natgillin/translations-raw huggingface dataset:
Keep syringes in the outer carton to protect from light.
Brizge shranjujte v zunanji ovojnini, za zagotovitev zaščite pred svetlobo.
Inform your doctor if you are pregnant or breast-feeding or think you might be pregnant.
Če ste noseči, domnevate, da ste noseči, ali če dojite, morate to povedati zdravniku.
Serum chemistry values including creatinine and potassium should be monitored regularly during Dynepo therapy.
Med zdravljenjem z Dynepom je treba redno kontrolirati biokemične vrednosti v serumu, vključno s kreatininom in kalijem.
If severe polycythaemia occurs, conventional methods (phlebotomy) may be indicated to decrease the haemoglobin level.
Če se pojavi huda policitemija, so za zmanjšanje koncentracije hemoglobina lahko indicirani
Sufficient time should be allowed to determine a patient's responsiveness to a dosage of Dynepo before adjusting the dose.
Pred prilagoditvijo odmerka je treba počakati dovolj dolgo, da je mogoče ugotoviti bolnikov odziv na zdravljenje z Dynepom.
- 1,000 IU in 0.5 ml
Odmerek raztopine je: - 1.000 i.e. v 0,5 ml
Therefore, in patients treated with Dynepo, special care should be taken to monitor closely and control blood pressure.
Zato je treba pri bolnikih, ki se zdravijo z Dynepom, krvni tlak posebej natančno spremljati in uravnavati.
Exposure to erythropoietin following administration of epoetin delta increases proportionately in patients given intravenous doses of 50 IU/kg to 300 IU/kg.
Po intravenski uporabi epoetina delta v odmerkih od 50 i.e./kg do 300 i.e./kg se izpostavljenost eritropoetinu pri bolnikih proporcionalno zvečuje.
In case of its use during pregnancy, concomitant iron substitution should be considered in the mother.
Pri uporabi med nosečnostjo je treba pretehtati
Treatment with Dynepo should be initiated by physicians experienced in the treatment of anaemia associated with CRF..
Zdravljenje z Dynepom mora začeti zdravnik, ki ima izkušnje z zdravljenjem anemije, ki je povezana
- The other ingredients of Dynepo are sodium phosphate monobasic (monohydrate), sodium phosphate dibasic (heptahydrate), polysorbate 20, sodium chloride and water for injections
Pomožne snovi zdravila Dynepo so natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat heptahidrat, polisorbat 20, natrijev klorid in voda za injekcije.
Read package leaflet before use.
Pred uporabo preberite priložena navodila za uporabo.
Do not shake the syringe.
Injekcijske brizge ne pretresajte.
Change the place that you inject each time so you don't become sore in one area.
Mesto vboda spreminjajte pri vsakem injiciranju in se tako izognite vnetju.
Discard the syringe after initial single use.
Po prvi uporabi injekcijsko brizgo zavrzite.
Pull slightly on the plunger to check that a blood vessel has not been punctured.
Narahlo pritisnite na bat ter preverite, če slučajno niste zadeli žile.
Do not try to inject yourself if you have not been trained.
Ne injicirajte si zdravila, če vam tega ni pokazal strokovno usposobljen zdravstveni delavec.
Your doctor will monitor the different chemical levels in your blood including: creatinine, potassium.
Zdravnik bo tudi nadzoroval koncentracijo različnih drugih snovi v vaši krvi, med drugim
Before you take Dynepo).
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI DYNEPO
No interactions have been reported during treatment with Dynepo in the course of clinical trials.
Med zdravljenjem z Dynepom v kliničnih preskušanjih ni bilo opisanih medsebojnih delovanj.
Find a comfortable, well-lit place and put the Dynepo pre-filled syringe where you can reach it. How do I prepare my Dynepo injection?
Poiščite udoben in dobro osvetljen prostor in si pripravite z zdravilom Dynepo napolnjeno injekcijsko
Unopened pre-filled syringes may be kept un-refrigerated but below 25oC for a single maximum period of 5 days.
Neodprtih napolnjenih injekcijskih brizg ni potrebno imeti v hladilniku, lahko jih namreč hranite v prostoru pri temperaturi, nižji od 25°C, vendar ne več kot pet dni.
