natgillin/translations-raw huggingface dataset:
Your doctor will use the lowest possible effective dose and will not infuse <Product name> for more than 24 hours.
Zdravnik bo uporabil najnižji možni učinkovit odmerek in ne bo infundiral zdravila <Ime zdravila> več kot 24 ur.
The product information shall be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Pristojni organi držav članic bodo kasneje, v povezavi z referenčno državo članico, posodobili Informacije o zdravilu, kot je primerno, v skladu s postopki, ki jih določa Poglavje 4, Naslov III Direktive 2001/83/ES.
What you need to know before you use <Product name>
Kaj morate vedeti, preden boste uporabili <Ime zdravila>
The lowest possible effective dose should be applied.
Uporabiti moramo najmanjši učinkoviti odmerek.
Frequency not known (cannot be estimated from the available data)
Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
Your doctor will decide on the correct dose for you to receive.
Zdravnik se bo odločil o pravilnem odmerku, ki ga boste prejeli.
Section 4.3 Contraindications
Poglavje 4.3 Kontraindikacije
• have too much fluid in your body and you have been told that you have a condition known as hyperhydration
• če imate preveč tekočine v telesu in so vam povedali, da je vaše stanje znano kot hiperhidracija
By reporting side effects you can help provide more information on the safety of this medicine.
S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
The maximum daily dose is <30ml/kg for 6% HES (130/0.40) and 6% HES (130/0.42); for other HES products the maximum daily dose should be recalculated accordingly>.
Največji dnevni odmerek je <30 ml/kg za HES 60 mg/ml (130/0,40) in HES 60 mg/ml (130/0,42); za druga zdravila, ki vsebujejo HES, je treba največji dnevni odmerek ustrezno preračunati>.
You can also report side effects directly via the national reporting system listed in Appendix V*.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V*.
• are critically ill (e.g. you need to stay in an intensive care unit)
• če ste kritično bolni (npr. morate ostati v enoti za intenzivno terapijo)
Therefore it is not recommended to use this medicine in children.
Zato se ne priporoča uporabe tega zdravila pri otrocih.
- hyperkalaemia [only applicable to products containing potassium]
• hiperkaliemija [velja samo za zdravila, ki vsebujejo kalij]
• suffer from serious generalised infection (sepsis)
• če imate resno splošno okužbo (sepso)
Monitoring of renal function in patients is recommended for at least 90 days.
Delovanje ledvic pri bolnikih je priporočljivo spremljati vsaj 90 dni.
In the case of repeated administration, blood coagulation parameters should be monitored carefully.
V primeru ponovnega dajanja je treba skrbno spremljati parametre strjevanja krvi.
The first 10-20 ml should be infused slowly and under careful monitoring of the patient so that any anaphylactoid reaction can be detected as early as possible.
Prvih 10-20 ml moramo infundirati počasi in skrbno spremljati bolnika, tako da čim prej odkrijemo kakršno koli anafilaktoidno reakcijo.
The dosage must be adjusted carefully, particularly in patients with pulmonary and cardiocirculatory problems.
Odmerjanje je treba natančno prilagoditi, zlasti pri bolnikih s pljučnimi in kardiocirkulatornimi težavami.
See the end of section 4 for how to report side effects.
Glejte na koncu poglavja 4, kako poročati o neželenih učinkih.>
See section 4.8 for how to report adverse reactions.>
Glejte poglavje 4.8, kako poročati o neželenih učinkih.>
How to use <Product name>
Kako uporabljati zdravilo <Ime zdravila>
The use of HES must be discontinued at the first sign of renal injury.
Uporabo HES je treba prekiniti ob prvem znaku poškodbe ledvic.
• are dehydrated
• če ste dehidrirani
If impaired kidney function occurs during therapy:
Če se okvarjeno delovanje ledvic pojavi med zdravljenjem:
• are allergic to any of the active substances or any of the other ingredients of this medicine
• če ste alergični na zdravilne učinkovine ali katero koli sestavino tega zdravila
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Priloga III Spremembe ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo
The relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Ustrezna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo so rezultat napotitvenega postopka.
