natgillin/translations-raw huggingface dataset:
Administer one dose of 2 ml by intramuscular injection to pigs of 18 weeks of age and older.
Dajte en odmerek po 2 ml intramuskularno prašičem, starim 18 tednov in starejšim.
Before use, allow the vaccine to reach room temperature.
Pred uporabo naj se cepivo ogreje na sobno temperaturo.
The first injection should be administered 6 weeks before the expected date of farrowing.
Prvi odmerek je treba dati 6 tednov pred pričakovano prasitvijo.
50 ml (25 doses)
50 ml (25 odmerkov)
Avoid introduction of contamination.
Pazite, da ne pride do kontaminacije.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
BESEDILO ''ZDRAVILO SHRANJUJTE IZVEN POGLEDA IN DOSEGA OTROK'' Zdravilo shranjujte izven pogleda in dosega otrok.
Do not use after the expiry date stated on the label.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojni.
For a full list of excipients, see section 6.1
≤1 mg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
The immunogens are incorporated in an adjuvant based on dl-α-tocopherol.
Imunogeni so vgrajeni v adjuvans na osnovi dl-alfa-tokoferola.
Revaccination: a single injection of one dose (2 ml) should be carried out 2 to 4 weeks prior to each subsequent farrowing.
Revakcinacija: en odmerek (2 ml) je treba dati 2 do 4 tedne pred vsako naslednjo prasitvijo.
Special precautions to be taken by the person administering the medicinal product to animals In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 20 ml (10 doses)
VSEBINA IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 20 ml (10 odmerkov)
The vaccine contains a non-toxic recombinant derivative of the Pasteurella multocida toxin and inactivated Bordetella bronchiseptica cells.
Cepivo vsebuje netoksični rekombinantni derivat toksina Pasteurelle multocide in inaktivirane celice Bordetelle bronchiseptice.
Shake vigorously before use and at intervals during use.
Dobro pretresite pred uporabo in v razmakih med uporabo.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
BESEDILO ''SAMO ZA ŽIVALI'' TER POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
Active substances: - Protein dO (non-toxic deletion derivative of Pasteurella multocida dermonecrotic toxin)
Zdravilne učinkovine: - protein dO (netoksični delecijski derivat dermonekrotičnega toksina bakterije Pasteurella multocida)
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ, ČE STA RAZLIČNA
Incompatibilities Do not mix with any other veterinary medicinal products.
Inkompatibilnosti Ne mešajte z drugimi zdravili za uporabo v veterinarski medicini.
MARKETING AUTHORISATION NUMBERS EU/2/00/026/001-006
ŠTEVILKE DOVOLJENJA ZA PROMET EU/2/00/026/001-006
20 ml (10 doses) Glass vial 50 ml (25 doses) Glass vial 20 ml (10 doses) PET vial 50 ml (25 doses) PET vial 100 ml (50 doses) PET vial 250 ml (125 doses) PET vial
20 ml (10 odmerkov), steklena viala 50 ml (25 odmerkov), steklena viala 20 ml (10 odmerkov), viala iz PET 50 ml (25 odmerkov), viala iz PET 100 ml (50 odmerkov), viala iz PET 250 ml (125 odmerkov), viala iz PET
PACKAGE SIZE 100 ml (50 doses) 250 ml (125 doses)
VELIKOST PAKIRANJA 100 ml (50 odmerkov) 250 ml (125 odmerkov)
Use during pregnancy, lactation or lay Can be used during pregnancy
Uporaba v obdobju brejosti, laktacije in nesnosti Zdravilo se lahko uporablja v obdobju brejosti.
≥6.2 log2 TN titre1
≥ 6,2 log2 toksin nevtralizirajočega titra1
ADVICE ON CORRECT ADMINISTRATION Before use, allow the vaccine to reach room temperature.
NASVET O PRAVILNI UPORABI ZDRAVILA Cepivo pred uporabo ogrejte na sobno temperaturo.
Colonisation of the surface of the nasal mucosa by Pasteurella multocida is most often promoted by Bordetella bronchiseptica.
Kolonizacijo površine nosne sluznice s Pasteurello multocido najpogosteje pospeši okužba z Bordetello bronchiseptico.
150 mg dl-α-tocopherol acetate
150 mg dl-alfa-tokoferol acetata
MANUFACTURER'S BATCH NUMBER Lot
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA
4.2 Indications for use, specifying the target species For the reduction of clinical signs of progressive atrophic rhinitis in piglets by passive oral immunisation with colostrum from dams actively immunised with the vaccine.
4.2 Indikacije za uporabo, opredelitev ciljne živalske vrste Zmanjšanje kliničnih znakov progresivnega atrofičnega rinitisa pujskov s pasivno peroralno imunizacijo prek kolostruma aktivno imuniziranih mater.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila za uporabo v veterinarski medicini ali odpadnih snovi
Primary vaccination: inject one dose (2 ml) per pig, followed by a second injection 4 weeks after the first injection.
Prvo cepljenje: en odmerek (2 ml) za enega prašiča, nato drugi odmerek 4 tedne po prvem.
Marketing authorisation holder and manufacturer: Intervet International B.V.
Imetnik dovoljenja za promet z zdravilom in izdelovalec: Intervet International B.V.
Pigs (sows and gilts).
Prašiči (svinje in mladice)
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
Read the package leaflet before use.
Pred uporabo preberite navodila za uporabo.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
ODMEREK ZA POSAMEZNE ŽIVALSKE VRSTE TER POT IN NAČIN UPORABE ZDRAVILA
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij O varnosti ter učinkovitosti ob sočasni uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini ni podatkov.
To stimulate active immunity in order to provide passive immunity to the progeny against progressive atrophic rhinitis.
Spodbujanje aktivne imunosti za razvoj pasivne imunosti pri potomcih proti progresivnemu atrofičnemu rinitisu.
For animal treatment only - to be supplied only on veterinary prescription.
Samo za živali - samo na veterinarski recept.
TARGET SPECIES Pigs (sows and gilts)
CILJNA ŽIVALSKA VRSTA Prašiči (svinje in mladice)
TARGET SPECIES Pigs (sows and gilts).
CILJNA ŽIVALSKA VRSTA Prašiči (svinje in mladice).
For animal treatment only - to be supplied only on veterinary prescription
Samo za živali - samo na veterinarski recept
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Wim de Körverstraat 35 NL-5831 AN Boxmeer NIZOZEMSKA
NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis AR-T DF suspension for injection for pigs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Porcilis AR-T DF, suspenzija za injiciranje za prašiče
Adjuvant: dl-α-tocopherol acetate
Adjuvans: dl-alfa-tokoferol acetat
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Intervet International B.V.
EXP {month/year} Once broached, use within 10 hours.
Načeto/odprto zdravilo uporabite v 10 urah.
A mean transient increase in body temperature of 1.5°C, in some pigs up to 3 °C, which could lead to an abortion, can generally be measured on the day of vaccination or the following day.
Na splošno se lahko pri nekaterih prašičih na dan cepljenja ali naslednji dan prehodno poveča telesna temperatura povprečno za 1,5 °C, pri nekaterih prašičih do 3 °C, kar lahko vodi do abortusa.. Na dan cepljenja se lahko zmanjšata aktivnost in tek in se pojavi prehodna oteklina na mestu injiciranja (največji premer je 10 cm), ki traja do dveh tednov.
2 Mean agglutination titre obtained after a single vaccination of a half dose in rabbits
2Srednji aglutinacijski titer je določen po enkratni vakcinaciji s polovičnim odmerkom pri kuncih.
PACKAGE LEAFLET Porcilis AR-T DF suspension for injection for pigs
Porcilis AR-T DF, suspenzija za injiciranje za prašiče
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
BESEDILO ''SAMO ZA ŽIVALI'' Samo za živali
Name and address of the manufacturer responsible for batch release:
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije:
For the reduction of clinical signs of progressive atrophic rhinitis in piglets by passive oral immunisation with colostrum from dams actively immunised with the vaccine.
Zmanjšanje kliničnih znakov progresivnega atrofičnega rinitisa pujskov s pasivno peroralno imunizacijo prek kolostruma aktivno imuniziranih mater.
Dermonecrotic toxin producing Pasteurella multocida is the pathogen responsible for turbinate atrophy in progressive atrophic rhinitis.
Pasteurella multocida, ki izloča dermonekrotični toksin, povzroča atrofijo nosnih školjk pri progresivnem atrofičnem rinitisu.
