natgillin/translations-raw huggingface dataset:
The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Priporočila odbora PRAC so bila posredovana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončno stališče.
Since lactation is a natural process that eventually stops if the infant is not breastfed, and other means of management are available, the French medicines agency (ANSM) asked the EMA to review the medicines and see if the benefits of such use still outweighed the risks.
Glede na to, da je laktacija naravni proces, ki se sčasoma ustavi, če se otrok ne doji, in se lahko uravnava tudi na druge načine, je francoska agencija za zdravila (ANSM) zaprosila Evropsko agencijo za zdravila, da pregleda zdravila in ugotovi, ali so koristi tovrstne uporabe še vedno večje od tveganj.
Although milk production eventually stops, women in the meantime can experience breast engorgement, leakage of milk, discomfort and pain.
Čeprav se tvorjenje mleka sčasoma ustavi, se lahko medtem pri ženskah pojavijo nabreklost dojk, iztekanje mleka, neugodje in bolečina.
Because of a possible risk of serious side effects, recommendations have been issued to clarify that these medicines should not be used routinely for preventing or stopping milk production.
Zaradi možnega tveganja za resne neželene učinke so bila izdana priporočila, ki pojasnjujejo, da se ta zdravila ne smejo več uporabljati za rutinsko preprečevanje ali zaustavljanje tvorjenja mleka.
The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Skupina CMDh je organ, ki zastopa države članice EU in je odgovoren za zagotovitev enotnih varnostnih standardov za zdravila, ki so v EU odobrena po nacionalnih postopkih.
• Patients who develop chest pain or an unusually severe headache should consult their doctor urgently.
• Bolnice, pri katerih se pojavi bolečina v prsnem košu ali neobičajno hud glavobol, se morajo nujno posvetovati z zdravnikom.
Restrictions in use of bromocriptine for stopping breast milk production
Omejitev uporabe bromokriptina za zaustavitev tvorjenja materinega mleka
Information to patients
Informacije za bolnice
Bromocriptine is also used to treat other conditions, such as hyperprolactinaemia (high levels of prolactin in the body) and Parkinson's disease; however these uses are not covered by this review.
Bromokriptin se uporablja tudi za zdravljenje drugih bolezni, kot sta hiperprolaktinemija (visoke ravni prolaktina v telesu) in Parkinsonova bolezen, vendar tovrstna uporaba ni zajeta v tem pregledu.
• Blood pressure should be monitored in those who take the medicine (especially on the first day of taking it) so that early signs of problems can be detected, and the medicine stopped.
• Pri vseh, ki jemljejo zdravilo, je treba spremljati krvni tlak (zlasti prvi dan jemanja zdravila), da se lahko ugotovijo zgodnji znaki težav in prekine jemanje zdravila.
On 20 August 2014, the Coordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)1 endorsed by majority recommendations on the use of bromocriptine-containing medicines by mouth to prevent or suppress breast milk production (lactation) after childbirth.
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh)1 je 20. avgusta 2014 z večino podprla priporočila za uporabo zdravil, ki vsebujejo bromokriptin in se jemljejo peroralnno za preprečevanje ali zaviranje tvorjenja materinega mleka (laktacije) po porodu.
Bromocriptine should not be used routinely for preventing or stopping milk production, and must not be used in women at increased risk of serious side effects, including women with various disorders that increase blood pressure or who have or have had heart disease or severe psychiatric disorders.
Bromokriptin se ne sme uporabljati za rutinsko preprečevanje ali zaustavitev tvorjenja mleka, prav tako pa se ne sme uporabljati pri ženskah, pri katerih obstaja večje tveganje za resne neželene učinke, kar vključuje ženske z različnimi motnjami, ki zvišujejo krvni tlak, in tiste, ki imajo ali so kdaj imele bolezen srca ali hude psihiatrične motnje.
As the CMDh position was adopted by majority vote, it was sent to the European Commission, which took an EU-wide legally binding decision on 30 October 2014.
Ker je skupina CMDh stališče sprejela z večino glasov, je bilo posredovano Evropski komisiji, ki je 30. oktobra 2014 sprejela pravno zavezujočo odločbo, ki velja za celotno EU.
The CMDh position followed a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) of available data on the safety and effectiveness of bromocriptine in controlling breast milk production after childbirth, which led to these recommendations.
Skupina CMDh je stališče sprejela, potem ko je Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila opravil pregled razpoložljivih podatkov o varnosti in učinkovitosti bromokriptina pri nadzorovanju tvorjenja materinega mleka po porodu, na podlagi katerega je podal ta priporočila.
