natgillin/translations-raw huggingface dataset:
Inflacam is an anti-inflammatory medicine used in cattle, pigs, horses, dogs and cats.
Inflacam je protivnetno zdravilo, ki se uporablja za zdravljenje govedi, prašičev, konjev, psov in mačk.
Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Dve zdravili sta biološko enakovredni, kadar dosegata enake ravni učinkovine v telesu.
Why is Inflacam authorised in the EU?
Zakaj je zdravilo Inflacam odobreno v EU?
What is Inflacam and what is it used for?
Kaj je zdravilo Inflacam in za kaj se uporablja?
Septicaemia and toxaemia are conditions where bacteria circulate in the blood and produce harmful substances (toxins).
Septikemija in toksemija sta bolezenski stanji, pri katerih bakterije krožijo v krvi in tvorijo škodljive snovi (toksine).
The withdrawal period for meat is five days for the 20 mg/ml solution for injection and three days for the granules and 15 mg/ml oral suspension.
Karenca za meso je pet dni pri uporabi raztopine za injiciranje v odmerku 20 mg/ml in tri dni pri uporabi zrnc v vrečkah in peroralne suspenzije v odmerku 15 mg/ml.
The European Medicines Agency concluded that, in accordance with EU requirements, Inflacam has been shown to have comparable quality and to be bioequivalent to Metacam.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Inflacam primerljivo raven kakovosti in je biološko enakovredno zdravilu Metacam.
This means that Inflacam contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Metacam.
To pomeni, da vsebuje enako učinkovino in ima enak način delovanja kot referenčno zdravilo Metacam, ki je že odobreno v Evropski uniji (EU).
The withdrawal period for meat is 15 days and for milk it is five days.
Karenca za meso je 15 dni, za mleko pa pet dni.
The precautions are the same as for the reference medicine since Inflacam is a generic medicine.
Previdnostni ukrepi so enaki kot pri referenčnemu zdravilu, saj je zdravilo Inflacam generično zdravilo.
Because Inflacam is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Inflacam generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Meloksikam deluje tako, da zavira encim, imenovan ciklooksigenaza, ki sodeluje pri tvorjenju prostaglandinov.
Inflacam contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Zdravilo Inflacam vsebuje meloksikam, ki spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSAID).
It can also be used as supportive therapy in the treatment of acute mastitis (inflammation of the udder), in combination with antibiotics.
Lahko se uporablja tudi kot podpora pri zdravljenju akutnega mastitisa (vnetja vimena) v kombinaciji z antibiotiki.
For further information about using Inflacam, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila Inflacam glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
Safety information has been included in the summary of product characteristics and the package leaflet for Inflacam, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
V povzetek glavnih značilnosti zdravila Inflacam in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
Inflacam contains the active substance meloxicam and is a generic medicine.
Zdravilo Inflacam vsebuje učinkovino meloksikam in je generično zdravilo.
It is also the time required after administration of a medicine before the milk may be used for human consumption.
Pomeni tudi čas, ki mora preteči po dajanju zdravila, preden se lahko mleko uporabi za prehrano ljudi.
The formulation and dose to use depends on the animal and the condition being treated.
Formulacija in višina odmerka sta odvisni od zdravljene živali in vrste bolezni, ki se zdravi.
In cattle, Inflacam is used together with appropriate antibiotic therapy, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways).
Pri govedu se zdravilo Inflacam uporablja skupaj z ustreznim antibiotičnim zdravljenjem za zmanjšanje kliničnih znakov akutne okužbe dihal (okužbe pljuč in dihalnih poti).
Since Inflacam is a generic medicine, studies have been conducted to determine that it is bioequivalent to the reference medicine, Metacam.
Ker je zdravilo Inflacam generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Metacam.
It can be used with oral re-hydration therapy (medicines given by mouth to restore water levels in the body) to reduce diarrhoea in calves of over one week of age and young, non-lactating cattle.
Uporablja se lahko tudi s peroralno rehidracijo (zdravili, ki jih žival zaužije peroralno za vzpostavitev ustrezne ravni vode v telesu) za zmanjševanje driske pri teletih, starejših od enega tedna, ter pri mladem govedu zunaj obdobja laktacije.
