natgillin/translations-raw huggingface dataset:
The most common side effects with Zactran in cattle (which may affect more than 1 in 10 cattle) are swellings at the site of injection. 
Najpogostejši neželeni učinek zdravila Zactran (ki lahko prizadene več kot 1 govedo od 10) je otekanje na mestu injiciranja.
The active substance of Zactran, gamithromycin, is an antibiotic of the macrolide group. 
Zdravilna učinkovina zdravila Zactran, gamitromicin, je antibiotik iz skupine makrolidov.
The most common side effects with Zactran in pigs and sheep (which may affect up to 1 in 10 animals) are mild to moderate swellings at the site of injection. 
Najpogostejši neželeni učinek zdravila Zactran pri prašičih in ovcah (ki lahko prizadene največ 1 žival od 10) je rahlo do zmerno otekanje na mestu injiciranja.
The withdrawal period is 64 days for meat from cattle, 16 days for meat from pigs and 29 days for meat from sheep treated with Zactran. 
Karenca za živali, zdravljene z zdravilom Zactran, je 64 dni za goveje meso, 16 dni za svinjsko meso in 29 dni za ovčje meso.
Treatment success was 97% in the Zactran-treated pigs compared to 93% in the tildipirosin group. 
Uspeh zdravljenja je bil v skupini, zdravljeni z zdravilom Zactran, 97-odstoten, v skupini, ki je prejemala tildipirozin, pa 93-odstoten.
If Zactran comes in direct contact with the eyes, they should be flushed immediately with clean water. 
V primeru nenamernega stika zdravila Zactran z očmi je treba oči nemudoma sprati s čisto vodo.
• swine respiratory disease (SRD), a lung infection in pigs, caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Bordetella bronchiseptica; 
• dihalnih obolenj prašičev (SRD), tj. okužbe pljuč pri prašičih, ki jih povzročajo bakterije Actinobacillus pleuropneumoniae, Pasteurella multocida,Haemophilus parasuisinBordetella bronchiseptica;
As Zactran is an antibiotic, it is essential to closely follow the instructions in the package leaflet to minimise the development of antibiotic resistance. 
Zdravilo Zactran je antibiotik, zato je treba nujno slediti napotkom v navodilu za uporabo, da se razvoj odpornosti proti antibiotikom zmanjša na najnižjo možno raven.
For the treatment of BRD, Zactran was studied in comparison to another macrolide antibiotic (tulathromycin) in cattle already affected by the disease. 
Pri zdravljenju dihalnih obolenj goveda so zdravilo Zactran primerjali z drugim antibiotikom iz skupine makrolidov (tulatromicinom) pri govedu, ki ga je bolezen že prizadela.
Safety information has been included in the summary of product characteristics and the package leaflet for Zactran, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers. 
V povzetek glavnih značilnosti zdravila Zactran in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno z ustreznimi previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
In the treatment of BRD, Zactran was shown to be as effective as tulathromycin. 
Pri zdravljenju dihalnih obolenj goveda se je zdravilo Zactran izkazalo za enako učinkovito kot tulatromicin.
For the metaphylaxis of BRD, the effect of Zactran was studied in comparison to placebo (dummy treatment) in cattle which had been in contact with diseased animals on the same farm and, therefore, likely also to develop the disease. 
Za metafilakso dihalnih obolenj goveda so zdravilo Zactran proučevali v primerjavi s placebom (zdravilom brez zdravilne učinkovine) pri govedu, ki je bilo v stiku z obolelimi živalmi na isti kmetiji in je zato pri njih obstajala velika verjetnost za obolenje.
Zactran was as effective as tilmicosin in treating severe foot rot in sheep. 
Zdravilo Zactran je bilo enako učinkovito kot tilmikozin pri zdravljenju hudih okužb z gnitjem nog pri ovcah.
For practical information about using Zactran, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za praktične informacije o uporabi zdravila Zactran naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Zactran was shown to be effective in the treatment and metaphylaxis of BRD associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. 
Zdravilo Zactran se je izkazalo za učinkovito pri zdravljenju in metafilaksi dihalnih obolenj goveda, ki jih pripisujejo bakterijam Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
Zactran contains the active substance gamithromycin. 
