natgillin/translations-raw huggingface dataset:
Detailed instructions on how to take purple coneflower herb medicines and who can use them can be found in the package leaflets that come with the medicines.
Podrobna navodila o jemanju zdravil, ki vsebujejo zel škrlatne ehinaceje, in o tem, kdo sme ta zdravila jemati, so v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
What are the risks associated with purple coneflower herb medicines?
Kakšna tveganja so povezana z zdravili, ki vsebujejo zel škrlatne ehinaceje?
For practical information about using purple coneflower herb medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
What is purple coneflower herb?
Kaj je zel škrlatne ehinaceje?
Other information about purple coneflower herb medicines
Druge informacije o zdravilih, ki vsebujejo zel škrlatne ehinaceje
The HMPC concluded that purple coneflower herb medicines to be taken by mouth can be used short term for the prevention and treatment of common colds.
Odbor HMPC je zaključil, da se zdravila, ki vsebujejo zel škrlatne ehinaceje in se jemljejo peroralno (uživajo skozi usta), lahko uporabljajo kratkoročno za preprečevanje in zdravljenje navadnih prehladov.
Allergic reactions such as rash have been reported with the use of purple coneflower herb medicines.
Pri uporabi zdravil, ki vsebujejo zel škrlatne ehinaceje, so poročali o alergičnih reakcijah, kot so izpuščaji.
A doctor or pharmacist should be consulted if symptoms persist for more than 10 days when using purple coneflower herb medicines for the treatment of common colds.
Če simptomi ob uporabi zdravil, ki vsebujejo zel škrlatne ehinaceje, za zdravljenje navadnih prehladov v desetih dneh ne popustijo, se je treba posvetovati z zdravnikom ali farmacevtom.
Annex III Conditions for lifting the suspension
Priloga III Pogoji za odpravo začasnega preklica
Convincing data to identify a patient population in which the benefits of buflomedil clearly outweigh its identified risks.
prepričljive podatke z opredelitvijo populacije bolnikov, v kateri koristi buflomedila jasno odtehtajo opredeljena tveganja.
For the suspension to be lifted the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following:
Za odpravo začasnega preklica mora imetnik dovoljenja za promet z zdravilom pristojnemu nacionalnemu organu predložiti:
It is a well-known substance, which has been used to control pain for many years.
To je dobro znana snov, ki se že več let uporablja za nadzorovanje bolečin.
The tablets contain 100, 200, 400, 600 or 800 micrograms of fentanyl.
Tablete vsebujejo 100, 200, 400, 600 ali 800 mikrogramov fentanila.
Because fentanyl has been in use for many years, the company presented data from the scientific literature, as well as from studies that it had carried out.
Ker se fentanil uporablja že mnogo let, je družba predstavila podatke iz znanstvene literature, pa tudi podatke iz študij, ki jih je izvedla sama.
Each patient ranked their pain intensity on an 11-point scale.
Vsak bolnik je intenzivnost bolečine ocenil na 11-točkovni lestvici.
This medicine can only be obtained by ‘special' prescription.
Izdaja zdravila je le na „poseben“ recept.
Doses of Effentora above 800 micrograms have not been tested.
Odmerki zdravila Effentora nad 800 mikrogramov niso bili preskušeni.
The European Commission granted a marketing authorisation valid throughout the EU for Effentora on 4 April 2008.
Evropska komisija je dovoljenje za promet z zdravilom Effentora, veljavno po vsej Evropski uniji, izdala 4. aprila 2008.
The full EPAR for Effentora 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) za zdravilo Effentora je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The main measure of effectiveness was the change in pain intensity over the first 30 or 60 minutes after taking the tablet.
Glavno merilo učinkovitosti je bila sprememba intenzivnosti bolečine v prvih 30 ali 60 minutah po zaužitju tablete.
Patients should be closely monitored for these side effects.
Bolnike je treba glede teh neželenih učinkov skrbno spremljati.
It is available as ‘buccal tablets' (tablets that dissolve in the mouth).
Na voljo je v obliki bukalnih tablet (tablet, ki se raztopijo v ustih).
Alternatively, the tablets can be placed under the tongue.
Druga možnost je, da se tableta položi pod jezik.
The tablets usually dissolve in 14 to 25 minutes, releasing the active substance, which is absorbed directly into the bloodstream.
Tableta se običajno raztopi v 14 do 25 minutah, pri čemer sprošča zdravilno učinkovino, ki se absorbira neposredno v krvni obtok.
This is a summary of the European public assessment report (EPAR) for Effentora.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Effentora.
After 30 minutes, any pieces of tablet remaining can be swallowed with a glass of water.
Če so po 30 minutah v ustih še ostanki tablete, se ti lahko splaknejo s kozarcem vode.
What measures are being taken to ensure the safe and effective use of Effentora?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Effentora?
The CHMP decided that Effentora's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Effentora večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
A risk management plan has been developed to ensure that Effentora is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Effentora je bil pripravljen načrt obvladovanja tveganj.
Effentora is taken at the start of a breakthrough pain episode.
Zdravilo Effentora se vzame na začetku epizode prebijajoče bolečine.
The most common side effects with Effentora (that may affect more than 1 patient in 10) are dizziness, headache, nausea (feeling sick), vomiting, and reactions at the site of application including bleeding, pain, ulcers, irritation, unusual sensations, numbness, redness, swelling and spots.
Najpogostejši neželeni učinki zdravila Effentora (ki lahko prizadenejo več kot 1 bolnika od 10) so omotica, glavobol, navzeja (slabost), bruhanje in reakcije na mestu namestitve tablete, vključno s krvavenjem, bolečino, razjedami, draženjem, neobičajnimi občutki, odrevenelostjo, pordelostjo, otekanjem in madeži.
Patients should not eat or drink anything while the tablet is in the mouth.
Bolniki ne smejo s tableto v ustih ničesar jesti ali piti.
The company that makes Effentora will also provide educational materials in each European Union (EU) Member State to make sure that patients and doctors are aware of how the medicine should be used safely, the risks of accidental exposure to fentanyl and how to dispose of Effentora.
Družba, ki izdeluje zdravilo Effentora, bo v vseh državah članicah Evropske unije (EU) priskrbela tudi izobraževalno gradivo, s katerim bo zagotovila, da so bolniki in zdravniki poučeni o varnem načinu jemanja zdravila, tveganjih v primeru nenamerne izpostavitve fentanilu in načinu odstranjevanja zdravila.
This means that because the medicine can be misused or cause addiction, it is used under stricter conditions than normal.
To pomeni, da se zdravilo zaradi možnosti zlorabe ali povzročitve zasvojenosti uporablja pod strožjimi pogoji kot sicer.
For more information about treatment with Effentora, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Effentora preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The tablets should not be broken or crushed, and they should not be sucked, chewed or swallowed whole.
Tablete se ne smejo lomiti ali drobiti oziroma sesati, žvečiti ali pogoltniti cele.
Other information about Effentora
Druge informacije o zdravilu Effentora
If this dose stops controlling the pain well enough, the doctor will need to work out a new individual dose.
Če ta odmerek ni več dovolj za zadosten nadzor bolečine, mora zdravnik za vsakega posameznika najti nov ustrezen odmerek.
The most serious of these are respiratory depression (inhibition of breathing), circulatory depression (slow heartbeat), hypotension (low blood pressure) and shock (a steep fall in blood pressure).
Najresnejši neželeni učinki so respiratorna depresija (oteženo dihanje), depresija obtočil (upočasnjen srčni utrip), hipotenzija (nizek krvni tlak) in šok (nenaden padec krvnega tlaka).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Effentora.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
In both studies, each patient was treated during 10 separate episodes of breakthrough pain: in seven of these episodes, each patient received Effentora, and in the other three episodes, each patient received placebo (a dummy tablet).
V obeh študijah so zdravili deset posamičnih epizod prebijajoče bolečine: pri sedmih od teh epizod je vsak bolnik prejel zdravilo Effentora, pri drugih treh epizodah pa placebo (tableto brez zdravilne učinkovine).
They should only have the necessary strengths of Effentora tablets available at any one time, to prevent confusion and possible overdose.
Vedno morajo imeti na voljo samo potrebno jakost tablet zdravila Effentora, da ne pride do zmešnjave ali prevelikega odmerjanja.
Effentora is used to treat ‘breakthrough' pain in adults with cancer who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.
Zdravilo Effentora se uporablja za zdravljenje „prebijajoče“ bolečine pri odraslih ljudeh z rakom, ki že jemljejo opioide (zdravila iz skupine protibolečinskih zdravil, kamor spadata morfin in fentanil) za nadzor dolgotrajne bolečine pri raku.
There must be a gap of at least four hours between treating each episode of pain.
