FrancophonIA/ELRC3.0 huggingface dataset:
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
Slovenian: osteonekroza čeljustnic*†, osteonekroza zunanjega sluhovoda (neželeni učinek skupine difosfonatov)†
English: Furthermore, Bonviva 150 mg once monthly was proven superior to ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p=0.002, and at two years, p<0.001.
Slovenian: Zdravilo Bonviva 150 mg enkrat na mesec se je izkazalo za boljše kakor ibandronska kislina 2,5 mg enkrat na dan v povišanju MKG ledvene hrbtenice v prospektivno načrtovani analizi po enem letu, p = 0,002, in dveh letih, p < 0,001.
English: - Patients should not lie down for 1 hour after taking Bonviva.
Slovenian: - Po zaužitju zdravila Bonviva bolniki 1 uro ne smejo leči.
English: Table 3: Results from 3 years fracture study MF 4411 (%, 95 % CI) Placebo (N=974)
Slovenian: Preglednica 3: Rezultati 3-letne študije zlomov MF 4411 (%, 95-% interval zaupanja).
English: Bonviva 150 mg once monthly was shown to be at least as effective as ibandronic acid 2.5 mg daily at increasing BMD in a two year, double-blind, multicentre study (BM 16549) of postmenopausal women with osteoporosis (lumbar spine BMD T score below -2.5 SD at baseline).
Slovenian: Zdravilo Bonviva 150 mg enkrat na mesec se je v povišanju MKG izkazalo za najmanj enako učinkovito kakor ibandronska kislina 2,5 mg enkrat na dan v dveletni dvojno slepi, multicentrični študiji (BM 16549) pri ženskah z osteoporozo v postmenopavzi (izhodiščna T-vrednost MKG ledvene hrbtenice pod -2,5 SD).
English: Due to limited clinical experience, Bonviva injection is not recommended for patients with a serum creatinine above 200 μmol/l (2.3 mg/dl) or with a creatinine clearance below 30 ml/min (see section 4.2 and section 5.2).
Slovenian: Zaradi omejenih kliničnih izkušenj zdravila Bonviva v obliki injekcije ne priporočamo bolnikom, ki imajo serumski kreatinin nad 200 µmol/l (2,3 mg/dl) ali kreatininski očistek, manjši kot 30 ml/min (glejte poglavje 4.2 in poglavje 5.2).
English: • If you have certain problems with your gullet/food pipe (oesophagus) such as narrowing or difficulty swallowing.
Slovenian: • Če imate določene težave s požiralnikom, kot je zožitev ali težave s požiranjem.
English: Bonviva is only for use in postmenopausal women and must not be taken by women of childbearing potential.
Slovenian: Zdravilo Bonviva lahko uporabljajo samo ženske v postmenopavzi, ženske v rodni dobi pa ga ne smejo uporabljati.
English: Bonviva injection is not recommended for use in patients who have a serum creatinine above 200 μmol/l (2.3 mg/dl) or who have a creatinine clearance (measured or estimated) below 30 ml/min, because of limited clinical data available from studies including such patients (see section 4.4 and section 5.2).
Slovenian: Uporaba zdravila Bonviva v obliki injekcije pri bolnikih s serumskim kreatininom nad 200 µmol/l (2,3 mg/dl) ali s kreatininskim očistkom (izmerjenim ali ocenjenim) pod 30 ml/min zaradi malo kliničnih podatkov iz študij, ki so vključevale take bolnike, ni priporočljiva (glejte poglavji 4.4 in 5.2).
English: If a dose of Bonviva is missed
Slovenian: Če ste pozabili odmerek zdravila Bonviva
English: tablet core: lactose monohydrate, povidone, cellulose microcrystalline, crospovidone, stearic acid purified, silica colloidal anhydrous tablet coat: hypromellose, titanium dioxide (E 171), talc, macrogol 6000
Slovenian: obloga tablet: hipromeloza, titanov dioksid (E 171), smukec in makrogol 6000.
English: Due to limited clinical experience, Bonviva is not recommended for patients with a creatinine clearance below 30 ml/min (see section 5.2).
