natgillin/translations-raw huggingface dataset:
Eptotermin alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce it.
Eptotermin alfa je izdelan z metodo, imenovano „tehnologija rekombinantne DNK“, pri kateri celica prejme gen (DNK), s katerim lahko tvori eptotermin alfa.
This mixture is then placed by the surgeon directly at the fracture site in contact with the prepared broken bone ends.
To mešanico kirurg nato nanese neposredno na mesto zloma v stiku s pripravljeno površino obeh koncev zlomljene kosti.
Osigraft should not be used in people who may be hypersensitive (allergic) to eptotermin alfa or to collagen.
Zdravila Osigraft ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) eptotermin alfa ali kolagen.
Osigraft was at least as effective as bone autograft, the standard treatment.
Zdravilo Osigraft je bilo vsaj tako učinkovito kot avtologni presadek kosti, ki predstavlja standardno obliko zdravljenja.
• skeletally immature (still growing);
• osebe z nezrelim okostjem (ki še rastejo);
Osigraft should be used by a qualified surgeon.
Zdravilo Osigraft sme uporabljati le ustrezno usposobljen kirurg.
Osigraft is used to repair fractures of the tibia (shin bone) that have not healed after at least nine months.
Zdravilo Osigraft se uporablja za zdravljenje zlomov golenice, ki se po najmanj devetih mesecih še niso zacelili.
For the full list of all side effects reported with Osigraft, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Osigraft, glejte navodilo za uporabo.
Why has Osigraft been approved?
Zakaj je bilo zdravilo Osigraft odobreno?
It is used in patients who have previously had an autograft (a bone graft taken from their own bone, usually the hip) that has failed or when such a graft is not possible.
Uporablja se pri bolnikih, ki so bili predhodno neuspešno zdravljeni z avtolognim presadkom (kostnim presadkom, pridobljenim iz njihove lastne kosti, običajno kolka), ali pri bolnikih pri katerih avtologno presajanje ni izvedljivo.
Osigraft is a powder to be made up into a suspension for implantation.
Zdravilo Osigraft je prašek za pripravo suspenzije za implantacijo.
When implanted, eptotermin alfa stimulates the formation of new bone, helping to repair the broken bone.
Ko je eptotermin alfa vsajen, spodbuja tvorbo nove kostnine, kar prispeva k celjenju zlomljene kosti.
The active substance in Osigraft, eptotermin alfa, acts on the bone structure.
Zdravilna učinkovina v zdravilu Osigraft, eptotermin alfa, učinkuje na strukturo kosti.
It contains the active substance eptotermin alfa.
Vsebuje zdravilno učinkovino eptotermin alfa.
• without enough skin or blood supply at the fracture site;
• osebe, pri katerih mesto zloma ni ustrezno pokrito s kožo ali dovolj prekrvavljeno;
What is Osigraft used for?
Za kaj se zdravilo Osigraft uporablja?
How has Osigraft been studied?
Kako je bilo zdravilo Osigraft raziskano?
How is Osigraft used?
Kako se zdravilo Osigraft uporablja?
What is Osigraft?
Kaj je zdravilo Osigraft?
How does Osigraft work?
Kako zdravilo Osigraft deluje?
Where necessary, treatment can be repeated every twelve weeks.
Po potrebi se lahko zdravljenje ponovi vsakih dvanajst tednov.
Further information on Bravecto Plus can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/bravecto-plus.
Nadaljnje informacije o zdravilu Bravecto Plus so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/bravecto-plus.
Bravecto Plus received a marketing authorisation valid throughout the EU on 8 May 2018.
Zdravilo Bravecto Plus je pridobilo dovoljenje za promet, veljavno po vsej EU, 8. maja 2018.
This results in paralysis and death of the parasites.
To povzroči paralizo in smrt parazitov.
The European Medicines Agency decided that Bravecto Plus's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je odločila, da so koristi zdravila Bravecto Plus večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Bravecto Plus (fluralaner / moxidectin)
Bravecto Plus (fluralaner/moksidektin)
For ear mite infestations, a veterinary check is necessary 28 days after treatment.
Za zdravljenje infestacij z ušesnimi garjami je potreben veterinarski pregled 28 dni po zdravljenju.
Fluralaner acts as an ‘ectoparasiticide'.
Fluralaner deluje kot „ektoparaziticid“.
This medicine is harmful if swallowed.
Zdravilo je škodljivo pri zaužitju.
Other information about Bravecto Plus
Druge informacije o zdravilu Bravecto Plus
Contact with the application site should be avoided until it is no longer noticeable.
Stiku z mestom nanosa se je treba izogibati, dokler ni več opazno.
In case of skin contact, the affected area should be rinsed immediately with soap and water whilst in case of eye contact, the affected area should be rinsed immediately with water.
V primeru stika s kožo je treba prizadeto območje takoj izprati z milom in vodo, v primeru stika z očmi je treba prizadeto območje takoj izprati z vodo.
Fluralaner kills fleas before they can lay eggs and so helps to reduce contamination of the cats' environment.
Fluralaner ubije bolhe, preden izležejo jajčeca, s čimer pomaga zmanjšati kontaminacijo okolice mačke.
The medicine should be kept in the original package until use, in order to prevent children directly accessing the medicine.
Do uporabe ga je treba shranjevati v originalni ovojnini, da se otrokom prepreči neposreden stik z njim.
What are the risks associated with Bravecto Plus?
Kakšna tveganja so povezana z zdravilom Bravecto Plus?
What benefits of Bravecto Plus have been shown in studies?
Kakšne koristi je zdravilo Bravecto Plus izkazalo v študijah?
Bravecto Plus kills fleas and ticks within 48 hours.
Zdravilo Bravecto Plus ubije bolhe in klope v 48 urah.
What is Bravecto Plus and what is it used for?
Kaj je zdravilo Bravecto Plus in za kaj se uporablja?
The most common side effects with Bravecto Plus (which may affect up to 1 in 10 animals) are mild and short-lived reactions at the application site such as hair loss, flaking skin and scratching.
Najpogostejši neželeni učinki zdravila Bravecto Plus (ki lahko prizadenejo največ 1 žival od 10) so blage in kratkotrajne reakcije na mestu nanosa, kot so izguba dlak, luščenje kože in praskanje.
Moxidectin causes paralysis and death of these parasites by interfering with the way signals are passed between nerve cells (neurotransmission) in the parasites' nervous system.
Moksidektin povzroči paralizo in smrt teh parazitov tako, da ovira prenos signalov med živčnimi celicami (živčni prenos) v njihovem živčevju.
For more information about using Bravecto Plus, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila Bravecto Plus glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
An overview of Bravecto Plus and why it is authorised in the EU
Pregled zdravila Bravecto Plus in zakaj je odobreno v EU
Why is Bravecto Plus authorised in the EU?
Zakaj je zdravilo Bravecto Plus odobreno v EU?
Fluralaner kills fleas and ticks that have ingested the cat's blood by causing uncontrolled activity of their nervous system.
Fluralaner ubije bolhe in klope, ki so zaužili mačkino kri, tako da povzroči nenadzorovano delovanje njihovega živčnega sistema.
Bravecto Plus is a veterinary medicine used in cats to treat mixed infestations with both ticks or fleas and ear mites and/or worms that live inside the body.
Bravecto Plus je zdravilo za uporabo v veterinarski medicini, ki se uporablja pri mačkah za zdravljenje mešanih infestacij s klopi ali bolhami ter ušesnimi garjami in/ali črvi, ki živijo v telesu.
Bravecto Plus was as effective as another medicine containing emodepside and praziquantel.
Zdravilo Bravecto Plus je bilo enako učinkovito kot drugo zdravilo, ki je vsebovalo emodepsid in prazikantel.
Fluralaner and moxidectin are already authorised on their own for the treatment of parasitic infestations.
Fluralaner in moksidektin sta za zdravljenje infestacij s paraziti že odobrena ločeno.
This means that it kills parasites present on the skin or in the fur or ears of animals, such as fleas, ticks and ear mites.