Zdravilo Zactran vsebuje zdravilno učinkovino gamitromicin.
In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label should be presented to the doctor. 
V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
For the full list of all side effects reported with Zactran, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zactran, glejte navodilo za uporabo.
• bovine respiratory disease (BRD), a lung infection in cattle, caused by the bacteria Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. 
• dihalnih obolenj goveda (BRD), tj. okužbe pljuč pri govedu, ki jih povzročajo bakterije Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
For more information about treatment with Zactran, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za več informacij o zdravljenju z zdravilom Zactran naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For the treatment of SRD, a field study was conducted in pigs with SRD comparing Zactran to tildipirosin, another macrolide antibiotic. 
Zdravljenje dihalnih obolenj prašičev so proučevali v terenski študiji s prašiči s tem obolenjem, v kateri so zdravilo Zactran primerjali s tildipirozinom, drugim antibiotikom iz skupine makrolidov.
People with known hypersensitivity (allergy) to similar antibiotics (macrolide class) should avoid contact with Zactran. 
Osebe z znano preobčutljivostjo za (alergijo na) podobne antibiotike (iz razreda makrolidov) se morajo stiku z zdravilom Zactran izogibati, saj lahko povzroči draženje oči ali kože.
How does Zactran work? 
Kako zdravilo Zactran deluje?
Similarly, if Zactran comes into direct contact with skin, the affected area should be washed immediately with clean water. 
Prav tako je treba s čisto vodo takoj sprati kožo, če zdravilo Zactran pride v stik z njo.
A second field study in pigs with SRD compared Zactran to tulathromycin, however, in this study Zactran was not as effective as tulathromycin. 
V drugi terenski študiji s prašiči z dihalnim obolenjem so zdravilo Zactran primerjali s tulatromicinom, pri čemer pa se je zdravilo Zactran izkazalo za manj učinkovito.
This summary was last updated on 18/02/2011. 
Ta povzetek je bil nazadnje posodobljen dne 18/02/2011.
These signs disappear without further treatment. 
Ti znaki izginejo brez dodatnega zdravljenja.
The European Commission granted a marketing authorisation valid throughout the European Union, for Activyl to Intervet International BV on 18/02/2011. 
Evropska komisija je dovoljenje za promet z zdravilom Activyl, veljavno po vsej Evropski uniji, odobrila družbi Intervet International BV dne 18/02/2011.
Dogs and cats might salivate after treatment. 
Psi in mačke se lahko po zdravljenju slinijo.
This active compound interferes with the parasites' nervous system and causes paralysis and death. 
Ta aktivna spojina vpliva na živčni sistem zajedavcev ter povzroči paralizo in smrt.
Other information about Activyl: 
Druge informacije o zdravilu Activyl:
Care should be taken to ensure that the content of the pipette should not come into contact with the eyes of the recipient or other animals. 
Paziti je treba, da vsebina kapalke ne pride v stik z očmi prejemnika ali drugih živali.
Activyl should not be allowed to enter surface water, as it may be harmful for aquatic organisms. 
Zdravilo Activyl ne sme priti v vodotoke, ker je lahko škodljivo za vodne organizme.
What benefit has Activyl shown during the studies? 
Kakšne koristi je zdravilo Activyl izkazalo med študijami?
This means that it will kill parasites that live on the skin or in the fur of animals, such as fleas. 
To pomeni, da uničuje zajedavce, ki živijo na koži ali v dlaki živali, kot so bolhe.
What is the risk associated with Activyl? 
Kakšna tveganja so povezana z zdravilom Activyl?
The product should be kept away from heat, sparks, open flames or other sources of ignition. 
Zdravilo je treba hraniti ločeno od vročine, isker, odprtega ognja ali drugih virov vžiga.
Efficacy against flea infestations of more than 95% was achieved in dogs by 14 days post treatment and in cats by 42 days post treatment in the study. 
V študiji je bila pri psih več kot 95-odstotna učinkovitost zoper infestacije z bolhami dosežena 14 dni po zdravljenju, pri mačkah pa 42 dni po zdravljenju.
