natgillin/translations-raw huggingface dataset:
Tablet coat (Opadry II Pink 33G240000): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide red and yellow (E172).
Obloga tablete: (Opadry II rožnato 33G240000): hipromeloza 6cP, titanov dioksid (E171), laktoza monohidrat, makrogol 3350, triacetin in rdeči ter rumeni železov oksid
98 film-coated tablets
100 filmsko obloženih tablet
White, oval shaped, biconvex film-coated tablets, 8 mm x 4.5 mm in size, with the marking “M5”
Bele, ovalne, bikonveksne filmsko obložene tablete, velikosti 8 mm x 4,5 mm z vtisnjeno oznako “M5” na eni strani.
Nemdatine 15 mg film-coated tablets memantine hydrochloride
Nemdatine 15 mg filmsko obložene tablete memantinijev klorid
White, oval shaped, biconvex film-coated tablet, 8 mm x 4.5 mm in size, with the marking “M5”
Bela, ovalna, bikonveksna filmsko obložena tableta, velikosti 8 mm x 4,5 mm z vtisnjeno oznako “M5” na eni strani.
Nemdatine 10 mg film-coated tablets memantine hydrochloride
Nemdatine 10 mg filmsko obložene tablete memantinijev klorid
NAME OF THE MEDICINAL PRODUCT Nemdatine 10 mg tablets memantine hydrochloride
IME ZDRAVILA Nemdatine 10 mg tablete memantinijev klorid
Nemdatine 5 mg film-coated tablets memantine hydrochloride
Nemdatine 5 mg filmsko obložene tablete memantinijev klorid
NAME OF THE MEDICINAL PRODUCT Nemdatine 15 mg tablets memantine hydrochloride
IME ZDRAVILA Nemdatine 15 mg tablete memantinijev klorid
CARTON FOR BLISTER PACK
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNI OMOT
NAME OF THE MEDICINAL PRODUCT Nemdatine 5 mg tablets memantine hydrochloride
IME ZDRAVILA Nemdatine 5 mg tablete memantinijev klorid
This leaflet was last revised in {MM/YYYY}
Navodilo je bilo odobreno MM/YYYY
Hypromellose 6cP Titanium dioxide (E171) Lactose monohydrate Macrogol 3350
Obloga tablete za 5 mg in 10 mg filmsko obložene tablete hipromeloza 6cP titanov dioksid (E171) laktoza monohidrat makrogol 3350 triacetin
CARTON FOR 7 TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE -IMMEDIATE CARTON (WITHOUT BLUE BOX)
PROGRAM ZDRAVLJENJA - NOTRANJA ŠKATLA (BREZ " BLUE BOX " PODATKOV)
One and a half 10 mg tablets Week 4 and beyond Two 10 mg tablets once a day
Dve 10 mg tableti enkrat dnevno
NAME OF THE MEDICINAL PRODUCT Nemdatine 20 mg film-coated tablets memantine hydrochloride
Navodilo za uporabo Nemdatine 20 mg filmsko obložene tablete memantinijev klorid
QUALITATIVE AND QUANTITATIVE COMPOSITION Nemdatine 5 mg
KAKOVOSTNA IN KOLIČINSKA SESTAVA
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI TRAKU
Each pack of 28 film-coated tablets for a 4 week treatment schedule contains: 7 film-coated tablets of Nemdatine 5 mg 7 film-coated tablets of Nemdatine 10 mg 7 film-coated tablets of Nemdatine 15 mg 7 film-coated tablets of Nemdatine 20 mg
7 filmsko obloženih tablet Nemdatine 5 mg 7 filmsko obloženih tablet Nemdatine 10 mg 7 filmsko obloženih tablet Nemdatine 15 mg 7 filmsko obloženih tablet Nemdatine 20 mg
NAME OF THE MEDICINAL PRODUCT Nemdatine 10 mg film-coated tablets memantine hydrochloride
Navodilo za uporabo Nemdatine 10 mg filmsko obložene tablete memantinijev klorid
15 mg tablet Week 4 and beyond 20 mg tablets once a day
Ena 20 mg tableta enkrat dnevno
How to store Nemdatine
Način jemanja
Continue to take Nemdatine as long as it is of benefit to you.
