natgillin/translations-raw huggingface dataset:
The reliever inhalations of DuoResp Spiromax should be taken in response to symptoms but are not intended for regular prophylactic use, e.g. before exercise.
Zdravilo DuoResp Spiromax kot olajševalec se uporablja v primerih, ko se pojavijo simptomi, ne pa redno v profilaktične namene, na primer pred telesnim naporom.
DuoResp Spiromax 320 micrograms/9 micrograms should be used as maintenance therapy only.
Zdravilo DuoResp Spiromax 320 mikrogramov/9,0 mikrogramov je treba uporabljati le kot vzdrževalno zdravljenje.
The safety and efficacy of DuoResp Spiromax in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Pediatrična populacija Varnost in učinkovitost zdravila DuoResp Spiromax pri otrocih, starih 12 let in manj, ter pri mladostnikih, starih od 13 do 17 let, še nista bili dokazani.
DuoResp Spiromax maintenance therapy: DuoResp Spiromax is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler.
Zdravilo DuoResp Spiromax za vzdrževalno zdravljenje: Zdravilo DuoResp Spiromax se uporablja za redno vzdrževalno zdravljenje, kot olajševalec pa se ločeno uporablja inhalator s hitrodelujočim bronhodilatatorjem.
a) You may be prescribed two asthma inhalers: DuoResp Spiromax together with a separate ‘reliever inhaler' such as salbutamol.
a) Lahko vam predpišejo inhalator DuoResp Spiromax skupaj z ločenim »inhalatorjem z olajševalcem«, npr. salbutamolom.
Also use DuoResp Spiromax as a ‘reliever inhaler' to treat asthma symptoms when they occur.
Zdravilo DuoResp Spiromax uporabite tudi kot »inhalator z olajševalcem« za odpravljanje simptomov astme, ko se pojavijo.
Always keep your DuoResp Spiromax with you and use it to relieve sudden attacks of breathlessness and wheezing.
Inhalator DuoResp Spiromax imejte vedno pri sebi in ga uporabite za lajšanje nenadnih napadov zasoplosti in piskajočega dihanja.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM C. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
DuoResp Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
Zdravilo DuoResp Spiromax je indicirano za redno zdravljenje astme v primerih, ko je primerna kombinacija zdravil (inhalacijski kortikosteroid in dolgodelujoči agonist adrenergičnih receptorjev β2):
• Use DuoResp Spiromax when you need to take extra inhalations or puffs to relieve asthma symptoms andto make it easier to breathe again.
• Poleg tega uporabljajte inhalator DuoResp Spiromax tudi v primerih, ko potrebujete dodatne odmerke ali vpihe za lajšanje simptomov astme in za lažje dihanje.
Each DuoResp Spiromax inhaler contains 120 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
En inhalator DuoResp Spiromax vsebuje 120 inhalacij zdravila in ima belo ohišje s polprozornim vinsko rdečim ustnikom.
A lower strength of DuoResp Spiromax is available for the maintenance and reliever therapy regimen.
Nižje jakosti zdravila DuoResp Spiromax so na voljo kot vzdrževalno in olajševalno zdravljenje.
However, do not use DuoResp Spiromax just before exercise to stop asthma symptoms from happening.
Ne uporabljajte pa zdravila DuoResp Spiromax neposredno pred telesno dejavnostjo, da bi preprečili pojav simptomov astme.
Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of DuoResp Spiromax.
Ko so simptomi astme dobro obvladani, bo vaš zdravnik morda predlagal, da odmerek zdravila DuoResp Spiromax postopoma zmanjšate.
Other medicines and DuoResp Spiromax
Druga zdravila in zdravilo DuoResp Spiromax
When used for asthma, your doctor will prescribe DuoResp Spiromax together with a separate ‘reliever inhaler' such as salbutamol.
Za zdravljenje astme vam bo zdravnik predpisal inhalator DuoResp Spiromax skupaj z ločenim inhalatorjem z olajševalcem, npr. salbutamolom.
DuoResp Spiromax is not intended for the initial management of asthma.
Zdravilo DuoResp Spiromax ni primerno za začetno zdravljenje astme.
DuoResp Spiromax maintenance and reliever therapy should especially be considered for patients with:
Vzdrževalno in olajševalno zdravljenje z zdravilom DuoResp Spiromax je primerno predvsem za bolnike:
Patients should be reassessed regularly by their prescriber/health care provider so that the dose of DuoResp Spiromax remains optimal.
Zdravljenje bolnikov mora redno ovrednotiti zdravnik, ki predpisuje zdravilo, tako da odmerek zdravila DuoResp Spiromax ostane optimalen.
If you forget to use DuoResp Spiromax
Če ste pozabili uporabiti zdravilo DuoResp Spiromax
(B) Using DuoResp Spiromax as your only asthma inhaler
(B) Uporaba zdravila DuoResp Spiromax kot edinega inhalatorja za astmo
In a 3-year clinical trial with budesonide in COPD, skin bruises and pneumonia occurred at a frequency of 10% and 6%, respectively, compared with 4% and 3% in the placebo group (p<0.001 and p<0.01, respectively).
so se modrice na koži pojavile pri 10 % bolnikov, pljučnica pa pri 6 % bolnikov, medtem ko so se modrice na koži v skupini, ki je prejemala placebo, pojavile pri 4 % bolnikov (p < 0,001), pljučnica pa pri 3 % (p < 0,01).
DuoResp Spiromax is not an appropriate treatment for the adult patient with only mild asthma who is not adequately controlled with an inhaled corticosteroid and “as needed” inhaled short-acting β2 adrenoreceptor agonists.
Zdravljenje z zdravilom DuoResp Spiromax ni ustrezno pri odraslih bolnikih z blago obliko astme, ki ni ustrezno nadzorovana z inhalacijskim kortikosteroidi in inhalacijskimi kratkodelujočimi agonisti adrenergičnih receptorjev β2, ki se uporabljajo po potrebi.
Do not use DuoResp Spiromax 320/9 micrograms as a ‘reliever inhaler'.
Ne uporabljajte inhalatorja DuoResp Spiromax 320/9 mikrogramov kot olajševalca.
b) You may be prescribed DuoResp Spiromax as your only asthma inhaler.
b) Lahko vam predpišejo inhalator DuoResp Spiromax kot edini inhalator za zdravljenje astme.
Use your DuoResp Spiromax every day.
Zdravilo DuoResp Spiromax uporabljajte vsak dan.
If either of these symptoms occur, stop using DuoResp Spiromax straightaway and use your 'reliever inhaler' if you have one.
Če se pojavi kateri od teh simptomov, takoj nehajte uporabljati inhalator DuoResp Spiromax in uporabite svoj
DuoResp Spiromax is indicated in adults 18 years of age and older only.
Zdravilo DuoResp Spiromax je indicirano izključno pri odraslih, starih 18 let in več.
• Use DuoResp Spiromax every day.
• Inhalator DuoResp Spiromax uporabljajte vsak dan.
DuoResp Spiromax is NOT indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
Zdravilo DuoResp Spiromax NI namenjeno za uporabo pri otrocih, starih 12 let in manj, ali mladostnikih, starih od 13 do 17 let.
Patients should be reminded to take their DuoResp Spiromax maintenance dose as prescribed, even when asymptomatic.
Bolnike je treba opozoriti, naj uporabljajo vzdrževalni odmerek zdravila DuoResp Spiromax skladno z navodili zdravnika, tudi če nimajo simptomov.
• If you have been prescribed DuoResp Spiromax as your only inhaler, read the section called (B) Using
• Če vam je zdravilo DuoResp Spiromax zdravnik predpisal kot edini inhalator, preberite poglavje »(B) Uporaba zdravila DuoResp Spiromax kot edinega inhalatorja za astmo«.