In the main field study, dogs and cats of various breeds, age groups, gender and different weights were treated either with Activyl or fipronil, another spot-on medicine which is authorised in the European Union for this indication. 
V glavni terenski študiji so pse in mačke različnih pasem, starostnih skupin, spola in različnih telesnih mas zdravili bodisi z zdravilom Activyl ali fipronilom, drugim zdravilom za kožni nanos, ki je v Evropski uniji odobreno za to indikacijo.
Data were provided on the pharmaceutical quality, the tolerance of the products in cats and dogs, the safety in humans (people in contact with the product) and the safety to the environment. 
Predloženi so bili podatki o farmacevtski kakovosti zdravila, o tem, kako ga mačke in psi prenašajo, o varnosti za ljudi (ljudi, ki prihajajo v stik z zdravilom) ter o varnosti za okolje.
Animals should not be stroked, groomed or allow to groom each other, until the application site is dry, and they should not be allowed to swim or treated with shampoo within 48 hours after treatment. 
Paziti je treba, da se živali ne božajo, čistijo ali čistijo druga drugi dlake, dokler mesto nanosa ni suho, prav tako pa živalim ne smete dovoliti plavanja ali jih šamponirati 48 ur po zdravljenju.
Furthermore, the CVMP concluded that the product is effective as part of a treatment strategy for flea allergy dermatitis and recommended that Activyl be given a marketing authorisation. 
Poleg tega je Odbor ugotovil, da je zdravilo učinkovito kot del strategije zdravljenje dermatitisa zaradi alergije na bolhe, ter priporočil, da se za zdravilo Activyl odobri dovoljenje za promet.
Why has Activyl been approved? 
Zakaj je bilo zdravilo Activyl odobreno?
The effectiveness against the specified parasites was investigated in both laboratory studies and in five field studies (four for the spot-on for cats or dogs only and one for both cats and dogs). 
Učinkovitost zoper določene zajedavce so proučevali v laboratorijskih in petih terenskih študijah (štirih za kožni nanos pri samo mačkah ali samo psih ter eni pri mačkah in psih).
Activyl is a medicine that contains the active substance indoxacarb. 
Activyl je zdravilo, ki vsebuje zdravilno učinkovino indoksakarb.
Pet owners should avoid skin contact with the pipette contents. 
Lastniki živali naj se izogibajo stika kože z vsebino kapalke.
After application, indoxacarb is eaten by the insects and activated in their gut into an active compound. 
Po nanosu indoksakarb pojedo insekti, ta pa se v njihovem črevesju aktivira v aktivno spojino.
The contents of one full Activyl pipette (appropriate to the animal and its weight) is applied directly to the skin, after parting the animals fur, onto the back of the cat's neck at the base of its head, or between the shoulder blades and along the back of dogs. 
Vsebina ene cele kapalke zdravila Activyl (primerne glede na žival in njeno težo) se nanese neposredno na kožo, potem ko ste razmaknili dlako živali, in sicer na zatilje pri mačkah ali med lopatice in vzdolž hrbta pri psih.
Activyl is used to treat and prevent flea infestations in dogs and cats and to treat flea allergy dermatitis (an allergic reaction to flea bites). 
Zdravilo Activyl se uporablja za zdravljenje in preprečevanje infestacije z bolhami pri psih in mačkah ter za zdravljenje dermatitisa zaradi alergije na bolhe (alergijske reakcije na ugrize bolh).
The results from the laboratory studies and from the field studies, in both cats and dogs, showed that Activyl is as effective as the comparator medicine. 
Rezultati laboratorijskih in terenskih študij so pokazali, da je zdravilo Activyl pri mačkah in psih enako učinkovito kot primerjalno zdravilo.
The studies also showed that Activyl helps with the management of allergic flea dermatitis. 
Študije so tudi pokazale, da zdravilo Activyl pomaga pri obvladovanju dermatitisa zaradi alergije na bolhe.
It is available as a clear, colourless to yellow solution presented as a ‘spot-on' in pipettes already filled with the correct amount of Activyl needed to treat one cat or dog depending on its weight (5 sizes of pipettes for different dog weights and 2 sizes of pipettes for different cat weights). 
