natgillin/translations-raw huggingface dataset:
Initial treatment is a single oral dose of 0.1 mg meloxicam/ kg body weight on the first day.
Odmerki Začetni odmerek prvi dan zdravljenja je 0, 1 mg meloksikama na kilogram telesne mase peroralno.
Route (s) and method of administration Shake well before use.
Pot( i) in način uporabe Pred uporabo dobro pretresite.
6 drops / kg body weight Maintenance dose:
6 kapljic/ kg telesne mase Vzdrževalni odmerek:
Push down and unscrew bottle top.
Plastenko z brizgo obrnite navzdol.
Attach the dosing syringe to the drop dispenser of the bottle by gently pushing.
Brizgin bat toliko izvlecite, da se
Turn the bottle/ syringe upside down.
Plastenko z brizgo obrnite navzgor in brizgo z blagim zasukom snemite.
Pull the plunger out until the black line on the plunger corresponds to your cat ´ s bodyw eight in kilogram s.
S pritiskom na brizgin bat vsebino brizge iztisnite na hrano
Turn the bottle right way up and w ith a tw isting m ovem ent separate the dosing syringe from the bottle.
Na kapalko plastenke pritrdite merilno brizgo, tako da jo nanjo previdno pritisnete.
B y pushing the plunger in em pty the contents of the syringe onto the food or directly into the m outh.
črna črta na njem ujema s telesno maso mačke v kilogramih.
10.
120/ 122 10.
Overdose Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels.
Preveliko odmerjanje Meloksikam ima pri mačkah ozko terapevtsko območje, zato se lahko klinični znaki prevelikega odmerjanja pojavijo pri razmeroma majhnih prekoračitvah odmerka.
In case of overdose, adverse reactions, as listed in Section "Adverse reactions", are expected to be more severe and more frequent.
Pri prevelikem odmerjanju lahko pričakujemo resnejše in pogostejše neželene učinkih, opisane v poglavju Neželeni učinki.
13.
121/ 122 13.
15 ml bottle.
Plastenka po 15 ml.
EMEA/ V/ C/ 079 Doc.
EMEA/ V/ C/ 079 Dok.
EMEA/ 245602/ 2006
EMEA/ CVMP/ 193371/ 2005
Naxcel is an antibiotic suspension that contains ceftiofur (as ceftiofur crystalline free acid) as the active substance.
Zdravilo Naxcel je antibiotična suspenzija, ki vsebuje ceftiofur (kristalinična prosta kislina, ki ustreza ceftiofurju) kot zdravilno učinkovino.
It is given by injection into the muscle.
Zdravilo se daje z vbrizgavanjem v mišico.
Naxcel is used to treat pigs that have an infection caused by specific groups of bacteria.
Zdravilo Naxcel se uporablja za zdravljenje okužb pri prašičih, ki so jih povzročile bakterije iz nekaterih skupin.
These infections can be respiratory tract infections (such as lung infections), infections of the joints and infections affecting the general health of the pigs (septicaemia,).
Te okužbe so lahko okužbe dihal (npr. okužbe pljuč), okužbe sklepov in okužbe, ki vplivajo na splošno zdravje prašičev (septikemija).
The active substance in Naxcel is ceftiofur, which belongs to a class of antibiotics called “ third generation cephalosporins”.
Zdravilna učinkovina zdravila Naxcel je ceftiofur, ki je antibiotik iz skupine „ cefalosporinov tretje generacije “.
Naxcel differs from other similar cephalosporin antibiotics as it stays in the pig’ s body for a longer time after it has been injected.
Zdravilo Naxcel se razlikuje od podobnih cefalosporinskih antibiotikov po tem, da po vbrizganju dlje ostane v telesu prašiča.
Data from laboratory studies with different bacteria showed that ceftiofur was effective against those bacteria involved in causing pig diseases as specified in the product information (see SPC and package leaflet).
Podatki iz laboratorijskih raziskav različnih bakterij kažejo, da je ceftiofur učinkovit proti tistim bakterijam, ki povzročajo bolezni, navedene v navodilih za uporabo.
Naxcel has also been investigated in pigs with respiratory diseases (caused by various bacterial species) or in pigs suffering from severe lameness, fever or other clinical signs of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infections.