If you stop using DuoResp Spiromax
Če ste prenehali uporabljati zdravilo DuoResp Spiromax
DuoResp Spiromax is indicated for use in adults 18 years of age and older only.
Zdravilo DuoResp Spiromax je namenjeno izključno za uporabo pri odraslih osebah, starih 18 let in več.
Patients should be advised to always have DuoResp Spiromax available for rescue use.
Bolnikom je treba svetovati, da naj imajo zdravilo DuoResp Spiromax vedno na razpolago za hitro obvladanje simptomov.
What DuoResp Spiromax looks like and contents of the pack
Izgled zdravila DuoResp Spiromax in vsebina pakiranja
DuoResp Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy is instituted if necessary (see section
V tem primeru je treba zdravljenje z zdravilom DuoResp Spiromax takoj prekiniti, režim zdravljenja ponovno ovrednotiti in po potrebi uvesti drugo vrsto zdravljenja (glejte poglavje
(A) Using DuoResp Spiromax and a separate ‘reliever inhaler'
(A) Uporaba zdravila DuoResp Spiromax in ločenega inhalatorja z olajševalcem
Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands Teva Operations Poland Sp. z o.o.
Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska Teva Operations Poland Sp. z o.o., Mogilska 80 Str. 31-546 Kraków, Poljska
Patients should also be advised to rinse their mouth with water after inhaling (see section 4.4) The patient may notice a taste when using DuoResp Spiromax due to the lactose excipient.
Bolnikom svetujte tudi, naj si po inhaliranju sperejo usta z vodo (glejte poglavje 4.4).
How to use DuoResp Spiromax
Kako uporabljati zdravilo DuoResp Spiromax
DuoResp Spiromax contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Mehanizem delovanja in farmakodinamični učinki Zdravilo DuoResp Spiromax vsebuje učinkovini formoterol in budezonid, ki imata različna mehanizma delovanja, njuni učinki pri zmanjšanju pogostnosti poslabšanj astme pa so aditivni.
Adults (18 years and older): 2 inhalations twice a day, taken in the morning and in the evening.
Odrasli (18 let in več) 1 vdih (sprožitev) dvakrat na dan, uporabi se zjutraj in zvečer.
Only use DuoResp Spiromax in this way if your doctor has told you to. Use your DuoResp Spiromax every day.
Zdravilo DuoResp Spiromax uporabljajte na ta način le, če vam je tako naročil zdravnik.
DuoResp Spiromax maintenance therapy
Zdravilo DuoResp Spiromax za vzdrževalno zdravljenje
DuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder
DuoResp Spiromax 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje
Since DuoResp Spiromax contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur.
Povzetek varnostnega profila Ker zdravilo DuoResp Spiromax vsebuje tako budezonid kot formoterol, lahko pri bolnikih pričakujemo enak vzorec neželenih učinkov, kot so jih opažali pri posameznih učinkovinah.
DuoResp Spiromax contains lactose
Zdravilo DuoResp Spiromax vsebuje laktozo.
DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder
DuoResp Spiromax 320 mikrogramov/9 mikrogramov prašek za inhaliranje
DuoResp Spiromax pharmacokinetic profile
Farmakokinetični profil zdravila DuoResp Spiromax
Patients take a daily maintenance dose of DuoResp Spiromax and in addition take DuoResp Spiromax as needed in response to symptoms.
Zdravilo DuoResp Spiromax za vzdrževalno in olajševalno zdravljenje Bolniki redno jemljejo dnevni vzdrževalni odmerek zdravila DuoResp Spiromax, ob pojavu simptomov pa po potrebi dodatne odmerke zdravila DuoResp Spiromax.
Before using your DuoResp Spiromax for the first time, you need to prepare it for use as follows:
Preden prvikrat uporabite nov inhalator DuoResp Spiromax, ga morate pripraviti za uporabo na naslednji način: • Vrečko iz folije odprite, tako da jo raztrgate na zarezi na vrhu vrečke iz folije, in iz nje vzemite inhalator.
