natgillin/translations-raw huggingface dataset:
Patients treated with albiglutide should be advised of the potential risk of dehydration, and take precautions to avoid fluid depletion.
Bolnike, ki se zdravijo z albiglutidom, je treba seznaniti z morebitnim tveganjem za dehidracijo.
It is important to avoid dehydration by drinking plenty of fluids.
Pomembno je, da zaužijete dovolj tekočine in se tako izognete dehidraciji.
Temozolomide - Meningoencephalitis herpetic (EPITT no
Temozolomid - herpetični meningoencefalitis (št. EPITT 18785)
Dehydration, sometimes leading to renal impairment and acute renal failure, has been reported in patients treated with albiglutide and has occurred in patients without gastrointestinal side effects.
Pri bolnikih, zdravljenih z albiglutidom, so poročali o dehidraciji, ki je včasih privedla do ledvične okvare in akutne ledvične odpovedi.
This summary was last updated on 18.02.2011.
Povzetek je bil nazadnje posodobljen 18.02.2011.
The cats should be revaccinated every year.
Mačke je treba vsako leto ponovno cepiti.
If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Če želite več informacij, ki temeljijo na priporočilih CVMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
The first injection should be given in cats aged at least 12 weeks.
Prva injekcija se vbrizga mačkam, ki so stare najmanj 12 tednov.
Protection starts at the latest four weeks after the injection and lasts for a year.
Zaščita pred okužbo se vzpostavi najkasneje štiri tedne po injiciranju, traja pa eno leto.
The European Commission granted a marketing authorisation valid throughout the European Union, for Purevax Rabies to MERIAL on 18.02.2011.
Evropska komisija je dovoljenje za promet z zdravilom Purevax Rabies, veljavno po vsej Evropski uniji, odobrila družbi MERIAL dne 18.02.2011.
The vaccine can boost the immune response in cats that have received primary vaccination with another rabies vaccine.
Cepivo lahko okrepi imunski odziv pri mačkah, ki so prejele osnovno cepljenje z drugim cepivom proti steklini.
There may be a local reaction at the injection site, with slight pain on touching or oedema (swelling) which disappears within one or two weeks at most.
Na mestu injiciranja se lahko pojavi lokalna reakcija z blagimi bolečinami ob dotiku ali edemom (oteklino), ki običajno izgine v enem do dveh tednih.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the doctor.
V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino zdravila.
Recombinant vaccine against rabies infection
Rekombinantno cepivo proti okužbi z virusom stekline
A number of studies, including laboratory studies and field trials, were performed in kittens and cats looking at Purevax Rabies used either on its own or together with other cat vaccines, for primary and booster vaccination.
Izvedene so bile številne študije, vključno z laboratorijskimi in terenskimi preskušanji, pri mladih in odraslih mačkah, v katerih so proučevali osnovno in obnovitveno cepljenje s cepivom Purevax Rabies kot samostojnim cepivom ali v kombinaciji z drugimi cepivi za mačke.
Occasionally, cats will develop temporary slight apathy (loss of interest in surroundings) and mild anorexia (loss of appetite) or hyperthermia (elevated body temperature) lasting for one or two days.
Občasno se lahko pri mačkah pojavijo blaga in prehodna apatija (izguba interesa za okolico), blaga anoreksija (izguba teka) ter hipertermija (zvišana telesna temperatura), ki lahko trajajo en dan ali dva.
The field trials showed that the vaccine is safe, and that it triggers a significant increase of anti-rabies antibodies.
Terenske študije so pokazale, da je cepivo varno in zagotavlja znatno zvišanje števila protiteles proti virusu stekline.
The main measure of effectiveness was the ability of the vaccine to trigger immunity against rabies.
Glavno merilo učinkovitosti je bila zmožnost cepiva za vzpostavitev imunosti na virus stekline.
The laboratory studies showed that Purevax Rabies can give protection against rabies, and that the protection lasts for up to a year.
Laboratorijske študije so pokazale, da cepivo Purevax Rabies zagotavlja zaščito pred okužbo s steklino in da zaščita traja do enega leta.
Transient mild local or general adverse reactions related to the injection itself may be observed.
Občasno se lahko pojavijo blage prehodne lokalne ali splošne reakcije, povezane z injiciranjem.
The CVMP concluded that the benefits of Purevax Rabies outweigh the risks for the active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection, and recommended that Purevax Rabies be given a marketing authorisation.
Odbor CVMP je zaključil, da koristi cepiva Purevax Rabies pri aktivni imunizaciji mačk, starejših od 12 tednov, za preprečevanje smrtnosti zaradi okužbe z virusom stekline odtehtajo z njim povezana tveganja, in priporočil, da se za zdravilo Purevax Rabies odobri dovoljenje za promet.
Purevax Rabies is a vaccine that contains rabies recombinant canarypox virus (vCP65).
Zdravilo Purevax Rabies je cepivo, ki vsebuje rekombinantni poxvirus kanarčkov (vCP65).
Other information about Purevax Rabies:
Druge informacije o zdravilu Purevax Rabies:
When a cat is given the vaccine, the immune system recognises the rabies glycoprotein G as ‘foreign' and makes antibodies against it.
Ko mačka prejme cepivo, imunski sistem prepozna glikoprotein G virusa stekline kot tujek in začne proti njemu tvoriti protitelesa.
Canarypox recombinants such as those contained in Purevax Rabies are known to be safe for humans.
Za rekombinantne poxviruse kanarčkov, ki jih vsebuje tudi cepivo Purevax Rabies, je znano, da so varni za ljudi.
Purevax Rabies is used to vaccinate cats from 12 weeks of age to protect against rabies infection.
Zdravilo Purevax Rabies se uporablja za cepljenje mačk po dopolnjenem 12 tednu starosti za zaščito pred okužbo z virusom stekline.
more quickly when it is exposed to rabies, and this helps to protect against mortality due to rabies infection.
sposoben hitreje tvoriti protitelesa, kar bo pripomoglo k zaščiti pred smrtnostjo zaradi okužbe z virusom stekline.
Purevax Rabies is a vaccine.
Zdravilo Purevax Rabies je cepivo.
For a full list of the side-effects reported with Purevax Rabies, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Purevax Rabies, glejte navodilo za uporabo.
What benefit has Purevax Rabies shown during the studies?
Kakšne koristi je zdravilo Purevax Rabies izkazalo med študijami?
In the future, the immune system will be able to produce antibodies
V prihodnosti bo tako imunski sistem ob izpostavitvi virusu stekline
The vaccine strain vCP65 in Purevax Rabies is a ‘carrier' canarypox virus that has been given a gene that makes it able to produce part of a rabies virus called ‘glycoprotein G'.
Sev virusa stekline vCP65 v cepivu Purevax Rabies je nosilni poxvirus kanarčkov, kateremu je bil dodan gen, s katerim lahko tvori sestavni del virusa stekline, ki se imenuje glikoprotein G. Poxvirusi kanarčkov se pri mačkah ne širijo oziroma ne razmnožujejo, lahko pa proizvajajo glikoprotein G virusa stekline.
What is the risk associated with Purevax Rabies?
Kakšna tveganja so povezana z zdravilom Purevax Rabies?
Why has Purevax Rabies been approved?
Zakaj je bilo zdravilo Purevax Rabies odobreno?
A 1 ml dose of Purevax Rabies is injected under the skin.
Živalim se v podkožje injicira 1-mililitrski odmerek cepiva Purevax Rabies.
How has Purevax Rabies been studied?
Kako je bilo zdravilo Purevax Rabies raziskano?
Purevax Rabies is a liquid suspension for injection.
Na voljo je v obliki tekoče suspenzije za injiciranje.
What is Purevax Rabies?
Kaj je zdravilo Purevax Rabies?
How does Purevax Rabies work?
