natgillin/translations-raw huggingface dataset:
There is no requirement to demonstrate better protection than existing products, nevertheless it has been shown under field conditions that Poulvac Bursa Plus is able to restore performance lost due to vvIBD which has broken through the protection provided by classical vaccines containing mild or intermediate strains.
Ni zahtev, da bi bilo treba dokazati boljšo zaščito od obstoječih cepiv, vendar je bilo v terenskih pogojih dokazano, da cepivo Poulvac Bursa Plus obnovi aktivnost, ki se je izgubila zaradi zelo virulentnih sevov virusa Gumborske bolezni, ki so premagali zaščito, zagotovljeno s klasičnimi cepivi, ki vsebujejo blage ali vmesne seve.
The breakthrough titre has been supported, which underpins the proposed recommendation for use and confirms the ability of the product to be used to overcome MDA (present at levels as specified in the SPC), an issue which typically causes problems for intermediate vaccines.
Cepivo premaga obstoječe titre, kar podpira predlagano priporočilo za uporabo in potrjuje sposobnost cepiva, da se uporabi pri premagovanju protiteles, pridobljenih od matere (prisotnih v ravneh, ki so določene v povzetku glavnih značilnosti zdravila), ki je običajna težava pri vmesnih cepivih.
The effect on serology is adequately reflected in the SPC.
Učinek na serologijo je ustrezno opisan v povzetku glavnih značilnosti zdravila.
It was considered that the risks associated with this immunosuppression were not sufficiently addressed in the application.
Izraženo je bilo mnenje, da v vlogi za pridobitev dovoljenja za promet tveganja, povezana z imunosupresijo, niso zadostno obravnavana.
A detailed analysis of the data provided concluded that Poulvac Bursa Plus is able to overcome Infectious Bursal Disease ELISA titres of ≥ 500.
Zaključek podrobne analize predloženih podatkov je, da lahko cepivo Poulvac Bursa Plus premaga titre protiteles proti virusu Gumborske bolezni ≥ 500 ELISA enot.
This allows the accurate dosing of the virus which, the MAH states, is not possible in very young birds by the oral route.
To omogoča natančno odmerjanje virusa, ki po navedbah imetnika dovoljenja za promet z zdravilom ni mogoče pri peroralnem cepljenju zelo mladih ptic.
Until the emergence of those strains the common practice in broiler production was to vaccinate hens just before laying in order to induce a high level of passive immunity in the chicks which could protect them up to an age when infection by IBDV was less detrimental with regards to immunosuppression.
Do pojava teh sevov je bila splošna praksa pri vzreji pitovnih piščancev cepljenje kokoši nesnic tik pred nesnostjo, da bi se spodbudila visoka raven pasivne imunosti v piščancih, ki bi jih zaščitila do starosti, ko je okužba z Gumborsko boleznijo manj škodljiva v smislu imunosupresije.
Benefit/Risk assessment
2.3 Ocena koristi in tveganj
This reduced serological response against NDV was however not translated into a reduction of the clinical protection against a virulent challenge.
Ta zmanjšan serološki odziv proti virusu atipične kokošje kuge pa se ni izrazil kot zmanjšana klinična zaščita pred izzivom z virulentnim povzročiteljem.
o The SPC provides adequate information to the end user to enable the appropriate use of the product, including a recommendation to only use the product where vvIBD was present.
o Povzetek glavnih značilnosti zdravila zagotavlja zadostne informacije končnemu uporabniku, da lahko ustrezno uporabi cepivo, vključno s priporočilom, da se cepivo uporabi le, ko je zelo virulentni sevi virusa Gumborske bolezni prisoten.
These have been under practical conditions, in flocks with levels of MDA which necessarily should be considered typical of situations where the product would be used.
To je v praktičnih pogojih v jatah z ravnmi protiteles, pridobljenih od matere, ki jih je treba obvezno šteti za tipične za primere, v katerih naj bi se cepivo uporabljalo.
