natgillin/translations-raw huggingface dataset:
In late-onset deficiency patients, including females heterozygous for ornithine transcarbamylase deficiency, who recovered from hyperammonaemic encephalopathy and were then treated chronically with dietary protein restriction and sodium phenylbutyrate, the survival rate was 98%.
Pri bolnikih z zakasnjenim pojavom bolezni (vključno z ženskami, heterozigotnimi za pomanjkljivost ornitin transkarbamoilaze), ki so si opomogli od hiperamoniemične encefalopatije in so bili kasneje kronično zdravljeni z omejevanjem prehranskega vnosa beljakovin ter natrijevim fenilbutiratom, je bila stopnja preživetja 98%.
The majority of the patients who were tested had an IQ in the average to low average/ borderline mentally retarded range.
Vrednosti IQ večine bolnikov, ki so bili testirani, so bile v območju
5 Reversal of pre-existing neurologic impairment is not likely to occur with treatment, and neurologic deterioration may continue in some patients.
Njihove kognitivne sposobnosti pa so med zdravljenjem z fenilbutiratom ostajale relativno stabilne.
AMMONAPS may be required life-long unless orthotopic liver transplantation is elected.
Zdravljenje z AMMONAPSOM je lahko potrebno celo življenje, če ne pride do odločitve za ortotopično presaditev jeter.
Plasma and urine concentrations of phenylbutyrate and its metabolites have been obtained from fasting normal adults who received a single dose of 5 g of sodium phenylbutyrate and from patients with urea cycle disorders, haemoglobinopathies and cirrhosis receiving single and repeated oral doses up to 20 g/ day (uncontrolled studies).
Plazemske in urinske koncentracije fenilbutirata ter njegovih presnovkov so bile določene pri teščih normalnih odraslih osebah, ki so prejele enkraten odmerek 5 g natrijevega fenilbutirata, in pri bolnikih z motnjami v ciklusu sečnine, hemoglobinopatijami ter cirozo, ki so prejeli enkraten odmerek ali ponavljajoče peroralne odmerke do 20 g/ dan (nekontrolirane študije).
The disposition of phenylbutyrate and its metabolites has also been studied in cancer patients following intravenous infusion of sodium phenylbutyrate (up to 2 g/ m²) or phenylacetate.
Razporejanje fenilbutirata in njegovih presnovkov je bilo preučeno tudi pri bolnikih z rakom po intravenski infuziji natrijevega fenilbutirata (do 2 g/ m2) ali fenilacetata.
Absorption Phenylbutyrate is rapidly absorbed under fasting conditions.
Absorpcija Fenilbutirat se pri tešči osebi hitro absorbira.
The mean time to peak concentration is 1.35 hour and the mean peak concentration 218 µg/ ml.
Povprečni čas do najvišje koncentracije je bil 1, 35 ure, povprečna najvišja koncentracija pa 218 µg/ ml.
The elimination half-life was estimated to be 0.8 hours.
Ocenjeno je bilo, da je razpolovni čas izločanja 0, 8 ure.
Distribution The volume of distribution of phenylbutyrate is 0.2 l/ kg.
Porazdelitev Volumen porazdelitve fenilbutirata je 0, 2 l/ kg.
Metabolism After a single dose of 5 g of sodium phenylbutyrate, in the form of tablets, measurable plasma levels of phenylacetate and phenylacetylglutamine are detected 30 and 60 minutes respectively after dosing.
Presnova Po enkratnem odmerku 5 g natrijevega fenilbutirata v obliki tablet, so se merljive količine fenilacetata pojavile po 30 minutah, merljive količine fenilacetilglutamina pa po 60 minutah po odmerjanju.
The mean time to peak concentration is 3.74 and 3.43 hours, respectively, and the mean peak concentration is 48.5 and 68.5 µg/ ml, respectively.
Povprečna najvišja koncentracija je bila za fenilacetat 48, 5 µg/ ml, za fenilacetilglutamin pa 68, 5 µg/ ml.
The elimination half-life was estimated to be 1.2 and 2.4 hours, respectively.
Razpolovni čas izločanja je bil za fenilacetat 1, 2 ure, za fenilacetilglutamin pa 2, 4 ure.
In the majority of patients with urea cycle disorders or haemoglobinopathies receiving various doses of phenylbutyrate (300 - 650 mg/ kg/ day up to 20 g/ day) no plasma level of phenylacetate could be detected after overnight fasting.