Preparing your new DuoResp Spiromax
Priprava novega inhalatorja DuoResp Spiromax
If the patient experiences paradoxical bronchopasm DuoResp Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
V tem primeru je treba zdravljenje z zdravilom DuoResp Spiromax takoj prekiniti, režim zdravljenja ponovno ovrednotiti in po potrebi uvesti drugo vrsto zdravljenja.
Each DuoResp Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
60 inhalacij zdravila in ima belo ohišje s polprozornim vinsko rdečim pokrovčkom ustnika.
The most common symptoms that may occur after when you use more DuoResp Spiromax than you should are trembling, headache or a rapid heartbeat.
Najpogostejši simptomi, ki se lahko pojavijo, če ste uporabili večji odmerek zdravila DuoResp
Serious asthma-related adverse reactions and exacerbations may occur during treatment with DuoResp Spiromax.
Med zdravljenjem z zdravilom DuoResp Spiromax se lahko pojavijo resni neželeni učinki, povezani z astmo, in poslabšanje bolezni.
Adults (18 years and older): 1 inhalation twice daily.
Odrasli (18 let in več): 1 vdih dvakrat na dan
Close monitoring for dose-related adverse reactions is needed in patients who frequently take high numbers of DuoResp Spiromax as-needed inhalations.
Pri bolnikih, ki pogosto uporabljajo veliko število inhalacij zdravila DuoResp Spiromax po potrebi, je treba skrbno nadzorovati z odmerkom povezane neželene učinke.
DuoResp Spiromax 320 mcg/9 mcg inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
DuoResp Spiromax 320 mcg/9 mcg prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
Tell your doctor if you have any of the following while taking DuoResp Spiromax they could be symptoms of a lung infection:
• pljučnica (okužba pljuč) pri bolnikih s KOPB (pogost neželen učinek) Svojemu zdravniku morate povedati, če imate med jemanjem zdravila DuoResp Spiromax kar koli od naštetega, ker so to lahko simptomi okužbe pljuč:
DuoResp Spiromax 160 mcg/4.5 mcg inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
DuoResp Spiromax 160 mcg/4,5 mcg prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
DuoResp Spiromax 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate
DuoResp Spiromax 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
How to store DuoResp Spiromax
Shranjevanje zdravila DuoResp Spiromax
DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
DuoResp Spiromax 320 mikrogramov/9 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
• If you have been prescribed DuoResp Spiromax and a separate reliever inhaler, read the section called
• Če vam je zdravnik predpisal zdravilo DuoResp Spiromax in ločen inhalator z olajševalcem, potem preberite poglavje »(A) Uporaba zdravila DuoResp Spiromax in ločenega inhalatorja z olajševalcem«.
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with DuoResp Spiromax.
Če po uvedbi zdravila DuoResp Spiromax simptomi astme niso nadzorovani ali se poslabšajo, naj bolniki nadaljujejo z zdravljenjem in poiščejo zdravniško pomoč.
Study months
Številka študije / trajanje
DuoResp Spiromax maintenance and reliever therapy
Zdravilo DuoResp Spiromax za vzdrževalno in olajševalno zdravljenje: Zdravilo DuoResp
DuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate Inhalation use.
DuoResp Spiromax 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
What you need to know before you use DuoResp Spiromax 3.
Kaj je zdravilo DuoResp Spiromax in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo DuoResp Spiromax Kako uporabljati zdravilo DuoResp Spiromax
Package leaflet: Information for the patient DuoResp Spiromax 320 micrograms/9 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate
Navodilo za uporabo DuoResp Spiromax 320 mikrogramov/9 mikrogramov, prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
OF THE MEDICINAL PRODUCT
UČINKOVITO UPORABO ZDRAVILA
Package leaflet: Information for the patient DuoResp Spiromax 160 micrograms/4.5 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate
Navodilo za uporabo DuoResp Spiromax 160 mikrogramov/4,5 mikrogramov, prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
DuoResp Spiromax 320 mikrogramov/9 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
1 or 2 inhalations (actuations), twice a day, taken in the morning and in the evening Your doctor may increase this to 4 inhalations, twice a day.
