natgillin/translations-raw huggingface dataset:
In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 μg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 × 109) was observed in younger children aged 0-5 years (8.9 days) compared to older children aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults.
ki so dobili 100 μg/kg pegfilgrastima po 1. ciklusu kemoterapije z vinkristinom, doksorubicinom in ciklofosfamidom (VAdriaC/IE), so pri mlajših otrocih, starih od 0 do 5 let, ugotovili dolgotrajnejšo hudo nevtropenijo (nevtrofilci < 0,5 x 109) (8,9 dni) kot pri starejših otrocih, starih od 6 do 11 let (6 dni) in 12 do 21 let (3,7 dni) in pri odraslih.
• spleen rupture.
 ruptura vranice.
• The other ingredients are sodium acetate, sorbitol (E 420), polysorbate 20 and water for injections.
 Pomožne snovi so natrijev acetat, sorbitol (E 420), polisorbat 20 in voda za injekcije.
• Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors.
• Pri bolnikih z rakom in zdravih darovalcih so redko poročali o vnetju aorte (velike žile, ki prenaša kri od srca po telesu).
Pelmeg has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Pelmeg nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Splenomegaly2; Splenic rupture2
srpastocelična kriza2, splenomegalija2, ruptura vranice2
One 6 mg dose (a single pre-filled syringe) of Pelmeg is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
Za vsak cikel kemoterapije priporočajo en 6-miligramski odmerek (eno napolnjeno injekcijsko brizgo) zdravila Pelmeg, ki je dana vsaj 24 ur po citotoksični kemoterapiji.
A higher frequency of serious adverse reactions in younger children aged 0-5 years (92 %) has been observed compared to older children aged 6-11 and 12-21 years respectively (80 % and 67 %) and adults.
Pri mlajših otrocih, starih od 0 do 5 let, so ugotovili večjo pogostnost resnih neželenih reakcij (92 %) kot pri starejših otrocih, starih od 6 do 11 (80 %) in 12 do 21 let
• if you experience a cough, fever and difficulty breathing.
 če začnete kašljati, se vam zviša telesna temperatura in začnete težko dihati.
Pre-filled syringe (Type I glass), with a bromobutyl rubber stopper and a stainless steel needle with an automatic needle guard.
6.5 Vrsta ovojnine in vsebina Napolnjena injekcijska brizga (iz stekla tipa I) z zaporko iz bromobutilne gume in iglo iz nerjavnega jekla z avtomatskim ščitnikom igle.
The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 μg·hr/mL) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 μg·hr/mL and 29.3 ± 23.2 μg·hr/mL, respectively) (see section 5.1).
večja (47,9 ± 22,5 μg h/ml) kot med otroci, starimi od 6 do 11 (22,0 ± 13,1 μg h/ml) in od 12 do 21 let (29,3 ± 23,2 μg h/ml) (glejte poglavje 5.1).
Very common side effects (may affect more than 1 in 10 people):
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):  bolečine v kosteh.
Please tell your doctor immediately if you have any of the following or combination of the following side effects:
 če se vam pojavi kateri od naslednjih neželenih učinkov ali kombinacija teh neželenih učinkov:
The overall rate of febrile neutropenia was 9 % of patients treated with pegfilgrastim and 18 % of patients treated with filgrastim (difference 9 %, 95 % CI of −16.8 %,−1.1 %).
Celotna pogostost febrilne nevtropenije je bila pri bolnikih, zdravljenih s pegfilgrastimom, 9 %, pri bolnikih, zdravljenih s filgrastimom, pa 18 % (razlika 9 %, 95 % IZ je
Respiratory Distress Syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Haemoptysis
pljučne neželene reakcije (intersticijska pljučnica, pljučni edem, pljučni infiltrati in pljučna fibroza), hemoptiza pljučna krvavitev
The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
(podkožna injekcija) z uporabo napolnjene injekcijske brizge, ki jo morate prejeti vsaj 24 ur po zadnjem odmerku kemoterapije na koncu vsakega cikla kemoterapije.
• if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing these could be signs of a severe allergic reaction.
otekanje obraza, ustnic, jezika ali drugih delov telesa, kratka sapa, piskajoče ali oteženo dihanje.