The onset and duration of immunity has been confirmed in commercial broiler chicks in a similar laboratory study in the presence of MDA.
Nastop in trajanje imunosti so potrdili pri komercialnih pitovnih piščancih v podobni laboratorijski študiji v prisotnosti protiteles, pridobljenih od matere.
(using SPF chickens).
(na piščancih brez specifičnih patogenov).
• Under field conditions it was shown that Poulvac Bursa Plus was able to restore performance lost due to vvIBD which had broken through the protection provided by classical vaccines containing mild or intermediate strains.
• V terenskih pogojih so dokazali, da cepivo Poulvac Bursa Plus obnovi aktivnost, ki se je izgubila zaradi zelo virulentnih sevov virusa Gumborske bolezni, ki so premagali zaščito, zagotovljeno s klasičnimi cepivi, ki vsebujejo blage ali vmesne seve.
Applicant/ Marketing Authorisation Holder
Predlagatelj/im etnik dovoljenja za promet z zdravilom
The vaccine has a negative effect on the level of the serological response to NDV vaccination, however there was no affect on the ability of NDV vaccine to induce a protective response capable of resisting challenge with virulent NDV.
Cepivo ima negativen učinek na raven serološkega odziva na cepljenje proti virusu atipične kokošje kuge, vendar ni učinka na sposobnost cepiva proti virusu atipične kokošje kuge za sprožitev zaščitnega odziva, ki zagotavlja imunost na izzivni preskus z virulentnim virusom atipične kokošje kuge.
However, this effect did not affect the ability of the Newcastle Disease vaccine to protect against challenge with virulent NDV.
Vendar ta učinek ni vplival na sposobnost cepiva proti atipični kokošji kugi za zaščito pred izzivom z virulentnim virusom atipične kokošje kuge.
Efficacy studies have been carried out both under laboratory conditions, in SPF and commercial chickens with MDA, and under field conditions.
Študije učinkovitosti so bile opravljene v laboratorijskih pogojih pri piščancih brez specifičnih patogenov in komercialnih piščancih s protitelesi, pridobljenimi od matere, ter na terenu.
Animal species
Živalska vrsta Pot uporabe
Assessment of Poulvac Bursa Plus
Vrednotenje zdravila Poulvac Bursa Plus
These benefits have been shown in the field in circumstances where the product is intended to be used and in the face of MDA levels which must necessarily be considered typical.
Te koristi so bile dokazane na terenu v pogojih, v katerih so cepivo nameravali uporabiti kljub ravnem protiteles, pridobljenih od matere, ki se morajo obvezno šteti za tipične.
• Poulvac Bursa Plus has a negative impact on the serological response induced by vaccination against NDV.
• Cepivo Poulvac Bursa Plus ima negativen učinek na serološki odziv, spodbujen s cepljenjem proti virusu atipične kokošje kuge.
Efficacy of the vaccine has been adequately demonstrated in the laboratory, sufficient to confirm prevention of mortality and reduction of bursal lesions caused by vvIBDV using SPF chickens.
Učinkovitost cepiva je bila zadostno dokazana v laboratoriju, in sicer da preprečuje smrtnost in zmanjša burzalne lezije zaradi vvIBDV pri piščancih brez specifičnih patogenov.
• Efficacy of the vaccine (minimum titre) has been shown using SPF chickens of the minimum age recommended: reduction of the bursal lesions and prevention of the mortality caused by a vvIBDV was achieved in those animals.
• Učinkovitost cepiva (minimalni titer) je bila dokazana na piščancih brez specifičnih patogenov z najmanjšo priporočeno starostjo: pri teh živalih so dosegli zmanjšanje burzalnih lezij in preprečili smrtnost zaradi zelo virulentnih sevov virusa Gumborske bolezni.
The onset and duration of immunity has also been confirmed in commercial broiler chicks in a similar laboratory study in the presence of MDA levels as specified in the SPC.
