natgillin/translations-raw huggingface dataset:
The efficacy of Esperoct for prophylaxis and treatment of bleeds was evaluated in an open-label, non-controlled trial in adolescents and adult patients with severe haemophilia A ages 12 years and above.
Učinkovitost in varnost zdravila Esperoct za profilaktično zdravljenje krvavitev so ocenili v odprtem, nekontroliranem preskušanju z eno samo skupino pri 68 otrocih, mlajših od 12 let, ki so imeli hudo hemofilijo A.
Inhibitors (antibodies) can develop during the treatment with all factor VIII medicines
Med zdravljenjem z vsemi zdravili s faktorjem VIII lahko nastanejo zaviralci (protitelesa).
If you cannot use the reconstituted solution immediately, it should be used within 4 hours when stored at room temperature (up to 30°C) and within 24 hours when stored in a refrigerator (2°C - 8°C).
Če raztopine zdravila Esperoct ne morete uporabiti takoj po pripravi, jo morate porabiti v 4 urah, če jo shranjujete pri sobni temperaturi (do 30 °C), in v 24 urah, če jo shranjujete v hladilniku
Posology
Vsebina
The solvent is clear and colourless.
Vehikel je bister in brezbarven.
If you touch the syringe tip, germs from your fingers can be transferred.
Če se konice injekcijske brizge dotaknete s prsti, jo lahko kontaminirate z mikrobi.
Powder and solvent for solution for injection Pack contains: 1 powder vial, 4 mL solvent in a pre-filled syringe, 1 plunger rod and 1 vial adapter
Vsebina pakiranja: 1 viala s praškom, 4 ml vehikla v napolnjeni injekcijski brizgi, 1 potisni bat in 1 nastavek za vialo.
Do not put Esperoct in the refrigerator again after it has been stored at room temperature.
Esperoct pri sobni temperaturi zdravila ne smete več dajati nazaj v hladilnik.
18 years and above N=42
N = 42
500 IU
500 i.e.
Including tooth extraction
PODATKI NA ZUNANJI OVOJNINI
Attach the vial adapter • Remove the protective paper from the vial adapter.
• Z nastavka za vialo odstranite zaščitni papir.
If you notice particles or discolouration, do not use it. Use a new package instead.
Če opazite delce ali kakršno koli drugačno barvo, raztopine ne uporabite.
Record the date when you store Esperoct at room temperature on the carton.
Datum začetka shranjevanja zdravila pri sobni temperaturi zabeležite na škatlo.
For instructions on reconstitution of the medicinal product before administration, see the package leaflet.
Za navodila za pripravo zdravila pred aplikacijo glejte navodilo za uporabo.
Esperoct is used to treat and prevent bleeding in people 12 years and above with haemophilia A (inborn factor VIII deficiency).
Za kaj uporabljamo zdravilo Esperoct Zdravilo Esperoct uporabljamo za zdravljenje in preprečevanje krvavitev pri bolnikih, starih 12 let in več, s hemofilijo A (prirojeno pomanjkanje faktorja VIII).
4.7 Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Esperoct nima vpliva na sposobnost vožnje in upravljanja strojev.
Do not open the equipment until you are ready to use it. Do not use the equipment if it has been dropped, or if it is damaged.
Pripomočkov ne odpirajte, dokler niste pripravljeni na njihovo uporabo.
• Unscrew the vial adapter with the vial.
• Odvijte nastavek za vialo skupaj z vialo.
For treatment of bleeds a maximum single dose of Esperoct at 75 IU/kg and a maximum total dose of 200 IU/kg/24 hours may be administered.
Pri zdravljenju krvavitev je lahko največji enkratni odmerek zdravila Esperoct 75 i.e./kg, največji skupni odmerek pa
Mild
VIALA
Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or a subcutaneous port:
Injiciranje raztopine preko naprave za centralni venski dostop (CVAD - Central Venous Access
Must not be returned to the refrigerator after storage at room temperature Date removed from refrigerator: ____________
Po začetku shranjevanja pri sobni temperaturi zdravila ne smete dajati nazaj v hladilnik.