Na voljo je kot bistra brezbarvna do rumena raztopina za kožni nanos v kapalkah, ki so že napolnjene z ustreznim odmerkom zdravila Activyl za zdravljenje ene mačke ali psa, odvisno od teže živali (pet velikosti kapalk za različne teže psov in dve velikosti kapalk za različne teže mačk).
The active substance in Activyl, indoxacarb, is an ectoparasiticide. 
Zdravilna učinkovina v zdravilu Activyl, indoksakarb, je ektoparaziticid.
For a full list of all side-effects reported with Activyl, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Activyl, glejte navodilo za uporabo.
The effectiveness was measured by counting of fleas, flea allergy dermatitis assessment, observations on local reactions at the application site after treatment. 
Učinkovitost so merili na podlagi števila bolh, ocene dermatitisa zaradi alergije na bolhe, opažanj glede lokalnih reakcij na mestu nanosa po zdravljenju.
They should not smoke, eat or drink, and should wash their hands thoroughly after use. 
Med nanašanjem zdravila ne smejo kaditi, jesti ali piti, po uporabi pa si morajo temeljito umiti roke.
The CVMP concluded that the benefits of Activyl exceed the risks for the treatment and prevention of flea infestations in dogs and cats. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Activyl za zdravljenje in preprečevanje infestacij z bolhami pri psih in mačkah večje od z njim povezanih tveganj.
A reduction in symptoms of flea allergy dermatitis was recorded in both target species. 
Pri obeh ciljnih vrstah je bilo zabeleženo zmanjšanje simptomov dermatitisa zaradi alergije na bolhe.
What is Activyl used for? 
Za kaj se zdravilo Activyl uporablja?
Activyl is given as a single treatment. 
Zdravilo Activyl se aplicira samo enkrat.
How has Activyl been studied? 
Kako je bilo zdravilo Activyl raziskano?
What is Activyl? 
Kaj je zdravilo Activyl?
How does Activyl work? 
Kako zdravilo Activyl deluje?
There might also be some temporary itchiness, inflammation or hair loss at the place where the product has been applied to the skin. 
Na mestu nanosa zdravila se lahko pojavi prehodno srbenje, vnetje ali izpadanje dlak.
This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU). 
To pomeni, da je kljub nezadostnim podatkom iz kliničnih preskušanj učinkovitost teh zdravil rastlinskega izvora verjetna, saj obstajajo dokazi, da so se na navedeni način varno uporabljala vsaj 30 let (najmanj 15 let tudi v EU).
The HMPC recommended that these medicines should not be used in patients with stomach and gut ulcers, hyperthyroidism (overactive thyroid gland) or cardiovascular problems, such as hypertension (high blood pressure) and arrhythmias (heart rhythm problems). 
Odbor HMPC je priporočil, da se teh zdravil ne sme uporabljati pri bolnikih z razjedami na želodcu ter črevesu, hipertiroidizmom (čezmerno dejavno ščitnico) ali srčno-žilnimi težavami, kot so hipertenzija (visok krvni tlak) in aritmije (motnje srčnega ritma).
Guarana seed should only be used in adults. 
Seme gvarane se lahko uporablja samo pri odraslih.
Guarana seed EMA/HMPC/284498/2013 
Seme gvarane EMA/HMPC/284498/2013
What is guarana seed? 
Kaj je seme gvarane?
Guarana seed is the common name for the seed of the plant Paulinia cupana Kunth ex H.B.K. 
Seme gvarane je splošno ime za seme rastline Paulinia cupana Kunth ex H.B.K.
In its assessment, the HMPC considered studies on the effects of guarana seed on behaviour, which showed that it had a stimulant effect and led to improvements in symptoms of fatigue. 
Pri svoji oceni je odbor HMPC upošteval študije učinkov semena gvarane na vedenje, ki so pokazale, da ima stimulativen učinek in izboljša simptome utrujenosti.
This summary is not intended to provide practical advice on how to use medicines containing guarana seed. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo seme gvarane.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of guarana seed. 
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo semena gvarane.
The HMPC conclusions on the use of guarana seed medicines for fatigue and weakness are based on their ‘traditional use'. 
