natgillin/translations-raw huggingface dataset:
Table 3: 10 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg)
Preglednica 3: preglednica za odmerjanje 10 mg/kg na dan za otroke s telesno maso do 20 kg Telesna masa (kg)
Table 2: 5 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg)
Preglednica 2: preglednica za odmerjanje 5 mg/kg na dan za otroke s telesno maso do 20 kg Telesna masa (kg)
Kuvan 100 mg soluble tablets Sapropterin dihydrochloride
Kuvan 100 mg tablete za peroralno raztopino sapropterinijev diklorid
Discard unused solution within 30 minutes for powder solution.
Neuporabljeno pripravljeno raztopino po 30 minutah zavrzite.
Table 4: 20 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg)
Preglednica 4: preglednica za odmerjanje 20 mg/kg na dan za otroke s telesno maso do 20 kg Telesna masa (kg)
Kuvan 100 mg powder for oral solution Sapropterin dihydrochloride
Kuvan 100 mg prašek za peroralno raztopino sapropterinijev diklorid
Number of 100 mg sachets (dose 20 mg/kg)
Število 100 mg vrečic (odmerek 20 mg/kg)
Sapropterin dihydrochloride
- Učinkovina je sapropterinijev diklorid.
Number of 100 mg sachets (dose 10 mg/kg)
Število 100 mg vrečic (odmerek 10 mg/kg)
Upon dissolving Kuvan powder for oral solution in water, the solution has a clear, colourless to yellow appearance.
Po raztopitvi zdravila Kuvan prašek za peroralno raztopino v vodi mora biti raztopina bistra, brezbarvna do rumenkasta.
Each tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
Ena tableta vsebuje 100 mg sapropterinijevega diklorida (kar ustreza 77 mg sapropterina).
A 10 ml oral syringe should be used for administration of volumes of ≤10 ml and a 20 ml oral syringe for administration of volumes of >10 ml.
Za dajanje količin ≤ 10 ml je treba uporabiti 10-ml brizgo za peroralno dajanje, za dajanje količin > 10 ml pa 20-ml brizgo za peroralno dajanje .
Each sachet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
Ena vrečica vsebuje 100 mg sapropterinijevega diklorida (kar ustreza 77 mg sapropterina).
Each soluble tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
Ena tableta za peroralno raztopino vsebuje 100 mg sapropterinijevega diklorida (kar ustreza 77 mg sapropterina).
Table 1: 2 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg) Total dose (mg/day)
Preglednica 1: preglednica za odmerjanje 2 mg/kg na dan za otroke s telesno maso do 20 kg Telesna masa (kg)
Rhinorrhoea
hipofenilalaninemija
Immediately contact your doctor or pharmacist if you take more Kuvan than prescribed.
Če ste vzeli večji odmerek zdravila Kuvan od predpisanega, se takoj posvetujte z zdravnikom ali s farmacevtom.
The dose is adjusted, usually between 5 and 20 mg/kg/day, to achieve and maintain adequate blood phenylalanine levels as defined by the physician.
Da bi dosegli in ohranjali ustrezne ravni fenilalanina v krvi, je potrebno odmerek prilagoditi po navodilih zdravnika, običajno v območju od 5 do 20 mg/kg/dan.
Dietary intake
Vnos hrane
Intravenous use vial (glass)
5 mg/ml prašek za disperzijo za infundiranje intravenska uporaba viala (steklo)
Safety was not assessed in this study.
Varnosti v tej študiji niso ocenjevali.
• The virus can affect any part of the body.
• Virus lahko prizadene kateri koli del telesa.
After that the tests will be done less often.
Pozneje bodo preiskave manj pogoste.
It will depend on:
To bo odvisno od:
This is to check the dose you are having is right for you.
Namen tega je preveriti, ali je odmerek, ki ga prejemate, pravi za vas.
• You will usually start by having one or two infusions every day.
• Na začetku boste po navadi dobivali eno ali dve infuziji vsak dan.
Your doctor will work out how much you need.
Zdravnik bo določil, koliko zdravila potrebujete.
Additional information on special populations
Dodatne informacije o posebnih populacijah
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http://www.ema.europa.eu.
• The virus can affect anyone, but it is a particular problem in people with a weak immune system.
• Virus lahko prizadene vsakogar, a posebno težavo pomeni za osebe z oslabelim imunskim sistemom.
• hallucinations - hearing or seeing things that are not real.
• halucinacije - slišanje ali videnje stvari, ki niso resnične.
For females: 0.85 x male value
Za ženske: 0,85 x vrednost za moške
This is called an intravenous infusionand it will usually take one hour.
To imenujemo intravenska infuzija in po navadi traja eno uro.
Currently available paediatric data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Pediatrični podatki, ki so trenutno na voljo, so opisani v poglavjih 5.1 in 5.2, toda priporočil za odmerjanje ni mogoče dati.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Če ni uporabljena takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika.
Of these, 25 received ganciclovir and 17 received no treatment.
Od teh jih je 25 prejemalo ganciklovir, 17 pa nobenega zdravila.
There were 9 deaths during the study, 3 in the ganciclovir group and 6 in the control group.
Med študijo je bilo 9 smrti: 3 v skupini z ganciklovirjem in 6 v kontrolni skupini.
No deaths were related to study medication.
Nobena smrt ni bila povezana z raziskovanim zdravilom.
The risk of neutropenia is not predictable on the basis of the number of neutrophils before treatment.
Tveganja za nevtropenijo ni mogoče napovedati na podlagi števila nevtrofilcev pred zdravljenjem.
In these people the CMV virus can lead to a serious disease.
Pri takšnih osebah lahko virus CMV povzroči resno bolezen.
Side effects in children and adolescents The following side effects are more likely in children:
Neželeni učinki pri otrocih in mladostnikih Naslednji neželeni učinki so verjetnejši pri otrocih:
* The frequencies of these adverse reactions are derived from post-marketing experience, all other frequency categories are based on the frequency recorded in clinical trials.
* Pogostnosti teh neželenih učinkov temeljijo na izkušnjah po prihodu zdravila na trg; vse druge kategorije pogostnosti temeljijo na pogosnosti, zabeleženi v kliničnih preskušanjih.
{Name and Address} <{tel}> <{fax}> <{e-mail}>
{Ime države članice}{Ime zdravila}
For the first 2 weeks these blood tests will be done often.
Prva 2 tedna bo zdravnik te preiskave opravljal pogosto.
This includes the retina at the back of the eye - this means the virus can cause problems with eye sight.
Med drugim tudi mrežnico na zadnjem delu očesa - to pomeni, da lahko ta virus povzroči težave z vidom.
If you are pregnant or think you might be pregnant, do not use this medicine unless your doctor tells you to.
Če ste noseči ali menite, da bi lahko bili noseči, ne uporabljajte tega zdravila, razen če vam tako naroči zdravnik.
• blood poisoning (sepsis)
• zastrupitev krvi (sepsa)
• eye infection (conjunctivitis)
• okužba očesa (konjunktivitis)
• If you have two infusions a day, this will continue for up to 21 days.
• Če boste dobivali dve infuziji na dan, boste zdravilo prejemali do 21 dni.
Cymevene should not be mixed with other intravenous products.
Zdravila Cymevene se ne sme mešati z drugimi intravenskimi zdravili.
No studies have been conducted in adults older than 65 years of age.
Starejši bolniki Študij pri odraslih, starejših od 65 let, niso izvedli.
• pancreatitis - signs are severe stomach pain which spreads into your back.
• pankreatitis - med znaki so hude bolečine v trebuhu, ki se širijo v hrbet.
Read all of this leaflet carefully before you start using this medicine - because it contains important information for you.
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Use with other medicines
Uporaba z drugimi zdravili
• abnormal thoughts or feelings, losing contact with reality
• nenormalne misli in občutja, izguba stika z resničnostjo
If such contact occurs, wash thoroughly with soap and water, rinse eyes thoroughly with plain water.
Če pride do takšnega stika, kožo temeljito umijte z milom in vodo; oko temeljito izperite s čisto vodo.
Tests and checks
Preiskave in kontrole
This medicinal product is authorised in the Member States of the EEA under the following names: <{Name of the Member State}> <{Name of the medicinal product}> <{Name of the Member State}> <{Name of the medicinal product}>
To zdravilo je odobreno v državah članicah EGP pod naslednjimi imeni: {Ime države članice}{Ime zdravila}
• blood in urine
• kri v urinu
Alanine aminotransferase increased
zvišanje alanin-aminotransferaze
The recommended dosage, frequency and infusion rates should not be exceeded.
Priporočenega odmerjanja, pogostnosti uporabe in hitrosti infundiranja se ne sme preseči.
Dosage reduction is required (see sections 4.2 and 5.2).
Potrebno je zmanjšanje odmerka (glejte poglavji 4.2 in 5.2).
(72) x (0.011 x serum creatinine [micromol/L])
(72) x (0,011 x kreatinin v serumu [mikromoli/l])
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.
Če ni uporabljena takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če sta priprava in razredčenje opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
Ganciclovir is a potential carcinogen.
Ganciklovir je potencialen kancerogen.
It should not be used after the expiry date which is stated on the carton.
Zdravila ne smete uporabljati po datumu izteku roka uporabnosti, ki je naveden na škatli.
Cymevene will be given to you by a doctor or nurse.
Zdravilo Cymevene vam bo dal zdravnik ali medicinska sestra.
There was no clinically significant effect on ganciclovir concentrations.
Klinično pomembnega vpliva na koncentracijo ganciklovirja ni bilo.
The infusion should be given into a vein with adequate blood flow, preferably via a plastic cannula.
Infuzijo je treba dati v veno, ki ima zadosten pretok krvi, po možnosti skozi plastično kanilo.
• you are having radiotherapy.
• če imate obsevanje (radioterapijo).
A total of 38.5% of subjects were spared antiviral medications beyond their initial postoperative prophylaxis.
Skupno 38,5 % bolnikov ni prejemalo protivirusnih zdravil zunaj uvodne profilakse po operaciji.
A weak immune system may be caused by other diseases (such as AIDS) or by medicines (such as chemotherapy or immunosuppressants).
Oslabelost imunskega sistema lahko povzročijo druge bolezni (npr. AIDS) ali zdravila (npr. zdravila za kemoterapijo ali imunosupresivna zdravila).
• infertility in men - see ‘Fertility' section
• neplodnost pri moških - glejte poglavje Plodnost
Forty-three patients were considered high-risk for CMV and 79 were routine-risk.
Triinštirideset bolnikov je bilo ocenjenih kot bolnikov z velikim tveganjem za CMV, 79 pa kot bolnikov z rutinskim tveganjem.
It is also used to prevent CMV infection after an organ transplant or during chemotherapy.
Uporabljamo ga tudi za preprečevanje okužbe s CMV po presaditvi organa ali med kemoterapijo.
Neutropenia usually occurs during the first or second week of induction therapy and following administration of a cumulative dose of ≤ 200 mg / kg.
Nevtropenija se po navadi pojavi v prvem ali drugem tednu indukcijskega zdravljenja in po uporabi kumulativnega odmerka ≤ 200 mg/kg.
Time to onset of CMV infection was comparable in both groups.
Čas do začetka okužbe s CMV je bil med skupinama podoben.
It is unknown if ganciclovir is excreted in human breast milk, but the possibility of ganciclovir being excreted in breast milk and causing serious adverse reactions in the breastfed infant cannot be excluded.
Ni znano, ali se ganciklovir pri človeku izloča v materino mleko, vendar možnosti izločanja ganciklovirja v materino mleko in povzročitve resnih neželenih učinkov pri dojenem otroku ni mogoče izključiti.
From a microbiological point of view, the reconstituted solution should be used immediately.
Z mikrobiološkega stališča je treba rekonstituirano raztopino uporabiti takoj.
In patients with normal renal function, more than 90% of the intravenously administered ganciclovir dose is recovered unchanged in the urine within 24 hours.
Pri bolnikih z normalnim delovanjem ledvic se več kot 90 % intravensko uporabljenega odmerka ganciklovirja v 24 urah pojavi nespremenjenega v urinu.
Of the 100 patients enrolled, 42 met all study criteria and had both baseline and 6-month follow up audiometric evaluations.
Od 100 vključenih bolnikov jih je 42 izpolnjevalo vsa merila študije in so imeli avdiometrično oceno opravljeno izhodiščno in po 6
• how well your kidneys are working
• tega, kako dobro vam delujejo ledvice,
Such an effect is also anticipated during concomitant administration of intravenous ganciclovir and probenecid.
Takšen učinek je treba pričakovati tudi med sočasno uporabo intravenskega ganciklovirja in probenecida.
Infusion concentrations greater than 10mg/mL are not recommended.
Koncentracija infuzije nad 10 mg/ml ni priporočljiva.
Neutropenia also occurs more often in paediatric patients, but there is no correlation between neutropenia and infectious adverse reactions in the paediatric population.
Tudi nevtropenija je pri pediatričnih bolnikih pogostejša, vendar v pediatrični populaciji ni korelacije med nevtropenijo in infekcijskimi neželenimi učinki.
• feeling short of breath.
• občutek kratke sape.
Serum creatinine (µmol/L)
Kreatinin v serumu (µmol/l)
difficulty swallowing or breathing.
težave s požiranjem ali dihanjem.
Chemical and physical in-use stability has been demonstrated for the reconstituted product for 12 hours at 25°C after dissolving with water for injections.
Kemijska in fizikalna stabilnost rekonstituiranega zdravila med uporabo sta dokazani za 12 ur pri temperaturi 25 °C po raztapljanju z vodo za injekcije.
While you are using Cymevene your doctor will do regular blood tests.
Med uporabo zdravila Cymevene vam bo zdravnik redno opravljal preiskave krvi.
There were no deaths secondary to CMV.
Smrti zaradi CMV ni bilo.
Information on the safety and efficacy of ganciclovir in children under 12 years of age, including neonates, is limited (see sections 4.4, 4.8 and 5.1).
Podatkov o varnosti in učinkovitosti ganciklovirja pri otrocih, mlajših od 12 let (vključno z novorojenčki), je malo (glejte poglavja 4.4, 4.8 in 5.1).
Three subjects developed acute rejection within 6 months of detection of CMV, but CMV was preceded by rejection in 13 subjects.
Pri treh bolnikih se je akutna zavrnitev razvila v 6 mesecih po odkritju CMV, a pri 13 bolnikih je do zavrnitve prišlo pred odkritjem CMV.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2 - 8°C (do not freeze).
Kemijska in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi od 2 do 8 °C (ne zamrzujte).
Antiviral treatment consisted of either:
Protivirusno zdravljenje je obsegalo bodisi:
4.5 Interaction with other medicinal products and other forms of interaction Pharmacokinetic interactions
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Cymevene may temporarily or permanently stop men from producing sperm.
Pri moških lahko začasno ali trajno prekine nastajanje semenčic.
It will be given through a tube into your vein.
Dobili ga boste po cevki v veno.
- Treatment of disease progression: Any patient, in whom CMV disease progresses, either while on maintenance treatment or because treatment with ganciclovir has been withdrawn, may be re-treated using the induction treatment regimen.
- Zdravljenje napredovale bolezni: Vsakega bolnika, pri katerem citomegalovirusna bolezen napreduje (bodisi med vzdrževalnim zdravljenjem bodisi ker je bilo zdravljenje z ganciklovirjem ukinjeno), je mogoče znova zdraviti z uporabo sheme za indukcijsko zdravljenje.
The use of ganciclovir warrants extreme caution, especially in the paediatric population due to the potential for long-term carcinogenicity and reproductive toxicity.
Ganciklovir je treba uporabljati skrajno previdno zlasti v pediatrični populaciji, ker obstaja možnost dolgoročne kancerogenosti in reproduktivnih toksičnih učinkov.
• you have had problems with your blood cell counts caused by medicines in the past
• če ste imeli težave s številom krvnih celic med zdravljenjem z zdravili v preteklosti.
However, ganciclovir readily diffuses across the human placenta.
Vendar pa ganciklovir zlahka difundira skozi človeško placento.
Cymevene solutions are alkaline (pH ~11).
Raztopine zdravila Cymevene so alkalne (pH ~11).
The safety of ganciclovir for use in pregnant women has not been established.
Varnost ganciklovirja pri nosečnicah ni ugotovljena.
Candida infections including oral candidiasis.
okužba sečil okužbe s Candido, vključno z oralno kandidozo
Such results are consistent with the positive mouse carcinogenicity study with ganciclovir.
Ti rezultati se skladajo s pozitivno študijo kancerogenosti ganciklovirja pri miših.
The range of exposures was comparable to those observed in adults.
Razpon izpostavljenosti je bil podoben kot pri odraslih.
You should not become pregnant while using this medicine.
Med uporabo tega zdravila ne smete zanositi.
However, the rates of certain adverse reactions, such as pyrexia and abdominal pain, which may be characteristic of the paediatric population, occur more often in paediatric than in adult patients.
Toda določeni neželeni učinki, npr. zvišana telesna temperatura in bolečine v trebuhu, ki so morda značilni za pediatrično populacijo, se pri pediatričnih bolnikih pojavljajo pogosteje kot pri odraslih.
Ganciclovir was associated with a decrease in the detection of CMV by culture or polymerase chain reaction.
Ganciklovir je bil povezan z zmanjšanjem detekcije CMV s kulturo ali z verižno reakcijo s polimerazo.
This is because Cymevene may pass into breast milk.
Zdravilo Cymevene namreč lahko prehaja v materino mleko.
• didanosine, stavudine, zidovudine or any other medicines used for HIV.
• didanozin, stavudin, zidovudin ali katero koli drugo zdravilo proti HIV.
The dose of Cymevene varies from one patient to another.
Odmerek zdravila Cymevene se od bolnika do bolnika razlikuje.
The diluted solution should then be infused intravenously over 1 hour as directed in section 4.2.
Razredčeno raztopino je nato treba infundirati intravensko v teku 1 ure, kot je navedeno v poglavju 4.2.
Patients with impaired renal function are at increased risk of toxicity (especially haematological toxicity).
Bolniki z okvarjenim delovanjem ledvic imajo večje tveganje za toksične učinke (zlasti za hematološko toksične učinke).
A retrospective study investigated the effect of antiviral treatment on late-onset hearing loss in infants with congenital CMV infection (4-34 months of age, mean age 10.3±7.8 months, median age 8 months).
Retrospektivna študija je raziskovala vpliv protivirusnega zdravljenja na pozno nastalo poslabšanje sluha pri dojenčkih s kongenitalno okužbo s CMV (starost od 4 do 34 mesecev, povprečna starost 10,3 ± 7,8 meseca, mediana starost 8 mesecev).
• you have low white blood cell, red blood cell or platelet counts - your doctor will do blood tests before you start and during your treatment
• če imate majhno število belih krvnih celic, rdečih krvnih celic ali krvnih ploščic - zdravnik bo opravljal preiskave krvi pred začetkom zdravljenja in med zdravljenjem.
Prior to initiation of ganciclovir treatment, patients should be advised of the potential risks to the foetus.
Pred začetkom zdravljenja z ganciklovirjem je treba bolnike seznaniti z možnimi tveganji za plod.
Cymevene is indicated in adults and adolescents from 12 years of age for the:
Zdravilo Cymevene je indicirano pri odraslih in mladostnikih, starejših od 12 let, za:
• The other ingredients are sodium hydroxide and hydrochloric acid.
• Drugi sestavini zdravila sta natrijev klorid in klorovodikova kislina.
If your doctor wants you to start using Cymevene you must stop breast-feeding before you start using the medicine.
Če zdravnik želi, da začnete uporabljati zdravilo Cymevene, morate nehati dojiti, preden začnete uporabljati to zdravilo.
This belongs to a group called anti-viral medicines.
Ta učinkovina spada v skupino protivirusnih zdravil.
• sight problems or eye pain
• težave z vidom ali bolečine v očeh
The reconstituted solution should be checked carefully to ensure that the product is in solution and practically free from visible particles prior to dilution with compatible solvent.
Rekonstituirano raztopino je treba skrbno pregledati za zagotovitev, da je zdravilo raztopljeno in praktično brez vidnih delcev pred razredčenjem s kompatibilnim vehiklom.
Neutropenia was the only side effect reported and it was not necessary to discontinue treatment in any patient.
Edini zabeleženi neželeni učinek je bila nevtropenija in zdravljenja ni bilo treba prenehati pri nobenem bolniku.
Ganciclovir penetrates the cerebrospinal fluid, where concentrations observed reach 24%−67% of the plasma concentrations.
Ganciklovir prodira v cerebrospinalno tekočino, v kateri opažena koncentracija dosega od 24 do 67 % koncentracije v plazmi.
Vials of Cymevene are supplied in packs of 1 or 5.
Viale zdravila Cymevene so na voljo v pakiranjih z 1 ali 5 vialami.
Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, nucleosides and nucleotides excluding reverse transcriptase inhibitors, ATC code: J05AB06.
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, zdravila z direktnim delovanjem na viruse, nukleozidi in nukleotidi (razen zaviralcev reverzne transkriptaze), oznaka ATC: J05AB06.
What Cymevene is and what it is used for What you need to know before you use Cymevene How to use Cymevene
Kaj je zdravilo Cymevene in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Cymevene Kako uporabljati zdravilo Cymevene
Asymptomatic CMV infection was detected by PCR in 34.4% of subjects and was more likely in high-risk than in routine-risk recipients (58.1% vs. 21.8%, p = 0.0001).
PCR je odkrila asimptomatsko citomegalovirusno okužbo pri 34,4 % bolnikov; ta je bila pri prejemnikih z velikim tveganjem verjetnejša kot pri prejemnikih z rutinskim tveganjem (58,1 % v primerjavi z 21,8 %, p = 0,0001).
No studies on the efficacy or safety of ganciclovir in the elderly have been conducted.
Študij o učinkovitosti ali varnosti ganciklovirja pri starejših bolnikih niso izvedli.
The study included 21 infants with normal hearing at birth who developed late-onset hearing loss.
Študija je zajela 21 dojenčkov, ki so imeli ob rojstvu normalen sluh in se jim je pojavilo pozno poslabšanje sluha.
The virustatic activity of ganciclovir is a result of the inhibition of viral DNA synthesis by: (1) competitive inhibition of incorporation of deoxyguanosine triphosphate into DNA by DNA polymerase, and (2) incorporation of ganciclovir triphosphate into viral DNA, causing termination of, or very limited, viral DNA elongation.
Virustatično delovanje ganciklovirja je posledica zavrtja sinteze virusne DNA s: (1) kompetitivnim zavrtjem vgradnje deoksigvanozin-trifosfata v DNA z virusno DNA-polimerazo in (2) vgradnjo ganciklovir-trifosfata v virusno DNA, kar povzroči zaključek ali le še zelo majhno podaljšanje virusne
In animals studies ganciclovir was associated with reproductive toxicity and teratogenicity (see sections 4.4 and 5.3).
V študijah na živalih je bil ganciklovir povezan z reproduktivnimi toksičnimi učinki in teratogenostjo (glejte poglavji 4.4 in 5.3).
The vial should be gently rotated/ swirled for some minutes to obtain a clear reconstituted solution.
Vialo je treba nekaj minut previdno vrteti/sukati, da nastane bistra rekonstituirana raztopina.
Read the leaflet for further information.
Za nadaljnje informacije glejte navodilo za uporabo.
All children received intravenous ganciclovir 5 mg/kg twice daily for 2 weeks following transplantation.
Vsi otroci so prejemali intravenski ganciklovir 5 mg/kg dvakrat na dan 2 tedna po presaditvi.