• On the basis of available safety data, a causal association between use of bromocriptine and serious cardiovascular, neurological or psychiatric events could not be excluded.
• Na podlagi razpoložljivih podatkov o varnosti ni bilo mogoče izključiti vzročne povezave med uporabo bromokriptina in resnimi srčno-žilnimi, nevrološkimi in psihiatričnimi dogodki.
• Medicines containing bromocriptine are licensed in many EU countries for use by mouth to prevent or stop milk production after childbirth in women who are not breastfeeding.
• Zdravila, ki vsebujejo bromokriptin, so v številnih državah EU odobrena za peroralno uporabo za preprečevanje ali zaustavljanje tvorjenja mleka po porodu pri ženskah, ki ne dojijo.
The review was triggered by concerns in France over increased reports of rare but potentially serious or fatal side effects, particularly cardiovascular side effects (such as heart attack and stroke), neurological side effects such as seizures (fits) and psychiatric side effects (such as hallucinations and manic episodes).
Pregled je bil sprožen, ker se je v Franciji pojavila zaskrbljenost zaradi povečanega števila poročil o redkih, vendar potencialno resnih ali smrtnih neželenih učinkih, zlasti srčno-žilnih (na primer srčna in možganska kap), nevroloških, kot so epileptični napadi (krči), in psihiatričnih (na primer halucinacije in manične epizode).
As the CMDh position on bromocriptine was adopted by majority vote, it was sent to the European Commission, which took an EU-wide legally binding decision on 30 October 2014.
Ker je skupina CMDh stališče o bromokriptinu sprejela z večino glasov, je bilo posredovano Evropski komisiji, ki je dne 30. oktobra 2014 sprejela pravno zavezujočo odločbo, ki velja za celotno EU.
However, the data available were such that conclusions on the efficacy of bromocriptine in mastitis, breast engorgement and painful breast engorgement could not be made.
Vendar na podlagi razpoložljivih podatkov ni bilo mogoče podati zaključkov o učinkovitosti bromokriptina pri mastitisu, nabreklosti dojk in boleči nabreklosti dojk.
• They should only be used for this purpose if there are medical reasons for doing so, for example to avoid further distress in women who lose a baby during or just after birth, or in women who have HIV infection (to avoid any risk of passing the virus on in breast milk).
• Za ta namen se lahko uporabijo samo, če za to obstajajo zdravstveni razlogi, na primer, da se prepreči nadaljnji stres pri ženskah, ki izgubijo otroka med porodom ali takoj po njem, ali če je ženska okužena z virusom HIV (da se prepreči vsakršno tveganje za prenos virusa z materinim mlekom).
• Evidence from the clinical trials originally used to license the product as well as those in the published literature suggests that bromocriptine is efficacious in the prevention and inhibition of lactation.
• Dokazi iz kliničnih preskušanj, ki so bili prvotno uporabljeni za pridobitev dovoljenja za zdravilo, in dokazi iz objavljene literature kažejo, da je bromokriptin učinkovit pri preprečevanju in zaviranju laktacije.
It mimics some of the actions of dopamine, a hormone that regulates the release of another hormone, prolactin, which in turn controls lactation.
Deluje tako, da posnema določene načine delovanja dopamina, tj. hormona, ki uravnava sproščanje drugega hormona, prolaktina, ki nadzoruje laktacijo.
Women may not always breastfeed after childbirth for a variety of reasons ranging from stillbirth and HIVinfection of the mother to personal choice.
Ženske včasih po porodu ne dojijo zaradi različnih razlogov, ki vključujejo vse od mrtvorojenega otroka in okužbe matere z virusom HIV do osebne odločitve.
If hypertension, suggestive chest pain, severe, progressive, or unremitting headache (with or without visual disturbance) or evidence of central nervous system toxicity develops, treatment should be discontinued and the patient evaluated promptly.
Če se pojavi hipertenzija, pomenljiva bolečina v prsnem košu, hud, progresiven ali neprekinjen glavobol (z motnjami vida ali brez njih) ali znaki toksičnih učinkov na centralni živčni sistem, je treba zdravljenje prekiniti in bolnico takoj pregledati.
The medicine should not be used routinely for preventing or stopping milk production after childbirth
Zdravilo se ne sme uporabljati za rutinsko preprečevanje ali zaustavljanje tvorjenja mleka po porodu
The above recommendations are based on a review of the available evidence of safety and efficacy of oral bromocriptine for prevention and suppression of lactation.
Zgornja priporočila temeljijo na pregledu razpoložljivih dokazov o varnosti in učinkovitosti peroralnega bromokriptina pri preprečevanju in zaviranju laktacije.
• Use is contraindicated for patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced hypertension), hypertension post-partum and in the puerperium, a history of coronary artery disease or other severe cardiovascular conditions, or a history of severe psychiatric disorders.
• Uporaba je kontraindicirana pri bolnicah z nenadzorovano hipertenzijo, hipertenzivnimi motnjami v nosečnosti (vključno z eklampsijo, preeklampsijo in hipertenzijo zaradi nosečnosti), hipertenzijo po porodu in v puerperiju, boleznijo koronarnih arterij ali drugimi hudimi srčno-žilnimi boleznimi v anamnezi ali z anamnezo hudih psihiatričnih motenj.
• Women who are at greater risk of side effects, such as those who have a condition that increases blood pressure, or who have a history of serious mental illness, should not take bromocriptine.
• Ženske, pri katerih obstaja večje tveganje za neželene učinke, na primer ženske z boleznijo, ki zvišuje krvni tlak, in tiste, ki so kdaj imele resne psihiatrične motnje, bromokriptina ne smejo jemati.
As a result, bromocriptine prevents the secretion of prolactin, thereby preventing or suppressing milk production.
Bromokriptin tako preprečuje izločanje prolaktina in s tem prepreči ali zavira tvorjenje mleka.
• Bromocriptine should not be used to relieve symptoms of pain or swelling of the breasts after childbirth when such symptoms can be managed by measures such as breast support or applying ice, and the use of painkillers if needed.
• Bromokriptin se ne sme uporabljati za lajšanje simptomov bolečine v dojkah ali nabrekanja dojk po porodu, kadar je te simptome mogoče obvladati z ukrepi, kot so podpiranje dojk ali ledeni obkladki, in z uporabo protibolečinskih zdravil, če je to potrebno.
The CMDh agreed that the medicines should only be used for this purpose (in strengths up to 2.5 mg) when there are compelling medical reasons for stopping lactation, such as the need to avoid further distress after loss of the baby during or just after childbirth, or in mothers with HIV infection, who should not breastfeed.
Skupina CMDh se je strinjala, da se lahko zdravila za ta namen uporabljajo (v jakostih do 2,5 mg) samo, kadar obstajajo prepričljivi zdravstveni razlogi za zaustavitev laktacije, na primer, da se prepreči nadaljnji stres po izgubi otroka med porodom ali takoj po njem ali če je mati okužena z virusom HIV in zato ne sme dojiti.
• Bromocriptine should not be used for the routine suppression of lactation, nor for the relief of symptoms of post-partum pain and engorgement, which can be adequately treated with nonpharmacological intervention (such as firm breast support, ice application) and simple analgesics.
• Bromokriptin se ne sme uporabljati za rutinsko zaviranje laktacije niti za lajšanje simptomov poporodne bolečine in nabreklosti, ki jih je mogoče ustrezno zdraviti z nefarmakološkimi ukrepi (na primer s podpiranjem dojk ali ledenimi obkladki) in s preprostimi analgetiki.
• Bromocriptine should only be used orally in strengths up to 2.5 mg to inhibit lactation when medically indicated, such as in case of intrapartum loss, neonatal death or HIV infection of the mother.
• Bromokriptin se lahko uporablja samo peroralno v jakostih do 2,5 mg za zaviranje laktacije, kadar so za to prisotne zdravstvene indikacije, na primer v primeru izgube otroka med porodom, smrti novorojenčka ali okužbe matere z virusom HIV.
Bromocriptine is used to prevent or suppress milk production in women who have given birth.
Bromokriptin se uporablja za preprečevanje ali zaviranje tvorjenja materinega mleka pri ženskah po porodu.
The following recommendations (some of which are already included in the product information) should be borne in mind when prescribing bromocriptine for the prevention or suppression of lactation.
Pri predpisovanju bromokriptina za preprečevanje ali zaviranje laktacije je treba upoštevati priporočila, navedena v nadaljevanju (nekatera od teh so že vključena v informacije o zdravilu).
This summary was last updated in January 2014.
Povzetek je bil nazadnje posodobljen januarja 2014.
If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Če želite več informacij o podlagi za priporočila CVMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
The European Commission granted a marketing authorisation valid throughout the European Union, for Equisolon on 12/03/2014.
Evropska komisija je dovoljenje za promet z zdravilom Equisolon, veljavno po vsej Evropski uniji, odobrila 12/03/2014.
The use of prednisolone in horses with RAO has been well described in the scientific literature.
Uporaba prednizolona pri konjih z RAO je dobro opisana v znanstveni literaturi.
