natgillin/translations-raw huggingface dataset:
Patients switching to Abseamed maintained haemoglobin levels to the same extent as those continuing with Eprex/Erypo.
Bolniki, ki so prešli na jemanje zdravila Abseamed, so ohranili vrednost hemoglobina na enaki ravni kot bolniki, ki so nadaljevali zdravljenje z zdravilom Eprex/Erypo.
How is Abseamed used?
Kako se zdravilo Abseamed uporablja?
Laboratory studies comparing Abseamed with the reference medicine Eprex/Erypo have shown that the active substance in Abseamed is highly similar to that in Eprex/Erypo in terms of structure, purity and biological activity.
Laboratorijske študije, v katerih so zdravilo Abseamed primerjali z referenčnim zdravilom Eprex/Erypo, so pokazale, da je učinkovina v zdravilu Abseamed po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Eprex/Erypo.
• to reduce the need for blood transfusions in adults with moderate anaemia who are about to undergo major orthopaedic (bone) surgery, such as hip surgery.
• za zmanjšanje potrebe po transfuziji krvi pri odraslih z blago obliko anemije pred zahtevnejšim ortopedskim kirurškim posegom (na kosteh), na primer operacijo kolkov.
• patients who have developed pure red cell aplasia (reduced or stopped red blood cell production)
(zmanjšano ali zaustavljeno tvorjenje rdečih krvnih celic);
For the full list of side effects of Abseamed, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Abseamed, glejte navodilo za uporabo.
In addition, studies have shown that the effects of the medicine are equivalent to those of Eprex/Erypo in increasing and maintaining blood cell counts in patients with chronic kidney failure or undergoing chemotherapy.
Poleg tega so študije pokazale, da so učinki tega zdravila pri zviševanju in ohranjanju števila rdečih krvnih celic pri bolnikih s kronično odpovedjo ledvic ali tistih, ki prejemajo kemoterapijo, enakovredni učinkom zdravila Eprex/Erypo.
Abseamed, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
V eni glavni študiji, ki je vključevala 479 bolnikov z anemijo, povezano z obolenjem ledvic, so zdravilo Abseamed, injicirano v veno, primerjali z referenčnim zdravilom.
Studies have also shown that giving Abseamed produces similar levels of the active substance in the body to giving Eprex/Erypo.
Študije so pokazale tudi, da zdravilo Abseamed vzpostavi podobne ravni učinkovine v telesu kot zdravilo Eprex/Erypo.
A further study showed that Abseamed was safe and effective when given under the skin in 416 patients with chronic kidney failure.
V dodatni študiji so pri 416 bolnikih s kronično odpovedjo ledvic dokazali, da je zdravilo Abseamed pri injiciranju v podkožje varno in učinkovito.
In addition, Abseamed was shown to be as effective as Eprex/Erypo at increasing and maintaining red blood cell counts in several studies.
Poleg tega so v več študijah dokazali, da je zdravilo Abseamed pri zviševanju in ohranjanju števila rdečih krvnih celic enako učinkovito kot zdravilo Eprex/Erypo.
Another study showed that Abseamed injected under the skin was as effective in maintaining haemoglobin levels as Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.
Druga študija pri 114 bolnikih z rakavimi obolenji, ki so prejemali kemoterapijo, je pokazala, da je bilo zdravilo Abseamed, injicirano v podkožje, enako učinkovito pri ohranjanju ravni hemoglobina kot zdravilo Eprex/Erypo.
How does Abseamed work?
Kako zdravilo Abseamed deluje?
Vial (type I glass) closed with a halogenobutyl rubber stopper and aluminium cap
Intramuskularno Viala (steklo tipa I) zaprta z zamaškom iz halogenobutilne gume in aluminijasto zaporko
--1 Equine influenza virus strains: A/equine-2/South Africa/4/03 strain
--1 Seva virusa influence konj: A/konjski-2/Južna Afrika/4/03 50 AU/ml A/konjski-2/ Newmarket/2/93 50 AU/ml Toksoid tetanusa
40 Lf/ml
40 Lf2
1 dose 10 glass vials
1 odmerek 10 steklenih vial Nič dni
Tetanus toxoid
Karenca
List of the names, pharmaceutical form, strength of the medicinal product, route of administration, applicant / marketing authorisation holder in the Member States
Seznam imen, farmacevtske oblike, jakosti zdravila, načina uporabe, predlagatelja, imetnika dovoljenja za promet z zdravilom v državah članicah
The application was submitted to Ireland as reference Member State and Austria, Bulgaria, Denmark, Spain, Finland, France, Hungary, the Netherlands, Poland, Portugal, Romania, Sweden, Slovenia as concerned Member States, as well as Iceland and Norway.
Vloga je bila predložena Irski kot referenčni državi članici in Avstriji, Bolgariji, Danski, Španiji, Finski, Franciji, Madžarski, Nizozemski, Poljski, Portugalski, Romuniji, Švedski ter Sloveniji kot zadevnim državam članicam ter Islandiji in Norveški.
The final opinion was converted into a Decision by the European Commission on 25 May 2012.
Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 25. maja 2012.
The applicant, Pfizer Limited, has submitted an application for a decentralised procedure for the above mentioned veterinary medicinal product in the framework of Article 32 of Directive 2001/82/EC, as amended.
Predlagatelj, družba Pfizer Limited, je predložil vlogo za začetek decentraliziranega postopka za zgoraj omenjeno zdravilo za uporabo v veterinarski medicini v okviru člena 32 Direktive 2001/82/ES, kakor je bila spremenjena.
Doramectin is a macrocyclic lactone and is closely related to ivermectin.
Doramektin je makrociklični lakton in je zelo soroden ivermektinu.
Potential serious risks were identified during the decentralised procedure by two concerned Member States regarding the environmental risk assessment (the Netherlands and France).
V okviru decentraliziranega postopka sta dve zadevni državi članici (Nizozemska in Francija) opredelili morebitna resna tveganja glede ocene tveganja za okolje.
Prontax 5 mg/ml pour-on solution for cattle (and associated names) contains doramectin.
Zdravilo Prontax 5 mg/ml kožni poliv, raztopina za govedo (in povezana imena) vsebuje doramektin.
Based on evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Prontax 5 mg/ml pour-on solution for cattle and associated names is deemed to be positive provided that the recommended risk mitigation measures are added to the product information regarding risk to aquatic organisms and dung fauna.
Na podlagi ocene trenutno razpoložljivih podatkov je odbor CVMP presodil, da razmerje med koristmi in tveganji za zdravilo Prontax 5 mg/ml kožni poliv, raztopina za govedo, in povezana imena, velja za pozitivno, če so informacijam o zdravilu dodani priporočeni ukrepi za zmanjšanje tveganja v zvezi s
referral for Prontax 5 mg/ml pour-on solution for cattle and associated names
za zdravilo Prontax 5 mg/ml kožni poliv, raztopina za govedo, in povezana imena
Opinion following an Article 33(4)F F referral for Prontax 5 mg/ml pour-on solution for cattle and associated names
Mnenje v zvezi z napotitvijo v skladu s členom 33(4)F F za zdravilo Prontax 5 mg/ml kožni poliv, raztopina za govedo, in povezana imena EMA/421650/2012
recommending the granting of a Marketing Authorisation for Prontax 5 mg/ml pour-on solution for cattle and associated names.
Odbor CVMP je zato 8. februarja2012 sprejel pozitivno mnenje, v katerem priporoča odobritev dovoljenja za promet z zdravilom Prontax 5 mg/ml kožni poliv, raztopina za govedo, in povezana imena.
The active substance in Pioglitazone Teva Generics, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Zdravilna učinkovina zdravila Pioglitazone Teva Generics, pioglitazon, poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
This means that Pioglitazone Teva Generics is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Actos.
Pioglitazone Teva Generics was to be used to treat type 2 diabetes in adults, particularly those who are overweight.
Zdravilo Pioglitazone Teva Generics naj bi se uporabljalo za zdravljenje sladkorne bolezni tipa 2 pri odraslih, zlasti tistih s prekomerno telesno maso.
The CHMP concluded that, in accordance with EU requirements, Pioglitazone Teva Generics had been shown to have comparable quality and to be bioequivalent to Actos.
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pioglitazone Teva Generics primerljivo raven kakovosti kot zdravilo Actos ter da mu je biološko enakovredno.
On 26 January 2012, TEVA Generics B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone Teva Generics, for the treatment of type 2 diabetes.
je dne 26. januarja 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Pioglitazone Teva Generics, namenjenim zdravljenju sladkorne bolezni tipa 2.
Because Pioglitazone Teva Generics is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Ker je zdravilo Pioglitazone Teva Generics generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Actos.
Pioglitazone Teva Generics was developed as a ‘generic medicine'.
Zdravilo Pioglitazone Teva Generics je bilo razvito kot „generično zdravilo“.
Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone Teva Generics for the treatment of type 2 diabetes.
Odbor je zato v času umika vloge izrazil pozitivno mnenje in priporočil odobritev vloge za pridobitev dovoljenja za promet z zdravilom Pioglitazone Teva Generics za zdravljenje sladkorne bolezni tipa 2.
Pioglitazone Teva Generics is a medicine that contains the active substance pioglitazone.
Pioglitazone Teva Generics je zdravilo, ki vsebuje zdravilno učinkovino pioglitazon.
Pioglitazone Teva Generics was to used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Prav tako naj bi se uporabljalo samostojno pri bolnikih, za katere metformin (drugo zdravilo proti sladkorni bolezni) ni primeren.
What is Pioglitazone Teva Generics?
Kaj je zdravilo Pioglitazone Teva Generics?
Pioglitazone Teva Generics was also to be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone.
Uporabljalo naj bi se tudi v kombinaciji z metforminom pri bolnikih, pri katerih zgolj z metforminom ni mogoče doseči zadovoljivega nadzora.
Pioglitazone Teva Generics was also to be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Uporabljalo naj bi se tudi skupaj z insulinom pri bolnikih, pri katerih bolezen ni zadostno nadzorovana samo z insulinom in za katere metformin ni primeren.
How is Pioglitazone Teva Generics expected to work?
Kako naj bi zdravilo Pioglitazone Teva Generics delovalo?
What was Pioglitazone Teva Generics expected to be used for?
Za kaj naj bi se zdravilo Pioglitazone Teva Generics uporabljalo?
o Your doctor will tell you if you need an observer for longer than 6 months.
o Zdravnik vam bo povedal, ali potrebujete opazovalca več kot 6 mesecev.
An observer is someone who:
Opazovalec je oseba, ki
BEFORE YOU START
PRED ZAČETKOM
Most people respond within 18 months, but it can sometimes take up to 30 months.
Pri večini ljudi do odziva pride v 18 mesecih, vendar lahko včasih traja do 30 mesecev.
A risk to infants cannot be excluded.
Tveganja za dojenčke ni mogoče izključiti.
The time to reach a response ranged from 0.5 to 30 months.
Čas za doseganje odziva je znašal od 0,5 do 30 mesecev.
Prior to independent self-injection, a healthcare professional should:
Pred samostojnim samoinjiciranjem mora zdravstveni delavec:
No differences in the safety profile were observed.
Ni bilo opaženih razlik v varnostnem profilu.
• Each day, change (rotate) your injection sites.
• Vsak dan spremenite (menjajte) mesta vbrizgavanja.
Study 302: Efficacy assessment
Študija 302: ocenjevanje učinkovitosti
Individual values for half-life range from 14 to 132 hours.
Posamezne vrednosti razpolovnega časa znašajo od 14 do 132 ur.
The clinical significance of these findings and functional consequences are unknown.
Klinična pomembnost teh ugotovitev in funkcijske posledice niso znane.
Keep it with you at all times.
Vedno ga imejte pri sebi.
Tell your doctor that you had a severe allergic reaction.
Zdravniku povejte, da ste imeli hudo alergijsko reakcijo.
Some of these allergic reactions can be more serious, as described below, and will require immediate attention.
Nekatere alergijske reakcije so lahko resnejše, kot je opisano spodaj, in zahtevajo takojšnje ukrepanje.
The absolute bioavailability in humans is unknown.
Absolutna biološka uporabnost pri ljudeh ni znana.
The effects in offspring were associated with maternal toxicity.
Učinki pri mladičih so bili povezani s toksičnostjo pri materi.
These medicines help to reduce the symptoms of an allergic reaction.
Ta zdravila pripomorejo k zmanjšanju simptomov alergijske reakcije.
Currently available data on patients aged 16 up to 18 years are described in section 4.8 and 5.1.
Trenutno razpoložljivi podatki za bolnike, stare od 16 do 18 let, so opisani v poglavjih 4.8 in 5.1.
There may be new information.
Morda bodo vključevala nove informacije.
The recommended injection sites are:
Priporočeni mesti vbrizgavanja sta:
No vacuolation was observed in the brain.
Vakuolizacija ni bila opažena v možganih.
Dose titration and time to achieve response
Titracija odmerka in čas, potreben za doseganje odziva
Study 301: Treatment initiation (Induction and Titration)
Študija 301: začetek zdravljenja (indukcija in titracija)
If you miss a dose, take your next dose at the regular time.
Če odmerka niste vzeli, naslednji odmerek vzemite ob običajnem času.
The immune response stabilises over 6 to 9 months of total treatment.
Imunski odziv se stabilizira v 6-9 mesecih celotnega zdravljenja.
Do not use a microwave and do not place in hot water.
Ne uporabite mikrovalovne pečice in ne potopite je v vročo vodo.
Table 1: Recommended dosing regimen
Tabela 1: Priporočeni režim odmerjanja
Duration prior to next dose increase
Čas do naslednjega povečanja odmerka
Seven out of the 16 patients discontinued treatment.
Sedem od 16 bolnikov se je prenehalo zdraviti.
Overall treatment experience from Study 301 and Study 302
Skupna izkušnja z zdravljenjem v študiji 301 in študiji 302
• Do not touch the cleaned injection site.
• Ne dotikajte se očiščenega mesta vbrizgavanja.
Step 8: Clean the chosen site with an alcohol pad.
8. korak: Izbrano mesto očistite z alkoholno krpico.
Step 1: Collect supplies:
1. korak: Zberite pripomočke:
Symptoms of inattention and mood were also evaluated during this period.
V tem obdobju so se ocenjevali tudi simptomi, povezani z nepozornostjo in razpoloženjem.
Serious side effects include:
Resni neželeni učinki so med drugim:
If your phenylalanine levels are too high or too low during pregnancy, this may harm you or your baby.
Če imate med nosečnostjo previsoke ali prenizke ravni fenilalanina, lahko to škoduje vam ali otroku.
Slowly increasing your dose over time allows your body to adjust to this medicine.
S počasnim postopnim povečevanjem odmerka se vaše telo lahko prilagodi na to zdravilo.
Osmolality: 260 - 290 mOsm/kg
Osmolalnost: 260-290 mOsm/kg
Efficacy results over time are presented in Table 4 and Figure 1.
Rezultati učinkovitosti glede na čas so predstavljeni v tabeli 4 in sliki 1.
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (od ≥ 1/100 do < 1/10), občasni (od ≥ 1/1.000 do < 1/100), redki (od ≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Relatively low titres of IgE has also been observed.
Opaženi so bili tudi relativno nizki titri protiteles razreda IgE.
The majority of patients (66%) reached a response by 18 months of total treatment.
Pri večini bolnikov (66 %) je bil odziv dosežen v 18 mesecih celotnega zdravljenja.
Posology is the same in these patients as in adults.
Odmerjanje je pri teh bolnikih enako kot pri odraslih.
Monitoring of blood phenylalanine level is recommended once a month.
