natgillin/translations-raw huggingface dataset:
Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary.
Pri bolnikih z jetrno okvaro (npr. s cirozo) se očistek sildenafila zmanjša, zato je priporočeni začetni odmerek 25 mg. Glede na učinkovitost in prenašanje se odmerek lahko postopoma zveča na 50 mg do 100 mg, če je to potrebno.
In a few seconds it begins disintegrating in the mouth and subsequently can be swallowed with or without water.
Lahko jo pogoltnete z vodo ali brez nje.
Retinal haemorrhage, Arteriosclerotic retinopathy, Retinal disorder, Glaucoma, Visual field defect, Diplopia,
Motnje reprodukcije in dojk krvavitev iz penisa, priapizem,* hematospermija, dolgotrajna erekcija
Your mouth should be empty before taking the tablet.
Ko vzamete tableto, v ustih ne smete imeti hrane.
They should not be pushed through the foil in the blister pack as this will cause damage to the tablet.
Orodisperzibilna tableta Vizarsin je krhka in je ne smete potisniti skozi pretisni omot, ker se lahko poškoduje.
Tip the tablet out onto your hand.
Tableto raztopite v ustih.
(E420)), crospovidone, calcium silicate and magnesium stearate (E572).
neohesperidin-dihidrohalkon (E959), eterično olje zelene mete, eterično olje poprove mete (ki vsebuje sorbitol (E420)), krospovidon, kalcijev silikat in magnezijev stearat (E572).
Dry mouth
Okvara jeter
747 70 Opava-Komárov Czech Republic
747 70 Opava-Komárov Češka republika
Iskedyl Fort tablets
Iskedyl Fort tablete
28703 San Sebastian de los Reyes (Madrid) Spain
28703 San Sebastian de los Reyes (Madrid) Španija
Czech Republic TEVA Czech Industries s.r.o.
Češka republika TEVA Czech Industries s.r.o.
Ferraz 80, 5º 28008 Madrid Spain
Ferraz 80, 5º 28008 Madrid Španija
PRT Lagoas Park, Edifício 11 2740-270 Porto Salvo Portugal
PRT Lagoas Park, Edifício 11 2740-270 Porto Salvo Portugalska
Arzneimittelvertriebs GmbH, Anton Anderer Platz 6/1, A-1210 Vienna Austria
Arzneimittelvertriebs GmbH, Anton Anderer Platz 6/1, A-1210 Vienna Avstrija
ISKEDYL, solution injectable en ampoule solution for injection IV/IM
ISKEDYL, solution injectable en ampoule raztopina za injekcije IV/IM
ARKOLEON 11, KATO PATISSIA, 10445 Greece
ARKOLEON 11, KATO PATISSIA, 10445 Grčija
Capsule hard
Trda kapsula
ERGODAVUR GOTAS 1 mg (monodose suchet)
ERGODAVUR GOTAS 1 mg (vrečka z enkratnim odmerkom)
FINIXFARM EPE DERVENAKION 38 & SAHINI, GERAKAS, 15344 Greece
FINIXFARM EPE DERVENAKION 38 & SAHINI, GERAKAS, 15344 Grčija
3mg/cap capsules, soft
3 mg/kap kapsule, mehke
ANTOR LTD P. MAVROMIHALI 1 VRILISSIA 15235 Greece
ANTOR LTD P. MAVROMIHALI 1 VRILISSIA 15235 Grčija
Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila,
ARGONAFTWN 22, ARGYROUPOLI, 16452 Greece
ARGONAFTWN 22, ARGYROUPOLI, 16452 Grčija
2.5 mg (1:1:1) prolonged-release capsule, soft
2,5 mg (1:1:1) kapsula s podaljšanim sproščanjem, mehka
0.10 g / 0.80 g oral solution
0,10 g / 0,80 g peroralna raztopina peroralna uporaba
powder for oral solution for single dose
prašek za peroralno raztopino za enkratni odmerek
6MG/SINGLE DOSE
MG/ENKRATNI ODMEREK
This summary was last updated in November 2016.
Povzetek je bil nazadnje posodobljen novembra 2016.
This will help protect the pigs against the infection and reduce the risk of disease.
S tem prašiče zaščitimo pred okužbo in zmanjšamo tveganje za bolezen.
The vaccine reduced the number of pigs with moderate to severe diarrhoea compared to non-vaccinated pigs.
Cepivo je zmanjšalo število prašičev z zmerno do hudo drisko v primerjavi z necepljenimi prašiči.
The strains of bacteria in the vaccine have these proteins but do not produce the toxins that cause the disease.
