natgillin/translations-raw huggingface dataset:
These increases of plasma concentrations of co-administered medicinal products could increase or prolong their therapeutic effect and adverse events (see sections 4.3 and
Zbog povišenih koncentracija u plazmi istodobno primijenjenih lijekova može se pojačati ili produžiti njihov terapijski učinak te pojačati nuspojave i produžiti njihovo trajanje (vidjeti dijelove 4.3 i 4.5).
Tablet coating
Ovojnica tablete
Outcomes at Week 48: Study M98-957
Rezultati u 48. tjednu: studija M98-957
Activity of other protease inhibitors against isolates that developed incremental resistance to lopinavir after Kaletra therapy in protease inhibitor experienced patients: The presence of cross resistance to other protease inhibitors was analysed in 18 rebound isolates that had demonstrated evolution of resistance to lopinavir during 3 Phase II and one Phase III studies of Kaletra in protease inhibitorexperienced patients.
Aktivnost ostalih inhibitora proteaze kod izoliranih sojeva koji su razvili pojačanu otpornost na lopinavir nakon terapije lijekom Kaletra u bolesnika koji su već uzimali inhibitore proteaze: Prisutnost križne rezistencije na druge inhibitore proteaze je analizirana u 18 izoliranih sojeva u bolesnika s ponovnim porastom broja virusa.
Package leaflet: Information for the user Kaletra (80 mg + 20 mg) / ml oral solution
Uputa o lijeku: Informacije za korisnika Kaletra (80 mg + 20 mg) / ml oralna otopina
Children less than 14 days of age and premature neonates Kaletra oral solution should not be administered to neonates before a postmenstrual age (first day of the mother's last menstrual period to birth plus the time elapsed after birth) of 42 weeks and a postnatal age of at least 14 days has been reached (see section 4.4).
Kaletra oralna otopina ne smije se davati novorođenčadi koja nije dosegla postmenstrualnu dob (razdoblje od prvog dana posljednje majčine mjesečnice do poroda plus vrijeme nakon poroda) od
In the absence and presence of 50% human serum, the mean IC50 of lopinavir against HIV-1IIIB in MT4 cells was 17 nM and 102 nM, respectively.
U odsutnosti i prisutnosti 50 % ljudskog seruma, srednje vrijednosti IC50 lopinavira prema HIV-1IIIB u stanicama MT4 iznosile su, redom, 17 nM i 102 nM.
Antiviral activity of Kaletra 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 Kaletra 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 lijekom Kaletra u odnosu na početni virusni genotip i fenotip u 56 bolesnika koji prethodno nisu reagirali na terapiju s više inhibitora proteaze.
You must not take Kaletra with colchicine if you have kidney and/or liver problems (see also ‘Do not take Kaletra' above);
Ne smijete uzimati lijek Kaletra s kolhicinom ako imate tegobe s bubrezima i/ili jetrom (pogledajte i dio
Due to BCRP (breast cancer resistance protein/ABCG2) and acute P-gp inhibition by lopinavir/ritonavir.
Zbog inhibicije proteina rezistencije raka dojke (engl. breast cancer resistant protein, BCRP/ABCG2) i akutne inhibicije P-gp-a lopinavirom/ritonavirom.
Through 360 weeks of treatment, genotypic analysis of viral isolates was successfully conducted in 19 of 28 patients with confirmed HIV RNA above 400 copies/ml revealed no primary or active site mutations in protease (amino acids at positions 8, 30, 32, 46, 47, 48, 50, 82, 84 and 90) or protease inhibitor phenotypic resistance.
Kroz 360 tjedana liječenja, genotipska analiza virusnih izolata, koja je uspješno provedena u 19 od 28 bolesnika kod kojih je potvrđen HIV RNK iznad 400 kopija/ml otkrila je nepostojanje primarnih mutacija ili mutacija aktivnog mjesta u proteazi (amino kiseline na pozicijama 8, 30, 32, 46, 47, 48, 50, 82, 84 i 90) ili fenotipsku rezistenciju inhibitora proteaze.