In pigs, Inflacam is used to reduce lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move), for the relief of post-operative pain after minor soft tissue surgery such as castration, and for supportive therapy together with appropriate antibiotic therapy in the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome).
Pri prašičih se zdravilo Inflacam uporablja za zmanjšanje šepavosti in vnetja pri neinfektivnih lokomotornih obolenjih (boleznih, ki prizadenejo gibalne sposobnosti živali), za lajšanje bolečin po manjših kirurških posegih na mehkih tkivih, kot je npr. kastracija, in kot podporna terapija v kombinaciji z ustreznimi antibiotiki pri zdravljenju bolezni po oprasitvi (kotitvi mladičev), kot so puerperalna septikemija in toksemija (sindrom mastitis-metritis-agalaktija).
Inflacam can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Inflacam je le na recept.
Therefore the Agency's view was that, as for Metacam, the benefits of Inflacam outweigh the identified risks and it can be authorised for use in the EU.
Zato je menila, da koristi zdravila Inflacam enako kot pri zdravilu Metacam odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
How has Inflacam been studied?
Kako je bilo zdravilo Inflacam raziskano?
How does Inflacam work?
Kako zdravilo Inflacam deluje?
In horses, Inflacam is used to reduce pain associated with colic (abdominal pain) and to lessen inflammation and relieve pain in acute and chronic musculo-skeletal disorders (disorders affecting the muscles and bones).
Pri konjih se zdravilo Inflacam uporablja za lajšanje bolečin, povezanih s kolikami (trebušnih bolečin), ter zmanjšanje vnetja in lajšanje bolečin pri akutnih in kroničnih kostno-mišičnih obolenjih (obolenjih, ki prizadenejo mišice in kosti).
Moreover, it is used to lessen inflammation and pain in acute and chronic musculo-skeletal disorders.
Poleg tega se uporablja tudi za lajšanje vnetja in bolečin pri akutnih in kroničnih kostno-mišičnih obolenjih.
How is Inflacam used?
Kako se zdravilo Inflacam uporablja?
Inflacam is available as granules, an oral (taken by mouth) suspension , chewable tablets and solution for injection .
Zdravilo Inflacam je na voljo v obliki zrnc, peroralne suspenzije, žvečljivih tablet in raztopine za injiciranje.
In dogs, Inflacam is used to reduce post-operative pain and inflammation following orthopaedic (e.g. fracture operation) and soft tissue surgery.
Pri psih se zdravilo Inflacam uporablja za lajšanje pooperativne bolečine in vnetja po ortopedskih kirurških posegih (npr. kirurškem posegu zaradi zloma kosti) in kirurških posegih na mehkih tkivih.
In cats, Inflacam is used to reduce post-operative pain and inflammation after ovariohysterectomy (spaying operation), orthopaedic and minor soft tissue surgery.
Pri mačkah se zdravilo Inflacam uporablja za lajšanje pooperativne bolečine in vnetja po ovariohisterektomiji (odstranitvi rodil), ortopedskih kirurških posegih in kirurških posegih na mehkih tkivih.
London, 14 August 2008 EMEA/CHMP/524251/2008
London, 14. avgust 2008 EMEA/CHMP/524245/2008
Avelox was initially approved in June 1999.
Zdravilo Avelox so prvič odobrili junija 1999.
Avelox film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Zdravilo Avelox, filmsko obložene tablete, vsebuje 400 mg moksifloksacina v obliki hidroklorida.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL Avelox and associated names International non-proprietary name (INN): moxifloxacin BACKGROUND INFORMATION *
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 6(12) ZA ZDRAVILO Avelox in povezana imena Mednarodno nelastniško ime (INN): moksifloksacin OSNOVNE INFORMACIJE*
It will also provide instructions on how to give the medicine correctly, in order to avoid the risk of low blood sugar levels.
Prav tako bo zagotovila navodila za pravilno dajanje zdravila, da se prepreči tveganje za nizke ravni sladkorja v krvi.
The European Commission granted a marketing authorisation valid throughout the European Union for Hemangiol on 23 April 2014.
Evropska komisija je dovoljenje za promet z zdravilom Hemangiol, veljavno po vsej Evropski uniji, izdala dne 23. aprila 2014.