Jemljite zdravilo Nemdatine tako dolgo, kot vam pomaga in se ne pojavijo neželeni učinki, ki jih ne prenašate.
NAME OF THE MEDICINAL PRODUCT Nemdatine 15 mg film-coated tablets memantine hydrochloride
Navodilo za uporabo Nemdatine 15 mg filmsko obložene tablete memantinijev klorid
NAME OF THE MEDICINAL PRODUCT Nemdatine 5 mg film-coated tablets memantine hydrochloride
Navodilo za uporabo Nemdatine 5 mg filmsko obložene tablete memantinijev klorid
Package leaflet: Information for the patient
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Nemdatine
Balance disorders Uncommon Gait abnormal Very rare
Pogosti motnje ravnotežja
• The ECG monitoring recommendations.
• Priporočila za nadziranje z EKG.
No food should be taken within 3 hours after each dose.
Po vsakem odmerku naj še 3 ure ne jedo ničesar.
The Physician Leaflet should contain the following key messages:
Navodilo za zdravnika mora vsebovati naslednje ključne informacije:
• In Member States where the EU safety registry will be available, the educational materials should include details on the registry and how to enter patients in it.
• V državah članicah, v katerih bodo registri o varnosti za EU na voljo, naj v izobraževalno gradivo vključijo podrobnosti o registru in kako vanj vnašati bolnike.
• The existence and scope of the pregnancy register and details of how to enter patients in it.
• Obstoj in obseg registra nosečnosti in podrobnosti o vnosu bolnikov vanj.
The Member States shall ensure that the MAH provides all physicians who are expected to prescribe or use Eurartesim a healthcare professional educational pack containing the following:
Države članice bodo zagotovile, da bo imetnik dovoljenja za promet z zdravilom vse zdravnike, za katere pričakuje, da bodo zdravilo Eurartesim predpisovali ali uporabljali, oskrbele s paketom izobraževalnega gradiva za zdravstvene delavce, ki vsebuje:
Conditions or restrictions with regard to the safe and effective use of medicinal product to be implemented by the member states
Pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, ki jih izvajajo države članice
The Member States shall agree the final educational material with the Marketing Authorization Holder (MAH) prior to launch of the product in their territory.
Države članice se bodo o končnem izobraževalnem gradivu dogovorile z imetnikom dovoljenja za promet z zdravilom, preden dajo zdravilo v promet na svojem ozemlju.
• That piperaquine absorption is increased in the presence of food, therefore to reduce this risk of QTc interval prolongation, the patients should be advised to take the tablets with water, without food, no less than three hours after the last food intake.
• Absorpcija piperakina se poveča v prisotnosti hrane, zato je treba bolnikom svetovati, da zmanjšajo tveganje podaljšanja intervala QTc tako, da zdravilo vzamejo z vodo in brez hrane vsaj tri ure po zadnjem zaužitju hrane.
Annex Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the member states
Dodatek Pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, ki jih izvajajo države članice
• The need to counsel patients on important risks associated with Eurartesim therapy and appropriate precautions when using the medicine.
• O potrebi po svetovanju bolnikom o pomembnih tveganjih, povezanih z zdravljenjem z zdravilom Eurartesim in o primernih varnostnih ukrepih med uporabo zdravila.
• That there is a potential risk of teratogenicity and so Eurartesim should not be used in situations where other suitable and effective anti-malarials are available.
• Zaradi možne teratogenosti se zdravila Eurartesim ne sme uporabljati, če so na voljo drugi primerni in učinkoviti antimalariki.
• That Eurartesim has a potential to prolong the QTc interval that may lead to potentially lethal arrhythmias.
• Zdravilo Eurartesim lahko podaljša interval QTc, kar lahko povzroči aritmije, ki so lahko usodne.
• That patients should be advised to contact their doctor about adverse events and that physicians/pharmacists should report suspected adverse reactions to Eurartesim, and in particular, those associated with a QT prolongation.
