natgillin/translations-raw huggingface dataset:
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.
This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija v napolnjeni injekcijski brizgi, kar v bistvu pomeni „brez natrija“.
In the pups of these animals, systemic exposure of pegvaliase was not detected.
Pri mladičih teh živali ni bila zaznana sistemska izpostavljenost pegvaliazi.
The bioavailability is not affected by the different injection sites on the body (see section 4.2).
Različna mesta injiciranja na telesu ne vplivajo na biološko uporabnost (glejte poglavje 4.2).
Of the 261 patients who enrolled in Study 301, 152 patients continued to the eligibility period of Study 302, and 51 patients continued directly from Study 301 into the long-term extension period of Study 302.
Od 261 bolnikov, vključenih v študijo 301, je 152 bolnikov sodelovanje nadaljevalo v obdobju ocenjevanja primernosti študije 302, 51 bolnikov pa je bilo iz študije 301 neposredno vključenih v dolgotrajno podaljšano obdobje študije 302.
Do not wipe it away.
Ne obrišite je.
If you see drops of blood at the injection site, press a sterile cotton ball or gauze over the injection site and hold for about 10 seconds.
Če na mestu vbrizgavanja opazite kapljice krvi, nanj pritisnite sterilno kroglico iz vate ali gazo ter držite približno 10 sekund.
Of the 100 patients who discontinued treatment, 40 patients discontinued due to an adverse event, 29 patients discontinued due to patient decision, 10 patients discontinued due to physician decision, and 21 patients discontinued to other reasons (e.g. lost to follow-up, pregnancy, or protocol deviation).
Od 100 bolnikov, ki so se prenehali zdraviti, se je 40 bolnikov prenehalo zdraviti zaradi neželenega dogodka, 29 bolnikov se je samih odločilo prenehati zdravljenje, 10 bolnikov je zdravljenje prekinilo zaradi odločitve zdravnika, 21 bolnikov pa zaradi drugih razlogov (npr. neodzivnost na nadaljnje spremljanje, zanositev ali odklon od protokola).
Patients or caregiver should be advised to rotate sites for subcutaneous injections.
Bolnikom ali negovalcem je treba svetovati, naj menjajo mesta za subkutano injiciranje.
Step 6: Choose your injection site.
6. korak: Izberite mesto vbrizgavanja.
Five out of the 7 patients who experienced serum sickness continued treatment without a recurrence, and managed serum sickness with treatment interruption, dose reduction and/or concomitant medicinal products.
Pet od 7 bolnikov, pri katerih se je pojavila serumska bolezen, je nadaljevalo zdravljenje brez ponovitve, pri čemer je bila serumska bolezen pri teh bolnikih obravnavana z začasno prekinitvijo zdravljenja, zmanjšanjem odmerka in/ali sočasno uporabo zdravil.
• If multiple syringes are needed for a single dose, you should inject at the same time of day.
• Če za enkratni odmerek potrebujete več injekcijskih brizg, jih vbrizgajte ob istem času.
Management of hypersensitivity reactions should be based on the severity of the reaction; in clinical trials, this has included dose adjustment, treatment interruption, additional antihistamines, antipyretics, and/or corticosteroids.
Preobčutljivostne reakcije je treba obravnavati na podlagi stopnje resnosti reakcije; v kliničnih preskušanjih je to vključevalo prilagajanje odmerka, prekinitev zdravljenja, dodatne antihistaminike, antipiretike in/ali kortikosteroide.
Check the expiry date on the carton.
Na škatli preverite datum izteka roka uporabnosti.
A mean (SD) half-life at 20 mg and 40 mg were 47.3 hours (41.6 hours) and 60.2 hours (44.6 hours), respectively.
Povprečni (SD) razpolovni čas pri 20 mg in 40 mg je bil 47,3 ure (41,6 ure) in 60,2 ure (44,6 ure), v tem zaporedju.
It is not known if Palynziq has an effect on fertility.
Ni znano, ali zdravilo Palynziq vpliva na plodnost.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
V vsaki skupini pogostnosti so neželeni učinki navedeni po padajoči stopnji resnosti.
12 weeks to 24 weeks2
12 tednov do 24 tednov2
The physician may decide, with the patient, to continue Palynziq treatment in those patients who show other beneficial effects (e.g. ability to increase protein intake from intact food or improvement of neurocognitive symptoms).
Zdravnik se lahko skupaj z bolnikom odloči za nadaljevanje zdravljenja z zdravilom Palynziq pri tistih bolnikih, pri katerih je mogoče opaziti druge koristne učinke (npr. možnost povečanja vnosa beljakovin iz nepredelane hrane ali izboljšanje nevrokognitivnih simptomov).
Available toxicological data in animals have shown excretion of pegvaliase in milk.
Razpoložljivi toksikološki podatki za živali so pokazali, da se pegvaliaza izloča v mleko.
• Do not use the pre-filled syringe if it looks damaged or used.
• Napolnjene injekcijske brizge ne uporabljajte, če je videti poškodovana ali uporabljena.
The most clinically significant hypersensitivity reactions include acute systemic hypersensitivity reaction (6%), angioedema (7%), and serum sickness (2%) (see sections 4.3 and 4.4).
Klinično najpomembnejše preobčutljivostne reakcije vključujejo akutno sistemsko preobčutljivostno reakcijo (6 %), angioedem (7 %) in serumsko bolezen (2 %) (glejte poglavji 4.3 in 4.4).
Analysis of pegvaliase concentration data from clinical trials indicated that body weight, gender and age did not have a notable effect on pegvaliase pharmacokinetics.
Analiza podatkov o koncentraciji pegvaliaze, pridobljenih v kliničnih preskušanjih, je pokazala, da telesna teža, spol in starost nimajo pomembnega vpliva na farmakokinetiko pegvaliaze.
Table 4: Efficacy results at Month 12, Month 18, Month 24 and Month 36 in Palynziq-treated patients Baseline Month 12 Month 18 Month 24 Month 36
Tabela 4: Rezultati učinkovitosti v 12. mesecu, 18. mesecu, 24. mesecu in 36. mesecu pri bolnikih, zdravljenih z zdravilom Palynziq
• Note: Do not inject multiple injections in the same spot.
• Opomba: Za več injekcij ne uporabite istega mesta.
Arteritis was attributed to the immune-mediated response associated with chronic administration of foreign protein to the animals.
Razlog za arteriitis je bil pripisan imunskemu odzivu, povezanemu z dolgotrajnim dajanjem tuje beljakovine živalim.
Decreased plasma phenylalanine and reduced body weight gain was reversible after cessation of treatment.
Nižja raven fenilalanina v plazmi in manjše pridobivanje telesne teže sta bila reverzibilna po ustavitvi zdravljenja.
Persistent arthralgia (lasting at least 6 months) occurred in 19 (7%) patients with a total of 24 episodes.
Do persistentne artralgije (s trajanjem vsaj 6 mesecev) je prišlo pri 19 bolnikih (7 %), in sicer do skupno 24 epizod.
In clinical trials, the majority of patients experienced injection site reactions (93%), arthralgia (85%), and hypersensitivity reactions (75%).
V kliničnih preskušanjih je pri večini bolnikov prišlo do reakcij na mestu injiciranja (93 %), artralgije (85 %) in preobčutljivostnih reakcij (75 %).
What Palynziq is and what it is used for
Kaj je zdravilo Palynziq in za kaj ga uporabljamo
In patients experiencing hypophenylalaninaemia on 10 mg/day, the dose may be reduced to 5 mg/day.
Pri bolnikih, pri katerih se hipofenilalaninemija pojavi pri odmerku 10 mg/dan, se lahko odmerek zmanjša na 5 mg/dan.
Figure A below shows what the pre-filled syringe looks like before use.
Na spodnji sliki A je prikazano, kako je napolnjena injekcijska brizga videti pred uporabo.
Check the syringe label to make sure you have the correct strength for your prescribed dose.
Preverite nalepko na injekcijski brizgi in se prepričajte, da je jakost zdravila ustrezna za vaš predpisani odmerek.
Eighteen out of 21 patients who experience angioedema were re-challenged and 5 patients had at least one recurrence.
Osemnajst od 21 bolnikov, pri katerih je prišlo do angioedema, je znova prejelo zdravilo in pri 5 bolnikih je prišlo do vsaj ene ponovitve.
Antibody titres were stable with long-term treatment and dose increases were not associated with increased antibody titres.
Pri dolgotrajnem zdravljenju je bila vrednost titrov protiteles stabilna in povečani odmerki niso bili povezani z večjo vrednostjo titrov protiteles.
• Before injecting, check to make sure the needle is not damaged or bent.
• Pred vbrizgavanjem preglejte iglo in se prepričajte, da ni poškodovana ali ukrivljena.
Acute systemic hypersensitivity reactions generally occurred within the first hour after injection (88%; 22/25 episodes); however, reactions have occurred up to 24 hours after dosing.
Akutne sistemske preobčutljivostne reakcije so se običajno pojavile v prvi uri po injiciranju (88 %; 22/25 epizod), vendar so se reakcije pojavile tudi do 24 ur po dajanju odmerka.
Randomised study arm
Randomizirana skupina v študiji
Necrobiosis lipoidica diabeticorum was treated with steroid injections and complicated by Pseudomonas infection.
Lipoidna diabetična nekrobioza je bila zdravljena z injiciranjem steroidov, pri čemer se je zapletla zaradi okužbe z bakterijo Pseudomonas.
Initial administration(s) should be performed under supervision of a healthcare professional and patients should be closely observed for at least 60 minutes following each of these initial injection(s) (see sections 4.4 and 4.8).
Dajanje začetnega odmerka oziroma začetnih odmerkov mora potekati pod nadzorom zdravstvenega delavca, pri čemer je treba bolnike skrbno opazovati vsaj 60 minut po tem začetnem injiciranju oz. vsakem od teh začetnih injiciranj (glejte poglavji 4.4 in 4.8).
Phenylalanine levels over time
Ravni fenilalanina glede na čas
The injection sites should be at least 5 centimetres away from each other.
Mesta vbrizgavanja morajo biti med seboj oddaljena vsaj 5 centimetrov.
• You will start Palynziq at the lowest dose.
• Zdravilo Palynziq boste začeli uporabljati pri najmanjšem odmerku.
• Front middle of the thighs.
• sredina sprednjega dela stegen,
Dietary phenylalanine intake should remain consistent until a maintenance dose is established.
Vnos fenilalanina s hrano mora ostati nespremenljiv, dokler se ne vzpostavi vzdrževalni odmerek.
Before using Palynziq, tell your doctor if you cannot use or do not want to use an adrenaline injection device to treat a severe allergic reaction to Palynziq.
Pred uporabo zdravila Palynziq zdravniku povejte, če ne morete ali ne želite uporabiti pripomočka za injekcijo adrenalina za ukrepanje v primeru hude alergijske reakcije na zdravilo Palynziq.
One patient reported soft tissue infection associated with mesenteric panniculitis, which resulted in treatment discontinuation.
En bolnik je poročal o okužbi mehkega tkiva, povezani z mezenteričnim panikulitisom, zaradi česar se je prenehal zdraviti.
If hypophenylalaninaemia develops prior to reaching daily dosing, the dose may be reduced to the previous titration dose.
Če se hipofenilalaninemija razvije, preden se doseže dnevno odmerjanje, se lahko odmerek zmanjša na prejšnji titracijski odmerek.
Each pre-filled syringe is for single use only.
Posamezna napolnjena injekcijska brizga je samo za enkratno uporabo.
Results for PKU-POMS confusion subscale over time are shown in Table 4.
Rezultati glede na čas, pridobljeni s podlestvico za zmedenost PKU-POMS, so prikazani v tabeli 4.
At the time of the data cut-off, 188 out of the 261 patients received treatment for at least 1 year, 4 patients completed treatment, and 69 discontinued treatment in the first year.
Na datum prenehanja zbiranja podatkov se je 188 od 261 bolnikov zdravilo vsaj 1 leto, 4 bolniki so zaključil zdravljenje, 69 pa se jih je prenehalo zdraviti v prvem letu.
Your doctor will tell you if you can continue Palynziq treatment.
Zdravnik vam bo povedal, ali lahko nadaljujete zdravljenje z zdravilom Palynziq.
It is not known if Palynziq passes into breast milk or if it will affect your baby.
Ni znano, ali zdravilo Palynziq prehaja v materino mleko in ali lahko vpliva na otroka.
Of these 188 patients, 164 patients received treatment for at least 2 years, 2 patients continued treatment but had not yet reached 2 years of treatment, and 22 patients discontinued in the second year, and 9 patients discontinued after 2 years of treatment.
Od teh 188 bolnikov se je 164 bolnikov zdravilo vsaj 2 leti, 2 bolnika sta nadaljevala zdravljenje, vendar še nista dosegla 2 let zdravljenja, 22 bolnikov se je prenehalo zdraviti v drugem letu, 9 bolnikov pa po 2 letih zdravljenja.
If your healthcare provider decides that you or your caregiver can give your injections of Palynziq at home, your healthcare provider will show you or your caregiver how to inject Palynziq before you inject it for the first time.
Če se zdravstveni delavec odloči, da si lahko injekcije zdravila Palynziq dajete sami doma oziroma da vam jih lahko daje negovalec, bo vam ali negovalcu pokazal, kako vbrizgati zdravilo Palynziq, preden ga prvič uporabite.
The PKU-POMS confusion subscale (ranging from 0 to 12 points with higher scores indicating greater degree of impairment) was considered most sensitive to changes in blood phenylalanine levels.
Podlestvica za zmedenost PKU-POMS (z vrednostmi od 0 do 12 točk, pri čemer več točk pomeni višjo stopnjo motnje) se je štela kot najnatančnejša pri določanju sprememb ravni fenilalanina v krvi.
Let the skin air dry for at least 10 seconds before injecting (see Figure H).
Pred vbrizgavanjem počakajte vsaj 10 sekund, da se koža posuši na zraku (glejte sliko H).
Look at the liquid through the viewing window (see Figure D).
Skozi okence za ogled si oglejte tekočino (glejte sliko D).
Step 2: Remove Palynziq tray(s) from carton and check expiry date: - Take out the cartons needed for your dose from the refrigerator.
2. korak: Enega ali več pladnjev z zdravilom Palynziq odstranite iz škatle in preverite datum izteka roka uporabnosti: - Iz hladilnika vzemite škatle, ki jih potrebujete za svoj odmerek.
The recommended starting dose of Palynziq is 2.5 mg administered once per week for 4 weeks.
Priporočeni začetni odmerek zdravila Palynziq je 2,5 mg, ki se daje enkrat na teden 4 tedne.
Presence of antibody titres were not predictive of hypersensitivity reactions.
Na podlagi prisotnosti titrov protiteles ni bilo mogoče napovedati preobčutljivostnih reakcij.
• The “Instructions for Use” (section 7 of this leaflet) shows you: o how to prepare and inject Palynziq and o how to throw away Palynziq syringes properly after you use them
• V navodilih za uporabo (poglavje 7 tega navodila) je prikazano: o kako pripravite in vbrizgate zdravilo Palynziq in o kako po uporabi ustrezno zavržete injekcijske brizge z zdravilom Palynziq.
Step 5: Check syringe strength and check for particles:
5. korak: Preverite jakost zdravila v injekcijski brizgi in prisotnost delcev: