natgillin/translations-raw huggingface dataset:
The other ingredients are: for the powder: ammonium sulphate and acetic acid and for the gel carbomer 980, disodium phosphate anhydrous, sodium hydroxide, and water for injections.
Druge sestavine so: prašek: amonijev sulfat in ocetna kislina; gel: karbomer 980, brezvodni natrijev hidrogenfosfat, natrijev hidroksid, voda za injekcije.
This endpoint can only be evaluated for deep partial-thickness wounds without full-thickness areas because full-thickness burns always require grafting.
Ta opazovani dogodek je bil ocenjen le za globoke dermalne opekline, saj je treba pri subdermalnih opeklinah vedno uporabiti presadek.
In the NexoBrid group, the event was graded as mild, moderate or severe in 30.0%, 5.6% and 1.1% of patients, respectively.
V skupini z zdravilom NexoBrid je bil pojav pri 30,0 % bolnikov ocenjen kot blag, pri 5,6 % kot zmeren in pri 1,1 % kot hud.
• Sterile isotonic sodium chloride 9 mg/ml (0.9%) solution must be sprinkled on the burn wound.
• Na opeklinsko rano morate nakapati sterilno izotonično 0,9-odstotno raztopino natrijevega klorida (9 mg/ml).
• NexoBrid powder is then transferred into the corresponding gel bottle.
• Prašek zdravila NexoBrid nato prenesite v ustrezno stekleničko z gelom.
Mixed wounds (deep partial and full thickness) Non-autografted mixed wounds
Mešane rane (dermalne in subdermalne) Mešane rane brez avtotransplantata
One vial contains 5 g of concentrate of proteolytic enzymes enriched in bromelain, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing (or 5 g/55 g gel).
Ena viala vsebuje 5 g koncentrata proteolitičnih encimov, obogatenih z bromelainom, kar po mešanju ustreza 0,09 g/g koncentrata proteolitičnih encimov, obogatenih z bromelainom (ali 5 g/55 g gela).
In the NexoBrid group, the event was graded as mild, moderate or severe in 0.9%, 0.9%, and 1.8% of patients, respectively.
V skupini z zdravilom NexoBrid so bili dogodki pri 0,9 % ocenjeni kot blagi, pri 0,9 % kot zmerni in 1,8 % kot hudi.
In studies implementing routine antibacterial soaking of the treatment area before and after NexoBrid application (see section 4.2) pyrexia or hyperthermia was reported in 19.1% of patients treated with NexoBrid and in 15.8% of the control patients treated according standard of care.
V študijah, kjer so rutinsko uporabljali protibakterijsko namakanje zdravljenega predela pred nanosom zdravila NexoBrid in po njem (glejte poglavje 4.2) pri 19,1 bolniku zdravljenem z zdravilom NexoBrid in pri 15,8 % bolnikov iz kontrolne skupine, zdravljenih s standardno nego, poročali o pireksiji ali hipertermiji.
One vial contains 2 g of concentrate of proteolytic enzymes enriched in bromelain, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing (or 2 g/22 g gel).
Ena viala vsebuje 2 g koncentrata proteolitičnih encimov, obogatenih z bromelainom, kar po mešanju ustreza 0,09 g/g koncentrata proteolitičnih encimov, obogatenih z bromelainom (ali 2 g/22 g gela).
Deep partial-thickness wounds requiring excision/dermabrasion (surgery) Number of wounds % of wounds requiring surgery % of wound area excised or dermabraded
Zdravilo NexoBrid Standardna nega vrednost p Globoke dermalne opekline, ki potrebujejo ekscizijo/dermabrazijo (operativni poseg) Število ran % ran, ki jih je treba operirati % predela ran z ekscizijo ali dermabrazijo
NexoBrid 5 g powder and gel for gel
NexoBrid 5 g prašek in gel za gel
In the NexoBrid group, the event was graded as mild, moderate or severe in 9.1%, 9.1%, and 0% of patients, respectively.
