desloratadine Teva is a ‘generic medicine'.
Desloratadine Teva je „generično zdravilo“.
Desloratadine Teva is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Zdravilo Desloratadine Teva se uporablja za lajšanje simptomov alergijskega rinitisa (vnetja nosne votline, ki ga povzroči alergija, na primer seneni nahod ali alergija na pršice) ali urtikarije (bolezni kože, ki jo povzroča alergija in katere simptomi vključujejo srbenje in izpuščaje).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Desloratadine Teva.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Desloratadine Teva, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Because Desloratadine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Desloratadine Teva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
This is a summary of the European public assessment report (EPAR) for Desloratadine Teva.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Desloratadine Teva.
Other information about Desloratadine Teva
Druge informacije o zdravilu Desloratadine Teva
The Committee recommended that Desloratadine Teva be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Desloratadine Teva odobri dovoljenje za promet.
The CHMP concluded that, in accordance with EU requirements, Desloratadine Teva has been shown to have comparable quality and to be bioequivalent to Aerius.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Desloratadine Teva primerljivo raven kakovosti kot zdravilo Aerius ter da mu je biološko enakovredno.
Because Desloratadine Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aerius.
Ker je zdravilo Desloratadine Teva generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Aerius.
Desloratadine Teva is a medicine containing the active substance desloratadine.
Desloratadine je zdravilo, ki vsebuje zdravilno učinkovino desloratadin.
It works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally fixes itself.
Deluje kot zaviralec receptorjev, na katere se običajno veže histamin, tj. snov v telesu, ki povzroča alergijske simptome.
The active substance in Desloratadine Teva, desloratadine, is an antihistamine.
Zdravilna učinkovina zdravila Desloratadine Teva je desloratadin, ki je antihistaminik.
Why has Desloratadine Teva been approved?
Zakaj je bilo zdravilo Desloratadine Teva odobreno?
What is Desloratadine Teva?
Kaj je zdravilo Desloratadine Teva?
How has Desloratadine Teva been studied?
Kako je bilo zdravilo Desloratadine Teva raziskano?
What is Desloratadine Teva used for?
Za kaj se zdravilo Desloratadine Teva uporablja?
How is Desloratadine Teva used?
Kako se zdravilo Desloratadine Teva uporablja?
How does Desloratadine Teva work?
Kako zdravilo Desloratadine Teva deluje?
1 bottle Zero days equivalent to titre prior to inactivation (log10)
(*) Ekvivalent titru pred inaktivacijo
The vaccine was also generally well tolerated and shown to be safe.
Živali so cepivo na splošno dobro prenašale in izkazalo se je kot varno.
The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response.
Cepivo vsebuje tudi „adjuvans“ (aluminijev hidroksid in saponin) za povečanje imunskega odziva.
The safety of the vaccine was studied in two main laboratory safety studies and a field safety study carried out in cattle as well as two studies carried out in pregnant cows.
Varnost zdravila je bila raziskana v dveh glavnih laboratorijskih študijah varnosti in v terenski študiji varnosti, ki so bile opravljene pri govedu, ter v dveh študijah, opravljenih pri brejih kravah.
The studies showed the vaccine prevents viraemia in cattle and offers protection for one year.
Študije so pokazale, da cepivo preprečuje viremijo pri govedu, in da zaščita traja eno leto.
Protection starts two weeks after the last injection and lasts for a year.
Zaščita je učinkovita od drugega tedna po zadnji injekciji in traja eno leto.
The first injection is given from two and a half months of age and the second injection is given three weeks later.
Prva injekcija se daje od starosti dveh mesecev in pol, druga pa tri tedne pozneje.
In 2012 the CVMP considered that the submitted data were adequate for the authorisation of Zulvac 1 Bovis to convert to normal.
Leta 2012 je CVMP menil, da predloženi podatki zadostujejo, da se dovoljenje za promet z zdravilom Zulvac 1 Bovis spremeni v običajno.
Cattle may have a slightly raised body temperature following vaccination.
Po cepljenju se lahko pri govedu pojavi rahlo povišana telesna temperatura.
Zulvac 1 Bovis was initially authorised under ‘exceptional circumstances'.
Zdravilo Zulvac 1 Bovis je prvotno pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
The vaccine is safe for cattle from two and a half months of age onwards and in pregnant cows.
Cepivo je varno za uporabo pri govedu, starejšemu od dveh mesecev in pol ter pri brejih kravah.
When it is given to cattle, the immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Ko govedo prejme cepivo, imunski sistem virus prepozna kot „tujek“ in proti njemu razvije protitelesa.
The European Medicines Agency (EMA) reviewed additional information submitted according to an agreed timetable on the quality and safety of the vaccine.
Evropska agencija za zdravila je pregledala vse nove podatke o kakovosti in varnosti cepiva, ki so bili predloženi v dogovorjenem časovnem razporedu.
The European Commission granted a marketing authorisation valid throughout the European Union, for Zulvac 1 Bovis on 05/08/2011.
Evropska komisija je dovoljenje za promet z zdravilom Zulvac 1 Bovis, veljavno po vsej Evropski uniji, odobrila dne 5. avgusta 2011.
The studies aim was to establish the smallest dose of vaccine that prevented viraemia as well as the duration of protection for Zulvac 1 Bovis.
Cilja študij sta bila določiti najmanjši odmerek, ki preprečuje viremijo, in ugotoviti trajanje zaščite po cepljenju s cepivom Zulvac 1 Bovis.
In the future, if the animals are exposed to the bluetongue virus, their immune systems will be able to produce antibodies more quickly.
Ob ponovni izpostavitvi virusu bolezni modrega jezika v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa.
Zulvac 1 Bovis is a vaccine that is available as a suspension for injection.
Zdravilo Zulvac 1 Bovis je cepivo, ki je na voljo v obliki suspenzije za injiciranje.
Other information about Zulvac 1 Bovis:
Druge informacije o zdravilu Zulvac 1 Bovis:
It contains inactivated (killed) bluetongue serotype 1 virus.
Vsebuje inaktiviran (uničen) serotip 1 virusa modrega jezika.
The withdrawal period for Zulvac 1 Bovis for meat and milk is zero days.
Karenca za cepivo Zulvac 1 Bovis za meso in mleko je nič dni.
Zulvac 1 Bovis is a vaccine.
Zdravilo Zulvac 1 Bovis je cepivo.
What benefit has Zulvac 1 Bovis shown during the studies?
Kakšne koristi je zdravilo Zulvac 1 Bovis izkazalo med študijami?
Zulvac 1 Bovis contains bluetongue virus of one serotype (serotype 1).
Cepivo Zulvac 1 Bovis vsebuje virus bolezni modrega jezika enega tipa (serotip 1).
This means that it was not possible to obtain complete information about Zulvac 1 Bovis at the time of the initial authorisation.
To pomeni, da ob prvotni izdaji dovoljenja za promet ni bilo mogoče pridobiti vseh podatkov o cepivu Zulvac 1
Zulvac 1 Bovis is used in cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges .
Zdravilo Zulvac 1 Bovis se uporablja pri govedu za zaščito pred boleznijo modrega jezika, tj. okužbo, ki jo povzroča virus modrega jezika, prenašajo pa jo trzače.
What is the risk associated with ZULVAC 1 Bovis?
Kakšna tveganja so povezana z zdravilom Zulvac 1 Bovis?
The vaccine is used to prevent viraemia (the presence of the viruses in the blood) in cattle from two and a half months of age.
Cepivo se uporablja za preprečevanje viremije (prisotnosti virusov v krvi) pri govedu, starejšem od dveh mesecev in pol. Cepivo se mladičem injicira v mišico v dveh odmerkih.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Zulvac 1 Bovis exceed the risks in the prevention of viraemia caused by bluetongue virus, serotype 1 in cattle from two and a half months of age.
CVMP je zaključil, da so pri govedu, starejšem od dveh mesecev in pol, koristi cepiva Zulvac 1 Bovis pri preprečevanju viremije, ki jo povzroča serotip 1 virusa bolezni modrega jezika, večje od z njim povezanih tveganj.
Why has Zulvac 1 Bovis been approved?
Zakaj je bilo zdravilo Zulvac 1 Bovis odobreno?
Zulvac 1 Bovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Cepivo Zulvac 1 Bovis vsebuje inaktiviran virus bolezni modrega jezika, ki ne povzroča bolezni.
The effectiveness of the vaccine was studied in three main laboratory studies in calves where animals were challenged with bluetongue virus serotype 1, after receiving Zulvac 1 Bovis vaccine containing different amounts of virus.
Živali so izpostavili serotipu 1 virusa bolezni modrega jezika po tem, ko so bile cepljene s cepivom Zulvac 1 Bovis, ki je vsebovalo različne količine virusa.
How has Zulvac 1 Bovis been studied?
Kako je bilo zdravilo Zulvac 1 Bovis raziskano?
Inactivated vaccine against Bluetongue virus, serotype 1
Zulvac 1 Bovis inaktivirano cepivo proti virusu bolezni modrega jezika, serotip 1
What is Zulvac 1 Bovis?
Kaj je zdravilo Zulvac 1 Bovis?
What is ZULVAC 1 Bovis used for?
Za kaj se zdravilo Zulvac 1 Bovis uporablja?
How does Zulvac 1 Bovis work?
Kako zdravilo Zulvac 1 Bovis deluje?
Date of first authorisation: 19 November 2015
Datum prve odobritve: 19. november 2015
< 50 years ≥ 50 years
< 50 let ≥ 50 let
Disproportionality analysis did not highlight events that met the criteria for signal of disproportionate reporting.
Analiza nesorazmernosti ni izpostavila dogodkov, ki bi izpolnjevali merila za signal nesorazmernega poročanja.
ATC code: J05AR18.
Oznaka ATC: J05AR18.
See sections 4.2, 4.4 and 5.1.
Glejte poglavja 4.2, 4.4 in 5.1.
3 These are medicinal products within class where similar interactions could be predicted.
3 To so zdravila znotraj skupine, kjer je mogoče predvideti podobne interakcije.
Since the previous review, 6 new cases were identified (5 valid and 1 invalid).
Od predhodnega pregleda je bilo ugotovljenih 6 novih primerov (5 veljavnih in 1 neveljaven).
The amount of this medicine in your blood may decrease during pregnancy which may stop it from working properly.
Količina tega zdravila v vaši krvi se lahko med nosečnostjo zmanjša in prepreči njegovo pravilno delovanje.
Data are presented as mean (%CV).
Podatki so predstavljeni kot povprečje (% CV).
Adults: one tablet each day with food
Odrasli: ena tableta vsak dan s hrano
The long-term effects of substantial increases in progestogen exposure are unknown.
Dolgoročni učinki bistvenega zvišanja izpostavljenosti progestogenu niso znani.
Cobicistat levels decrease and may not provide sufficient boosting.
Ravni kobicistata se zmanjšajo in morda ne bodo zagotovile zadostne okrepitve.