Pri večini bolnikov z motnjami ciklusa sečnine ali hemoglobinopatijami, ki so prejemali različne odmerke fenilbutirata (300 – 650 mg/ kg/ dan do 20 g/ dan) ni bilo moč zaznati plazemskih koncentracij fenilacetata po prekonočnem postu.
Three cirrhotic patients (out of 6) who received repeated oral administration of sodium phenylbutyrate (20 g/ day in three doses) showed sustained plasma levels of phenylacetate on the third day that were five times higher than those achieved after the first dose.
Trije bolniki s cirozo (od šestih), ki so prejemali ponavljajoče se peroralne odmerke natrijevega fenilbutirata (20 g/ dan v treh odmerkih), so imeli na tretji dan konstantne plazemske koncentracije fenilacetata petkrat višje od koncentracij, ki so bile dosežene po prvem odmerku.
In normal volunteers gender differences were found in the pharmacokinetic parameters of phenylbutyrate and phenylacetate (AUC and Cmax about 30-50% greater in females), but not phenylacetylglutamine.
Pri normalnih prostovoljcih so bile med spoloma opažene razlike v farmakokinetičnih parametrih fenilbutirata in fenilacetata (vrednosti AUC in Cmax sta bili približno 30- 50% višji pri ženskah), vendar razlik ni bilo opaziti pri parametrih fenilacetilglutamina.
Excretion Approximately 80-100% of the medicinal product is excreted by the kidneys within 24 hours as the conjugated product, phenylacetylglutamine.
Izločanje Približno 80– 100% zdravila se izloči preko ledvic v 24 urah v obliki konjugiranega produkta, fenilacetilglutamina.
6 5.3 Preclinical safety data
6 5. 3 Predklinični podatki o varnosti
Sodium phenylbutyrate was negative in 2 mutagenicity tests, i. e. the Ames test and the micronucleus test.
Natrijev fenilbutirat je dal negativne rezultate v 2 preskusih mutagenosti, t. j. v Amesovem preskusu in v mikronukleusnem preskusu.
Micronucleus test results indicate that sodium phenylbutyrate was considered not to have produced any clastogenic effect in rats treated at toxic or non-toxic dose levels (examined 24 and 48 hours after a single oral administration of 878 to 2800 mg/ kg).
Rezultati mikronukleusnega preskusa pa kažejo, da natrijev fenilbutirat ni proizvedel klastogenih učinkov pri podganah, katerim je bil dajan v toksičnih in netoksičnih odmerkih (preverjano po 24 in 48 urah po enkratnem peroralnem odmerku 878 do 2800 mg/ kg).
HDPE bottles containing 250 or 500 tablets.
Plastenke iz HDPE s po 250 ali 500 tabletami.
The bottles are equipped with child resistant caps.
Plastenke so opremljene z otrokom varno zaporko
Swedish Orphan International AB Drottninggatan 98 SE-111 60 Stockholm Sweden
Swedish Orphan International AB Drottninggatan 98 SE- 111 60 Stockholm Švedska
EU/ 1/ 99/ 120/ 001 (250 tablets) EU/ 1/ 99/ 120/ 002 (500 tablets)
EU/ 1/ 99/ 120/ 001 (250 tablet) EU/ 1/ 99/ 120/ 002 (500 tablet)
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
08/ 12/ 1999 Date of latest renewal:
08/ 12/ 1999 Datum zadnjega podaljšanja:
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
AMMONAPS 940 mg/ g granules
AMMONAPS 940 mg/ g zrnca
Sodium phenylbutyrate:
Natrijev fenilbutirat:
940 mg/ g of granules
940 mg/ g zrnc.
AMMONAPS granules should be administered orally (to infants and children unable to swallow tablets and to patients with dysphagia) or via gastrostomy or nasogastric tube.
AMMONAPS zrnca se dajejo peroralno (dojenčkom in otrokom, ki ne morejo pogoltniti tablet, in bolnikom z disfagijo) ali preko gastrostome ali nazogastrične cevke.
The safety and efficacy of doses in excess of 20 g/ day have not been established.