There is insufficient information on the excretion of pegfilgrastim / metabolites in human milk a risk to the newborns/infants cannot be excluded.
Dojenje Ni dovolj podatkov o izločanju pegfilgrastima/presnovkov v materino mleko.
Transient elevations in
 povečana vranica.
G-CSF can promote growth of myeloid cells, including malignant cells, in vitro and similar effects may be seen on some non-myeloid cells in vitro.
G-CSF lahko pospešuje rast mieloidnih celic, z malignimi celicami vred, in vitro,
• if you get left upper abdominal pain or pain at the tip of your shoulder.
 če začutite bolečino levo zgoraj v trebuhu ali v predelu lopatice.
Step 2: Get ready A Wash your hands thoroughly.
2. korak: Pripravite se
Pelmeg 6 mg solution for injection in pre-filled syringe pegfilgrastim
Pelmeg 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi pegfilgrastim
• The active substance is pegfilgrastim.
 Učinkovina je pegfilgrastim.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
DATUM ZADNJE REVIZIJE BESEDILA Podrobni podatki o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
Solution for injection Clear, colourless solution for injection.
FARMACEVTSKA OBLIKA raztopina za injiciranje bistra, brezbarvna raztopina za injiciranje
If you use more Pelmeg than you should contact your doctor, pharmacist or nurse.
Če ste uporabili večji odmerek zdravila Pelmeg, kot bi smeli Če uporabite več zdravila Pelmeg, kot bi smeli, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Pulmonary hemorrhage
Srpastocelična anemija
The number of cases is small, but because of the seriousness of the ADR, the PRAC recommends that the Product Information should be updated accordingly.
Število primerov je majhno, vendar zaradi resnosti
The incidence of hospitalisations and IV anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1 % versus 14 %, p < 0.001; and 2 % versus 10 %, p < 0.001).
kot med prejemnicami placeba (1 % v primerjavi s 14 %, p < 0,001, ter 2 % v primerjavi z 10 %, p < 0,001).
Syringe label Syringe barrel
OVOJNINAH NALEPKA BRIZGE
Injection site reactions, including injection site erythaema (uncommon) as well as injection site pain (common) have occurred on initial or subsequent treatment with pegfilgrastim.
Med začetnim ali nadaljnjim zdravljenjem s pegfilgrastimom so se pojavile reakcije na mestu injiciranja, vključno z eritemom na mestu injiciranja (občasni) in tudi bolečino na mestu injiciranja
Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
6.1 Seznam pomožnih snovi natrijev acetat* sorbitol (E 420) polisorbat 20 voda za injekcije klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
Talk to your doctor, pharmacist or nurse before using Pelmeg:
Pred začetkom uporabe zdravila Pelmeg se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
Unless your doctor directs you otherwise, you must stop breast-feeding if you use Pelmeg.
Če uporabljate zdravilo Pelmeg, morate prenehati dojiti, razen če vam zdravnik ne naroči drugače.
(ng/ml)
(PEG).
Additionally a higher incidence of febrile neutropenia was observed in younger children aged 0-5 years (75 %) compared to older children aged 6-11 years and 12-21 years (70 % and 33 %, respectively) and adults (see sections 4.8 and 5.2).
(70 %) in 12 do 21 let (33 %) ter pri odraslih (glejte poglavji 4.8 in 5.2).
Stop using Pelmeg and seek medical attention immediately if you notice any of the symptoms described in section 4.
Če opazite katerega od simptomov, opisanih v poglavju 4, prenehajte uporabljati zdravilo Pelmeg in nemudoma poiščite zdravniško pomoč.
Pelmeg 6 mg solution for injection in pre-filled syringe
IME ZDRAVILA Pelmeg 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
NAME OF THE MEDICINAL PRODUCT Pelmeg 6 mg solution for injection pegfilgrastim NAME OF THE MARKETING AUTHORISATION HOLDER Mundipharma EXPIRY DATE
IME ZDRAVILA Pelmeg 6 mg raztopina za injiciranje pegfilgrastim
Skin and subcutaneous tissue disorders
Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečina v kosteh mišično-skeletna bolečina
This medicinal product contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / mL.
Zdravilo Pelmeg vsebuje sorbitol (E 420) in natrijev acetat To zdravilo vsebuje 30 mg sorbitola v eni napolnjeni injekcijski brizgi, kar je enako 50 mg/ml.
The safety and efficacy of Pelmeg have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Pri bolnikih, ki dobivajo kemoterapijo, povezano z odloženo mielosupresijo, na primer nitrozouree,
Bone pain Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain)
mišično-skeletna bolečina, bolečina v vratu)
• pain at the site of injection.
Splošne težave in spremembe na mestu aplikacije bolečina na mestu injiciranja,
PharmaKorell GmbH Marie-Curie-Str. 8 79539 Loerrach Germany
PharmaKorell GmbH Marie-Curie-Str. 8
6.6 Special precautions for disposal and other handling Before administration, Pelmeg solution should be inspected visually for particulate matter.
Pred uporabo morate raztopino zdravila Pelmeg pregledati glede vidnih delcev.
Used syring barrel
Uporabljeni valj brizge
Three reported cases show a causal relationship between the adverse drug reaction (ADR) StevensJohnson syndrome and pegfilgrastim.
Trije poročani primeri kažejo na vzročno povezanost med neželenim učinkom zdravila (NUZ)
• damage to the tiny filters inside your kidneys (glomerulonephritis).
 kožni vaskulitis (vnetje krvnih žil v koži)  okvara drobnih filtrov v ledvicah (glomerulonefritis)  pordelost na mestu injiciranja  izkašljevanje krvi (hemoptiza)
Acute
Bat
How to store Pelmeg
Shranjevanje zdravila Pelmeg
Strength Pharmaceutical Form
ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija) velikost pakiranja
Route of Administration
številka EU
The European Commission granted a marketing authorisation valid throughout the European Union for Evotaz on 13 July 2015.
Evropska komisija je dovoljenje za promet z zdravilom Evotaz, veljavno po vsej Evropski uniji, izdala 13. julija 2015.
What measures are being taken to ensure the safe and effective use of Evotaz?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Evotaz?
Other information about Evotaz
Druge informacije o zdravilu Evotaz
This was comparable to a reduction in 87% of patients (304 of 348) treated with atazanavir and ritonavir.
To je bilo primerljivo z zmanjšanjem pri 87 % bolnikov (304 od 348), zdravljenih z atazanavirjem in ritonavirjem.
The main measure of effectiveness was the proportion of patients in whom the HIV-1 count in the blood (known as viral load) was reduced to less than 50 copies/ml after 48 weeks of treatment.
Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih se je število virusov HIV-1 v krvi (kar se imenuje virusno breme) po 48 tednih zdravljenja zmanjšalo na manj kot 50 kopij/ml.
This is a summary of the European public assessment report (EPAR) for Evotaz.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Evotaz.
The full EPAR and risk management plan summary for Evotaz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Evotaz sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Evotaz must not be taken by patients who have moderately or severely reduced liver function.
Zdravila Evotaz ne smejo jemati bolniki, ki imajo zmerno ali hudo poslabšano delovanje jeter.
A risk management plan has been developed to ensure that Evotaz is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Evotaz je bil pripravljen načrt obvladovanja tveganj.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Evotaz's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Evotaz večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
It must also not be taken by patients taking certain medicines because of the possibility of interactions which could be harmful.
Prav tako ga ne smejo jemati bolniki, ki uporabljajo nekatera druga zdravila, saj lahko ta medsebojno delujejo, kar je škodljivo.
It is not intended to provide practical advice on how to use Evotaz.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What benefits of Evotaz have been shown in studies?
Kakšne koristi je zdravilo Evotaz izkazalo v študijah?
In addition, the use of atazanavir with cobicistat has been evaluated in one main study in 698 HIV patients who had not been treated previously.
Poleg tega so uporabo atazanavirja v kombinaciji s kobicistatom ocenili v eni glavni študiji pri 698 bolnikih, okuženih s HIV, ki se še niso zdravili.
The medicine is for use only in patients whose infection is not expected to be resistant to atazanavir.
Zdravilo je namenjeno samo bolnikom, pri katerih okužba zelo verjetno ne bo odporna proti atazanavirju.
What is Evotaz and what is it used for?
Kaj je zdravilo Evotaz in za kaj se uporablja?
Evotaz is an antiviral medicine used in combination with other medicines to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Evotaz je protivirusno zdravilo, ki se uporablja v kombinaciji z drugimi zdravili za zdravljenje odraslih, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
What are the risks associated with Evotaz?
Kakšna tveganja so povezana z zdravilom Evotaz?
This therefore boosts atazanavir's antiviral effect.
To okrepi protivirusni učinek atazanavirja.
Evotaz is available as tablets that contain 300 mg of atazanavir and 150 mg of cobicistat.
Zdravilo Evotaz je na voljo v obliki tablet, ki vsebujejo 300 mg atazanavirja in 150 mg kobicistata.
Cobicistat increases the level of atazanavir in the blood by slowing its breakdown.
Kobicistat poviša raven atazanavirja v krvi, tako da upočasni njegov razkroj.
Overall, 85% of patients (293 out of 344) treated with atazanavir and cobicistat achieved this reduction.
To zmanjšanje je doseglo 85 % bolnikov (293 od 344), zdravljenih z atazanavirjem in kobicistatom.
The most common side effects with Evotaz (which may affect more than 1 in 10 people) are jaundice, which may show as yellow discoloration of the eye, and nausea (feeling sick).
Najpogostejša neželena učinka zdravila Evotaz (ki lahko prizadeneta več kot 1 osebo od 10) sta zlatenica, ki se lahko kaže kot porumenelost beločnice, in navzeja (slabost).
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Evotaz, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
When the enzyme is blocked, the virus cannot reproduce itself and its spread in the body slows down.
Pri zaviranju tega encima se virus ne more razmnoževati, njegovo širjenje po telesu pa se upočasni.
For more information about treatment with Evotaz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Evotaz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Atazanavir is a protease inhibitor.
Atazanavir je zaviralec proteaze.
Why is Evotaz approved?
Zakaj je bilo zdravilo Evotaz odobreno?
Combining atazanavir and cobicistat in a single tablet has the potential of simplifying the dosing regimen.
Kombinacija atazanavirja in kobicistata v eni tableti lahko poenostavi režim odmerjanja.
Atazanavir and cobicistat were compared with atazanavir and ritonavir; all patients also received the HIV medicines emtricitabine and tenofovir disoproxil.
Atazanavir in kobicistat so primerjali z atazanavirjem in ritonavirjem; vsi bolniki so prejemali tudi zdravili proti virusu HIV, emtricitabin ter tenofovirdizoproksil.
The virus needs protease to make more viruses.
Virus potrebuje proteazo za svoje razmnoževanje.
For practical information about using Evotaz, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Evotaz naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
It does not cure HIV infection, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Zdravilo Evotaz ne ozdravi okužbe z virusom HIV ali aidsa, vendar lahko upočasni slabšanje imunskega sistema in prepreči razvoj okužb ter bolezni, povezanih z aidsom.
It blocks an HIV enzyme called protease from working.
Zavira delovanje encima virusa HIV, imenovanega proteaza.
Evotaz's adverse effects were similar to those that occur with the individual medicines.
Neželeni učinki zdravila Evotaz so bili podobni kot pri posameznih zdravilnih učinkovinah, ki ju vsebuje.
Because atazanavir and cobicistat have both previously been shown to be effective and are authorised for use in the treatment of HIV infection, studies were mainly carried out to show that Evotaz produced similar levels of atazanavir in the blood to the two active substances given separately, and to atazanavir given with a different booster medicine, ritonavir (an established combination).
Ker so dokazali, da sta atazanavir in kobicistat učinkovita in odobrena za uporabo pri zdravljenju okužbe HIV, so večino študij izvedli za dokazovanje, da je zdravilo Evotaz povzročilo podobne ravni atazanavirja v krvi kot obe zdravilni učinkovini, kadar sta se dajali ločeno, oziroma kot atazanavir v kombinaciji z drugim krepilnim zdravilom, ritonavirjem (uveljavljena kombinacija).