What <Product name> is and what it is used for [This section should be amended to include the below wording] <Product name> is a plasma volume substitute that is used to restore the blood volume when you have lost blood when other products called crystalloids are not considered sufficient alone.
Kaj je zdravilo <Ime zdravila> in za kaj ga uporabljamo [To poglavje je treba spremeniti tako, da se vključi naslednje besedilo] Zdravilo <Ime zdravila> je nadomestek volumna plazme, ki se uporablja za ponovno vzpostavitev volumna krvi pri izgubi le te, ko druga zdravila, ki se imenujejo kristaloidi, ne zadoščajo.
Because of the risk of allergic (anaphylactic/anaphylactoid) reactions, you will be monitored closely to detect early signs of an allergic reaction when you receive this medicine.
Zaradi tveganja za alergijske (anafilaktične/anafilaktoidne) reakcije, vas bodo skrbno spremljali, ko boste prejeli to zdravilo, da ugotovijo zgodnje znake alergičnih reakcij.
I. Summary of Product Characteristics <This medicinal product is subject to additional monitoring.
I. Povzetek glavnih značilnosti zdravila < Za to zdravilo se izvaja dodatno spremljanje varnosti.
Hepatic injury < frequency not known (cannot be estimated from the available data)> Renal injury < frequency not known (cannot be estimated from the available data)>
Poškodba jeter <neznana (ni mogoče oceniti iz razpoložljivih podatkov)> Poškodba ledvic <neznana (ni mogoče oceniti iz razpoložljivih podatkov)>
If you are given <Product name> repeatedly your doctor will monitor the ability of your blood to clot, bleeding time and other functions.
Če večkrat prejemate odmerke zdravila <Ime zdravila>, bo zdravnik spremljal strjevanje vaše krvi, čas krvavitve in druge funkcije.
An increased need for renal replacement therapy has been reported up to 90 days after HES administration.
Poročali so o povečani potrebi po nadomestnem ledvičnem zdravljenju v obdobju 90 dni po dajanju HES.
There is only limited experience of the use of this medicine in children.
Obstaja zgolj omejena izkušnja uporabe pri otrocih.
Volume overload due to overdose or too rapid infusion must always be avoided.
Vedno se je potrebno izogniti preobremenitvi volumna zaradi prevelikega odmerjanja ali prehitrega infundiranja.
The expected benefit of treatment should be carefully weighed against uncertainty with regard to this long term safety.
Pričakovano korist zdravljenja je treba skrbno pretehtati glede na negotovost dolgoročne varnosti ter upoštevati druge razpoložljive možnosti zdravljenja.
The nursing staff will also take measures to observe your body's fluid balance, blood salt level, and kidney function.
Negovalno osebje bo tudi sprejelo ukrepe za spremljanje vašega ravnovesja tekočin, koncentracije soli v krvi in delovanja ledvic.
• have been told that you have a severe increase of potassium [Note: only for products which contain potassium], sodium or chloride in your blood
• če so vam povedali, da imate močno povečano koncentracijo kalija [Opomba: samo za zdravila, ki vsebujejo kalij], natrija ali klorida v krvi
[This section should be amended to include the following contraindications]
[To poglavje je treba spremeniti tako, da se vključi naslednje kontraindikacije]
In patients undergoing open heart surgery in association with cardiopulmonary bypass the use of HES products is not recommended due to the risk of excess bleeding.
Pri bolnikih z operacijo na odprtem srcu v povezavi s kardiopulmonalnim obvodom se uporaba zdravil, ki vsebujejo HES, ne priporoča zaradi tveganja prekomerne krvavitve.
Section 4.8 Undesirable effects [This following wording should be reflected in this section]
Poglavje 4.8 neželeni učinki [To poglavje je treba spremeniti, da odraža naslednje besedilo]
• suffer from bleeding in the brain (intracranial or cerebral bleeding)
• če imate možgansko krvavitev (intrakranialno ali cerebralno krvavitev)
Treatment should be guided by continuous haemodynamic monitoring so that the infusion is stopped as soon as appropriate haemodynamic goals have been achieved.
