natgillin/translations-raw huggingface dataset:
Increased plasma concentrations of quetiapine which may lead to coma.
Povišena koncentracija kvetiapina u plazmi što može dovesti do kome.
Antiviral activity of lopinavir/ritonavir in patients failing protease inhibitor therapy The clinical relevance of reduced in vitro susceptibility to lopinavir has been examined by assessing the virologic response to lopinavir/ritonavir therapy, with respect to baseline viral genotype and phenotype, in 56 patients previous failing therapy with multiple protease inhibitors.
Klinički značaj smanjene osjetljivosti na lopinavir in vitro određen je procjenom virološkog odgovora na terapiju lopinavirom/ritonavirom u odnosu na početni virusni genotip i fenotip u 56 bolesnika koji prethodno nisu reagirali na terapiju s više inhibitora proteaze.
Sildenafil used to treat erectile dysfunction may be taken under doctor's supervision (see Other medicines and Lopinavir/ritonavir Mylan section);
Sildenafil koji se koristi za liječenje erektilne disfunkcije može se koristiti samo pod liječničkim nadzorom (pogledajte dio Drugi lijekovi i Lopinavir/Ritonavir Mylan); pripravke koji sadrže gospinu travu (Hypericum perforatum).
How to take Lopinavir/Ritonavir Mylan
Kako uzimati Lopinavir/Ritonavir Mylan
Concomitant administration of Lopinavir/Ritonavir Mylan and alfuzosin is contra-indicated (see section 4.3) as alfuzosin-related toxicity, including hypotension, may be increased.
Istodobna primjena lijeka Lopinavir/Ritonavir Mylan i alfuzosina je kontraindicirana (vidjeti dio 4.3) jer može doći do povećanja toksičnosti povezane s alfuzosinom, uključujući hipotenziju.
Lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years.
Lopinavir/ritonavir je indiciran za liječenje odraslih, adolescenata i djece starije od 2 godine inficiranih virusom humane imunodeficijencije (HIV-1) u kombinaciji s ostalim antiretrovirusnim lijekovima.
Study M98-863 was a randomised, double-blind trial of 653 antiretroviral treatment naïve patients investigating lopinavir/ritonavir (400/100 mg twice daily) compared to nelfinavir (750 mg three times daily) plus stavudine and lamivudine.
Bolesnici bez ranije terapije antiretrovirusnim lijekovima Studija M98-863 bila je randomizirano, dvostrukoslijepo ispitivanje lopinavira/ritonavira (400/100 mg dvaput na dan) u usporedbi s nelfinavirom (750 mg triput na dan) plus stavudin i lamivudin u 653 bolesnika bez prethodne antiretrovirusne terapije.
Trazodone single dose (Ritonavir, 200 mg BID)
Antidepresivi i anksiolitici Trazodon jednokratna doza (Ritonavir, 200 mg BID)
AUC: ↑ 6.10-fold Cmax: ↑ 4.76-fold Ctrough: ↑ 12.33-fold
AUC: ↑ 6,10 puta Cmax: ↑ 4,76 puta Ctrough: ↑ 12,33 puta
The use of rivaroxaban is not recommended in patients receiving concomitant treatment with Lopinavir/Ritonavir Mylan (see section 4.4).
Ne preporučuje se primjena rivaroksabana kod bolesnika koji se istodobno liječe lijekom Lopinavir/Ritonavir Mylan (vidjeti dio 4.4).
Patients were randomised in a 1:1 ratio to receive either lopinavir/ritonavir 800/200 mg once daily (n = 333) or lopinavir/ritonavir 400/100 mg twice daily (n = 331).
Bolesnici su bili podijeljeni u grupe u omjeru 1:1 na taj način da su jedni primali 800/200 mg lopinavira/ritonavira jednom dnevno (n = 333), a drugi 400/100 mg lopinavira/ritonavira dva puta dnevno (n = 331).
