natgillin/translations-raw huggingface dataset:
Telmisartan Actavis is a medicine that contains the active substance telmisartan.
Telmisartan Actavis je zdravilo, ki vsebuje zdravilno učinkovino telmisartan.
Other information about Telmisartan Actavis:
Druge informacije o zdravilu Telmisartan Actavis
Why has Telmisartan Actavis been approved?
Zakaj je bilo zdravilo Telmisartan Actavis odobreno?
What is Telmisartan Actavis?
Kaj je zdravilo Telmisartan Actavis?
How has Telmisartan Actavis been studied?
Kako je bilo zdravilo Telmisartan Actavis raziskano?
How is Telmisartan Actavis used?
Kako se zdravilo Telmisartan Actavis uporablja?
What is Telmisartan Actavis used for?
Za kaj se zdravilo Telmisartan Actavis uporablja?
How does Telmisartan Actavis work?
Kako zdravilo Telmisartan Actavis deluje?
MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration
(Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe
MA (EU) Number
Številka EU
0.6 ml (10 mg/ml) 1 pre-filled syringe
0,6 ml (10 mg/ml) 1 napolnjena uporaba
Content (concentration)
(koncentracija) pakiranja
(Invented) name
Velikost ime
Strength Pharmaceutical Form
(Izmišljeno) Jakost Farmacevtska oblika Pot uporabe Stična ovojnina Vsebina
Subcutaneous use pre-filled syringe (glass)
6 mg raztopina za injiciranje subkutana napolnjena
This overview was last updated in March 2019.
Ta povzetek je bil nazadnje posodobljen marca 2019.
In the future if the animals are exposed to similar proteins the immune system will be able to respond more quickly.
Ob ponovni izpostavitvi živali podobnim beljakovinam v prihodnosti se bo imunski sistem tako hitreje odzval.
Safety studies have shown that the strain is safe for turkeys, however, precautionary measures must be followed to avoid direct or indirect contact between vaccinated chickens and turkeys.
V študijah varnosti so dokazali, da je sev varen za purane, vendar je treba upoštevati previdnostne ukrepe, da ne pride do neposrednega ali posrednega stika med cepljenimi piščanci in purani.
It can make birds more prone to other diseases and can interfere with effective vaccination.
Zaradi nje so ptice lahko dovzetnejše za druge bolezni in lahko vpliva na učinkovitost cepljenja.
Vaccinated birds had a protection level of between 81% and 95% against disease signs.
Pri cepljenih pticah je bila raven zaščite pred znaki bolezni med 81 % in 95 %.
Innovax-ND-IBD received a marketing authorisation valid throughout the EU on 22 August 2017.
Zdravilo Innovax-ND-IBD je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 22. avgusta 2017.
The full EPAR for Innovax-ND-IBD can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/innovax-nd-ibd.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Innovax-ND-IBD je na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/innovax-nd-ibd.
Similar challenges were carried out after hatching to show the effects of vaccination of chicken eggs.
Podobni provokacijski testi so bili izvedeni po izvalitvi, da bi dokazali učinke cepljenja kokošjih jajc.
The vaccine can be given to one-day-old chicks as a single injection under the skin in the neck or directly into 18 - 19-day-old chicken eggs containing embryos (unhatched developing chicks).
Cepivo se lahko uporablja pri en dan starih piščancih v obliki enkratnega injiciranja pod kožo na vratu ali neposrednega injiciranja v 18-19 dni stara jajca, ki vsebujejo zarodke (še ne izvaljene piščance v razvoju).
The European Medicines Agency decided that Innovax-ND-IBD's benefits are greater than its risks and recommended it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Innovax-ND-IBD večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
ND is a viral infection of chickens which causes gasping and coughing, nervous signs (drooping wings, twisting of the head and neck, circling and paralysis), swelling of the tissues around the eyes and neck, greenish watery diarrhoea and reduced egg production.
Atipična kokošja kuga je virusna okužba pri piščancih, ki povzroča sopenje in kašelj, znake obolenja živcev (povešena krila, obračanje glave in vratu, kroženje in paralizo), otekanje tkiv okoli oči ter vratu, zelenkasto vodeno drisko in zmanjšano nesenje jajc.
As the vaccine is stored in liquid nitrogen, it is important that any handling is done in a well-ventilated area and that precautions are taken when preparing the vaccine.