A sustained haemoglobin level of greater than 12 g/dL (7.5 mmol/l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dL (7.5mmol/l) are observed, are described below (see Dose Management section below).
Smernice za ustrezno prilagajanje odmerkov, ko raven hemoglobina preseže 12 g/dl (7,5 mmol/l) so opisana v nadaljevanju (glejte razdelek Prilagajanje odmerjanja).
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
When the injection has been administered the needle safety guard will cover the needle when releasing the plunger.
Po uporabi bo zaščitni pokrovček pokril iglo, ko potegnete bat nazaj.
When given subcutaneously, the site of injection should be rotated with each administration.
Pri subkutani uporabi je treba mesto injiciranja za vsako aplikacijo izmenično menjati.
The marketing authorisation holder for Dynepo is Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, United Kingdom
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, Velika Britanija.
Taking Dynepo with food and drink Food and drink has no influence on Dynepo.
Jemanje zdravila Dynepo s hrano in pijačo
Subcutaneous self administration may be used after training by a medical professional.
Bolnik si lahko sam odmeri zdravilo v obliki subkutane injekcije, če ga je tega predhodno naučil strokovno usposobljen zdravstveni delavec.
Measurable concentrations of erythropoietin are maintained in the serum for at least 24 hours following doses ranging from 50 IU/kg to 300 IU/kg.
Po odmerkih od 50 i.e./kg do 300 i.e./kg ostane koncentracija eritropoetina v serumu merljiva vsaj še 24 ur.
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Although it has not been observed with Dynepo, since anaphylactoid reactions may occur with erythropoietin, it is recommended that the first dose be administered under medical supervision.
Med uporabo Dynepa takšnih reakcij sicer ni bilo, vendar je prvi odmerek kljub temu priporočljivo uporabiti pod zdravniškim nadzorom.
Allow the syringe to move up until the entire needle is guarded.
Brizgo namestite v prvotni položaj, tako da bo celotna igla zaščitena z zaščitnim pokrovčkom.
Your blood pressure needs to be checked closely before and during treatment with Dynepo.
Pred zdravljenjem z Dynepom in med zdravljenjem z njim je treba skrbno nadzirati krvni tlak.
- headache
- Glavobol.
Blood pressure should be controlled adequately before initiation and during therapy to avoid acute complications like hypertensive encephalopathy and related complications (seizures, stroke).
Za preprečitev akutnih zapletov, npr. hipertenzivne encefalopatije in sorodnih zapletov (epileptoidnih napadov, možganske kapi), mora biti krvni tlak ustrezno nadzorovan pred začetkom zdravljenja in med njim.
Starting dose is 50 IU/kg three times a week if administered intravenously.
Pri intravenski uporabi je začetni odmerek 50 i.e./kg trikrat na teden, pri subkutani pa 50 i.e./kg dvakrat na teden.
Solution for injection, 0.5ml of epoetin delta in a pre-filled syringe: pack size of 6
Raztopina za injiciranje, 0,5 ml epoetina delta v napolnjeni injekcijski brizgi; velikost pakiranja: 6
Diarrhoea Nausea
Žilne bolezni:
Solution for injection, 0.3ml of epoetin delta in a pre-filled syringe: pack size of 6
Raztopina za injiciranje, 0,3 ml epoetina delta v napolnjeni injekcijski brizgi; velikost pakiranja: 6
Solution for injection, 0.4ml of epoetin delta in a pre-filled syringe: pack size of 6
Raztopina za injiciranje, 0,4 ml epoetina delta v napolnjeni injekcijski brizgi; velikost pakiranja: 6
Water for injections
NALEPKA NA INJEKCIJSKI BRIZGI
Tel. : +44 1256 894 894
Tel/Tlf/Tηλ/Sími /Puh: +44 1256 894 894
Diarrhoea Nausea Pruritus
glavobol konvulzije
Dynepo may also cause changes in the composition of your blood.
Dynepo lahko spremeni sestavo krvi, vključno z zvečanjem števila eritrocitov in trombocitov.
You do not have to remove the air bubble before injecting.
Le-tega pred injiciranjem ni potrebno odstraniti, saj pri injiciranju ne povzroča nobene škode.
Severe reactions, possibly fatal, involving the heart and blood vessels may occur.
Pojavijo se lahko hudi zapleti na srcu in ožilju, ki so lahko
Treatment can result in polycythaemia if the haemoglobin/haematocrit is not carefully monitored and the dose appropriately adjusted.
Brez natančnega spremljanja hemoglobina oz. hematokrita in ustreznega prilagajanja odmerka lahko zdravljenje povzroči policitemijo.
NAME OF THE MEDICINAL PRODUCT Dynepo 8,000 IU/0.4ml Injection
IME ZDRAVILA Dynepo 8.000 i.e./0,4ml
It must be clear.
Zdravilo mora biti bistro.
NAME OF THE MEDICINAL PRODUCT Dynepo 6,000 IU/0.3ml Injection
IME ZDRAVILA Dynepo 6.000 i.e./0,3ml
What should I do before I give myself a subcutaneous injection of Dynepo?
Kaj morate storiti preden si injicirate zdravilo?
Your doctor or nurse will show you how to inject yourself.
Postopek injiciranja vam bosta pokazala zdravnik ali pa medicinska sestra.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
OSNOVNI PODATKI, KI MORAJO BITI ZABELEŽENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
NAME OF THE MEDICINAL PRODUCT Dynepo 4,000 IU/0.4ml Injection
IME ZDRAVILA Dynepo 4.000 i.e./0,4ml
PHARMACEUTICAL FORM Solution for injection in a pre-filled syringe.
Izgled Dynepo in vsebina pakiranja Raztopina za injiciranje v napolnjeni injekcijski brizgi.
The required weekly dose of Dynepo is lower when Dynepo is administered subcutaneously compared to intravenously.
Če se Dynepo uporablja subkutano, je potrebni tedenski odmerek manjši, kot če se uporablja
Pre-filled syringe containing 8,000 IU per 0.4 ml dose (20,000 IU/ml) of the active substance epoetin delta.
Ena napolnjena injekcijska brizga vsebuje 8.000 i.e. učinkovine, epoetina delta, na 0,4-ml odmerek (20.000 i.e./ml).
NAME OF THE MEDICINAL PRODUCT Dynepo 4,000 IU/0.4 ml solution for injection in a pre-filled syringe.
IME ZDRAVILA Dynepo 4.000 i.e./0,4 ml raztopina za injiciranje v napolnjeni injekcijski brizgi.
Pre-filled syringe containing 2,000 IU per 0.5 ml dose (4,000 IU/ml) of the active substance epoetin delta.
Ena napolnjena injekcijska brizga vsebuje 2.000 i.e. učinkovine, epoetina delta, na 0,5 ml odmerek (4.000 i.e./ml).
Pre-filled syringe containing 10,000 IU per 0.5 ml dose (20,000 IU/ml) of the active substance epoetin delta.
Ena napolnjena injekcijska brizga vsebuje 10.000 i.e. učinkovine, epoetina delta, na 0,5 ml odmerek (20.000 i.e./ml).
NAME OF THE MEDICINAL PRODUCT Dynepo 3,000 IU/0.3ml Injection
IME ZDRAVILA Dynepo 3.000 i.e./0,3ml
Pre-filled syringe containing 3,000 IU per 0.3 ml dose (10,000 IU/ml) of the active substance epoetin delta.
Ena napolnjena injekcijska brizga vsebuje 3.000 i.e. učinkovine, epoetina delta, na 0,3-ml odmerek (10.000 i.e./ml).
NAME OF THE MEDICINAL PRODUCT Dynepo 6,000 IU/0.3 ml solution for injection in a pre-filled syringe.
IME ZDRAVILA Dynepo 6.000 i.e./0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi.
Pre-filled syringe containing 6,000 IU per 0.3 ml dose (20,000 IU/ml) of the active substance epoetin delta.
Ena napolnjena injekcijska brizga vsebuje 6.000 i.e. učinkovine, epoetina delta, na 0,3-ml odmerek (20.000 i.e./ml).