Zdravilo Naxcel je bilo preučeno tudi pri prašičih z boleznimi dihal (ki so jih povzročile različne bakterijske vrste) in prašičih, ki so imeli hudo šepavost, zvišano telesno temperaturo ali druge klinične znake septikemije, poliartritisa oz. poliserozitisa, povezanega z okužbo s Streptococcus suis.
In these trials, Naxcel was either used on its own or compared with another authorised antibiotic (ceftiofur sodium) or a placebo (a dummy treatment without any active ingredient).
V teh preskušanjih so uporabili samo zdravilo Naxcel ali pa so ga primerjali z drugim odobrenim antibiotikom (ceftiofur natrij) ali s placebom (zdravilom brez vsake zdravilne učinkovine).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Naxcel shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšne koristi je zdravilo Naxcel izkazalo med raziskavami?
In all studies, Naxcel was as effective in curing the infection as the comparator antibiotic.
V vseh raziskavah je bilo zdravilo Naxcel za ozdravljenje okužbe enako učinkovito kot primerjalni antibiotik.
Naxcel has the benefit of a long duration of activity.
Zdravilo Naxcel ima koristno lastnost dolgotrajnega učinkovanja.
The most common side effects noted during the studies are local swellings and/ or other mild reactions (skin discolouration, small cysts) at the injection site.
Najpogostejši neželeni učinki v raziskavah so bile lokalne otekline in/ ali druge blage reakcije (sprememba barve kože, majhne ciste) na mestu injiciranja.
These effects disappear after a few weeks and do not require any further treatment.
Ti učinki izzvenijo po nekaj tednih in ne zahtevajo dodatnega zdravljenja.
Ceftiofur (as other cephalosporins or penicillins) may cause allergic reaction in humans or in animals, which may occasionally be serious.
Ceftiofur (kot drugi cefalosporini oz. penicilini) lahko povzročijo alergijske reakcije pri človeku ali živalih, ki so lahko v določenih primerih hude.
It should therefore not be used in pigs, which have shown an allergy to any cephalosporin or penicillin-type antibiotics.
Zato ga ne smemo uporabiti pri prašičih z znano alergijo za katerikoli cefalosporin ali penicilinski antibiotik.
As no studies have been made in pregnant or lactating sows or in breeding pigs and Naxcel has an exceptionally long duration in the body, Naxcel should only be used in these animals after careful consideration by the veterinarian.
Ker raziskave na brejih svinjah ali svinjah v obdobju laktacije oz. plemenskih prašičih niso bile opravljene in ker ima zdravilo Naxcel izjemno dolgo obstojnost v telesu, lahko zdravilo Naxcel uporabite samo po natančnem posvetovanju z veterinarjem.
Cephalosporin and penicillin antibiotics can cause allergies in humans, and sometimes these allergies can be very serious.
Cefalosporinski in penicilinski antibiotiki lahko alergije pri človeku, ki so lahko v določenih primerih zelo hude.
Naxcel should therefore not be handled by anyone who is hypersensitive (allergic) to such antibiotics, or by anyone who has been advised not to work with them.
Z zdravilom Naxcel ne smejo rokovati osebe, ki so preobčutljive za (alergične na) takšne antibiotike, oziroma osebe, ki so jim odsvetovali delo z njimi.
Naxcel should be handled with care and all the recommended precautions be taken to avoid exposure to the product.
Z zdravilom Naxcel je treba ravnati previdno in upoštevati vse previdnostne ukrepe proti izpostavitvi zdravilu.
If any symptoms occur after accidental exposure to Naxcel, for example a skin rash, then the advice of a doctor should be sought immediately.
Če se po nenamerni izpostavitvi zdravilu Naxcel pojavijo kakršnikoli simptomi (npr. kožni izpuščaj), se nemudoma posvetujte z zdravnikom.
Swelling of the face, lips or eyes, or any difficulty breathing are more serious symptoms and require urgent medical attention.
Otekanje obraza, ustnic ali oči oz. oteženo dihanje so resnejši simptomi, ki zahtevajo nujno medicinsko oskrbo.
The withdrawal period of the product is 71 days.