Cepivo se shranjuje v tekočem dušiku, zato je pomembno, da rokovanje z njim poteka v dobro prezračevanem prostoru in da se pri pripravi cepiva upoštevajo previdnostni ukrepi.
The withdrawal period for meat and eggs from chickens treated with Innovax-ND-IBD is ‘zero' days, which means there is no mandatory waiting time.
Karenca za meso in jajca piščancev, zdravljenih z zdravilom Innovax-ND-IBD, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
Vaccinated chickens were taken from a field study and challenged (brought in contact with the viruses) in the laboratory to show protection after vaccination.
Cepljene piščance so iz terenske študije prenesli v laboratorij, kjer so izvedli provokacijski test (jih izpostavili virusom), da bi pokazali, da se je po cepljenju razvila zaščita.
IBD, also known as Gumboro disease, is a viral infection of chickens associated with death at 3-6 weeks of age.
Gumborska bolezen je virusna okužba pri piščancih, povezana s poginom pri starosti 3-6 tednov.
Other information about Innovax-ND-IBD
Druge informacije o zdravilu Innovax-ND-IBD
Innovax-ND-IBD is available as a suspension and solvent to be made into a suspension for injection and can only be obtained with a prescription.
Zdravilo Innovax-ND-IBD je na voljo v obliki suspenzije in vehikla za pripravo suspenzije za injiciranje in se izdaja le na recept.
For IBD, vaccinated birds were challenged at 3, 4, 6 and 8 weeks after vaccination.
Pri Gumborski bolezni so provokacijski test pri cepljenih pticah izvedli 3, 4, 6 in 8 tednov po cepljenju.
Safety information has been included in the summary of product characteristics and the package leaflet for Innovax-ND-IBD, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
V povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
An overview of Innovax-ND-IBD and why it is authorised in the EU
Pregled zdravila Innovax-ND-IBD in zakaj je odobreno v EU
Innovax-ND-IBD is a vaccine containing turkey herpesvirus serotype 3, a type of herpesvirus which does not cause disease in chickens but which is similar to the virus that causes MD.
Innovax-ND-IBD je cepivo, ki vsebuje serotip 3 puranjega herpesvirusa, vrsto herpesvirusa, ki pri piščancih ne povzroča bolezni, vendar je podoben virusu, ki povzroča Marekovo bolezen.
Innovax-ND-IBD contains a live modified strain of turkey herpesvirus called strain HVP360.
Zdravilo Innovax-ND-IBD vsebuje živ, modificiran sev puranjega herpesvirusa, imenovan sev HVP360.
For ND, 60% of vaccinated chickens did not develop ND when challenged at 4 weeks after vaccination and 95% of vaccinated chickens were protected 6 weeks after vaccination.
Pri 60 % cepljenih piščancev se ob provokaciji štiri tedne po cepljenju ni pojavila atipična kokošja kuga in 95 % cepljenih piščancev je bilo zaščitenih šest tednov po cepljenju.
Why is Innovax-ND-IBD authorised in the EU?
Zakaj je bilo zdravilo Innovax-ND-IBD odobreno v EU?
When Innovax-ND-IBD is given to chickens, the animals' immune system recognises the virus as ‘foreign' and makes antibodies against its proteins.
Ko piščanci prejmejo cepivo Innovax-ND-IBD, imunski sistem živali prepozna virus kot „tujek“ ter začne proti njemu tvoriti protitelesa.
Since Innovax-ND-IBD is a live vaccine, the vaccine strain can be passed into the environment from vaccinated chickens and may spread to turkeys.
Cepivo Innovax-ND-IBD je živo cepivo, zato lahko sev cepiva iz cepljenih piščancev prehaja v okolje in se lahko razširi na purane.
The virus in the vaccine has been modified so that it also makes proteins from ND and IBD viruses.
Virus v cepivu je bil spremenjen tako, da lahko tvori tudi beljakovine iz virusov atipične kokošje kuge in Gumborske bolezni.
What are the risks associated with Innovax-ND-IBD?
Kakšna tveganja so povezana z zdravilom Innovax-ND-IBD?
The turkey herpesvirus strain HVP360 has been modified so that it will produce proteins from ND virus and IBD virus.
Sev puranjega herpesvirusa HVP360 je bil spremenjen tako, da proizvaja beljakovine virusa atipične kokošje kuge in virusa Gumborske bolezni.
What is Innovax-ND-IBD and what is it used for?
Kaj je zdravilo Innovax-ND-IBD in za kaj se uporablja?