NAME OF THE MEDICINAL PRODUCT Dynepo 8,000 IU/0.4 ml solution for injection in a pre-filled syringe.
IME ZDRAVILA Dynepo 8.000 i.e./0,4 ml raztopina za injiciranje v napolnjeni injekcijski brizgi.
Pre-filled syringe containing 4,000 IU per 0.4 ml dose (10,000 IU/ml) of the active substance epoetin delta.
Ena napolnjena injekcijska brizga vsebuje 4.000 i.e. učinkovine, epoetina delta, na 0,4-ml odmerek (10.000 i.e./ml).
NAME OF THE MEDICINAL PRODUCT Dynepo 4,000 IU/0.4 ml solution for injection in a prefilled syringe Epoetin delta
Dynepo 4.000 i.e./0,4 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin delta
Unopened pre-filled syringes may be kept un-refrigerated but below 25oC for a sinlge maximum period of 5 days.
Če napolnjene injekcijske brizge hranite izven hladilnika, pri temperaturi, nižji od 25°C, jih morate po preteku petih dni zavreči.
NAME OF THE MEDICINAL PRODUCT Dynepo 6,000 IU/0.3 ml solution for injection in a prefilled syringe Epoetin delta
Dynepo 6.000 i.e./0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin delta
Iron evaluation
Prilagajanje odmerjanja
NAME OF THE MEDICINAL PRODUCT Dynepo 8,000 IU/0.4 ml solution for injection in a prefilled syringe Epoetin delta
Dynepo 8.000 i.e./0,4 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin delta
Pre-filled syringe containing 5,000 IU per 0.5 ml dose (10,000 IU/ml) of the active substance epoetin delta
Ena napolnjena injekcijska brizga vsebuje 5.000 i.e. učinkovine, epoetina delta, na 0,5-ml odmerek (10.000 i.e./ml).
NAME OF THE MEDICINAL PRODUCT Dynepo 5,000 IU/0.5 ml solution for injection in a pre-filled syringe.
IME ZDRAVILA Dynepo 5.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi.
NAME OF THE MEDICINAL PRODUCT Dynepo 5,000 IU/0.5ml Injection
IME ZDRAVILA Dynepo 5.000 i.e./0,5ml
NAME OF THE MEDICINAL PRODUCT Dynepo 2,000 IU/0.5ml Injection
IME ZDRAVILA Dynepo 2.000 i.e./0,5ml
Pre-filled syringe containing 1,000 IU per 0.5 ml dose (2,000 IU/ml) of the active substance epoetin delta.
Ena napolnjena injekcijska brizga vsebuje 1.000 i.e. zdravilne učinkovine, epoetina delta, na 0,5 ml odmerek (2.000 i.e./ml).
Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Polysorbate 20
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev dihidrogenfosfat monohidrat
NAME OF THE MEDICINAL PRODUCT Dynepo 5,000 IU/0.5 ml solution for injection in a prefilled syringe Epoetin delta
Dynepo 5.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin delta
NAME OF THE MEDICINAL PRODUCT Dynepo 10,000 IU/0.5ml Injection
IME ZDRAVILA Dynepo 10.000 i.e./0,5ml
NAME OF THE MEDICINAL PRODUCT Dynepo 1,000 IU/0.5 ml solution for injection in a pre-filled syringe.
IME ZDRAVILA Dynepo 1.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi.
NAME OF THE MEDICINAL PRODUCT Dynepo 3,000 IU/0.3 ml solution for injection in a pre-filled syringe.
IME ZDRAVILA Dynepo 3.000 i.e./0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi.
NAME OF THE MEDICINAL PRODUCT Dynepo 3,000 IU/0.3 ml solution for injection in a prefilled syringe Epoetin delta
Dynepo 3.000 i.e./0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin delta
NAME OF THE MEDICINAL PRODUCT Dynepo 1,000 IU/0.5ml Injection
IME ZDRAVILA Dynepo 1.000 i.e./0,5ml
NAME OF THE MEDICINAL PRODUCT Dynepo 2,000 IU/0.5 ml solution for injection in a pre-filled syringe.
IME ZDRAVILA Dynepo 2.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi.
- if you have difficulties controlling your blood pressure.
- če ste alergični na (preobčutljivi za) epoetin delta ali katerokoli pomožno Dynepa, - če imate težave z obvladovanjem krvnega tlaka.
If you stop taking Dynepo Do not stop taking Dynepo before discussing the implications with your doctor or pharmacist.
Zdravilo lahko prenehate jemati samo, če ste se o posledicah pogovorili z zdravnikom ali z medicinsko
NAME OF THE MEDICINAL PRODUCT Dynepo 1,000 IU/0.5 ml solution for injection in a prefilled syringe Epoetin delta
Dynepo 1.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin delta
NAME OF THE MEDICINAL PRODUCT Dynepo 2,000 IU/0.5 ml solution for injection in a prefilled syringe Epoetin delta
Dynepo 2.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin delta
NAME OF THE MEDICINAL PRODUCT Dynepo 10,000 IU/0.5 ml solution for injection in a pre-filled syringe.
IME ZDRAVILA Dynepo 10.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi.
Headache
Občasni
QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled syringe containing 4,000 IU per 0.4 ml dose (10,000 IU/ml) of the active substance epoetin delta.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 4.000 i.e. učinkovine, epoetina delta, na 0,4 ml odmerek
NAME OF THE MEDICINAL PRODUCT Dynepo 10,000 IU/0.5 ml solution for injection in a prefilled syringe Epoetin delta
Dynepo 10.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin delta
QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled syringe containing 8,000 IU per 0.4 ml dose (20,000 IU/ml) of the active substance epoetin delta.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 8.000 i.e. učinkovine, epoetina delta, na 0,4 ml odmerek
However your haemoglobin level should not consistently exceed 12 g/dl.
Občasno so lahko posamezne vrednosti hemoglobina nad ali pod to priporočeno ciljno koncentracijo, vendar ne smejo biti stalno nad 12 g/dl.
Epoetin delta
SHRANJEVANJE DYNEPA
Dose should be decreased by 25 % - 50 % or treatment temporarily withdrawn and then re-introduced with a lower dosage if: - Haemoglobin reaches ≥ 12 g/dl or - The rate of increase of haemoglobin > 2 g/dl in any 4 week period.
Odmerek je treba zmanjšati za 25% - 50% ali pa zdravljenje začasno prekiniti in nato znova uvesti z
QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled syringe containing 5,000 IU per 0.5 ml dose (10,000 IU/ml) of the active substance epoetin delta.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 5.000 i.e. učinkovine, epoetina delta, na 0,5 ml odmerek
QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled syringe containing 1,000 IU per 0.5 ml dose (2,000 IU/ml) of the active substance epoetin delta.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 1.000 i.e. učinkovine, epoetina delta, na 0,5 ml odmerek
In very rare cases (<1/100,000), hypersensitivity can be observed.
V zelo redkih primerih (< 1/100000) so opazili preobčutljivostne reakcije.
Do not mix with any other vaccine or immunological product.
Ne mešajte z nobenim drugim cepivom ali imunološkim izdelkom.
Mineral oil (Marcol 52)
Mineralno olje (Marcol 52)
Use sterile syringes and needles.
Uporabljajte sterilne brizge in igle.
* CCID50 - the quantity of virus, which infects 50 % of the cell cultures inoculated.
* CCID50 = količina virusa, ki inficira 50 % inokuliranih celičnih kultur
a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzora ali zatiranja živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodov, pridobljenih iz zdravljenih živali.
Date of last renewal: 22/08/2008
Datum podaljšanja dovoljenja za promet: 22/08/2008
One dose of 2 ml contains:
En odmerek (2 ml) vsebuje:
MARKETING AUTHORISATION NUMBER(S) EU/2/98/009/001-006
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/98/009/001-006
Wash and disinfect hands and equipment after use.
Po dajanju si operite in razkužite roke in opremo.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Apart from an increase in the extent of the tissue reaction at the site of injection, no other undesirable effects have been observed.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Razen lokalne reakcije na mestu dajanja, ni bilo opaziti nobenih drugih neželenih učinkov.
