natgillin/translations-raw huggingface dataset:
57 Preparation notes:
Opombe v zvezi s pripravo:
c CANCIDAS is formulated to provide the full labeled vial dose (70 mg) when 10 ml is withdrawn from the vial.
Zdravilo CANCIDAS je pripravljeno tako, da zagotavlja polni na viali označeni odmerek (70 mg), če iz viale potegnete 10 ml.
EU Number EU/ 1/ 02/ 246/ 001 EU/ 1/ 02/ 246/ 002 EU/ 1/ 02/ 246/ 003
Številka EU EU/ 1/ 02/ 246/ 001
Invented name Carbaglu Carbaglu Carbaglu
zaščiteno ime Carbaglu
Strength 200 mg 200 mg 200 mg
jakost 200 mg
Pharmaceutical Form Dispersible tablet Dispersible tablet Dispersible tablet
velikost pakiranja 15 disperzibilnih tablet
Route of administration Oral use Oral use Oral use
Disperzibilne tablete Za peroralno uporabo
Packaging Tablet container Tablet container Tablet container
Disperzibilne tablete Za peroralno uporabo
Package size 15 dispersible tablets 60 dispersible tablets 5 dispersible tablets
vsebnik za tablete 5 disperzibilnih tablet
It is available as dispersible tablets. ‘ Dispersible ’ means that the tablets can be dispersed (mixed) in water.
„ Disperzibilen “ pomeni, da se lahko tablete raztopijo (zmešajo) v vodi.
Carbaglu is used for the treatment of hyperammonaemia (high blood levels of ammonia) in patients who lack an enzyme called N-acetylglutamate synthase (NAGS).
Zdravilo Carbaglu se uporablja za zdravljenje hiperamonemije (povečane koncentracije amoniaka v krvi) pri bolnikih s pomanjkanjem encima (N- acetilglutamat sintaze, NAGS).
This enzyme normally helps to break down ammonia.
Ta encim običajno sodeluje pri razgradnji amoniaka.
If the enzyme is not present, ammonia cannot be broken down and it builds up in the blood.
Če encim ni prisoten, amoniaka ni mogoče razgraditi, zato se kopiči v krvi.
The disease is extremely rare.
Bolezen je izredno redka.
Patients with severe complete NAGS deficiency rapidly develop high levels of ammonia in the blood soon after birth.
Pri bolnikih s hudim popolnim pomanjkanjem encima NAGS se hitro, že kmalu po rojstvu, vzpostavi visoka raven amoniaka v krvi.
Patients with partial NAGS deficiency (a milder form of the disease) can have symptoms at almost any time of life following a stressful event such as an infection or a viral illness.
Pri bolnikih z delnim pomanjkanjem encima NAGS (blažja oblika bolezni) se simptomi lahko pojavijo skorajda kadar koli v življenju po stresnemu dogodku, npr. okužbi ali virusni bolezni.
Because the number of patients with NAGS deficiency is low, it is considered ‘ rare’ and Carbaglu was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 18 October 2000.
Ker je število bolnikov s pomanjkanjem encima NAGS majhno, velja ta bolezen za redko, zato je bilo zdravilo Carbaglu 18. oktobra 2000 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
Treatment may be started as early as the first day of life.
Zdravljenje se lahko začne že prvi dan po rojstvu.
The first daily dose should be 100 mg per kilogram body weight, but up to 250 mg/ kg can be used if necessary.
Začetni dnevni odmerek mora znašati 100 mg na kilogram telesne mase, po potrebi pa do 250 mg/ kg.
The dose should then be adjusted to maintain normal blood ammonia levels: the daily doses usually range from 10 to 100 mg/ kg.
Za vzdrževanje normalne ravni amoniaka v krvi je treba odmerek nato ustrezno prilagajati: dnevni odmerki običajno znašajo od 10 do 100 mg/ kg.
The medicine is used for the patient ’ s whole life.
Bolnik uporablja zdravilo doživljenjsko.
People with NAGS deficiency cannot break down and excrete ammonia.
Ljudje s pomanjkanjem encima NAGS ne morejo razgraditi in izločati amoniaka.
When this happens, ammonia builds up in the blood.
V tem primeru se amoniak kopiči v krvi.