Običajni celokupni dnevni odmerek natrijevega fenilbutirata je po kliničnih izkušnjah: • 450 – 600 mg/ kg/ dan pri novorojenčkih, dojenčkih in otrocih, ki tehtajo manj kot 20 kg 9, 9 – 13, 0 g/ m2/ dan pri otrocih, ki tehtajo več kot 20 kg, ter pri mladostnikih in pri odraslih. • Varnost in učinkovitost odmerkov večjih od 20 g/ dan še ni bila dokazana.
The total daily dose should be divided into equal amounts and given with each meal or feeding (e. g.
Celokupni dnevni odmerek naj se razdeli na enake dele in se daje z vsakim obrokom (npr.
4- 6 times per day in small children).
4– 6 krat dnevno pri majhnih otrocih).
Three dosing spoons are provided which dispense 0.95 g, 2.9 g or 8.6 g of sodium phenylbutyrate.
Priložene so tri merilne žličke, s katerimi odmerimo 0, 95 g ali 2, 9 g ali 8, 6 g natrijevega fenilbutirata.
9 Therapeutic monitoring:
9 Nadzorovanje zdravljenja:
Nutritional management:
Prehrana bolnika:
Citrulline or arginine supplementation is required for patients diagnosed with neonatal-onset form of carbamyl phosphate synthetase or ornithine transcarbamylase deficiency at a dose of 0.17 g/ kg/ day or 3.8 g/ m2/ day.
Za bolnike z diagnozo neonatalnega pojava pomanjkljivosti karbamoilfosfat- sintaze je potrebno dopolnjevanje prehrane s citrulinom v odmerku 0, 17 g/ kg/ dan oziroma pri pomanjkljivosti ornitin transkarbamoilaze pa je potrebno dopolnjevanje prehrane z argininom v odmerku 3, 8 g/ m2/ dan.
AMMONAPS granules contain 124 mg (5.4 mmol) of sodium per gram of sodium phenylbutyrate, corresponding to 2.5 g (108 mmol) of sodium per 20 g of sodium phenylbutyrate, which is the maximum daily dose.
Zdravilo AMMONAPS zrnca vsebuje 124 mg (5, 4 mmol) natrija na gram natrijevega fenilbutirata, kar ustreza 2, 5 g (108 mmol) natrija v maksimalnem dnevnem odmerku natrijevega fenilbutirata, ki znaša 20 g.
Prenatal exposure of rat pups to phenylacetate (the active metabolite of phenylbutyrate) produced lesions in cortical pyramidal cells; dendritic spines were longer and thinner
Pomen tega
The significance of these data in pregnant women is not known; therefore the use of AMMONAPS is contra-indicated during pregnancy (see section 4.3).
10 pojava za nosečnice ni znan, zato je uporaba zdravila AMMONAPS v nosečnosti kontraindicirana (glejte poglavje 4. 3).
Depression, irritability
11 Psihiatrične motnje Pogosto: depresija, preobčutljivost
A probable case of toxic reaction to AMMONAPS (450 mg/ kg/ d) was reported in an 18-year old anorectic female patient who developed a metabolic encephalopathy associated with lactic acidosis, severe hypokalaemia, pancytopaenia, peripheral neuropathy, and pancreatitis.
Poročali so o verjetnem primeru toksične reakcije na zdravilo AMMONAPS (450 mg/ kg/ d) pri 18- letni anorektični bolnici, pri kateri se je razvila metabolična encefalopatija, povezana z laktično acidozo, težko hipokaliemijo, pancitopenijo, periferno nevropatijo in pankreatitisom.
The majority of
Pri bolnikih z zakasnjenim pojavom bolezni (vključno z ženskami, heterozigotnimi za pomanjkljivost ornitin transkarbamoilaze), ki so si opomogli od hiperamoniemične encefalopatije in so bili kasneje kronično zdravljeni z omejevanjem prehranskega vnosa beljakovin ter natrijevim fenilbutiratom, je
12 the patients who were tested had an IQ in the average to low average/ borderline mentally retarded range.
Vrednosti IQ večine bolnikov, ki so bili testirani, so bile v območju povprečja do območja nizkega povprečja oz. mejne umske zaostalosti.
The mean time to peak concentration is 1 hour and the mean peak concentration 195 µg/ ml.
Povprečni čas do najvišje koncentracije je bil 1 ura, povprečna najvišja koncentracija pa 195 µg/ ml.
Metabolism After a single dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylacetate and phenylacetylglutamine are detected 30 and 60 minutes respectively after dosing.