Obdobje karence zdravila je 71 dni.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Naxcel outweigh its risks, for the treatment of pigs with specified bacterial respiratory diseases or the treatment of septicaemia, polyarthritis and polyserositis associated with Streptococcus suis infection.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so za zdravljenje prašičev z navedenimi bakterijskimi boleznimi dihal in zdravljenje septikemije, poliartritisa in poliserozitisa, povezanega z okužbo s Streptococcus suis, koristi zdravila Naxcel večje od z njim povezanih tveganj.
The Committee, therefore, recommended that Naxcel should be given a marketing authorisation.
Odbor je zato priporočil odobritev dovoljenja za promet z zdravilom Naxcel.
The benefit-risk balance may be found in module 6 of this EPAR.
Razmerje med koristnimi učinki in tveganji najdete v modulu 6 tega Evropskega javnega poročila o oceni zdravila (EPAR).
The European Commission granted a marketing authorisation valid throughout the European Union, for Naxcel to Pfizer Ltd on 19 May 2005.
Evropska Komisija je dovoljenje za promet z zdravilom Naxcel, veljavno po vsej Evropski uniji, odobrila družbi Pfizer Ltd dne 19. maja 2005.
This summary was last updated on 21 August 2006.
Ta povzetek je bil nazadnje posodobljen 21/ 08/ 2006.
Page 2/ 2 ©EMEA 2006
Stran 2/ 2 ©EMEA 2006
Invented Name
izmišljeno ime
Target species
ciljna živalska vrsta
Route of administration
način uporabe zdravila
Withdrawal Period
karenca
100 ml
steklena viala 100 ml
71 days
71 dni
50 ml
steklena viala 50 ml
NAXCEL 100 mg/ ml suspension for injection for pigs.
NAXCEL 100 mg/ ml suspenzija za injiciranje za prašiče
Ceftiofur crystalline free acid corresponding to ceftiofur
Ceftiofur kristaliničnaprosta kislina, ki ustreza ceftiofurju
Oily vehicle (vegetable origin)
Oljni vehikel( rastlinsko olje)
•
- Zdravljenje bakterijskih respiratornih obolenj, ki so povezana z Actinobacillus
Treatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis.
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis in Streptococcus suis.
Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infection.
- Zdravljenje septikemije, poliartritisa ali poliserozitisa, ki je povezan z okužbo s Streptococcus
4.3
suis.
Do not use in case of hypersensitivity to ceftiofur or other β-lactam antibiotics.
Ne uporabite v primeru preobčutljivosti na ceftiofur ali druge ß- laktamske antibiotike.
Penicillins and cephalosporins may cause hypersensitivity following injection, inhalation, ingestion or skin contact.
Penicilini in cefalosporini lahko po injiciranju, inhalaciji, zaužitju ali v stiku s kožo povzročijo preobčutljivostne reakcije.
Allergic reactions to these substances may occasionally be serious.
Alergične reakcije na te snovi so lahko resne.
Do not handle this product if you know you are hypersensitive.
Osebe z znano preobčutljivostjo na ceftiofur naj se izogibajo stiku z zdravilom.
2/20 Avoid contact with skin or eyes.
2/ 20 Izogibajte se stiku zdravila s kožo ali očmi.
If you develop symptoms following exposure such as a skin rash or persistent eye irritation, you should seek medical advice.
Če se po uporabi zdravila pokažejo simptomi, kot so npr. izpuščaj ali dolgotrajno draženje oči, poiščite zdravniško pomoč.
Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Otekline obraza, ustnic ali oči oziroma težave dihanja so resni simptomi, zato nemudoma poiščite medicinsko pomoč.
Laboratory studies in rats revealed no teratogenic effects but maternotoxic (soft faeces) and foetotoxic (reduced fetal weight) effects were observed.
Z laboratorjiskimi študijami na podganah niso ugotovili teratogenih učnikov, opaženi pa so bili maternotoksični (mehki iztrebki) in fetotoksični (zmanjšana fetalna teža) učinki.
Use only according to the benefit/risk assessment by the responsible veterinarian.
Uporabljajte samo potem, ko odgovorni veterinar oceni razmerje korist / tveganje.
5 mg ceftiofur/kg body weight (equivalent to 1 ml of NAXCEL per 20 kg body weight) administered once in the neck by intramuscular injection.