This is toxic to the body, especially the brain.
To je toksično za telo, še zlasti za možgane.
Carbaglu is very similar in structure to N-acetylglutamate, which activates an enzyme that breaks down ammonia.
Zdravilo Carbaglu je po strukturi zelo podobno N- acetilglutamatu, ki aktivira encim za razgradnjo amoniaka.
Carbaglu therefore helps break down ammonia, reducing ammonia blood levels and its toxic effects.
Zdravilo Carbaglu torej prispeva k razgradnji amoniaka in znižuje njegovo raven v krvi ter tako zmanjšuje toksičnost.
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 preučevali pri 20 bolnikih, izmed katerih je 12 bolnikom primanjkovalo encima NAGS in so bili zdravljeni povprečno približno tri leta.
In most patients, ammonia levels were brought back to normal after Carbaglu treatment.
Pri večini bolnikov so je po zdravljenju z zdravilom Carbaglu raven amoniaka vrnila na normalno raven.
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.
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 preobčutljivi za (alergični na) kargluminsko kislino ali katero koli drugo sestavino zdravila.
NAGS deficiency is a rare, serious disease, with potentially devastating consequences and for which there are no other similar treatments.
Pomanjkanje encima NAGS je redka in resna bolezen s potencialno uničujočimi posledicami, na voljo pa ni nobenega drugega podobnega zdravljenja.
On the basis of the limited information on effectiveness and safety that was submitted, the Committee for Medicinal Products for Human Use (CHMP) concluded that Carbaglu was effective in reducing blood ammonia to normal levels.
Na podlagi omejenih predloženih podatkov o učinkovitosti in varnosti je Odbor za zdravila za uporabo v humani medicini (CHMP) zaključil, da je zdravilo Carbaglu učinkovito pri zniževanju ravni amoniaka v krvi na normalno raven.
The Committee decided that Carbaglu’ s benefits are greater than its risks for the treatment of hyperammonaemia due to NAGS deficiency.
Odbor je odločil, da so koristi zdravila Carbaglu za zdravljenje hiperamonemije zaradi pomanjkanja encima NAGS večje od z njim povezanih tveganj.
Carbaglu was originally authorised under ‘ Exceptional Circumstances’, because, as the disease is rare, it had not been possible to obtain complete information on the medicine.
Zdravilo Carbaglu je bilo prvotno odobreno „ v izjemnih okoliščinah “, ker zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o zdravilu.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 26 June 2006.
Ker je družba predložila dodatne zahtevane podatke, so bile „ izjemne okoliščine “ razveljavljene 26. junija 2006.
Other information about Carbaglu:
Druge informacije o zdravilu Carbaglu:
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 družbi Orphan Europe dne 24. januarja 2003.
The marketing authorisation was renewed on 24 January 2008.
Dovoljenje za promet je bilo podaljšano dne 24. januarja 2008.
The record of Carbaglu’ s designation as an orphan medicine is available here.
Dopis o določitvi zdravila Carbaglu kot zdravila sirote je na voljo tukaj.
The full EPAR for Carbaglu is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Carbaglu je na voljo tukaj.
For a full list of excipients, see section 6.1
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Dispersible tablet The tablets are white and elongated with three score marks.
Disperzibilne tablete Tablete so bele in podolgovate, s tremi oznakami vrednosti.
4.1 Therapeutic indications
4. 1 Indikacije za zdravljenje
Treatment of hyperammonaemia due to N-acetylglutamate synthase deficiency.
Zdravljenje hiperamonemije, ki je posledica nezadostne sintaze N- acetilglutamata.
The initial daily dose should be 100 mg/ kg, up to 250 mg/ kg if necessary.
Začetni dnevni odmerek mora znašati 100 mg/ kg, po potrebi pa do 250 mg/ kg.
It should then be adjusted individually in order to maintain normal ammonia plasma levels (see section 4.4).
Za vzdrževanje normalne ravni amoniaka v plazmi je treba nato odmerek individualno prilagajati (glejte poglavje 4. 4).
In the long term, it may not be necessary to increase the dose according to body weight as long as adequate metabolic control is achieved; daily doses range from 10 mg/ kg to 100 mg/ kg.