What benefits of Innovax-ND-IBD have been shown in studies?
Kakšne koristi je zdravilo Innovax-ND-IBD izkazalo v študijah?
Innovax-ND-IBD is a veterinary vaccine used to protect chickens against Newcastle disease (ND), infectious bursal disease (IBD) and Marek's disease (MD).
Innovax-ND-IBD je cepivo za uporabo v veterinarski medicini, ki se uporablja za zaščito piščancev pred atipično kokošjo kugo, Gumborsko boleznijo in Marekovo boleznijo.
This will help protect the chickens against ND, IBD and herpesvirus infections like MD.
To pomaga zaščititi piščance pred atipično kokošjo kugo, Gumborsko boleznijo in okužbami s herpesvirusi, kot je Marekova bolezen.
Protection against MD starts 9 days after vaccination and lasts for life.
Zaščita pred Marekovo boleznijo se razvije devet dni po cepljenju in traja celo življenje.
Protection against IBD starts 3 weeks after vaccination and lasts 8 weeks.
Zaščita pred Gumborsko boleznijo se razvije tri tedne po cepljenju in traja osem tednov.
How is Innovax-ND-IBD used?
Kako se zdravilo Innovax-ND-IBD uporablja?
For MD, 87% of the vaccinated chickens were protected against challenge at 9 days after vaccination.
Ob provokacijskem testu za Marekovo bolezen, opravljenem devet dni po cepljenju, je bilo zaščitenih 87 % cepljenih piščancev.
How does Innovax-ND-IBD work?
Kako zdravilo Innovax-ND-IBD deluje?
Protection against ND starts 4 weeks after vaccination and lasts 8 weeks.
Zaščita pred atipično kokošjo kugo se razvije štiri tedne po cepljenju in traja osem tednov.
For MD, 91% of chickens from vaccinated eggs did not develop MD when challenged at 8 days of age.
Provokacijski test osem dni starih piščancev iz cepljenih jajc, je pokazal, da je pred Marekovo boleznijo zaščitenih 91 % ptic.
For IBD, 100% of vaccinated chickens did not develop IBD when challenged at 46 days after vaccination.
Provokacijski test 46. dan po cepljenju je pokazal, da je pred Gumborsko boleznijo zaščitenih 100 % piščancev.
List of the names, pharmaceutical form, strength of the medicinal products, route of administration and applicants in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila in predlagateljev v državah članicah
This summary was last updated in 10-2012.
Povzetek je bil nazadnje posodobljen 10-2012.
The European Commission granted a marketing authorisation valid throughout the European Union for Sildenafil Teva on 30 November 2009.
Evropska komisija je dovoljenje za promet z zdravilom Sildenafil Teva, veljavno po vsej Evropski uniji, odobrila dne 30. novembra 2009.
The full EPAR for Sildenafil 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 Sildenafil Teva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended dose of Sildenafil Teva is 50 mg taken as needed about one hour before sexual activity.
Priporočeni odmerek zdravila Sildenafil Teva je 50 mg, ki se vzame po potrebi eno uro pred spolnim odnosom.
For more information about treatment with Sildenafil Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Sildenafil Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This means that Sildenafil Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Viagra.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Viagra.
This is a summary of the European public assessment report (EPAR) for Sildenafil Teva.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sildenafil Teva.
What are the benefits and risks of Sildenafil Teva?
Kakšne so koristi in tveganja, povezani z zdravilom Sildenafil Teva?
Sildenafil Teva is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Zdravilo Sildenafil Teva se uporablja za zdravljenje erektilne disfunkcije (imenovane tudi impotenca) pri odraslih moških, kadar ne zmorejo doseči ali ohraniti take erekcije penisa, ki omogoča zadovoljive spolne odnose.
Because Sildenafil 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 Sildenafil Teva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
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 Sildenafil Teva.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Sildenafil Teva, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
kidney problems should start treatment with the 25 mg dose.
ledvic naj začnejo zdravljenje s 25-miligramskim odmerkom.
The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects.
Odmerek zdravila se lahko glede na učinkovitost in neželene učinke poveča na največ 100 mg ali zmanjša na 25 mg. Bolniki z jetrnimi obolenji ali resnimi motnjami v delovanju
The CHMP concluded that, in accordance with EU requirements, Sildenafil Teva has been shown to have comparable quality and to be bioequivalent to Viagra.
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Sildenafil Teva primerljivo raven kakovosti kot zdravilo Viagra ter da mu je biološko enakovredno.