Kako zdravilo Purevax Rabies deluje?
What is Purevax Rabies used for?
Za kaj se zdravilo Purevax Rabies uporablja?
These events are often transitory.
Ti dogodki so bili pogosto prehodni.
Date of first authorisation: 21 September 2017
Datum prve odobritve: 21. september 2017
The clinical relevance of this increase is unknown.
Klinični pomen tega povečanja ni znan.
Such changes may in part be linked to disease control and life style.
Takšne spremembe so deloma lahko povezane z obvladovanjem bolezni in načinom življenja.
Typically, such reactions have been observed within the first weeks or months of initiation of CART.
Značilno so takšne reakcije opažali v prvih nekaj tednih ali mesecih po uvedbi CART.
Keep the tablet bottle with you so that you can show what you have taken.
S seboj imejte plastenko tablet, da boste lahko pokazali, kaj ste zaužili.
The disease may then become harder to treat.
Nato bo morda bolezen še težje zdraviti.
3 years After first opening: 6 weeks
3 leta Po prvem odprtju plastenke: 6 tednov
Some additional tests might be necessary.
Morda bodo potrebne nekatere dodatne preiskave.
EU/1/17/1225/001- 30 film-coated tablets EU/1/17/1225/002- 90 film-coated tablets (3 x 30)
EU/1/17/1225/001 - 30 filmsko obloženih tablet EU/1/17/1225/002 - 90 filmsko obloženih tablet (3 x 30)
Discuss with your physician the precautions needed to avoid infecting other people.
Z zdravnikom se posvetujte o previdnostnih ukrepih, potrebnih za preprečitev okužbe drugih ljudi.
You must take Symtuza every day and always with food.
Zdravilo Symtuza morate jemati vsak dan in vedno s hrano.
These interactions are described in the interaction table below.
Navedene interakcije so opisane v spodnji preglednici interakcij.
• severe swelling of the skin and other tissues (most often the lips or the eyes)
• hudo otekanje kože in drugih tkiv (najpogosteje ustnic in oči)
When co-administration is required, the daily dose of itraconazole should not exceed 200 mg.
Če je potrebna sočasna uporaba, dnevni odmerek itrakonazola ne sme preseči 200 mg.
Further dosage reduction of rifabutin has not been studied.
Nadaljnjega zmanjševanja odmerka rifabutina niso proučili.
Symtuza tablets should be taken with food.
Tablete Symtuza je treba jemati skupaj s hrano.
The tablet can be taken with a drink such as water, milk or any nutritional drink.
Tableto zaužijte s pijačo, kot je voda, mleko ali s katerim od prehranskih napitkov.
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Te ugotovitve ne vplivajo na trenutna nacionalna priporočila o uporabi protiretrovirusnih zdravil pri nosečnicah za preprečevanje vertikalnega prenosa okužbe z virusom HIV.
Virologic Failure
Virološki neuspeh
Whether the neurological disorders are transient or permanent is currently unknown.
Zaenkrat ni znano, ali so nevrološke motnje prehodne ali trajne.
Take Symtuza at around the same time each day.
Zdravilo Symtuza jemljite vsak dan ob približno istem času.
The effects of Symtuza might be reduced if you take any of the following products.
Učinki zdravila Symtuza so lahko zmanjšani, če jemljete katero od naslednjih zdravil.
Therefore, always tell your doctor if you take other anti-HIV medicines and follow your doctor's instruction carefully on which medicines can be combined.
Zato zdravniku vedno povejte, če jemljete druga zdravila proti HIV in natančno upoštevajte njegova navodila o tem, katera zdravila se sme kombinirati.
In more than half of the reported cases, treatment with HIV PIs was continued or reintroduced if treatment had been discontinued.
Pri več kot polovici prijavljenih primerov so z zdravljenjem z zaviralci proteaz HIV nadaljevali ali so le-tega uvedli, če je bilo ukinjeno.
If the combination is needed, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example Monday-Wednesday-Friday).