Spremljanje ravni fenilalanina v krvi se priporoča enkrat mesečno.
People who have PKU have high levels of phenylalanine and this can lead to serious health problems.
Ljudje s PKU imajo visoke ravni fenilalanina, kar lahko povzroči resne zdravstvene težave.
Based on its mechanism of action, pegvaliase is not expected to be tumorigenic.
Glede na mehanizem delovanja se ne pričakuje, da bi bila pegvaliaza tumorogena.
6 Reflects high sensitivity CRP (hsCRP) levels above upper limit of normal (greater than 0.287 mg/dl) over a 6 month period.
6 Predstavlja ravni CRP visoke občutljivosti (hs-CRP), višje od zgornje meje normalne vrednosti (več kot 0,287 mg/dl) v obdobju 6 mesecev.
An additional 7% of patients responded to Palynziq after 18 months of treatment.
Dodatnih 7 % bolnikov se je na zdravilo Palynziq odzvalo po 18 mesecih zdravljenja.
Patients should be instructed to pre-medicate with an H1-receptor antagonist, H2-receptor antagonist, and antipyretic.
Bolnikom je treba naročiti uporabo premedikacije z antagonistom receptorja H1, antagonistom receptorja H2 in antipiretikom.
Figure F Inject at least 5 cm apart
Slika F Vbrizgavajte vsaj 5 cm narazen
The potency of this medicinal product should not be compared to any other PEGylated or non-PEGylated protein of the same therapeutic class.
Jakost tega zdravila se ne sme primerjati s katero koli drugo pegilirano ali nepegilirano beljakovino iz iste terapevtske skupine.
Vacuoles in all tissues, with the exception of the kidney, resolved or were diminished by the end of the recovery period, suggesting partial reversibility.
Vakuole v vseh tkivih, razen v ledvicah, so se do konca obdobja okrevanja odpravile ali zmanjšale, kar kaže na delno reverzibilnost.
Gather your supplies for the injection and place them on a clean flat surface.
Zberite pripomočke za injekcijo in jih položite na čisto, ravno površino.
Also, talk to your healthcare provider about your medical condition or your treatment.
Prav tako se glede svojega zdravstvenega stanja ali zdravljenja posvetujte z zdravstvenim delavcem.
Protein intake from intact food (g) N
Vnos beljakovin iz nepredelane hrane (g) N
• Do not change your protein intake unless your doctor tells you to.
• Vnosa beljakovin ne spreminjajte, če vam tega ne naroči zdravnik.
No data are available in paediatric patients less than 16 years of age.
Za pediatrične bolnike, mlajše od 16 let, ni na voljo podatkov.
If more than one syringe is needed:
Če potrebujete več kot eno injekcijsko brizgo:
• 1 alcohol pad
• 1 alkoholna krpica
The mean duration of serum sickness was 5 days and ranged from 1 to 8 days.
Povprečno trajanje serumske bolezni je bilo 5 dni, pri čemer je znašalo od 1 do 8 dni.
Angioedema can also present as one of the symptoms of an acute systemic hypersensitivity reaction.
Angioedem se lahko pojavi tudi kot eden od simptomov akutne sistemske preobčutljivostne reakcije.
These patients received the same induction/titration/maintenance regimen as patients aged 18 years and older in this study.
V tej študiji se je za te bolnike izvajal enak režim odmerjanja za indukcijo/titracijo/vzdrževalno zdravljenje kot za bolnike, stare 18 let in več.
In maintenance phase of the treatment, steady state is expected 4 to 24 weeks after maintenance dose started.
V fazi vzdrževalnega zdravljenja se pričakuje, da se stanje dinamičnega ravnovesja doseže 4-24 tednov po začetku dajanja vzdrževalnega odmerka.
Long-term extension period
Dolgotrajno podaljšano obdobje
Immune response affects clearance and time to reach steady state.
Imunski odziv vpliva na očistek in čas do doseženega stanja dinamičnega ravnovesja.
The median duration was 161 days (range: 35, 1408).