Regarding safety, the CHMP considered that the safety profile is acceptable; the risks identified are those already known for propranolol and can be appropriately managed.
Kar zadeva varnost, je odbor CHMP menil, da je varnostni profil sprejemljiv, saj so ugotovljena tveganja skladna s tistimi, ki so že znana za propranolol, in jih je mogoče ustrezno obvladati.
What measures are being taken to ensure the safe and effective use of Hemangiol?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Hemangiol?
This is a summary of the European public assessment report (EPAR) for Hemangiol.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Hemangiol.
The full EPAR and risk management plan summary for Hemangiol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Hemangiol sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Hemangiol's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Hemangiol večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Treatment with Hemangiol should last for six months and the child should be monitored once a month, in particular for dose adjustments.
Zdravljenje z zdravilom Hemangiol mora trajati šest mesecev, spremljanje otroka pa se mora izvajati enkrat na mesec, zlasti zaradi prilagajanja odmerka.
Treatment should be started by a doctor who has experience in the diagnosis, treatment and management of infantile haemangioma.
Zdravljenje mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem, zdravljenjem in oskrbo infantilnega hemangioma.
Treatment with Hemangiol is started in babies aged five weeks to five months.
Zdravljenje z zdravilom Hemangiol se uvede pri dojenčkih, ki so stari od pet tednov do pet mesecev.
The dose is progressively increased to a maintenance dose of 1.5 mg/kg twice a day.
Odmerek se nato postopoma povečuje do vzdrževalnega odmerka 1,5 mg/kg dvakrat na dan.
The Company will provide caregivers who will give Hemangiol to children with an educational pack to inform them of the need to monitor children for certain side effects and how to manage them.
Družba bo negovalcem, ki bodo otrokom dajali zdravilo Hemangiol, zagotovila izobraževalno gradivo, s katerim jih bo seznanila s potrebo po spremljanju otrok glede določenih neželenih učinkov in ukrepi za njihovo obvladovanje.
Other information about Hemangiol
Druge informacije o zdravilu Hemangiol
Hemangiol is used in infants with serious complications, such as painful ulcers, scarring and breathing difficulties, who require systemic therapy (treatment which can have an effect on the whole body).
Zdravilo Hemangiol se uporablja pri dojenčkih z resnimi zapleti, kot so boleče razjede, brazgotine in težave z dihanjem, ki zahtevajo sistemsko zdravljenje (zdravljenje, ki lahko učinkuje na celo telo).
The Committee concluded that Hemangiol was an effective treatment for haemangioma.
Odbor je zaključil, da je Hemangiol učinkovito zdravilo za zdravljenje hemangioma.
Hemangiol must not be used in: premature babies who have not reached the corrected age of 5 weeks (the corrected age is the age a premature baby would be if he/she had been born on the due date); breastfed children if the mother is being treated with medicines that must not be used with propranolol; children with asthma or with a history of bronchospasm; children with certain diseases of the heart and blood vessels, such as low blood pressure; and children who tend to have low blood sugar levels.
Zdravilo Hemangiol se ne sme uporabljati pri: nedonošenčkih, ki še niso dosegli popravljene starosti 5 tednov (popravljena starost je starost, v kateri bi bil nedonošenček, če bi se rodil na predvideni datum poroda); dojenih otrocih, če se mati zdravi z zdravili, ki se ne smejo uporabljati skupaj s propranololom; otrocih z astmo ali bronhospazmom v anamnezi; otrocih z določenimi boleznimi srca in ožilja, kot je na primer nizek krvni tlak, ter otrocih, ki so nagnjeni k nizkim ravnem sladkorja v krvi.
A risk management plan has been developed to ensure that Hemangiol is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Hemangiol je bil pripravljen načrt obvladovanja tveganj.
Hemangiol was investigated in one main study involving 460 children aged from five weeks to five months at the start of treatment and who had proliferative infantile haemangioma that required systemic therapy.
Zdravilo Hemangiol so raziskali v eni glavni študiji, v katero so vključili 460 otrok, ki so bili ob začetku zdravljenja stari od pet tednov do pet mesecev in so imeli hitro rastoči infantilni hemangiom, ki je zahteval sistemsko zdravljenje.
The study compared different doses of propranolol with placebo (a dummy treatment) and the main measure of effectiveness was based on whether the haemangiomas disappeared completely or almost completely after 6 months of treatment.