The active ingredient in Sildenafil Teva, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Zdravilna učinkovina v zdravilu Sildenafil Teva, sildenafil, spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (PDE5).
It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Deluje tako, da zavira encim fosfodiesteraza, ki običajno razgrajuje snov, imenovano ciklični gvanozinmonofosfat (cGMP).
Sildenafil Teva is a ‘generic medicine'.
Sildenafil Teva je „generično zdravilo“.
Therefore, the CHMP's view was that, as for Viagra, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi, tako kot pri zdravilu Viagra, odtehtajo znana tveganja.
Because Sildenafil Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra.
Ker je zdravilo Sildenafil Teva generično zdravilo, so bile študije na bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Viagra.
The Committee recommended that Sildenafil Teva be given marketing authorisation.
Priporočil je, da se za zdravilo Sildenafil Teva odobri dovoljenje za promet.
Other information about Sildenafil Teva
Druge informacije o zdravilu Sildenafil Teva
Sildenafil Teva is a medicine that contains the active substance sildenafil.
Sildenafil Teva je zdravilo, ki vsebuje zdravilno učinkovino sildenafil.
If Sildenafil Teva is taken with food, the onset of activity may be delayed compared with taking Sildenafil Teva without food.
Če se zdravilo Sildenafil Teva zaužije sočasno s hrano, lahko začne delovati pozneje, kot če se zaužije brez nje.
By blocking the breakdown of cGMP, Sildenafil Teva restores erectile function.
Zdravilo Sildenafil Teva z zaviranjem razgradnje cGMP ponovno vzpostavi erektilno funkcijo.
Why has Sildenafil Teva been approved?
Zakaj je bilo zdravilo Sildenafil Teva odobreno?
How has Sildenafil Teva been studied?
Kako je bilo zdravilo Sildenafil Teva raziskano?
For Sildenafil Teva to be effective, sexual stimulation is required.
Zdravilo Sildenafil Teva je učinkovito le ob spolnem vzburjenju.
What is Sildenafil Teva?
Kaj je zdravilo Sildenafil Teva?
What is Sildenafil Teva used for?
Za kaj se zdravilo Sildenafil Teva uporablja?
How is Sildenafil Teva used?
Kako se zdravilo Sildenafil Teva uporablja?
How does Sildenafil Teva work?
Kako zdravilo Sildenafil Teva deluje?
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila, predlagateljev, imetnikov dovoljenja za promet z zdravilom v državah članicah
F-92787 Issy Les Moulineaux, Cedex 9 France
F-92787 Issy Les Moulineaux, Cedex
5026 RH Tilburg The Netherlands
Janssenweg 150 5026 RH Tilburg The Netherlands
Janssen Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo2734 503 Barcarena Portugal
Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo2734 503
High Wycombe Buckinghamshire HP12 4EG United Kingdom
50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom
Janssen-Cilag Pharma GmbH
Janssen-Cilag GmbH
Janssen-Cilag SpA Via M.Buonarroti, 23 I-20093 Cologno Monzese MI, Italy
I-20093 Cologno Monzese MI, Italy
The Netherlands Janssen-Cilag BV Dr. Paul Janssenweg
Janssen-Cilag BV Dr. Paul
Janssen-Cilag GmbH Johnson & Johnson Platz 1
Johnson & Johnson Platz 1
JANSSEN-CILAG AS Drammensveien 288 0283 Oslo
0283 Oslo Norway
United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm Way
Združeno kraljestvo Janssen-Cilag Limited
56 Eirinis Ave, Pefki, Athens GR-151 21 Greece
56 Eirinis Ave, Pefki,
Date of latest renewal: 18 September 2017
Datum zadnjega podaljšanja: 18. september 2017
This results in protection against the disease.
To privede do zaščite pred boleznijo.
These symptoms have been of mild and transient nature)
Ti simptomi so bili blage in prehodne narave).
Frequencies are defined as follows: Very common:
Pogostnosti so opredeljene kot: Zelo pogosti:
- if your child was born prematurely (before or at 28 weeks of pregnancy), particularly if they had breathing difficulties.
- če je bil vaš otrok rojen prezgodaj (pred ali v 28. tednu nosečnosti), še posebej, če je imel težave z dihanjem.
The potential risk for pregnant women is unknown.
Tveganje za nosečnice ni znano.
See section 5.1 for information on protection against specific group B strains.
