natgillin/translations-raw huggingface dataset:
Imprida HCT should not be used in people who may be hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Imprida HCT.
Zdravila Imprida HCT ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilne učinkovine, druge sulfonamide, derivate dihidropiridina ali katero koli drugo sestavino zdravila Imprida HCT.
The most common side effects with Imprida HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention).
Najpogostejši neželeni učinki zdravila Imprida HCT (opaženi pri 1 od 10 bolnikov izmed 100) so hipokaliemija (nizka raven kalija v krvi), omotičnost, glavobol, hipotenzija (nizek krvni tlak), dispepsija (zgaga), polakisurija (neobičajno pogosto uriniranje), utrujenost in edem (zadrževanje tekočine).
The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Imprida HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.
Povprečno znižanje krvnega tlaka je bilo okrog 39,7/24,7 mmHg pri bolnikih, ki so prejemali zdravilo Imprida HCT, v primerjavi z 32/19,7 mmHg pri bolnikih, ki so prejemali kombinacije valsartan/hidroklorotiazid, 33,5/21,5 mmHg pri bolnikih, ki so prejemali kombinacije valsartan/amlodipin, in 31,5/19,5 mmHg pri bolnikih, ki so prejemali kombinacije hidroklorotiazid/amlodipin.
When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction.
Ko kalcijevi ioni vstopijo v celice mišic v stenah žil, se te začnejo krčiti.
Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Angiotenzin II je učinkovit vazokonstriktor (snov, ki zožuje žile).
What is the risk associated with Imprida HCT?
Kakšna tveganja so povezana z zdravilom Imprida HCT?
Imprida HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
Zdravilo Imprida HCT se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih, pri katerih je krvni tlak že ustrezno nadzorovan z uporabo kombinacije amlodipina, valsartana in hidroklorotiazida.
Imprida HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Zdravilo Imprida HCT je zdravilo, ki vsebuje tri zdravilne učinkovine amlodipin, valsartan in hidroklorotiazid.
The full EPAR for Imprida HCT can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Imprida HCT je na voljo tukaj.
Finally, Imprida HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Zdravila Imprida HCT ne smejo uporabljati bolniki s hipokaliemijo (nizko ravnjo kalija v krvi), hiponatriemijo (nizko ravnjo natrija v krvi) in hiperkalciemijo (visoko ravnjo kalcija v krvi), ki se ne odzivajo na zdravljenje, ter bolniki s simptomatsko hiperurikemijo (visoko koncentracijo sečne kisline v krvi).
Imprida HCT amlodipine, valsartan and hydrochlorothiazide EPAR summary for the public
Imprida HCT amlodipin, valsartan in hidroklorotiazid
The CHMP therefore decided that Imprida HCT's benefits are greater than its risks for the treatment of essential hypertension in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
CHMP je torej zaključil, da so koristi zdravila Imprida HCT pri zdravljenju esencialne hipertanzije pri odraslih, pri katerih je krvni tlak že ustrezno nadzorovan s kombinacijo amlodipina, valsartana in hidroklorotiazida, večje od z njim povezanih tveganj.
It must also not be used in patients who have liver or bile problems (such as jaundice), severe kidney problems, anuria (a condition in which a patient cannot make or pass urine) or in patients undergoing dialysis (a blood clearance technique).
Prav tako zdravila ne smejo uporabljati osebe, ki imajo obolenja jeter ali žolčnika (zlatenica), hude ledvične okvare, anurijo (nezmožnost izločanja urina) ali bolniki na dializi (tehniki čiščenja krvi).
Why has Imprida HCT been approved?
Zakaj je bilo zdravilo Imprida HCT odobreno?
In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Imprida HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide).
Poleg tega je bila izvedena glavna študija, v kateri so proučevali 2 271 bolnikov z zmerno do hudo hipertenzijo, ki prejemajo največji odmerek zdravila Imprida HCT (320 mg valsartana, 10 mg amlodipina in 25 mg hidroklorotiazida) Bolniki so osem tednov prejemali bodisi zdravilo Imprida HCT bodisi eno od treh kombinacij, ki vsebujejo le dve zdravilni učinkovini.
What is Imprida HCT?
Kaj je zdravilo Imprida HCT?
What is Imprida HCT used for?
Za kaj se zdravilo Imprida HCT uporablja?
How has Imprida HCT been studied?
Kako je bilo zdravilo Imprida HCT raziskano?
How is Imprida HCT used?
Kako se zdravilo Imprida HCT uporablja?
How does Imprida HCT work?
Kako zdravilo Imprida HCT deluje?
Further information on Hulio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Hulio so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
After 24 weeks, a 20% improvement in symptoms was seen in 74% of Hulio-treated patients (270 of 363) and 76% of Humira treated patients (271 of 358).
Po 24 tednih so 20-odstotno izboljšanje simptomov opazili pri 74 % (270 od 363) bolnikov, zdravljenih z zdravilom Hulio, in 76 % (271 od 358) bolnikov, zdravljenih z zdravilom Humira.
An alert card will also be given to patients.
Sočasno bodo bolniki prejeli opozorilno kartico.
This means that Hulio is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
What measures are being taken to ensure the safe and effective use of Hulio?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Hulio?
An overview of Hulio and why it is authorised in the EU
Pregled zdravila Hulio in zakaj je odobreno v EU
Other information about Hulio
Druge informacije o zdravilu Hulio
After training, patients or their carers may inject Hulio if their doctor considers it appropriate.
Bolniki ali njihovi skrbniki lahko po opravljenem usposabljanju sami injicirajo zdravilo Hulio, če zdravnik meni, da je to zanje primerno.
As for all medicines, data on the use of Hulio are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Hulio stalno spremljajo.
What benefits of Hulio have been shown in studies?
Kakšne koristi zdravila Hulio so se pokazale v študijah?
Side effects reported with Hulio are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Hulio, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Why is Hulio authorised in the EU?
Zakaj je bilo zdravilo Hulio odobreno v EU?
Hulio is a medicine that acts on the immune system and is used to treat the following conditions:
Hulio je zdravilo, ki učinkuje na imunski sistem in se uporablja za zdravljenje naslednjih bolezni:
The company that markets Hulio must provide educational packs for doctors who prescribe the medicine.
Podjetje, ki trži zdravilo Hulio, mora pripraviti izobraževalno gradivo za zdravnike, ki zdravilo predpisujejo.
Hulio is available as a solution for injection under the skin in a vial or pre-filled syringe or pen and is usually given every 2 weeks.
Zdravilo Hulio je na voljo v obliki raztopine za injiciranje pod kožo v viali ali napolnjeni injekcijski brizgi ali peresniku in se običajno daje vsaka dva tedna.
Hulio is mostly used in adults when their condition is severe, moderately severe or getting worse, or when patients cannot use other treatments.
Zdravilo Hulio se večinoma uporablja pri odraslih, pri katerih je bolezen huda, zmerno huda ali se poslabšuje, oziroma kadar bolnik ne more prejemati drugega zdravljenja.
What are the risks associated with Hulio?
Kakšna tveganja so povezana z zdravilom Hulio?
The dose and frequency of injection depends on the condition to be treated and the dose for a child is usually calculated according to the child's weight.
Odmerek in pogostnost injiciranja sta odvisna od bolezni, ki se zdravi, pri otrocih pa se odmerek običajno izračuna na podlagi telesne mase otroka.
Hulio must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Zdravilo Hulio se ne sme uporabljati pri bolnikih z aktivno tuberkulozo ali drugimi hudimi okužbami ali bolnikih z zmernim do hudim srčnim popuščanjem (stanjem, pri katerem srce ne zmore črpati dovolj krvi po telesu).
What is Hulio and what is it used for?
Kaj je zdravilo Hulio in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hulio have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Hulio upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The active substance in Hulio, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Učinkovina v zdravilu Hulio, adalimumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da v telesu prepozna snov, imenovano tumorje nekrotizirajoči faktor (TNF), in se veže nanjo.
TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Hulio is used to treat.
TNF sodeluje pri povzročanju vnetij in je prisoten v visokih koncentracijah pri bolnikih z boleznimi, za katere se zdravilo Hulio uporablja.
Like other medicines of its class, Hulio may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Tako kot druga zdravila iz istega razreda lahko tudi zdravilo Hulio vpliva na obrambno sposobnost imunskega sistema proti okužbam in raku; pri bolnikih, ki prejemajo adalimumab, so bili namreč zabeleženi nekateri primeri resnih okužb in krvnega raka.
Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).
Drugi redki resni neželeni učinki (ki se lahko pojavijo pri največ 1 bolniku od 1 000) so nezmožnost kostnega mozga za proizvodnjo krvnih celic, motnje živčevja, lupus in lupusu podobna obolenja (pri katerih imunski sistem napada bolnikova lastna tkiva, to pa povzroča vnetje in poškodbe organov) in Stevens-Johnsonov sindrom (smrtno nevarno reakcijo z gripi podobnimi simptomi in bolečim izpuščajem, ki prizadene kožo, usta, oči in spolovila).
The reference medicine for Hulio is Humira.
Referenčno zdravilo za zdravilo Hulio je zdravilo Humira.
All these data were considered sufficient to conclude that Hulio will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Hulio pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Humira.
For more information on the use of Hulio in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Hulio pri vseh navedenih boleznih, vključno s tem, kdaj se lahko uporablja pri otrocih, glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Najpogostejši neželeni učinki adalimumaba (opaženi pri več kot 1 bolniku od 10 so okužbe (vključno z okužbami nosu, grla in sinusov), reakcije na mestu injiciranja (rdečina, srbenje, krvavenje, bolečina ali oteklina), glavobol ter bolečine v mišicah in kosteh.
Hulio can only be obtained with a prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Hulio is used.
Predpisovanje in izdaja zdravila Hulio je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolezni, za katere se zdravilo Hulio uporablja.
• non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).
• neinfekcijskega uveitisa (vnetja sloja pod beločnico očesa).
Eye specialists treating uveitis should also take advice from doctors who have experience of using adalimumab.
Zdravniki specialisti za očesne bolezni, ki zdravijo uveitis, se morajo posvetovati z zdravniki, ki imajo izkušnje z uporabo adalimumaba.
Because Hulio is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Hulio.
Zdravilo Hulio je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti adalimumaba, ki so že bile izvedene z zdravilom Humira, z zdravilom Hulio ni treba ponavljati.
• axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation;
• aksialnega spondiloartritisa (vnetja hrbtenice, ki povzroča bolečine v hrbtu), vključno z ankilozirajočim spondilitisom in kadar rentgenska slika ne kaže poškodb, so pa prisotni očitni znaki vnetja;
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Hulio has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Hulio po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Humira in da se po telesu enako prenaša.
Hulio contains the active substance adalimumab and is a ‘biosimilar medicine'.
Zdravilo Hulio vsebuje učinkovino adalimumab in je „podobno biološko zdravilo“.
For the full list of side effects and restrictions with Hulio, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Hulio glejte navodilo za uporabo.
For more information about using Hulio, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Hulio glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
In addition, a study in patients with rheumatoid arthritis has shown that the effects of the medicine are equivalent to those of Humira in this condition.
Poleg tega je študija pri bolnikih z revmatoidnim artritisom pokazala, da so učinki zdravila Hulio pri tej bolezni enakovredni učinkom zdravila Humira.
Therefore, the Agency's view was that, as for Humira, the benefit of Hulio outweighs the identified risk and it can be authorised.
Agencija je zato menila, da koristi zdravila Hulio enako kot pri zdravilu Humira odtehtajo znana tveganja in da se zdravilo lahko odobri.
Laboratory studies comparing Hulio with the reference medicine Humira have shown that the active substance in Hulio is highly similar to that in Humira in terms of structure, purity and biological activity.
Laboratorijske študije, v katerih so zdravilo Hulio primerjali z zdravilom Humira, so pokazale, da je učinkovina v zdravilu Hulio po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Humira.
• hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin;
• obolenja hidradenitis suppurativa (acne inversa), tj. dolgotrajnega obolenja kože, ki povzroča vozliče, abscese (gnojne tvorbe) in kožne brazgotine;
Studies have also shown that giving Hulio produces similar levels of the active substance in the body to giving Humira.
Študije so pokazale tudi, da zdravilo Hulio vzpostavi podobne ravni učinkovine v telesu kot zdravilo Humira.
• Crohn's disease (a disease causing inflammation of the gut);
• Crohnove bolezni (bolezni, ki povzroča vnetje črevesja);
In addition, Hulio was as effective as Humira in a study involving 730 patients with rheumatoid arthritis that was not adequately controlled with the medicine methotrexate.
Poleg tega je bilo v študiji, ki je vključevala 730 bolnikov z revmatoidnim artritisom, ki z metotreksatom ni bil dovolj nadzorovan, zdravilo Hulio enako učinkovito kot zdravilo Humira.
How is Hulio used?
Kako se zdravilo Hulio uporablja?
How does Hulio work?
Kako zdravilo Hulio deluje?
• polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints);
• poliartikularnega juvenilnega idiopatskega artritisa in aktivnega artritisa, povezanega z entezitisom
• plaque psoriasis (a disease causing red, scaly patches on the skin);
• psoriaze v plakih (bolezni, ki povzroča nastajanje rdečih, luskastih zaplat na koži);
• ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
• ulceroznega kolitisa (bolezni, ki povzroča vnetje in razjede v črevesni sluznici);
• rheumatoid arthritis (a disease causing inflammation of the joints);
• revmatoidnega artritisa (bolezni, ki povzroča vnetje sklepov);
• psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
• psoriatičnega artritisa (bolezni, ki povzroča nastajanje rdečih, luskastih zaplat na koži in vnetje sklepov);
2 (Pediatrics Vol. 79 No. 4 April 1987)(2)
79, št. 4, april 1987)(2)
• The Committee considered the notification of the referral triggered by the United Kingdom under Article 29(4) of l Directive 2001/83/EC.
• Odbor je preučil obvestilo o napotitvenem postopku, ki ga je sprožilo Združeno kraljestvo v skladu s členom 29(4) Direktive 2001/83/ES;
Chronic under-dosing has consequences to normal brain development of children.
Kronično premajhno odmerjanje pa ima posledice za normalen razvoj možganov pri otrocih.
Overall summary of the scientific evaluation of Levothyroxine Alapis and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Levothyroxine Alapis in povezanih imen (glej Prilogo I)
Harmful for those suffering from alcoholism.
Škoduje ljudem, ki imajo težave zaradi alkoholizma.
There was a significant difference in the occurrence of clinical seizures (P = .021).
Razlika v pojavu kliničnih napadov je bila statistično pomembna (P = 0,021).
• The Committee reviewed all the data that was available to address the potential serious risk to public health, in particular with regard to the safety of Levothyroxine Alapis 100 microgram/ml oral drops solution.
• Odbor je pregledal vse razpoložljive podatke, da bi obravnaval morebitno resno tveganje za javno zdravje, zlasti glede varnosti raztopine Levothyroxine Alapis 100 mikrogramov/ml v obliki peroralnih kapljic;
Deviation from a vertical position is more likely in situations where the patient / carer is attempting to manage / slow the drop rate to enable a relatively high number of drops to be counted.
Odklon od navpičnega položaja je bolj verjeten, kadar bolnik/negovalec poskuša obvladati/upočasniti hitrost kapljic, da bi lahko preštel sorazmerno veliko število kapljic.
Therefore the risk of medication error was considered to be a potential serious risk to public health.
Zato se je štelo, da tveganje za napako pri uporabi zdravila lahko pomeni resno tveganje za javno zdravje;
It is also noted that the proposed package leaflet (PL) recommends that the drops are not administered directly to the patient, but should first be delivered to a spoon.
Navedeno je tudi, da predlagano navodilo za uporabo vsebuje priporočilo, da se kapljice ne dajejo neposredno bolniku, temveč jih je najprej treba odmeriti na žlico.
Levothyroxine Alapis contains 200mg/ml of ethanol per dose.
Zdravilo Levothyroxine Alapis vsebuje 200 mg/ml etanola na odmerek.
More seizures occurred with the higher dose of propylene glycol, where 33% of the infants had seizures, vs only 14% of infants who received the lower dose of propylene glycol.
Pri višjih odmerkih propilen glikola je bilo napadov več: imelo jih je 33 % dojenčkov, medtem ko jih je imelo samo 14 % dojenčkov, ki so prejemali nižje odmerke propilen glikola.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.'
To je treba upoštevati pri nosečnicah in ženskah, ki dojijo, otrocih in skupinah z visokim tveganjem, kot so bolniki z obolenjem jeter ali epilepsijo.“
Based on the above, the CHMP considers that the safety concerns relating to Levothyroxine Alapis that were raised during the decentralised procedure and the CMDh referral procedure have not been sufficiently addressed.
CHMP na podlagi zgoraj navedenega meni, da pomisleki v zvezi z varnostjo zdravila Levothyroxine Alapis, ki so bili izraženi med decentraliziranim postopkom in napotitvenim postopkom CMDh, niso bili dovolj obravnavani.
Despite the shortcomings of this study the data suggest a dose-dependent trend towards a higher incidence of seizures with higher doses of propylene glycol.
Čeprav ima študija nekaj pomanjkljivosti, podatki kažejo na od odmerkov odvisno nagnjenost k večji pojavnosti napadov z višjimi odmerki propilen glikola.
• The Committee was of the opinion that there was an unacceptable risk of medication error due to the dropper insert, where the inappropriate orientation of the dropper insert would result in inaccurate and variable drop volume.
• Odbor je menil, da zaradi kapalnega vložka obstaja nesprejemljivo tveganje za napako pri uporabi zdravila, da bi lahko neprimerna usmeritev kapalnega vložka pripeljala do nepravilnega in spremenljivega volumna kapljic.
However this was not accepted due to the risk of dosing errors.
Predlog pa ni bil sprejet zaradi tveganja za napake pri odmerjanju zdravila.
The proposed patient populations are: adults, children over 12 years (in the treatment of diffuse non-toxic goitre), and neonates and infants (with congenital hypothyroidism).
Predlagane skupine bolnikov so: odrasli, otroci, starejši od 12 let (pri zdravljenju difuzne netoksične golše), ter novorojenčki in dojenčki (s prirojenim hipotiroidizmom).