Presnova Po enkratnem odmerku 5 g natrijevega fenilbutirata v obliki zrnc, so se merljive količine fenilacetata pojavile po 30 minutah, merljive količine fenilacetilglutamina pa po 60 minutah po odmerjanju.
The mean time to peak concentration is 3.55 and 3.23 hours, respectively, and the mean peak concentration is 45.3 and 62.8 µg/ ml, respectively.
Povprečna najvišja koncentracija je bila za fenilacetat 45, 3 µg/ ml, za fenilacetilglutamin pa 62, 8 µg/ ml.
The elimination half-life was estimated to be 1.3 and 2.4 hours, respectively.
Razpolovni čas izločanja je bil za fenilacetat 1, 3 ure, za fenilacetilglutamin pa 2, 4 ure.
13 5.3 Preclinical safety data
13 5. 3 Predklinični podatki o varnosti
During the shelf life the patient may store the finished product for a single period of 3 months at a temperature not above 25°C, after which the product must be discarded.
V času roka uporabnosti lahko bolnik shrani zdravilo za enkratno obdobje 3 mesecev pri temperaturi do 25 °C, zatem mora zdravilo zavreči.
HDPE bottles containing 266 g or 532 g of granules.
Plastenke iz HDPE s po 266 g ali 532 g zrnc.
Three dosage spoons of different measures are provided.
Plastenke so opremljene z otrokom varno zaporko Priložene so tri merilne žličke različnih mer.
It is recommended that a heaped measuring spoon is removed from the container and a flat surface, e. g. the blade of a knife, is drawn across the top of the measure.
Priporočljivo je, da vzamemo iz plastenke zvrhano merilno žličko zdravila in nato z ravno površino (npr. rezilom noža) potegnemo po žlički in vrnemo odvečno zdravilo.
This will give the following doses: small measure 0.95 g, medium measure 2.9 g and large measure 8.6 g of sodium phenylbutyrate.
S tem dobimo naslednje odmerke: z majhno žličko 0, 95 g; s srednjo žličko 2, 9 g in z veliko žličko 8, 6 g natrijevega fenilbutirata.
Where a patient requires administration by tube, it is possible to re-constitute AMMONAPS in water prior to use (solubility for sodium phenylbutyrate is up to 5 g in 10 ml water).
Pri bolnikih, ki potrebujejo dajanje po cevki, je možno suspendirati AMMONAPS v vodi (topnost natrijevega fenilbutirata je do 5 g v 10 ml vode).
Where AMMONAPS granules need to be added to food, liquid or water, it is important that it is taken immediately after mixing.
Pri bolnikih, kjer se AMMONAPS dodajajo hrani, tekočinam ali vodi, je pomembno, da se zdravilo vzame takoj po vmešanju.
EU/ 1/ 99/ 120/ 003 (266 g granules) EU/ 1/ 99/ 120/ 004 (532 g granules)
EU/ 1/ 99/ 120/ 003 (266 g zrnc) EU/ 1/ 99/ 120/ 004 (532 g zrnc)
Bioglan AB, Borrgatan 31, SE-211 24 Malmö, Sweden
Bioglan AB, Borrgatan 31, SE- 211 24 Malmö, Švedska
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
19 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
OUTER CARTON AND BOTTLE LABEL FOR TABLETS
ZUNANJA ŠKATLA IN NALEPKA ZA PLASTENKO ZA TABLETE
Contains sodium, see package leaflet for further information.
Za podrobnejše informacije glejte navodilo za uporabo.
EXP {month/ year}
{MM/ LLLL}
EU/ 1/ 99/ 120/ 001 250 tablets EU/ 1/ 99/ 120/ 002 500 tablets
EU/ 1/ 99/ 120/ 001 250 tablet EU/ 1/ 99/ 120/ 002 500 tablet
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
21 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
OUTER CARTON AND BOTTLE LABEL FOR GRANULES
ZUNANJA ŠKATLA IN NALEPKA ZA PLASTENKO ZA ZRNCA
AMMONAPS 940 mg/ g granules. sodium phenylbutyrate
AMMONAPS 940 mg/ g zrnca natrijev fenilbutirat
266 g granules 532 g granules
266 g zrnc 532 g zrnc
[the below is for immediate packaging only] AMMONAPS granules can be stored for a single period of 3 months at a temperature not above 25°C, after which the product must be discarded.
Zdravilo AMMONAPS zrnca lahko shranite za enkratno obdobje 3 mesecev pri temperaturi do 25 °C, zatem morate zdravilo zavreči.