Pharmacotherapeutic group: inactivated bacterial vaccine.
IMUNOLOŠKE LASTNOSTI Farmakoterapevtska skupina: inaktivirano bakterijsko cepivo Oznaka ATCvet: QI09AB04
EXPIRY DATE EXP {month/year} Once broached, use within 10 hours.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
QUANTITY OF THE ACTIVE SUBSTANCE(S) Read the package leaflet before use.
KOLIČINA ZDRAVILNEUČINKOVINE Pred uporabo preberite navodilo za uporabo.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE [100 and 250 ml vials]
PODATKI NA STIČNI OVOJNINI [Viale po 100 ml in 250 ml]
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of 2 ml: ≥6.2 log2 TN titre Protein dO (non-toxic deletion derivative of Pasteurella multocida dermonecrotic toxin) ≥5.5 log2 Aggl.
- ≥ 6,2 log2 toksin nevtralizirajočega titra1 proteina dO (netoksični delecijski derivat dermonekrotičnega toksina Pasteurella multocida) - ≥ 5,5 log2 aglutinacijskega titra1 inaktiviranih celic bakterije Bordetella bronchiseptica
Shake vigorously before and at intervals during use.
Pred uporabo in občasno med njo dobro pretresite.
IMMUNOLOGICAL PROPERTIES
PODATKI NA ZUNANJI OVOJNINI
Interaction with other medicinal products and other forms of interaction
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI
INDICATION(S) Vaccine against progressive atrophic rhinitis.
INDIKACIJE Cepivo proti progresivnemu atrofičnemu rinitisu
Cardboard box containing one PET vial of 20 ml, 50 ml, 100 ml or 250 ml.
Zloženka z eno vialo po 20 ml ali 50 ml iz stekla 1. hidrolitične skupine Zloženka z eno vialo po 20 ml, 50 ml, 100 ml ali 250 ml iz tereftalata [PET] Ni nujno, da so v prometu vsa navedena pakiranja.
4.8 Interaction with other medicinal products and other forms of interaction
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij O varnosti ter učinkovitosti ob sočasni uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini ni podatkov.
Special precautions for use in animals
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
Neonatal piglets derive passive immunity via ingestion of colostrum from vaccinated sows/gilts.
Novorojeni pujski pridobijo pasivno imunost s kolostrumom cepljenih svinj/mladic.
6.1 List of excipients
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Natrijev klorid
C. STATEMENT OF THE MRLs
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL)
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of 2 ml: ≥6.2 log2 TN titre Protein dO ≥5.5 log2 Aggl.
- ≥ 6,2 log2 toksin nevtralizirajočega titra1 proteina dO - ≥ 5,5 log2 aglutinacijskega titra1 inaktiviranih celic bakterije Bordetella bronchiseptica dl-alfa-tokoferol acetata
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
ROUTE(S) OF ADMINISTRATION
NAČIN(I) UPORABE ZDRAVILA
titre2
formaldehid
INDICATION(S)
DODATEK I
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS [20 and 50 ml vials]
[Viale po 20 ml in 50 ml]
In such cases, the Western blot method is negative.
V teh primerih je metoda Western blot negativna.
(2015/2016 season)
(sezona 2015/2016)
* These reactions usually disappeared within 1-2 days without treatment.
* Te reakcije so navadno izginile v 1 do 2 dneh brez zdravljenja.
Component of a multipack, can't be sold separately.
Sestavni del večkratnega pakiranja, ne sme se prodajati ločeno.
These reactions are usually mild and only last a few days.
Te reakcije so navadno blage in trajajo le nekaj dni.
- Allergic reactions, in very rare cases leading to shock
- Alergijske reakcije, ki v redkih primerih povzročijo šok
Vaccine Efficacy*
Učinkovitost cepiva*
Table 1: Frequency in adults (18-60 years of age)
Preglednica 1: Pogostnost pri odraslih (18-60 let)
If you need a blood test to look for evidence of infection with certain viruses in the first few weeks after vaccination with Optaflu, the result of the test may not be correct.
Če je potreben pregled krvi zaradi znakov okužbe z nekaterimi virusi v prvih tednih po cepljenju s cepivom Optaflu, morda rezultati testov ne bodo pravilni.