Slovenian: Zaradi malo kliničnih izkušenj zdravila Bonviva ne priporočamo bolnikom, ki imajo kreatininski očistek manjši kot 30 ml/min (glejte poglavje 5.2).
English: Bonviva 3 mg solution for injection ibandronic acid
Slovenian: Bonviva 3 mg raztopina za injiciranje ibandronska kislina
English: How to receive Bonviva
Slovenian: Kako prejemati zdravilo Bonviva
English: What Bonviva contains
Slovenian: Kaj vsebuje zdravilo Bonviva
English: At one year, 83.5 % (p= 0.006) of patients receiving Bonviva 150 mg once monthly and 73.9 % of patients receiving ibandronic acid 2.5 mg daily were identified as responders (defined as a decrease ≥50 % from baseline).
Slovenian: Po enem letu je bilo odzivnih 83,5 % bolnikov (p = 0,006), ki so prejemali zdravilo Bonviva 150 mg enkrat na mesec, in 73,9 % bolnikov, ki so jemali ibandronsko kislino 2,5 mg enkrat na dan, odzivnost so definirali kot ≥ 50 % zmanjšanje od izhodišča.
English: Oesophagitis, Gastritis, Gastro oesophageal reflux disease, Dyspepsia, Diarrhoea, Abdominal pain, Nausea
Slovenian: Bolezni prebavil gastritis, dispepsija, diareja, abdominalna bolečina, navzea, zaprtje
English: In the pivotal two-year study in postmenopausal women with osteoporosis (BM16550), the overall safety of intravenous injection of Bonviva 3 mg every 3 months and oral ibandronic acid 2.5 mg daily were shown to be similar.
Slovenian: V ključni dveletni študiji pri ženskah z osteoporozo v postmenopavzi (BM 16550) je bila celokupna varnost zdravila Bonviva 3 mg v obliki intravenske injekcije, dane vsake 3 mesece, in ibandronske kisline 2,5 mg, dane peroralno enkrat na dan, podobna.
English: Furthermore, Bonviva 3 mg injection every 3 months was proven superior to oral ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p<0.001, and at two years, p<0.001.
Slovenian: Zdravilo Bonviva 3 mg v obliki injekcije, dane vsake 3 mesece, se je izkazalo za boljše kakor peroralno dana ibandronska kislina 2,5 mg enkrat na dan v povišanju MKG ledvene hrbtenice v prospektivno načrtovani analizi po enem letu, p < 0,001, in dveh letih, p < 0,001.
English: Do not use Bonviva this medicine after the expiry date which is stated on the carton and on the syringe after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake Uporabno do in na injekcijski brizgi poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: Among these patients, the incidence of upper gastrointestinal events in the patients treated with Bonviva 150 mg once monthly was similar to that in patients treated with ibandronic acid 2.5 mg daily.
Slovenian: Pri teh bolnikih je bila incidenca neželenih učinkov v zgornjem delu prebavil podobna pri tistih, ki so se zdravili z zdravilom Bonviva 150 mg enkrat na mesec ali ibandronsko kislino 2,5 mg vsak dan.
English: The dose of Bonviva is one tablet once a month.
Slovenian: NAČRTOVANJE JEMANJA ZDRAVILA BONVIVA Odmerek zdravila Bonviva je ena tableta enkrat na mesec.
English: At one year (primary analysis), 91.3 % (p=0.005) of patients receiving Bonviva 150 mg once monthly had a lumbar spine BMD increase above or equal to baseline (BMD responders), compared with 84.0 % of patients receiving ibandronic acid 2.5 mg daily.
Slovenian: Po enem letu (primarna analiza) se je 91,3 % (p = 0,005) bolnikom, ki so prejemali zdravilo Bonviva 150 mg enkrat na mesec, MKG lumbalne hrbtenice povišala ali ostala enaka izhodiščni vrednosti (bolniki, odzivni na povišanje MKG) v primerjavi s 84,0 % bolnikov, ki so prejemali ibandronsko kislino 2,5 mg na dan.
English: NAME OF THE MEDICINAL PRODUCT Bonviva 3 mg solution for injection
Slovenian: IME ZDRAVILA Bonviva 3 mg raztopina za injiciranje
English: Continuing to receive Bonviva
Slovenian: Nadaljevanje prejemanja zdravila Bonviva
English: Bonviva may also do so.