Če je potrebno uporabiti kombinacijo teh zdravil, je priporočeni odmerek rifabutina 150 mg 3-krat na teden ob določenih dneh (na primer ponedeljek-sreda-petek).
Cumulative Protocol-Defined Virologic Rebound a, %
Kumulativni s protokolom opredeljen virološki povratni odziv a, %
The systemic clearance of emtricitabine averaged 307 mL/min.
Sistemski očistek emtricitabina je bil povprečno 307 ml/min.
What Symtuza is and what it is used for
Kaj je zdravilo Symtuza in za kaj ga uporabljamo
It should be kept in mind that the twice weekly dosage of 150 mg may not provide an optimal exposure to rifabutin thus leading to a risk of rifamycin resistance and a treatment failure.
Treba je poudariti, da dvakrat tedensko odmerjanje po 150 mg bolniku morda ne zagotavlja optimalne izpostavljenosti rifabutinu, kar zveča tveganje za razvoj odpornosti na rifamicin in neuspeh zdravljenja.
Do not use this medicine after the expiry date which is stated on the carton and on the bottle after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na plastenki poleg oznake “EXP”.
The EC50 values for emtricitabine were in the range of 0.0013 to 0.64 μM.
Vrednosti EC50 za emtricitabin so bile v razponu od 0,0013 do 0,64 µM.
Symtuza should be taken orally, once daily with food (see section 5.2).
Zdravilo Symtuza je treba jemati peroralno, enkrat na dan s hrano (glejte poglavje 5.2).
Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and not known (frequency cannot be estimated from the available data)
Pogostnost neželenih učinkov je opredeljena kot sledi: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000) in pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov).
These EC50 values are well below the 50% cellular toxicity concentration range of 87 µM to > 100 µM.
Te vrednosti EC50 so precej nižje od 50% vrednosti koncentracij, ki so toksične za celice, v razponu od 87 µM do > 100 µM.
Other medicines and Symtuza Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Druga zdravila in zdravilo Symtuza Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo.
You may require blood tests for several months after stopping treatment with Symtuza.
Morda bodo pri vas potrebne krvne preiskave še več mesecev po prenehanju zdravljenja z zdravilom Symtuza.
Your doctor will explain these to you.
Te spremembe vam bo pojasnil vaš zdravnik.
You must eat a meal or a snack within 30 minutes before taking your Symtuza.
Obrok ali prigrizek morate pojesti 30 minut preden vzamete zdravilo Symtuza.
These are mentioned above under the heading ‘Do not combine Symtuza with any of the following medicines:'
Navedena so zgoraj pod naslovom "Zdravila Symtuza ne smete kombinirati z nobenim od naslednjih zdravil".
• if you are allergic to sulphonamides (e.g. used to treat certain infections).
• če ste alergični na sulfonamide (za zdravljenje določenih okužb).
Darunavir is approximately 95% bound to plasma protein.
Darunavir je v približno 95% vezan na plazemske beljakovine.
It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Domnevajo, da so ti simptomi posledica izboljšanja imunskega odziva, kar telesu omogoči, da se bojuje proti okužbam, ki so bile že prej prisotne, a ni bilo očitnih simptomov.
OESTROGEN-BASED CONTRACEPTIVES Drospirenone Ethinylestradiol (3 mg/0.02 mg once daily)
ESTROGENSKI KONTRACEPTIVI drospireron/etinilestradiol (3 mg/0,02 mg enkrat na dan)
Each bottle contains 30 tablets.
Ena plastenka vsebuje 30 tablet.
In vitro selection of darunavir-resistant virus from wild type HIV-1 was lengthy (> 3 years).
In vitro selekcija virusa, odpornega na darunavir, iz divjega tipa virusa HIV-1 je bila dolgotrajna (> 3 leta).
EXP Do not use after 6 weeks of first opening the bottle.
EXP Porabite v 6 tednih od prvega odprtja plastenke.
If you belong to this age group, please discuss with your doctor if you can use Symtuza.
Če sodite v to starostno skupino, se s svojim zdravnikom pogovorite, ali lahko uporabljate zdravilo Symtuza.
Treatment of overdose with Symtuza consists of general supportive measures, including monitoring of vital signs as well as observation of the clinical status of the patient.
Zdravljenje prevelikega odmerjanja zdravila Symtuza predstavljajo splošni podporni ukrepi, vključno s spremljanjem vitalnih znakov in opazovanjem kliničnega stanja bolnika.
Symtuza has only been used in limited numbers of patients 65 years or older.
Zdravilo Symtuza je bilo uporabljeno le pri majhnem številu bolnikov, starih 65 let ali več.
In juvenile rats receiving darunavir up to days 23-26 (equivalent to less than 2 years of age in humans), increased mortality was observed with convulsions in some animals.
Pri mladih podganah, ki so prejemale darunavir do 23-26 dni (ekvivalentno starosti 2 leti ali manj pri človeku), so pri nekaterih živalih opazili povečano smrtnost s konvulzijami.
Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%.
Tenofovir lahko učinkovito odstranimo s hemodializo s koeficientom ekstrakcije približno 54%.
Symtuza might reduce its effectiveness.
Zdravilo Symtuza lahko zmanjša njihovo učinkovitost.
• if you notice symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, tell your doctor immediately.
• če opazite kakršne koli simptome kot so mišična oslabelost, oslabelost, ki se najprej pojavi v dlaneh in stopalih in se nato širi proti trupu, palpitacije, tremor ali hiperaktivnost, takoj obvestite zdravnika.
Darunavir After a 400/100 mg [
Darunavir Po odmerjanju 400/100 mg s
MedDRA system organ class Frequency category
Organski sistem po klasifikaciji MedDRA kategorija pogostnosti
Then take the next dose at your usual time.
Nato vzemite naslednji odmerek kot običajno.
Skin rash may affect more than 1 in 10 patients receiving Symtuza.
Kožni izpuščaj se lahko pojavi pri več kot 1 od 10 bolnikov, ki prejemajo zdravilo Symtuza.
The type of food does not affect exposure to Symtuza.
Vrsta hrane ne vpliva na izpostavljenost zdravilu Symtuza.
If you notice any of these symptoms tell your doctor.
Če opazite katerega koli od teh simptomov, obvestite svojega zdravnika.
Other severe side effects, seen up to 1 patient in 10, were diabetes, increased blood fat levels and symptoms of infection.
Drugi resni neželeni učinki, ki so jih opažali pri največ 1 od 10 bolnikov, so bili sladkorna bolezen, zvišanje maščob v krvi in simptomi okužbe.
People taking Symtuza may still develop infections or other illnesses associated with HIV infection.
Pri osebah, ki jemljejo zdravilo Symtuza, se lahko še vedno pojavijo okužbe ali druge bolezni, povezane z okužbo z virusom HIV.
Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infection, combinations ATC code: J05AR22
Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, zdravila za zdravljenje infekcij s HIV, kombinacije, oznaka ATC: J05AR22
Table 1: Interactions between the individual components of Symtuza and other medicinal products
Preglednica 1: Medsebojno delovanje med posameznimi učinkovinami zdravila Symtuza in drugimi zdravili
Inflammation of the pancreas (pancreatitis) has been reported in up to 1 patient in 100.
O vnetju trebušne slinavke (pankreatitisu) so poročali pri največ 1 od 100 bolnikov.
Medicinal products that decrease renal function may increase concentrations of emtricitabine.
Zdravila, ki zmanjšujejo ledvično funkcijo, lahko povečajo koncentracijo emtricitabina.
• if you have had problems with your kidneys.
• če ste že imeli težave z ledvicami.
• The tablet should not be crushed, but swallowed whole.
• Tableto ne smete zdrobiti ampak jo morate celo pogoltniti.
The risk of muscle damage might be increased.
Lahko se zveča tveganje za poškodbo mišic.
While effective viral suppression with antiretroviral therapy (ART) has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Čeprav je dokazano, da učinkovita virusna supresija s protiretrovirusnimi zdravili bistveno zmanjša tveganje spolnega prenosa, preostalega tveganja ni mogoče izključiti.
There are some medicines that you must not combine with Symtuza.
Obstajajo določena zdravila, ki jih ne smete kombinirati z zdravilom Symtuza.
It is not known whether emtricitabine or tenofovir can be removed by peritoneal dialysis.
Ni znano, ali je mogoče emtricitabin in tenofovir odstraniti s peritonealno dializo.
The following viral load values were observed for these subjects at Week 96: 54 copies/mL, 78 copies/mL, 111 copies/mL, 152 copies/mL, and 210 copies/mL.
Pri teh preiskovancih so po 96 tednih izmerili naslednje virusno breme: 54 kopij/ml, 78 kopij/ml, 111 kopij/ml, 152 kopij/ml in 210 kopij/ml.
Week 96* D/C/F/TAF
v 96. tednu* D/C/F/TAF
The European Medicines Agency has deferred the obligation to submit the results of studies with Symtuza in one or more subsets of the paediatric population in the treatment of HIV-1 infection (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Symtuza za eno ali več podskupin pediatrične populacije za zdravljenje okužbe z virusom HIV-1 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Darunavir Results from a mass balance study with [
Darunavir Rezultati študije masnega ravnovesja s
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
However, unbound darunavir concentrations were approximately 55% (Child-Pugh Class A) and 100% (Child-Pugh Class B) higher, respectively.
Koncentracije nevezanega darunavirja pa so bile približno 55% (razred A po Child-Pughovi lestvici) in 100% (razred B po Child-Pughovi lestvici) višje.
Ex vivo binding of tenofovir alafenamide to human plasma proteins in samples collected during clinical studies was approximately 80%.
Ex vivo je bila vezava alafenamidtenofovirata na humane plazemske beljakovine v vzorcih, zbranih v okviru kliničnih študij, približno 80%.
Postpartum (6-12 weeks) N = 6
Obdobje po porodu (6-12 tednov) (n=6)
Do not operate machines or drive if you feel dizzy after taking Symtuza.
Ne upravljajte strojev in ne vozite avtomobila, če ste po jemanju zdravila Symtuza omotični.
Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Po prenehanju zdravljenja takoj obvestite zdravnika o vsakem novem ali nenavadnem simptomu, zlasti če gre za simptome, ki so povezani z okužbo s hepatitisom B.
If you have both HIV infection and hepatitis B, it is very important not to stop taking Symtuza without talking to your doctor first.
Če ste okuženi tako z virusom HIV kot s hepatitisom B, je zelo pomembno, da ne prenehate z jemanjem zdravila Symtuza, ne da bi se prej posvetovali z zdravnikom.
It selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in virus infected cells, thereby preventing the formation of mature infectious virus particles.
Selektivno zavira cepljenje poliproteinov Gag-Pol, ki jih kodira virus HIV v z virusom okuženih celicah, in tako preprečuje nastajanje zrelih infektivnih virusnih delcev.
6 cells/mm 3).
6 celic/mm 3).
They either switched to Symtuza (N = 763) or continued their treatment regimen (N = 378) (randomised 2:1).
Bolniki so bodisi prešli na zdravljenje z zdravilom Symtuza (n = 763) ali nadaljevali s prejšnjim režimom zdravljenja (n = 378) (po randomizaciji v razmerju 2:1).
The safety and efficacy of Symtuza in children aged 3-11 years, or weighing < 40 kg, have not yet been established.
Varnost in učinkovitost zdravila Symtuza pri otrocih, starih od 3 do 11 let ali s telesno maso manj kot 40 kg, še nista bili dokazani.
• low red blood cell count (anaemia)
• zmanjšano število rdečih krvnih celic (anemija)