5 mg ceftiofurja na kg telesne mase (ekvivalentno 1 ml zdravila NAXCEL na 20 kg telesne mase), z enkratnim intramuskularnim dajanjem v področje vratu.
To ensure a correct dosage, body weight should be accurately determined to avoid under-dosing.
Priporočljivo je, da natančno določimo telesno maso živali, da se s tem izognemo prenizkemu odmerjanju.
Owing to the low toxicity of ceftiofur in pigs overdoses do not typically lead to any clinical signs, other than transient local swellings as described in section 5.4 (undesirable effects).
Zaradi nizke toksičnosti ceftiofurja predoziranje praviloma ne povzroči drugih simptomov, razen prehodne lokalne otekline, kot je že opisano v poglavju 4. 6 Neželeni učinki (pogostost in resnost).
ATCvet code:
Cefalosporini tretje generacije, ATCvet oznaka:
3/20 Ceftiofur is particularly active against the following target pathogens causing respiratory and other diseases in pigs:
Ceftiofur je aktiven predvsem proti naslednjim povzročiteljem respiratornih in drugih obolenj pri prašičih:
Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis.
Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis in
Desfuroylceftiofur is the principal active metabolite.
3/ 20 Streptococcus suis.
It has an antimicrobial activity similar to that of ceftiofur against the target pathogens.
Bordetella bronchiseptica je zaradi prenosa rezistence neobčutljiva na ceftiofur pri in- vitro preizkusih.
At the recommended therapeutic dose, concentrations in plasma were higher than the MIC (< 0.2 µg/ml) for the target bacteria isolated in clinical studies for at least 158 hours.
V priporočenem terapevtskem odmerku so bile koncentracije v plazmi za ciljne bakterije izolirane med kliničnimi študijami, tudi še 158 ur po začetku poskusa višje od MIC90 vrednosti (< 0, 2 mg/ ml),.
One hour after a single administration, plasma concentrations are above 1 µg/ml.
70% ceftiofura in njegovega metabolita desfuroilceftiofura se veže na plazemske beljakovine. Po enkratnem odmerku je po eni uri koncentracija v plazmi nad 1 µg/ ml.
Maximum concentrations in plasma (4.2 ± 0.9 µg/ml) are reached at approximately 22 hours after administration.
Najvišja koncentracija v plazmi (4, 2 ± 0, 9 µg/ ml) je dosežena po 22 urah po dajanju.
Plasma concentrations above 0.2 µg/ml of ceftiofur and its metabolite are maintained for an appropriate period of time.
Koncentracija ceftiofura in desfuroilceftiofura v plazmi nad 0, 2 µg/ ml se ohrani dalj časa.
Triglycerides Cottonseed oil
6. 1 Seznam pomožnih snovi
28 days
Srednjeverižni trigliceridi Olje bombaževčevega semena, kemično spremenjeno
2 years
6. 2 Inkompatibilnosti
Cardboard box with one Type I glass vial of 50 ml or 100 ml with a chlorobutyl-isoprene rubber stopper and aluminium cap.
Kartonasta škatla z eno vialo iz stekla tipa 1 s 50 ml ali 100 ml s klorobutilno- izopirenskim gumijastim zamaškom in aluminijasto zaporko.
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Združeno Kraljestvo
8.
4/ 20 8.
19th May 2005
19. maj 2005
5/20 ANNEX II
5/ 20 DODATEK II
B.
IMETNIK
CONDITIONS
DOVOLJENJA
OR
ZA
RESTRICTIONS
IZDELAVO
THE
ZDRAVILA,
MARKETING
ODGOVOREN ZA SPROŠČANJE SERIJE
AUTHORISATION REGARDING SUPPLY OR USE
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
CONDITIONS
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE
RESTRICTIONS
6/ 20 A.
OF
IMETNIK DOVOLJENJA SPROŠČANJE SERIJE
THE
ZA
MARKETING
IZDELAVO
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
ZDRAVILA,
STATEMENT OF THE MRLs
ODGOVOREN
6/20 A.
ZA
Pfizer N.V/S.A Rijksweg 12 B-2870 Puurs Belgium
Rijksweg 12 B- 2870 Puurs Belgija
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Nosilec tega dovoljenja za promet z zdravilom mora obvestiti Evropsko komisijo o načrtu trženja za zdravilo, odobreno s to odločbo.