Other information about Equisolon:
Druge informacije o zdravilu Equisolon:
This document is a summary of the European Public Assessment Report.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR).
A field study was conducted in which the same 8 horses with RAO after exposure to hay participated in 4 treatment periods receiving either no treatment or Equisolon at three different doses, each for ten days.
Opravili so terensko študijo, v kateri je istih 8 konjev z RAO po izpostavljenosti senu sodelovalo v 4 obdobjih zdravljenja, med katerimi niso prejeli nobenega zdravljenja ali so prejemali zdravilo Equisolon v treh različnih odmerkih po deset dni.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equisolon exceed the risks for the approved indication and recommended that Equisolon be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Equisolon večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
The product should not be shaken to prevent dust formation.
Zdravilo se ne sme stresati, da se prepreči tvorjenje prahu.
The medicine should not be given to horses by pregnant women as there is a risk of malformation to the unborn baby.
Konjem zdravila ne smejo dajati nosečnice, saj obstaja tveganje malformacije (nepravilnosti v razvoju) pri nerojenem otroku.
The main measures of effectiveness were clinical signs of RAO disease as well as the amount of fluid and immune cells in the airways and the air pressure in the lungs.
Glavna merila učinkovitosti so bili klinični znaki bolezni RAO, količina tekočine in imunskih celic v dihalnih poteh ter zračni tlak v pljučih.
What benefit has Equisolon shown during the studies?
Kakšne koristi je zdravilo Equisolon izkazalo med študijami?
The most common side effects (seen in more than 1 in 10 horses) with Equisolon are suppression of production of cortisol (a natural corticosteroid important in the body's response to stress), and an increase in the level of triglycerides (a type of fat) in the blood.
Najpogostejša neželena učinka (pojavita se pri več kot 1 od 10 konjev) zdravila Equisolon sta zaviranje tvorbe kortizola (naravnega kortikosteroida s pomembno vlogo pri odzivu telesa na stres) in povišanje ravni trigliceridov (vrste maščob) v krvi.
RAO is a chronic (long-term) allergic condition in which horses wheeze, cough and have difficulty in breathing.
RAO je kronično (dolgotrajno) alergijsko stanje, pri katerem imajo konji piskanje v prsnem košu, kašelj in oteženo dihanje.
Treatment with prednisolone at the recommended dose of 1 mg per kg bodyweight over ten days in combination with environmental control resulted in significant improvements in fluid in the airways and clinical signs associated with RAO.
Zdravljenje s prednizolonom v priporočenem odmerku 1 mg na kg telesne mase, ki je trajalo deset dni, je v kombinaciji z nadzorovanjem okoljskih pogojev povzročilo pomembno izboljšanje količine tekočine v dihalnih poteh in kliničnih znakov, povezanih z RAO.
The active substance in Equisolon, prednisolone, is a corticosteroid, a medicine that acts to reduce the activity of the immune system.
Zdravilna učinkovina v zdravilu Equisolon, prednizolon, je kortikosteroid, ki deluje tako, da zmanjša dejavnost imunskega sistema.
The environmental measures include keeping horses outside as much as possible or improving the ventilation in the stable, soaking hay or feeding silage (fermented grass) and using bedding with a minimum of dust in the stable.
Okoljski ukrepi vključujejo čim daljše zadrževanje konjev na prostem ali izboljšanje prezračevanja v staji, namakanje sena ali krmilne silaže (fermentirane trave) in uporabo stelje z minimalno vsebnostjo prahu.
What is the risk associated with Equisolon?
Kakšna tveganja so povezana z zdravilom Equisolon?
Equisolon is used to treat recurrent airway obstruction (RAO or heaves) in horses in combination with environmental measures.
Zdravilo Equisolon se uporablja za zdravljenje ponavljajoče se obstrukcije dihal (recurrent airway obstruction - RAO ali naduhe) pri konjih v kombinaciji z okoljskimi ukrepi.
In horses with RAO, the immune system (the body's natural defences) over-reacts to triggering substances (antigens) that are present in dust that the horse breathes in.
Pri konjih z RAO imunski sistem (naravna obramba telesa) čezmerno reagira na sprožilce (antigene), prisotne v prahu, ki ga vdihavajo konji.
Prednisolone
Equisolon prednizolon
In addition to treatment with prednisolone, the exposure to organic dust was reduced by substituting hay with silage and by improving the ventilation in the stable.
Poleg zdravljenja s prednizolonom so izpostavljenost organskemu prahu zmanjšali z zamenjavo sena s silažo in izboljšanjem prezračevanja v staji.