Slovenian: Zdravilo Bonviva ima lahko enak učinek.
English: There is no relevant use of Bonviva in children below 18 years, and Bonviva was not studied in this population (see section 5.1 and 5.2).
Slovenian: Zdravila Bonviva pri tej populaciji bolnikov niso proučevali (glejte poglavji 5.1 in 5.2).
English: Based on the results of study BM 16550, Bonviva 3 mg intravenous injection, administered every 3 months is expected to be at least as effective in preventing fractures as the oral regimen of ibandronic acid 2.5 mg daily.
Slovenian: Glede na rezultate študije BM 16550 pričakujemo, da je zdravilo Bonviva 3 mg v obliki intravenske injekcije, ki jo dajemo vsake 3 mesece, najmanj enako učinkovito v preprečevanju zlomov kakor peroralno odmerjena ibandronska kislina 2,5 mg enkrat na dan.
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving Bonviva for osteoporosis (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo Bonviva za zdravljenje osteoporoze, so v obdobju po prihodu zdravila na trg zelo redko poročali o osteonekrozi čeljustnic (glejte poglavje 4.8).
English: Bonviva may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won't be able to see or feel a difference.
Slovenian: S tem kostno maso poveča pri večini bolnic, ki ga jemljejo, čeprav same ne bodo videle ali čutile razlike.
English: Bonviva 3 mg solution for injection in pre-filled syringe should be injected intravenously over a period of 15 - 30 seconds.
Slovenian: Dajanje zdravila Bonviva 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi: Bonviva 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi se daje intravensko 15 do 30 sekund.
English: When a more stringent criterion is considered, which combines both lumbar spine and total hip BMD, 83.9 % (p<0.001) and 65.7 % of patients receiving Bonviva 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders at one year.
Slovenian: Če upoštevamo strožji kriterij, ki združuje MKG ledvene hrbtenice in kolka, je bilo po enem letu odzivnih 83,9 % (p < 0,001) bolnikov, ki so prejemali zdravilo Bonviva 150 mg enkrat na mesec, in 65,7 % bolnikov, ki so prejemali ibandronsko kislino 2,5 mg na dan.
English: Where the medicinal product is administered into an existing intravenous infusion line, the infusate should be restricted to either isotonic saline or 50 mg/ml (5 %) glucose solution.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje Kadar se zdravilo daje v obstoječe intravenske infuzijske kanale, je infuzat lahko le izotonična raztopina natrijevega klorida ali 50 mg/ml (5-%) raztopina glukoze.
English: • If you have any swallowing or digestive problems.
Slovenian: • če imate težave s požiranjem ali prebavo.
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving Bonviva for osteoporosis.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Bonviva za zdravljenje osteoporoze, so v obdobju po prihodu zdravila na trg zelo redko poročali o neželenem učinku, imenovanem osteonekroza čeljustnic (poškodba kosti v čeljusti).
English: • stomach pain (such as gastritis) or tummy pain, indigestion, nausea, having diarrhoea (loose bowels) or constipation
Slovenian: • bolečina v želodcu (kot je npr. gastritis) ali trebuhu, slaba prebava, slabost, driska ali zaprtje,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/265/005 1 pre-filled syringe EU/1/03/265/006 4 pre-filled syringes
Slovenian: ŠTEVILKA(E) DOVOLJENJA ZA PROMET EU/1/03/265/005 1 napolnjena injekcijska brizga EU/1/03/265/006 4 napolnjene injekcijske brizge
English: Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid.
Slovenian: Pri bolnikih, zdravljenih z ibandronsko kislino, dano intravensko, so poročali o primerih anafilaktične reakcije/šoku, vključno z dogodki s smrtnim izidom.
English: Bonviva is not recommended for patients with a creatinine clearance below 30 ml/min due to limited clinical experience (see section 4.4 and section 5.2).
Slovenian: Uporaba zdravila Bonviva pri bolnikih s kreatininskim očistkom pod 30 ml/min zaradi malo kliničnih izkušenj ni priporočljiva (glejte poglavji 4.4 in 5.2).