Med zdravljenjem posamičnih epizod bolečine mora biti najmanj štiriurni premor.
What benefit has Effentora shown during the studies?
Kakšne koristi je zdravilo Effentora izkazalo med študijami?
Effentora can also cause the side effects typically seen with other opioids, but these tend to decrease or stop with continued use.
Zdravilo Effentora lahko povzroči tudi neželene učinke, značilne za druge opioide, vendar pa se ti z nadaljevanjem uporabe zmanjšujejo oziroma izzvenijo.
The ability of Effentora to treat breakthrough pain was tested in two main studies involving a total of 150 adults with cancer who were being treated with opioids.
Učinkovitost zdravila Effentora pri zdravljenju prebijajoče bolečine so proučevali v dveh glavnih študijah s skupno 150 odraslimi bolniki z rakavim obolenjem, ki so jemali opioide.
The active substance in Effentora, fentanyl, is an opioid.
Zdravilna učinkovina v zdravilu Effentora, fentanil, je opioid.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Effentora, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Effentora in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
When a patient starts to take Effentora, the doctor will need to work out the appropriate individual dose that will provide adequate pain relief for the patient with few side effects.
Ko bolnik začne jemati zdravilo Effentora, mora zdravnik ugotoviti ustrezen odmerek za vsakega posameznika posebej, ki bo zagotovil ustrezno lajšanje bolečin s čim manj neželenimi učinki.
Effentora was more effective than placebo in reducing pain in both studies.
V obeh študijah je bilo zdravilo Effentora pri zmanjševanju bolečine učinkovitejše od placeba.
In the second study, pain intensity had fallen by 9.7 points at 60 minutes after Effentora and by 4.9 points after placebo.
V drugi študiji se je intenzivnost bolečine zmanjšala za 9,7 točke 60 minut po uporabi zdravila Effentora oziroma za 4,9 točke po uporabi placeba.
See the package leaflet for further information.
Za več informacij glejte navodilo za uporabo.
Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.
O „prebijajoči bolečini“ govorimo takrat, ko bolnik občuti nenadno dodatno bolečino, čeprav že prejema protibolečinska zdravila.
Once the appropriate dose for the patient has been found, the patient should take this dose as a single tablet.
Ko je ustrezni odmerek določen, naj ga bolnik vzame v eni tableti.
What is the risk associated with Effentora?
Kakšna tveganja so povezana z zdravilom Effentora?
The patient should be monitored carefully while the dose is increased.
Med povečevanjem odmerka je treba bolnika skrbno spremljati.
Effentora is a medicine that contains the active substance fentanyl.
Effentora je zdravilo, ki vsebuje zdravilno učinkovino fentanil.
Effentora must not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression, or who have severe obstructive lung conditions (diseases that severely impede breathing).
Zdravila Effentora ne smejo uporabljati bolniki, ki še ne jemljejo opioidov za vzdrževanje nadzora nad bolečino, kakor tudi ne tisti, ki imajo resno respiratorno depresijo ali obolenje s hudo obstrukcijo pljuč
It must not be used to treat short-term pain other than breakthrough pain.
Lahko se uporablja samo za zdravljenje prebijajoče bolečine, ne sme pa se uporabljati za zdravljenje drugih vrst kratkotrajnih bolečin.
For the full list of all side effects reported with Effentora, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Effentora, glejte navodilo za uporabo.
In the first study, pain intensity had fallen by an average of 3.2 points at 30 minutes after the patients took Effentora and by 2.0 points after they took placebo.
V prvi študiji se je intenzivnost bolečine v povprečju zmanjšala za 3,2 točke 30 minut po zaužitju zdravila Effentora oziroma za 2,0 točke po zaužitju placeba.
Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to prevent pain
Ko fentanil vstopi v krvni obtok, začne delovati na receptorje v možganih in hrbtenjači ter tako olajša bolečine.
Treatment with Effentora should be started by and remain under the guidance of a doctor who has experience in the management of opioid treatment in cancer patients.
Zdravljenje z zdravilom Effentora sme uvesti in ves čas voditi le zdravnik, ki ima izkušnje z izvajanjem zdravljenja z opiodi pri bolnikih z rakom.
Why has Effentora been approved?
Zakaj je bilo zdravilo Effentora odobreno?
The tablets should be removed from the packaging immediately before being placed between the gum and the cheek.