Can be used during pregnancy and lactation.
Lahko se uporablja v času brejosti in laktacije.
• Inject one dose per gilt before the first mating, or
• Injicirajte en odmerek na mladico pred prvim parjenjem, ali
Mannide mono oleate (Arlacel A)
Manidijev monooleat (Arlacel A)
Excipient: Thiomersal
Pomožne snovi: Tiomersal
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/08/1998
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 07/08/1998
QUALITATIVE AND QUANTITATIVE COMPOSITION Powder:
KAKOVOSTNA IN KOLIČINSKA SESTAVA
The presence of maternal antibodies against Aujeszky's disease virus may have a negative influence on the result of vaccination.
Prisotnost maternalnih protiteles proti Aujeszkyjevi bolezni lahko negativno učinkuje na rezultat cepljenja.
For the full list of excipients, see section 6.1.
0,15 mg Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
Disodiumhydrogenphosphate Sodiumhydrogenphosphate Mannitol
Dinatrijev hidrogenfosfat Natrijev hidrogenfosfat Manitol
MANUFACTURER'S BATCH NUMBER Lot: {number} for the powder:
IZDELOVALČEVA ŠTEVILKA SERIJE Lot:{številka} za prašek:
Shelf-life after reconstitution according to directions: 1 hour.
Rok uporabnosti po rekonstituciji v skladu z navodili: 1 ura.
Each piglet of vaccinated gilts or sows should ingest a sufficient quantity of colostrum and milk.
Vsak novorojeni pujsek cepljene svinje ali mladice naj dobi določeno količino kolostruma in mleka.
Apart from an increase in the extent of the tissue reaction at the site of injection, no other undesirable effects have been observed.
Razen lokalne reakcije na mestu dajanja, ni bilo opaziti nobenih drugih neželenih učinkov.
17 µl
17 μl
7-ml vials of Type I hydrolytic glass containing 10, 50 or 100 doses of freeze-dried powder.
7 ml viala iz hidrolitičnega stekla (tip I), ki vsebuje 10, 50 ali 100 odmerkov liofiliziranega praška.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 10 doses
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 10 odmerkov
Therefore, the product is suitable to be used in eradication programmes against Aujeszky's disease field virus in pigs based on the presence or absence of antibodies against the gE-antigen of that virus.
Tako je pripravek primeren za uporabo za program eradikacije proti virusom Aujeszkyjeve bolezni pri prašičih, temelječ na prisotnosti ali odsotnosti specifičnih protiteles proti gE-antigenu tega virusa.
In general these reactions disappear within 3 weeks after the first vaccination.
Na splošno ta oteklina izgine v 3 tednih po prvem cepljenju.
The immunity lasts for 3 months after basic vaccination.
Imunost traja 3 mesece po osnovnem cepljenju.
If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Če vam je bilo to zdravilo nenamerno injicirano, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodila za uporabo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton label 1 x 10 doses, 1 x 50 doses, 1 x 100 doses, 10 x 10 doses, 10 x 50 doses, 10 x 100 doses
Kartonska nalepka 1 x 10 odmerkov, 1 x 50 odmerkov, 1 x 100 odmerkov, 10 x 10 odmerkov, 10 x 50 odmerkov, 10 x 100 odmerkov
Re-vaccination of breeding pigs (gilts, sows and boars):
Re-vakcinacija plemenskih prašičev (mladic, svinj in merjascev):
425 µl,
425 μl
The bottles are closed with a butyl rubber stopper and sealed with an aluminium cap.
Stekleničke so zaprte z gumijastim zamaškom iz butila, zaščitenim z aluminijasto kapico.
Aluminium hydroxide, Mineral oil (Marcol 52), Mannide mono oleate (Arlacel A), Polysorbate 80 (Tween 80), Thiomersal.
Aluminijev hidroksid, mineralno olje (Marcol 52), manidijev monooleat (Arlacel A), polisorbat 80 (Tween 80), tiomersal
A second dose may be injected 3-4 weeks after the first injection.
Naslednji odmerek aplicirajte 3-4 tedne po prvem cepljenju.