Pod pogojem, da je doseženo ustrezno obvladovanje presnove, dolgoročno ni nujno povečevati odmerka glede na telesno maso; dnevni odmerki znašajo od 10 mg/ kg do 100 mg/ kg.
Carglumic acid responsiveness test It is recommended to test individual responsiveness to carglumic acid before initiating any long term treatment.
Test odgovora na kargluminsko kislino Pred uvedbo dolgotrajnega zdravljenja je priporočljivo individualno testiranje odgovora na kargluminsko kislino.
- In a comatose child, start with a dose of 100 to 250 mg/ kg/ day and measure ammonia plasma
- Pri komatoznih otrocih je treba začeti z odmerkom 100 do 250 mg/ kg/ dan in preverjati
concentration at least before each administration; it should normalise within a few hours after starting Carbaglu.
koncentracijo amoniaka v plazmi vsaj pred vsako aplikacijo; vrednosti bi se morale normalizirati nekaj ur po uvedbi zdravljenja s Carbaglu.
- In a patient with moderate hyperammonaemia, administer a test dose of 100 to 200 mg/ kg/ day
- Bolnik z zmerno hiperamonemijo naj tri dni prejema poskusni odmerek od 100 do 200 mg/ kg/ dan
for 3 days with a constant protein intake and perform repeated determinations of ammonia plasma concentration (before and 1 hour after a meal); adjust the dose in order to maintain normal ammonia plasma levels.
ob stalnem vnosu proteinov; preverjanje koncentracij amoniaka v plazmi se ponavlja (pred jedjo in 1 uro po jedi); za vzdrževanje normalnih ravni amoniaka v plazmi se odmerek ustrezno prilagaja.
The tablets must be dispersed in a minimum of 5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric tube.
Tablete je treba dispergirati v najmanj 5- 10 ml vode in takoj zaužiti, ali aplicirati s hitrim vbrizganjem skozi nazogastrično sondo.
Breast-feeding during the use of carglumic acid is contraindicated (see sections 4.6 and 5.3).
Dojenje je med uporabo kargluminske kisline kontraindicirano (glejte poglavji 4. 6 in 5. 3).
Therapeutic monitoring Plasma levels of ammonia and amino acids should be maintained within normal limits.
Spremljanje zdravljenja Plazemske vrednosti amoniaka in aminokislin je treba ohranjati v mejah normalnih vrednosti.
Animal studies have revealed minimal developmental toxicity (see section 5.3).
Raziskave na živalih so razkrile minimalno toksičnost za razvoj (glejte poglavje 5. 3).
Although it is not known whether carglumic acid is secreted into human milk, it has been shown to be present in the milk of lactating rats (see section 5.3).
Čeprav ni znano, ali se kargluminska kislina izloča v materinem mleku, so dokazali njeno prisotnost v mleku doječih podgan (glejte poglavje 5. 3).
(see section 4.3).
Zato je dojenje med uporabo kargluminske kisline kontraindicirano (glejte poglavje 4. 3).
Clinical experience has been collected in about 170 patient-years.
Klinične izkušnje so zbrali pri okrog 170 bolnikih - let.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10) and uncommon (≥ 1/ 1,000 to < 1/ 100).
Pogostnosti so opredeljene kot: zelo pogoste (≥ 1/ 10), pogoste (≥1/ 100 do < 1/ 10) in občasne (≥1/ 1. 000 do < 1/ 100).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Uncommon: increased transaminases
občasne: zvišane transaminaze
Common: increased sweating
pogosto: zvečano znojenje
In one patient treated with carglumic acid, where the dose was increased up to 750 mg/ kg/ day, symptoms of intoxication occurred which can be characterised as a sympathomimetic reaction: tachycardia, profuse sweating, increased bronchial secretion, increased body temperature and restlessness.
Pri enem bolniku, zdravljenem s kargluminsko kislino, kjer se je odmerek povečal do 750 mg/ kg/ dan, so se pojavili znaki zastrupitve, ki so značilni za simpatomimetično reakcijo: tahikardija, močno znojenje, povečano izločanje bronhialne sluzi, povišana telesna temperatura in nemir.
Amino acids and derivatives; ATC code:
Farmakoterapevtska skupina: aminokisline in njihovi derivati; oznaka ATC:
Carglumic acid is a structural analogue of N-acetylglutamate, which is the naturally occurring activator of carbamoyl phosphate synthetase, the first enzyme of the urea cycle.
Kargluminska kislina je strukturni analog N- acetilglutamata, ki je naravni vzpodbujevalec karbamoilfosfat- sintetaze, prvega encima ciklusa sečnine
Carglumic acid has been shown in vitro to activate liver carbamoyl phosphate synthetase.
Raziskave in vitro so pokazale, da kargluminska kislina aktivira karbomoilfosfat- sintetazo v jetrih.
Despite a lower affinity of carbamoyl phosphate synthetase for carglumic acid than for N-acetylglutamate, carglumic acid has been shown in vivo to stimulate carbamoyl phosphate synthetase and to be much more effective than N-acetylglutamate in protecting against ammonia intoxication in rats.
Kljub temu, da ima karbamoilfosfat- sintetaza nižjo afiniteto za kargluminsko kislino kot za N - acetilglutamat, so raziskave in vivo na podganah pokazale, da kargluminska kislina stimulira karbamoilfosfat- sintetazo in v primerjavi z N- acetilglutamatom veliko bolj učinkovito ščiti pred zastrupitvijo z amoniakom.
This could be explained by the following observations: i) The mitochondrial membrane is more readily permeable for carglumic acid than for N- acetylglutamate ii) Carglumic acid is more resistant than N-acetylglutamate to hydrolysis by aminoacylase present in the cytosol.
To se da razložiti z naslednjimi ugotovitvami: i) Mitohondrijska membrana je bolj propustna za kargluminsko kislino kot za N- acetilglutamat. ii) Kargluminska kislina je v primerjavi z N- acetilglutamatom bolj odporna na hidrolizo z aminoacilazo v citosolu.
Other studies have been conducted in rats under different experimental conditions leading to increased ammonia availability (starvation, protein-free or high-protein diet).
V drugih raziskavah na podganah, ki so jih izvajali pod različnimi eksperimentalnimi pogoji, so dobili povečano raven amoniaka (stradanje, dieta brez proteina ali visoko- proteinska dieta).
Carglumic acid was shown to decrease blood ammonia levels and increase urea levels in blood and urine, whereas the liver content of carbamoyl phosphate synthetase activators was significantly increased.
Izkazalo se je, da kargluminska kislina znižuje raven amoniaka v krvi in zvišuje koncentracije sečnine v krvi in urinu, medtem ko je bila prisotnost aktivatorjev karbomoilfosfat- sintetaze v jetrih značilno višja.
In patients with N-acetylglutamate synthase deficiency, carglumic acid was shown to induce a rapid normalisation of plasma ammonia levels, usually within 24 hours.
Ugotovili so, da pri bolnikih s pomanjkanjem N- acetilglutamat- sintaze kargluminska kislina povzroči hitro normalizacijo ravni amoniaka v plazmi, običajno že v 24 urah.
Absorption After a single oral dose of 100 mg/ kg body weight, approximately 30% of carglumic acid is estimated to be absorbed.
Absorpcija Ocenjujejo, da se po enkratnem peroralnem odmerku 100 mg/ kg telesne teže absorbira približno 30% kargluminske kisline.
At that dose-level, in 12 volunteers given Carbaglu tablets, plasma concentration peaked at 2.6 µg/ ml (median; range 1.8-4.8) after 3 hours (median; range 2-4).
Pri tej velikosti odmerka je koncentracija v plazmi pri 12 prostovoljcih, ki so prejeli tablete Carbaglu, dosegla vrh pri 2, 6 µg/ ml (mediana; območje 1, 8- 4, 8) po 3 urah (mediana; območje 2- 4).
Distribution The plasma elimination curve of carglumic acid is biphasic with a rapid phase over the first 12 hours after administration followed by a slow phase (terminal half life up to 28 hours).
Porazdelitev Krivulja eliminacije kargluminske kisline iz plazme je bifazična s hitro fazo v prvih 12 urah po uporabi, sledi pa ji počasna faza (terminalni razpolovni čas do 28 ur).
Metabolism A proportion of carglumic acid is metabolised.
Presnova Nekaj kargluminske kisline se presnovi.
Metabolites are detectable in plasma with a peak at 36-48 hours and a very slow decline (half-life around 100 hours).
V plazmi lahko najdemo presnovke, katerih koncentracija je najvišja pri 36- 48 urah, nato pa se zelo počasi znižuje (razpolovni čas okrog 100 ur).
Elimination After a single oral dose of 100 mg/ kg body weight, 9% of the dose is excreted unchanged in the urine and up to 60% in the faeces.
Odstranjevanje iz telesa Po enkratnem peroralnem odmerku 100 mg/ kg telesne teže se 9% odmerka izloči v nespremenjeni obliki v urinu, do 60% pa v blatu.
Plasma levels of carglumic acid were measured in patients of all age categories, from newborn infants to adolescents, treated with various daily doses (7 – 122 mg/ kg/ day).
Koncentracije kargluminske kisline v plazmi so merili pri bolnikih vseh starostnih skupin, od novorojenčkov do mladostnikov, ki so jih zdravili z različnimi dnevnimi odmerki (7 – 122 mg/ kg/ dan).
Their range was consistent with
Njihove vrednosti so bile celo pri novorojenčkih primerljive s tistimi, ki so jih
4 those measured in healthy adults, even in newborn infants.
4 izmerili pri zdravih odraslih.
Whatever the daily dose, they were slowly declining over 15 hours to levels around 100 ng/ ml.
Ne glede na višino dnevnega odmerka so se vrednosti v 15 urah počasi znižale na raven okrog 100 ng/ ml.
Safety pharmacology studies have shown that Carbaglu administered orally at doses of 250, 500, 1000 mg/ kg had no statistically significant effect on respiration, central nervous system and cardiovascular system.
V študijah farmakološke varnosti niso ugotovili, da bi Carbaglu v peroralnih odmerkih po 250, 500 in 1. 000 mg/ kg imel statistično pomembne učinke na dihala, osrednji živčni sistem in srčno- žilni sistem.
Carbaglu showed no significant mutagenic activity in a battery of genotoxicity tests performed in vitro (Ames test, human lymphocyte metaphase analysis) and in vivo (micronucleus test in rat).
S serijo genotoksičnih testov in vitro (Amesov test, analiza metafaze humanih limfocitov) kot tudi in vivo (mikrojedrni test pri podganah) niso ugotovili, da bi Carbaglu imel pomembne mutagene učinke.
Single doses of carglumic acid up to 2800 mg/ kg orally and 239 mg/ kg intravenously did not induce any mortality or abnormal clinical signs in adult rats.
Kargluminska kislina v enkratnih odmerkih do 2. 800 mg/ kg peroralno in 239 mg/ kg intravensko pri odraslih podganah ni povzročila smrtnosti ali nenormalnih kliničnih znakov.
In newborn rats receiving daily carglumic acid by oral gavage for 18 days as well as in young rats receiving daily carglumic acid for 26 weeks, the No Observed Effect Level (NOEL) was established at 500 mg/ kg/ day and the No Observed Adverse Effect Level (NOAEL) was established at 1000 mg/ kg/ day.
Pri novorojenih podganah, ki so prejemale kargluminsko kislino 18 dni po oralni sondi, kot tudi pri mladih podganah, ki so prejemale kargluminsko kislino dnevno skozi 26 tednov, je bila meja ravni brez opaznih učinkov (NOEL – No Observed Effect Level) pri 500 mg/ kg/ dan, meja brez opaznih neželenih učinkov (NOAEL – No Adverse Effect Level) pa pri 1. 000 mg/ kg/ dan.
Carglumic acid is secreted in the milk of lactating rats and although developmental parameters were unaffected, there were some effects on body weight / body weight gain of pups breast-fed by dams treated with 500 mg/ kg/ day and a higher mortality of pups from dams treated with 2000/ kg/ day, a dose that caused maternotoxicity.
Kargluminska kislina se izloča v mleku doječih podgan in čeprav razvojni parametri niso bili prizadeti, sta se pokazala manjši vpliv na telesno težo / naraščanje telesne teže mladičev, ki so jih dojile samice, ki so prejemale 500 mg/ kg/ dan, in večja smrtnost mladičev samic, tretiranih z odmerkom 2000 mg/ kg/ dan, kar je odmerek, ki je povzročil toksičnost za mater.
The maternal systemic exposures after 500 and 2000 mg/ kg/ day were twenty five times and seventy times the expected human exposure.
Sistemska izpostavljenost mater pri odmerkih 500 oziroma 2000 mg/ kg/ dan je bila petindvajsetkrat oziroma sedemdesetkrat večja od pričakovane izpostavljenosti ljudi.
30 months After first opening of the tablet container:
30 mesecev Po prvem odprtju vsebnika s tabletami:
5 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
Do not refrigerate.
5 Ne shranjujte v hladilniku.
5-, 15- or 60- polypropylene tablet containers closed by a polyethylene cap with a desiccant unit.
Polipropilenski vsebnik s 5, 15 ali 60 tabletami, zaprt s polietilenskim pokrovčkom s sušilnim sredstvom.
No special requirements
Ni posebnih zahtev
Orphan Europe Immeuble “ Le Wilson” F-92058 Paris La Défense France
Orphan Europe Immeuble “ Le Wilson ” F- 92058 Paris la Défense Francija
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILK( E) DOVOLJENJ( A) ZA PROMET
EU/ 1/ 02/ 246/ 001 (15 dispersible tablets) EU/ 1/ 02/ 246/ 002 (60 dispersible tablets) EU/ 1/ 02/ 246/ 003 (5 dispersible tablets)
EU/ 1/ 02/ 246/ 001 (15 disperzibilnih tablet) EU/ 1/ 02/ 246/ 002 (60 disperzibilnih tablet) EU/ 1/ 02/ 246/ 003 (5 disperzibilnih tablet)
24 January 2003
24. januar 2003
6 ANNEX II
6 DODATEK II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
7 A IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Orphan Europe, Immeuble ‘ Le Wilson’, 70 avenue du Général de Gaulle, F-92800 Puteaux, France
Orphan Europe, Immeuble ‘ Le Wilson ’, 70 avenue du Général de Gaulle, F- 92800 Puteaux, Francija
8 ANNEX III
8 DODATEK III
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
10 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Oral use Read the package leaflet before use
Za peroralno uporabo Pred uporabo preberite priloženo navodilo.
EXP {MM/ YYYY} Discard one month after first opening.
{MM/ LLLL} Zavrzite en mesec po prvem odprtju.
After first opening of the tablet container: do not refrigerate, do not store above 30°C.
Po prvem odprtju vsebnika s tabletami:
Keep the container tightly closed in order to protect from moisture.
Ne shranjujte v hladilniku in pri temperaturi nad 30 °C.
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
12 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Oral use Read the package leaflet before use.
Za peroralno uporabo Pred uporabo preberite priloženo navodilo.
17 PACKAGE LEAFLET: INFORMATION FOR THE USER
INFORMACIJE ZA UPORABNIKA
- If you have further questions, please ask your doctor or your pharmacist.
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali farmacevtom.
It
Njim bi lahko celo
may harm them, even if their symptoms are the same as yours.
škodovalo, čeprav imajo znake bolezni, podobne vašim.
What Carbaglu is and what it is used for 2.
Kaj je zdravilo Carbaglu in za kaj ga uporabljamo 2.
Before you take Carbaglu 3.
Kaj morate vedeti, preden vzamete zdravilo Carbaglu 3.
How to take Carbaglu 4.
Kako se jemlje zdravilo Carbaglu 4.
Possible side effects 5 How to store Carbaglu 6.
Možni neželeni učinki 5 Shranjevanje zdravila Carbaglu 6.
Carbaglu can help eliminating excess of hyperammonaemia (elevated ammonia level in the blood), due to the lack of a specific liver enzyme N- acetylglutamate synthase.
Carbaglu lahko pomaga zniževati hiperamonemijo (povišana raven amoniaka v krvi), ki nastane zaradi pomanjkanja določenega jetrnega encima, N- acetilglutamat- sintaze.
Nitrogen waste is in the form of ammonia, which is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
Odpadni dušik se kopiči v obliki amoniaka, ki je še posebej toksičen za možgane in lahko v hudih primerih privede do izgube zavesti in kome.