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Esperoct.
Pri bolnikih s hemofilijo A, zdravljenih s faktorjem VIII, vključno z zdravilom Esperoct, lahko pride do nastanka nevtralizirajočih protiteles (zaviralcev).
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
V redkih primerih so opažali preobčutljivostne ali alergijske reakcije (med njimi so lahko angioedem, pekoč občutek in zbadanje na mestu injiciranja, mrzlica, zardevanje, generalizirana urtikarija,
Injection site reactions*** Common
Splošne težave in spremembe na mestu aplikacije reakcije na mestu injiciranja***
• Screw the pre-filled syringe securely onto the vial adapter until resistance is felt.
• Napolnjeno injekcijsko brizgo trdno privijte na nastavek za vialo, dokler ne začutite upora.
• Take the vial, the vial adapter and the pre-filled syringe out of the carton.
• Iz škatle vzemite vialo, nastavek za vialo in napolnjeno injekcijsko brizgo.
Powder: 1500 IU turoctocog alfa pegol (approx. 375 IU/mL after reconstitution),
NAVEDBA UČINKOVINE Prašek: 1500 i.e. turoktokog alfa pegola (približno 375 i.e./ml po rekonstituciji),
Pre-filled syringe with solvent Syringe tip (under syringe cap) Scale
Napolnjena injekcijska brizga z vehiklom konica brizge (pod zaporko brizge) odmerna skala batni zamašek zaporka brizge
Powder: 500 IU turoctocog alfa pegol (approx. 125 IU/mL after reconstitution),
NAVEDBA UČINKOVINE Prašek: 500 i.e. turoktokog alfa pegola (približno 125 i.e./ml po rekonstituciji),
If you touch the sides or the thread, germs from your fingers can be transferred.
Če se ga dotaknete ob straneh ali na navoju, ga lahko kontaminirate z mikrobi.
1000 IU
1000 i.e.
Powder: 1000 IU turoctocog alfa pegol (approx. 250 IU/mL after reconstitution),
NAVEDBA UČINKOVINE Prašek: 1000 i.e. turoktokog alfa pegola (približno 250 i.e./ml po rekonstituciji),
UNIQUE IDENTIFIER - 2D BARCODE
Oznaka ATC: B02BD02.
Powder: 2000 IU turoctocog alfa pegol (approx. 500 IU/mL after reconstitution),
NAVEDBA UČINKOVINE Prašek: 2000 i.e. turoktokog alfa pegola (približno 500 i.e./ml po rekonstituciji),
Powder: 3000 IU turoctocog alfa pegol (approx. 750 IU/mL after reconstitution),
NAVEDBA UČINKOVINE Prašek: 3000 i.e. turoktokog alfa pegola (približno 750 i.e./ml po rekonstituciji),
Moderate
Zaviralci
• headache, nausea or vomiting.
• kožni izpuščaj, koprivnica, podplutbe ali srbenje
0 to below 6 years N=13
N = 13
The number of units of factor VIII administered is expressed in International Units (IU), which is related to the current WHO concentrate standard for factor VIII products.
Število apliciranih enot faktorja VIII je izraženo v mednarodnih enotah
The prophylactic effect of Esperoct was demonstrated with a dosing at 50 IU per kg body weight every 4 days or every 3-4 days (twice weekly) in 175 patients.
nekontroliranim preskušanjem pri mladostnikih, starih 12 let ali več, in odraslih bolnikih s hudo hemofilijo A. Profilaktični učinek zdravila Esperoct je bil dokazan med uporabo v odmerku 50 i.e. na kilogram telesne mase na 4 dni ali na 3 do 4 dni (dvakrat na teden) pri 175 bolnikih.
Stop the injection and contact your doctor or an emergency unit immediately if you have early signs of allergic reactions.
Če opazite zgodnje znake alergijske reakcije, nemudoma prekinite injiciranje in se posvetujte z zdravnikom ali poiščite zdravniško pomoč v najbližjem urgentnem centru.
