natgillin/translations-raw huggingface dataset:
• Locate the plaque at the point of maximum concavity (or focal point) in the bend of the penis
• Določite plak na točki največje vbokline (fokalni točki) v prelomu penisa • Točko označite s kirurškim markerjem.
Almost all patients had positive titers for anti-AUX-I antibodies (97.9%) and anti-AUX-II antibodies (97.5%) 60 days post two concurrent injections.
AUX-I (97,9 %) in protitelesa proti AUX-II (97,5 %).
Xiapex 0.58 mg dose†
Volumen injekcije za aplikacijo odmerka zdravila Xiapex 0,58 mg†
Treatment area
Operacija po zdravljenju
Hold pressure for 30 seconds then release.
Pritisk na penis je treba vzdrževati 30 sekund.
Other endpoints included ≥50% reduction from baseline in degree of contracture, percent change from baseline in degree of contracture, change from baseline in range of motion, subject global assessment of treatment satisfaction and physician global assessment of severity.
spremembo razpona gibanja glede na izhodišče, globalno oceno zadovoljnosti z zdravljenjem preskušanca in zdravnikovo globalno oceno resnosti.
• pain at the injection site and above the penis
• bolečina na mestu injiciranja in nad penisom • mehur ali rdečina/obarvanje penisa
• For cords affecting PIP joints, each dose is administered in an injection volume of 0.20 ml.
• Za vozliče, ki prizadenejo PIP sklepe, za vsak odmerek uporabite volumen za injiciranje
Using a 1 ml syringe with 0.01 ml graduations with a 27-gauge 12-13 mm needle (not supplied), withdraw the correct volume of the diluent supplied:
Uporabite 1 ml brizgo, ki ima oznake po 0,01 ml, in 12-13 mm iglo velikosti G 27 (ni priložena) ter izvlecite pravilni volumen priloženega vehikla:
In the double-blind portion of the two phase 3 placebo-controlled clinical trials in Peyronie's disease, a greater proportion of Xiapex-treated patients (4%) compared to placebo-treated patients (1%) had localized pruritus after up to 4 treatment cycles (involving up to 8 Xiapex injections).
V dvojno slepem delu dveh kliničnih preskušanj 3. faze za Peyroniejevo bolezen, ki sta bila nadzorovana s placebom, je imel po do 4 ciklih zdravljenja (vključno z do 8 injekcijami zdravila
N=203 c
n = 202
• dizziness, headache, nausea
• omotica, glavobol, navzea;
Skin disorder, nodule, granuloma, blister, irritation or oedema
napetost kože, odrevenelost, draženje ali vozliči, krasta, rana;
An anaphylactic reaction was reported in a post-marketing clinical study in a patient who had previous exposure to Xiapex for the treatment of Dupuytren's contracture, demonstrating that severe reactions including anaphylaxis can occur following Xiapex injections.
Iz klinične študije v obdobju trženja zdravila so poročali o anafilaktični reakciji pri bolniku, ki je bil predhodno izpostavljen zdravilu Xiapex zaradi zdravljenja Dupuytrenove kontrakture, kar kaže na to,
Administration of a local anaesthetic medicinal product prior to injection of Xiapex into a Dupuytren's cord is not recommended, as it may interfere with proper placement of the injection.
Dajanje lokalnih anestetikov pred injiciranjem zdravila Xiapex v Dupuytrenov vozlič se ne priporoča,
Each vial of powder contains 0.9 mg of collagenase clostridium histolyticum*.
Ena viala praška vsebuje 0,9 mg kolagenaze clostridium histolyticum*.
Sodium injected per joint in the treatment of Dupuytren's contracture: Metacarpophalangeal (MP) joints: 0.9 mg.
natrij, injiciran na sklep pri zdravljenju Dupuytrenove kontrakture: metakarpofalangealni (MP) sklepi: 0,9 mg proksimalni interfalangealni (PIP) sklepi: 0,7 mg natrij, injiciran na plak pri zdravljenju Peyroniejeve bolezni: 0,9 mg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Mean duration of PD (years) (Min-Max)
Povprečno trajanje PB (leta)
• a small collection of blood under the skin at the injection site
• majhno število krvnih ploščic v krvi;
3 ml solution is supplied in a 5 ml type I clear glass vial with rubber stopper, aluminium seal and flip-off plastic cap.
3 ml raztopine je na voljo v 5 ml viali iz prosojnega stekla tipa I z gumijastim zamaškom, aluminijastim obročkom in plastično polipropilensko dvižno zaporko.
System organ class Very common Common Uncommon
Organski sistem zelo pogosti pogosti
Xiapex 0.9 mg powder and solvent for solution for injection collagenase clostridium histolyticum
Xiapex 0,9 mg prašek in vehikel za raztopino za injiciranje kolagenaza clostridium histolyticum
• scrotal redness, swelling and pain
• rdečina, oteklina in bolečina skrotuma
Discard the unused portion of the reconstituted solution and solvent after injection.
Po injiciranju zavrzite neporabljeno rekonstituirano raztopino in vehikel.
The powder is a white lyophilised powder.
prašek in vehikel za raztopino za injiciranje Prašek je bel, liofiliziran prašek.
The solution should slowly be swirled to ensure that all of the lyophilised powder has gone into solution.
Raztopino morate sukati počasi s krožnimi gibi, da se bo ves liofiliziran prašek raztopil v raztopini.
Mean Percent Change from Baseline in Curvature Deformity at Week 36 (LOCF) (mITT* Population) - study AUX-CC-806
36. tednu (LOCF) (populacija mITT*) - študija AUX-CC-806 Xiapex N = 126
Solvent for Xiapex
Zdravilo XIAPEX
The following side effects have been seen with Xiapex administered in up to two cords or joints per treatment visit:
Pri zdravilu Xiapex, danem v do dva vozliča ali sklepa na obisk za zdravljenje, so opažali naslednje neželene učinke:
Dupuytren's MP joints
Dupuytrenovi MP sklepi
Digital necrosisd Digital fractured a reported with a higher incidence (very common) in patients who received two concurrent injections of Xiapex in the same hand compared with subjects treated with up to three single injections in the Phase 3 placebo-controlled pivotal studies in Dupuytren's contracture.
Xiapex,v isto roko v primerjavi z osebami, zdravljenimi z do tremi enkratnimi injekcijami v ključnih študijah 3. faze za Dupuytrenovo kontrakturo, nadzorovanih s placebom.
12 or 13 mm needle (not supplied), withdraw a volume of 0.25 ml of reconstituted solution
12 ali 13-milimetrske igle velikosti G 27 (ni priložena) izvlecite volumen 0,25 ml rekonstituirane raztopine (ki vsebuje 0,58 mg zdravila Xiapex).
Injections in up to two cords or two affected joints in the same hand can be administered during a treatment visit.
Med obiskom za zdravljenje se lahko injicira zdravilo v do dva vozliča ali dva prizadeta sklepa iste roke.
• burning sensation, partial loss of sensitivity, feeling of “pins and needles” or numbness
• oteklina in bolečina sklepov; • pekoč občutek, delna izguba občutkov, mravljinčenje ali odrevenelost;
• reactions at the site of injection including peeling of the skin, skin discolouration, infection, pain, skin tightness, numbness, irritation or nodules, scab, wound
• reakcije na mestu injiciranja, vključno z luščenjem kože, obarvanje kože, okužba, bolečina,
• shortness of breath, hyperventilation
• kratka sapa, pospešeno dihanje;
Suprapubic pain
Dupuytrenovi PP sklepi
A.
AUX-II.
• tenderness in ligament at base of penis
• občutljivost ligamenta na korenu penisa
• tenderness
• omotičnost
Peyronie's Disease Questionnaire (PDQ)b,Mean Patient-Reported PD Bother Domain Score (range: 0-16) c
(PDQ)b, - povprečni rezultat Področja težav, kot jih poročajo bolniki (razpon:
Powder: Contains sucrose, trometamol, hydrochloric acid Solvent: Contains calcium chloride dihydrate, sodium chloride, water for injection
Vehikel: vsebuje kalcijev klorid dihidrat, natrijev klorid, vodo za injekcije.
A single-use syringe containing 0.01-ml graduations with a permanently fixed 27-gauge 12 or 13 mm needle (not supplied) should be used to withdraw the volume of reconstituted solution.
Za izvlek volumna rekonstituirane raztopine je treba uporabiti brizgo za enkratno uporabo z oznakami po 0,01 ml s fiksno pritrjeno 12- ali 13-mm iglo velikosti G 27 (ni priložena).
Sexual dysfunction Scrotal erythema Genital discomfort Genital haemorrhage Pelvic pain
presnovne in prehranske motnje zastajanje tekočine psihiatrične motnje nenormalne sanje depresija zavrta spolnost bolezni živčevja glavobol omotica disgevzija parestezija pekoč občutek hiperestezija hipoestezija
Penile blister Pruritus genital Painful erection Erectile dysfunction Dyspareunia Penile erythema
oteklinab, bolečinac ali ekhimozad mehur na penisu genitalni pruritus boleča erekcija erektilna disfunkcija disparevnija eritem penisa adhezija penisa bolezen penisa napredovanje Peyroniejeve bolezni spolna disfunkcija eritem skrotuma genitalno nelagodje genitalna krvavitev bolečina v medenici zmanjšanje velikosti penisa tromboza vene penisa edem skortuma bolečina skrotuma
• penis disorder
• bolezen penisa
• constipation
• občutljivost
30 seconds.
0 stopinj).
• skin cut
• raztrganina na koži
Musculoskeletal discomfort or stiffness, joint stiffness or crepitation Limb discomfort Tendonitis Muscle spasms or weakness
obarvanje ali krasta bolezni mišično skeletnega sistema in vezivnega tkiva bolečina v udu artralgija tvorba pod pazduho oteklina sklepa mialgija bolečina v prsnem košu, dimljah, vratu ali rami nelagodje ali togost mišično-skeletnega sistema, togost ali krepitacije sklepa nelagodje uda tendonitis mišični spazmi ali šibkost mišic motnje reprodukcije in dojk občutljivost dojk hipertrofija dojk
Questionnaire (PDQ)
povprečje (SD)
A popping noise or popping sensation in the penis, sometimes described as “snapping” or “cracking” and sometimes accompanied by detumescence, haematoma and/or pain, were reported in 73/551 (13.2%) Xiapex-treated patients and 1/281 (0.3%) placebo-treated patients, in Studies 1 and 2 combined.
zdravljenih s placebom, se je v študiji 1 in 2 skupaj pojavil pokajoč zvok ali pokajoč občutek v penisu, včasih opisan kot "tleskanje" ali "pokanje", ki so ga včasih spremljali detumescenca, hematom in/ali bolečina.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial for use with Xiapex label
OVOJNINAH nalepka na viali vehikla za uporabo z zdravilom Xiapex
Each powder vial contains 0.9 mg collagenase clostridium histolyticum
Ena viala s praškom vsebuje 0,9 mg kolagenaze clostridium histolyticum.
In the two Phase 3 double-blind placebo-controlled studies, most adverse reactions were local events of the penis and groin and the majority of these events were of mild or moderate severity, and most (79%) resolved within 14 days of the injection.
Večina teh posledic je bila blagih ali zmernih in največ (79 %) jih je izzvenelo v 14 dneh po injiciranju.
After needle placement, if there is any concern that the needle is in the flexor tendon, apply a small amount of passive motion at the distal interphalangeal (DIP) joint.
Po namestitvi igle izvedite majhen pasiven gib distalnega interfalagealnega sklepa (DIP), da se prepričate, da igla ni v kiti upogibalki.
• pain in your penis
• bolečina v prsnem košu
Solvent: 3 ml solution supplied in a clear glass vial (5 ml, type I glass) with rubber stopper, aluminium seal and flip-off cap (polypropylene).
Vehikel: 3 ml raztopine v viali iz prosojnega stekla (5 ml, steklo tip I) z gumijastim zamaškom,
Next, keeping the needle under the skin at all times, withdraw the needle tip from the cord and reposition it in a slightly more distal location (approximately 2-3 mm) to the initial injection in the cord and inject another one-third of the dose.
Nato izvlecite konico igle iz vozliča in jo namestite nekoliko bolj distalno v vozlič (približno 2
How to store Xiapex
Shranjevanje zdravila Xiapex
Xiapex treatment significantly improved penile curvature deformity in patients with Peyronie's disease compared with placebo (Table 9).
Peyroniejevo boleznijo v primerjavi s placebom (preglednica 9).
• hives
• modrice
Caution should be exercised when Xiapex is administered to a breast-feeding woman.
Xiapex doječim ženskam je potrebna previdnost.
Slowly swirl the solution to ensure that all of the lyophilized powder has gone into solution.
Počasi s krožnimi gibi sukajte raztopino, da se bo ves liofiliziran prašek raztopil.
• groin pain and discomfort
• bolečina v bezgavki in otekle bezgavke
• sore on the skin of the penis
• razjede na koži penisa
Symptoms of penile fracture (corporal rupture) or other serious injury to your penis may include:
Simptomi zloma penisa (rupture korpusa) ali drugih resnih poškodb penisa lahko vključujejo: • pokajoč zvok ali občutek v penisu med erekcijo
Baselinea
• koprivnica
• increased perspiration
• povečano znojenje.
• discomfort, injury, paralysis of the limb
• kronična bolečina; • nelagodje, poškodba ali ohromelost okončine;
The white lyophilized powder is supplied in a 3 ml type I clear glass vial with rubber stopper, aluminium seal and flip-off plastic cap.
3 ml viali iz prosojnega stekla tipa I z gumijastim zamaškom, aluminijastim obročkom in plastično dvižno zaporko.
• swollen or enlarged glands near the elbow or under the arm
• občutek bolečine v roki, zapestju ali celi zgornji okončini; • otečene ali povečane bezgavke blizu komolca ali pod pazduho;
- If you get any side effects, talk to your doctor.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Inspect the solution visually for particulate matter and discolouration prior to administration.
Pred uporabo raztopino preglejte s prostim očesom, ali vsebuje delce in ali je obarvana.
Visually inspect the vial containing Xiapex.
Vialo, ki vsebuje zdravilo Xiapex, preglejte s prostim očesom.
The solution should visually be inspected for particulate matter and discoloration prior to administration.
Raztopino morate pred aplikacijo pregledati s prostim očesom, da se prepričate, da ne vsebuje delcev in da ni obarvana.
• skin disorder/irritation
• kožna bolezen/draženje kože
Use caution with cords as they approach the PIP flexion crease area.
Pri vozličih, ki se nahajajo blizu predela PIP fleksijske gube, bodite previdni.
Penile size reduced Penile vein thrombosis Scrotal oedema Scrotal pain
OVOJNINAH nalepka na viali praška Xiapex
• vomiting, diarrhoea, upper abdominal pain
• bruhanje, driska, bolečina v zgornjem delu trebuha; • izpuščaj, ekcem;
XIAPEX N=199
n = 199
Skin lacerationa,b
Bel liofoliziran prašek je na voljo v
• injection site rash
• izpuščaj na mestu injiciranja
f) The reconstituted Xiapex solution can be kept at room temperature (20º to 25ºC) for up to one hour or refrigerated at 2º to 8°C for up to 4 hours prior to administration.
f) Rekonstituirano raztopino zdravila Xiapex lahko hranite pri sobni temperaturi (20 º do 25 ºC)
STATEMENT OF ACTIVE SUBSTANCE(S)
Sprememba od izhodišča povprečje (SD)
Procedural pain Fracture of penis Skin laceration
• bolečino v penisu • vijolično modrico in oteklino penisa
• itching in the hand
• srbenje roke;
Powder and solvent for solution for injection.
PIP sklepov po enkratni injekciji na prizadeti sklep.
The company withdrew the application on 29 October 2019.
Družba je vlogo umaknila 29. oktobra 2019.
In addition, more data were needed to show that the quality of the medicine is consistent.
Poleg tega je potrebnih več podatkov, ki bodo pokazali doslednost pri kakovosti zdravila.
As a result, bacteria cannot multiply and they die.
Bakterije se tako ne morejo razmnoževati in posledično umrejo.
The Agency considered that the two studies presented did not show convincingly that the medicine was effective.
Agencija je menila, da predstavljeni študiji nista dovolj prepričljivo pokazali, da je zdravilo učinkovito.
What did the Agency recommend at that time?
Kakšno je bilo takrat priporočilo agencije?
This was intended to slow down the medicine's release into the lungs, allowing it to act for longer.
Tako naj bi se upočasnilo sproščanje zdravila v pljuča, kar bi omogočilo daljše delovanje.
How does Linhaliq work?
Kako zdravilo Linhaliq deluje?
The company presented the results of two studies in a total of 582 patients with non-cystic fibrosis bronchiectasis.
Družba je predstavila rezultate dveh študij pri skupno 582 bolnikih z bronhiektazijami brez cistične fibroze.
What is Linhaliq and what was it intended to be used for?
Kaj je zdravilo Linhaliq in za kaj naj bi se uporabljalo?
Does this withdrawal affect patients in clinical trials or compassionate use programmes?
Kakšne so posledice umika vloge za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila?
Fluoroquinolones work by preventing bacteria from making copies of their DNA (genetic material).
Fluorokinoloni delujejo, tako da bakterijam preprečujejo kopiranje njihove lastne DNK (genetskega materiala).
The application was withdrawn after that the European Medicines Agency had evaluated the information from the company and prepared questions for the company.
Vlogo so umaknili po tem, ko je Evropska agencija za zdravila že ocenila informacije, ki jih je predložila družba, in oblikovala seznam vprašanj.
The company informed the Agency that there are no ongoing clinical trials or compassionate use programmes with Linhaliq.
Družba je agencijo obvestila, da trenutno ne potekajo klinična preskušanja ali programi sočutne uporabe z zdravilom Linhaliq.
Withdrawal of application for the marketing authorisation of Linhaliq (ciprofloxacin) EMA/610519/2019
Umik vloge za pridobitev dovoljenja za promet z zdravilom Linhaliq (ciprofloksacin) EMA/610519/2019
The main measure of effectiveness was the time it took until patients had a flare-up of bronchiectasis.
Glavno merilo učinkovitosti je bil čas do izbruha bronhiektazij pri bolniku.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it decided to withdraw its application because the data provided do not allow EMA's committee for human medicines to conclude on a positive benefit-risk balance for the medicine.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da se je odločila umakniti vlogo, saj predloženi podatki odboru CHMP pri agenciji EMA ne omogočajo pozitivne ocene razmerja med tveganji in koristmi zdravila.
The active substance in Linhaliq, ciprofloxacin, is an antibiotic belonging to a group called fluoroquinolones.
Učinkovina v zdravilu Linhaliq, ciprofloksacin, je antibiotik, ki spada v skupino, imenovano fluorokinoloni.
The company had responded to the last round of questions, and the Agency was completing its assessment of the responses at the time of the withdrawal.
Družba je odgovorila na zadnja zastavljena vprašanja in agencija je ob umiku vloge ocenjevala odgovore družbe na zastavljena vprašanja.
Linhaliq was developed for patients with ‘non-cystic fibrosis bronchiectasis', which means it was not intended for patients with bronchiectasis due to cystic fibrosis.
Zdravilo Linhaliq so razvili za bolnike z „bronhoektazijami brez cistične fibroze“, kar pomeni, da ni bilo namenjeno bolnikom z bronhiektazijami, ki so posledica cistične fibroze.
Therefore, at the time of the withdrawal, the Agency's opinion was that the benefits of Linhaliq did not outweigh its risks.
Zato je agencija ob umiku vloge menila, da koristi zdravila Linhaliq ne odtehtajo z njim povezanih tveganj.
In each study Linhaliq was compared with placebo (a dummy treatment).
V obeh študijah so zdravilo Linhaliq primerjali s placebom (zdravilom brez učinkovine).
Withdrawal of application for the marketing authorisation of Linhaliq (ciprofloxacin)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Linhaliq (ciprofloksacin)
Linhaliq contains the active substance ciprofloxacin and was to be available for inhalation using an inhaler device.
Zdravilo Linhaliq vsebuje učinkovino ciprofloksacin in naj bi bilo na voljo za inhaliranje z uporabo inhalacijskega pripomočka.