In accordance with Council Regulation (EEC) No 2377/90, as amended and in accordance with Article 34.4b of Regulation (EEC) No 726/2004 of 31 March 2004.
726/ 2004 z dne 31. marca 2004.
Ceftiofur is included in Annex I of Council Regulation (EEC) No 2377/90 in accordance with the following table:
2377/ 90 kot je navedeno v tabeli:
Pharmacologica lly active substance(s)
Farmakološko aktivna snov
MRLs
Najvišje dovoljene količine zaostankov (MRL)
Ceftiofur
ceftiofur
Miglyol1 is covered by Annex II of Council Regulation (EEC) No.
Migliol1 je vključen v Dodatek II Uredbe Sveta (EGS) št.
2377/90 for all food producing species and Cotton seed oil is considered out of scope of Council Regulation (EEC) No.
Olje bombaževega semena ni vkjučeno v Uredbo Sveta (EGS) št.
1 Commission Regulation (EC) No.
1 Uredba Komisije (EC) št.
2796/95, of 04.12.95, revised by 508/99 of 04/03/99.
2796/ 95, z dne 04. 12. 95, revidirana z 508/ 99 z dne 04. 03. 99.
Miglyol is the commercial name of Triglycerides medium chain, Ph.
Eur (Triglycerides medium chain, Ph.
Eur.
Eur).
7/20 ANNEX III
7/ 20 DODATEK III
9/20 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
9/ 20 PODATKI NA ZUNANJI OVOJNINI
NAXCEL 100 mg/ml suspension for injection for pigs
NAXCEL 100 mg/ ml suspenzija za injiciranje za prašiče
Ceftiofur crystalline free acid corresponding to ceftiofur 100 mg / ml
100 mg
Oily vehicle
Oljni vehikel
q.s. ad 1 ml
q. s. do 1 ml
Treatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis.
Zdravljenje bakterijskih respiratornih obolenj, ki so povezana z Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis in Streptococcus suis.
8 WITHDRAWAL PERIOD
KARENCA
EXP {month/year} Once broached, use within 28 days
EXP {mesec/ leto} Načeto zdravilo porabite v 28 dneh.
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
EU/2/05/053/001 (100 ml) EU/2/05/053/002 (50 ml)
EU/ 2/ 05/ 053/ 001 (100ml)
12/20 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
12/ 20 PODATKI NA PRIMARNI OVOJNINI
VIAL – 100 ml
VIALA 100 ml
5 mg ceftiofur/kg body weight (1 ml / 20 kg body weight) Shake bottle vigorously It is recommended to limit injection volumes to a maximum of 4 ml.
Pred uporabo preberite priloženo navodilo.
5 WITHDRAWAL PERIOD
KARENCA
EXP {month/year} Once broached, use by ….. < leave space for the date to be inserted >
EXP {mesec/ leto} Načeto zdravilo uporabite do ………... < ohranite prostor za vpis datuma >
14/20 PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGE
14/ 20 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL – 50 ml
VIALA 50 ml
NAXCEL 100 mg/ml suspension for injection for pigs
NAXCEL 100 mg/ ml suspenzija za injiciranje za prašiče Ceftiofur
5 mg ceftiofur/kg (1 ml / 20 kg) Shake bottle vigorously It is recommended to limit injection volumes to a maximum of 4 ml.
Pred uporabo močno stresajte..
Read the package leaflet before use.
Priporočamo, da volumen enega odmerka ne preseže 4 ml.
16/20 PACKAGE INSERT
16/ 20 NAVODILO ZA UPORABO
Marketing authorisation holder Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom.
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Združeno Kraljestvo
Pfizer NV/SA Rijksweg 12 B-2870 Puurs Belgium
Imetnik dovoljenja za proizvodnjo zdravila, odgovoren za sproščanje serij v EGP Pfizer NV/ SA Rijksweg 12 B- 2870 Puurs Belgija
Oily vehicle (vegetable oil)
Pomožne snovi:
Do not use in case of hypersensitivity to ceftiofur or other ß-lactam antibiotics.
Ne uporabljajte zdravila pri živalih, ki so preobčutljive na ceftiofur ali druge ß- laktamske antibiotike.
If you notice any other side effects, please inform your veterinary surgeon.