To pomeni, da ubije parazite na koži, v dlaki ali ušesih živali, kot so bolhe, klopi in ušesne garje.
Bravecto Plus was as effective as selamectin, another medicine already licensed for the treatment of ear mites in cats.
Zdravilo Bravecto Plus je bilo enako učinkovito kot selamektin, drugo zdravilo, ki je že odobreno za zdravljenje ušesnih garij pri mačkah.
• to prevent heartworm disease Bravecto Plus must only be used when there is a need to treat ticks or fleas and one or more of the parasites listed above.
Zdravilo Bravecto Plus se lahko uporablja le, ko obstaja potreba po zdravljenju infestacij s klopi ali bolhami in enim ali več zgoraj navedenih parazitov.
For the full list of side effects and restrictions of Bravecto Plus, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Bravecto Plus glejte navodilo za uporabo.
In order to be exposed to the active substance fluralaner, fleas and ticks must commence feeding on the cat.
Da bi bili izpostavljeni fluralanerju, se morajo bolhe in klopi začeti hraniti z mačkino krvjo.
In a field study of 167 cats infested with 5 or more ear mites, treatment with Bravecto Plus resulted in 94% of cats free from ear mites 14 days after treatment and 100% of cats free from ear mites 28 days after treatment.
V terenski študiji s 167 mačkami, okuženimi s petimi ali več ušesnimi garjami, je zdravljenje z zdravilom Bravecto Plus po 14 dneh popolnoma odpravilo ušesne garje pri 94 % mačk, po 28 dneh pa pri 100 % mačk.
The spot-on solution is available in different strengths for cats of different weights.
Raztopina za kožni nanos je na voljo v različnih jakostih za mačke z različnimi telesnimi masami.
Bravecto Plus spot-on solution should be kept away from heat, sparks, open flames or other fire sources as it is highly flammable.
Zdravilo Bravecto Plus v obliki raztopine za kožni nanos je treba hraniti ločeno od vročine, isker, odprtega ognja ali drugih virov vžiga, saj je zelo vnetljivo.
Skin rashes, tingling or numbness have been reported in a small number of individuals after skin contact, either when handling the product or when handling the treated animal.
Po stiku s kožo so pri manjšem številu posameznikov poročali o izpuščajih, mravljinčenju ali otrplosti kože, in sicer po ravnanju z zdravilom ali ravnanju z zdravljeno živaljo.
A field study involving cats naturally infested with ticks and/or fleas showed treatment with Bravecto Plus to reduce tick and flea counts by more than 95% and to be as effective as treatment using fipronil, another medicine already licensed for the treatment of ticks and fleas.
Terenska študija, ki je vključevala mačke, naravno infestirane s klopi in/ali z bolhami, je pokazala, da zdravljenje z zdravilom Bravecto Plus zmanjša število klopov in bolh za več kot 95 % ter da je enako učinkovito kot zdravljenje s fipronilom, drugim zdravilom, že registriranim za odpravljanje klopov in bolh.
Bravecto Plus is effective at preventing heartworm disease for 8 weeks.
Za preprečevanje obolenja srčne glistavosti je zdravilo Bravecto Plus učinkovito osem tednov.
In case of spillage on table or floor surfaces, excess Bravecto Plus spot-on solution should be removed using paper tissue and the area cleaned with a detergent.
V primeru razlitja po mizi ali talnih površinah zdravilo Bravecto Plus v obliki raztopine za kožni nanos odstranite s papirnatimi brisačami in očistite površino s čistilom.
Two laboratory studies involving healthy cats which were artificially infected with heartworm larvae showed Bravecto Plus to be 100% effective in preventing heartworm disease during 8 weeks.
Dve laboratorijski študiji, ki sta vključevali zdrave mačke, ki so jih umetno okužili z ličinkami srčne gliste, sta pokazali, da je zdravilo Bravecto Plus v osemtedenskem obdobju 100-odstotno učinkovito pri preprečevanju obolenja srčne glistavosti.
The content of one full Bravecto Plus pipette is applied to the cat's skin at the base of the skull.