Lopinavir/Ritonavir Mylan contains sodium
Lopinavir/Ritonavir Mylan sadrži natrij
(inhibition of CYP3A/efflux transporters)
(inhibicija CYP3/prijenosnika efluksa)
A more pronounced effect on bedaquiline plasma exposures may be observed during prolonged co-administration with lopinavir/ritonavir.
Mogući je izraženiji učinak na izloženost bedakilinu u plazmi tijekom produljene istodobne primjene s lopinavirom/ritonavirom.
Concomitant administration of Lopinavir/Ritonavir Mylan and ergot alkaloids are contraindicated as it may lead to acute ergot toxicity, including vasospasm and ischaemia (see section
Istodobna primjena lijeka Lopinavir/Ritonavir Mylan i ergot alkaloida kontraindicirana je jer može dovesti do akutne ergotne toksičnosti, uključujući vazospazam i ishemiju (vidjeti dio 4.3).
AUC: ↑ 2.71-fold Cmax: ↑ 1.87-fold C24: ↑ 3.58-fold
AUC: ↑ 2,71 put Cmax: ↑ 1,87 puta C24: ↑ 3,58 puta
Lovastatin and Simvastatin Lovastatin, Simvastatin: Markedly increased plasma concentrations due to CYP3A inhibition by lopinavir/ritonavir.
Lovastatin, simvastatin: Značajno povećane koncentracije u plazmi zbog inhibicijskog učinka lopinavira/ritonavira na CYP3A.
Therefore, the antiviral activity of lopinavir/ritonavir is due to lopinavir.
Za antivirusnu aktivnost lopinavira/ritonavira odgovoran je lopinavir.
Due to induction of lamotrigine glucuronidation Valproate: ↓
Zbog indukcije glukuronidacije lamotrigina
Since lopinavir/ritonavir is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.
Budući da je veći dio lopinavira/ritonavira vezan za proteine, dijaliza vjerojatno ne bi znatnije pomogla u uklanjanju djelatne tvari.
If you or your child forget to take Lopinavir/Ritonavir Mylan
Ako Vi ili Vaše dijete zaboravite uzeti Lopinavir/Ritonavir Mylan
Lopinavir/Ritonavir Mylan tablets contain lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A.
Lopinavir/Ritonavir Mylan tablete sadrže lopinavir i ritonavir, a oba su inhibitori P450 izoforme CYP3A.
Monitor for ADRs related to afatinib
Nadzirati bolesnike zbog mogućih nuspojava povezanih s afatinibom.
More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.5 and refer to the bedaquiline SmPC).
Preporučuje se učestalije praćenje elektrokardiograma i transaminaza (vidjeti dio 4.5 te Sažetak opisa svojstava lijeka za bedakilin).
Across studies, administration of lopinavir/ritonavir 400/100 mg twice daily yields mean steady-state lopinavir plasma concentrations 15 to 20-fold higher than those of ritonavir in HIV-infected patients.
Ispitivanja su pokazala da se u bolesnika zaraženih HIV-om pri primjeni lopinavira/ritonavira u dozi od 400/100 mg dvaput na dan postižu, srednje vrijednost plazmatske koncentracije lopinavira, koje su u stanju ravnoteže 15-20 puta veće od koncentracija ritonavira.
Multiple dosing with 400/100 mg lopinavir/ritonavir twice daily for 2 weeks and without meal restriction produced a mean ± SD lopinavir peak plasma concentration (Cmax) of 12.3 ± 5.4 μg/ml, occurring approximately 4 hours after administration.
Pri uzimanju lopinavira/ritonavira u dozi od 400/100 mg dvaput na dan tijekom 2 tjedna, bez ograničenja uzimanja hrane, vršna je koncentracija lopinavira u plazmi (Cmax) postignuta oko 4 sata nakon uzimanja, a iznosila je 12,3 ± 5,4 μg/ml (srednja vrijednost ± SD).
Therefore, concomitant administration of Lopinavir/Ritonavir Mylan with salmeterol is not recommended (see section 4.4).
Stoga nije preporučena istodobna primjena lijeka Lopinavir/Ritonavir Mylan i salmeterola (vidjeti dio 4.4).