Nastop in trajanje imunosti so potrdili tudi pri komercialnih pitovnih piščancih v podobni laboratorijski študiji v prisotnosti ravni protiteles, pridobljenih od matere, kakor so določene v povzetku glavnih značilnosti zdravila.
o It was accepted that the immunosuppression seen was an acknowledged risk associated with the product, which was offset against the demonstrated ability to provide protection against vvIBD in the face of MDA levels as specified in the SPC.
o Upošteva se, da je imunosupresija znano tveganje, povezano s cepivom, ki je manj pomembno od dokazane sposobnosti zagotavljanja zaščite pred vvIBD v prisotnosti ravni protiteles, pridobljenih od matere, ki so določene v povzetku glavnih značilnosti zdravila.
This is an acceptable risk associated with the protection provided against vvIBD in the face of MDA.
To je sprejemljivo tveganje, povezano z zagotovljeno zaščito pred zelo virulentnimi sevi virusa Gumborske bolezni ob upoštevanju protiteles, pridobljenih od matere.
The results showed that the vaccine strain notably reduced the serological response induced by vaccination against Newcastle Disease Virus (NDV) observed in chickens previously vaccinated using Poulvac Bursa Plus.
Rezultati so pokazali, da je cepilni sev pri piščancih, ki so bile predhodno cepljeni s cepivom Poulvac Bursa Plus, bistveno zmanjšal serološki odziv zaradi cepljenja proti virusu atipične kokošje kuge (NDV).
Efficacy
2.2 Učinkovitost
At that time, because the hypervirulent strains were able to breakthrough high maternally derived antibodies (MDA) levels, live vaccination of broilers became necessary.
V tistem času je postalo nujno cepljenje pitovnih piščancev z živim cepivom, ker so hipervirulentni sevi lahko premagali visoke ravni protiteles, pridobljenih od matere (MDA).
Under laboratory conditions, efficacy against vvIBDV was shown using SPF chickens.
V laboratorijskih pogojih je bila učinkovitost proti vvIBDV dokazana na piščancih brez specifičnih patogenov.
Safety
2.1 Varnost
monograph 01/2008:0587 is not directly applicable, the vaccine strain was shown to be compliant with its section 2.4.1 “safety”.
01/2008:0587, čeprav se ta ni neposredno ne uporablja.
• When administered to SPF chickens using a 10 times overdose, the vaccine does not cause clinical signs or mortality.
• Cepivo ni povzročilo kliničnih znakov ali smrti pri piščancih brez specifičnih patogenov po uporabi 10-kratno prevelikega odmerka.
Latvia Fort Dodge Animal Health
Latvija Fort Dodge Animal Health
Belgium Fort Dodge Animal Health
Belgija Fort Dodge Animal Health
Estonia Fort Dodge Animal Health
Estonija Fort Dodge Animal Health
Romania Fort Dodge Animal Health
Romunija Fort Dodge Animal Health
Hungary Fort Dodge Animal Health
Madžarska Fort Dodge Animal Health
Spain Fort Dodge Animal Health
Španija Fort Dodge Animal Health
Bulgaria Fort Dodge Animal Health
Bolgarija Fort Dodge Animal Health
Poland Fort Dodge Animal Health
Poljska Fort Dodge Animal Health
Greece Fort Dodge Animal Health
Grčija Fort Dodge Animal Health
Slovenia Fort Dodge Animal Health
Slovenija Fort Dodge Animal Health
Slovakia Fort Dodge Animal Health
Slovaška Fort Dodge Animal Health
• The vaccine does not comply with the Ph. Eur.
• Cepivo ni v skladu z določbami poglavja 2.4.2 monografije Ph.
Denmark Fort Dodge Animal Health
Danska Fort Dodge Animal Health
Germany Fort Dodge Animal Health
Nemčija Fort Dodge Animal Health
monograph concerning the section 2.4.2 since higher than acceptable damage to the bursa of Fabricius was observed.
Dokazali so, da je cepilni sev v skladu s poglavjem 2.4.1 „Varnost“ monografije Ph. Eur.
In most cases you will need a doctor.
Večinoma boste potrebovali zdravnika.
This helps prevent:
To pomaga preprečiti:
Tell your relatives, friends and close colleagues the following:
Svojim sorodnikom, prijateljem in bližnjim znancem povejte naslednje:
Open here
Odprite tukaj.
Change the needle and try again.
Zamenjajte iglo in poskusite znova.
Be familiar with your warning symptoms.
Bodite seznanjeni s svojimi opozorilnimi simptomi.
• Contamination and/or infection
• onesnaženje in/ali okužbo,
Alternatively, it may emerge gradually over a period of several weeks.
Po drugi strani pa se lahko pojavi postopoma med obdobjem več tednov.
This ensures that you get an accurate dose by:
To zagotovi, da dobite točen odmerek, ker:
No evidence of toxic effects was found.
Ugotovili niso nobenih toksičnih učinkov.
Slowly count to 10 before you withdraw the needle from the skin.
Počasi preštejte do 10, preden iglo potegnete iz kože.
Do not share it with anyone else.
Ne uporabljajte ga skupaj z nikomer drugim.
These injections are justified even if it is not certain that you have hypoglycaemia.
Uporaba teh injekcij je upravičena, tudi če ni gotovo, da imate hipoglikemijo.
Important information for use of SoloStar:
Pomembne informacije za uporabo SoloStarja:
Your doctor has decided that SoloStar is appropriate for you based on your ability to handle SoloStar.
Vaš zdravnik je presodil, da je SoloStar primeren za vas, na podlagi vaše sposobnosti za ravnanje s Solostarom.
The pictures below are for illustrative purposes only.
Slike spodaj imajo samo ponazorilne namene.
Always tell people who are caring for you or treating you that you require insulin.
Ljudem, ki za vas skrbijo ali vas zdravijo, vedno povejte, da potrebujete insulin.
Make sure that you contact a doctor early.
Poskrbite, da boste zdravnika poiskali zgodaj.
• Severe allergic reaction with low blood pressure (shock)
• Huda alergijska reakcija z nizkim krvnim tlakom (šok)
Illnesses and injuries
Bolezni in poškodbe
These symptoms often develop before the symptoms of a low sugar level in the brain.
Ti simptomi se pogosto pojavijo pred simptomi nizkega krvnega sladkorja v možganih.
Always carry some sugar (at least 20 grams) with you.
Vedno imejte pri sebi nekaj sladkorja (vsaj 20 gramov).
If the hypoglycaemia comes back again take another 10 to 20 g sugar.
Če se hipoglikemija znova pojavi, zaužijte dodatnih 10 do 20 gramov sladkorja.
This is because the insulin may have lost some of its effectiveness.
Morda je insulin izgubil nekaj svoje učinkovitosti.
Therefore, no specific frequency can be presented.
Zato specifične pogostnosti ni mogoče navesti.
Be careful when you start or stop taking another medicine.
Pozorni bodite tudi, kadar začnete ali prenehate jemati kakšno drugo zdravilo.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
Most minor reactions to insulins usually resolve in a few days to a few weeks.
Večina manjših reakcij na insuline ponavadi mine v nekaj dneh do nekaj tednih.
Your doctor or nurse should have discussed this with you previously.
Zdravnik ali medicinska sestra naj bi se o tem predhodno pogovorila z vami.
No effects on the suckling child are anticipated.
Učinki na dojenčke niso pričakovani.
It should be handled with care.
Z njim mora ravnati previdno.
To prevent the possible transmission of disease, each pen must be used by one patient only.
Da bi preprečili možen prenos bolezni, mora vsak injekcijski peresnik uporabljati en sam bolnik.
It is specially stabilised to minimise loss of efficacy which may result from mechanical and thermal stress in such pumps.
Je posebej stabiliziran tako, da je minimizirano zmanjšanje učinkovitosti, ki se lahko pojavi zaradi mehaničnih in toplotnih obremenitev v takšnih črpalkah.
Insulin must always be infused under aseptic conditions.
Insulin je vedno treba infundirati pod aseptičnimi pogoji.
The puncture site within a given injection area must be changed regularly (generally, every 1 to 3 days).
Punkcijsko mesto na posameznem predelu injiciranja je treba redno menjavati (praviloma na 1 do 3 dni).
Each cartridge contains three small metal balls to facilitate quick and thorough mixing of the contents.
V vsakem vložku so tri drobne kovinske kroglice, ki olajšajo hitro in temeljito premešanje vsebine.
Subcutaneous or intravenous use.
Za subkutano ali intravensko uporabo.
Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital.
Hudo hiperglikemijo ali ketoacidozo mora vedno zdraviti zdravnik, praviloma v bolnišnici.
For these reasons, it must be done in a clinic or a similar setting.
Zato mora potekati v bolnišnici ali podobnem okolju.
- In your body
- V vašem telesu
You may have to perform the safety test several times before insulin is seen.
Morda boste morali varnostni preizkus narediti večkrat, preden se bo pokazal insulin.
SoloStar is designed to work accurately and safely.
SoloStar je izdelan za natančno in varno delovanje.
Do not shake the vial vigorously as this may lead to changes in the suspension (giving the vial a frosted appearance; see below) and cause frothing.
Viale ne stresajte močno, ker to lahko povzroči spremembe v suspenziji (ji da "zamrznjen" videz, glejte spodaj) in povzroči penjenje.
Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.
Bolniki z diabetesom tipa 1 morajo še naprej redno uživati vsaj malo ogljikovih hidratov, čeprav zmorejo užiti le malo ali nič hrane ali če bruhajo itd., ter ne smejo nikoli povsem opustiti insulina.
SoloStar has to be used as recommended in these Instructions for Use (see section 6.6).
SoloStar uporabljajte kot je priporočeno v navodilih za ravnanje s SoloStarjem (glejte poglavje 6.6).
• Always perform the safety test before each injection (see Step 3).
• Pred vsakim injiciranjem opravite varnostni preizkus (glejte korak 3).
Careful monitoring of glucose control is essential.
Nujno je skrbno nadziranje urejenosti glukoze.
Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
Bolečine v trebuhu, hitro in globoko dihanje, zaspanost ali celo izguba zavesti pa so lahko znaki resnega stanja (ketoacidoze), ki se pojavi zaradi pomanjkanja insulina.
This helps prevent contamination and/or infection, entry of air into the insulin reservoir and leakage of insulin.
To pomaga preprečiti onesnaženje in/ali okužbo, vstopanje zraka v rezervoar z insulinom in iztekanje insulina.
The need to adjust (e.g. reduce) the dose may become evident immediately after transfer.
Potreba po prilagoditvi (npr. zmanjšanju) odmerka se lahko pokaže takoj po prehodu.
Concerning incompatibility with other insulins, see section 6.2.
Glede inkompatibilnosti z drugimi insulini glejte poglavje 6.2.
Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished.
Bolniki morajo poznati okoliščine, v katerih se opozorilni simptomi hipoglikemije lahko zmanjšajo.
Before travelling, consult your doctor.
Preden greste na potovanje, se posvetujte z zdravnikom.
Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta).
Potem zaužijte nekaj, kar krvni sladkor dvigne za dalj časa (kot je kruh ali testenine).
Inject as soon as you have mixed them.
Injicirajte takoj, ko ste ju zmešali.
If you are not able to swallow or if you are unconscious, you will require an injection of glucose or glucagon (a medicine which increases blood sugar).
Če ne morete požirati ali ste nezavestni, boste potrebovali injekcijo glukoze ali glukagona (zdravila, ki dvigne krvni sladkor).
It is advisable to inject immediately after mixing.
Mešanico je priporočljivo injicirati takoj po mešanju.
Please note: The needles shown are for illustrative purposes only.
Prosimo upoštevajte: Prikazane igle imajo samo ponazorilen namen.
You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low.
Poznati jih morate, da se boste lahko pravilno odzvali na spremembe v koncentraciji krvnega sladkorja in preprečili, da bi se preveč zvečala ali zmanjšala.
If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
Če se pojavijo normalne ali znižane vrednosti glikiranega hemoglobina, je treba pomisliti na možnost ponavljajočih se, neugotovljenih (zlasti nočnih) hipoglikemij.
This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
To je lahko nevarno v okoliščinah, v katerih sta ti zmožnosti posebno pomembni (npr. pri vožnji avta ali upravljanju s stroji).
Secondary dose adjustment
Sekundarna prilagoditev odmerka
After inserting a new cartridge:
Po vstavitvi novega vložka:
If you are not able to use SoloStar or follow all the instructions completely on your own, you must use SoloStar only if you have help from a person who is able to follow the instructions completely.
Če Solostarja ne morete uporabljati ali vseh teh navodil ne morete popolnoma upoštevati vi sami, uporabite SoloStar le v primeru, da vam lahko pomaga oseba, ki lahko popolnoma upošteva ta navodila.
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy.
Nujno je, da bolnice z obstoječim ali gestacijskim diabetesom vso nosečnost vzdržujejo dobro presnovno urejenost.
Studies of pharmacodynamic effects following subcutaneous administration in rabbits and dogs revealed the expected hypoglycaemic reactions.
Raziskave farmakodinamičnih učinkov po subkutani uporabi pri kuncih in psih so pokazale pričakovane hipoglikemične reakcije.
For insulin human, no clinical data on exposed pregnancies from controlled clinical studies are available.
Za humani insulin ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu v kontroliranih kliničnih študijah.
Perform a safety test
Opravite varnostni preizkus
In clinical studies and during marketed use, the frequency varies with patient population and dose regimens.
V kliničnih študijah in med marketinško uporabo se je pogostnost razlikovala glede na populacijo bolnikov in sheme odmerjanja.
If you are not confident about recognising your warning symptoms, avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
Če se ne morete povsem zanesti na prepoznavanje svojih opozorilnih simptomov, se izogibajte okoliščinam (na primer vožnji avtomobila), v katerih bi zaradi hipoglikemije ogrožali sebe ali druge.
Changing the injection site with each injection may help to prevent such skin changes.
Menjavanje mesta injiciranja pri vsaki injekciji pomaga preprečiti takšne kožne spremembe.
Frequency of these reactions cannot be estimated from available data.
Pogostnosti teh reakcij ni mogoče oceniti iz razpoložljivih podatkov.
In healthy subjects, the serum half-life of insulin is approximately 4 to 6 minutes.
Pri zdravih osebah je razpolovni čas insulina v serumu približno 4 do 6 minut.
This is facilitated by the special equipment available for the insulin pumps (e.g. catheters, cannulas).
To olajšuje posebna oprema, ki je na voljo za insulinske črpalke (npr. katetri, kanile).
Your doctor will show you in which area of the skin you should inject your insulin.
Zdravnik vam bo pokazal, v kateri predel kože morate injicirati insulin.
Intravenous insulin therapy must generally take place in an intensive care unit or under comparable monitoring and treatment conditions (see "Daily doses and timing of administration").
Intravensko zdravljenje z insulinom mora praviloma potekati v enoti za intenzivno nego oz. v primerljivih pogojih za nadzor in zdravljenje (glejte "Dnevni odmerki in čas uporabe").
For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.
Za dodatne informacije glede neželenih učinkov nizkega krvnega sladkorja ali visokega krvnega sladkorja glejte okvir na koncu tega navodila za uporabo.
In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar.
Na splošno morate za preprečitev hipoglikemije uživati več hrane in nadzirati krvni sladkor.