English: Continuing to take Bonviva
Slovenian: Nadaljevanje jemanja zdravila Bonviva
English: NAME OF THE MEDICINAL PRODUCT Bonviva 3 mg solution for injection Ibandronic acid
Slovenian: IME ZDRAVILA Bonviva 3 mg raztopina za injiciranje ibandronska kislina
English: Table 1: Adverse reactions occurring in postmenopausal women receiving Bonviva 150 mg once monthly or ibandronic acid 2.5 mg daily in the phase III studies BM16549 and MF4411 and in postmarketing experience.
Slovenian: Preglednica 1: Neželeni učinki, ki so se pojavili pri postmenopavznih ženskah, ki so v študijah faze III BM16549 in MF4411 ter po prihodu zdravila na trg prejemale zdravilo Bonviva 150 mg enkrat na mesec ali ibandronsko kislino 2,5 mg na dan. Organski sistem Pogosti
English: There is no relevant use of Bonviva in children below 18 years, and Bonviva was not studied in this population.
Slovenian: Uporaba zdravila Bonviva pri otrocih, mlajših od 18 let, ni smotrna.
English: At two years 78.7 % (p=0.002) and 65.6 % of patients were identified as responders in the 150 mg monthly and 2.5 mg daily arms respectively.
Slovenian: Po dveh letih je bilo odzivnih 78,7 % bolnikov (p = 0,002), ki so prejemali 150 mg enkrat na mesec, in 65,6 % bolnikov, ki so jemali 2,5 mg enkrat na dan.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/265/003 1 film-coated tablet EU/1/03/265/004 3 film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA ZA PROMET EU/1/03/265/003 1 filmsko obložena tableta
English: Arthralgia, Myalgia, Musculoskeletal pain, Muscle cramp, Musculoskeletal stiffness
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija, mialgija, mišičnoskeletna bolečina, mišični krči, mišičnoskeletna otrplost bolečina v hrbtu atipični subtrohanterni zlomi stegnenice in zlomi diafize stegnenice†
English: Bonviva contains lactose.
Slovenian: Zdravilo Bonviva vsebuje laktozo.
English: Ibandronic acid 2.5 mg daily
Slovenian: Ibandronska kislina 2,5 mg enkrat na dan
English: Do not receive Bonviva
Slovenian: Ne prejemajte zdravila Bonviva:
English: • muscle cramps, stiffness of your joints and limbs
Slovenian: • mišični krči, togost v sklepih ali okončinah,
English: So be especially careful if you take painkillers or anti-inflammatories while you're taking Bonviva.
Slovenian: Če jemljete zdravila proti bolečini ali protivnetna zdravila med zdravljenjem z zdravilom Bonviva, bodite še posebno previdni.
English: • You should take calcium and vitamin-D supplements while receiving Bonviva.
Slovenian: • Med zdravljenjem z zdravilom Bonviva morate jemati dodatke kalcija in vitamina D. Obvestite svojega zdravnika, če to ni mogoče.
English: • If you get any side effects, talk to your doctor or pharmacist.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
English: How to take Bonviva
Slovenian: Kako jemati zdravilo Bonviva
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/265/005
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/03/265/005 EU/1/03/265/006
English: At two years, 93.5 % (p=0.004) and 86.4 % of patients receiving Bonviva 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders.
Slovenian: Po dveh letih je bilo odzivnih 93,5 % bolnikov (p = 0,004), ki so prejemali zdravilo Bonviva 150 mg enkrat na mesec, in 86,4 % bolnikov, ki so prejemali ibandronsko kislino 2,5 mg enkrat na dan.
English: You may develop low levels of calcium, phosphorus or magnesium in the blood.
Slovenian: Če so vam dali večji odmerek zdravila Bonviva, kot bi smeli To lahko povzroči nizke koncentracije kalcija, fosforja ali magnezija v krvi.
English: You should take one tablet the next morning after the day you remember; then, continue taking one tablet once a month on the scheduled days you've marked on your calendar.