Zdravljenje mora temeljiti na kontinuiranem spremljanju hemodinamike in infundiranje je treba prekiniti takoj, ko se doseže ustrezna hemodinamika.
In addition your doctor may need to monitor your kidney function for up to 90 days.
Poleg tega bo morda zdravnik še 90 dni spremljal delovanje vaših ledvic.
<Product name> is contraindicated if you have kidney impairment or of kidney injury requiring dialysis.
Zdravilo <Ime zdravila> je kontraindicirano, če imate okvarjeno delovanje ledvic ali poškodbo ledvic, pri kateri je potrebna dializa.
• have severe problems with your blood clotting
• če imate hude težave s strjevanjem krvi
Because of the risk of allergic (anaphylactoid) reactions, the patient should be monitored closely and the infusion instituted at a low rate (see section 4.8).
Zaradi tveganja alergijskih (anafilaktoidnih) reakcij je potrebno bolnike pozorno spremljati in zdravilo infundirati počasi (glejte poglavje 4.8).
Particular caution should be exercised when treating patients with impaired hepatic function or in patients with blood coagulation disorders.
Posebna previdnost je potrebna pri zdravljenju bolnikov z okvarjenim delovanjem jeter ali pri bolnikih z motnjami strjevanja krvi.
If you are undergoing open heart surgery and you are on a heart-lung machine to assist in pumping your blood during the surgery, the administration of this solution is not recommended.
Če imate operacijo na odprtem srcu in ste priključeni na aparat srce-pljuča, ki pomaga črpati vašo kri med kirurškim posegom, se uporabe te raztopine ne priporoča.
[This section should be amended to reflect the following wording]
[To poglavje je treba spremeniti, da odraža naslednje besedilo]
Dosage
• sepsa
If the doctor detects first signs of kidney impairment he/she will stop giving you this medicine.
Če je zdravnik ugotovil prve znake okvarjenega delovanja ledvic, se bo odločil za ukinitev dajanja tega zdravila.
• have fluid in the lungs (pulmonary oedema)
• če imate tekočino v pljučih (pljučni edem)
Serum electrolytes, fluid balance and renal function should be monitored closely.
Pozorno je treba spremljati koncentracije elektrolitov v serumu, ravnovesje tekočin in delovanje ledvic.
Do not use <Product name> if you:
Zdravila <Ime zdravila> ne boste prejeli:
Surgery and trauma:
Kirurški posegi in poškodbe:
HES products are contraindicated in patients with renal impairment or renal replacement therapy (see section 4.3).
Zdravila, ki vsebujejo HES, so kontraindicirana pri bolnikih z okvarjenim delovanjem ledvic ali bolnikih, ki se zdravijo z nadomestnim ledvičnim zdravljenjem (glejte poglavje 4.3).
Data are limited in children therefore it is recommended not to use HES products in this population.
Pri otrocih so podatki omejeni, zato je priporočljivo, da se zdravil, ki vsebujejo HES, v tej populaciji ne uporablja.
Possible side effects [This section should be amended to include the below wording]
Možni neželeni učinki [To poglavje je treba spremeniti tako, da se vključi naslednje besedilo]
- congestive heart failure
• kongestivno srčno popuščanje
• have kidney impairment or receive dialysis
• če imate okvarjeno delovanje ledvic ali prejemate dializo
• problems with your heart or circulation
• težave s srcem ali krvnim obtokom
• problems with your kidneys
• težave z ledvicami
Section 4.1 Therapeutic indications [The wording of this section should be read as below] Treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient.
Poglavje 4.1 Terapevtske indikacije [Besedilo tega poglavja se mora glasiti, kakor je navedeno spodaj] Zdravljenje hipovolemije zaradi akutne izgube krvi, kadar zdravljenje s kristaloidi ne zadošča (glejte poglavja 4.2., 4.3. in 4.4).
• have received an organ transplant
• pri bolnikih po presaditvi organov
In case of an impairment of the ability of your blood to clot, your doctor will stop giving you this medicine.
V primeru motnje strjevanja krvi se bo zdravnik odločil za ukinitev dajanja tega zdravila.
- severe hypernatraemia or severe hyperchloraemia - severely impaired hepatic function
• huda hipernatriemija ali huda hiperkloridemija
Package Leaflet <This medicine is subject to additional monitoring.
<Za to zdravilo se izvaja dodatno spremljanje varnosti.
• blood clotting (coagulation) disorders
• motnje v strjevanju krvi (koagulaciji)
Surgery and trauma: Your doctor will consider carefully if this medicine is suitable for you.
Zdravnik bo skrbno preučil, če je zdravilo za vas ustrezno.
Discontinue the use of HES at the first sign of coagulopathy.
Ob prvem znaku koagulopatije prekinite uporabo HES.
This includes any possible side effects not listed in this leaflet.
Posvetujete se tudi, če opazite neželene učinke, ki so navedeni v tem navodilu.
• Liver injury
• poškodba ledvic
Severe haemodilution resulting from high doses of HES solutions must also be avoided in the treatment of hypovolaemic patients.
Pri zdravljenju hipovolemičnih bolnikov se izogibajte tudi hudi hemodiluciji, ki je posledica visokih odmerkov raztopine HES.
Your doctor will adjust the dose of <Product name> carefully in order to prevent fluid overload.
Zdravnik bo natančno prilagodil odmerek zdravila <Ime zdravila>, da se prepreči preobremenitev s tekočino, še posebno, če imate težave s pljuči, srcem ali krvnim obtokom.
• have severely impaired liver function
• hudo okvarjeno delovanje jeter
The indication for volume replacement with HES has to be considered carefully, and haemodynamic monitoring is required for volume and dose control.
Indikacijo za nadomeščanje volumna s HES je treba skrbno preučiti.
• have severe liver disease
• če imate hudo bolezen jeter
• have severe heart failure
• če imate hudo popuščanje srca
There is a lack of robust long term safety data in patients undergoing surgical procedures and in patients with trauma.
Pri bolnikih s predvidenimi kirurškimi posegi in bolnikih s poškodbami so realni podatki o dolgoročni varnosti pomanjkljivi.
Use of HES should be restricted to the initial phase of volume resuscitation with a maximum time interval of 24 h.
Poglavje 4.2 Odmerjanje in način uporabe [To poglavje je treba spremeniti, da odraža naslednje besedilo] Uporabo HES moramo omejiti na začetno fazo nadomeščanja volumna, najdaljši čas uporabe je 24 ur.
• suffer from burn injury
• opekline
• impairment of your liver function
• okvarjeno delovanje jeter
- severe coagulopathy - organ transplant patients
• huda koagulopatija
(Invented) name Strength Pharmaceutical form Route of administration
Farmacevtska oblika Pot uporabe
2.5 mg/ml
2,5 mg/ml prašek za raztopino za infundiranje intravenska uporaba viala (steklo)
Immediate packaging Pack size
Velikost pakiranja
2013 [cited April 2014].
2013 [citirano aprila 2014].
National approval was obtained in most of the European countries.
Nacionalna odobritev je bila pridobljena v večini evropskih držav.
is approved in all EU Member States except Latvia, Malta and Slovenia.
je bilo odobreno v vseh državah članicah EU, razen v Latviji, na Malti in v Sloveniji.
There were no major discrepancies between the existing wordings in the individual Member States.
Ni bilo bistvenih razlik med obstoječimi besedili v posameznih državah članicah.
2 Department of Health and Human Services.
Ameriško ministrstvo za zdravje in človeške vire.
was first approved in United Kingdom on 15 June 1988, which marks its International Birth Date (IBD).
je bilo najprej odobreno v Združenem kraljestvu 15. junija 1988; ta datum označuje njegov mednarodni datum rojstva (International Birth Date - IBD).