Multipack: 60 (2 cartons of 30) Film-coated tablets Multipack: 60x1 (2 cartons of 30x1) Film-coated tablets
Višestruko pakiranje: 60 (2 kutije s 30) filmom obloženih tableta Višestruko pakiranje: 60 x 1 (2 kutije s 30 x 1) filmom obloženih tableta
Concomitant administration of Lopinavir/Ritonavir Mylan and amiodarone or dronedarone is contraindicated (see section 4.3) as the risk of arrhythmias or other serious adverse reactions may be increased.
Istodobna primjena lijeka Lopinavir/Ritonavir Mylan i amiodarona ili dronedarona je kontraindicirana (vidjeti dio 4.3) jer može doći do povišenog rizika od aritmija ili ostalih ozbiljnih nuspojava.
Ombitasvir/paritaprevir/ritonavir with or without dasabuvir
Ombitasvir/paritaprevir/ritonavir s dasabuvirom ili bez njega
Omeprazole (40 mg QD) Omeprazole: ↔
Lijekovi koji smanjuju kiselost želučanog soka Omeprazol (40 mg QD) Omeprazole: ↔
− Diabetes as increased blood sugars has been reported in patients receiving lopinavir/ritonavir.
Dijabetes (šećernu bolest) jer je u bolesnika koji su uzimali lopinavir/ritonavir zabilježena povećana razina šećera u krvi.
Multipack: 120 (4 cartons of 30) Film-coated tablets Multipack: 120x1 (4 cartons of 30x1) Film-coated tablets Multipack: 360 (12 cartons of 30) Film-coated tablets
Višestruko pakiranje: 120 (4 kutije s 30) filmom obloženih tableta Višestruko pakiranje: 120 x 1 (4 kutije s 30 x 1) filmom obloženih tableta Višestruko pakiranje: 360 (12 kutija s 30) filmom obloženih tableta
INFORMATION IN BRAILLE Lopinavir/Ritonavir Mylan 100 mg/25 mg
PISMU Lopinavir/Ritonavir Mylan 100 mg/25 mg
2nd Trimester n =
2. tromjesečje n = 17*
Mean baseline CD4+ T-cell count was 259 cells/mm3 (range: 2 to 949 cells/mm3) and mean baseline plasma HIV-1 RNA was 4.9 log10 copies/ml (range: 2.6 to 6.8 log10 copies/ml).
Srednja početna vrijednost broja CD4+ T stanica je bila 259 stanica/mm3 (raspon 2 do 949 stanica/mm3) i srednja početna vrijednost HIV-1 RNA u plazmi je bila 4,9 log10 kopija/ml (raspon: 2,6 do 6,8 log10 kopija/ml).
HIV RNA < 400 copies/ml*
HIV RNA < 400 kopija/ml*
51 patients receiving 400/100 mg twice daily and 49 patients at either 200/100 mg twice daily or 400/200 mg twice daily).
U početku studije ukupno je 100 bolesnika liječeno lopinavirom/ritonavirom (51 bolesnik primao je 400/100 mg dva puta dnevno, a 49 bolesnika primalo je 200/100 mg dva puta dnevno ili 400/200 mg dva puta dnevno).
− medicines used to correct heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);
lijekove za ispravljanje srčanog ritma (npr. bepridil, sistemski lidokain, kinidin); HIV CCR5 antagonisti (npr. maravirok);
Raltegravir: AUC: ↔ Cmax: ↔ C12 : ↓ 30%
Raltegravir: AUC: ↔ Cmax: ↔ C12: ↓ 30% Lopinavir: ↔
If you or your child stop taking Lopinavir/Ritonavir Mylan
Ako Vi ili Vaše dijete prestanete uzimati Lopinavir/Ritonavir Mylan
Lopinavir/Ritonavir Mylan tablets contain lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A in vitro.
Lopinavir/Ritonavir Mylan tablete sadrže lopinavir i ritonavir, koji su oba inhibitori P450 izoforme CYP3A in vitro.
INFORMATION IN BRAILLE Lopinavir/Ritonavir Mylan 200 mg/50 mg
PISMU Lopinavir/Ritonavir Mylan 200 mg/50 mg
For patients with renal impairment (CrCL < 30 ml/min) dose reduction of clarithromycin should be considered (see section 4.4).
Smanjenje doze klaritromicina mora se razmotriti u bolesnika s oštećenom funkcijom bubrega (klirens kreatinina < 30 ml/min) (vidjeti dio 4.4).
How to store Lopinavir/Ritonavir Mylan
Kako čuvati Lopinavir/Ritonavir Mylan
HIV RNA < 400 copies/ml
HIV RNA < 400 kopija/ml
Clinical recommendation concerning co-administration with Lopinavir/Ritonavir Mylan
Klinička preporuka o istodobnoj primjeni s lijekom Lopinavir/Ritonavir Mylan
Concomitant use of sildenafil prescribed for the treatment of pulmonary arterial hypertension with lopinavir/ritonavir is contraindicated (see section 4.3).
Isodobna primjena sildenafila propisanog zbog liječenja plućne arterijske hipertenzije zajedno s lopinavirom/ritonavirom je također kontraindicirana (vidjeti dio 4.3).
Concomitant administration of Lopinavir/Ritonavir Mylan with colchicine in patients with renal and/or hepatic impairment is contraindicated due to a potential increase of colchicine-related serious and/or life-threatening reactions such as neuromuscular toxicity (including rhabdomyolysis) (see sections 4.3 and 4.4).
bolesnika s oštećenjem funkcije bubrega i/ili jetre jer može doći do povećanja ozbiljnih i/ili po život opasnih reakcija povezanih s kolhicinom poput neuromuskularne toksičnosti (uključujući rabdomiolizu) (vidjeti dijelove 4.3 i 4.4).
− colchicine (used to treat gout) if you have kidney and/or liver problems (see the section on Other medicines and Lopinavir/Ritonavir); elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV]); ombitasvir/paritaprevir/ritonavir with or without dasabuvir (used to treat chronic hepatitis C virus [HCV]);
Kada se koristi za liječenje dugotrajnih infekcija kostiju i zglobova, fusidatna kiselina se može uzimati pod liječničkim nadzorom (pogledajte dio Drugi lijekovi i Lopinavir/Ritonavir Mylan); kolhicin (lijek za liječenje gihta) - ako imate tegobe s bubrezima i/ili jetrom (pogledajte dio Drugi lijekovi i Lopinavir/Ritonavir Mylan); elbasvir/grazoprevir (koristi se za liječenje kronične infekcije virusom hepatitisa C [HCV]); ombitasvir/paritaprevir/ritonavir s dasubavirom ili bez njega (koristi se za liječenje kronične infekcije virusom hepatitisa C [HCV]); avanafil ili vardenafil (lijek za liječenje erektilne disfunkcije); sildenafil koji se koristi za plućnu arterijsku hipertenziju (visok krvni tlak u plućnoj arteriji).
− HIV-1 integrase inhibitor (e.g. raltegravir);
Inhibitori integraze Raltegravir
The induced QRS interval prolongation from 6 ms to 9.5 ms with high dose lopinavir/ritonavir (800/200 mg twice daily) contributes to QT prolongation.
Visokom dozom lopinavira/ritonavira (800/200 mg dva puta dnevno) inducirana prolongacija QRS intervala sa 6 ms na 9.5 ms pridonosi QT prolongaciji.
The adult dose of lopinavir/ritonavir tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2. For children weighing less than 40 kg or with a BSA between 0.5 and 1.4 m2 and able to swallow tablets, please refer to the dosing guideline tables below.
Pedijatrijska populacija (djeca u dobi od 2 godine i starija) Doza za odrasle (400/100 mg dva puta dnevno) može se dati djeci od 40 kg ili više ili s površinom tijela (PT)* većom od 1,4 m².
If the benefit outweighs the risk, co-administration of bedaquiline with Lopinavir/Ritonavir Mylan must be done with caution.
Ukoliko korist nadmašuje rizik, bedakilin se istodobno s lijekom Lopinavir/Ritonavir Mylan mora primjenjivati s oprezom.
− digoxin;
digoksin;
- Lopinavir/Ritonavir Mylan contains the active substances lopinavir and ritonavir.
Lopinavir/Ritonavir Mylan sadrži djelatne tvar lopinavir i ritonavir.
AUC: ↑ 3-fold Cmax: ↑ 1.8-fold
AUC: ↑ 3 puta Cmax: ↑ 1,8 puta
No dose adjustment is needed for Lopinavir/Ritonavir Mylan.
Prilagodba doze lijeka Lopinavir/Ritonavir Mylan nije potrebna.
Lopinavir/Ritonavir Mylan 200 mg/50 mg film-coated tablets Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.
Lopinavir/Ritonavir Mylan 200 mg/50 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 200 mg lopinavira u kombinaciji s 50 mg ritonavira kao farmakokinetičkog pojačivača.
Lopinavir/Ritonavir Mylan 100 mg/25 mg film-coated tablets Each film-coated tablet contains 100 mg of lopinavir co-formulated with 25 mg of ritonavir as a pharmacokinetic enhancer.
Lopinavir/Ritonavir Mylan 100 mg/25 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 100 mg lopinavira u kombinaciji s 25 mg ritonavira, kao farmakokinetičkog pojačivača.
Mean baseline CD4+ T-cell count was 216 cells/mm3 (range: 20 to 775 cells/mm3) and mean baseline plasma HIV-1 RNA was 5.0 log10 copies/ml (range: 1.7 to 7.0 log10 copies/ml).
Srednja početna vrijednost broja -stanica CD4+ bila je 216 stanica/mm³ (raspon od 20 do 775 stanica/mm³), a srednja početna vrijednost HIV-1 RNA u plazmi bila je 5,0 log10 kopija/ml (raspon od 1,7 do 7,0 log10 kopija/ml).
Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Tijekom antivirusne terapije mogu se povećati tjelesna težina i povisiti razine lipida i glukoze u krvi (vidjeti dio 4.4).
Rash including maculopapular rash, dermatitis/rash including eczema and seborrheic dermatitis, night sweats, pruritus
Osip uključujući makulopapularni osip, dermatitis/osip uključujući ekcem i seboroični dermatitis, noćno znojenje, svrbež Manje često Alopecija, kapilaritis, vaskulitis Nepoznato
3rd Trimester n =
3. tromjesečje n = 23
Read the list of medicines below under ‘Other medicines and Lopinavir/Ritonavir Mylan' for information on certain other medicines which require special care.
”Drugi lijekovi i Lopinavir/Ritonavir Mylan” za informacije o posebnim upozorenjima kod uporabe s drugim lijekovima.
The combination of Lopinavir/Ritonavir Mylan with atorvastatin is not recommended.
Kombinacija lijeka Lopinavir/Ritonavir Mylan s atorvastatinom se ne preporučuje.
Plasma concentrations may be increased due to P-glycoprotein inhibition by lopinavir/ritonavir.
Koncentracije u plazni mogu biti povećane zbog inhibicije Pglikoproteina izazvane lopinavirom/ritonavirom.
The enrolled population was moderately PI-experienced with more than half of patients having never received prior PI and around 80% of patients presenting a viral strain with less than 3 PI mutations.
Uključena populacija bila je umjereno izložena inhibitorima proteaze (IP) s više od pola bolesnika koji nikad nisu primali IP i oko
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
NAČIN I PUT PRIMJENE LIJEKA Prije uporabe pročitajte Uputu o lijeku.
Dosage adjustment for midazolam should be considered especially if more than a single dose of midazolam is administered.
Klinička preporuka o istodobnoj primjeni s lijekom Lopinavir/Ritonavir Mylan prilagođavanje doze midazolama, osobito ako se daje više od jedne doze midazolama.
Caution should be exercised in administering Lopinavir/Ritonavir Mylan with bosentan.
Oprez je nužan kada se Lopinavir/Ritonavir Mylan primjenjuje s bosentanom.
Mean baseline CD4+ T-cell count was 254 cells/mm3 (range: 4 to 952 cells/mm3) and mean baseline plasma HIV-1 RNA was 4.3 log10 copies/ml (range: 1.7 to 6.6 log10 copies/ml).
Srednja početna vrijednost CD4+ T-stanica je bila 254 stanica/mm³ (raspon: 4 do 952 stanica/mm³) i srednja početna vrijednost HIV-1 RNA u plazmi bila je 4,3 log10 kopija/ml (raspon: 1,7 do 6,6 log10 kopija/ml).
Plasma concentrations ↑ Cortisol levels ↓ 86%
Flutikazonpropionat, 50 g intranazalno četiri puta na dan: Plazmatske koncentracije ↑ Razine kortizola ↓ 86%
Fusidic acid:
Fusidatna kiselina:
Risk of increased adverse events due to higher serum concentrations because of CYP3A4 inhibition by lopinavir/ritonavir.
Rizik povećanja štetnih događaja zbog povišenih koncentracija u plazmi zbog inhibcije CYP3A4 lopinavirom/ritonavirom.
Lopinavir: AUC: ↔ Cmin: ↓ 11% Cmax: ↔
AUC: ↔ Cmin: ↓ 11% Cmax: ↔
* weight based dosing recommendations are based on limited data If more convenient for patients, the lopinavir/ritonavir 200/50 mg tablets may also be considered alone or in combination with the lopinavir/ritonavir 100/25 mg tablet to achieve the recommended dose.
Ukoliko je zgodnije za bolesnike, 200 mg/50 mg tablete lopinavira/ritonavira se mogu razmotriti za primjenu same ili u kombinaciji s 100 mg/25 mg tabletama lopinavira/ritonavira kako bi se postigla potrebna doza.
Elbasvir/grazoprevir (50/200 mg QD)
Antivirusni lijekovi s direktnim djelovanjem na hepatitis C Elbasvir/grazoprevir (50/200 mg QD)
− upper respiratory tract infection.
Infekcije gornjeg dišnog sustava
A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with Lopinavir/Ritonavir Mylan is required.
Ukoliko je potrebno liječenje lijekom Lopinavir/Ritonavir Mylan kod bolesnika s normalnom funkcijom bubrega ili jetre, preporučuje se smanjenje doze kolhicina ili prekid liječenja kolhicinom.
Lopinavir/ritonavir was not found to be mutagenic or clastogenic in a battery of in vitro and in vivo assays including the Ames bacterial reverse mutation assay, the mouse lymphoma assay, the mouse micronucleus test and chromosomal aberration assays in human lymphocytes
Serija in vitro i in vivo ispitivanja, uključujući i Amesov bakterijski test reverzne mutacije, test mišjeg limfoma, test mišjih mikronukleusa i test kromosomskih aberacija ljudskih limfocita, nije pokazala mutagenost niti klastogenost lopinavira/ritonavira.
Hepatitis including AST, ALT and GGT increases Uncommon Hepatic steatosis, hepatomegaly, cholangitis, hyperbilirubinemia
Manje često Steatoza jetre, hepatomegalija, kolangitis, hiperbilirubinemija
In clinical studies with a limited number of isolates analysed, the selection of resistance to lopinavir has not been observed in naïve patients without significant protease inhibitor resistance at baseline.
Analiza rezistencije u bolesnika koji nisu primali antitretrovirusne lijekove U kliničkim ispitivanjima s ograničenim brojem analiziranih izolata, u bolesnika koji nisu prethodno primali antiretrovirusne lijekove, a bez značajne rezistencije inhibitora proteaza na početku, nije uočena rezistencija na lopinavir.
You must not take Lopinavir/Ritonavir Mylan with colchicine if you have kidney and/or liver problems (see also ‘Do not take Lopinavir/Ritonavir Mylan' above);
Ne smijete uzimati Lopinavir/Ritonavir Mylan s kolhicinom ako imate tegobe s bubrezima i/ili jetrom (pogledajte i dio
To date, there is limited human experience of acute overdose with lopinavir/ritonavir.
Zasad su iskustva o akutnom predoziranju lopinavirom/ritonavirom u čovjeka ograničena.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (BOTTLE)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (BOCA)
Caution should be exercised in administering afatinib with Lopinavir/Ritonavir Mylan.
Potreban je oprez kada se afatinib primjenjuje zajedno s lijekom Lopinavir/Ritonavir Mylan.
When co-administered with phenytoin, an increase of Lopinavir/Ritonavir Mylan dosage may be envisaged.
Pri istodobnoj primjeni s fenitoinom treba razmotriti povećanje doze lijeka Lopinavir/Ritonavir Mylan.
3 tablets (300/75 mg) 4 tablets (400/100 mg)
3 tablete (300/75 mg) 4 tablete (400/100 mg) *preporuke za doziranje na osnovu tjelesne težine je bazirano na ograničenim podacima
The co-administration of riociguat with Lopinavir/Ritonavir Mylan is not recommended (see section 4.4 and refer to riociguat SmPC).
Istodobna primjena riocigvata i lijeka Lopinavir/Ritonavir Mylan se ne preporučuje (vidjeti dio 4.4 i Sažetak opisa svojstava lijeka za riocigvat).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE MULTIPACK (LABEL)
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU VIŠESTRUKO PAKIRANJE BOCA (NALJEPNICA)
Uncommon Immune reconstitution inflammatory syndrome
Manje često Upalni sindrom imunološke rekonstitucije
− Nausea, vomiting, abdominal pain as large increases in the amount of triglycerides (fats in the blood) have been considered a risk factor for pancreatitis (inflammation of the pancreas) and these symptoms may suggest this condition.
Mučninu, povraćanje, bol u trbuhu jer to može upućivati na pankreatitis (upalu gušterače) za koji povećana koncentracija triglicerida (masnoće u krvi) predstavlja rizičan faktor.
Outcomes at Week 48: Study M98-863 Lopinavir/ritonavir (N=326)
Rezultati u 48. tjednu: studija M98-863
The following table contains dosing guidelines for lopinavir/ritonavir tablets based on BSA when used in combination with efavirenz or nevirapine in children.
Istodobna primjena drugih lijekova: efavirenz ili nevirapin Sljedeća tablica sadrži smjernice za doziranje 100/25 mg tableta lopinavira/ritonavira, korištenih u djece u kombinaciji s efavirenzom ili nevirapinom, temeljene na površini tijela.
Lopinavir/ritonavir Mylan is not a cure for HIV infection or AIDS - Lopinavir/ritonavir is used by children 2 years of age or older, adolescents and adults who are infected with HIV, the virus which causes AIDS.
Lopinavir/ritonavir je namijenjen za liječenje djece s navršene 2 godine ili starije, adolescenata i odraslih koji su zaraženi HIV-om, tj. virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS; engl. acquired immunodeficiency syndrome).
It is not recommended to coadminister Lopinavir/Ritonavir Mylan and boceprevir.
Ne preporučuje se istodobna primjena lijeka Lopinavir/Ritonavir Mylan i boceprevira.
Ear and labyrinth disorders
Poremaćaj uha i labirinta
The combination of lopinavir/ritonavir with atorvastatin is not recommended.
Istodobna primjena lopinavira/ritonavira s atorvastatinom se ne preporučuje.
Lopinavir/Ritonavir Mylan 200 mg/50 mg film-coated tablets.
Lopinavir/Ritonavir Mylan 200 mg/50 mg filmom obložene tablete.
Lopinavir/Ritonavir Mylan 100 mg/25 mg film-coated tablets.
Lopinavir/Ritonavir Mylan 100 mg/25 mg filmom obložene tablete.