Reconstitute the powder with the solvent • Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
• Napolnjeno injekcijsko brizgo držite rahlo nagnjeno, tako da je viala usmerjena navzdol.
How to store Esperoct
Shranjevanje zdravila Esperoct
Esperoct is given as an injection into a vein (intravenously), see “Instructions on how to use Esperoct” for more information.
Za več informacij glejte »Navodila za uporabo zdravila Esperoct«.
After reconstitution, 1 mL of solution contains approximately 375 IU turoctocog alfa pegol.
Po pripravi vsebuje 1 ml raztopine približno 375 i.e. učinkovine turoktokog alfa pegol.
After reconstitution, 1 mL of solution contains approximately 125 IU turoctocog alfa pegol.
Po pripravi vsebuje 1 ml raztopine približno 125 i.e. učinkovine turoktokog alfa pegol.
4 hours when stored at room temperature (up to 30°C) and within 24 hours when stored in a refrigerator (2°C - 8°C).
in v 24 urah, če jo shranjujete v hladilniku (2 °C do 8 °C).
Powder
katetre
• 1 pre-filled syringe with solvent
• 1 napolnjeno injekcijsko brizgo z vehiklom,
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the users and would normally not be recommended for longer than 4 hours stored at room temperature (up to 30°C) or 24 hours in a refrigerator (2°C - 8°C), unless reconstitution has taken place in controlled and validated aseptic conditions.
Zdravila običajno ni priporočljivo shranjevati dlje kot 4 ure pri sobni temperaturi (do 30 °C) ali 24 ur v hladilniku
(bromobutyl) and a rubber tip cap (bromobutyl) - 1 plunger rod (polypropylene).
- 1 napolnjeno injekcijsko brizgo s 4 ml vehikla in z batnim zaviralom (polipropilen), gumijastim batnim zamaškom (brombutil) in gumijasto zaporko konice (brombutil), - 1 potisni bat (polipropilen).
After reconstitution, 1 mL of solution contains approximately 750 IU turoctocog alfa pegol.
Po pripravi vsebuje 1 ml raztopine približno 750 i.e. učinkovine turoktokog alfa pegol.
Read the package leaflet before use Intravenous use, after reconstitution
za intravensko uporabo po rekonstituciji
Do not use the equipment if it has expired.
Pripomočkov ne uporabljajte po datumu izteka roka uporabnosti.
• Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
• Potisni bat potegnite rahlo navzdol, da boste pripravljeno raztopino izvlekli v injekcijsko brizgo.
Factor VIII inhibitors
Potrebna koncentracija faktorja VIII
Esperoct 2000 IU powder for solution for injection turoctocog alfa Pegol
Esperoct 2000 i.e. prašek za raztopino za injiciranje turoktokog alfa Pegol i.v.
After reconstitution, 1 mL of solution contains approximately 250 IU turoctocog alfa pegol.
Po pripravi vsebuje 1 ml raztopine približno 250 i.e. učinkovine turoktokog alfa pegol.
Esperoct 3000 IU powder for solution for injection turoctocog alfa Pegol
Esperoct 3000 i.e. prašek za raztopino za injiciranje turoktokog alfa Pegol i.v.
6 to below 12 years N=11
od 6 do 12 let
Esperoct 500 IU powder for solution for injection turoctocog alfa Pegol
Esperoct 500 i.e. prašek za raztopino za injiciranje turoktokog alfa Pegol i.v.
The following side effects have been observed with Esperoct
Pri uporabi zdravila Esperoct so poročali o naslednjih neželenih učinkih
• Turn the syringe with the vial upside down.
• Injekcijsko brizgo obrnite z vialo obrnjeno na glavo.
After reconstitution, 1 mL of solution contains approximately 500 IU turoctocog alfa pegol.
Po pripravi vsebuje 1 ml raztopine približno 500 i.e. učinkovine turoktokog alfa pegol.