In Linhaliq, some of the active substance is enclosed in tiny fat particles called liposomes.
V zdravilu Linhaliq nekaj učinkovine vsebujejo majhni maščobni delci, imenovani liposomi.
Bronchiectasis is a long-term condition in which the airways have widened and become flabby and scarred, with a build-up of mucus.
Bronhiektazije so dolgotrajna bolezen, pri kateri se kopiči sluz in se razširijo dihalne poti, ki postanejo mlahave in brazgotinaste.
Based on the review of the data, at the time of the withdrawal, the Agency had several concerns and its provisional opinion was that Linhaliq could not have been authorised for treating or preventing flare-ups in adults with non-cystic fibrosis bronchiectasis who have long-term lung infection with Pseudomonas aeruginosa.
Agencija je na podlagi pregleda podatkov ob umiku vloge izrazila več zadržkov in je začasno menila, da zdravila Linhaliq ni mogoče odobriti za zdravljenje ali preprečevanje izbruhov bronhiektazij brez cistične fibroze pri odraslih, ki imajo dolgotrajno pljučno okužbo z bakterijo Pseudomonas aeruginosa.
Linhaliq was developed as a medicine for preventing and reducing exacerbations (flare-ups) of bronchiectasis in adults who have long-term lung infection with Pseudomonas aeruginosa bacteria.
Zdravilo Linhaliq so razvili za preprečevanje in zmanjševanje poslabšanj (izbruhov) bronhiektazij pri odraslih z dolgotrajno pljučno okužbo z bakterijo Pseudomonas aeruginosa.
Aradigm Pharmaceuticals Limited withdrew its application for a marketing authorisation of Linhaliq for treating and preventing flare-ups of bronchiectasis in patients with long-term lung infection caused by Pseudomonas aeruginosa bacteria.
Družba Aradigm Pharmaceuticals Limited je umaknila vlogo za pridobitev dovoljenja za promet z zdravilom Linhaliq, namenjenim zdravljenju in preprečevanju izbruhov bronhiektazije pri bolnikih z dolgotrajno pljučno okužbo z bakterijo Pseudomonas aeruginosa.
The most common side effect with Bovilis Blue-8 (which may affect up to 1 in 10 animals) is an increase in body temperature between 0.5 and 1.0˚C that lasts no longer than one to two days.
Najpogostejši neželeni učinek zdravila Bovilis Blue-8 (ki lahko prizadene največ 1 žival od 10) je povišanje telesne temperature od 0,5 do 1,0 ˚C, ki ne traja dlje kot dan do dva.
The effectiveness of the vaccine was investigated in a number of laboratory trials in sheep and cattle of the minimum recommended age.
Učinkovitost zdravila so proučevali v vrsti laboratorijskih preskušanj pri ovcah in govedu najmanjše priporočene starosti.
For booster vaccination a single injection is given every year.
Za poživitveno cepljenje se vsako leto injicira en odmerek.
The full EPAR for Bovilis Blue-8 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Bovilis Blue-8 je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bovilis Blue-8's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Bovilis Blue-8 večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Bovilis Blue-8.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Bovilis Blue-8.
This medicine is the same as Bluevac BTV8, which is already authorised in the EU.
To zdravilo je enako zdravilu Bluevac BTV8, ki je že odobreno v Evropski uniji (EU).
In the future, if the animals are exposed to the same type of bluetongue virus, the immune system will be able to produce antibodies more quickly.
Ob ponovni izpostavitvi istemu tipu virusa modrega jezika v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa.
The European Commission granted a marketing authorisation valid throughout the EU for Bovilis Blue-8 on 21 November 2017.
Evropska komisija je dovoljenje za promet z zdravilom Bovilis Blue-8, veljavno po vsej Evropski uniji, izdala 21/11/2017.
The withdrawal period for meat and milk from cattle and sheep treated with Bovilis Blue-8 is ‘zero' days, which means there is no mandatory waiting time.
Karenca za meso in mleko goveda in ovac, zdravljenih z zdravilom Bovilis Blue-8, je nič dni, kar pomeni, da ni obvezne čakalne dobe.