Date removed from refrigerator: _______________
Zdravilo vzeto iz hladilnika dne: _______________
EU/ 1/ 99/ 120/ 003 266 g granules EU/ 1/ 99/ 120/ 004 532 g granules
EU/ 1/ 99/ 120/ 003 266 g zrnc EU/ 1/ 99/ 120/ 004 532 g zrnc
24 PACKAGE LEAFLET:
24 NAVODILO ZA UPORABO
What AMMONAPS is and what it is used for 2.
Kaj je zdravilo AMMONAPS in za kaj ga uporabljamo 2.
Before you take AMMONAPS 3.
Kaj morate vedeti, preden boste vzeli zdravilo AMMONAPS 3.
How to take AMMONAPS 4.
Kako jemati zdravilo AMMONAPS 4.
How to store AMMONAPS 6.
Shranjevanje zdravila AMMONAPS 6.
WHAT AMMONAPS IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO AMMONAPS IN ZA KAJ GA UPORABLJAMO
Patients with these rare disorders lack certain liver enzymes and are therefore unable to eliminate nitrogen waste, which builds up in the body after eating protein.
Bolniki s temi redkimi motnjami nimajo določenih encimov v jetrih in zato ne morejo odstranjevati odpadnega dušika, ki nastaja v telesu po uživanju beljakovin.
Nitrogen waste, in the form of ammonia, is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
Odpadni dušik v obliki amoniaka je še posebej toksičen za možgane in v hudih primerih povzroči zmanjšano zavest in komo.
AMMONAPS helps the body to eliminate nitrogen waste.
Zdravilo AMMONAPS telesu pomaga odstraniti odpadni dušik.
BEFORE YOU TAKE AMMONAPS
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO AMMONAPS
Do not take AMMONAPS
Ne jemljite zdravila AMMONAPS
- if you are pregnant.
- če ste noseči
- if you are breast-feeding.
- če dojite
- if you are allergic (hypersensitive) to sodium phenylbutyrate or any of the other ingredients of
če ste alergični na (preobčutljivi za) natrijev fenilbutirat ali katerokoli sestavino zdravila −
Take special care with AMMONAPS
Bodite posebno pozorni pri zdravila AMMONAPS
- if you have difficulty swallowing.
- če imate težave pri požiranju.
AMMONAPS tablets can get stuck in the esophagus and
Zdravilo AMMONAPS se lahko zatakne v požiralniku in
cause ulcers.
povzroči razjede.
- if you suffer from heart failure, decreased kidney function or other diseases where retention of
- če vam odpoveduje srce, če imate zmanjšano delovanje ledvic ali druge bolezni, kjer lahko
the sodium salt contained in AMMONAPS may make your condition worse.
zadrževanje natrijeve soli, ki jo vsebuje zdravilo AMMONAPS, poslabša vaše stanje.
- if you have decreased kidney or liver function, since AMMONAPS is eliminated from the body
- če imate zmanjšano delovanje ledvic ali jeter, ker se zdravilo AMMONAPS odstranjuje iz telesa
through the kidney and liver.
preko ledvic in jeter.
- when given to small children, since they may not be able to swallow the tablets and may choke.
- kadar se z zdravilom AMMONAPS zdravijo majhni otroci, ker morda ne morejo pogoltniti
It is recommended to use AMMONAPS granules instead.
Priporočamo jemanje AMMONAPS zrnc.
AMMONAPS must be combined with a protein limited diet, designed especially for you by the doctor and the dietician.
AMMONAPS se mora kombinirati s prehrano, ki ima omejeno vsebnost beljakovin in jo je vaš zdravnik ali dietetik prilagodil posebej za vas.
AMMONAPS does not completely prevent the occurrence of an acute excess of ammonia in the blood and is not appropriate for treating such a condition, which is a medical emergency.
AMMONAPS ne prepreči pojava odvečnih količin amonija v krvi popolnoma in ni primeren za zdravljenje takšnega stanja, ki je medicinski nujen primer.
25 If you require laboratory tests, it is important to remind your doctor that you take AMMONAPS, since sodium phenylbutyrate may influence certain laboratory test results.
25 Če boste morali opraviti laboratorijske preiskave, je pomembno, da opomnite svojega zdravnika, da jemljete zdravilo AMMONAPS, ker lahko natrijev fenilbutirat vpliva na rezultate nekaterih laboratorijskih preiskav.