It is also the time allowed after administration of the medicine before milk can be used for human consumption.
To je tudi čas, ki mora preteči po dajanju zdravila, preden se lahko mleko uporabi za prehrano ljudi.
The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Razmerje med koristmi in tveganji je na voljo v modulu znanstvene razprave v tem povzetku.
This results in inflammation and blockage of the airways inside the lungs, leading to difficulty in breathing.
To povzroči vnetje in zaprtje dihalnih poti v pljučih, kar privede do oteženega dihanja.
Equisolon is a veterinary medicine that contains the active substance prednisolone.
Equisolon je zdravilo za uporabo v veterinarski medicini, ki vsebuje zdravilno učinkovino prednizolon.
Equisolon should be mixed with a small amount of food and given by mouth at a dose of 1 mg prednisolone per kg bodyweight once a day.
Zdravilo Equisolon je treba zmešati z majhno količino krme in dati peroralno (prek ust) v odmerku 1 mg prednizolona na kg telesne mase enkrat na dan. Odmerjanje lahko traja deset zaporednih dni.
For a full list of all side effects reported with Equisolon, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Equisolon, glejte navodilo za uporabo.
It is available as a powder to be given by mouth.
Na voljo je v obliki praška, ki se daje peroralno (prek ust).
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Obdobje karence je čas, ki mora preteči po dajanju zdravila, preden se lahko žival zakolje in njeno meso uporabi za prehrano ljudi.
This decreases inflammation, thereby helping to keep the airways clear and allowing the horse to breathe more easily.
To zmanjša vnetje in posledično pomaga pri vzdrževanju prehodnosti dihalnih poti ter olajša dihanje.
Equisolon must not be used in horses with viral or fungal infections, gastrointestinal or corneal ulcers or in pregnant mares.
Zdravilo Equisolon se ne sme uporabljati pri konjih z virusnimi ali glivičnimi okužbami, razjedami v prebavilih ali na roženici in pri brejih kobilah.
Why has Equisolon been approved?
Zakaj je bilo zdravilo Equisolon odobreno?
The withdrawal period for Equisolon for meat is ten days.
Karenca zdravila Equisolon pri mesu je deset dni.
Equisolon should not be used in mares producing milk for human consumption.
Zdravilo Equisolon se ne sme uporabljati pri kobilah, katerih mleko je namenjeno prehrani ljudi.
How has Equisolon been studied?
Kako je bilo zdravilo Equisolon raziskano?
How does Equisolon work?
Kako zdravilo Equisolon deluje?
What is Equisolon used for?
Za kaj se zdravilo Equisolon uporablja?
What is Equisolon?
Kaj je zdravilo Equisolon?
These measures should help to protect the environment.
Taki ukrepi pomagajo varovati okolje.
However, these reactions may be more severe and/or last longer.
Vendar pa so te reakcije lahko resnejše in/ali dlje trajajo.
If such reactions occur appropriate treatment is recommended.
Če nastanejo take reakcije, se priporoča ustrezno zdravljenje.
DATE OF REVISION OF THE TEXT
DATUM REVIZIJE BESEDILA
Protect from light.
Zaščitite pred svetlobo.
EXP {month/year}
EXP {mesec/leto}
Duration of immunity: 1 year.
Trajanje imunosti: 1 leto.
Avoid accidental self-injection or contact with the eyes.
Izogibajte se nenamernemu samo-injiciranju ali stiku z očmi.
In very rare cases a transient acute hypersensitivity reaction may occur.
V zelo redkih primerih se lahko pojavi prehodna akutna preobčutljivostna reakcija.
Any such swelling will either have disappeared or be clearly diminished by 14 days post-vaccination.
Vsaka taka oteklina je bodisi izginila ali pa se znatno zmanjšala v 14 dneh po cepljenju.
Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening.
Take reakcije se lahko razvijejo v resnejše stanje (anafilakso), ki lahko ogrozi življenje.
1 Antigenic mass ELISA units.
1 ELISA enote mase antigena
Onset of immunity: 3 weeks.
Nastop imunosti: 3 tedni.
Interaction with other medicinal products and other forms of interaction:
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
The CVMP at their meeting on 17-19 January 2017 decided that one further five-year renewal was required in view of the outstanding pharmacovigilance concerns regarding serious adverse events that were undergoing evaluation at the time of the renewal procedure.
CVMP se je na sestanku v dnevih 17.-19. januarja odločila, da je potrebno še eno nadaljnje podaljšanje zaradi izrednih problemov farmakovigilance glede resnih neželenih učinkov, ki so bili ugotovljeni v času postopka podaljšanja.