• Bolnike je treba opozoriti, da se o neželenih učinkih posvetujejo z zdravnikom, in da mora zdravnik/farmacevt poročati sum na neželene učinke z zdravilom Eurartesim, še zlasti tiste, povezane s podaljšanjem intervala QT.
• That Eurartesim is contraindicated in patients with severe malaria according to WHO definition and in patients with a history of clinical conditions that may lead to QTc interval prolongation, and in patients taking drugs that are known to prolong the QTc interval.
• Zdravilo Eurartesim je kontraindicirano pri osebah s hudo obliko malarije po opredelitvi SZO in pri bolnikih z anamnezo kroničnih stanj, ki lahko povzročijo podaljšanje intervala QTc, ter pri bolnikih, ki jemljejo zdravila, za katera je znano, da podaljšajo interval QTc.
• The Physician Leaflet including the Contraindicated Conditions of Use and Contraindicated
• navodilo za zdravnika, vključno s seznamom kontraindiciranih pogojev za uporabo in kontraindiciranih sočasnih zdravil.
• The scope and use of the Contraindicated Conditions of Use and Contraindicated Concomitant Medication checklist
• Obseg in uporabo seznama pogojev, v katerih je uporaba zdravila kontraindicirana, in zdravila, katerih sočasna uporaba je kontraindicirana.
The European Commission issued a decision on 27 March 2009.
Evropska komisija je odločbo izdala dne 27. marca 2009.
1 Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
1 Člen 30 Direktive 2001/83/ES, kakor je bila spremenjena, napotitev na podlagi različnih odločitev, ki so jih sprejele države članice.
The maximum dosage is 200 mg daily.
Največji odmerek je 200 mg dnevno.
Ref. EMEA/CHMP/263995/2009
EMEA/263928/2009
London, 7 April 2009 Doc.
London, 7. aprila 2009 Sklic dok.
The CHMP adopted the following:
CHMP je sprejel naslednje:
Therapeutic Indication
Terapevtske indikacije
No data is available for children under 6 years of age.”
Za otroke, mlajše od 6 let, podatki niso na voljo.“
Prevention of recurrence of major depressive episodes”
Preprečevanje ponovnega pojava hudih epizod depresije“
Neurotransmitters are chemicals that transfer chemical signals from one nerve cell to another.
Nevrotransmiterji so kemične snovi, ki prenašajo kemične signale od ene živčne celice do druge.
The CHMP also discussed this indication.
CHMP je razpravljal tudi o tej indikaciji.
The review was carried out under an ‘Article 30' referral1.
Pregled je bil izveden v skladu z napotitvijo1 iz člena 30.
Low levels of serotonin in the central nervous system may be associated with depression or anxiety.
Nizke ravni serotonina v osrednjem živčnem sistemu so lahko povezane z depresijo ali anksioznostjo.
Questions and answers on the referral for Zoloft Hard capsules and film coated tablets containing 25 mg, 50 mg or 100 mg sertraline Concentrate for oral solution containing 20 mg/ml sertraline
Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Zoloft trde kapsule in filmsko obložene tablete, ki vsebujejo 25 mg, 50 mg ali 100 mg sertralina koncentrat za peroralno raztopino, ki vsebuje 20 mg/ml sertralina
Why was Zoloft reviewed?
Zakaj je bilo zdravilo Zoloft pregledano?
The CHMP discussed the results of the clinical programme that showed a significant improvement in reducing panic attacks.
CHMP je razpravljal o rezultatih kliničnega programa, ki je pokazal znatno izboljšanje pri zmanjševanju paničnih napadov.
Zoloft can also be available in the EU and the EEA under other trade names: Tresleen, Serlain, Lustral, Tatig, Sertraline and Besitran.
Zdravilo Zoloft je v EU in EGP lahko na voljo tudi pod drugimi imeni: Tresleen, Serlain, Lustral, Tatig, Sertraline in Besitran.
Zoloft is authorised in the European Union (EU) via national procedures.
Zdravilo Zoloft je v Evropski uniji (EU) odobreno z nacionalnimi postopki.