It is especially important to tell your doctor if you are taking medicines containing valproic acid, haloperidol, corticosteroids or probenicid, since these medicines may change the effect of AMMONAPS and you will therefore need more frequent blood controls.
Zlasti pomembno je, da obvestite svojega zdravnika, če jemljete zdravila, ki vsebujejo valprojsko kislino, haloperiodol, kortikosteroide ali probenecid, ker lahko ta zdravila spremenijo delovanje zdravila AMMONAPS in boste morali pogosteje na preiskave krvi.
Pregnancy and breast-feeding Do not use AMMONAPS if you are pregnant, since this medicine could harm your unborn baby.
Nosečnost in dojenje Ne jemljite zdravila AMMONAPS med nosečnostjo, saj lahko škoduje vašemu otroku.
If you are a woman who could get pregnant during treatment with AMMONAPS, you must use reliable contraception.
Če lahko zanosite med jemanjem zdravila AMMONAPS, morate uporabljati zanesljivo metodo kontracepcije.
Do not use AMMONAPS if you are breast-feeding, since this medicine could pass into the breast-milk and harm your baby.
Ne jemljite zdravila AMMONAPS, če dojite, ker lahko prehaja v mleko in škoduje vašemu otroku.
Important information about some of the ingredients of AMMONAPS Each AMMONAPS tablet contains 62 mg of sodium.
Pomembne informacije o nekaterih sestavinah zdravila AMMONAPS Vsaka tableta zdravila AMMONAPS vsebuje 62 mg natrija.
To be taken into consideration by patients on a sodium controlled diet.
To moratjo upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.
HOW TO TAKE AMMONAPS
KAKO JEMATI ZDRAVILO AMMONAPS
Always take AMMONAPS exactly as your doctor has told you.
Pri jemanju zdravila AMMONAPS natančno upoštevajte zdravnikova navodila.
Remember that AMMONAPS must be taken with the special protein reduced diet.
Pazite, da zdravilo AMMONAPS jemljete skupaj s posebno prehrano z znižano vsebnostjo beljakovin.
You will therefore need regular blood tests to determine the correct daily dose.
Zaradi tega boste morali opravljati redne krvne preiskave, da se bo določil pravilni dnevni odmerek zdravila AMMONAPS.
You should take AMMONAPS by mouth in equally divided doses with each meal.
AMMONAPS morate jemati skozi usta v enakomerno razdeljenih odmerkih z vsakim obrokom.
You should take AMMONAPS with a large volume of water.
AMMONAPS je treba jemati z veliko količino vode.
AMMONAPS tablets should not be given to children who are not able to swallow tablets.
Tablet AMMONAPS ne smete dajati otrokom, ki tablet ne morejo pogoltniti.
If you take more AMMONAPS than you should Patients who have taken very high doses of AMMONAPS experienced sleepiness, tiredness, light- headedness and less frequently confusion, headache, taste disturbances, decrease in hearing, disorientation, impaired memory and worsening of existing neurological conditions.
Če ste vzeli večji odmerek zdravila AMMONAPS, kot bi smeli Pri bolnikih, ki so vzeli zelo velike odmerke zdravila AMMONAPS, se je pojavila zaspanost, utrujenost, vrtoglavost, redkeje pa zmedenost, glavobol, motnje okušanja, naglušnost, dezorientiranost, spominske motnje in poslabšanje obstoječih nevroloških stanj.
26 If you forget to take AMMONAPS You should take a dose as soon as possible with your next meal.
26 Če ste pozabili vzeti zdravilo AMMONAPS Vzemite odmerek takoj, ko je možno, z naslednjim obrokom.
Like all medicines, AMMONAPS can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo AMMONAPS neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Very common side effects (likely to occur in more than 1 out of 10 persons): irregular menstrual periods and cessation of menstrual periods.
Zelo pogosti neželeni učinki (pojav teh je možen pri več kot 1 od 10 oseb): neredna menstruacija in izostanek menstruacije.
If this occurs, please discuss it with your doctor, as the absence of your period may be caused by pregnancy (see Pregnancy and breast-feeding section above).
Če se to zgodi, se posvetujete s svojim zdravnikom, saj lahko izostanek menstruacije pomeni, da ste noseči (glejte poglavje Nosečnost in dojenje zgoraj).