Esperoct 2000 IU powder and solvent for solution for injection turoctocog alfa Pegol (recombinant coagulation factor VIII)
Esperoct 2000 i.e. prašek in vehikel za raztopino za injiciranje turoktokog alfa Pegol (rekombinantni koagulacijski faktor VIII)
Reporting of side effects
Preglednica neželenih učinkov
Esperoct 1500 IU powder for solution for injection turoctocog alfa Pegol
Esperoct 1500 i.e. prašek za raztopino za injiciranje turoktokog alfa Pegol i.v.
Esperoct 2000 IU powder and solvent for solution for injection Each powder vial contains nominally 2000 IU turoctocog alfa pegol*.
Ena viala s praškom vsebuje nominalno 2000 i.e. učinkovine turoktokog alfa pegol*.
Esperoct 500 IU powder and solvent for solution for injection turoctocog alfa Pegol (recombinant coagulation factor VIII)
Esperoct 500 i.e. prašek in vehikel za raztopino za injiciranje turoktokog alfa Pegol (rekombinantni koagulacijski faktor VIII)
Description of selected adverse reactions
Opis izbranih neželenih učinkov Zaviralci faktorja VIII
Esperoct 3000 IU powder and solvent for solution for injection turoctocog alfa Pegol (recombinant coagulation factor VIII)
Esperoct 3000 i.e. prašek in vehikel za raztopino za injiciranje turoktokog alfa Pegol (rekombinantni koagulacijski faktor VIII)
“Allergic reactions (hypersensitivity)” above for more information
za več informacij glejte poglavje »Alergijske reakcije (preobčutljivost)«.
Esperoct 1500 IU powder and solvent for solution for injection turoctocog alfa Pegol (recombinant coagulation factor VIII)
Esperoct 1500 i.e. prašek in vehikel za raztopino za injiciranje turoktokog alfa Pegol (rekombinantni koagulacijski faktor VIII)
Stop the injection immediately if you develop severe and sudden allergic reactions (anaphylactic reactions).
Če pride do pojava hude in nenadne alergijske (anafilaktične) reakcije, morate injiciranje zdravila takoj prekiniti.
Do not lift the vial adapter from the vial when removing the protective cap.
Pri odstranjevanju zaščitnega pokrovčka pazite, da nastavka za vialo ne boste dvignili z viale.
Keep the reconstituted solution out of direct light.
Pripravljeno raztopino shranjujte zaščiteno pred svetlobo.
Esperoct 1000 IU powder for solution for injection turoctocog alfa Pegol
Esperoct 1000 i.e. prašek za raztopino za injiciranje turoktokog alfa Pegol i.v.
2D barcode carrying the unique identifier included
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
Minor surgery
večji kirurški posegi
PK Parameter N=No.
Farmakokinetični parameter N = število bolnikov od 0 do 6 let
Esperoct 1000 IU powder and solvent for solution for injection turoctocog alfa Pegol (recombinant coagulation factor VIII)
Esperoct 1000 i.e. prašek in vehikel za raztopino za injiciranje turoktokog alfa Pegol (rekombinantni koagulacijski faktor VIII)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10.
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Esperoct 1500 IU powder and solvent for solution for injection Each powder vial contains nominally 1500 IU turoctocog alfa pegol*.
Ena viala s praškom vsebuje nominalno 1500 i.e. učinkovine turoktokog alfa pegol*.
Store the reconstituted product in the vial.
Pripravljeno zdravilo shranjujte v viali.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja izpuščaj eritem pruritus pogosti
Syringe cap
• tiščanje v prsnem košu
Heart disease
NAPOLNJENA INJEKCIJSKA BRIZGA
Esperoct 3000 IU powder and solvent for solution for injection Each powder vial contains nominally 3000 IU turoctocog alfa pegol*.
Ena viala s praškom vsebuje nominalno 3000 i.e. učinkovine turoktokog alfa pegol*.
GENERAL CLASSIFICATION FOR SUPPLY
Namestitev nastavka za vialo
Esperoct 1000 IU powder and solvent for solution for injection Each powder vial contains nominally 1000 IU turoctocog alfa pegol*.
Ena viala s praškom vsebuje nominalno 1000 i.e. učinkovine turoktokog alfa pegol*.
• Use a clean and germ-free (aseptic) technique.
