natgillin/translations-raw huggingface dataset:
- allergic reactions (hypersensitivity)** - serious inflammation or infection inside the eye (endophthalmitis) - inflammation in the iris or other parts of the eye (iritis, uveitis, iridocyclitis, anterior chamber flare) - abnormal sensation in the eye - eyelid irritation
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): - alergijske reakcije (preobčutljivost)** - hudo vnetje ali okužba v očesu (endoftalmitis) - vnetje šarenice ali drugih delov očesa (iritis, uveitis, iridociklitis, migljanje v sprednjem očesnem prekatu) - nenormalen občutek v očesu - draženje veke - oteklina sprednje plasti zrkla (roženice) ** Poročali so o alergijskih reakcijah, kot so izpuščaj, srbenje (pruritus), koprivnica (urtikarija), in posameznih primerih hudih alergijskih (anafilaktičnih/anafilaktoidnih) reakcij.
ALTAIR was a 96 week multicentre, randomised, open-label study in 247 Japanese patients with treatment naïve wet AMD, designed to assess the efficacy and safety of Eylea following two different adjustment intervals (2-weeks and 4-weeks) of a treat-and-extend dosing regimen.
Študija ALTAIR je trajala 96 tednov in je bila multicentrična, randomizirana, odprta študija, v katero je bilo vključenih 247 japonskih bolnikov, ki predhodno niso bili zdravljeni za vlažno AMD.
A ≥ 2 step improvement in DRSS was assessed in a pre-specified manner in VIVIDDME and VISTADME.
V študijah VIVIDDME in VISTADME je bilo na vnaprej določen način ocenjeno izboljšanje za ≥ 2 stopnji po lestvici resnosti diabetične retinopatije.
NAME OF THE MEDICINAL PRODUCT Eylea 40 mg/ml solution for injection Aflibercept
IME ZDRAVILA IN POT UPORABE Eylea 40 mg/ml raztopina za injiciranje aflibercept intravitrealna uporaba
NAME OF THE MEDICINAL PRODUCT Eylea 40 mg/ml solution for injection in pre-filled syringe.
IME ZDRAVILA Eylea 40 mg/ml raztopina za injiciranje v napolnjeni injekcijski brizgi
Mean change in BCVA as measured by ETDRS letter score from Baseline (SD)
Povprečna sprememba BCVA, ocenjena z ETDRS tablicami glede na izhodiščne vrednosti (SD)
Eylea 2mg Q8 (N = 91)D)
zdravilo Eylea 2 mg, vsakih 8 tednov (N = 91)D
C Difference is Eylea group minus active control (laser) group D Difference with confidence interval (CI) and statistical test is calculated using Mantel-Haenszel weighting scheme adjusted by region (Europe/Australia vs. Japan) for VIVIDDME and medical history of MI or CVA for VISTADME E BCVA: Best Corrected Visual Acuity ETDRS: Early Treatment Diabetic Retinopathy Study LOCF: Last Observation Carried Forward LS: Least square means derived from ANCOVA CI: Confidence interval
Razlika intervala zaupanja (IZ) in statističnega testa se izračunata s pomočjo Mantel-Haenszelovega testa, prilagojenega za regijo (Evropa/Avstralija v primerjavi z Japonsko) za študijo VIVIDDME in anamneza MI ali CVA za študijo VISTADME
No specific studies in patients with hepatic and/or renal impairment have been conducted with Eylea.
Okvara jeter in/ali ledvic Specifičnih študij o uporabi zdravila Eylea pri bolnikih z okvaro jeter in/ali ledvic niso izvedli.
Posology wet AMD
IZ: interval zaupanja
Adjusted Difference D,C,E
Razlika v povprečni vrednosti LSB,C,E
BCVA as covariate.
- Navodilo shranite.
Table 2: Efficacy outcomes at week 52 (primary analysis) and week 96; combined data from the VIEW1 and VIEW2 studiesB)
(primarna analiza) in 96. tednu; združeni podatki iz študij VIEW1 in VIEW2B
Prior to use, the unopened vial may be stored at room temperature (below 25°C) for up to 24 hours.
Pred uporabo lahko zaprto vialo shranjujete pri sobni temperaturi (do 25 °C) do 24 ur.
Proportion of patients with ≥ 15 letters gain from Baseline
Delež bolnikov, ki so pridobili > 15 črk glede na izhodiščne vrednosti
VEGF levels are elevated in response causing the leakage of fluid into the retina and thereby causing macular oedema.
Zaradi iztekanja tekočine v mrežnico se povečajo vrednosti VEGF v krvi, kar povzroči oteklino rumene pege.
Weighted differenceA,B,E) (95% CI)
Prilagojena razlikaA,B (%) (95 % IZ) vrednost p p = 0,0003
Prior to usage, the unopened blister of Eylea may be stored at room temperature (below 25°C) for up to 24 hours.
Pred uporabo se lahko neodprto vialo z zdravilom Eylea shranjuje pri sobni temperaturi (do 25 °C) do 24 ur.
Mean change in BCVA C) as measured by ETDRSC) letter score from baseline (SD)
Povprečna sprememba BCVAB, ocenjena z ETDRS tablicami glede na izhodiščne vrednosti (SD)B
Difference in LS
Prilagojena razlika
NAME OF THE MEDICINAL PRODUCT Eylea 40 mg/ml solution for injection in a vial.
IME ZDRAVILA Eylea 40 mg/ml raztopina za injiciranje v viali
NAME OF THE MEDICINAL PRODUCT Eylea 40 mg/ml solution for injection in pre-filled syringe Aflibercept
Eylea 40 mg/ml raztopina za injiciranje v napolnjeni injekcijski brizgi aflibercept
A low incidence rate of arterial thromboembolic events was observed in the Eylea clinical trials in patients with AMD, DME, RVO and myopic CNV.
V kliničnih preskušanjih pri bolnikih z AMD, DME, RVO in miopično CNV so opazili nizko stopnjo incidence trombemboličnih dogodkov.
• Intravitreal injection procedure pictogram
• slikovna navodila postopka intravitrealnega injiciranja
A developmental NOAEL was not identified.
Odmerka brez vidnega neželenega učinka na razvoj niso določili.
Prior to usage, the unopened vial of Eylea may be stored at room temperature (below 25°C) for up to 24 hours.
Pred uporabo lahko zaprte viale z zdravilom Eylea shranjujete pri sobni temperaturi (do 25 °C) do 24 ur.
• Prior to usage, the unopened blister may be stored at room temperature (below 25°C) for up to
• Pred uporabo lahko zaprte pretisne omote z napolnjeno injekcijsko brizgo shranjujete pri sobni temperaturi (do 25 °C) do 24 ur.
Proportion of patients with < 15 letters loss from baseline (PPS A))
Povprečno število injekcij od 52. do 96. tedna Delež bolnikov, ki so izgubili < 15 črk glede na izhodiščne vrednosti (PPSA)
• Prior to usage, the unopened vial may be stored at room temperature (below 25°C) for up to
• Pred uporabo lahko zaprto vialo shranjujete pri sobni temperaturi (do 25 °C) do 24 ur.
Mean change in BCVA as measured by ETDRS E letter score from Baseline
Povprečna sprememba BCVA, ocenjena z ETDRSE tablicami glede na izhodiščne vrednosti
Prior to use, the unopened blister may be stored at room temperature (below 25°C) for up to 24 hours.
Pred uporabo lahko zaprt pretisni omot shranjujete pri sobni temperaturi (do 25 °C) do 24 ur.
Macular oedema secondary to RVO (branch RVO or central RVO)
Makularni edem, ki nastane kot posledica zapore mrežnične vene (zapora veje mrežnične vene ali centralne mrežnične vene)
A) Difference is Eylea 2 mg Q4 weeks minus control B) Difference and confidence interval (CI) are calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for region (America vs. rest of the world for COPERNICUS and Europe vs. Asia/Pacific for GALILEO) and baseline BCVA category (> 20/200 and ≤ 20/200) C) BCVA: Best Corrected Visual Acuity ETDRS: Early Treatment Diabetic Retinopathy Study LOCF: Last Observation Carried Forward SD: Standard deviation LS: Least square means derived from ANCOVA D) LS mean difference and confidence interval based on an ANCOVA model with factors treatment group, region (America vs. rest of the world for COPERNICUS and Europe vs. Asia/Pacific for GALILEO) and baseline BCVA category (> 20/200 and ≤ 20/200) E) In COPERNICUS study, control group patients could receive Eylea on an as-needed basis as frequently as every 4 weeks during week 24 to week 52; patients had visits every 4 weeks.
Razlika in interval zaupanja (IZ) se izračunata s pomočjo Cochran-Mantel-Haenszelovega (CMH) testa, prilagojenega za regijo (Amerika v primerjavi s preostalim svetom za študijo COPERNICUS in Evropa v primerjavi z Azijo/Pacifikom za študijo GALILEO) in izhodiščno vrednostjo BCVA (> 20/200 in ≤ 20/200)
Eylea 2 mg (N = 103)
zdravilo Eylea 2 mg vsake 4 tedne (N = 103)
- neovascular (wet) age-related macular degeneration (wet AMD), - impaired vision due to macular oedema secondary to retinal vein occlusion (branch RVO (BRVO)
• neovaskularne (vlažne) starostne degeneracije makule (AMD - Age-related Macular
Using aseptic technique withdraw all of the Eylea vial contents into the syringe, keeping the vial in an upright position, slightly inclined to ease complete withdrawal.
Aseptično izvlecite celotno vsebino zdravila Eylea iz viale v brizgo.
Ask your doctor for advice before starting Eylea treatment.
Preden se začnete zdraviti z zdravilom Eylea, se posvetujte z zdravnikom.
Ranibizumab 0.5Q4 (ranibizumab 0.5 mg every 4 weeks) (N = 595) Week 52 Week 96 Week 52 Week 96
52 tednov zdravilo Eylea 2 mg, vsake 4 tedne (N = 91)
Visual acuity reduced, Conjunctival haemorrhage, Eye pain
Vlažna starostna degeneracija rumene pege
After your injection with Eylea, you may experience some temporary visual disturbances.
Vpliv na sposobnost upravljanja vozil in strojev Po injiciranju zdravila Eylea lahko pride do prehodnih motenj vida.
EMEA/459391/2008-EN
EMEA/459391/2008-SL
London, August 2008 EMEA/459391/2008
London, avgust 2008 EMEA/459391/2008
The gel is applied on the skin and its indications are:
Gel se nanaša na kožo, njegove indikacije pa so:
The CVMP started the referral procedure during its meeting of 15-17 January 2008.
CVMP je napotitveni postopek sprožil med svojim zasedanjem od 15. do 17. januarja 2008.
The CVMP Opinion was adopted on 13 February 2008 and the subsequent Commission Decision on 2 April 2008.
Mnenje Odbora za zdravila za uporabo v veterinarski medicini (CVMP) je bilo sprejeto dne 13. februarja 2008, s tem povezana odločba Komisije pa 2. aprila 2008.
The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) and subsequently to the CVMP.
Zadeva je bila napotena na Usklajevalno skupino za postopek medsebojnega priznavanja in decentralizirani postopek (CMD(v)) ter naknadno na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
Having considered the referral notification and responses of the applicant, the CVMP concluded that all concerned member states in the mutual recognition procedure agreed that Compagel Gel for Horses is essentially similar to Tensolvet 50000.
Ob upoštevanju obvestila o napotitvi in odgovorov predlagatelja je CVMP zaključil, da se vse zadevne države članice v postopku medsebojnega priznavanja strinjajo, da je zdravilo Compagel gel za konje bistveno podobno zdravilu Tensolvet 50000.
No differences between the two products have been identified that would justify different conclusions on the safety and efficacy.
Med obema zdraviloma ni bilo ugotovljenih nobenih razlik, ki bi lahko utemeljile različne zaključke glede varnosti in učinkovitosti.
Therefore, the absence of efficacy documentation does not present a potential serious risk to animal health.
Tako odsotnost dokumentacije o učinkovitosti ne pomeni možnega resnega tveganja za zdravje živali.
In June 2007 a mutual recognition procedure started with Germany as Reference Member State and 5 Concerned Member States.
Nemčija kot referenčna država članica je skupaj s 5 zadevnimi državami članicami junija 2007 sprožila postopek medsebojnega priznavanja.
The objections from France and Sweden should not prevent the granting of a marketing authorisation.
Zadržki Francije in Švedske ne bi smeli preprečiti odobritve dovoljenja za promet z zdravilom.
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR COMPAGEL GEL FOR HORSES
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 33(4) ZA ZDRAVILO COMPAGEL GEL ZA KONJE
Compagel Gel for Horses is a generic product.
Zdravilo Compagel gel za konje je generično zdravilo.
Compagel Gel for Horses contains heparin sodium, levomenthol and hydroxyethyl salicylates.
Zdravilo Compagel gel za konje vsebuje natrijev heparinat, levomentol in hidroksietil salicilate.
• To accelerate the absorption of infiltrates (e.g. postoperative swelling, penile paralysis).
• za pospešitev absorpcije infiltratov (npr. pooperativno otekanje, paraliza penisa);
France and Sweden could not agree to the granting of a marketing authorisation as they considered there were potential serious risks to animal health.
Francija in Švedska se nista strinjali z odobritvijo dovoljenja za promet z zdravilom, saj sta menili, da obstaja možnost resnega tveganja za zdravje živali.
The Marketing Authorisation Holder was requested to provide a copy of the dossier and, in view of the concerns raised by France and Sweden, to indicate and to substantiate where necessary any differences between Compagel Gel for Horses and the reference product that could justify different conclusions on the safety or efficacy for the two products.
Imetnik dovoljenja za promet z zdravilom je bil naprošen, da predloži kopijo dokumentacije, zaradi izraženih zadržkov Francije in Švedske pa tudi, da navede in po potrebi obrazloži kakršne koli razlike med zdravilom Compagel gel za konje in referenčnim zdravilom, ki bi lahko utemeljile različne zaključke glede varnosti ali učinkovitosti obeh zdravil.
contusion, bruising, inflammation of the joint capsule (synovitis), muscle rupture, after nerve block anaesthesia, after paravenous injection.
vnetje sklepnih kapsul (sinovitis), natrgane mišice, po anesteziji z živčno blokado, po paravenoznem injiciranju;
In response to the questions, the applicant submitted the dossier and argued on the basis of a comparison of the compositions that there are no differences between Compagel Gel for Horses and the reference product that could justify different conclusions on the safety and efficacy.
V odgovor na vprašanja je predlagatelj predložil dokumentacijo in na podlagi primerjave sestave trdil, da ne obstajajo nobene razlike med zdravilom Compagel gel za konje in referenčnim zdravilom, ki bi lahko utemeljile različne zaključke o varnosti in učinkovitosti.
France and Sweden considered that due to the absence of efficacy documentation it cannot be assumed that the product is efficacious and that this as such presents a potential serious risk to animal health.
Francija in Švedska sta menili, da zaradi pomanjkanja dokumentacije o učinkovitosti ni mogoče domnevati, da je zdravilo učinkovito, in zaradi tega pomeni možno resno tveganje za zdravje živali.
• To treat inflammations of superficial veins (e.g. phlebitis, thrombophlebitis, infusion thrombophlebitis).
• zdravljenje vnetja površinskih ven (npr. flebitis, tromboflebitis, infundirajoči tromboflebitis).
proposed product and can claim the same indications for use as for the reference product.
predlagatelju ni treba predložiti nadaljnjih predkliničnih ali kliničnih podatkov o učinkovitosti predlaganega zdravila in lahko zahteva iste indikacije za uporabo kot za referenčno zdravilo.
• Haematoma, tendinitis, tendovaginitis, bursitis, capped hock, saddle sore, sprain, torsion,
(burzitis), vnetje podkolenice, vnetja zaradi sedla, zvini, torzije, poškodbe, mehanske poškodbe,
Bottle (LDPE) oval
kapalni vsebnik (LDPE), okrogli kapalni vsebnik (LDPE), ovalni
Bottle (LDPE)
Velikost pakiranja kapalni vsebnik (LDPE)
One year later, the child's development remained normal.
Leto pozneje je bil otrokov razvoj normalen.
3 also applies to pregnant women.
3 velja tudi za nosečnice.
To date no other relevant epidemiological data are available.
Do sedaj ni na voljo drugih relevantnih epidemioloških podatkov.
There are no adequate and well-controlled studies in pregnant women.
Na voljo ni ustreznih in dobro nadzorovanih raziskav pri nosečnicah.
It is particularly important that you tell your doctor if you are taking or have recently taken:
Še zlasti pomembno je, da zdravniku poveste, če jemljete ali ste pred kratkim jemali:
** Includes American Indians/Alaska natives and Hawaiian/Pacific islanders.
** Zajema ameriške Indijance ali domorodce na Aljaski in prebivalce Havajev oziroma Pacifiških otokov.
SN {number} [serial number]
SN {številka} [serijska številka]
The opposite side is marked with the company symbol.
Na drugi strani je simbol podjetja.
These can become severe and even life threatening.
Te lahko postanejo hude in celo življenjsko nevarne.
ND = Not Determined, ↑ = Increased, ↓ = Decreased,  = No Effect
ND = ni določeno, ↑ = povečanje, ↓ = zmanjšanje,  = ni učinka
3 (11.0 % versus 0.9 %).
3 (11,0 % v primerjavi z 0,9 %).
Gender - Male - Female
Spol - moški - ženski
Such reactions can be life-threatening.
Takšne reakcije so lahko življenjsko nevarne.
(compared to 300/100mg without nevirapine)
(v primerjavi s 300/100 mg brez nevirapina)
If you need a higher dose, repeat steps 4-5 above.
Če potrebujete večji odmerek, ponovite postopke od 4 do 5.
NN {number} [national reimbursement number or other national number identifying the medicinal product]
NN {številka} [nacionalna številka povračila stroškov za zdravilo ali druga nacionalna številka za identifikacijo zdravila]
DMPA AUC  DMPA Cmin  DMPA Cmax 
AUC DMPA  Cmin DMPA  Cmax DMPA 
The usual dose is the same for all adults (20 ml).
Običajni odmerek je za vse odrasle enak (20 ml).
Inform your doctor if you find tablet pieces in your faeces.
Obvestite zdravnika, če v vašem blatu najdete delce tablet.
Interferons (pegylated interferons alfa 2a and alfa 2b)
Interferoni (pegilirana interferona alfa 2a in alfa 2b)
Race - White - Black - Asian - Other
Rasa - belci - črnci - Azijci - drugo**
Region - North America
Regija - Severna Amerika
Therefore, you may continue to develop infections and other illnesses associated with HIV infection.
Zato se pri vas lahko še nadalje razvijajo okužbe in druge bolezni, ki se pojavljajo pri okužbi s HIV.
Reverse transcriptase is an enzyme that HIV needs in order to multiply.
Reverzna transkriptaza je encim, ki ga HIV potrebuje za razmnoževanje.
Other published data support these conclusions.
Drugi objavljeni podatki se z njimi ujemajo.
However, in the absence of specific studies, the clinical impact of these findings is not known.
Ker pa niso opravili specifičnih študij, klinični pomen teh izsledkov ni znan.
25 and above
25 in več
This difference is not considered clinically relevant.
Razlika ne velja za klinično pomembno.
PC {number} [product code]
PC {številka} [koda zdravila]
** Based on Cochran's statistic with continuity correction for the variance calculation
** Cochranova statistika z Yeatsovim popravkom za izračun variance
In such patients haematological parameters should be carefully monitored.
Pri teh bolnikih je treba natančno spremljati hematološke parametre.
During the first 18 weeks of treatment with Viramune it is very important that you and your doctor watch out for signs of liver or skin reactions.
Prvih 18 tednov zdravljenja z zdravilom Viramune je zelo pomembno, da ste vi in vaš zdravnik pozorni na znake jetrnih ali kožnih reakcij.
Interferons have no known effect on CYP 3A4 or 2B6.
Interferoni nimajo znanega učinka na CYP 3A4 ali 2B6.
Long-term efficacy appears to be most likely in patients whose nevirapine trough levels exceed 3.5 µg/ml.
Dolgoročna učinkovitost je najverjetnejša pri bolnikih, pri katerih so najmanjše ravni nevirapina nad 3,5 µg/ml.
Interaction has not been studied.
Interakcij niso raziskali.
In some cases, hepatic injury has progressed despite discontinuation of treatment.
V nekaterih primerih se je jetrna okvara povečala kljub ukinitvi zdravljenja.
Gender and elderly
Spol in starejši
2NN study
Študija 2NN
2NN Three-year follow-up-study
Študija 2NN s 3-letnim sledenjem
NEFA study
Študija NEFA
Hypersensitivity (allergic) reactions can occur.
Možne so preobčutljivostne (alergijske) reakcije.
In these cases, more frequent liver monitoring is required.
V tem primeru je treba jetrno funkcijo spremljati pogosteje.
Mild isolated neutropenia and hyperlactataemia was observed, which spontaneously disappeared within one week without any clinical complications.
Pojavili sta se izolirana nevtopenija in hiperlaktatemija, ki sta v enem tednu spontano minili brez kliničnih zapletov.
Cases of jaundice have been reported.
Poročajo o primerih zlatenice.
You should therefore remain in regular contact with your doctor.
Pomembno je, da ste še naprej v rednem stiku z vašim zdravnikom.
Discontinued medicinal product prior to week 48
Prekinitev jemanja zdravila pred 48. tednom
Greater than 80 % of the radioactivity in urine was made up of glucuronide conjugates of hydroxylated metabolites.
Več kot 80 % radioaktivne snovi v seču so sestavljali glukuronidni konjugati hidroksiliranih presnovkov.
Your doctor will recommend the best medicines for you.
Zdravnik vam bo priporočil za vas najustreznejša zdravila.
Total cholesterol/HDL
Skupni holesterol/HDL
Patients who participated in the 2NN study and were still under active follow-up at week 48 when the study closed and were still being treated at the study clinic, were asked to participate in this study.
Za sodelovanje v njej so prosili bolnike, ki so sodelovali v študiji 2NN in so bili 48. teden, ko je bila študija zaključena, še vedno zajeti v aktivnem sledenju in so se še zdravili na kliniki, kjer so študijo izvajali.
Patients 16 years and older
Bolniki, 16-letni in starejši
There is at present little information on the effects of Viramune overdose.
Zaenkrat je malo podatkov o učinkih prevelikega odmerka zdravila Viramune.
ANTIVIRALS FOR CHRONIC HEPATITIS B AND C Adefovir
PROTIRETROVIRUSNA ZDRAVILA ZA KRONIČNI HEPATITIS B IN C Adefovir
This is therefore an important period which requires close monitoring by your doctor.
Zato je to pomembno obdobje, v katerem vas bo zdravnik skrbno spremljal.
Patients who discontinued treatment during the lead-in period are excluded.
Izključeni so bolniki, ki so prekinili zdravljenje med uvajalnim obdobjem.
The consolidated analysis of Paediatric AIDS Clinical Trials Group (PACTG) protocols 245, 356, 366, 377, and 403 allowed for the evaluation of paediatric patients less than 3 months of age (n=17) enrolled in these PACTG studies.
Zbirna analiza protokolov PACTG (Paediatric AIDS Clinical Trials Group) 245, 356, 366, 377 in 403 je omogočila ovrednotenje pri otrocih, mlajših od 3 mesecev (n = 17), ki so bili vključeni v študije PACTG.
Also, both dosing regimens were effective in reducing the viral load.
Oba režima odmerjanja sta poleg tega učinkovito zmanjšala virusno breme.
In these patients nevirapine must not be restarted.
Pri teh bolnikih zdravljenja z nevirapinom ne smemo ponoviti.
Open the bottle.
Plastenko odprite.
Where other antiretroviral medicines are accessible, the single dose Viramune regimen should be combined with additional effective antiretroviral medicines (as recommended in internationally recognized guidelines).
Če so na voljo druga protiretrovirusna zdravila, je treba režim zdravljenja z enkratnim odmerkom zdravila Viramune kombinirati z dodatnimi učinkovitimi protiretrovirusnimi zdravili (kot priporočajo mednarodno sprejete smernice).
3 in adult females and >400/mm
3 pri odraslih ženskah in > 400/mm
What Viramune is and what it is used for
Kaj je zdravilo Viramune in za kaj ga uporabljamo
It is in general recommended that you do not breast-feed if you have HIV infection because it is possible that your baby can become infected with HIV through your breast milk.
Splošno priporočajo prekinitev dojenja, če ste okuženi s HIV, ker obstaja možnost, da bi se otrok okuži s HIV z vašim mlekom.
White to off-white homogenous suspension.
Bela do skoraj bela homogena suspenzija.
A clinically not relevant increase in the apparent clearance of nevirapine (by 9%) compared to historical data was reported.
Poročali so o klinično nepomembnem povečanju navideznega očistka nevirapina (za 9 %) v primerjavi s prejšnjimi kontrolnimi podatki.
The clinical relevance of these data in European populations has not been established.
Klinični pomen teh izsledkov pri evropskih populacijah še ni raziskan.
The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the marketing authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
No clinical data available.
Ni kliničnih podatkov.