Tableto je treba vzeti iz ovojnine, tik preden se vstavi med dlesen in lice v notranjem delu ustne votline.
In Effentora, it is given as a buccal tablet, so that the fentanyl is absorbed through the lining of the mouth.
Zdravilo Effentora se daje v obliki bukalnih tablet, tako da se fentanil absorbira skozi ustno sluznico.
How has Effentora been studied?
Kako je bilo zdravilo Effentora raziskano?
What is Effentora used for?
Za kaj se zdravilo Effentora uporablja?
What is Effentora?
Kaj je zdravilo Effentora?
How is Effentora used?
Kako se zdravilo Effentora uporablja?
How does Effentora work?
Kako zdravilo Effentora deluje?
Patients should not possess or use any other medicines containing fentanyl for the treatment of breakthrough cancer pain at the same time as using Effentora.
Med zdravljenjem prebijajoče bolečine pri raku z zdravilom Effentora bolniki ne smejo imeti pri sebi ali jemati drugih zdravil, ki vsebujejo fentanil.
Oral use bottle (HDPE)
peroralna uporaba plastenka (HDPE)
MA (EU) Number (Invented) name
Številka (EU) dovoljenja za promet
Pharmaceutical form Route of administration Immediate Packaging
Farmacevtska oblika Pot uporabe
Pack size
Stična ovojnina Velikost pakiranja
The CHMP agrees with the responses.
CHMP se strinja z odgovori.
Protein binding is 85-90%.
Vezava na beljakovine je 85-90%.
After first opening: 3 months
Po prvem odprtju: 3 mesece
The impact of the differences of the two preparations is unknown.
Vpliv razlik med obema pripravkoma ni znan.
Member State EU/EEA
Država članica ES/EGP
You must use this medicine regularly or it will not work properly.
To zdravilo morate redno uporabljati, sicer ne bo ustrezno delovalo.
The patient should be informed that the full effect is not achieved until after a few days of treatment.
Bolnika moramo obvestiti, da bo popoln učinek dosežen šele po nekaj dneh zdravljenja.
Adults, adolescents and children from 6 years of age:
Odrasli, mladostniki in otroci od 6. leta dalje:
Undesirable effects frequencies were defined as follows:
Pogostnost neželenih učinkov je definirana na naslednji način:
This is an infection that can affect your lungs.
To je okužba, ki lahko prizadene vaša pljuča.
ATC Code: R01AD05
Oznaka ATC: R01AD05
A reduction of the dose may also be considered.
Razmislimo lahko tudi o znižanju odmerka.
Children should be treated under guidance of an adult.
Otroci naj bodo zdravljeni pod vodstvom odrasle osebe.
If this happens, your doctor will need to treat these other symptoms separately.
Če se vam to zgodi, bo moral vaš zdravnik te druge simptome zdraviti ločeno.
The desired clinical effect appears within about 1-2 weeks.
Želen klinični učinek se pojavi v približno 1-2 tednih.
The dosage should be determined individually.
Odmerjanje moramo določiti individualno.
You are unlikely to experience any medical problems.
Malo je verjetno, da boste imeli kakšne zdravstvene težave.
Remove the protective cap.
Odstranite zaščitno zaporko.
Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant.
Svojemu zdravniku zagotovo nemudoma povejte, če ste noseči, mislite, da bi lahko bili noseči, ali če nosečnost načrtujete.
Further Information).
Dodatne informacije).
Special care is needed in patients with tuberculosis.
Pri bolnikih s tuberkulozo je potrebna posebna previdnost.
Hold the bottle as shown in figure 2.
Stekleničko držite, kot je prikazano na sliki 2.
C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Danmark
C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Danska
The priming effect remains for approximately 24 hours.
Učinek polnjenja ostane približno 24 ur.
You can either use this medicine:
Zdravilo lahko uporabljete bodisi:
The CHMP adopted the following List of Questions focusing on the paediatric and adolescent indication:
CHMP je sprejel naslednji seznam vprašanj, ki se osredotočajo na indikacijo za otroke in mladostnike:
The dose should be adjusted to suit you.
Odmerek je treba prilagoditi tako, da vam bo ustrezal.
Veluwezoom 22 1327 AH Almere Netherlands
Veluwezoom 22 1327 AH Almere Nizozemska
- very common (≥1/10) - common (≥1/100 to <1/10) - uncommon (≥1/1,000 to <1/100) - rare (≥1/10,000 to <1/1,000) - very rare (<1/10,000), not known (cannot be estimated from the available data)
- zelo pogosti (≥ 1/10) - pogosti (≥ 1/100 do < 1/10) - občasni (≥ 1/1.000 do < 1/100) - redki (≥ 1/10.000 do < 1/1.000) - zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov)
The volume of distribution of budesonide is approximately 3 L/kg.
Volumen porazdelitve budezonida je približno 3 l/kg.
It should be sprayed into your nostrils as described below.
Pršiti ga morate v nosnici, kot je opisano spodaj.
Rare: growth suppression in children (see section 4.4), Very rare: adrenal supression
Redki: zaviranje rasti pri otrocih (glejte poglavje 4.4), Zelo redki: supresija nadledvične žleze
They should be treated additionally if needed.
Če je potrebno, jih dodatno zdravimo.
Clinically, the most important outcome measure of human growth is the final height in relation to the expected final height.
Klinično najpomembnejše merilo izida rasti pri človeku je končna višina v odvisnosti od pričakovane končne višine.
The metabolites are eliminated in the urine in unchanged or conjugated form.
Presnovki se izločajo v urin v nespremenjeni ali konjugirani obliki.
Gently blow your nose to clean the nostrils, if necessary.
Rahlo se useknite, da si očistite nosnici, če je potrebno.
• if you have had an operation on your nose or any other injury to your nose that has not yet fully recovered
• če ste imeli operacijo nosu ali kakršnokoli poškodbo nosu, ki še ni povsem zaceljena;
• slowing of the growth rate in children and adolescents, particularly after taking high doses for a long time
• upočasnjena rast pri otrocih in mladostnikih, zlasti po jemanju visokih odmerkov v daljšem časovnem obdobju.
The Applicant therefore concludes that there is no justification for additional clinical data in the paediatric population.
Predlagatelj je zato zaključil, da ni razloga za dodatne klinične podatke pri pediatrični populaciji.
Discard the opened bottle with any remaining solution after 3 months.
Odprto stekleničko s preostalo raztopino zavzite po 3 mesecih.
• fragile bones
• krhke kosti
In addition, consideration should be given to referring the patient to the paediatric specialist.
Dodatno je potrebno razmisliti o napotitvi bolnika k specialistu pediatrije.
Ideally, you should start to use this medicine up to 14 days before you expect your symptoms to start.
Najbolje je, da to zdravilo začnete uporabljati do 14 dni prej, preden pričakujete začetek simptomov.
Raiffeisenstraße 11 83607 Holzkirchen Germany
Raiffeisenstraße 11 83607 Holzkirchen Nemčija
After this, your doctor may lower your dose.
Po tem času vam bo zdravnik morda znižal odmerek.
• if you were told by your doctor you have infection of airways or lung tuberculosis.
• če vam je zdravnik povedal, da imate okužbo dihalnih poti ali pljučno tuberkulozo.
However, disagreement between the member states involved in the procedure regarding the inclusion of children and adolescents remained, and the procedure was referred to the CHMP.
Vendar je ostalo nesoglasje med državami članicami, ki sodelujejo v postopku, glede vključitve otrok in mladostnikov, zato je bil postopek napoten na Odbor za zdravila za uporabo v humani medicini (CHMP).
The Applicant stated that growth is divided into 3 distinct age-related phases and that conclusions from studies in one age group cannot be generalised to other age groups.
Predlagatelj je navedel, da se rast razdeli v 3 ločene, od starosti odvisne faze ter da zaključkov iz študij v eni starostni skupini ni mogoče posplošiti na druge starostne skupine.
Note, it is not necessary to breathe in at the same time as you spray.
Ni nujno, da sočasno, ko popršite, vdihnete.
• if you are a child and are taking high doses of this medicine for a long time, your doctor will check your height regularly
• če ste otrok in jemljete visoke odmerke tega zdravila daljše časovno obdobje, bo vaš zdravnik redno preverjal vašo višino;
You should also tell your doctor if you are takng any other medicines such as:
Svojemu zdravniku tudi povejte, če jemljete katerakoli druga zdravila, kot so:
For a full therapeutic benefit regular use is essential.
Za popoln terapevtski učinek je nujna redna uporaba zdravila.
• irritation of the skin
• razdraženje kože
If you notice these symptoms you should contact your doctor immediately.
Če opazite omenjene simptome, se nemudoma posvetujte s svojim zdravnikom.