Sevi bakterij v cepivu vsebujejo ti beljakovini, vendar ne proizvajajo toksinov, ki povzročajo bolezen.
The effectiveness of the vaccine was studied in four laboratory studies in pigs that looked chiefly at the incidence, severity and duration of diarrhoea as well as the presence of disease-causing E. coli in the animals' excrement.
Učinkovitost cepiva so proučevali v štirih laboratorijskih študijah na prašičih, pri katerih so v glavnem ugotavljali pojavnost, resnost in trajanje driske ter prisotnost E. coli, ki povzroča bolezen, v živalskih iztrebkih.
E. coli O8:K87 / O141:K94 vaccine (live)
cepivo z E. coli O8:K87/O141:K94 (živo)
Two studies showed the vaccine starts to be effective 7 days after vaccination and two studies showed protection lasts for 21 days after vaccination.
Dve študiji sta pokazali, da začne cepivo učinkovati sedem dni po cepljenju, dve študiji pa, da zaščita traja 21 dni po cepljenju.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Coliprotec F4/F18's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Coliprotec F4/F18 večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The full EPAR for Coliprotec F4/F18 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Coliprotec F4/F18 je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
This is more likely to occur at weaning time when the piglet no longer receives protecting antibodies through the sow's milk.
To se najpogosteje zgodi ob odstavitvi, ko prašiček s svinjinim mlekom ne prejema več zaščitnih protiteles.
Although E. coli bacteria are naturally found in the gut, some strains (known as enterotoxigenic strains) produce toxins that cause diarrhoea and can result in dehydration, weight loss and occasionally death of the animal.
Čeprav so bakterije E. coli naravno prisotne v črevesju, pa nekateri sevi (imenovani enterotoksigeni sevi) proizvajajo toksine, ki povzročajo drisko, kar lahko privede do dehidracije, izgube telesne mase in včasih tudi smrti živali.
Two studies used the F4 strain while the other two used the F18 strain.
V dveh študijah so uporabljali sev F4, v drugih dveh pa sev F18.
Coliprotec F4/F18 contains two strains of live E. coli bacteria (O8:K87 and O141:K94) which do not produce toxins that cause disease.
Cepivo Coliprotec F4/F18 vsebuje dva seva živih bakterij E. coli (O8:K87 in O141:K94), ki ne proizvajata toksinov, ki povzročajo bolezen.
In case of spillage onto skin, the affected area should be rinsed with water and medical advice should be sought immediately and the package leaflet or label shown to the doctor.
V primeru razlitja na koži je treba prizadeto območje izprati z vodo, nemudoma poiskati zdravniško pomoč in zdravniku pokazati navodilo za uporabo ali nalepko.
The vaccine starts to be effective 7 days after vaccination and protection lasts for 21 days after vaccination.
Učinkovati začne sedem dni po cepljenju, zaščita pa traja 21 dni po cepljenju.
This is a summary of the European public assessment report (EPAR) for Coliprotec F4/F18.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Coliprotec F4/F18.
Pigs aged 17 - 18 days were vaccinated with Coliprotec F4/F18 and then artificially infected with E. coli strains.
Prašiče, stare 17-18 dni, so cepili s cepivom Coliprotec F4/F18 in nato umetno okužili s sevi E. coli.
The types of E. coli associated with post-weaning diarrhoea often produce proteins called F4 and F18 on their outer coat that allows them to attach to the cells of the gut.
Vrste E. coli, ki so povezane z drisko po odstavitvi, na svoji zunanji ovojnici pogosto tvorijo beljakovini, imenovani F4 in F18, zaradi katere se lahko vežejo na celice črevesja.
The European Commission granted a marketing authorisation valid throughout the EU for Coliprotec F4/F18 on 9 January 2017.
Evropska komisija je dovoljenje za promet z zdravilom Coliprotec F4/F18, veljavno po vsej Evropski uniji, izdala 09/01/2017.
Coliprotec F4/F18 is available as a lyophilisate (a freeze-dried pellet) which is made up into a suspension with water to be given by mouth.
Cepivo Coliprotec F4/F18 je na voljo v obliki liofilizata (pelet, posušenih z zamrzovanjem), iz katerega se z vodo pripravi suspenzija, ki se daje peroralno.
In the future, if the animals are exposed to disease-causing bacteria with the F4 or F18 proteins, the immune system will be able to respond more quickly.
Ob morebitni ponovni izpostavitvi bakterijam z beljakovino F4 ali F18, ki povzročajo bolezen, se bo imunski sistem lahko odzval hitreje.
For practical information about using Coliprotec F4/F18, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Coliprotec F4/F18 naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
The withdrawal period for meat from pigs treated with Coliprotec F4/F18 is ‘zero' days, which means there is no mandatory waiting time.
Karenca za meso prašičev, cepljenih s cepivom Coliprotec F4/F18, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
Coliprotec F4/F18 is a vaccine used to protect pigs from 18 days of age against post-weaning diarrhoea caused by E. coli.
Zdravilo Coliprotec F4/F18 je cepivo, ki se uporablja za zaščito prašičev, starejših od 18 dni, pred drisko zaradi E. coli po odstavitvi.
For more information about treatment with Coliprotec F4/F18, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Coliprotec F4/F18 naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Coliprotec F4/F18 is a vaccine.
Zdravilo Coliprotec F4/F18 je cepivo.
In case of accidental ingestion, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
V primeru nenamernega zaužitja nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
When Coliprotec F4/F18 is given to pigs, the animals' immune system recognises the bacteria as ‘foreign' and makes antibodies against them.
Ko prašiče cepimo s cepivom Coliprotec F4/F18, njihov imunski sistem bakterije prepozna kot „tujke“ in proti njim razvije protitelesa.
What is Coliprotec F4/F18 and what is it used for?
Kaj je zdravilo Coliprotec F4/F18 in za kaj se uporablja?
What benefits of Coliprotec F4/F18 have been shown in studies?
Kakšne koristi je zdravilo Coliprotec F4/F18 izkazalo v študijah?
What are the risks associated with Coliprotec F4/F18?
Kakšna tveganja so povezana z zdravilom Coliprotec F4/F18?
Why is Coliprotec F4/F18 approved?
Zakaj je bilo zdravilo Coliprotec F4/F18 odobreno?
Other information about Coliprotec F4/F18?
Druge informacije o zdravilu Coliprotec F4/F18
There are currently no known side effects associated with Coliprotec F4/F18.
Znanih neželenih učinkov zdravila Coliprotec F4/F18 ni.
How does Coliprotec F4/F18 work?
Kako zdravilo Coliprotec F4/F18 deluje?
How is Coliprotec F4/F18 used?
Kako se zdravilo Coliprotec F4/F18 uporablja?
Coliprotec F4/F18 is given by mouth to pigs as a single dose either as a drench or by addition to the drinking water.
Prašičem se daje peroralno v obliki enkratnega odmerka bodisi z drenažno aplikacijo bodisi kot dodatek v vodo za pitje.
The recommended dose is one tablet taken once a day with food for 8 or 12 weeks.
Priporočeni odmerek je ena tableta, ki se jemlje enkrat na dan skupaj s hrano v obdobju 8 ali 12 tednov.
Vosevi must not be used together with certain medicines such as:
Zdravilo Vosevi se ne sme jemati sočasno z določenimi zdravili, kot so:
What measures are being taken to ensure the safe and effective use of Vosevi?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vosevi?
Other information about Vosevi
Druge informacije o zdravilu Vosevi
The full EPAR for Vosevi 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 Vosevi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The clearance rates with Vosevi were typically above 95%.
Stopnje izčistkov z zdravilom Vosevi so bile običajno višje od 95 %.
This is a summary of the European public assessment report (EPAR) for Vosevi.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vosevi.
Sofosbuvir/velpatasvir has been authorised in the EU as Epclusa since July 2016.
Sofosbuvir/velpatasvir je v EU odobren od julija 2016 kot zdravilo Epclusa.
It is not intended to provide practical advice on how to use Vosevi.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The European Medicines Agency therefore decided that Vosevi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Vosevi večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
What are the risks associated with Vosevi?
Kakšna tveganja so povezana z zdravilom Vosevi?
What benefits of Vosevi have been shown in studies?
Kakšne koristi je zdravilo Vosevi izkazalo v študijah?
What is Vosevi and what is it used for?
Kaj je zdravilo Vosevi in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vosevi have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Vosevi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Vosevi is available as tablets containing 400 mg sofosbuvir, 100 mg velpatasvir and 100 mg voxilaprevir.
Zdravilo Vosevi je na voljo v obliki tablet, ki vsebujejo 400 mg sofosbuvirja, 100 mg velpatasvirja in 100 mg voksilaprevirja.
The fact that Vosevi can be given for 8 weeks (instead of the usual 12) to patients who do not have liver cirrhosis is considered an advantage.
Dejstvo, da je zdravilo Vosevi bolnikom, ki nimajo ciroze jeter, mogoče dajati 8 tednov (namesto običajnih 12), velja za prednost.
The most common side effects with Vosevi (which may affect more than 1 in 10 people) are headache, nausea (feeling sick) and diarrhoea.
Najpogostejši neželeni učinki zdravila Vosevi (ki se lahko pojavijo pri več kot 1 bolniku od 10) so glavobol, navzea (slabost) in driska.
Sofosbuvir blocks the action of an enzyme (a type of protein) called ‘NS5B RNA-dependent RNA polymerase', velpatasvir targets a protein called ‘NS5A', while voxilaprevir blocks an enzyme called NS3/4A protease.
Sofosbuvir zavira delovanje encima (vrste beljakovine), imenovanega „RNK-polimeraza NS5B, odvisna od RNK“, velpatasvir je usmerjen proti beljakovini, imenovani „NS5A“, voksilaprevir pa zavira delovanje encima, imenovanega proteaza NS3/4A.
• rifampicin, rifabutin (antibiotics usually used to treat tuberculosis);
• rifampicin, rifabutin (antibiotika, ki se običajno uporabljata za zdravljenje tuberkuloze);
Why is Vosevi approved?
Zakaj je bilo zdravilo Vosevi odobreno?
For more information about treatment with Vosevi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Vosevi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
• rosuvastatin (medicine for lowering cholesterol in the blood);
• rosuvastatin (zdravilo za zniževanje holesterola v krvi);
This study is being carried out in light of data suggesting that patients treated with medicines belonging to the same class as Vosevi who have had liver cancer could be at risk of their cancer returning early.
Ta študija se izvaja na podlagi podatkov, ki kažejo, da pri bolnikih, zdravljenih z zdravili istega razreda, kot je zdravilo Vosevi, in predhodno obolelih za rakom jeter, obstaja tveganje zgodnje ponovitve raka.
The duration of treatment depends on whether patients have liver cirrhosis (scarring of the liver) or have received treatment with other direct-acting antivirals.
Trajanje zdravljenja je odvisno od tega, ali imajo bolniki cirozo jeter (brazgotinjenje jeter) ali pa so bili zdravljeni z drugimi neposredno delujočimi protivirusnimi zdravili.
Regarding safety, Vosevi was well tolerated with no major safety concern emerging.
Z vidika varnosti so bolniki zdravilo Vosevi dobro prenašali, pojavil pa se ni noben večji varnostni zadržek.
For practical information about using Vosevi, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Vosevi naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
By blocking these proteins, Vosevi stops the hepatitis C virus from multiplying and infecting new cells.
Zdravilo Vosevi z zaviranjem teh beljakovin prepreči virusu hepatitisa C, da bi se razmnoževal in okužil nove celice.
Vosevi is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus (HCV).
Zdravilo Vosevi je protivirusno zdravilo, namenjeno zdravljenju odraslih s kroničnim (dolgotrajnim) hepatitisom C, tj. nalezljivo boleznijo, ki prizadene jetra in jo povzroča virus hepatitisa C (HCV).
For the full list of side effects and restrictions with Vosevi, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Vosevi glejte navodilo za uporabo.
• carbamazepine, phenobarbital, phenytoin (medicines for epilepsy);
• karbamazepin, fenobarbital, fenitoin (zdravila za zdravljenje epileptičnih napadov);
• ethinyl oestradiol-containing products (such as contraceptive medicines);
• zdravila, ki vsebujejo etinilestradiol (kot so kontraceptivi);
Vosevi can only be obtained with a prescription, and treatment should be started and monitored by a doctor experienced in the management of patients with hepatitis C virus infection.
Predpisovanje in izdaja zdravila Vosevi je le na recept, zdravljenje pa mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem bolnikov, okuženih z virusom hepatitisa C.
In two further studies between 95 and 96% of Vosevi patients tested negative for the virus, compared with 96 to 98% of patients taking sofosbuvir/velpatasvir.
V dveh preostalih študijah je bil test za prisotnost virusa negativen pri 95 do 96 % bolnikov, ki so prejemali zdravilo Vosevi, pri bolnikih, ki so prejemali sofosbuvir/velpatasvir, pa je bilo bolnikov z negativnim testom od 96 do 98 %.
The active substances in Vosevi (sofosbuvir, velpatasvir and voxilaprevir) block three proteins essential for the hepatitis C virus to multiply.
Zdravilne učinkovine zdravila Vosevi (sofosbuvir, velpatasvir in voksilaprevir) zavirajo tri beljakovine, ki jih virus hepatitisa C potrebuje za razmnoževanje.
Additionally, Vosevi was shown to be very effective at eliminating the hepatitis C virus in patients in whom previous treatment with a NS5A inhibitor failed.
Poleg tega je bilo dokazano, da je zdravilo Vosevi zelo učinkovito pri odstranjevanju virusa hepatitisa C iz krvi bolnikov, pri katerih predhodno zdravljenje z zaviralcem NS5A ni bilo uspešno.
Vosevi has been shown in four main studies of 1,459 patients to be effective at clearing all six varieties (genotypes) of the hepatitis C virus, including in patients with liver cirrhosis and those who have previously tried other direct-acting antivirals.
V štirih glavnih študijah s 1 459 bolniki se je zdravilo Vosevi izkazalo za učinkovito pri odstranjevanju vseh šestih različic (genotipov) virusa hepatitisa C, tudi pri bolnikih s cirozo jeter in pri tistih, ki so bili prej zdravljeni z drugimi neposredno delujočimi protivirusnimi zdravili.
Over 96% of patients taking Vosevi in one study tested negative for HCV (their blood tests did not show any sign of the virus) after 12 weeks of treatment, compared with none of the patients who received placebo (a dummy treatment).
V eni od študij je bil test za prisotnost virusa hepatitisa C pri več kot 96 % bolnikov, ki so prejemali zdravilo Vosevi, po 12 tednih zdravljenja negativen (pri njihovih krvnih preiskavah ni bilo nobenega sledu o virusu), pri bolnikih, ki so prejemali placebo (zdravilo brez zdravilne učinkovine), pa bolnikov z negativnim testom ni bilo.
Over 97% of patients taking Vosevi in a second study tested negative, compared with 90% of patients taking only sofosbuvir/velpatasvir.
V drugi študiji je bil test negativen pri 97 % bolnikov, ki so prejemali zdravilo Vosevi, pri bolnikih, ki so prejemali samo sofosbuvir/velpatasvir, pa je bil test negativen pri 90 % bolnikov.
How is Vosevi used?
Kako se zdravilo Vosevi uporablja?
Vosevi contains the active substances sofosbuvir, velpatasvir and voxilaprevir.
Zdravilo Vosevi vsebuje zdravilne učinkovine sofosbuvir, velpatasvir in voksilaprevir.
The company that markets Vosevi will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals.
Družba, ki trži zdravilo Vosevi, bo za oceno tveganja ponovitve raka jeter po zdravljenju z neposredno delujočimi protivirusnimi zdravili izvedla študijo pri bolnikih, ki so preboleli raka jeter.
Vosevi has been shown to be highly effective in clearing the hepatitis C virus of all genotypes from the blood of both previously treated and untreated patients, including patients who have cirrhosis.
Zdravilo Vosevi se je izkazalo za visoko učinkovito pri odstranjevanju vseh genotipov virusa hepatitisa C iz krvi bolnikov, ki so bili predhodno zdravljeni, in tistih, ki niso bili, vključno z bolniki s cirozo.
How does Vosevi work?
Kako zdravilo Vosevi deluje?
• St John's wort (a herbal remedy used for depression and anxiety).
• šentjanževka (zdravilo rastlinskega izvora proti depresiji in anksioznosti).
• dabigatran etexilate (medicine for preventing blood clots);
• dabigatraneteksilat (zdravilo za preprečevanje krvnih strdkov);
The clinical relevance of these interactions is unknown.
Klinični pomen teh interakcij ni znan.
Each individual pack cannot be sold separately.
Posamezni zavitki se ne smejo prodajati ločeno.
These reactions were primarily transient in nature.
Reakcije so bile večinoma prehodne.
Epidemiological data between 1988 and 2003 indicated that in Europe coverage is lower and varies from country to country.
Epidemiološki podatki med letoma 1988 in 2003 so pokazali, da je pokritost v Evropi nižja in se od države do države razlikuje.
The immunisation schedules for Prevenar should be based on official recommendations.
Imunizacijske sheme za Prevenar morajo temeljiti na uradnih priporočilih.
F - 69007 Lyon
F - 69007 Lyon Francija
• CONDITIONS AND RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
These measures will help to protect the environment.
Takšni ukrepi pomagajo varovati
- if your child has a severe infection with a high temperature (over 38°C).
- če ima hujšo okužbo z zvišano telesno temperaturo (nad 38 °C).
WHO technical report No 927, 2005; Appendix serological criteria for calculation and licensure of new pneumococcal conjugate vaccine formulations for use in infants.
Tehnično poročilo SZO št. 927, 2005; Appendix serological criteria for calculation and licensure of new pneumococcal conjugate vaccine formulations for use in infants.
• Fever of 39°C or higher
• zvišana telesna temperatura 39 °C ali višja
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Velika Britanija
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Ker je korist cepljenja v tej skupini dojenčkov velika, cepljenja ne bi smeli odložiti ali ga izpustiti.