“Subsequent doses may be increased in case of less than desired response in 50 mg increments over a period of some weeks, as needed.
„Naslednje odmerke lahko po potrebi, če je odziv manjši od želenega, v obdobju več tednov povečujemo v korakih po 50 mg.
Dose changes should not occur at intervals of less than one week.”
Odmerkov se ne sme spreminjati v obdobjih, ki so krajša od enega tedna.
The European Medicines Agency (EMEA) has completed a review of Zoloft.
Evropska agencija za zdravila (EMEA) je zaključila pregled zdravila Zoloft.
Post-traumatic Stress Disorder:.
Posttravmatska stresna motnja.
The CHMP considered the wordings proposed for this section to be acceptable.
CHMP je besedilo, predlagano za to poglavje, ocenil kot sprejemljivo.
Data from the clinical programme for the indication PTSD were submitted and the results showed that only two of the four studies demonstrated efficacy.
Predloženi so bili podatki iz kliničnega programa za indikacijo posttravmatske stresne motnje, rezultati pa so pokazali, da le dve od štirih študij dokazujeta učinkovitost.
On 18 October 2007, the European Commission referred the matter to the Committee for Medicinal Products for Human Use (CHMP) in order to harmonise the marketing authorisations for Zoloft in the EU and the EEA.
Evropska komisija je dne 18. oktobra 2007 zadevo napotila na Odbor za zdravila za uporabo v humani medicini (CHMP), da bi uskladila dovoljenja za promet z zdravilom Zoloft v EU in EGP.
What is Zoloft?
Kaj je zdravilo Zoloft?
Obsessive Compulsive Disorder in adults.
Obsesivno kompulzivna motnja pri odraslih.
This has led to divergences across member states on the way the medicine can be used, as seen in the differences observed in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed.
To je v državah članicah vodilo v razhajanja glede uporabe zdravila, kot je razvidno iz povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo v državah, v katerih je zdravilo na trgu.
Zoloft can be used in adults to treat depression and prevent recurrence of depression, social anxiety disorder, post traumatic stress disorder (PTSD), panic disorder; and to treat obsessive compulsive disorder (OCD) in adults and children and adolescents, aged 6-17 years old.
Zdravilo Zoloft se lahko uporablja pri odraslih za zdravljenje depresije in preprečevanje ponovnega pojava depresije, socialne anksiozne motnje, posttravmatske stresne motnje, panične motnje ter za zdravljenje obsesivno kompulzivne motnje pri odraslih, otrocih in mladostnikih, starih od 6 do 17 let.
Pimozide.
Kontraindikacije Pimozid.
The CHMP considered acceptable the evidence in support of the depression indication.
CHMP je dokaze v podporo indikaciji depresije opredelil kot sprejemljive.
“Sertraline is indicated for the treatment of major depressive episodes.
„Sertralin je indiciran za zdravljenje hudih epizod depresije.
Panic disorder with or without agoraphobia disorder.
Panična motnja z agorafobijo ali brez nje.
The CHMP endorsed the harmonised indication: “Panic disorder with or without agoraphobia”.
CHMP je odobril usklajeno indikacijo: „Panična motnja z agorafobijo ali brez nje“.
The CHMP concluded that the safety in children and adolescents has not sufficiently been established and that a commitment to further investigate safety in paediatric patients is required in order to adopt the following indication: “Sertraline is indicated for the treatment of obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years.” with the condition that the following text is inserted in the section 5.1 “Pharmacodynamic Properties” of the SPC: "Long term safety and efficacy data are lacking for this paediatric population.
CHMP je zaključil, da varnost pri otrocih in mladostnikih ni bila zadostno dokazana in da je pri pediatričnih bolnikih nujno potrebno dodatno raziskovanje varnosti za sprejetje naslednje indikacije: „Sertralin je indiciran za zdravljenje obsesivno kompulzivne motnje pri odraslih in pediatričnih bolnikih, starih od 6 do 17 let.“, pod pogojem, da se naslednje besedilo vstavi v poglavje 5.1 „Farmakodinamične lastnosti“ povzetka glavnih značilnosti zdravila.
However, the generally lower body weights of children compared to those of adults should be taken into consideration when increasing the dose from 50 mg.
Vendar pa je ob povečevanju odmerka s 50 mg treba upoštevati splošno manjšo telesno maso otrok v primerjavi z odraslimi.
The CHMP concluded that short-term efficacy has been demonstrated, but that concerns remain over the lack of evidence with respect to relapse.
CHMP je zaključil, da je bila dokazana kratkotrajna učinkovitost, ostajajo pa zadržki o pomanjkanju dokazov o ponovnem pojavu motnje.
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SPCs, labelling and package leaflets should be harmonised across the EU.
CHMP je ob upoštevanju predloženih podatkov in znanstvenih razprav v okviru Odbora menil, da je treba povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo uskladiti v celotni EU.
Noting that major depression is considered to be a chronic or chronic intermittent condition, the CHMP considered it unnecessary to accept this separate indication.
CHMP je ob upoštevanju, da se huda depresija uvršča med kronična ali kronična prehodna stanja, menil, da sprejetje te ločene indikacije ni potrebno.
Considering the incidence of adverse events in PTSD, the CHMP agreed that the safety of sertraline in the treatment of PTSD is similar to that of major depressive disorder and does not present any new issues.
Ob upoštevanju pojavnosti neželenih učinkov pri posttravmatski stresni motnji se je CHMP strinjal, da je varnost sertralina pri zdravljenju posttravmatske stresne motnje podobna kot pri hudi depresivni motnji in ne pomeni nikakršnih novih zadržkov.
The CHMP considered that patients with significant hepatic impairment are not strictly contraindicated with sertraline and that appropriate warnings are provided in the concerning section of the product information.
CHMP je ocenil, da huda okvara jeter pri bolnikih ni strogo kontraindicirana za uporabo sertralina in da so v zadevnem poglavju podatkov o zdravilu prisotna ustrezna opozorila.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Zoloft in the European Union and the European Economic Area (EEA).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba v Evropski uniji (EU) in v Evropskem gospodarskem prostoru (EGP) uskladiti podatke o predpisovanju zdravila Zoloft.
Zoloft contains the active substance sertraline.
Zdravilo Zoloft vsebuje zdravilno učinkovino sertralin.
Company responses provided on: 22 February 2008, 10 September 2008, 09 December 2008 Opinion date:
22. februarja 2008, 10. septembra 2008, 9. decembra 2008
Regarding the use of sertraline in Hepatic Insufficiency and in Renal Insufficiency, the CHMP agreed with the wording proposed by the MAH for harmonisation.
Glede uporabe sertralina pri jetrni insuficienci in ledvični insuficienci se je CHMP strinjal z besedilom, ki ga je za usklajevanje predlagal imetnik dovoljenja za promet z zdravilom.
Regarding the dosing of paediatric patients with OCD, the CHMP requested the insertion of the following wording in this section:
Glede odmerjanja pri pediatričnih bolnikih z obsesivno kompulzivno motnjo je CHMP zahteval, da se v to poglavje doda besedilo:
The clinical programme for the indication OCD was submitted and sertraline demonstrated a modest short-term effect and no safety concerns.
Predložen je bil klinični program za indikacijo obsesivne kompulzivne motnje, dokazan pa je bil skromen kratkotrajni učinek sertralina brez varnostnih zadržkov.
The CHMP endorsed the following: “Concomitant intake of pimozide is contraindicated (see section 4.5)”
CHMP je odobril sledeče: „Sočasno uživanje pimozida je kontraindicirano (glejte poglavje
Obsessive Compulsive Disorder in paediatric patients .In order to support the paediatric indication, one single study was submitted including children and adolescents aged 6-17.
V podporo pediatrični indikaciji je bila predložena le ena študija, ki je vključevala otroke in mladostnike, stare od 6 do 17 let.
Paediatric-onset OCD shares important similarities with the adult disorder but also shows important differences.
Obsesivno kompulzivna motnja z začetkom v otroštvu kaže pomembne podobnosti z motnjo pri odraslih, a tudi pomembne razlike.
The CHMP, considered the benefit/risk balance, approved the following indication: “Sertraline is indicated for the treatment of social anxiety disorder”.
CHMP je ob upoštevanju razmerja med koristmi in tveganji odobril naslednjo indikacijo: „Sertralin je indiciran za zdravljenje socialne anksiozne motnje“.
Therefore the CHMP endorsed the following indication: “Sertraline is indicated for the treatment of obsessive compulsive disorder (OCD) in adults”,
Zato je CHMP je odobril naslednjo indikacijo: „Sertralin je indiciran za zdravljenje obsesivno kompulzivne motnje pri odraslih“,
The CHMP endorsed the harmonised indication: “Sertraline is indicated for the treatment of post traumatic stress disorder (PTSD)”,
CHMP je odobril usklajeno indikacijo: „Sertralin je indiciran za zdravljenje posttravmatske stresne motnje“,
Prevention of relapse and recurrence was proposed during the assessment by the CHMP.
Med ocenjevanjem, ki ga je izvedel CHMP, so predlagali preprečevanje vrnitve in ponovnega pojava bolezni.
Sertraline is a selective serotonin re-uptake inhibitor (SSRI), It works by preventing the neurotransmitter serotonin from being taken back up into nerve cells in the brain and spinal cord.
Deluje tako, da v možganih in hrbtenjači preprečuje ponovni privzem nevrotransmiterja serotonina v živčne celice.
Zoloft has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Usklajevalna skupina za postopek medsebojnega priznavanja in decentralizirane postopke (CMD(v)) je ugotovila, da je za zdravilo Zoloft potrebno usklajevanje.
Although the safety profile of sertraline is acceptable, the CHMP implemented the section ‘Posology and Method of Administration' of the SPC, to indicate that the need for continued treatment should be regularly evaluated.
dopolnil poglavje „Odmerjanje in način uporabe“ povzetka glavnih značilnosti zdravila, da bi navedel potrebo po stalnem ocenjevanju nadaljevanja zdravljenja.
Hepatic Impairment.
Okvara jeter.
These measures should help to protect the environment.
Ti ukrepi naj bi pomagali varovati okolje.
In the event of such reactions, treatment may be needed.
V primeru takih reakcij je potrebno zdravljenje.
In post marketing experience:
V postmarketinških izkušnjah:
This veterinary medicinal product contains mineral oil.
To zdravilo za uporabo v veterinarski medicini vsebuje mineralno olje.
30938 Burgwedel GERMANY
30938 Burgwedel Nemčija
In very rare cases anaphylactic-type reactions can occur, which may be life-threatening.
V zelo redkih primerih se lahko pojavijo reakcije anafilaktičnega tipa, ki so lahko življenjsko ogrožujoče.
In such cases it is advised to perform PCV2 serology, using suitable diagnostics, to select the most appropriate vaccination schedule.
V takšnih primerih je priporočeno opraviti serološki test za PCV2 ob ustrezni diagnostiki, na podlagi katerega izberemo najprimernejšo shemo cepljenja.
4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary)
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
Vaccination may result in a transient impairment of growth rate in the immediate period after administration of the vaccine.
Zaradi cepljenja se lahko v takojšnjem obdobju po dajanju cepiva prehodno zmanjša hitrost rasti.
22 weeks.
22 tednov
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na spletni strani Evropske agencije za zdravila (http://www.ema.europa.eu)
A transient increase in body temperature, normally not exceeding 1 °C, was very commonly observed until 2 days after vaccination.
Prehodno povišanje telesne temperature, običajno ne za več kot 1°C, je bilo zelo pogosto opaženo do 2 dni po cepljenju.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12/01/2009.
Datum prvega dovoljenja za promet: 12/01/2009 Datum zadnjega podaljšanja: 13/12/2013
Avoid use of vaccination equipment with rubber parts.
Izogibajte se uporabi opreme za cepljenje z gumijastimi deli.