V skupini z zdravilom NexoBrid je bil pojav pri 9,1 % bolnikov ocenjen kot blag, 9,1 % kot zmeren in 0 % kot hud.
• The dressed wound must be covered with a loose, thick fluffy dressing, held in place with a bandage.
• Rano z oblogo morate prekriti z ohlapno, debelo in kosmičavo oblogo ter jo pritrditi z ovojem.
An aseptic technique must be used when mixing the powder with the gel.
Pri mešanju praška z gelom morate uporabiti aseptično tehniko.
• NexoBrid powder and gel must be mixed thoroughly until a uniform, slightly tan to slightly brown mixture is obtained.
• Zdravilo NexoBrid prašek in gel morate dobro premešati, da dobite enakomerno, rahlo svetlorjavo do rjavkasto mešanico.
Wound complication*
zapleti z rano*
In case of skin exposure, rinse NexoBrid off with water.
V primeru izpostavljenosti kože izpirajte zdravilo NexoBrid z vodo.
• Before a permanent skin cover or temporary skin substitute is applied to a freshly enzymatically debrided area, a soaking wet-to-dry dressing must be applied.
• Pred nanosom trajnega kožnega presadka ali začasnega kožnega nadomestka na sveže encimsko očiščeno rano morate rano prekriti z oblogo, ki je na rano mokra in navzven suha.
In case of eye exposure, irrigate exposed eyes with copious amounts of water for at least 15 minutes.
Če pride do izpostavitve, izpostavljene oči vsaj 15 minut izpirajte z veliko vode.
What NexoBrid looks like and contents of the pack NexoBrid is provided as a powder and gel for gel (powder in a vial (2 g) and gel in a bottle (20 g)), pack size of 1 (a pack contains one vial of powder and one bottle of gel)
Zdravilo NexoBrid je na voljo v obliki praška in gela za gel (prašek v viali (2 g) in gel v steklenički (20 g)), velikost pakiranja 1 (pakiranje vsebuje eno vialo s praškom in eno stekleničko z gelom).
• A total wound area of not more than 15% TBSA can be treated by NexoBrid.
• V enem postopku se lahko zdravilo NexoBrid nanese na največ 15 % CPT.
NexoBrid 2 g powder and gel for gel Concentrate of proteolytic enzymes enriched in bromelain
NexoBrid 2 g prašek in gel za gel koncentrat proteolitičnih encimov, obogatenih z bromelainom
What NexoBrid contains - The active substance (in the powder in the vial) is a concentrate of proteolytic enzymes enriched in bromelain: 2 g, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing.
Kaj vsebuje zdravilo NexoBrid - Zdravilna učinkovina (v prašku v viali) je koncentrat proteolitičnih encimov, obogatenih z bromelainom: 2 g, kar po mešanju ustreza 0,09 g/g koncentrata proteolitičnih encimov, obogatenih z bromelainom.
What NexoBrid contains - The active substance (in the powder in the vial) is a concentrate of proteolytic enzymes enriched in bromelain: 5 g, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing.
Kaj vsebuje zdravilo NexoBrid - Zdravilna učinkovina (v prašku v viali) je koncentrat proteolitičnih encimov, obogatenih z bromelainom: 5 g, kar po mešanju ustreza 0,09 g/g koncentrata proteolitičnih encimov, obogatenih z bromelainom.
Excipients: Carbomer 980, disodium phosphate anhydrous, sodium hydroxide, water for injections.
Pomožne snovi: karbomer 980, brezvodni natrijev hidrogenfosfat, natrijev hidroksid, voda za injekcije.
NexoBrid 5 g powder and gel for gel Concentrate of proteolytic enzymes enriched in bromelain
NexoBrid 5 g prašek in gel za gel koncentrat proteolitičnih encimov, obogatenih z bromelainom
Excipients for the gel: Carbomer 980, disodium phosphate anhydrous, sodium hydroxide, water for injections.
