natgillin/translations-raw huggingface dataset:
If patients did not experience a serious infusion-related reaction with their first or subsequent infusions of a dose of 1000 mg Truxima administered over the standard infusion schedule, a more rapid infusion can be administered for second and subsequent infusions using the same concentration as in previous infusions (4 mg/mL in a 250 mL volume).
1000 mg zdravila Truxima, ki je potekalo v skladu z originalno shemo dajanja, lahko drugo in nadaljnje infuzije prejmejo hitreje z enako koncentracijo kot v prejšnjih infuzijah (4 mg/ml v 250-ml volumnu).
Initial treatment, in combination with chemotherapy In an open-label randomised trial, a total of 322 previously untreated patients with follicular lymphoma were randomised to receive either CVP chemotherapy (cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1-5) every 3 weeks for 8 cycles or rituximab 375 mg/m2 in combination with CVP (R-CVP).
V odprtem randomiziranem preskušanju so skupaj 332 predhodno še nezdravljenih bolnikov s folikularnimi limfomi randomizirali na prejemanje kemoterapije CVP (750 mg/m2 ciklofosfamida, 1,4 mg/m2 vinkristina do največ 2 mg 1. dan in 40 mg/m2/dan prednizolona od 1. do 5. dneva) na 3 tedne 8 ciklov, ali na 375 mg/m2 rituksimaba v kombinaciji s CVP (R-CVP).
The recommended dosage of Truxima in combination with chemotherapy for previously untreated and relapsed/refractory patients is 375 mg/m2 body surface area administered on day 0 of the first treatment cycle followed by 500 mg/m2 body surface area administered on day 1 of each subsequent cycle for 6 cycles in total.
Priporočeni odmerek zdravila Truxima v kombinaciji s kemoterapijo pri bolnikih, ki predhodno še niso bili zdravljeni oziroma se na prejšnje zdravljenje niso odzvali ali pa se je bolezen pri njih ponovila, je 375 mg/m2 telesne površine, ki ga damo na dan 0 prvega cikla zdravljenja, v naslednjih ciklih zdravljenja pa dajemo 1. dan 500 mg/m2 telesne površine, skupaj 6 ciklov.
Contraindications for use in rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris
Kontraindikacije za uporabo pri revmatoidnem artritisu, granulomatozi s poliangiitisom,mikroskopskem poliangiitisu in navadnem pemfigusu
If patients did not experience a serious infusion related reaction with their first or subsequent infusions of a dose of 1000 mg Truxima administered over the standard infusion schedule, a more rapid infusion can be administered for second and subsequent infusions using the same concentration as in previous infusions (4 mg/mL in a 250 mL volume).
1.000 mg zdravila Truxima, ki je potekalo v skladu z originalno shemo dajanja, lahko drugo in nadaljnje infuzije prejmejo hitreje z enako koncentracijo kot v prejšnjih infuzijah (4 mg/ml v 250-ml volumnu).
The recommended dose of Truxima in combination with chemotherapy for induction treatment of previously untreated or relapsed/refractory patients with follicular lymphoma is: 375 mg/m2 body surface area per cycle, for up to 8 cycles.
Priporočeni odmerek zdravila Truxima v kombinaciji s kemoterapijo za indukcijsko zdravljenje bolnikov s folikularnimi limfomi, ki se predhodno še niso zdravili ali se na prejšnje zdravljenje niso odzvali ali se jim je bolezen ponovila, je: 375 mg/m2 telesne površine na cikel do 8 ciklov.
Truxima is a clear, colourless solution, supplied as a concentrate for solution for infusion in a glass vial.
Na voljo je v obliki koncentrata za raztopino za infundiranje v stekleni viali.
Truxima is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Zdravilo Truxima se uporablja za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
Log-rank p value
Vrednost p v testu log-rang
Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of Truxima.
Pred uporabo zdravila Truxima mora bolnik vedno dobiti premedikacijo, ki obsega antipiretik in antihistaminik, npr. paracetamol in difenhidramin.
granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris.
granulomatozo s poliangiitisom, mikroskopski poliangiitis ali navadni pemfigus.
You must also do this for 12 months after your last treatment with Truxima.
Učinkovito kontracepcijsko zaščito morate nadaljevati še 12 mesecev po zadnjem odmerku zdravila Truxima.
Rituximab was administered as an intravenous infusion at a first-cycle dose of 375 mg/m2 increased to 500 mg/m2 each cycle for 5 doses in combination with fludarabine and cyclophosphamide in CLL patients.
Rituksimab so bolnikom s KLL dajali v obliki intravenske infuzije v odmerku 375 mg/m2 telesne površine v prvem ciklu zdravljenja, odmerek pa se je v naslednjih 5 ciklih zdravljenja povečal na 500 mg/m2 telesne površine (v kombinaciji s fludarabinom in ciklofosfamidom).
The efficacy and safety of rituximab in alleviating the symptoms and signs of rheumatoid arthritis in patients with an inadequate response to TNF-inhibitors was demonstrated in a pivotal randomised, controlled, double-blind, multicentre trial (Trial 1).
ki niso zadostno odgovorili na zdravljenje z zaviralci TNF, sta bili dokazani v ključnem randomiziranem, kontroliranem, dvojno slepem, multicentričnem preskušanju (preskušanje 1).
Ear and labyrinth tinnitus, ear pain hearing loss5
vključno z motnjami labirinta tinitus, bolečine v ušesu izguba sluha5
Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following rituximab treatment, as appropriate according to local clinical practice guidelines.
Pri bolnikih z granulomatozo s poliangiitisom, mikroskopskim poliangiitisom ali navadnim pemfigusom je med zdravljenjem z zdravilom Truxima in po njem priporočljiva profilaksa proti pljučnici, ki jo povzroča Pneumocystis jirovecii, kot je ustrezno glede na lokalne smernice klinične prakse.
How to store Truxima
Shranjevanje zdravila Truxima
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti po posegih z infuzijo povezane reakcije2
cell return, with counts > 10 cells/μL by month 12, increasing to 87% of patients by month 18.
Pri večini bolnikov (81%) se je število celic B ponovno povečalo na > 10 celic/µl do 12. meseca, do 18.
This syndrome may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, hyperphosphataemia, acute renal failure, elevated lactate dehydrogenase (LDH) and may be associated with acute respiratory failure and death.
hipokalciemijo, hiperfosfatemijo, akutno ledvično odpoved, zvišano laktat-dehidrogenazo (LDH), ter ga lahko spremlja akutna odpoved dihal in smrt.
How much and how often you will receive your treatment a)
Koliko zdravila boste dobili in kako pogosto a) Če se zdravite zaradi ne-Hodgkinovega limfoma
Truxima in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes.
Zdravilo Truxima v kombinaciji s kemoterapijo uniči te celice.
Truxima is used for the treatment of rheumatoid arthritis.
Zdravilo Truxima uporabljamo za zdravljenje revmatoidnega artritisa, ki je bolezen sklepov.
Truxima has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Zdravilo Truxima v kombinaciji z metotreksatom zmanjša hitrost napredovanja okvar sklepov, ki jih spremljamo z rentgenskim slikanjem, in izboljša funkcijsko zmogljivost.
Sodium chloride Tri-sodium citrate dihydrate Polysorbate 80
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid trinatrijev citrat dihidrat polisorbat 80 voda za injekcije
Measure blood neutrophils prior to each course of rituximab, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8).
6 mesecev po končanem zdravljenju ter pri znakih ali simptomih okužbe (glejte poglavje 4.8).
Adverse drug reaction rituximab + low-dose prednisone (n = 38)
Rituksimab + majhen odmerek rednizona (n = 38)
Clinical experience in non-Hodgkin's lymphoma and in chronic lymphocytic leukaemia
Klinične izkušnje pri ne-Hodgkinovem limfomu in kronični limfocitni levkemiji Folikularni limfom
Truxima is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Rituksimab je bistra brezbarvna tekočina v sterilnih vialah za enkratno uporabo, apirogena in brez konzervansov.
A total of 197 patients aged 15 years or older with severe active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicentre, non-inferiority trial.
V randomiziranem, dvojno slepem, s placebom kontroliranem multicentričnem preskušanju neinferiornosti z aktivnim primerjalnim zdravilom so vključili in v njej zdravili skupno 197 bolnikov, starih 15 let ali več s hudo, aktivno granulomatozo s poliangiitisom (75 %) in mikroskopskim poliangiitisom (24%).
Cases of posterior reversible encephalopathy syndrome (PRES) / reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Poročali so o primerih sindroma posteriorne reverzibilne encefalopatije (posterior reversible encephalopathy syndrome - PRES)/oziroma sindroma reverzibilne posteriorne levkoencefalopatije (reversible posterior leukoencephalopathy syndrome - RPLS).
Gastrointestinal disorders dyspepsia, diarrhoea, gastro-oesophageal reflux, mouth ulceration, upper abdominal pain
Bolezni prebavil dispepsija, diareja, gastroezofagealni refluks, razjede v ustih,
You should also tell them about your Truxima treatment.
Povejte, da se zdravite z zdravilom Truxima.
Truxima 500 mg concentrate for solution for infusion
Truxima 500 mg koncentrat za raztopino za infundiranje
The recommended dose of Truxima used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 infusions in total).
• Ponovitev folikularnih limfomov ali neodzivna bolezen Priporočeni odmerek zdravila Truxima za vzdrževalno zdravljenje bolnikov s ponovitvijo folikularnih limfomov ali neodzivno boleznijo, ki so se odzvali na indukcijsko zdravljenje, je: 375 mg/m2 telesne površine enkrat na 3 mesece (z začetkom 3 mesece po zadnjem odmerku indukcijskega zdravljenja) do napredovanja bolezni ali največ dve leti (skupaj 8 infuzij).
The majority of patients (81%) showed signs of B
Pri večini bolnikov (81 %) se je število celic B ponovno povečalo na > 10 celic/µl do 12.
Risk reduction1)
R-CHOP Vrednost p Zmanjšanje tveganja1)
The chemotherapy should be given after Truxima infusion.
Kemoterapijo dajemo po infuziji zdravila Truxima.
The recommended dosage of Truxima for the treatment of pemphigus vulgaris is 1000 mg administered as an IV infusion followed two weeks later by a second 1000 mg IV infusion in combination with a tapering course of glucocorticoids.
Priporočeni odmerek zdravila Truxima za zdravljenje navadnega pemfigusa je 1.000 mg v intravenski infuziji, ki ji čez dva tedna sledi druga intravenska infuzija 1.000 mg; uporablja se v kombinaciji z glukokortikoidi, katerih odmerke postopoma zmanjšujemo.
• If you are having Truxima alone Truxima will be given to you once a week for 4 weeks.
ga boste prejeli enkrat na teden 4 tedne.
In pooled data from three trials, 39 patients with relapsed or chemoresistant, bulky disease (single lesion ≥ 10 cm in diameter), low grade or follicular B cell NHL received 375 mg/m2 of rituximab as intravenous infusion weekly for four doses.
Združeni podatki treh preskušanj navajajo, da je 39 bolnikov, pri katerih se je nizko maligni ali folikularni B-celični ne-Hodgkinov limfom ponovil ali pa so bili bolniki neodzivni na kemoterapijo in so imeli obsežno bolezen (ena lezija ≥ 10 cm v premeru), prejelo 4 odmerke po 375 mg/m2 rituksimaba v obliki intravenske infuzije enkrat na teden.
For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with Truxima to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
povezanih z infuzijo, in/ali sindroma sproščanja citokinov priporočljivo intravensko dati 100 mg prednizona/prednizolona malo pred infuzijo zdravila Truxima.
They were characterised by pulmonary events and in some cases included rapid tumour lysis and features of tumour lysis syndrome in addition to fever, chills, rigors, hypotension, urticaria, angioedema and other symptoms (see section 4.8).
Značilni zanje so bili pljučni dogodki in v nekaterih primerih hiter razpad tumorja z značilnostmi sindroma razpada tumorja, poleg zvišane telesne temperature, mrzlice, drgetanja,
• a complex of symptoms occurring within a few weeks of an infusion of Truxima including allergic like reactions such as rash, itching, joint pain, swollen lymph glands and fever
Zelo redki neželeni učinki (pojavijo se lahko pri 1 od 10.000 bolnikov): skupek simptomov, ki se pojavi v nekaj tednih po prejemu infuzije zdravila Truxima, in vključuje alergijske reakcije, kot so kožni izpuščaji, srbenje, bolečine v sklepih, otekle bezgavke in zvišano telesno temperaturo,
For retreatment with Truxima monotherapy for patients who have responded to previous treatment with Truxima monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (see section 5.1).
Priporočeni odmerek zdravila Truxima za ponovno samostojno zdravljenje bolnikov s folikularnim limfomom, ki so se odzvali na prejšnje samostojno zdravljenje z zdravilom Truxima po tem, ko se na predhodno zdravljenje niso odzvali ali se je pri njih bolezen ponovila, je: 375 mg/m2 telesne površine v obliki intravenske infuzije enkrat na teden 4 tedne (glejte poglavje 5.1).
Duration of response * Disease free survival (DFS)**
Preživetje brez boleznia (DFS) Analiza podskupin Preživetje brez napredovanja bolezni (PFS)
Truxima 100 mg concentrate for solution for infusion
Truxima 100 mg koncentrat za raztopino za infundiranje
Immunisations The safety of immunisation with live viral vaccines, following rituximab therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended.
Cepljenja Varnosti imunizacije z živimi virusnimi cepivi po zdravljenju z zdravilom rituksimab pri bolnikih z NHL
This is because side effects can develop several months after you have had treatment.
Kartico pri sebi hranite še 2 leti po zadnjem odmerku zdravila Truxima, ker se lahko neželeni učinki pojavijo več mesecev po zdravljenju.
• indigestion, diarrhoea, acid reflux, irritation and /or ulceration of the throat and the mouth • pain in the tummy, back, muscles and/or joints
• nenormalni občutki v koži, kot je otrplost, mravljinčenje, zbadanje ali žarjenje, išias, migrena, omotica, izpadanje las, tesnoba, depresija, slaba prebava, driska, zgaga, vnetje in/ali razjede v žrelu in ustih, bolečina v trebuhu, hrbtu, mišicah in/ali sklepih.
Infusion-related reactions*
Hude reakcije, povezane z infuzijo (npr.
The MAH must ensure that all physicians who are expected to prescribe Truxima are provided with the following:
Imetnik dovoljenja za promet mora zagotoviti, da zdravniki, ki lahko predpišejo zdravilo Truxima, prejmejo: povzetek glavnih značilnosti zdravila, gradivo za zdravnika
• producing more tears, tear duct problems, inflamed eye (conjunctivitis)
močnejše solzenje, težave s solznimi izvodili, vnetje očesa (konjunktivitis), zvonjenje v ušesih, bolečine v ušesu,
log-rank p value hazard ratio (95% CI) risk reduction
Celokupno preživetje (mediana) vrednost p v testu log-rang razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
Hypogammaglobulinaemia (IgG or IgM below the lower limit of normal) has been observed in RA patients treated with rituximab.
Laboratorijske nepravilnosti Pri bolnikih z revmatoidnim artritisom, ki so jih zdravili z rituksimabom, so opazili hipogamaglobulinemijo (IgG ali IgM pod spodnjo mejo normale).
Skin papilloma
levkocitoklastični vaskulitis
You will always be given Truxima as a drip (intravenous infusion).
Zdravilo Truxima boste dobili v intravenski infuziji.
• changes in blood pressure, nausea, rash, fever, feeling itchy, runny or blocked nose and sneezing, shaking, rapid heart beat, and tiredness
smrkav ali zamašen nos ter kihanje, drgetanje, hitro bitje srca in utrujenost, glavobol,
3infusion-related reactions (hypertension, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythma)
hipotenzija, rinitis, okorelost, tahikardija, utrujenost, orofaringealna bolečina, periferni edem, eritem)
• abnormal sensations of the skin, such as numbness, tingling, pricking or burning,
kožne reakcije, kot so koprivnica, srbenje in izpuščaji,
Truxima 500 mg concentrate for solution for infusion Rituximab
Truxima 500 mg koncentrat za raztopino za infundiranje rituksimab
In a subgroup analysis, the ORR was higher in patients with IWF B, C, and D histological subtypes as compared to IWF A subtype (58% vs. 12%), higher in patients whose largest lesion was < 5 cm vs. > 7 cm in greatest diameter (53% vs. 38%), and higher in patients with chemosensitive relapse as compared to chemoresistant (defined as duration of response < 3 months) relapse (50% vs. 22%).
boljši pri bolnikih, katerih največje lezije so bile v največjem premeru manjše od 5 centimetrov (53%) kot pri bolnikih, katerih lezije so bile v največjem premeru večje kot 7 centimetrov (38%).
This is a type of protein called a “monoclonal antibody”.
Zdravilo Truxima vsebuje učinkovino rituksimab, ki je vrsta beljkovine, imenovana monoklonsko protitelo.
• flushing or redness of the skin
omotica ali občutek tesnobe,
The recommended dose of Truxima monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks.
IV. stadijem folikularnih limfomov, ki so neodzivni na kemoterapijo ali se je pri njih bolezen po kemoterapiji drugič ali že večkrat ponovila, je: 375 mg/m2 telesne površine v obliki intravenske infuzije enkrat na teden 4 tedne.
Respiratory, thoracic and mediastinal disorders bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis asthma, bronchiolitis obliterans, lung disorder, hypoxia interstitial lung disease7
Bolezni dihal, prsnega koša in mediastinalneg a prostora bronhospazem4, bolezen dihal,
Respiratory, thoracic and mediastinal disorders bronchospasm4 , respiratory disease, chest pain, dyspnoea, increased cough, rhinitis asthma, bronchiolitis obliterans, lung disorder, hypoxia interstitial lung disease7
bolečina v prsnem košu, dispneja, izrazitejši kašelj, rinitis astma, bronhiolitis obliterans,
p = 0.0096
(p = 0,0312 in p = 0,0096) (preglednica 15).
Description of selected adverse drug reactions
Opis izbranih neželenih učinkov Z infuzijo povezane z infuzijo
Truxima 100 mg concentrate for solution for infusion Rituximab
Truxima 100 mg koncentrat za raztopino za infundiranje rituksimab
sciatica, migraine, dizziness
pruritus, urtikarija, draženje žrela,
Truxima is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Zdravilo Truxima je indicirano za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
Peripheral oedema
+alopecija urtikarija,
Progression-free survival (median)
Preživetje brez dogodka (mediana) 38 mesecev
The safety of immunisation with live viral vaccines, following rituximab therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended.
in KLL niso proučevali in cepljenje z živimi virusnimi cepivi ni priporočljivo.
Truxima
ZDRAVILA
• excess fluid retention in the face and body
• zvišana telesna temperatura,
during and after the 4 week induction course of Truxima treatment.
tedne pred začetkom naslednjega cikla zdravila rituksimab.
Number of Subjects with Major Relapse
Odstotek bolnikov s prvim hujšim recidivom
• infections of the blood (sepsis), pneumonia, shingles, cold, bronchial tube infections,
Pogosti neželeni učinki (pojavijo se lahko pri do 1 od 10 bolnikov): okužba krvi (sepsa), pljučnica, pasovec, prehlad, okužbe sapnic (bronhov), glivične okužbe,
• inflammation, irritation and / or tightness of the lungs and throat, coughing
zadrževanje odvečne tekočine v obrazu in telesu, vnetje, draženje in/ali stiskanje v pljučih ter v žrelu, kašljanje,
The European Commission issued a decision on 13 July 2010.
Evropska komisija je odločbo izdala dne 13. julija 2010.
Pierre Demolis (France)
Pierre Demolis (Francija)
Tomas Salmonson (Sweden)
Tomas Salmonson (Švedska)
Treatment should be evaluated after six to 12 months.
Zdravljenje je treba oceniti po šestih do 12 mesecih;
The company that markets these medicines is GlaxoSmithKline.
Družba, ki ta zdravila trži, je GlaxoSmithKline.
13 July 2010
13. julij 2010
20 November 2008 Company responses provided on: 2 March 2009, 22 September 2009, 19 January 2010, 24 March
2. marca 2009, 22. septembra 2009, 19. januarja 2010, 24. marca 2010
Valtrex was authorised in the EU via national procedures.
Zdravilo Valtrex je bilo v EU odobreno z nacionalnimi postopki.
Why was Valtrex reviewed?
Zakaj je bilo zdravilo Valtrex pregledano?
Valtrex is also available in the EU under other trade names: Talavir, Valaciclovir Allen, Valaciclovir Biogaran, Valaciclovir GSK, Valaciclovir Sandoz, Valaciclovir Winthrop, Valavir, Valherpes, Valtrex S, Virval and Zelitrex.
Zdravilo Valtrex je v EU na voljo tudi pod drugimi imeni: Talavir, Valaciclovir Allen, Valaciclovir Biogaran, Valaciclovir GSK, Valaciclovir Sandoz, Valaciclovir Winthrop, Valavir, Valherpes, Valtrex S, Virval in Zelitrex.
The European Medicines Agency has completed a review of Valtrex and associated names.
Evropska agencija za zdravila je zaključila pregled zdravila Valtrex in povezanih imen.
For recurrent episodes treatment should be for three to five days.
Zdravljenje ponovitev mora trajati od tri do pet dni.
The areas harmonised include: 4.1 Therapeutic indications The CHMP recommended that Valtrex should be used for:
Področja, ki jih je treba uskladiti, so: 4.1 Terapevtske indikacije CHMP je priporočil, da se zdravilo Valtrex uporablja za:
The CHMP recommended that Valtrex should only be used in pregnancy if the potential benefits of treatment outweigh the risks.
CHMP je priporočil, da se lahko zdravilo Valtrex med nosečnostjo uporablja le, če so morebitne koristi zdravljenja večje od tveganja.
This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
To je v državah članicah privedlo do razhajanj glede uporabe zdravila, kakor je razvidno iz povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo v državah, v katerih je zdravilo v prometu.
What is Valtrex?
Kaj je zdravilo Valtrex?
Cytomegalovirus can cause harmful effects in high-risk populations such as infants and patients who have had a solid organ transplant.
Citomegalovirus lahko škoduje populacijam z velikim tveganjem, kot so dojenčki in bolniki po presaditvi čvrstega organa.
Immunocompromised patients should be treated for a further two days after the crusting of their lesions.
Pri imunsko kompromitiranih bolnikih mora zdravljenje trajati še dva dni po oblikovanju krast na lezijah.
The Committee recommended that the doses of Valtrex should be reduced in patients with impaired kidney function.
Odbor je priporočil, da se odmerki zdravila Valtrex zmanjšajo za bolnike z okvarjenim delovanjem ledvic.