Slovenian: • Če ste pozabili vzeti tableto na vaš izbrani dan in je vaš načrtovani odmerek čez več kot 7 dni … vzemite eno tableto naslednje jutro, potem ko se spomnite, nato jemanje tablet nadaljujte enkrat na mesec, na izbrane dni, ki ste si jih označili na koledarju.
English: An expected decrease in bone turnover, normal quality of bone and absence of defects in mineralization were also seen after two years of treatment with Bonviva 3 mg injection.
Slovenian: Tudi dveletno zdravljenje s 3-mg injekcijo zdravila Bonviva je pokazalo pričakovano zmanjšanje kostne premene, normalno kakovost kosti in odsotnost motenj mineralizacije.
English: Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Slovenian: Neželeni učinki ibandronske kisline v študijah vplivov na sposobnost razmnoževanja pri podganah so bili pričakovano značilni za to skupino zdravil (difosfonati).
English: Influenza like illness*, Fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije bolezen, podobna gripi*
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bonviva 3 mg solution for injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Bonviva 3 mg raztopina za injiciranje ibandronska kislina
English: ibandronic acid 2.5 mg daily (N=318)
Slovenian: ibandronska kislina 2,5 mg enkrat na dan (n = 318)
English: ibandronic acid 2.5 mg daily (N=294)
Slovenian: ibandronska kislina 2,5 mg enkrat na dan (n = 294)
English: Do not take Bonviva
Slovenian: Ne jemljite zdravila Bonviva:
English: For total hip BMD, 90.0 % (p<0.001) of patients receiving Bonviva 150 mg once monthly and 76.7 % of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline at one year.
Slovenian: MKG kolka se je po enem letu povišala ali ostala enaka izhodiščni vrednosti pri 90,0 % (p < 0,001) bolnikov, ki so prejemali 150 mg enkrat na mesec, in 76,7 % bolnikov, ki so prejemali ibandronsko kislino 2,5 mg na dan.
English: Talk to your doctor before taking Bonviva:
Slovenian: Pred začetkom jemanja zdravila Bonviva se posvetujte z zdravnikom:
English: Headache
Slovenian: utrujenost
English: Talk to your doctor before receiving Bonviva:
Slovenian: Preden boste prejeli zdravilo Bonviva, se posvetujte z zdravnikom:
English: Oesophagitis including oesophageal ulcerations or strictures and dysphagia, Vomiting, Flatulence
Slovenian: Bolezni prebavil* ezofagitis, gastritis, gastroezofagealna refluksna bolezen, dispepsija, diareja, abdominalna bolečina, navzea ezofagitis, vključno z ezofagealnimi ulceracijami ali zožitvami ter disfagijo, bruhanje, flatulenca duodenitis
English: At two years 93.4 % (p<0.001) of patients receiving Bonviva 150 mg once monthly and 78.4 %, of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline.
Slovenian: Po dveh letih se je MKG kolka povišala ali ostala enaka izhodiščni vrednosti pri 93,4 % bolnikov (p < 0,001), ki so prejemali zdravilo Bonviva 150 mg enkrat na mesec, in 78,4 % bolnikov, ki so prejemali ibandronsko kislino 2,5 mg enkrat na dan.
English: Anaphylactic reaction/shock*†
Slovenian: Bolezni imunskega sistema poslabšanje astme preobčutljivostna reakcija anafilaktična reakcija/šok*†
English: Arthralgia, Myalgia, Musculoskeletal pain, Back pain
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija, mialgija, mišičnoskeletna bolečina, bolečina v hrbtu bolečina v kosteh atipični subtrohanterni zlomi stegnenice in zlomi diafize stegnenice†
English: Tablet coat
Slovenian: PRETISNI OMOT
English: • not smoking; and not drinking too much alcohol.
Slovenian: • opustitev kajenja in zmerno pitje alkohola.
English: PROHIBITION OF SALE; SUPPLY AND/OR USE Not applicable.
Slovenian: PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Ni smiselno.
English: For intramuscular use.
Slovenian: Intramuskularna uporaba.
English: Interaction with other medicinal products and other forms of interaction
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij:
English: Sodium chloride solution (0.9%)
Slovenian: Natrijev klorid, raztopina (0,9 %)
English: Excipient: Thiomersal
Slovenian: Pomožna snov: Tiomersal
English: 0.21 mg For the full list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: Special warnings for each target species
Slovenian: Posebna opozorila za vsako ciljno živalsko vrsto Jih ni.
English: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above.
Slovenian: 4 mesece pri prašičih cepljenih v starosti med 56 in 96 dni 6 mesecev pri prašičih, ki so bili prvič cepljeni po 96 dneh starosti
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection only a minor injection site reaction is expected.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samo-injiciranja lahko pride do blage reakcije na mestu injiciranja.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Respiporc FLU3 suspension for injection for pigs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Respiporc FLU3 suspenzija za injiciranje za prašiče
English: DATE OF FIRST AUTHORISATION Date of first authorisation: 14/01/2010 Date of last renewal: 04/12/2014
Slovenian: Datum podaljšanja dovoljenja za promet: 04.12.2014
English: 20 ml vials, glass type I 50 ml vials, glass type II 100 ml vials, glass type II
Slovenian: Steklene Viale: 20 ml viale, steklo tipa I 50 ml viale, steklo tipa II 100 ml viale, steklo tipa II
English: Major incompatibilities
Slovenian: 6.2 Glavne inkompatibilnosti
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 20 ml (10 doses)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 20 ml (10 odmerkov),
English: PHARMACEUTICAL FORM Clear, yellowish orange to pink coloured suspension for injection.
Slovenian: FARMACEVTSKA OBLIKA Bistra, rumeno-oranžna do rožnato obarvana suspenzija za injiciranje
English: Name and address of the manufacturers of the biological active substances
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box for 20ml, 50 ml, 100 ml, 8 x 500 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla za 20 ml, 50 ml, 100 ml, 8 x 500 ml
English: PACKAGE SIZE 100 ml (50 doses) 500 ml (250 doses)
Slovenian: VELIKOST PAKIRANJA 100 ml (50 odmerkov) 500 ml (250 odmerkov)
English: Pharmacotherapeutic group: Immunologicals, Inactivated viral vaccines ATCvet code: QI09AA03
Slovenian: Farmakoterapevtska skupina: cepiva, inaktivirana virusna cepiva Oznaka ATC vet:
English: On very rare occasions, a slight transient rectal temperature increase might occur after vaccination (“very rare” corresponds to a frequency of adverse reactions less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: (»Zelo redko« pri navajanju neželenih učinkov pomeni pogostost pojavljanja neželenih učinkov manj kot 1 žival na 10.000 zdravljenih živali, vključno s posamičnimi primeru).
English: or - Between the age of 56 and 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 4 months.
Slovenian: ali - Med 56. in 96. dnem starosti v razmiku 3 tednov za zagotovitev trajanja imunosti 4 mesece.
English: PACKAGE LEAFLET: Respiporc FLU3 Suspension for injection for pigs
Slovenian: Respiporc FLU3 suspenzija za injiciranje za prašiče
English: STATEMENT OF ACTIVE SUBSTANCES Each dose of 2 ml contains:
Slovenian: Vsak odmerek (2ml) vsebuje:
English: 20 ml (10 doses) 50 ml (25 doses) 100 ml (50 doses) 8 x 500 ml (250 doses)
Slovenian: 20 ml (10 odmerkov), 50 ml (25 odmerkov), 100 ml (50 odmerkov), 8 x 500 ml (250 odmerkov)
English: (H3N2) ≥ 10.53 log2 GMNU, (H1N1) ≥ 10.22 log2 GMNU, (H1N2) ≥ 12.34 log2 GMNU
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Sevi inaktiviranega virusa Influenca A /prašiči (H3N2) ≥ 10.53 log2 GMNU, (H1N1) ≥ 10.22 log2 GMNU, (H1N2) ≥ 12.34 log2 GMNU
English: In particular cases of multiple contacts of the sows with antigens (field infections + vaccination) the antibodies transmitted to the piglets may last until week 12 of life.
Slovenian: V posebnih primerih, ko svinje prihajajo v stik z več antigeni (naravne okužbe in cepljenje), lahko protitelesa, ki jih dobijo pujski,