Pomožne snovi za gel: karbomer 980, brezvodni natrijev hidrogenfosfat, natrijev hidroksid, voda za injekcije.
There have been reports of serious allergic reactions including anaphylaxis (with manifestations such as rash, erythema, hypotension, tachycardia) in patients undergoing debridement with NexoBrid.
Pri bolnikih, ki so se zdravili z zdravilom NexoBrid, obstajajo poročila o resnih alergijskih reakcijah, vključno z anafilakso (ki se kažejo z izpuščajem, eritemom, hipotenzijo, tahikardijo).
General principles of proper burn wound care must be adhered to when using NexoBrid.
Pri uporabi zdravila NexoBrid upoštevajte splošna načela pravilnega čiščenja opeklinskih ran.
• Before NexoBrid application, a dressing soaked with an antibacterial solution will be applied for 2 hours.
• Pred nanosom zdravila NexoBrid vam bodo na rano za 2 uri položili oblogo, namočeno v antibakterijsko raztopino.
Wound complications
Okvara ledvic
Full Thickness wounds
Subdermalne rane
NexoBrid is not recommended for use on: - penetrating burn wounds where foreign materials (e.g. implants, pacemakers, and shunts) and/ or vital structures (e.g. larger vessels, eyes) are or could become exposed during debridement.
Zdravilo NexoBrid se ne priporoča za uporabo pri: - prodirajočih opeklinskih ranah z izpostavitvijo ali možno izpostavitvijo tujkov (npr. vsadkov, spodbujevalnikov in šantov) in/ali vitalnih struktur (npr. velikih žil, oči) med čiščenjem, - kemičnih opeklinskih ranah, - ranah, kontaminiranih z radioaktivnimi ali drugimi nevarnimi snovmi, da se preprečijo nepredvidljive reakcije z zdravilom in zaradi večjega tveganja širjenja nevarnih snovi.
• All topically applied antibacterial medicinal products must be removed before applying NexoBrid.
• Pred nanosom zdravila NexoBrid morate odstraniti vsa topikalno nanesena antibakterijska zdravila.
Topically applied medicinal products (such as silver sulfadiazine or povidone-iodine) at the wound site must be removed and the wound cleansed prior to NexoBrid application.
Pred nanosom zdravila NexoBrid je treba topikalno nanesena zdravila (kot sta srebrov sulfadiazin ali povidon-jod) z rane odstraniti in rano očistiti.
% wound area autografted 55.5% (n=48)
55,5 % (n = 48)
• A dressing soaked with an antibacterial solution must be applied for an additional 2 hours.
• Na rano morate za še 2 uri položiti oblogo, namočeno z antibakterijsko raztopino.
Autografted mixed wounds
% avtotransplantiranega predela rane
There is limited information on the use of NexoBrid on facial burn wounds.
Podatkov o uporabi zdravila NexoBrid pri opeklinskih ranah na obrazu je malo.
OUTER CARTON
ZUNANJA ŠKATLA
In case of skin contact, rinse NexoBrid off with water.
V primeru, da je zdravilo prišlo v stik s kožo, izpirajte zdravilo NexoBrid z vodo.
• Dressing soaked with an antibacterial solution must be applied for 2 hours.
• Na rano morate za 2 uri položiti oblogo, namočeno z antibakterijsko raztopino.
- Keep this leaflet.
Shranjujte pokončno.
Aseptic technique must be used when mixing NexoBrid powder with the gel.
Pri mešanju zdravila NexoBrid prašek z gelom morate uporabiti aseptično tehniko.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING UNITS
Izhodiščne značilnosti vseh mešanih opeklin
Size: % mean TBSA Depth: Superficial (%TBSA) DPT (% TBSA) FT (% TBSA) Incidence of autograft
Velikost: % povprečje CPT 7,43 Globina: Površinske (% CPT) Globoke dermalne (% CPT) 3,85 Subdermalne (% CPT) Incidenca avtotransplantata 70,8 % (34/48)
NexoBrid should not be applied to more than 15% Total Body Surface Area (TBSA) (see also section 4.4, Coagulopathy).
Zdravilo NexoBrid 2 g praška v 20 g gela se nanese na predel opeklinske rane površine 100 cm V enem postopku nanašanja zdravila NexoBrid ne nanesite na več kot 15 % celotne površine telesa (CPT) (glejte tudi poglavje 4.4, Koagulopatija).
Concentrate of proteolytic enzymes enriched in bromelain
NexoBrid 5 g prašek koncentrat proteolitičnih encimov, obogateni z bromelainom
Based on:
Na podlagi:
Scientific conclusions and grounds for refusal and suspension presented by the European Medicines Agency
Znanstveni zaključki ter podlaga za zavrnitev in začasni umik, ki jih je predstavila Evropska agencija za zdravila
• the rapporteur's and co-rapporteur's assessment reports
• poročil poročevalca in soporočevalca o oceni zdravila,
Isotretinoin Ranbaxy 10 mg & 20 mg, capsules (soft) was authorised in the reference member state (UK) under Article 10 of Directive 2001/83/EC and the application was submitted in the concerned member states (France and Spain) under the mutual recognition procedure.
Zdravilo Isotretinoin Ranbaxy 10 mg in 20 mg, kapsule (mehke) je bilo odobreno v referenčni državi članici (Združenem kraljestvu) v skladu s členom 10 Direktive 2001/83/ES, vloga pa je bila predložena v zadevnih državah članicah (Franciji in Španiji) v skladu s postopkom z medsebojnim priznavanjem.
However, the results failed to show that the Isotretinoin Ranbaxy generic is bioequivalent to the originator product in real conditions of use (fed conditions), as the 90% confidence intervals (CI) fell outside the predefined interval of 80-125%, which constitutes a risk to public health.
Rezultati so pokazali, da generično zdravilo Isotretinoin Ranbaxy ni biološko enakovredno originatorskemu zdravilu v dejanskih pogojih uporabe (jemanje s hrano), saj je 90 % intervalov zaupanja bilo zunaj predhodno določenega intervala 80 %-125 %, kar predstavlja tveganje za javno zdravje.
At the time of the initial authorisation, bioequivalence was shown under fasting conditions (study No 237/00).
V času prvotne odobritve je bila dokazana biološka enakovrednost pri jemanju zdravila na tešče (študija št. 237/00).
Therefore, the Committee adopted an opinion recommending the refusal of the marketing authorisations in the concerned member states and the suspension of the marketing authorisations in the reference member state, subject to the conditions outlined in annex III of the Opinion.
Odbor je zato sprejel mnenje, v katerem priporoča zavrnitev dovoljenj za promet z zdravilom v zadevnih državah članicah in začasni umik dovoljenj za promet z zdravilom v referenčni državi članici v skladu s pogoji, opredeljenimi v Dodatku III tega mnenja.
It is therefore considered that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Na podlagi tega velja, da podatki, predloženi v podporo vlogi, ne izpolnjujejo zahtev iz člena 10 Direktive 2001/83/ES, kakor je bila spremenjena.
• and scientific discussion within the Committee the CHMP was of the opinion that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
• znanstvene razprave znotraj odbora je CHMP menil, da podatki, predloženi v podporo vlogi, ne izpolnjujejo zahtev iz člena 10 Direktive 2001/83/ES, kakor je bila spremenjena.
The totality of data submitted does not support the conclusion that the product is bioequivalent.
Skupni predloženi podatki ne podpirajo trditve, da je zdravilo biološko enakovredno.
Isotretinoin is effective against severe acne via a direct effect on the size and activity of sebaceous glands, plus a probable dermal anti-inflammatory effect.
Izotretinoin je učinkovit proti hudim oblikam aken, ker deluje neposredno na velikost in aktivnost lojnic, verjetno pa ima tudi dermalni protivnetni učinek.