Mediana trajanja je bila 161 dni (razpon: 35, 1.408).
The long-term clinical consequences of chronic hypophenylalaninaemia are unknown.
Dolgoročne klinične posledice kronične hipofenilalaninemije niso znane.
The average molecular mass is approximately 1,000 kDa of which the protein moiety constitutes approximately 248 kDa.
Povprečna molekulska masa znaša približno 1.000 kDa, pri čemer beljakovinski del znaša približno 248 kDa. Mehanizem delovanja
It is not known if Palynziq is safe and effective in children and adolescents less than 16 years of age with PKU and therefore should not be used in people aged less than 16 years.
Ni znano, ali je zdravilo Palynziq varno in učinkovito pri otrocih in mladostnikih s PKU, mlajših od 16 let, zato se ne sme uporabljati pri osebah, mlajših od 16 let.
Use your other hand to pinch up the skin around the injection site.
Z drugo roko stisnite kožo okoli mesta vbrizgavanja.
- Place each sealed tray on a clean, flat surface out of reach of children and pets.
- Posamezni zatesnjeni pladenj položite na čisto, ravno površino zunaj dosega otrok in domačih živali.
Check with your doctor, pharmacist or nurse about the right way to throw away the container.
Zdravnika, farmacevta ali medicinsko sestro vprašajte, kako lahko pravilno zavržete vsebnik.
Colourless to pale yellow, clear to slightly opalescent solution with pH 6.6 - 7.4.
Brezbarvna do bledo rumena, bistra do nekoliko opalescentna raztopina s pH 6,6-7,4.
Step 7: Wash your hands well with soap and water (see Figure G).
7. korak: Roke si dobro umijte z milom in vodo (glejte sliko G).
Osmolality: 285 - 315 mOsm/kg, viscous solution
Osmolalnost: 285-315 mOsm/kg, viskozna raztopina
Step 11: Hold the body of the pre-filled syringe in 1 hand between your thumb and index finger.
11. korak: Telo napolnjene injekcijske brizge držite v 1 roki, in sicer med palcem in kazalcem.
Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with pegvaliase.
Dolgotrajne študije na živalih za ocenjevanje karcinogenega potenciala oziroma študije za ocenjevanje mutagenega potenciala s pegvaliazo niso bile izvedene.
- Open each carton and take out the sealed tray you need for your dose.
- Odprite posamezno škatlo in iz nje vzemite zatesnjeni pladenj, ki ga potrebujete za svoj odmerek.
• Never pull back on the plunger.
• Nikoli ne vlecite za bat.
The mean (SD) time from first dose of pegvaliase to onset was 372 (384) days.
Povprečni (SD) čas od prvega odmerka pegvaliaze do nastopa kožne reakcije ,je znašal 372 (384) dni.
After 6 months of Palynziq treatment, the need for an observer may be reconsidered.
Po 6 mesecih zdravljenja z zdravilom Palynziq se lahko znova razmisli o prisotnosti opazovalca.
Following a single subcutaneous dose (0.01, 0.03 or 0.1 mg/kg), pegvaliase is absorbed slowly with a median tmax of 3.5 to 4 days (individual range of 2.5 to 7 days).
Po enkratnem subkutanem odmerku (0,01, 0,03 ali 0,1 mg/kg) se pegvaliaza absorbira počasi z mediano tmax 3,5-4 dni (posamezni razpon 2,5-7 dni).
• train the patient and assess patient competency on proper self-administration of this medicinal product.
• poučiti bolnika in oceniti njegovo sposobnost ustreznega samoinjiciranja tega zdravila;
• can call for emergency medical support and administer adrenaline, if warranted.
• lahko pokliče nujno medicinsko pomoč in aplicira adrenalin, če je potrebno.
Date removed from refrigeration: _____/_____/______
Datum, ko se je zdravilo vzelo iz hladilnika: _____/_____/______
Additional risk to the unborn child due to hypophenylalaninaemia is not established.
Druga tveganja za nerojenega otroka zaradi hipofenilalaninemije niso bila dokazana.