Evotaz can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Zdravilo Evotaz se izdaja le na recept, zdravljenje pa mora uvesti zdravnik z izkušnjami z zdravljenjem okužb z virusom HIV.
Both active substances have already been shown to be effective and Evotaz may be a useful substitute for atazanavir accompanied by ritonavir as a booster.
Za obe zdravilni učinkovini so že dokazali, da sta učinkoviti, zato je lahko zdravilo Evotaz koristni nadomestek za atazanavir, ki se za krepitev učinka uporablja v kombinaciji z ritonavirjem.
The active substances in Evotaz are already available in the EU as individual medicines: atazanavir is available as Reyataz and cobicistat as Tybost.
Zdravilni učinkovini v zdravilu Evotaz sta že na voljo v EU kot samostojni zdravili: atazanavir je na voljo kot zdravilo Reyataz, kobicistat pa kot zdravilo Tybost.
Evotaz, taken with other HIV medicines, reduces HIV in the blood and keeps the virus at a low level.
Če se zdravilo Evotaz jemlje v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV, zmanjša količino tega virusa v krvi in ga ohranja na nizki ravni.
For the full list of all side effects reported with Evotaz, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Evotaz, glejte navodilo za uporabo.
How is Evotaz used?
Kako se zdravilo Evotaz uporablja?
Evotaz contains two active substances: atazanavir and cobicistat.
Zdravilo Evotaz vsebuje dve zdravilni učinkovini: atazanavir in kobicistat.
How does Evotaz work?
Kako zdravilo Evotaz deluje?
Evotaz contains the active substances atazanavir and cobicistat.
Zdravilo Evotaz vsebuje zdravilni učinkovini atazanavir in kobicistat.
Subcutaneous use vial (glass)
150 mg prašek za raztopino za injiciranje subkutana uporaba viala (steklena)
1 ml (150 mg/ml) 6 (3 x 2) pre-filled syringes (multipack)
1 ml (150 mg/ml) 6 (3 x 2) napolnjenih injekcijskih peresnikov (skupno pakiranje)
1 ml (150 mg/ml) 6 (3 x 2) pre-filled pens (multipack)
1 ml (150 mg/ml) 6 (3 x 2) napolnjenih injekcijskih brizg (skupno pakiranje)
1 ml (150 mg/ml) 2 pre-filled syringes
1 ml (150 mg/ml) 2 napolnjena injekcijska peresnika
1 ml (150 mg/ml) 1 pre-filled syringe
1 ml (150 mg/ml) 1 napolnjena injekcijska brizga
1 ml (150 mg/ml) 2 pre-filled pens
1 ml (150 mg/ml) 2 napolnjeni injekcijski brizgi
This is a summary of the European public assessment report (EPAR) for Kovaltry.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kovaltry.
What measures are being taken to ensure the safe and effective use of Kovaltry?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kovaltry?
Other information about Kovaltry
Druge informacije o zdravilu Kovaltry
The full EPAR and risk management plan summary for Kovaltry can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Kovaltry sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kovaltry's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Kovaltry večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
If they occur they may include: angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash over the whole body, headache, hives, hypotension (low blood pressure), lethargy, nausea (feeling sick), restlessness, tachycardia (rapid heartbeat), tightness of the chest, tingling, vomiting and wheezing.
Če se pojavijo, lahko vključujejo angioedem (otekanje podkožnega tkiva), pekoč občutek in zbadanje na mestu injiciranja, mrzlico, rdečico, srbeč izpuščaj po vsem telesu, glavobol, koprivnico, hipotenzijo (nizek krvni tlak), letargijo, navzejo (slabost), nemir, tahikardijo (pospešen srčni utrip), tiščanje v prsnem košu, mravljinčenje, bruhanje in sopenje.
Data from a supportive study also confirmed the benefits of preventative treatment with Kovaltry in reducing the number of bleeds.
Tudi podatki podporne študije so potrdili koristi preventivnega zdravljenja z zdravilom Kovaltry pri zmanjševanju števila krvavitev.