Isotretinoin is a vitamin A derivative indicated for the treatment of severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy.
Izotretinoin je derivat vitamina A, ki je indiciran za zdravljenje hudih oblik aken (nodulocističnih oz. konglobiranih aken ali aken, ki lahko povzročijo brazgotine), ki se ne odzivajo na ustrezno standardno zdravljenje s sistemskimi antibakterijskimi zdravili in topično terapijo.
• the results of the bioequivalence study in fed conditions provided by the MAH,
• rezultatov študije biološke enakovrednosti pri jemanju zdravila s hrano, ki jih je predložil imetnik dovoljenja za promet,
The CHMP considered that the data submitted in support of this application failed to show bioequivalence between the test and the reference product, and that therefore the product is not approvable for the sought indications.
CHMP meni, da podatki, predloženi v podporo tej vlogi, ne dokazujejo biološke enakovrednosti med testiranim in referenčnim zdravilom, zaradi česar zdravila ni mogoče odobriti za omenjene indikacije.
Having regard to the fact that the absorption of Isotretinoin in fed state is larger than that observed in fasted state (which motivates the SPC recommendation of intake with food (as clearly mentioned in the Posology section of the SPC), the CHMP agreed that a study in the fed state was essential.
Ker je absorpcija zdravila Isotretinoin pri jemanju s hrano višja kot pri jemanju na tešče (to je tudi razlog, zakaj je v povzetku glavnih značilnosti zdravila v poglavju o odmerjanju priporočeno jemanje zdravila s hrano), se je CHMP strinjal, da je potrebno izvesti študijo o jemanju zdravila s hrano.
However, during the mutual recognition procedure, demonstration of bioequivalence in fed state was considered essential by the Concerned Member States and the matter was referred to the CHMP.
Med postopkom z medsebojnim priznavanjem pa so zadevne države članice menile, da je treba dokazati tudi biološko enakovrednost pri jemanju zdravila sočasno s hrano, zato je bila zadeva napotena na odbor CHMP.
Results of a study in healthy adult human male subjects under fed conditions (study No 122_ISOTR_10) were subsequently provided by the marketing authorisation holder.
Imetnik dovoljenja za promet z zdravilom je naknadno predložil rezultate študije jemanja zdravila s hrano, ki je bila izvedena med zdravimi odraslimi moškimi (študija št. 122_ISOTR_10).
The Committee further considered that it is not possible, on the basis of the data submitted in support of this application, to establish a positive benefit-risk balance for this product and that, in these circumstances, the marketing of the product constitutes a risk to public health.
Odbor nadalje meni, da na podlagi podatkov, predloženih v podporo vlogi, ni mogoče ugotoviti pozitivnega razmerja med koristmi in tveganji za to zdravilo in da zato trženje tega zdravila v danih okoliščinah predstavlja tveganje za javno zdravje.
The Committee further considered that it is not possible, on the basis of the data submitted in support of this application, to establish a positive benefit-risk balance for this product and, in these circumstances, the marketing of the product constitutes a risk to public health.
Odbor nadalje meni, da na podlagi navedenih podatkov ni mogoče ugotoviti pozitivnega razmerja med koristmi in tveganji za to zdravilo, zato trženje tega zdravila v danih okoliščinah predstavlja tveganje za javno zdravje.
Chemin de la Chatanérie 2 1023 Crissier-Lausanne SWITZERLAND
Chemin de la Chatanérie 2 1023 Crissier-Lausanne ŠVICA
ATCvet code: QI02AT01.
Oznaka ATCvet: QI02AT01
Merial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
Merial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCIJA
MARKETING AUTHORISATION NUMBER(S) EU/2/99/011/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/99/011/001
* microagglutination method
* z metodo mikroaglutinacije
Methyl parahydroxybenzoate ≤ 0.8 mg/ml.
Metilparahidroksibenzoat ≤ 0.8 mg/ml.
Dispose of waste material in accordance with local requirements.
Odpadne stvari odstranite v skladu z lokalnimi predpisi.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/03/1999.
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 29/03/1999.
Special warnings for each target species:
Posebna opozorila za vsako živalsko vrsto:
This should be borne in mind when planning vaccination programmes for calves, which receive Locatim.
To moramo upoštevati pri načrtovanju programa zaščitnih cepljenj za teleta, ki so prejela Locatim.
Date of last renewal: 05/12/2008.
Datum podaljšanja dovoljenja za promet: 05/12/2008
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove izdelavo, uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če ugotovi da:
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 voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
The product is produced from colostrum collected from cows kept under field conditions.
Zdravilo je proizvedeno iz kolostruma krav , ki se vzrejajo v terenskih pogojih.
b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.
bolezen, za katero se z zdravilom pridobi imunost, na zadevnem območju skoraj ni prisotna.
Keep the bottle in the outer carton.
Stekleničko shranjujte v zunanji ovojnini.
In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini.
Pregnancy and lactation: The product is not intended for use during pregnancy and lactation.
Brejost ali laktacija: Zdravilo ni namenjeno za uporabo v obdobju brejosti in laktacije.
6.5 Nature and composition of immediate packaging Cardboard box with one 60 ml type III glass bottle closed with a polypropylene stopper with a polyethylene seal and a detachable lock-ring.
Kartonska škatla s 60 ml stekleničko iz stekla tipa III, ki je zaprta s polipropilenskim zamaškom in polietilenskim čepom s snemljivim zapornim prstanom.
Special precautions for use in animals: This product may contain antibodies against BVD virus.
Posebni previdnostni ukrepi za uporabo pri živalih: Zdravilo lahko vsebuje protitelesa proti virusu goveje virusne diareje (BVD).
Reduction of mortality caused by enterotoxicosis associated with E. coli F5 (K99) adhesin during the first days of life as a supplement to colostrum from the dam.
Zmanjšanje stopnje umrljivosti zaradi enterotoksičnosti, ki jo povzroča adhezin E. coli F5 (K99) v prvih dneh po telitvi kot dodatek kolostrumu.
Store in a refrigerator (2 °C - 8 °C).
Shranjujte v hladilniku (2 C - 8 C).
In the absence of information specifically demonstrating the safety of more than one repeated dose, it is recommended that calves should only be dosed once.
Zaradi nezadostnih podatkov o varnosti večkratnega dajanja zdravila priporočamo, da teleta dobijo le en odmerek zdravila.
The product supplements the protective properties of normal colostrum against E. coli F5 (K99) adhesin.
Zdravilo dopolnjuje zaščitno vlogo normalnega kolostruma proti adhezinu E. coli F5 (K99).
Pack size: 60 ml bottle.
Pakiranje: 60ml steklenička.
Consequently, in addition to antibodies to E. coli F5 (K99) it also contains antibodies to other organisms, as a result of vaccination and/or exposure of the donor cows to organisms in their environment.
E. coli F5 (K99) lahko posledično vsebuje tudi protitelesa proti drugim organizmom, kar je posledica cepljenja ali/in izpostavljenja donorskih krav organizmom v njihovem okolju.
4.7 Use during pregnancy or lactation
4.7 Uporaba v obdobju brejosti in laktacije
A decision to use this immunological veterinary medicinal product before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Zato se za uporabo tega imunološkega zdravila pred ali po uporabi katerega koli drugega zdravila odločamo od primera od primera.
The product is not intended for use during pregnancy and lactation.
Zdravilo ni namenjeno za uporabo v obdobju brejosti in laktacije.
MANUFACTURER'S BATCH NUMBER Batch{number}
IZDELOVALČEVA ŠTEVILKA SERIJE
No information is available on the safety and efficacy of this immunological veterinary medicinal product when used with any other veterinary medicinal product.
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega imunološkega zdravila s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
The calf must be given other normal colostrum in addition to the product.
Teletu dajemo poleg zdravila še običajni kolostrum.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN