natgillin/translations-raw huggingface dataset:
Not known: Post-procedural complications (e.g. post procedural discharge, swelling, other wound complications)
Neznana: zapleti po posegu (npr. izcedek po posegu, oteklost, drugi zapleti
Care should be used when Opgenra is used in patients with renal or hepatic impairment (see section
Pri uporabi zdravila Opgenra pri bolnikih z ledvično ali jetrno okvaro je potrebna previdnost (glejte poglavje 4.4).
Bovine collagen Carmellose
6.1 Seznam pomožnih snovi goveji kolagen karmeloza
General disorders and administration site conditions
Infekcijske in parazitske bolezni Splošne težave in spremembe na mestu aplikacije
Each outer carton contains one 3.3 mg eptotermin alfa vial containing 1 g of powder and one carmellose powder vial containing 230 mg powder.
Vsaka zunanja škatla vsebuje eno vialo s 3,3 mg eptotermina alfa, ki vsebuje 1 g praška, in eno vialo s praškom karmeloze, ki vsebuje 230 mg praška.
Inform your doctor or surgeon if you have a history of heart problems or are prone to frequent infections so that they can closely monitor you.
Če imate zgodovino težav s srcem ali ste nagnjeni k pogostim okužbam, o tem obvestite svojega zdravnika ali kirurga, da vas bo lahko skrbno spremljal.
Antibodies to OP-1 and bovine bone collagen type 1 were found after both exposures.
Po obeh izpostavitvah so opazili protitelesa proti OP-1 in govejemu kostnemu kolagenu vrste 1.
2 x 1 vial containing 1 g of powder (3.3 mg eptotermin alfa).
2 x 1 viala, ki vsebuje 1 g praška (3,3 mg eptotermina alfa).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
IME ZDRAVILA IN POT(I) UPORABE Carmellose (Opgenra)
Once the vacuums are broken, remove the vial stoppers while holding the vials upright to prevent loss of contents.
Viali pri tem držite pokonci, da preprečite izgubo vsebine.
Interaction with bone void fillers
Medsebojno delovanje s kostnimi polnili
Name and address of the manufacturer of the biological active substance
Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (učinkovin)
Opgenra 3.3 mg powder for implantation suspension.
IME ZDRAVILA Opgenra 3,3 mg prašek za suspenzijo za implantacijo
Keep the blisters in the outer carton.
Pretisne omote shranjujte v zunanji ovojnini.
Marketing Authorisation Holder Olympus Biotech International Limited Block 2, International Science Centre National Technology Park Castletroy
Imetnik dovoljenja za promet z zdravilom Olympus Biotech International Limited Block 2, International Science Centre National Technology Park Castletroy
Opgenra should not be administered during pregnancy unless the benefits to the mother outweigh the risks to the unborn child. Women of child-bearing potential should inform their surgeon of the possibility of pregnancy before they are administered this medicine.
Zdravilo Opgenra se med nosečnostjo ne sme uporabljati, razen če koristi za mater odtehtajo tveganje za nerojenega otroka.
- a pack of two units with 2 x 1 vial containing 1g of powder (3.3 mg eptotermin alfa) and 2 x 1 vial containing 230 mg carmellose powder.
- pakiranje z dvema enotama vsebuje 2 x 1 vialo z 1 g praška (3,3 mg eptotermina alfa) in 2 x 1 vialo z 230 mg karmeloznega praška
1 vial containing 1 g of powder (3.3 mg eptotermin alfa).
1 viala vsebuje 1 g praška (3,3 mg eptotermina alfa).
Other medicines and Opgenra
Shranjevanje zdravila Opgenra
Therefore, upon re-administration of Opgenra, a risk of developing autoimmunity towards the endogenous BMP proteins may exist.
Protitelesa proti OP-1 lahko in vitro nevtralizirajo biološko aktivnost vsaj beljakovine BMP-6, zato lahko ob ponovni uporabi zdravila Opgenra obstaja tveganje za razvoj avtoimunosti za endogene beljakovine BMP.