Vaccine Efficacy = (1 - Relative Risk) x 100 %
Učinkovitost cepiva = (1 - relativno tveganje) x 100 %
Seroprotection is generally obtained within 3 weeks, as shown by the pivotal phase III clinical study V58P4 for the adult and elderly population.
Serološka zaščita je navadno dosežena v 3 tednih, kot je pokazala ključna klinična študija III. faze V58P4 za populacijo odraslih in starejših bolnikov.
- Fever greater than 39.0°C
- Telesna temperatura nad 39,0 °C
Among the overall study population enrolled, the mean age was 33 years, 55% were female, 84% were Caucasian, 7% were Black, 7% were Hispanic, and 2% were of other ethnic origin.
Pri v študijo vključeni populaciji je bila povprečna starost 33 let, 55 % je bilo žensk, 84 % je bilo belcev, 7 % črncev, 7 % ljudi hispanskega porekla in 2 % ljudi drugega etničnega porekla.
Rare to <1/1000
Redki do < 1/1.000
Adverse reactions are listed according to the following frequency:
Neželni učinki so navedeni po naslednji pogostnosti:
Reporting of suspected adverse reactions after authorisation of the medicinal products is important.
Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
Very serious side effects
Zelo resni neželeni učinki
A multinational (US, Finland, and Poland), randomized, observer-blinded, placebo-controlled trial was performed to assess clinical efficacy and safety of Optaflu during the 2007-2008 influenza season in adults aged 18 to 49 years.
Opravljeno je bilo mednarodno (ZDA, Finska in Poljska), randomizirano, za opazovalca slepo, s placebom nadzorovano preskušanje za oceno klinične učinkovitosti in varnosti cepiva Optaflu v sezoni gripe 2007-2008 pri odraslih osebah, starih od 18 do 49 let.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Odziv protiteles pri bolnikih z endogeno ali iatrogeno imunosupresijo morda ne bo zadosten.
• if you are allergic to influenza vaccine or any of the other ingredients of this vaccine (listed in
•če ste alergični na cepivo proti gripi ali katero koli sestavino tega cepiva (navedeno v poglavju 6);
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
If you take any medicines against cancer (chemotherapy), corticosteroid medicines (such as cortisone) or other medicines affecting the immune system, the immune response of your body may be weakened.
Če uporabljate zdravila proti raku (kemoterapijo), kortikosteroide (recimo kortizon) ali druga zdravila, ki vplivajo na imunski system, bo morda imunski odziv vašega telesa oslabljen.
• you should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see Section 2, “Taking other medicines”).
• morate vi povedati zdravniku, če je vaš imunski sistem okvarjen in ali prejemate zdravljenje, ki vpliva na imunski sistem, npr. zdravila proti raku (kemoterapija) ali kortikosteroidna zdravila (glejte poglavje 2, „Jemanje drugih zdravil“);
Number of Subjects with Influenza
Število oseb z gripo
Optaflu should be used in accordance to Official guidance.
Cepivo Optaflu je treba uporabljati v skladu z uradnimi smernicami.
The safety of Optaflu has been assessed in seven randomized, active controlled clinical trials performed as part of the development program.
Varnost cepiva Optaflu so ocenili v sedmih randomiziranih, aktivno nadzorovanih kliničnih preskušanjih, opravljenih kot del razvojnega programa.
Date of latest renewal: 01 June 2012
Datum prve odobritve: 1. junij 2007 Datum zadnjega podaljšanja: 1. Junij 2012
It is important that procedures are in place to avoid injury from faints.
Pomembno je, da se postopek opravi na mestu, kjer se je možno izogniti poškodbam zaradi omedlevice.
For intramuscular use.
Za intramuskularno uporabo.
Overall 7253 single doses of Optaflu were administered to 6180 adults aged 18 - 60 years of age and to 1073 elderly (aged 61 years or older).
Skupaj 7253 enkratnih odmerkov cepiva Optaflu so dali 6180 odraslim, starim od 18 do 60 let, in 1073 starejšim osebam, starim 61 let ali več.
Other medicines and Optaflu
Druga zdravila in cepivo Optaflu
It should be noted that adverse reactions may be intensified.
Treba je biti pozoren na to, da so lahko neželeni učinki okrepljeni.
In a repeated-dose toxicity study in rabbits there was no evidence of systemic toxicity and the vaccine was locally well tolerated.
V študijah toksičnosti pri ponavljajočih odmerkih pri kuncih ni bilo dokazov o sistemski toksičnosti in cepivo so lokalno dobro prenašali.
The European Medicines Agency has deferred the obligation to submit the results of studies withOptaflu in one or more subsets of the paediatric population in the prevention of influenza (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s cepivom Optaflu za eno ali več podskupin pediatrične populacije za preprečevanje gripe (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The safety and efficacy of Optaflu in children and adolescents less than 18 years of age have not yet been established.
Varnost in učinkovitost cepiva Optaflu pri otrocih in mladostnikih, starih do 18 let, še nista bili dokazani.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Kot pri vseh cepivih, ki se injicirajo, morata biti ustrezno zdravljenje in zdravstveni nadzor vedno na voljo za primer redke anafilaktične reakcije po uporabi cepiva.
All pack sizes are available with or without needle(s).
Vse velikosti pakiranj so na voljo z iglami ali brez njih.
In the elderly frequencies were similar, except for myalgia, headache and injection site pain which were classified as ‘common'.
Pri starejših je bila pogostnost podobna, z izjemo mialgije, glavobola in bolečine na mestu injiciranja, ki so bili razvrščeni kot ‘pogosti'.
This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Spremlja jo lahko več nevroloških znakov, kot so prehodne motnje vida, parestezija in tonično-klonični gibi udov med okrevanjem.
Seroconversion/Significant increase rate
Stopnja serološke zaščite Stopnja serološke konverzije/ pomembnega povečanja
Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07BB02
Farmakoterapevtska skupina: Cepiva proti gripi, Oznaka ATC: J07BB02
Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Pred začetkom uporabe natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
(convulsions) (only observed with egg-derived influenza vaccines)
(konvulzije) (opazili so jih samo pri cepivih proti gripi, pridobljenih iz jajc).
A total of 11,404 subjects were enrolled to receive Optaflu (N=3828), Agrippal (N=3676) or placebo (N=3900) in a 1:1:1 ratio.
Vključenih je bilo skupno 11.404 oseb, ki so prejele cepivo Optaflu (N=3828), cepivo Agrippal (N=3676) ali placebo (N=3900) v razmerju 1:1:1.
No effects on the breastfed newborn /infant are anticipated.
Učinki na dojene novorojence/otroke se ne pričakujejo.
Data for adults were as follows (values in brackets show the 95% confidence intervals):
Podatki pri odraslih so bili naslednji (vrednosti v oklepajih so 95-odstotni intervali zaupanja):
Immunisation should be carried out on separate limbs.
Imunizacijo je treba opraviti na ločenih okončinah.
In this case the vaccines should be injected into separate limbs.
V takšnem primeru je treba cepiva injicirati v ločene okončine.
Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Po cepljenju proti gripi so lahko rezultati seroloških preizkusov z metodo ELISA za odkrivanje protiteles proti virusu-1 humane imunske pomanjkljivosti (HIV-1), virusu hepatitisa C in zlasti proti virusu HTLV-1 lažno pozitivni.
What you need to know before you receive OPTAFLU
Kaj morate vedeti, preden boste prejeli cepivo OPTAFLU
** Thrombocytopenia (some very rare cases were severe with platelet counts less than 5000 per mm3)
** Trombocitopenija (zelo redki primeri so bili hudi s številom trombocitov manj kot 5.000 na mm
The limited data from influenza vaccinations in pregnant women do not indicate that there are negative effects for the unborn child.
Omejeni podatki iz cepljenj proti gripi pri nosečnicah ne kažejo na negativne vplive za nerojenega otroka.
These transitory false-positive results may be due to IgM production in response to the vaccine.
Ti prehodno lažno pozitivni rezultati so lahko posledica nastajanja protiteles IgM na cepivo.
A single syringe contains 0.5 ml of suspension for injection.
Posamezna brizga vsebuje 0,5 ml suspenzije za injiciranje.
The safety of Optaflu in pregnancy and breast-feeding has not been assessed in clinical trials.
Varnosti cepiva Optaflu v nosečnosti in pri dojenju niso ocenili v kliničnih preskušanjih.
Detailed information on this medicine is available on the European Medicines Agency web site:
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.