Vsebina polne merilne kapalke zdravila Bravecto Plus se nanese na kožo mačke, in sicer na spodnji del lobanje.
If skin reactions occur, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Če pride do reakcij na koži, se je treba nemudoma posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali nalepko.
The active substances in Bravecto Plus, fluralaner and moxidectin, work via different routes to kill parasites.
Učinkovini v zdravilu Bravecto Plus, fluralaner in moksidektin, uničujeta parazite na različen način.
The pipette to use is selected on the basis of the cat's weight.
Merilno kapalko je treba izbrati na podlagi telesne mase mačke.
The medicine's actions against fleas and ticks last for 12 weeks after being applied.
Zdravilo deluje proti bolham in klopom 12 tednov po nanosu.
Another field study involving cats naturally infected with roundworms and/or hookworms showed treatment with Bravecto Plus to reduce faecal egg counts by 100%.
Druga terenska študija, ki je vključevala mačke, naravno okužene z glistami in/ali trakuljami, je pokazala, da zdravljenje z zdravilom Bravecto Plus zmanjša število jajčec v blatu za 100 %.
Moxidectin kills parasites present in the body of animals such as roundworms, hookworms and heartworm as well as ear mites.
Moksidektin ubije parazite v telesu živali, kot so gliste, trakulje in srčne gliste ter ušesne garje.
How is Bravecto Plus used?
Kako se zdravilo Bravecto Plus uporablja?
Bravecto Plus contains the active substances fluralaner and moxidectin.
Zdravilo Bravecto Plus vsebuje učinkovini fluralaner in moksidektin.
Suitable gloves should be worn when handling or applying Bravecto Plus to cats.
Ob nanašanju zdravila Bravecto Plus ali ravnanju z njim je treba nositi zaščitne rokavice.
• to treat roundworms and hookworms in the gut
• za zdravljenje infestacij z glistami in trakuljami v črevesju,
Bravecto Plus is available as a spot-on solution in a pipette.
Zdravilo Bravecto Plus je na voljo v obliki raztopine za kožni nanos v merilni kapalki.
How does Bravecto Plus work?
Kako zdravilo Bravecto Plus deluje?
• to treat flea infestations.
• zdravljenje infestacij z bolhami.
• to treat ear mite infestations
• za zdravljenje infestacij z ušesnimi garjami,
Precautionary measures:
Previdnostni ukrepi:
2.4 Risks for pregnant women
2.4 Tveganja za nosečnice
SCIENTIFIC CONCLUSIONS 1.
ZNANSTVENI ZAKLJUČKI 1.
No new substantial data were submitted.
Novih bistvenih podatkov niso prejeli.
2.5 Advice to doctors
2.5 Nasvet za zdravnike
There are no adequate and well-controlled studies in pregnant women.
Ustreznih in dobro kontroliranih študij pri nosečnicah niso izvajali.
Treatment should be supportive with appropriate intensive therapy.
Zdravljenje mora biti podporno s terapijo primerne intenzivnosti.
This is considered to be the appropriate way of expressing such an advice to doctors.
Slednje se smatra za primeren način sporočanja takega nasveta zdravnikom.
Remove contaminated clothes.
Slecite kontaminirana oblačila.
Furthermore, it is stated that it is not known whether Precedex is excreted in human milk.
Poleg tega je navedeno tudi, da ni znano, ali se zdravilo Precedex izloča v človeškemu mleku.
These products are used for sedation or analgesia in various species.
Ta zdravila se uporabljajo za sedacijo ali analgezijo različnih živalskih vrst.
It was considered that the term toxicity implies an overdose and since that will not always be the case, a modification was agreed upon.
Veljalo je, da izraz toksičnost pomeni prekomerni odmerek, ker pa to ne bo vedno tako, so se dogovorili o spremembi.
In addition, Article 78 of Directive 2001/82/EC applies only to the addition of precautionary measures in this procedure.
Nadalje se člen 78 Direktive 2001/82/ES nanaša le na dodatne varnostne ukrepe v tem postopku.
The recommendation to wear gloves when handling such a product was considered impractical for the veterinarian.
Priporočilo o nošenju rokavic pri delu s takim zdravilom se je zdelo nepraktično za veterinarje.
Respiratory and haemodynamic symptoms should be treated symptomatically.
Respiratorne in hemodinamične simptome je treba zdraviti simptomatsko.
The CVMP also considered other publicly available data for the scientific evaluation.
CVMP je upošteval tudi druge javno dostopne podatke za znanstveno vrednotenje.
2.1 Systemic effect on sedation and hypotension
2.1 Sistemski učinek na sedacijo in hipotenzijo
Pregnant women should not handle the product.
Nosečnice ne smejo rokovati z zdravilom.
Such effects had never been reported after use of the product (detomidine).
O takih učinkih po uporabi zdravila (detomidin) niso nikoli poročali.
A revised list of questions addressed to the Marketing Authorisation Holders concerned was adopted on 16 July 2008.
Popravljen seznam vprašanj, naslovljen na zadevne imetnike dovoljenja za promet z zdravilom, je bil sprejet dne 16. julija 2008.
Following this request, the CVMP during its meeting of 15-17 July 2008 restarted the procedure for evaluating the products indicated by the Member States.
Na to zahtevo je CVMP med sejo od 15. do 17. julija 2008 znova sprožil postopek za ovrednotenje zdravil, ki so jih navedle države članice.
The proposed precautionary measures relate to different user safety concerns.
Predlagani previdnostni ukrepi se nanašajo na različne zadržke glede varnosti uporabnika.
Country Product invented name
Država Izmišljeno ime zdravila
4, 40472 Düsseldorf, GERMANY
4, 40472 Düsseldorf, NEMČIJA
Europa, 20 B. Parque Empresarial La Moraleja, 28108 Alcobendas (Madrid), SPAIN
Europa, 20 B. Parque Empresarial La Moraleja, 28108 Alcobendas (Madrid), ŠPANIJA
Both these dose levels are above the NOEL for acute pharmacologic effects.
Oba odmerka sta presegala NOEL za dejanske farmakološke učinke.
The set of precautionary measures then served as basis for the proposals made by the Dutch competent regulatory authority for this procedure under Article 78 of Directive 2001/82/EC, as amended.
Zbirka varnostnih ukrepov je nato služila kot temelj za predloge nizozemskega pristojnega regulacijskega organa za ta postopek skladno s členom 78 Direktive 2001/82/ES, kakor je bila spremenjena.
This resulted in the wording as proposed, which was agreed by all concerned Member States and the applicant.
S tem so prišli do omenjenega predloga besedila, s katerimi so se strinjale vse države članice in predlagatelj.
The CVMP concluded that the recommended general statements on precautionary measures are final recommendations given in response to the notification received from the Netherlands.
CVMP je zaključil, da so priporočeni splošni stavki o previdnostnih ukrepih končna priporočila, izdana kot odgovor na obvestilo, prejeto iz Nizozemske.
Xylazine, Ketamine, Atropine
Ksilazin, ketamin, atropin
The maximal exposure was estimated to 0.3 ml Sedivet (3 mg romifidine).
Največja izpostavitev je bila ocenjena na 0,3 ml zdravila Sedivet (3 mg romifidina).
It was considered difficult to assess whether the results on corneal effects of xylazine in the studies using mice and rats are relevant for humans.
Težko je bilo oceniti, ali so rezultati o učinkih ksilazina na roženico v študijah, ki so vključevale podgane in miši, pomembni za ljudi.
The CVMP during its meeting of 12-14 September 2006 initiated a procedure for evaluating the matter under Article 78(3) of Directive 2001/82/EC for these products.
CVMP je na srečanju od 12. do 14. septembra 2006 sprožil postopek za ovrednotenje zadeve skladno s členom 78(3) Direktive 2001/82/ES za ta zdravila.
It was concluded that systemic effects after dermal exposure could not be excluded.
Zaključili so, da sistemskih učinkov po izpostavljanju kože ni mogoče izključiti.
On the basis of the notification sent by the Dutch competent regulatory authority, the matters considered by the Committee for Medicinal Products for Veterinary Use (CVMP) were the following proposed precautionary measures:
Na podlagi obvestila, ki ga je poslal nizozemski pristojni regulacijski organ, je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pretehtal naslednje previdnostne ukrepe:
This resulted in a set of precautionary measures, which was agreed by all concerned Member States and the applicant at the time.
S tem so prišli do zbirke varnostnih ukrepov, s katerimi so se tisti čas strinjale vse države članice in predlagatelj.
Orion Corporation animal health
Orion Corporation animal helth
Precedex is a product containing dexmedetomidine, the active enantiomer of medetomidine, that is approved for use in humans in the United States.
Precedex je zdravilo, ki vsebuje deksmedetomidin, aktivni enantiomer medetomidina, ki je za humano uporabo odobren v Združenih državah.
The advice to doctors lists the potential clinical effects and suggested treatment.
V opozorilu zdravnikom so navedeni morebitni klinični učinki in predlagani načini zdravljenja.
In the mutual recognition procedure concerning Sedaxylan, a user safety evaluation was performed.
Pri postopku vzajemnega priznavanja za zdravilo Sedaxylan so izvedli ocenitev varnosti uporabnika.
The objective of the variations was to add a set of new precautionary measures concerning user safety, and information on human adverse reactions, to the product literature.
Cilj spremembe je bil dodati serijo novih previdnostnih ukrepov, ki se tičejo varnosti uporabnika ter informacij o neželenih škodljivih učinkih pri ljudeh, k literaturi o zdravilu.
1, 76139 Karlsruhe, GERMANY
1, 76139 Karlsruhe, NEMČIJA
The safety of Precedex during labour and delivery has not been studied.
Varnost zdravila Precedex med porodnimi popadki in rojevanjem ni bila raziskana.
Most of these products are presented as solutions for injection, and some are presented as powders to be dissolved in water for solution for injection.
Večina teh zdravil je v obliki raztopin za injiciranje, nekatera pa so v obliki praškov, ki se jih raztopi v vodi za pripravo raztopine za injiciranje.
The proposed precautionary measures were considered relevant and proportionate, since it relates to the clinical effects, which may be expected depending on the amount injected or ingested, and because it highlights one of the main dangers for a veterinary practitioner after a self-injection or ingestion of such a product, i.e. a sedative effect in combination with driving.
Predlagani previdnostni ukrepi so se obravnavali kot ustrezni in sorazmerni, ker se tičejo kliničnih učinkov, ki jih lahko pričakujemo v odvisnosti od vbrizgane ali zaužite količine in ker je poudarjena ena od glavnih nevarnosti za veterinarja po samoinjiciranju ali zaužitju takega zdravila, tj. učinek sedacije v kombinaciji z vožnjo.
Since systemic effects may occur in rather low doses of romifidine in humans (0.2 mg/person), the CVMP concluded that the effects experienced by a person accidentally having injected a maximum of 0.3 ml Sedivet (3 mg romifidine) could be related to the active substance of the product.
Ker lahko pride do sistemskih učinkov pri razmeroma nizkih odmerkih romifidina pri ljudeh (0,2 mg/osebo), je CVMP zaključil, da so učinki pri osebi, ki si nenamerno vbrizga največ 0,3 ml zdravila Sedivet (3 mg romifidina), lahko povezani z zdravilno učinkovino tega zdravila.
Aimed at the user are systemic sedative and hypotensive effect, skin contact, eye contact and risks for pregnant women.
Na uporabnika vplivajo sistemski sedacijski in hipotenzijski učinki, stik s kožo, stik z očmi in tveganja za nosečnice.
On 3 June 2008 the European Commission requested the Committee to complete the procedure to take into account all marketing authorisations of the 21 notified products throughout the EU.
Dne 3. junija 2008 je Evropska komisija od Odbora zahtevala, naj v zaključku postopka upošteva vsa dovoljenja za promet z zdravilom za 21 prijavljenih zdravil in celotne EU.