V študiji so različne odmerke propranolola primerjali s placebom (zdravilom brez zdravilne učinkovine), glavno merilo učinkovitosti pa je temeljilo na tem, ali so hemangiomi po 6 mesecih zdravljenja popolnoma ali skoraj popolnoma izginili.
What are the risks associated with Hemangiol?
Kakšna tveganja so povezana z zdravilom Hemangiol?
Hemangiol is a medicine that contains the active substance propranolol.
Hemangiol je zdravilo, ki vsebuje zdravilno učinkovino propranolol.
What benefits of Hemangiol have been shown in studies?
Kakšne koristi je zdravilo Hemangiol izkazalo v študijah?
For more information about treatment with Hemangiol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Hemangiol preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is Hemangiol and what is it used for?
Kaj je zdravilo Hemangiol in za kaj se uporablja?
The most common side effects with Hemangiol (which may affect more than 1 in 10 children) are sleep disorders, respiratory tract infections such as bronchitis (inflammation of the airways in the lungs), diarrhoea and vomiting.
Najpogostejši neželeni učinki zdravila Hemangiol (ki lahko prizadenejo več kot 1 otroka od 10) so motnje spanja, okužbe dihal, kot je na primer bronhitis (vnetje dihalnih poti v pljučih), driska in bruhanje.
The recommended starting dose of Hemangiol is 0.5 mg per kilogram bodyweight (0.5 mg/kg), twice a day (at least 9 hours apart).
Priporočeni začetni odmerek zdravila Hemangiol je 0,5 mg na kilogram telesne mase (0,5 mg/kg) dvakrat na dan (med odmerkoma mora miniti najmanj 9 ur).
Serious side effects observed with Hemangiol include bronchospasm (temporary narrowing of the airways) and low blood pressure.
Resni neželeni učinki, ki so jih opazili pri uporabi zdravila Hemangiol, vključujejo bronhospazem (začasno zoženje dihalnih poti) in nizek krvni tlak.
The active substance in Hemangiol, propranolol, belongs to a group of medicines called beta-blockers, which have been widely used to treat several conditions in adults, including diseases of the heart and high blood pressure.
Zdravilna učinkovina v zdravilu Hemangiol, propranolol, spada v skupino zdravil, imenovanih zaviralci receptorjev beta, ki se pogosto uporabljajo za zdravljenje različnih bolezni pri odraslih, med drugim tudi za srčne bolezni in povišan krvni tlak.
Hemangiol at a dose of 3 mg/kg per day (given as two separate doses of 1.5 mg/kg) given for 6 months was shown to be more effective than placebo.
Zdravilo Hemangiol v odmerku 3 mg/kg na dan (ki so ga dajali z dvema ločenima odmerkoma po 1,5 mg/kg) je bilo po 6 mesecih dajanja učinkovitejše od placeba.
Why is Hemangiol approved?
Zakaj je bilo zdravilo Hemangiol odobreno?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Hemangiol, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Hemangiol in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For practical information about using Hemangiol, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Hemangiol naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
It is used to treat children with proliferating infantile haemangioma, which are benign tumours (abnormal non-cancerous growths) of blood vessels.
Uporablja se za zdravljenje otrok s hitro rastočimi infantilnimi hemangiomi, ki so benigni tumorji (nenormalne nerakave tvorbe) krvnih žil.
Treatment should be started in appropriate facilities in case serious side effects develop.
Uvede se lahko le v ustreznih zdravstvenih ustanovah, saj se lahko pojavijo resni neželeni učinki.
For the full list of all side effects reported with Hemangiol, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Hemangiol, glejte navodilo za uporabo.
In around 60% (61 out of 101) of children treated with the most effective dose of Hemangiol (3 mg/kg/day for 6 months), haemangiomas disappeared completely or almost completely compared with around 4% (2 out of 55) in children who received placebo.
Hemangiomi so popolnoma ali skoraj popolnoma izginili pri približno 60 % (61 od 101) otrok, zdravljenih z najučinkovitejšim odmerkom zdravila Hemangiol (3 mg/kg/dan v obdobju 6 mesecev), v primerjavi s približno 4 % (2 od 55) otrok, ki so prejemali placebo.
It is not intended to provide practical advice on how to use Hemangiol.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The dose is given to the baby during or immediately after a feed using the oral syringe provided.
Zdravilo se dojenčku odmerja s priloženo brizgo za peroralno dajanje med hranjenjem ali takoj po njem.
Although it is not exactly known how Hemangiol works in proliferative infantile haemangioma, it is thought to do so by several mechanisms including narrowing the blood vessels and so decreasing blood supply to the haemangioma, blocking the formation of new blood vessels in the growth, triggering cell death of the abnormal blood vessel cells and blocking the effect of certain proteins (called VEGF and bFGF), which are important for the growth of blood vessels.
Med drugim zoži krvne žile in tako zmanjša oskrbo hemangioma s krvjo, prepreči nastajanje novih krvnih žil v tvorbi, povzroči odmiranje nenormalnih celic krvnih žil in prepreči učinek določenih beljakovin (imenovanih VEGF in bFGF), ki imajo pomembno vlogo pri rasti krvnih žil.
Hemangiol can only be obtained with a prescription.
Izdaja zdravila Hemangiol je le na recept.
How does Hemangiol work?
Kako zdravilo Hemangiol deluje?
How is Hemangiol used?
Kako se zdravilo Hemangiol uporablja?
Hemangiol is available as a solution to be taken by mouth.
Zdravilo Hemangiol je na voljo v obliki raztopine, ki se daje peroralno.
Adopted at the 9-12 April 2018 PRAC
Sprejeto na seji odbora PRAC od 9. do 12. aprila 2018
Therefore, if you are breastfeeding, your child should receive vitamin K1.
Če dojite, mora vaš otrok prejemati vitamin K1.
Phenprocoumon is contraindicated during pregnancy (see section 4.3).
Uporaba fenprokumona med nosečnostjo je kontraindicirana (glejte poglavje 4.3).
This means taking <...> during pregnancy can lead to malformations and even death of your unborn child.
To pomeni, da lahko jemanje zdravila <…> med nosečnostjo povzroči malformacije in celo smrt nerojenega otroka.
You must not use <…> when you are pregnant, as it passes from mother to child.
Med nosečnostjo ne smete uporabljati zdravila <…>, saj prehaja z matere na otroka.
Table 2: Tabulated summary of adverse reactions
Preglednica 2: Tabelarični pregled neželenih učinkov
There is also a risk of bleeding in the foetus (foetal hemorrhage).
Obstaja tudi tveganje za krvavitev pri plodu (fetalno krvavitev).
Women of childbearing age who are taking <…> have to use effective contraceptive measures during treatment and should continue for 3 months after the last dose.
Ženske v rodni dobi, ki jemljejo zdravilo <…>, morajo med zdravljenjem in tri mesece po zadnjem odmerku uporabljati učinkovito kontracepcijo.
In cases of exposure to phenprocoumon during second and third trimester of pregnancy, the foetus is at an increased risk of intrauterine or parturitional (cerebral) hemorrhage due to foetal anticoagulation.
V primerih izpostavljenosti fenprokumonu v drugem in tretjem trimesečju nosečnosti je pri plodu povečano tveganje za intrauterino ali obporodno (možgansko) krvavitev zaradi fetalne antikoagulacije.
There is epidemiological evidence suggesting that the risk of birth defects and foetal death increases with the increasing duration of exposure to phenprocoumon during the first trimester of pregnancy, with a steep increase of the rate of major birth defects when phenprocoumon treatment is continued beyond the 5th gestational week.
Epidemiološki dokazi kažejo, da se tveganje za prirojene napake in smrt plodu povečuje s trajanjem izpostavljenosti fenprokumonu v prvem trimesečju nosečnosti, z izrazitim povečanjem deleža resnih prirojenih napak, če se zdravljenje s fenprokumonom nadaljuje še po petem gestacijskem tednu.
Women of childbearing potential planning a pregnancy should be switched to a safer alternative treatment prior to pregnancy.
Ženske v rodni dobi, ki načrtujejo nosečnost, morajo pred zanositvijo preiti na varnejše drugo zdravljenje.
Lapatinib - Pulmonary hypertension (EPITT no 19089)
Lapatinib - Pljučna hipertenzija (EPITT št. 19089)