Device), kot sta centralni venski kateter ali podkožni port: • Uporabite čisto in aseptično (brezkužno) tehniko.
Esperoct 500 IU powder and solvent for solution for injection Each powder vial contains nominally 500 IU turoctocog alfa pegol*.
Ena viala s praškom vsebuje nominalno 500 i.e. učinkovine turoktokog alfa pegol*.
EU/1/19/1374/005
ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/19/1374/005
EU/1/19/1374/004
ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/19/1374/004
EU/1/19/1374/002
ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/19/1374/002
They can easily be broken into two equal halves.
Brez težav jih je mogoče razpoloviti na dve enaki polovici.
The tablets should be dispersed (mixed) in a small amount of water before being given to the patient.
Tablete je treba raztopiti (zmešati) v manjši količini vode, preden se dajo bolniku.
It is available as dispersible tablets.
Na voljo je v obliki disperzibilnih tablet.
‘Dispersible' means that the tablets can be dispersed (mixed) in water.
„Disperzibilen“ pomeni, da se tablete lahko raztopijo (zmešajo) v vodi.
The summaries of opinion of the Committee for Orphan Medicinal Products for Carbaglu can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations (NAGS deficiency: 18 October 2000; isovaleric acidaemia: 7 November 2008; methylmalonic acidaemia: 7 November 2008; propionic acidaemia: 7 November 2008).
Povzetki mnenj Odbora za zdravila sirote o zdravilu Carbaglu so na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/Rare disease designations (pomanjkanje NAGS: 18. oktobra 2000; izovalerična acidemija: 7. novembra 2008; metilmalonska acidemija: 7. novembra 2008; propionska acidemija: 7. novembra 2008).
The initial daily dose of Carbaglu should be 100 mg per kilogram body weight, but up to 250 mg/kg can be used if necessary.
Začetni dnevni odmerek zdravila Carbaglu mora znašati 100 mg na kilogram telesne mase, po potrebi pa do 250 mg/kg.
In all of the studies, the main measure of effectiveness was the change in ammonia levels in the blood.
V vseh študijah je bilo glavno merilo učinkovitosti sprememba ravni amonijaka v krvi.
The most common side effect with Carbaglu (seen in between 1 and 10 patients in 100) is increased sweating.
Najpogostejši neželeni učinek (opažen pri 1 do 10 bolnikih izmed 100) je povečano znojenje.
This is a summary of the European public assessment report (EPAR) for Carbaglu.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Carbaglu.
The other eight patients were treated for hyperammonaemia of another cause.
Preostalih 8 bolnikov je bilo zdravljenih zaradi hiperamonemije, ki je bila posledica drugačnega vzroka.
The full EPAR for Carbaglu 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 Carbaglu je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Carbaglu has been studied in 20 patients, 12 of whom had NAGS deficiency and were treated for an average of about three years.
Zdravilo Carbaglu so proučevali pri 20 bolnikih, izmed katerih je 12 bolnikom primanjkovalo encima NAGS in so bili zdravljeni povprečno približno tri leta.
For more information about treatment with Carbaglu, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Carbaglu preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
When ammonia builds up in the blood, it is toxic to the body, especially the brain.
Amonijak, ki se kopiči v krvi, je strupen za telo, zlasti za možgane.
• N-acetylglutamate synthase (NAGS) deficiency.
• pomanjkanje encima N-acetilglutamat sintaze (NAGS).
The European Commission granted a marketing authorisation valid throughout the European Union for Carbaglu to Orphan Europe on 24 January 2003.
Evropska komisija je dovoljenje za promet z zdravilom Carbaglu, veljavno po vsej Evropski uniji, odobrila dne 24. januarja 2003.
Other information about Carbaglu
Druge informacije o zdravilu Carbaglu
The company also presented information from the published literature on a further four patients treated with the active substance in Carbaglu.
Družba je tudi predložila informacije iz objavljene literature o dodatnih štirih bolnikih, ki so bili zdravljeni z zdravilno učinkovino v zdravilu Carbaglu.
What benefit has Carbaglu shown during the studies?
Kakšne koristi je zdravilo Carbaglu izkazalo med študijami?
Because the number of patients with these diseases is low, they are considered ‘rare' and Carbaglu was designated an ‘orphan medicine' (a medicine used in rare diseases) on various dates (see below).
Ker je bolnikov s temi boleznimi malo, veljajo te bolezni za redke, zato je bilo zdravilo Carbaglu večkrat (glejte datume spodaj) določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
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 Carbaglu.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Carbaglu, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
In patients with organic acidaemias, treatment is started when the patient has a hyperammonaemia crisis and continued until the crisis is finished.
Pri bolnikih z organskimi acidemijami se zdravljenje začne, ko se pri bolniku pojavi hiperamonemična kriza, in se nadaljuje, dokler kriza traja.
The Committee recommended that Carbaglu be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Carbaglu odobri dovoljenje za promet.
In patients with NAGS deficiency, treatment may be started as early as the first day of life and the medicine is used for the patient's whole life.
Pri bolnikih s pomanjkanjem encima NAGS se lahko zdravljenje začne že prvi dan po rojstvu, zdravilo pa se uporablja celo življenje.
Carbaglu must not be used in women who are breastfeeding.
Zdravilo Carbaglu se ne sme uporabljati pri ženskah, ki dojijo.
Carbaglu treatment should be started by a doctor who has experience in treating patients with metabolic diseases.
Zdravljenje z zdravilom Carbaglu mora uvesti zdravnik z izkušnjami z zdravljenjem bolnikov s presnovnimi boleznimi.
Carbaglu should not be used in people who may be hypersensitive (allergic) to carglumic acid or any of the other ingredients.
Zdravila Carbaglu ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) kargluminsko kislino ali katero koli drugo sestavino zdravila.
Patients on Carbaglu could be kept stable without a need for restrictions to the diet or the use of other medicines.
Pri bolnikih, zdravljenih z zdravilom Carbaglu, je bilo mogoče vzdrževati stabilno stanje brez posebnih prehranskih omejitev ali potrebe po jemanju drugih zdravil.
Carbaglu is used for the treatment of hyperammonaemia (high blood levels of ammonia) in patients with the following metabolic diseases:
Zdravilo Carbaglu se uporablja za zdravljenje hiperamonemije (povečanih ravni amonijaka v krvi) pri bolnikih z naslednjimi presnovnimi boleznimi:
Patients with this lifelong disease lack a liver enzyme called NAGS, which normally helps to break down ammonia.
Bolnikom s to vseživljenjsko boleznijo primanjkuje jetrnega encima, imenovanega NAGS, ki običajno sodeluje pri razgradnji amonijaka.
Carbaglu has also been studied in 57 patients (about two-thirds were newborn babies) with isovaleric acidaemia, methylmalonic acidaemia or propionic acidaemia who were treated with Carbaglu during hyperammonaemia crises.
Zdravilo Carbaglu so proučevali tudi pri 57 bolnikih (od katerih sta bili dve tretjini novorojenčkov) z izovalerično, metilmalonsko ali propionsko acidemijo, ki so zdravilo Carbaglu prejemali med hiperamonemično krizo.
What is the risk associated with Carbaglu?
Kakšna tveganja so povezana z zdravilom Carbaglu?
Carbaglu is a medicine that contains the active substance carglumic acid.
Carbaglu je zdravilo, ki vsebuje zdravilno učinkovino kargluminska kislina.
Carbaglu carglumic acid
Carbaglu kargluminska kislina
For the full list of side effects reported with Carbaglu, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Carbaglu, glejte navodilo za uporabo.
In patients with isovaleric acidaemia, methylmalonic acidaemia or propionic acidaemia, Carbaglu also induced a decrease in ammonia levels in the blood, following an average of 5.5 days of treatment.
Pri bolnikih z izovalerično, metilmalonsko ali propionsko acidemijo je zdravilo Carbaglu po povprečno 5,5 dneh zdravljenja povzročilo znižanje ravni amonijaka v krvi.