Glejte poglavje 5.1 za informacije o zaščiti pred specifičnimi sevi skupine B.
Do not inject intravascularly.
Ne injicirajte intravaskularno.
Side effects that have been reported during marketed use include:
Neželeni učinki, ki so bili sporočeni v obdobju trženja zdravila vključujejo:
- This vaccine has been prescribed for you or your child only.
- Cepivo je bilo predpisano vam osebno ali vašemu otroku.
The vaccine works by specifically stimulating the body's natural defense system of the vaccinated person.
Cepivo deluje s specifičnim spodbujanjem naravnega telesnega obrambnega sistema cepljene osebe.
Immunogenicity in special populations
Imunogenost pri posebnih populacijah
If this is the case, then vaccination will be postponed.
V tem primeru bodo cepljenje odložili.
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Ker je v tej skupini dojenčkov korist cepljenja velika, cepljenja ne smete zadržati ali odložiti.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Uporaba z drugimi cepivi
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency and they are consequently listed with the frequency unknown.
Ker so ti neželeni učinki sporočeni spontano iz populacije neznane velikosti, ni vedno možno zanesljivo oceniti njihove pogostnosti in so zato navedeni z neznano pogostnostjo.
Most of the primary immunogenicity studies were conducted as randomized, controlled, multicenter, clinical trials.
Večina primarnih študij imunogenosti je bila opravljenih v obliki randomiziranih, kontroliranih, multicentričnih kliničnih preskušanj.
The clinical significance of this observation and the need for additional booster doses to maintain longer term protective immunity has not been established.
Klinični pomen tega opažanja in potreba po nadaljnjih poživitvenih odmerkih za vzdrževanje dolgotrajnejše zaščitne imunosti še nista bila ugotovljena.
Pack sizes of 1 or 10 syringes.
Velikosti pakiranja po 1 ali 10 injekcijskih brizg.
In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
V primeru prevelikega odmerjanja je priporočljivo spremljanje življenjskih funkcij in po potrebi simptomatsko zdravljenje.
The suspension is white opalescent liquid.
Suspenzija je bela opalescentna tekočina.
Kanamycin is used in early manufacturing process and is removed during the later stages of manufacture.
V zgodnjih fazah izdelave se uporablja kanamicin, ki se odstrani v kasnejših fazah izdelave.
1 month after 2nd dose
1 mesec po 2. odmerku
Feeling faint or fainting.
Omotico ali omedlevico.
Adults above 50 years of age
Odrasli, starejši od 50 let
Immunogenicity was evaluated in infants, children, adolescents and adults.
Imunogenost so ocenjevali pri dojenčkih, otrocih, mladostnikih in odraslih.
Tell your doctor or nurse if you or your child are taking, have recently taken, or might take any other medicines, or have recently received any other vaccine.
Obvestite zdravnika ali medicinsko sestro, če vi ali vaš otrok jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo ali ste pred kratkim prejeli katero koli drugo cepivo.
If present, kanamycin levels in the final vaccine are less than 0.01 micrograms per dose.
V primeru prisotnosti kanamicina v končnem cepivu so njegove ravni pod 0,01 mikrogramov na odmerek.
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
V skladu s 114. členom Direktive 2001/83/ES, serijo uradno sprosti državni laboratorij ali laboratorij,
pre-vaccination titer <1:4
titer pred cepljenjem < 1:4
PHARMACEUTICAL FORM Suspension for injection.
FARMACEVTSKA OBLIKA suspenzija za injiciranje
Rare: urticaria
Redki: koprivnica
The safety and efficacy of Bexsero in infants less than 8 weeks of age has not yet been established.
Varnost in učinkovitost cepiva Bexsero pri dojenčkih, starih manj kot 8 tednov, še nista bili dokazani.
Insufficient clinical data on exposed pregnancies are available.
Na voljo je premalo kliničnih podatkov o uporabi pri nosečnicah.
The effect of antipyretics other than paracetamol on the immune response has not been studied.
Učinek drugih antipiretikov (razen paracetamola) na imunski odziv ni bil preučen.
The risk for developing an allergic reaction is very small, but your doctor or nurse needs to be aware of your allergy when deciding if you or your child should receive Bexsero.
Tveganje pojava alergijske reakcije je zelo majhno, vendar morata zdravnik ali medicinska sestra vedeti za vašo alergijo, ko se odločata, ali boste vi ali vaš otrok prejeli cepivo Bexsero.