Zaključki odbora HMPC o uporabi zdravil proti utrujenosti in šibkosti, ki vsebujejo seme gvarane, temeljijo na njihovi „tradicionalni uporabi“.
Further information on the risks associated with guarana seed medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use. 
Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo seme gvarane, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
If symptoms persist for longer than one week during the use of Guarana seed, a qualified healthcare practitioner should be consulted. 
Če simptomi med njegovo uporabo vztrajajo več kot en teden, se je treba posvetovati z zdravnikom.
Detailed instructions on how to take guarana seed medicines and who can use them can be found in the package leaflet that comes with the medicine. 
Podrobna navodila o tem, kako jemati zdravila s semenom gvarane in o tem, kdo jih lahko jemlje, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
Guarana seed can also be found in combination with other herbal substances in some herbal medicines. 
Seme gvarane je v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
Information on the use and licensing of guarana seed medicines in EU Member States should be obtained from the relevant national authorities. 
Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo seme gvarane, v državah članicah EU se obrnite na pristojni nacionalni organ.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing guarana seed. 
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo seme gvarane.
Guarana seed 
Seme gvarane
Herbal medicines containing guarana seed are usually available in solid forms to be taken by mouth. 
Zdravila rastlinskega izvora, ki vsebujejo seme gvarane, so navadno na voljo v trdnih oblikah, ki se jemljejo peroralno (zaužijejo skozi usta).
Any applications for the licensing of medicines containing guarana seed have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC. 
Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo seme gvarane, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
Further information on the HMPC assessment of guarana seed medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use. 
Dodatne informacije o oceni zdravil, ki vsebujejo seme gvarane, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
The HMPC concluded that, on the basis of its long-standing use, guarana seed can be used for the relief of symptoms of fatigue (tiredness) and weakness. 
Odbor HMPC je sklenil, da se lahko na podlagi izkušenj dolgoletne uporabe seme gvarane uporablja za lajšanje simptomov utrujenosti in šibkosti.
How are guarana seed medicines approved in the EU? 
Kako so zdravila, ki vsebujejo seme gvarane, odobrena v EU?
Other information about guarana seed medicines 
Druge informacije o zdravilih, ki vsebujejo seme gvarane
What are the risks associated with guarana seed medicines? 
Kakšna tveganja so povezana z zdravili, ki vsebujejo seme gvarane?
What evidence supports the use of guarana seed medicines? 
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo seme gvarane?
For more information about treatment with guarana seed medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravili, ki vsebujejo seme gvarane, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
EMA/HMPC/284498/2013 
EMA/HMPC/284498/2013 Odbor za zdravila rastlinskega izvora (HMPC)
For practical information about using guarana seed medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravil s semenom gvarane naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
Guarana seed preparations are obtained by drying and powdering the seeds. 
Pripravki s semenom gvarane se pridobivajo s sušenjem semen in njihovo predelavo v prašek.
Intravenous use vial (plastic) 
viala (plastična)
Pharmaceutical Form Route of Administration 
Farmacevtsk a oblika
Intravenous use vial (glass) 
Velikost pakiranja viala (steklena)
--1 Cell-associated live recombinant turkey herpesvirus expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus: 103.3 - 104.6 PFU* * PFU: plaque forming units. 
--1 Na celico vezan živ rekombinantni puranji herpesvirus (sev HVP360) z izraženim fuzijskim proteinom virusa atipične kokošje kuge in proteinom VP2 Gumborske bolezni: 103.3 - 104.6 PFU1.
Invented name Strength Pharmaceutical form 
EU številka Izmišljeno ime Jakost Farmacevtska oblika
This depends on the patient's response and requirements (e.g. diet, physical activity and life-style). 
Ta je odvisen od bolnikovega odziva in potreb (kot so prehrana, telesna dejavnost in življenjski stil).
The marketing authorisation holder is Pfizer Limited. 
Imetnik dovoljenja za promet z zdravilom je Pfizer Limited.
The European Commission granted a marketing authorisation valid throughout the European Union for Exubera on 24 January 2006. 
Evropska komisija je dovoljenje za promet z zdravilom Exubera, veljavno po vsej Evropski uniji, odobrila dne 24. januarja 2006.