Če opazite kakršnekoli druge stranske učinke, o njih obvestite svojega veterinarja.
DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT( I) IN NAČIN UPORABE ZDRAVILA
Shelf-life after first opening the container:
Shranjujte nedosegljivo otrokom Ne shranjujte pri temperaturi nad 25°C Rok uporabnosti po prvem odpiranju vsebnika:
Do not use after the expiry date stated on the label.
28 dni Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
In the event of contact, wash with clean water.
Izogibajte se stiku s kožo ali očmi, V primeru stika takoj sperite s čisto vodo.
If you develop symptoms following exposure such as a skin rash or persistent eye irritation, you should seek medical advice.
Če se po uporabi zdravila pokažejo simptomi, kot so npr. izpuščaj ali dolgotrajno draženje oči, poiščite zdravniško pomoč in pokažite to opozorilo.
Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Otekline obraza, ustnic ali oči in težave dihanja so resni simptomi, zato nemudoma poiščite medicinsko pomoč
OTHER INFORMATION4
DRUGE INFORMACIJE
Polska Pfizer Trading Polska sp. z.o.o.
Polska España Pfizer Trading Polska sp. z. o. o.
Tel: +48 22 335 62 00
Pfizer S. A., Tel: +48 22 335 62 00 Teléfono: +34 91 4909900
EU Number
EU evidenčna št.
Tradename
Zaščiteno ime
Pharmaceutical form
Farmacevts Ciljna ka oblika živalska vrsta
Package size
Vsebina vsebnika
adhesins F4 (F4ab, F4ac, F4ad), at least 2.1 SA. U* adhesin F5, at least 1.7 SA. U* adhesin F6, at least 1.4 SA. U* adhesin F41, at least 1.7 SA. U*
adhezini F4 (F4ab, F4ac, F4ad), najmanj 2. 1 SA. U * adhezin F5, najmanj 1. 7 SA. U * adhezin F6, najmanj 1. 4 SA. U * adhezin F41, najmanj 1. 7 SA. U *
Intramuscular injection
Intramuskularno
Glass type I vial with butyl rubber stopper
Steklenička tipa I z butilnim gumijastim zamaškom
Box of 5-dose 10 ml vial
Škatla s 5 odmerki, 10 ml steklenička
10 ml vial
10 ml steklenička
Box of 10-dose 20 ml vial
Škatla z 10 odmerki, 20 ml steklenička
20 ml vial
20 ml steklenička
Box of 25-dose 50 ml vial
Škatla s 25 odmerki, 50 ml steklenička
50 ml vial
50 ml steklenička
adhesins F4 (F4ab, F4ac, F4ad), at least 2.1 SA. U* adhesin F5, at least 1.7 SA. U* adhesin F6, at least 1.4 SA. U* adhesin F41, at least 1.7 SA. U*
adhezini F4 (F4ab, F4ac, F4ad),
Suspension for injection
Suspenzija
Pigs (sows and gilts)
Prašiči
Glass type I vial with butyl rubber stopper
Steklenička tipa I z
Box of 50-dose 100 ml vial
100 ml
100 ml vial
odmerki, 100 ml steklenička
Zero days
steklenička
NEOCOLIPOR EPAR summary for the public
NEOCOLIPOR Povzetek EPAR za javnost
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Če potrebujete več informacij o zdravstvenem stanju ali zdravljenju živali, se posvetujte z veterinarjem.
Neocolipor is an inactivated vaccine intended to be used to reduce neonatal enterotoxicosis (a bacterial infection caused by strains of E. coli) in very young piglets.
Zdravilo Neocolipor je neaktivirano cepivo, namenjeno zmanjševanju poporodne enterotoksemije (bakterijske okužbe, ki jo povzročajo sevi bakterije E. coli) pri zelo mladih pujskih.
Neocolipor contains inactivated strains of E. coli expressing the adhesins F4ab (K88ab), F4ac (K88ac), F4ad (_BAR_K88 ad) F5 (K99) F6 (987P) and F41.
Neocolipor vsebuje neaktiviran bakterijski sev E. coli, ki izraža adhezine F4ab (K88ab), F4ac (K88ac), F4ad (_BAR_K88 ad) F5 (K99) F6 (987P) in F41.