natgillin/translations-raw huggingface dataset:
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.
In clinical trials, doses of pegvaliase were explored up to 150 mg/day and no specific signs or symptoms were identified following these higher doses. 
V kliničnih preskušanjih so se preskušali odmerki pegvaliaze do 150 mg/dan; po teh večjih odmerkih ni prišlo do nobenih posebnih znakov ali simptomov.
Due to lack of human data, Palynziq should only be administered to breast-feeding women if the potential benefit is considered to outweigh the potential risk to the infant. 
Zaradi pomanjkanja podatkov za ljudi se sme zdravilo Palynziq dajati doječim materam le, kadar se šteje, da potencialna korist odtehta potencialno tveganje za otroka.
Hold the skin firmly (see Figure K). 
Kožo dobro držite (glejte sliko K).
During dose escalation from 20 mg/day to 40 mg/day and 40 mg/day to 60 mg/day, a greater dose proportional increase in exposure was observed. 
Pri povečanju odmerka z 20 mg/dan na 40 mg/dan in s 40 mg/dan na 60 mg/dan je bilo opaženo več kot proporcionalno povečanje izpostavljenosti.
The safety and efficacy of Palynziq in paediatric patients from birth to less than 16 years have not been established. 
Varnost in učinkovitost zdravila Palynziq pri pediatričnih bolnikih od rojstva do starosti manj kot 16 let nista bili dokazani.
Anti-PAL IgG was detected in almost all patients by 4 months. 
Protitelesa proti PAL razreda IgG so bila zaznana pri skoraj vseh bolnikih do 4. meseca.
If a patient does not reach a clinically relevant blood phenylalanine reduction after 18 months of treatment, continuation should be reconsidered. 
Če se pri bolniku ne doseže klinično pomembno znižanje fenilalanina v krvi po 18 mesecih zdravljenja, je treba ponovno razmisliti o nadaljevanju zdravljenja.
Step 15: Treat injection site (if needed). 
15. korak: Oskrbite mesto vbrizgavanja (po potrebi).
For this study, the maintenance period was defined as at least 3 weeks dosing at randomised 20 mg or 40 mg once daily. 
Za to študijo je bilo obdobje vzdrževalnega zdravljenja opredeljeno kot vsaj 3-tedensko dajanje randomiziranega odmerka 20 mg ali 40 mg enkrat na dan.
If the expiry date has passed, do not use the pre-filled syringe in that carton. 
Če je datum izteka roka uporabnosti potekel, napolnjene injekcijske brizge v tej škatli ne uporabljajte.
Place the thumb of your other hand on the plunger head (see Figure L). 
Palec druge roke položite na glavo bata (glejte sliko L).
Pharmacotherapeutic group: Other alimentary tract and metabolism products, Enzymes, ATC code: A16AB19 
Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, encimi, oznaka ATC: A16AB19
Prior to launch of Palynziq in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority. 
Pred prihodom zdravila Palynziq na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom z nacionalnim pristojnim organom dogovoriti o vsebini in obliki izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in morebitnimi drugimi vidiki programa.
The arterial inflammation observed in these studies involved small arteries and arterioles in a wide range of organs and tissues and in subcutaneous injection sites. 
Vnetje arterij, opaženo v teh študijah, je vključevalo majhne arterije in arteriole v velikem naboru organov in tkiv ter na mestih subkutanega injiciranja.
Three out of 7 (1%) patients had severe serum sickness (see section 4.8). 
Pri treh od 7 (1 %) bolnikov je šlo za hudo serumsko bolezen (glejte poglavje 4.8).
The vascular inflammation observed in these studies was reversible upon cessation of treatment. 
Vnetje arterij, opaženo v teh študijah, je bilo reverzibilno po ustavitvi zdravljenja.
- if you have a severe allergy to pegvaliase or any other ingredients of this medicine, or another medicine that contains polyethylene glycol (PEG) (listed in section 6). 
- če ste hudo alergični na pegvaliazo ali katero koli drugo sestavino tega zdravila oziroma drugo zdravilo, ki vsebuje polietilen glikol (PEG) (navedeno v poglavju 6).
• is able to recognise the signs and symptoms of an acute systemic hypersensitivity reaction, 
• zna prepoznati znake in simptome akutne sistemske preobčutljivostne reakcije,
The liquid should look clear and colourless to pale yellow. 
Tekočina mora biti bistra in brezbarvna do bledo rumena.
Your doctor will tell you how long to stay at each dose. 
Povedal vam bo, kako dolgo morate uporabljati posamezni odmerek.
Tell your doctor or pharmacist if you are injecting, have recently injected or might inject any other medicines. 
Obvestite zdravnika ali farmacevta, če vbrizgavate, ste pred kratkim vbrizgavali ali pa boste morda začeli vbrizgavati katero koli drugo zdravilo.
The impact of anti-PEG antibodies on the clinical effects of other PEG-containing medicinal products is unknown. 
Vpliv protiteles proti PEG na klinične učinke drugih zdravil, ki vsebujejo PEG, ni znan.
The MAH shall ensure that in each Member State where Palynziq is marketed, all healthcare professionals and patients, carers and observers who are expected to prescribe, use or oversee the administration of Palynziq have access to/are provided with the following educational package: 
Imetnik dovoljenja za promet z zdravilom mora v vsaki državi članici, kjer se trži zdravilo Palynziq, zagotoviti, da bodo vsi zdravstveni delavci ter bolniki, skrbniki in opazovalci, za katere se pričakuje, da bodo predpisovali, uporabljali ali nadzorovali dajanje zdravila Palynziq, imeli dostop oziroma prejeli naslednji paket izobraževalnih gradiv:
Patients previously treated with sapropterin were required to discontinue treatment at least 14 days prior to first dose of Palynziq. 
Bolniki, ki so se pred tem zdravili s sapropterinom, so se morali prenehati zdraviti vsaj 14 dni pred prvim odmerkom zdravila Palynziq.
Adverse reactions were similar in type and frequency to that of adult patients. 
Neželeni učinki pri njih so bili glede na vrsto in pogostnost podobnim tistim, ki so se pojavili pri odraslih bolnikih.
No human data are available. 
Podatki za ljudi niso na voljo.
- Do not warm up the pre-filled syringe in any other way. 
- Napolnjene injekcijske brizge ne segrevajte na nikakršen drug način.
Severe arthralgia (severe pain limiting self-care activities of daily living) was experienced in 14 (5%) patients. 
Huda artralgija (huda bolečina, ki omejuje vsakodnevne dejavnosti samooskrbe) se je pojavila pri 14 bolnikih (5 %).
Your healthcare provider will also tell you which signs and symptoms to look out for and what to do if you have a severe allergic reaction. 
Zdravstveni delavec vam bo prav tako povedal, na katere znake in simptome morate biti pozorni in kako ukrepate v primeru hude alergijske reakcije.
In case of hypophenylalaninaemia during pregnancy, there is a risk of intrauterine foetal growth retardation. 
V primeru hipofenilalaninemije med nosečnostjo obstaja tveganje za intrauterini zastoj rasti ploda.
5 Complement factor C3/C4 decrease is defined changing from normal or high baseline complement value to low post-baseline complement value. 
5 Znižanje ravni faktorja C3/C4 komplementa je opredeljeno kot sprememba z normalne ali visoke izhodiščne vrednosti komplementa na nizko vrednost komplementa, pridobljeno po izhodiščni vrednosti.
Do not use this medicine after the expiry date which is stated on the syringe label, tray cover, and carton after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na injekcijski brizgi, ovoju za pladenj in škatli poleg oznake „EXP“.
Acute systemic hypersensitivity reactions require treatment with adrenaline and immediate medical care. 
Pri akutnih sistemskih preobčutljivostnih reakcijah sta potrebna zdravljenje z adrenalinom in takojšnja medicinska pomoč.
Hypersensitivity reactions that include symptoms such as dizziness or syncope may affect the ability to drive and use machines. 
Preobčutljivostne reakcije, ki vključujejo simptome, kot je omotica ali sinkopa, lahko vplivajo na sposobnost vožnje in upravljanja strojev.
Rates decreased over time as the immune response matured (see Description of selected adverse reactions section). 
Stopnje so se s časom zmanjševale zaradi zorenja imunskega odziva (glejte poglavje Opis izbranih neželenih učinkov).
- Put the carton with any remaining trays back in the refrigerator. 
- Škatlo z morebitnimi ostalimi pladnji položite nazaj v hladilnik.
Step 16: If your health care provider tells you to use more than one syringe for your dose, repeat Steps 4 to 15 listed above for each syringe that you use. 
16. korak: Če vam zdravstveni delavec naroči, da morate za svoj odmerek uporabiti več kot eno injekcijsko brizgo, za vsako injekcijsko brizgo, ki jo uporabite, ponovite zgornje postopke v 4.-15. koraku.
Release the pinch of skin. 
Popustite prijem na koži.
4 Change from baseline was based on subjects with available measurements at both time points. 
4 Sprememba glede na izhodiščno vrednost je temeljila na preiskovancih, za katere so bile na voljo meritve za obe časovni točki.
Animal studies suggest that women may have difficulty becoming pregnant if their phenylalanine levels are abnormally low. 
Študije na živalih kažejo, da lahko ženske težje zanosijo, če imajo nenormalno nizko raven fenilalanina.
If you have a severe allergic reaction, do not continue to use Palynziq until you have talked with the doctor who prescribes you Palynziq. 
Če imate hudo alergijsko reakcijo, zdravila Palynziq ne uporabljajte, dokler se ne posvetujete z zdravnikom, ki vam je predpisal zdravilo Palynziq.