1 ali 2 vdiha (sprožitvi) dvakrat na dan, uporabi se zjutraj in zvečer.
This will change as your child grows.
To se bo z otrokovo rastjo spremenilo.
Take the next dose at the usual time.
Vzemite naslednji odmerek ob običajnem času.
Use in all patients
Uporaba pri vseh bolnikih
• A glass or cup
• kozarec ali skodelica
Their frequency is not known (frequency cannot be estimated from the available data).
Njihova pogostnost ni znana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
It may take a few minutes for the tablets to dissolve.
Lahko traja nekaj minut, da se tablete raztopijo.
Open the sachet(s) only when you are ready to use them.
Vrečico(ce) odprite šele, ko ste pripravljeni na uporabo.
Treatment of overdose should be directed to symptoms.
Zdravljenje prevelikega odmerjanja mora biti usmerjeno k simptomom.
*Reflects volume for total daily dose.
*Odraža količino celotnega dnevnega odmerka.
See leaflet for further information.
Glejte navodilo za več informacij.
If you notice these signs, contact your doctor immediately.
Če opazite takšne znake, takoj stopite v stik s svojim zdravnikom.
The table below is an example of how an appropriate dose is calculated
Spodnja tabela podaja primer izračuna ustreznega odmerka
If you are pregnant your doctor will tell you how to control phenylalanine levels adequately.
Če ste nosečnosti, vam bo vaš zdravnik povedal, kako boste ustrezno nadzorovali raven fenilalanina.
Do not change your diet without contacting your doctor.
Svoje prehrane ne smete spreminjati brez posvetovanja z zdravnikom.
What Kuvan is and what it is used for
Kaj je zdravilo Kuvan in za kaj ga uporabljamo
Paediatric population The posology is the same in adults, children and adolescents.
Pediatrična populacija Odmerjanje je enako za odrasle, otroke in mladostnike.
Few cases of allergic reactions (such as skin rash and serious reactions) have been reported.
Poročali so o nekaj primerih alergijskih reakcij (kot je kožni izpuščaj in hude reakcije).
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj.
Discontinuation of treatment should be done only under the supervision of a physician.
Zdravljenje se lahko prekine le pod nadzorom zdravnika.
Population pharmacokinetic analysis of sapropterin including patients from birth to 49 years of age showed that body weight is the only covariate substantially affecting clearance or volume of distribution.
Analiza populacijske farmakokinetike sapropterina, vključno z bolniki od rojstva do 49 let starosti, je pokazala, da je telesna masa edina sospremenljivka, ki bistveno vpliva na očistek ali volumen porazdelitve.
Health disturbances
Motnje zdravja
BH4 deficiency
Pomanjkanje BH4
Safety and efficacy of Kuvan in patients above 65 years of age have not been established.
Varnost in učinkovitost zdravila Kuvan pri bolnikih, starejših od 65 let, nista bili dokazani.
• the amount of solution you will need to give your child for their prescribed dose
• količino raztopine, ki jo boste morali dati otroku za njegov predpisani odmerek
For small infants an oral syringe can be used.
Za manjše otroke je možno uporabiti brizgo za peroralno dajanje.
Very common side effects (may affect more than 1 in 10 people) Headache and runny nose.
Zelo pogosta neželena učinka (lahko se pojavijo pri več kot 1 od 10 bolnikov) glavobol in izcedek iz nosu.
For instructions for use, see section 4.2.
Za navodila za uporabo glejte poglavje 4.2.
EU/1/08/481/004 100 mg sachet EU/1/08/481/005 500 mg sachet
EU/1/08/481/004 100 mg vrečica EU/1/08/481/005 500 mg vrečica
Taking the medicine • Drink the solution within 30 minutes.
Jemanje zdravila • Raztopino spijte v 30 minutah.
Each bottle contains 30, 120 or 240 tablets.
Vsaka plastenka vsebuje 30, 120 ali 240 tablet.
Steps for preparing and taking your dose:
Postopek za pripravo in jemanje odmerka:
In vitro, sapropterin did not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4/5, nor induce CYP1A2, 2B6, or 3A4/5.
In vitro sapropterin ni zaviral CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali CYP3A4/5 in ni aktiviral CYP1A2, 2B6 ali 3A4/5.
• If your baby is too small to drink from a glass or a cup you may administer the solution via the oral syringe.
• Če je dojenček premajhen, da bi pil iz kozarca ali skodelice, mu lahko raztopino daste z brizgo za peroralno dajanje.
Each carton contains 30 sachets.
Vsaka škatla vsebuje 30 vrečic.
• A medicine cup with graduation markings at 20, 40, 60 and 80 ml
• merica za zdravilo z oznakami za 20, 40, 60 in 80 ml
The dose is based on body weight.
Odmerek je odvisen od telesne mase.
BH4 deficiency is a group of disorders arising from mutations or deletions in the genes encoding for one of the five enzymes involved in the biosynthesis or recycling of BH4.
Pomanjkanje BH4 je skupina motenj, do katerih pride zaradi mutacij ali izbrisov v genih, ki kodirajo enega izmed petih encimov, ki sodelujejo pri biosintezi ali recikliranju BH4.
Because of very low BH4 levels phenylalanine is not used properly and its levels rise, resulting in harmful effects.
Zaradi nizkih ravni BH4 se fenilalanin ne more ustrezno uporabljati in se zato njegove ravni povišajo, kar ima za posledico škodljive učinke.
The solution should be drank within 15 to 20 minutes.
Raztopino je treba popiti v 15 do 20 minutah.
Absolute bioavailability or bioavailability for humans after oral administration is not known.
Absolutna biološka uporabnost ali biološka uporabnost pri ljudeh po peroralnem odmerku ni poznana.
If you take more Kuvan than prescribed, you may experience side effects that could include headache and dizziness.
Če vzamete večji odmerek zdravila Kuvan od predpisanega, se pri vas lahko pojavijo neželeni učinki, ki lahko vključujejo glavobol in omotico.
No clear evidence of teratogenic activity was found in rats and in rabbits at doses of approximately 3 and 10 times the maximum recommended human dose, based on body surface area.
Pri podganah in zajcih niso našli nobenega jasnega dokaza o teratogenem delovanju pri odmerkih, ki so bili približno 3- in 10-kratniki največjega priporočenega odmerka pri ljudeh, na osnovi velikosti površine telesa.
If these are not strictly controlled before or when you become pregnant, this could be harmful to you and to your baby.
Če pred ali med nosečnostjo te ravni niso skrbno nadzorovane, lahko to škoduje vam in vašemu otroku.
Oral use, after dissolution.
Peroralna uporaba, po raztapljanju.
Slowly pull back the plunger to withdraw the amount as instructed by your doctor.
Bat počasi vlecite nazaj in izvlecite količino, kot vam je naročil zdravnik.
To make the tablets dissolve faster you can crush them.
Da se tablete hitreje raztopijo, jih lahko prej zdrobimo.
It is of primary importance to initiate treatment as early as possible to avoid the appearance of non-reversible clinical manifestations of neurological disorders in paediatric patients and cognitive deficits and psychiatric disorders in adults due to sustained elevations of blood phenylalanine.
Najbolj pomembno je, da se z zdravljenjem začne čim prej, da se izognemo pojavu ireverzibilnih kliničnih manifestacij nevroloških motenj pri pediatričnih bolnikih in kognitivnega primanjkljaja ter psihičnih motenj pri odraslih zaradi dolgotrajno povišanih ravni fenilalanina v krvi.
Your child should drink the solution with a meal.
Vaš otrok naj raztopino spije z obrokom.