Additional data in this population need to be submitted in the future via the appropriate regulatory procedure.
Dodatne podatke za to populacijo bo treba predložiti v skladu z ustreznim regulativnim postopkom.
Some of the studies are conducted predominantly in adults, but also included children.
Nekatere študije se izvajajo prvenstveno na odraslih, vendar vključujejo tudi otroke.
and associated names is considered to be favourable.
in povezanih imen šteje za ugodno.
The only strength of 500 mg is available.
Edina razpoložljiva jakost je 500 mg.
The majority of these studies were open-label controlled studies.
Večinoma je šlo za odprte nadzorovane študije.
Ten clinical studies were conducted during the period from 1986 till 1996 in patients with AIDS.
V obdobju od 1986 do 1996 je bilo pri bolnikih z AIDS-om izvedenih deset kliničnih študij.
In animals studies ganciclovir was associated with reproductive toxicity and teratogenicity.
Pri študijah na živalih je bil ganciklovir povezan z reproduktivno toksičnostjo in teratogenostjo.
In most of the studies efficacy of ganciclovir 2.5 mg/kg, 5 mg/kg, 6 mg/kg i.v.
V večini študij učinkovitosti ganciklovirja so preučevali odmerke 2,5 mg/kg, 5 mg/kg, 6 mg/kg i.v.
Cymevene i.v.
Zdravilo Cymevene i.v.
Consideration should be given to official guidance on the appropriate use of antiviral agents.
Upoštevati je treba uradne smernice za ustrezno uporabo protivirusnih zdravil.
Sensitive human viruses include human cytomegalovirus (HCMV), herpes-simplex virus-1 and -2 (HSV-1 and HSV-2), human herpes virus -6, -7 and -8 (HHV-6, HHV-7, HHV-8), Epstein-Barr virus (EBV), varicella-zoster virus (VZV), and hepatitis B virus.
Občutljivi humani virusi vključujejo humani citomegalovirus (HCMV), virus herpesa simpleksa tip 1 in tip 2 (HSV-1 in HSV-2), humani virus herpesa tip 6, tip 7 in tip 8 (HHV-6, HHV-7, HHV-8), virus Epstein-Barr (EBV), virus varicella zoster (VZV) in virus hepatitisa B.
On 15 September 2014 the European Commission on behalf of all marketing authorisation holders presented to the European Medicines Agency a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the national summary of product characteristics, labelling and package leaflet of the medicinal products, Cymevene i.v.
15. septembra 2014 je Evropska komisija v imenu vseh imetnikov dovoljenja za promet z zdravilom Evropski agenciji za zdravila predložila napotitev v skladu s členom 30 Direktive 2001/83/ES z namenom uskladitve nacionalnega povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo zdravila Cymevene i.v.
Results of these studies demonstrated beneficial effect on progression of disease, relapse of CMV infections and incidence of the disease.
Rezultati teh študij so pokazali ugodne učinke na napredovanje bolezni, ponovitve okužb CMV in pojavnost bolezni.
The safety and efficacy of ganciclovir in children under 12 years of age has not been established.
Varnost in učinkovitost ganciklovirja pri otrocih, mlajših od 12 let, še nista bili dokazani.
Therefore, ganciclovir should not be used in pregnant women unless the clinical need for treatment of the woman outweighs the potential teratogenic risk to the foetus.
Ganciklovir se zato ne sme uporabljati pri nosečnicah, razen če klinična potreba po zdravljenju ženske odtehta potencialno teratogeno tveganje za plod.
and associated names (see Annex I)
in povezanih imen (glejte Prilogo I)
The safety of ganciclovir for use in pregnant women has not been established.
Varnost ganciklovirja za uporabo pri nosečnicah ni bila dokazana.
Based on the review of data the CHMP adopted a harmonised Module 3.
Na podlagi pregleda podatkov je odbor CHMP sprejel usklajen modul 3.
Therefore, breastfeeding must be discontinued during treatment with ganciclovir.
Zato je treba med zdravljenjem z ganciklovirjem prekiniti dojenje.
contains ganciclovir, a synthetic analogue of 2'-deoxyguanosine which inhibits replication of herpes viruses.
vsebuje ganciklovir, sintetični analog 2'-deoksigvanozina, ki zavira replikacijo virusov herpesa.
The high pH of ganciclovir can result in severe tissue irritation if the product is given by intramuscular or subcutaneous injection and toxicity may be increased if intravenous administration is rapid.
Visok pH ganciklovirja lahko povzroči močno draženje tkiv, če se zdravilo daje z intramuskularno ali subkutano injekcijo, poleg tega se lahko poveča toksičnost, če intravensko dajanje poteka hitro.
However, ganciclovir readily diffuses across the human placenta.
Vendar pa ganciklovir zlahka pronica skozi človeško posteljico.
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 izloča v materino mleko, vendar možnosti, da se ganciklovir izloča v materino mleko in da utegne povzročiti resne neželene učinke na dojenem otroku, ni mogoče izključiti.
The medicinal product is available in vials of 10 ml as powder for concentrate for solution for infusion.
Zdravilo je na voljo v 10 ml vialah kot prašek za koncentrat za pripravo raztopine za infundiranje.
and associated names (see Annex I).
in povezanih imenih (glejte Prilogo I).
Cymevene is indicated for use in adults and adolescents from 12 years of age.
Zdravilo Cymevene je indicirano za uporabo pri odraslih in mladostnikih od 12. leta dalje.
Special dosage instructions for patients with renal impairment, older people and paediatric patients are provided.
Na voljo so navodila za posebno odmerjanje pri bolnikih z okvaro ledvic, starejših ljudeh in pediatričnih bolnikih.
Overall summary of the scientific evaluation of Cymevene i.v.
Splošni povzetek znanstvenega vrednotenja zdravila Cymevene i.v.
The MAH submitted a proposal for harmonisation of the Quality module.
Imetnik dovoljenja za promet z zdravilom je predložil predlog za uskladitev modula kakovosti.
Panel on Opportunistic Infections in HIV-exposed and HIV-Infected Children.
Odbor za opurtunistične okužbe pri otrocih, ki so izpostavljeni virusu HIV in okuženi z njim.
These additions to the safety information were considered relevant and were accepted by the CHMP.
Odbor CHMP je menil, da so ti dodatki k informacijam o varnosti pomembni, in jih je sprejel.
Two contraindications were finally in this section regarding the cross-hypersensitivity and the breast-feeding.
Dve kontraindikaciji sta bili vendarle umeščeni v to poglavje, in sicer navzkrižna preobčutljivost in dojenje.
The CHMP agreed on a common wording.
Odbor CHMP je potrdil skupno besedilo.
In addition the wording on precautions of handling the product has been harmonised.
Usklajeno je bilo tudi besedilo o previdnostnih ukrepih pri ravnanju z zdravilom.
In allogenic HSCT recipients, the review concluded that CMV disease should be treated with antiviral agents such as ganciclovir or foscarnet with 2-3 weeks of induction therapy followed by 3-4 weeks of maintenance therapy.
Pri prejemnikih alogenskih HSCT so rezultati pregleda pokazali, da je treba bolezen CMV zdraviti s protivirusnimi zdravili, kot sta ganciklovir ali foskarnet, z 2−3 tedni indukcijskega zdravljenja, čemur sledijo 3−4 tedni vzdrževalnega zdravljenja.
Clinical trials included only patients with haematological malignancy.
Klinične študije so vključevale le bolnike s hematološkimi malignostmi.
In patients with AIDS prevention of CMV disease is no longer recommended because the highly active antiretroviral therapy (HAART) has reduced the risk of CMV disease in patients with AIDS.
Pri bolnikih z AIDS-om preprečevanje bolezni CMV ni več priporočljivo, saj je pri njih visokoaktivna antiretrovirusna terapija (HAART) zmanjšala tveganje za bolezni CMV.