What you need to know before you are administered Opgenra Do not use Opgenra
Kaj je zdravilo Opgenra in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Opgenra Kako uporabljati zdravilo Opgenra Možni neželeni učinki
Pack sizes: - a single unit pack with 1 vial containing 1g of powder (3.3 mg eptotermin alfa) and 1 vial containing 230 mg carmellose powder
Velikosti pakiranj: - pakiranje z eno enoto vsebuje 1 vialo z 1 g praška (3,3 mg eptotermina alfa) in 1 vialo z 230 mg karmeloznega praška
• have an autoimmune disease, including Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/polymyositis;
• z znano avtoimunsko boleznijo, vključno s Crohnovo boleznijo, revmatoidnim artritisom,
The same procedure should be used to prepare the medicinal product for the contralateral side of the spine.
Zdravilo za drugo stran hrbtenice pripravite po istem postopku.
• interaction with bone void fillers
• interakciji s polnili za luknje v kosteh,
Pre-existing co-morbidities
Že obstoječe bolezni
Follow-up measures
POSTOPEK UPORABE
Carmellose powder for implantation suspension for Opgenra Intraosseous use
FARMACEVTSKA OBLIKA prašek za suspenzijo za implantacijo
Opgenra 3.3 mg
IME ZDRAVILA IN POT(I) UPORABE Opgenra 3,3 mg
Eptotermin alfa in Freund's adjuvant was first administered subcutaneously with booster doses given after 14 and 28 days.
Eptotermin alfa v Freundovem adjuvansu so najprej dali subkutano.
- if you have an active infection in your spine or have been told that you have an active internal
sklerodermijo, Sjögrenovim sindromom in dermatomiositisom/polimiositisom; - če imate aktivno okužbo v hrbtenici ali so vam povedali, da imate aktivno notranjo (sistemsko)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS CARMELLOSE VIAL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BLISTER FOIL ACTIVE SUBSTANCE POWDER VIAL
PODATKI NA PRIMARNI OVOJNINI VIALA S PRAŠKOM ZDRAVILNE UČINKOVINE V PRETISNEM OMOTU
Instrumentation
Odmerjanje
Renal/hepatic impairment
Ledvična/jetrna okvara
The powder containing the excipient carmellose (carboxymethylcellulose) is yellowish white.
Prašek, ki vsebuje zdravilno učinkovino, je granularen in bel do umazano bel. Prašek, ki vsebuje karmelozo (karboksimetilcelulozo), je rumenkasto bel.
Irrigate the surgical site as necessary prior to the implantation of the medicinal product.
Če je mogoče, končajte kirurške posege na tem mestu pred vsaditvijo zdravila.
One vial containing 3.3 mg of eptotermin alfa.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 3,3 mg eptotermina alfa.
Once Opgenra is prepared it should be used immediately.
Zdravilo Opgenra morate porabiti takoj, ko ga pripravite.
One vial contains 1g powder with 3.3 mg of eptotermin alfa*.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 1 g praška s 3,3 mg eptotermina alfa.
What you will need:
Kaj boste potrebovali:
Some patients have actually committed suicide.
Nekaj bolnikov je dejansko storilo samomor.
● you may not have received an entire dose.
• je možno, da niste prejeli celega odmerka.
However, due to high variability, the confidence intervals were quite wide.
Vendar pa so bili zaradi visoke variabilnosti intervali zaupanja precej široki.
This can be discussed with your doctor.
O tem se lahko pogovorite z zdravnikom.
3) Clean your hands
3) Umijte si roke
Please read the instructions carefully and follow them step by step.
Pozorno preberite napotke in jih izvajajte po korakih.
However in neither disease was this correlated with lack of therapeutic response.
Vendar pa pri nobeni bolezni to ni bilo v zvezi s pomanjkanjem terapevtskega odziva.
CAUTION: If the viewing window is not completely filled by the red indicator,
OPOZORILO: Če okence ni popolnoma zapolnjeno z rdečim indikatorjem:
● if you have ever had anaemia.
• če ste kdaj imeli anemijo,
This will lessen the chance for ribavirin to be left in the woman's body.
To bo zmanjšalo možnost, da ribavirin ostane v ženskem telesu.
Laboratory tests prior to and during therapy
Laboratorijske preiskave pred in med zdravljenjem
● if you have been told you have VKH syndrome.
• če so vam kdaj povedali, da imate sindrom VKH,
● use through clothing covering the skin.
• uporabljate ga skozi obleko, ki prekriva kožo;
These side effects can be serious and you may need urgent medical attention.
Ti neželeni učinki so lahko resni in boste morda potrebovali nujno medicinsko pomoč.
The study was not powered for efficacy considerations.
Študija ni bila zasnovana za ugotavljanje učinkovitosti.
It is important to read, understand and follow these instructions so that you or your caregiver use the pre-filled pen correctly.
Pomembno je, da preberete, razumete in upoštevate ta navodila, da boste vi ali vaš skrbnik pravilno uporabljali napolnjeni injekcijski peresnik.
Your doctor will monitor you for signs and symptoms of these conditions.
Zdravnik bo spremljal vaše znake in simptome teh stanj.
Please check with your doctor and follow the recommended duration of treatment.
Prosimo, preverite z vašim zdravnikom in sledite priporočenemu trajanju zdravljenja.
● the needle-shield may not have locked.
• je možno, da se ščitnik za iglo ni zaklenil.
The average molecular mass is approximately 60,000 of which the protein moiety constitutes approximately 20,000.
Povprečna molekulska masa je približno 60.000, od tega predstavlja beljakovinski del približno 20.000.
 The viewing window will now be completely red.
 Okence bo postalo popolnoma rdeče.
< 12 g/dl despite 4 weeks at reduced dose
< 12 g/dl kljub 4-tedenskemu zmanjšanemu odmerku
The risk of developing anaemia is higher in the female population.
Tveganje za pojav anemije je večje pri ženski populaciji.
Date of latest renewal: 20 June 2007
Datum prve odobritve: 20. junij 2002 Datum zadnjega podaljšanja: 20. junij 2007
The instructions below should be used as a general guide for proper disposal: Recapping is not required.
Spodnja navodila naj služijo kot splošna navodila za primerno odstranjevanje: Pokrovčka ni treba ponovno pritrditi.
 A "click" sound will indicate the start of the injection.
 Zvok “klik” naznanja začetek injiciranja.
Consideration for early treatment discontinuation should be evaluated in the context of a particular clinical situation.
Razlog za zgodnjo prekinitev zdravljenja je treba oceniti v okviru posamezne klinične situacije.
● the expiration date has passed.
• je rok uporabnosti potekel.
 The red indicator will move down in the viewing window as the injection is ongoing.
 Rdeči indikator se bo pomikal navzdol po okencu, ko bo injekcija tekla.
● if the patient is a child less than 3 years old.
• je bolnik otrok, mlajši od treh let,
● expose to excessive forces or shock.
• izpostavljajte ga prekomernim silam ali udarcem;
Haematological tests should be repeated after 2 and 4 weeks and biochemical tests should be performed at 4 weeks.
Hematološke preiskave moramo ponoviti po 2 in 4 tednih, biokemične preiskave pa po 4 tednih.
A return to original dosing is not recommended.
Vrnitev na prvotni odmerek ni priporočljiva.
It is important to note that ribavirin should never be given as monotherapy.
Pomembno je, da se ribavirina nikoli ne da kot monoterapijo.
● a container for the waste material
• vsebnik za odpadni material.
All patients who completed the phase III studies were eligible for entry into a long-term follow-up study (WV16866).
Vsi bolniki, ki so zaključili fazo III študij, so bili primerni za vključitev v dolgotrajno študijo sledenja (WV16866).
**Scheduled treatment duration was 48 weeks regardless of the genotype
**Program zdravljenja je trajal 48 tednov, ne glede na genotip
You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.
Mogoče boste želeli prositi člana vaše družine ali prijatelja, da bi bila skupaj pozorna na znake depresije ali spremembe vašega vedenja.
Predictability of response Please refer to section 4.2, in Table 2.
Predvidljivost odziva Prosimo, glejte poglavje 4.2, preglednica 2.
Take your next doses at 5 day intervals until you return to your regularly scheduled day of the week.
Naslednje odmerke vzemite v 5-dnevnih intervalih, dokler se ne vrnete na vaš določeni dan v tednu.
This is normal.
To je normalen pojav.
Predictability of response
Predvidljivost odziva
Increased alanine aminotransferase (ALT)
Zvišane vrednosti alaninaminotransferaze (ALT)
For spontaneous reports of undesirable effects from post-marketing experience, the frequency is not known (cannot be estimated from the available data).
Za spontana poročila o neželenih učinkih v obdobju po prihodu zdravila na trg pogostnost ni znana (je ni mogoče oceniti iz razpoložljivih podatkov).
Change your injection site each time.
Mesto injiciranja vsakič spremenite.
● the medicine contains particles
• zdravilo vsebuje delce;
• A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months (see section 4.4)
• anamneza težkega srčnega obolenja, vključno z nestabilnim ali nekontroliranim srčnim obolenjem v predhodnih 6 mesecih (glejte poglavje 4.4),
The extent of available data is not sufficient to conclude that growth inhibition due to Pegasys exposure is always reversible.
Obseg razpoložljivih podatkov ni dovolj velik, da bi zaključili, da je zastoj rasti zaradi izpostavljenosti zdravilu Pegasys vedno reverzibilen.
If necessary, the dose may be changed during treatment.
Če bo potrebno, bo zdravnik odmerek med zdravljenjem spremenil.
● Do contact your healthcare provider.
• Obrnite se na zdravstvenega delavca.
The potency of this medicinal product should not be compared to the one of another pegylated or nonpegylated protein of the same therapeutic class.
Jakosti tega zdravila ne smete primerjati z jakostjo drugih pegiliranih ali nepegiliranih beljakovin iz istega terapevtskega razreda.
Efficacy results were similar to those reported in adults.
Izsledki o učinkovitosti so podobni tistim, ki so jih opazili pri odraslih.
Pegasys must not be given to children below the age of 3 years because it contains benzyl alcohol and may cause toxic reactions and allergic reactions in these children.
Zdravila Pegasys ne smemo dajati otrokom, mlajšim od 3 let, ker vsebuje benzilalkohol in lahko pri teh otrocih povzroči toksične reakcije in alergije.
The study efficacy results for these patients are summarised in Table 25.
Podatki učinkovitosti študije za te bolnike so povzeti v preglednici 25.
Additional testing should be performed periodically during therapy (including glucose monitoring).
Med zdravljenjem moramo periodično opravljati dodatne preiskave (vključno s spremljanjem ravni glukoze).
Interferon is a protein that modifies the response of the body's immune system to help fight infections and severe diseases.
Interferon je beljakovina, ki spremeni imunski odgovor organizma, tako da se telo lahko brani pred okužbami in težkimi boleznimi.
As an example: Your regular weekly Pegasys injection is on Monday.
Primer: vaš običajni dan injiciranja injekcije zdravila Pegasys je ponedeljek.
Most of the adverse reactions reported in the study were mild or moderate in severity.
Večina neželenih učinkov, o katerih so poročali v študiji, je bila po izraženosti blagih ali zmernih.
Patients who develop dizziness, confusion, somnolence or fatigue should be cautioned to avoid driving or operating machinery.
Bolnike, pri katerih se pojavi omotičnost, zmedenost, somnolenca ali utrujenost, moramo opozoriti, naj se izogibajo vožnji ali upravljanju strojev.
You remember on Friday that you forgot to take your injection on Monday (4 days late).
V petek se spomnite, da ste si v ponedeljek pozabili dati svojo injekcijo (4 dni pozneje).
All patients should be closely monitored for any signs or symptoms of psychiatric disorders.
Pri vseh bolnikih je treba skrbno spremljati kakršne koli znake ali simptome psihiatričnih motenj.
- Adequately controlled thyroid function (TSH and T4)
- ustrezno nadzirano delovanje ščitnice (TSH in T4).
Progressive decreases after 8 weeks of therapy were infrequent.
Progresivno zmanjšanje po 8 tednih zdravljenja je bilo redko.
NOTE: Do not yet attempt to press the activation button.
OPOMBA: Ne poskušajte še pritisniti gumba.
Pegasys is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Zdravilo Pegasys se lahko uporablja med nosečnostjo samo, če potencialna korist upravičuje potencialno tveganje za plod.
Study ML17131
Študija ML17131
Within 24 hours, about 80% of the peak serum concentration is reached.
V 24 urah dosežemo 80 % največje plazemske koncentracije.
While most children returned to their projected height within two years after completing treatment, and the majority of the remaining children within six years after completing treatment, it remains possible that Pegasys may affect the final adult height.
Čeprav je večina otrok dosegla njihovo pričakovano višino v dveh letih po zaključku zdravljenja, večina preostalih otrok pa v šestih letih po zaključku zdravljenja, ostaja možnost, da zdravilo Pegasys vpliva na končno višino v odrasli dobi.
Whenever possible the child should be treated after the pubertal growth spurt, in order to reduce the risk of growth inhibition.
Kadar koli je le mogoče, je treba zdravljenje pri otroku uvesti po obdobju intenzivne rasti v puberteti, da bi zmanjšali tveganje za zastoj rasti.
Predictive Value
Napovedna vrednost
The dose reduction levels are provided in Table 8.
Nivoji zmanjšanja odmerka so navedeni v preglednici 8.
● Slowly pull back the plunger to withdraw a bit more than the dose prescribed by your doctor into the syringe.
● Bat počasi potegnite nazaj in v brizgo zajemite malo več kot odmerek, ki vam ga je predpisal zdravnik.
55% (21 of 38) of subjects who completed the original study enrolled in the long-term follow up extending up to 6 years post-treatment.
55 % (21 od 38) preizkušancev, ki so zaključili prvotno študijo, je bilo vključenih v dolgoročno spremljanje, ki je trajalo do šest let po zdravljenju.
Operating characteristics of these biomarkers are presented in Table 11.
Značilnosti teh bioloških označevalcev so predstavljene v preglednici 11.
• If your child has or has ever had a psychiatric disorder, talk to your doctor, who will monitor your child for signs or symptoms of depression (see section 4).
• Če ima vaš otrok psihične motnje ali jih je kadar koli imel, se posvetujte z zdravnikom, ki bo spremljal vašega otroka glede pojava znakov ali simptomov depresije (glejte poglavje 4).
It is not yet known whether they will return to their projected height and weight after completing treatment.
Ni še znano, ali bodo po zaključku zdravljenja dosegli svojo pričakovano višino in maso.
Response rates in groups A and B at the end of 24 weeks follow-up are presented in Table 22.
Deleži odzivov skupin A in B ob koncu 24-tedenskega spremljanja so predstavljeni v preglednici 22.
There are no data on long-term effects on sexual maturation.
Podatkov o dolgotrajnih učinkih na spolno dozorevanje ni na voljo.
● if you have been withdrawn from previous therapy for Hepatitis C because of anaemia or low blood count.
• če ste prejšnje zdravljenje hepatitisa C prekinili zaradi anemije ali nizkega števila krvnih celic.
After the Week 24 follow-up visit, patients from group A, B and C entered a long-term follow-up period (lasting for 5 years after end of treatment).
Po obisku v 24. tednu spremljanja so bolnike iz skupin A, B in C vključili v dolgoročno obdobje spremljanja (s trajanjem 5 let po koncu zdravljenja).
A full listing of adverse reactions reported in this treatment group (n=55) is provided in Table 10.
Celoten seznam poročanih neželenih učinkov iz te zdravljene skupine (n=55) je naveden v preglednici 10.
For more information, see section 5.1.
Za dodatne informacije glejte poglavje 5.1.
● the medicine is any colour besides colourless to light yellow
• je zdravilo kakršne koli druge barve razen brezbarvno do rahlo rumeno;
Patients who also have HIV infection: Tell your doctor if you are taking anti-HIV therapy.
Bolniki, okuženi z virusom HIV: obvestite svojega zdravnika, da jemljete zdravila proti virusu HIV.
Wash your hands well using soap and water.
Z milom in vodo si dobro umijte roke.
Your next injection will be on the Monday, 5 days later after the Wednesday injection.
Vaš naslednji odmerek bo v ponedeljek, 5 dni po sredini injekciji.
HBV genotype A B
HBV genotipa A B
Any patient complaining of decrease or loss of vision must have a prompt and complete eye examination.
Vsak bolnik, pri katerem se pojavi poslabšanje ali izguba vida, mora na takojšen in celovit pregled oči.
Thus, the lower the BSA of the child, the lower the clearance of the drug and the higher the resultant exposure.
Nižja kot je telesna površina otroka, nižji je očistek zdravila in tako je večja izpostavljenost zdravilu.
*Grading according to Trey, Burns and Saunders (1966)
* stopnja po Treyu, Burnsu in Saundersu (1966)
The syringe, needle and all injection materials are intended for single use and must be discarded after the injection.
Injekcijska brizga, igla in vsi injekcijski materiali so namenjeni enkratni uporabi in morajo biti po injiciranju uničeni.
● if you have diabetes or high blood pressure, your doctor may ask you to have an eye examination.
• če imate sladkorno bolezen ali visok krvni tlak, da vas bo zdravnik morda napotil na pregled oči,
Psychiatric evaluation abnormal
Preiskave nenormalna psihiatrična ocena
Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Bolniki si morajo dvakrat na dan temeljito umiti zobe in imeti redne preglede pri zobozdravniku.
Haematological (see also Table 3)
Hematološki (glejte tudi preglednico 3)
Moreover, the benefit of the combination of telbivudine with interferon alfa (pegylated or standard) is not currently established.
Razen tega korist kombinacije telbivudina in interferona alfa (pegiliranega ali standardnega) trenutno ni dokazana.
 You might hear a second “click” as the activation button pops back up.
 Lahko zaslišite drugi “klik”, ko se sprožilni gumb vrne na prvotno mesto.
Must not be given to premature babies or neonates.
Predčasno rojenim otrokom in novorojenčkom ga ne smemo dajati.
Do not attempt to administer an injection until you are sure that you understand how to use the pre-filled pen.
Ne poskušajte si dati injekcije, dokler niste prepričani, kako uporabljati napolnjeni injekcijski peresnik.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Nosečnost, dojenje in plodnost Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
Pulmonary changes
Pulmonalne spremembe
Preliminary and limited safety data demonstrated no obvious departure from the known safety profile of the combination in adults with chronic HCV infection, but, importantly, the potential impact on growth has not been reported.
Preliminarni in omejeni podatki o varnosti niso pokazali očitne razlike glede na znan varnostni profil te kombinacije pri odraslih s kronično okužbo s HCV, pomembno pa je, da niso poročali o potencialnem vplivu na rast.
Response rates at the end of follow-up for the two studies are presented in Table 12.
Deleži odzivov po koncu obdobja sledenja bolnikom za ti dve študiji so predstavljeni v preglednici 12.
The difference between treatment regimens was in general not influenced by presence/absence of cirrhosis; therefore treatment recommendations for genotype 1, 2 or 3 are independent of this baseline characteristic.
Prisotnost ali odsotnost ciroze v splošnem na razlike med shemami zdravljenja ni imela vpliva, zato so priporočila za zdravljenje za genotipe 1, 2 ali 3 neodvisna od te osnovne značilnosti.
HBeAg negative / anti-HBe positive Study WV16241
HBeAg negativni / anti-HBe pozitivni študija WV16241
No data is available on long-term follow-up posttreatment in these patients (see section 4.4).
Podatkov o dolgoročnem spremljanju po zdravljenju pri teh bolnikih ni na voljo (glejte poglavje 4.4).
The ribavirin dose should be administered with food.
Odmerek ribavirina je treba zaužiti s hrano.
• When receiving Pegasys, your child may have slower growth and development (see section 4).
• Ob prejemanju zdravila Pegasys sta lahko rast in razvoj vašega otroka upočasnjena (glejte poglavje 4).