natgillin/translations-raw huggingface dataset:
Ryzodeg 100 units/mL solution for injection in pre-filled pen 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a multidose disposable pre-filled pen made of polypropylene.
Ryzodeg 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku 3 ml raztopine v vložku (steklo tipa 1) z batom (halobutil) in plastjo laminirane gume
Initiation
Izhodiščna vrednost
Ryzodeg 100 units/mL solution for injection in pre-filled pen Ryzodeg comes in a pre-filled pen (FlexTouch) designed to be used with NovoFine or NovoTwist injection needles.
Ryzodeg 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Zdravilo Ryzodeg je na voljo v napolnjenem injekcijskem peresniku (FlexTouch) in je namenjeno za uporabo z injekcijskimi iglami NovoFine ali NovoTwist.
Common (may affect up to 1 in 10 people)
(pojavi se lahko pri več kot 1 od 10 bolnikov).
Few severe hypoglycaemic episodes were reported in each group; the observed rate of severe hypoglycaemia within the Ryzodeg arm was higher for subjects aged 2-5 years compared to subjects aged 6-11 years or 12-17 years (0.42 vs 0.21 and 0.21 respectively).
starimi od 6 do 11 let, ali od 12 do 17 let (0,42 v primerjavi z 0,21 in 0,21).
Insulins and analogues for injection, intermediateor long-acting combined with fast-acting, ATC code: A10AD06.
Oznaka ATC: A10AD06.
Each pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 mL solution.
En napolnjen injekcijski peresnik vsebuje 300 enot insulina degludek/insulina aspart v 3 ml raztopine.
in two trials in type 2 diabetes mellitus (Table 2) and to insulin degludec (IDeg) o.d. plus insulin aspart (IAsp) 2-4 times daily in one trial in type 2 diabetes mellitus.
Zdravilo Ryzodeg dvakrat na dan (2x/dan) so primerjali z dvofaznim insulinom aspart 30 (BIAsp 30) 2x/dan v dveh preskušanjih pri sladkorni bolezni tipa 2 (preglednica 2) in z insulinom degludek (IDeg) 1x/dan v kombinaciji z insulinom aspart (IAsp) 2-4 krat na dan v enem preskušanju pri sladkorni bolezni tipa 2.
Ryzodeg 100 units/mL solution for injection in pre-filled pen Solution for injection (FlexTouch).
Ryzodeg 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku raztopina za injiciranje (FlexTouch)
Table 1 Result from two 26-weeks' trials in type 2 diabetes mellitus with Ryzodeg given once daily
Rezultati dveh 26-tedenskih preskušanj pri sladkorni bolezni tipa 2 z zdravilom Ryzodeg enkrat na dan
1 mL solution contains 100 units insulin degludec/insulin aspart* in the ratio 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart).
1 ml raztopine vsebuje 100 enot insulina degludek/insulina aspart* v razmerju 70/30 (kar ustreza 2,56 mg insulina degludek in 1,05 mg insulina aspart).
Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi glicerol metakrezol fenol natrijev klorid cinkov acetat klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
Ryzodeg allows for flexibility in the timing of insulin administration as long as it is dosed with the main meal(s).
Prilagodljivost časa odmerjanja Zdravilo Ryzodeg omogoča prilagodljivost v času apliciranja, pomembno je le, da si bolnik zdravilo aplicira ob glavnih obrokih.
)1 Insulin users
Uporabniki insulina
Each mL of solution contains 100 units insulin degludec/insulin aspart in the ratio 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart).
En ml raztopine vsebuje 100 enot insulina degludek/insulina aspart v razmerju 70/30 (kar ustreza 2,56 mg insulina degludek in 1,05 mg insulina aspart).
Your pen is designed to be used with NovoTwist or NovoFine single-use disposable needles up to a length of 8 mm.
Injekcijski peresnik je namenjen za uporabo z iglami NovoTwist ali NovoFine za enkratno uporabo,
IDet (o.d./b.i.d.
IDet (1x/dan/2x/dan)2
The following substances may reduce the insulin requirement Oral antidiabetic medicinal products, GLP-1 receptor agonists, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
peroralni antidiabetiki, agonisti receptorja GLP-1, zaviralci monoaminooksidaze (zaviralci MAO),
If you drink alcohol, your need for insulin may change.
Če pijete alkohol, se vam potreba po insulinu lahko spremeni, kajti koncentracija krvnega sladkorja se vam lahko poveča ali zmanjša.
The half-life of the basal component (insulin degludec) at steady state is 25 hours independent of dose.
Razpolovni čas bazalne sestavine (insulina degludek) v stanju dinamičnega ravnovesja je
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (100 units/mL cartridge (Penfill))
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (Vložek 100 enot/ml (Penfill))
Primary analysis (3-point MACE) CV Death
Primarna analiza (3-komponentni
• oral contraceptives (birth control pills)
• peroralne kontraceptive (tablete za preprečevanje zanositve), • ščitnične hormone (uporabljajo se za zdravljenje motenj v delovanju žleze ščitnice),
Read the package leaflet before use Subcutaneous use
POSTOPEK IN POT UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
How to store Ryzodeg
Shranjevanje zdravila Ryzodeg
Ryzodeg 100 units/mL solution for injection in pre-filled pen 70% insulin degludec / 30% insulin aspart
Ryzodeg 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku 70 % insulina degludek/30 % insulina aspart
Ryzodeg 100 units/mL solution for injection in cartridge After first opening or carried as a spare, the medicinal product may be stored for a maximum of 4 weeks.
Po prvem odprtju ali ko se uporablja kot rezerva, se lahko zdravilo shranjuje največ 4 tedne.
Ryzodeg pre-filled pen 100
PODATKI V BRAILLOVI PISAVI Ryzodeg vložek 100
Ryzodeg should be used with special caution in children 2 to 5 years old.
V skupini z zdravilom Ryzodeg je bil opaženi delež hude hipoglikemije večji pri osebah, starih od 2 do 5 let, v primerjavi z osebami,
The basal component of Ryzodeg (insulin degludec) forms soluble multi-hexamers upon subcutaneous injection, resulting in a depot from which insulin degludec is continuously and slowly absorbed into the circulation leading to a flat and stable glucose-lowering effect.
Tako nastane depo, iz katerega se insulin degludek stalno in počasi absorbira v obtok, zaradi česar je zniževanje koncentracije glukoze enakomerno in stabilno.
Ryzodeg 100 units/mL solution for injection in cartridge 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) in a carton.
3 ml raztopine v vložku (steklo tipa 1) z batom (halobutil) in plastjo laminirane gume
Always keep the cap on the pen when you are not using it in order to protect from light.
Kadar injekcijskega peresnika ne uporabljate, naj bo vedno pokrit s pokrovčkom za zagotovitev zaščite pred svetlobo.
demonstrated similar glycaemic control (HbA1c) compared with BIAsp 30 b.i.d.
Urejenost glikemije (HbA1c) pri bolnikih s sladkorno boleznijo tipa 2 je z zdravilom Ryzodeg 2x/dan podobna kot z BIAsp 30 2x/dan.
PARTICULARS TO APPEAR ON THE INNER PACKAGING INNER CARTON FOR MULTIPACK (100 units/mL pre-filled pen (FlexTouch))
PODATKI, KI MORAJO BITI NAVEDENI NA STIČNIH OVOJNINAH NOTRANJA ŠKATLA SKUPNEGA PAKIRANJA (Napolnjen injekcijski peresnik 100 enot/ml (FlexTouch))
insulin detemir (IDet) plus IAsp in type 1 diabetes mellitus (Table 3).
Zdravilo Ryzodeg 1x/dan v kombinaciji z insulinom aspart (IAsp) so primerjali tudi s kombinacijo insulina detemir (IDet) in IAsp 1x/dan ali 2x/dan pri sladkorni bolezni tipa 1 (preglednica 3).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (100 units/mL cartridge (Penfill))
NALEPKA (Vložek 100 enot/ml (Penfill))
In one trial of patients with type 2 diabetes mellitus treated with basal insulin, in need of treatment intensification with mealtime insulin, Ryzodeg o.d. was compared to IGlar o.d. plus IAsp o.d. over 26 weeks.
so v primeru potrebe po intenziviranju zdravljenja z insulinom ob obroku zdravilo Ryzodeg 1x/dan primerjali z IGlar 1x/dan v kombinaciji z IAsp 1x/dan 26 tednov.
This medicine can cause allergic reactions such as hives, swelling of the tongue and lips, diarrhoea, nausea, tiredness and itching.
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) To zdravilo lahko povzroči alergijske reakcije, na primer koprivnico, otekanje jezika in ustnic, drisko,
How to use Ryzodeg
Kaj vsebuje zdravilo Ryzodeg
Mean HbA1c (%)
Povprečni HbA1c (%) Na koncu preskušanja Povprečna sprememba
In one trial in type 2 diabetes mellitus Ryzodeg o.d. was compared to insulin glargine (IGlar) o.d. plus IAsp o.d. After 26 weeks of treatment the Ryzodeg dose could be split into b.i.d.
V enem preskušanju pri sladkorni bolezni tipa 2 so zdravilo Ryzodeg 1x/dan primerjali z insulinom glargin (IGlar) 1x/dan v kombinaciji z IAsp 1x/dan.
If you have kidney or liver problems
Če ste noseči ali dojite,
Ryzodeg (o.d.)1 Insulin naïve
(2x/dan)1 Uporabniki insulina
Ryzodeg 100 units/mL solution for injection in pre-filled pen Ryzodeg 100 units/mL solution for injection in cartridge
Ryzodeg 100 enot/ml raztopina za injiciranje v vložku
In two trials combining insulin and OAD treatment in both insulin-naïve (insulin initiation) and insulin-using (insulin intensification) patients with type 2 diabetes mellitus, Ryzodeg o.d. demonstrated similar glycaemic control (HbA1c) compared to IGlar (administered according to label) (Table 1).
(intenziviranje insulinskega zdravljenja)), je bila urejenost glikemije (HbA1c) z zdravilom Ryzodeg 1x/dan podobna kot z IGlar (uporabljenim v skladu z navodili) (preglednica 1).
One pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 mL solution 1 mL solution contains 100 units of insulin degludec/insulin aspart in the ration of 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart)
1 ml raztopine vsebuje 100 enot insulina degludek/insulina aspart v razmerju 70/30 (kar ustreza 2,56 mg insulina degludek in 1,05 mg insulina aspart),
Always use this medicine exactly as your doctor has told you.
Kako uporabljati zdravilo Ryzodeg Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika.
Very common Hypoglycaemia
Presnovne in prehranske motnje zelo pogosti hipoglikemija
This medicinal product must not be drawn from the cartridge of the pre-filled pen into a syringe (see section 4.4).
Tega zdravila se ne sme izvleči iz vložka napolnjenega injekcijskega peresnika v injekcijsko brizgo
Start by checking your pen to make sure that it contains Ryzodeg 100 units/mL, then look at the illustrations below to get to know the different parts of your pen and needle.
Začnite tako, da preverite injekcijski peresnik in se tako prepričate, da vsebuje zdravilo Ryzodeg 100 enot/ml.
Package leaflet: Information for the patient Ryzodeg 100 units/mL solution for injection in pre-filled pen
Navodilo za uporabo Ryzodeg 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
Avoidance of accidental mix-ups
Preprečevanje naključne zamenjave zdravila
• Pull off the pen cap.
• Snemite pokrovček injekcijskega peresnika.
The risk for very low blood sugar may be higher in this age group.
Je lahko zelo nevarna, saj se lahko v primeru zelo nizkega krvnega sladkorja onesvestite.
This summary was last updated in 02-2011.
Povzetek je bil nazadnje posodobljen 04-2017.
This means that they are fixed onto aluminium compounds to help stimulate a better response.
To pomeni, da so vezani na aluminijeve spojine, kar spodbudi boljši odziv.
The full EPAR for HBVaxPro 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 HBVaxPro je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This helps to protect against infection with the hepatitis B virus.
To pomaga pri zaščiti pred okužbo z virusom hepatitisa B.
This is a summary of the European public assessment report (EPAR) for HBVaxPro.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo HBVaxPro.
Vaccination should be postponed for people with a severe illness with fever.
Cepljenje je treba pri osebah s hudim obolenjem s povišano telesno temperaturo odložiti.
The CHMP concluded that the removal of thiomersal from vaccines did not reduce their effectiveness in protecting against hepatitis B virus infection, but reduced their risks.
Odbor CHMP je zaključil, da odstranitev tiomersala iz cepiva ni zmanjšala njegove učinkovitosti za zaščito pred okužbo z virusom hepatitisa B, so se pa zmanjšala tveganja.
A course of vaccination should include at least three injections of HBVaxPro.
Cikel cepljenja bi moral vključevati vsaj tri injekcije cepiva HBVaxPro.
For more information about treatment with HBVaxPro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom HBVaxPro preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The surface antigens are also ‘adsorbed'.
Površinski antigeni so adsorbirani.
HBVaxPro is available in two strengths (10 and 40 micrograms/ml).
Na voljo je v dveh jakostih (10 in 40 mikrogramov/ml).
The surface antigens in HBVaxPro are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Površinski antigeni v cepivu HBVaxPro se proizvedejo z metodo, znano kot „tehnologija rekombinantne DNK“: proizvede jih kvasovka, ki je prejela gen (DNK), s katerim lahko tvori te beljakovine.
HBVaxPro hepatitis B vaccine (rDNA)
HBVaxPro cepivo proti hepatitisu B (rDNK)
Therefore, the Committee decided that HBVaxPro's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Other information about HBVaxPro
Druge informacije o zdravilu HBVaxPro
HBVaxPro was specifically developed from a vaccine that was already in use in the European Union (EU), in order to produce a vaccine that does not contain the preservative thiomersal.
Cepivo HBVaxPro je bilo posebej razvito iz cepiva, že uporabljanega v Evropski uniji (EU), da bi pridobili cepivo, ki ne vsebuje konzervansa tiomersala.
The company provided information comparing other vaccines with and without thiomersal, including studies of a vaccine that contains the same active substance as HBVaxPro.
Družba je predložila informacije, ki primerjajo druga cepiva s tiomersalom in brez njega, vključno s študijami cepiva, ki vsebuje enako zdravilno učinkovino kot cepivo HBVaxPro.
The most common side effects with HBVaxPro (seen in between 1 and 10 patients in 100) are reactions at the injection site, including temporary soreness, erythema (redness) and induration (hardening).
Najpogostejši neželeni učinki cepiva HBVaxPro (opaženi pri 1 do 10 osebah od 100) so reakcije na mestu injiciranja, vključno s prehodno bolečino, eritemom (pordelost) in otrdelostjo.
The medicine can only be obtained with a prescription.
Predpisovanje in izdaja cepiva je le na recept.
The European Commission granted a marketing authorisation valid throughout the European Union for HBVaxPro to Sanofi Pasteur MSD SNC on 27 April 2001.
Evropska komisija je dovoljenje za promet z zdravilom HBVaxPro, veljavno po vsej Evropski uniji, izdala 27. aprila 2001.
For the full list of all side effects reported with HBVaxPro, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila HBVaxPro, glejte navodilo za uporabo.
HBVaxPro is a vaccine.
Zdravilo HBVaxPro je cepivo.
The results of the studies presented showed that the thiomersal-free vaccines produced protective levels of antibodies against hepatitis B virus to a similar extent to the vaccines that contained thiomersal at the end of the vaccination course.
Rezultati predstavljenih študij kažejo, da so s cepivi, ki ne vsebujejo tiomersala, dosežene zaščitne ravni proti virusu hepatitisa B podobne kot s cepivi, ki vsebujejo tiomersal ob koncu cikla cepljenja.
HBVaxPro should not be given to people who may be hypersensitive (allergic) to the active substance or any of the other ingredients including substances present at very low (trace) levels, such as formaldehyde and potassium thiocyanate, used in the manufacture of the vaccine.
Cepiva HBVaxPro ne smejo prejemati osebe, ki so morda preobčutljive za (alergične na) zdravilno učinkovino ali katero koli drugo sestavino, vključno s sestavinami, prisotnimi v zelo majhnih količinah (v sledeh), kot sta formaldehid in kalijev tiocianat.
This included the vaccines that contain the same active substance as HBVaxPro.
To velja tudi za cepiva, ki vsebujejo enako zdravilno učinkovino kot cepivo HBVaxPro.
HBVaxPro is used to vaccinate against hepatitis B in people who are at risk of exposure to the hepatitis B virus, as determined on the basis of official recommendations.
Zdravilo HBVaxPro je cepivo, ki se uporablja za zaščito proti hepatitisu B pri osebah, pri katerih obstaja tveganje za izpostavljenost virusu hepatitisa B, kot je določeno z uradnimi priporočili.
What benefit has HBVaxPro shown during the studies?
Kakšne koristi je zdravilo HBVaxPro izkazalo v študijah?
The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the viruses.
Posledično bo imunski sistem ob ponovni izpostavitvi virusom sposoben hitreje tvoriti protitelesa.
HBVaxPro is a vaccine, which is available as a suspension for injection in vials and pre-filled syringes.
Cepivo HBVaxPro je na voljo kot suspenzija za injiciranje v vialah in napolnjenih injekcijskih brizgah.
What is the risk associated with HBVaxPro?
Kakšna tveganja so povezana z zdravilom HBVaxPro?
Because the active substance used in HBVaxPro was already authorised for use in the EU, there have been no formal studies with HBVaxPro.
Zdravilne učinkovine v cepivu HBVaxPro so že odobrene za uporabo v EU, zato z njim ni bilo uradnih študij.
The timing of injections depends on the patient's age, strength of the immune system, response to vaccination and likelihood of exposure to the hepatitis B virus.
Časovni razpored injekcij je odvisen od starosti posameznika, jakosti imunskega sistema, odziva na cepivo in verjetnosti izpostavljenosti virusu hepatitisa B. Za več informacij glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
Why has HBVaxPro been approved?
Zakaj je bilo zdravilo HBVaxPro odobreno?
The higher strength (40 micrograms/ml) is used in patients who are undergoing or are about to undergo dialysis (a blood clearance technique).
Injekcija z nizko jakostjo se uporablja pri vseh osebah, razen tistih, ki prejemajo ali bodo prejemale dializo (tehniko čiščenja krvi).
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 HBVaxPro.
Pojasnjuje, kako je agencija ocenila zdravilo, na podlagi česar je priporočila njegovo odobritev v EU in pogoje njegove uporabe.
It contains parts of the hepatitis B virus as the active substance.
Cepivo HBVaxPro vsebuje dele virusa hepatitisa B kot zdravilno učinkovino.
How does HBVaxPro work?
Kako zdravilo HBVaxPro deluje?
How is HBVaxPro used?
Kako se zdravilo HBVaxPro uporablja?
What is HBVaxPro used for?
Kaj je zdravilo HBVaxPro in za kaj se uporablja?
HBVaxPro contains small amounts of ‘surface antigens' (proteins from the surface) of the hepatitis B virus.
Cepivo HBVaxPro vsebuje majhne količine površinskih antigenov (površinskih beljakovin) virusa hepatitisa B. Ko oseba prejme cepivo, imunski sistem prepozna površinske antigene kot tujke in proti njim razvije protitelesa.
27 March 2015 EMA/149624/2015
27. marec 2015 EMA/149624/2015
The review of hydroxyzine was initiated on 25 April 2014 at the request of Hungary, under Article 31 of Directive 2001/83/EC.
Pregled hidroksizina je bil na zahtevo Madžarske uveden 25. aprila 2014 skladno s členom 31 Direktive 2001/83/ES.
These medicines are available under various trade names including Atarax.
Ta zdravila so na voljo pod različnimi tržnimi imeni, vključno z imenom Atarax.
The data showed that the risk did not differ between indications.
Podatki so pokazali, da se tveganje med indikacijami ni razlikovalo.
For similar reasons, it was recommended that the treatment duration should be as short as possible.
Zaradi podobnih razlogov so priporočili, naj bo zdravljenje čim krajše.
Hydroxyzine-containing medicines have been authorised by national procedures in 22 Member States of the EU (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovakia, Spain, Sweden and United Kingdom) plus Norway and Iceland.
Zdravila, ki vsebujejo hidroksizin, so bila z nacionalnimi postopki odobrena v 22 državah članicah EU (v Avstriji, Belgiji, Bolgariji, na Cipru, v Češki republiki, na Danskem, Finskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, Irskem, v Italiji, Luksemburgu, na Malti, Nizozemskem, Poljskem, Portugalskem, Slovaškem, v Španiji, na Švedskem in v Združenem kraljestvu) in na Norveškem ter v Islandiji.
In the meantime, patients who have any concerns should speak to their doctor or pharmacist.
Medtem naj se bolniki, ki imajo kakršne koli pomisleke, posvetujejo z zdravnikom ali farmacevtom.
Hydroxyzine medicines are available in most EU countries.
Zdravila s hidroksizinom so na voljo v večini držav EU.
The new measures will now be implemented according to an agreed timetable in the individual EU countries.
Novi ukrepi se bodo v posameznih državah EU uvedli skladno s sprejetim časovnim razporedom.
The above risk minimisation measures were taken following an assessment of the available evidence, including published studies and data from regular safety monitoring.
Zgornji ukrepi za zmanjševanje tveganja so bili sprejeti po oceni razpoložljivih dokazov, vključno z objavljenimi študijami in podatki rednega spremljanja varnosti.
This potential risk was confirmed by clinical and post-marketing data.
To morebitno tveganje so podprli klinični podatki in podatki iz obdobja trženja.
• Medicines containing the antihistamine hydroxyzine are available in most EU countries.
• Zdravila, ki vsebujejo antihistaminik hidroksizin, so na voljo v večini držav EU.
The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Pregled je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC), tj. odbor, ki je odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini, ki je sestavil niz predlogov.
The CMDh is a regulatory body representing EU Member States plus Iceland, Liechtenstein and Norway, and is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Skupina CMDh je regulativni organ, ki zastopa države članice EU ter Islandijo, Lihtenštajn in Norveško in je odgovoren za zagotovitev enotnih varnostnih standardov za zdravila, ki so v EU odobrena po nacionalnih postopkih.
Having assessed the available evidence, including published studies and data from regular safety monitoring, the PRAC concluded that the risk did not differ between indications and that such events are most likely to occur in patients who have risk factors.
Ko je odbor PRAC ocenil razpoložljive dokaze, vključno z objavljenimi študijami ter podatki iz rednega spremljanja varnosti, je zaključil, da se tveganje med posamičnimi indikacijami ni razlikovalo in da se ti dogodki najverjetneje pojavijo pri bolnikih, pri katerih obstajajo dejavniki tveganja.