Patients taking the oral solution, particularly those with renal impairment or with decreased ability to metabolise propylene glycol (e.g. those of Asian origin), should be monitored for adverse reactions potentially related to propylene glycol toxicity (i.e. seizures, stupor, tachycardia, hyperosmolarity, lactic acidosis, renal toxicity, haemolysis) (see section 4.3).
Bolesnike koji uzimaju oralnu otopinu, napose one s oštećenjem funkcije bubrega ili smanjenom sposobnošću metaboliziranja propilenglikola (npr. bolesnici azijskog podrijetla), potrebno je nadzirati zbog mogućih nuspojava povezanih s toksičnošću propilenglikola (npr. napadaji, stupor, tahikardija,
• fusidic acid used to treat long-term infections of the bones and joints (e.g. osteomyelitis);
• fusidatna kiselina koja se koristi za liječenje dugotrajnih infekcija kostiju i zglobova (npr.
PR interval prolongation
Produljenje PR intervala
Monitor for ADRs related to afatinib.
Nadzirati bolesnike zbog mogućih nuspojava povezanih s afatinibom.
Increased plasma concentrations of paritaprevir; thereby, increasing the risk of alanine transaminase (ALT) elevations (see section 4.5).
Povišena koncentracija paritaprevira u plazmi; time je povišen rizik od porasta vrijednosti alanin transaminaze (ALT) (vidjeti dio 4.5).
The lopinavir mean steadystate AUC, Cmax, and Cmin were 72.6 ± 31.1 µg•h/ml, 8.2 ± 2.9 µg/ml and 3.4 ± 2.1 µg/ml, respectively after Kaletra oral solution 230/57.5 mg/m2 twice daily without nevirapine (n=12), and were 85.8 ± 36.9 µg•h/ml, 10.0 ± 3.3 µg/ml and 3.6 ± 3.5 µg/ml, respectively after 300/75 mg/m2 twice daily with nevirapine (n=12).
Srednje vrijednosti AUC, Cmax, i Cmin lopinavira u ravnotežnom stanju pri uzimanju Kaletra oralne otopine u dozi od 230/57,5 mg/m² dvaput na dan bez nevirapina (n=12) iznosile su, redom, 72,6 ± 31,1 µg•h/ml, 8,2 ± 2,9 µg/ml i 3,4 ± 2,1 µg/ml, dok su pri uzimanju Kaletra oralne otopine u dozi od 300/75 mg/m² dvaput na dan s nevirapinom (n=12) iznosile, redom, 85,8 ± 36,9 µg•h/ml, 10,0 ± 3,3 µg/ml i 3,6 ± 3,5 µg/ml.
Both treatment arms included zidovudine 180 mg/m2 every 12 hours and lamivudine 4 mg/kg every 12 hours.
180 mg/m2 svakih 12 sati te lamivudin u dozi od 4 mg/kg svakih 12 sati.
The median fold IC50 of lopinavir for these 18 isolates at baseline and rebound was 6.9- and 63-fold, respectively, compared to wild type virus.
Medijan povećanja IC50 lopinavira za ovih 18 izoliranih sojeva na početku i nakon ponovnog porasta broja virusa bio je povećanje od 6,9 puta odnosno 63 puta u odnosu na divlji soj virusa.
How should I dispose of any unused Kaletra?
Kako treba ukloniti preostalu lijek Kaletra?
≥ 0.9 to < 1.4
≥ 0,9 do < 1,4
• In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
• Nakon početka uzimanja lijeka za liječenje Vaše infekcije HIV-om, uz oportunističke infekcije dodatno se mogu pojaviti autoimuni poremećaji (stanja koja se događaju kada imunološki sustav napadne zdravo tkivo).
HCV direct acting antivirals Elbasvir/grazoprevir (50/200 mg QD)
Elbasvir/grazoprevir (50/200 mg QD)
Concomitant use of Kaletra with lomitapide is contraindicated (see prescribing information for lomitapide) (see section 4.3).
Istodobna primjena lijeka Kaletra i lomitapida je kontraindicirana (vidjeti sažetak opisa svojstava lijeka za lomitapid) (vidjeti dio 4.3).
The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients (see sections 4.4 and 5.1).
Izbor lijeka Kaletra za liječenje osoba s HIV-1 infekcijom, koje su prethodno primale inhibitor proteaze, mora se zasnivati na provjeri individualne virusne rezistencije i povijesti liječenja bolesnika
Uncommon Atherosclerosis such as myocardial infarction1, atrioventricular block, tricuspid valve incompetence
Manje često Ateroskleroza kao što je infarkt miokarda1, atrioventrikularni blok, insuficijencija trikuspidalne valvule
Monitor for ADRs related to abemaciclib.
Nadzirati bolesnike zbog mogućih nuspojava povezanih s abemaciklibom.
A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with Kaletra is required.
Ukoliko je potrebno liječenje lijekom Kaletra kod bolesnika s normalnom funkcijom bubrega ili jetre, preporučuje se smanjenje doze kolhicina ili prekid liječenja kolhicinom.
The combination of Kaletra with: - tadalafil, indicated for the treatment of pulmonary arterial hypertension, is not recommended
- tadalafilom, indiciranim za liječenje plućne arterijske hipertenzije, se ne preporučuje (vidjeti dio
Herbal preparations containing St John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of lopinavir and ritonavir (see section 4.5).
Biljni pripravci koji sadrže gospinu travu (Hypericum perforatum) ne smiju se uzimati za vrijeme primjene lopinavira i ritonavira zbog rizika od smanjenja koncentracije lopinavira i ritonavira u plazmi, a time i slabljenja njihovih kliničkih učinaka (vidjeti dio 4.5).
Anti-gout agents Colchicine single dose
Lijekovi protiv gihta Kolhicin u jednokratnoj dozi
Marked triglyceride elevation is a risk factor for development of pancreatitis.
Izrazito povišena razina triglicerida čimbenik je rizika nastanka pankreatitisa.
Colloidal anhydrous silica, copovidone, sodium stearyl fumarate, sorbitan laurate.
Bezvodni, koloidni silicijev dioksid, kopovidon, natrijev stearilfumarat, sorbitanlaurat.
Carton of blister pack containing 120 200 mg/50 mg film-coated tablets
Kutija s blister pakiranjem koje sadrži 120 filmom obloženih tableta od 200 mg/50 mg
Rivaroxaban:
Rivaroksaban:
In the QD group,
uključujući QT prolongaciju,
• haemorrhoids;
• upala gušterače;
Concomitant use of sildenafil prescribed for the treatment of pulmonary arterial hypertension with Kaletra is contraindicated (see section 4.3).
Istodobna primjena sildenafila propisanog zbog liječenja plućne arterijske hipertenzije zajedno s lijekom Kaletra je također kontraindicirana (vidjeti dio 4.3).
How to store Kaletra
Kako čuvati lijek Kaletra
If the benefit outweighs the risk, co-administration of bedaquiline with Kaletra must be done with caution.
Ukoliko korist nadmašuje rizik, bedakilin se istodobno s lijekom Kaletra mora primjenjivati s oprezom.
(Lopinavir/ritonavir 400/100 mg BID, multiple dose)
(Lopinavir/ritonavir 400/100 mg BID, višestruke doze)
The recommended dosage of Kaletra is 5 ml of oral solution (400/100 mg) twice daily taken with food.
Odrasli i adolescenti Preporučena doza lijeka Kaletra je 5 ml oralne otopine (400/100 mg) dvaput na dan uz jelo.
* intent to treat analysis where patients with missing values are considered virologic failures Paediatric Use
* analiza svih bolesnika koji su predviđeni za liječenje u ispitivanju (engl. intent to treat analysis), u kojoj su bolesnici s nedostajućim vrijednostima smatrani kao virološki neuspjeh
Please refer to the Aptivus Summary of Product Characteristics for additional information on the use of tipranavir, including genotypic predictors of response, in treatment of lopinavir-resistant HIV-1 infection.
Za detaljnije podatke o primjeni tipranavira, uključujući genotipske prediktore odgovora, u terapiji HIV-1 infekcija otpornih na lopinavir, pogledati sažetak opisa svojstava lijeka za Aptivus.
Rare reports of 2nd or 3rd degree atroventricular block in patients with underlying structural heart disease and pre-existing conduction system abnormalities or in patients receiving drugs known to prolong the PR interval (such as verapamil or atazanavir) have been reported in patients receiving lopinavir/ritonavir.
U bolesnika koji su uzimali lopinavir/ritonavir zabilježeni su rijetki slučajevi AV bloka drugog i trećeg stupnja u bolesnika s podležećom strukturalnom bolesti srca i prethodno prisutnim poremećajem sustava provođenja impulsa u srcu ili u bolesnika koji su uzimali lijekove za koje je poznato da izazivaju prolongaciju PR intervala (poput verapamila ili atazanavira).
Includes: alcohol, high fructose corn syrup, propylene glycol, glycerol, polyoxyl 40 hydrogenated castor oil, potassium (as acesulfame potassium).
Sadrži: alkohol, kukuruzni sirup bogat fruktozom, propilenglikol, glicerol, polioksil 40 hidrogenirano ricinusovo ulje, kalij (u obliku acesulfamkalija).
Alcohol, high fructose corn syrup, propylene glycol, purified water, glycerol, povidone, magnasweet110 flavour (mixture of monoammonium glycyrrhizinate and glycerol), vanilla flavour (containing p-hydroxybenzoic acid, p-hydroxybenzaldehyde, vanillic acid, vanillin, heliotropin, ethyl vanillin), polyoxyl 40 hydrogenated castor oil, cotton candy flavour (containing ethyl maltol, ethyl vanillin, acetoin, dihydrocoumarin, propylene glycol), acesulfame potassium, saccharin sodium, sodium chloride, peppermint oil, sodium citrate, citric acid, levomenthol.
pročišćena voda glicerol povidon okus Magnasweet 110 (mješavina monoamonijevog glicerizinata i glicerola) okus vanilije (sadrži p-hidroksibenzoatnu kiselinu, p-hidroksibenzaldehid, vanilinsku kiselinu, vanilin, heliotropin, etilvanilin) polioksil 40 hidrogenirano ricinusovo ulje okus Cotton candy (sadrži etilmaltol, etilvanilin, acetoin, dihidrokumarin, propilenglikol) acesulfamkalij saharinnatrij natrijev klorid eterično ulje paprene metvice natrijev citrat citratna kiselina levomentol
Caution should be exercised in administering Kaletra with bosentan.
Oprez je nužan kada se Kaletra primjenjuje s bosentanom.
Refer to the afatinib SmPC for dosage adjustment recommendations.
Vidjeti sažetak opisa svojstava lijeka za afatinib za preporuke vezane uz prilagodbu doze.
Maximum PR interval was 286 ms and no second or third degree heart block was observed (see section 4.4).
a srčani blok drugog ili trećeg stupnja nije primijećen (vidjeti dio 4.4).
AUC: ↑ 49-fold
Vardenafil: AUC: ↑ 49 puta
No age or gender related pharmacokinetic differences have been observed in adult patients.
U odraslih bolesnika nisu uočene razlike u farmakokinetici s obzirom na dob ni s obzirom na spol.
Modest decreases in amprenavir activity were noted with a median increase of IC50 from 3.7- to 8-fold in the baseline and rebound isolates, respectively.
Umjerena sniženja aktivnosti amprenavira su primijećena s medijanom porasta IC50 od 3,7 puta u sojeva izoliranih na početku do 8 puta u sojeva izoliranih nakon ponovnog porasta broja virusa.
Increased plasma concentrations of lomitapide (see section 4.5).
Povišene koncentracije lomitapida u plazmi (vidjeti dio 4.5).
Store in a refrigerator (2°C - 8°C).
6.4 Posebne mjere pri čuvanju lijeka Čuvati u hladnjaku (2°C - 8°C).
Lomitapide
Lomitapid
Age ≥ 6 months to < 12 years cohort (N = 53):
Kohorta u dobi od ≥ 6 tjedana do < 6 mjeseci (N = 18): Kohorta u dobi od ≥ 6 mjeseci do < 12 godina (N = 53):
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 200 mg/50 mg Tablets - Carton of multipack containing 360 (3 bottles of 120) film-coated tablets - including blue box
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU 200 mg/50 mg tablete - Kutija višestrukog pakiranja od 360 (3 boce od 120) filmom obloženih tableta - uključujući plavi okvir
Lipid-modifying agents Lomitapide
Lijekovi koji modificiraju lipide Lomitapid
Increased plasma concentrations of pimozide.
Povišena koncentracija pimozida u plazmi.
Talc
AUC
Voriconazole
Vorikonazol
Тел.
Tijelo
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.
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.
• allergic reactions including hives and inflammation in the mouth;
• upala jetre uključujući povišenje jetrenih enzima; • alergijske reakcije uključujući koprivnjaču i upale u ustima;
120 ml (2 bottles x 60 ml) oral solution with two 2 ml oral dosing syringes.
120 ml (2 boce x 60 ml) oralne otopine i 2 štrcaljke od 2 ml za primjenu kroz usta.
No dose adjustment necessary.
Nije potrebno prilagođavanje doze.
• If you have any further questions, ask your doctor or pharmacist.
Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
The median EC50 of lopinavir against isolates with 0 − 3, 4 − 5, 6 − 7 and 8 − 10 mutations at the above amino acid positions was 0.8, 2.7 13.5 and 44.0-fold higher than the EC50 against wild type HIV, respectively.
− 3, 4 − 5, 6 − 7 i 8 − 10 mutacija na mjestima gore navedenih aminokiselina bio je, redom, 0,8; 2,7; 13,5 i 44,0 puta veći u odnosu na EC50 prema divljem tipu HIV-a.
Rivaroxaban (Ritonavir 600 mg twice daily)
Rivaroksaban (Ritonavir 600 mg dvaput na dan)
Fusidic Acid
Fusidatna kiselina
PARTICULARS TO APPEAR ON THE INTERMEDIATE CARTON Inner carton of multipack of 120 (3 packs of 40) 200 mg/50 mg film-coated tablets) - without blue box
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJOJ KUTIJI Unutarnja kutija višestrukog pakiranja od 120 (3 pakiranja od 40) 200 mg/50 mg filmom obloženih tableta - bez plavog okvira
Unsuitable in hereditary fructose intolerance.
Nije prikladno za primjenu u osoba s nasljednim nepodnošenjem fruktoze.
Concomitant use of neratinib with Kaletra is contraindicated due to serious and/or life-threatening potential reactions including hepatotoxicity (see section 4.3).
Istodobna primjena neratiniba i lijeka Kaletra je kontraindicirana zbog ozbiljnih i/ili po život opasnih mogućih reakcija, uključujući hepatotoksičnost (vidjeti dio 4.3).
Thereby, increasing the risk of arrhythmias or other serious adverse reactions (see section 4.5).
Time je povišen rizik od aritmija ili ostalih ozbiljnih nuspojava (vidjeti dio 4.5).
Study M05-730 was a randomised, open-label, multicentre trial comparing treatment with Kaletra 800/200 mg once daily plus tenofovir DF and emtricitabine versus Kaletra 400/100 mg twice daily plus tenofovir DF and emtricitabine in 664 antiretroviral treatment-naïve patients.
Studija M05-730 je bila randomizirano, otvoreno (''open-label''), multicentrično ispitivanje, u kojem se uspoređivalo liječenje lijekom Kaletra 800/200 mg jednom dnevno u kombinaciji s tenofovirom DF i emtricitabinom naspram lijeka Kaletra 400/100 mg dva puta dnevno plus tenofovir DF i emtricitabin u 664 bolesnika koji prethodno nisu koristili antiretrovirusnu terapiju.
See adult dosage recommendation *weight based dosing recommendations are based on limited data ** the volume (ml) of oral solution represents the average dose for the weight range
Vidjeti preporuke za doziranje u odraslih *doziranje na osnovu težine je temeljeno na ograničenim podacima
Not known Stevens-Johnson syndrome, erythema multiforme
Manje često Alopecija, kapilaritis, vaskulitis Nepoznato Stevens-Johnsonov sindrom, erythema multiforme
Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
korištenje alkohola, jaku imunosupresiju, viši indeks tjelesne mase) zabilježeni su slučajevi osteonekroze osobito u bolesnika koji imaju uznapredovalu HIV bolest i/ili su bili dugoročno izloženi kombiniranoj antiretrovirusnoj terapiji (CART).
HIV RNA < 50 copies/ml
HIV RNK < 50 kopija/ml
− If you notice you miss a dose within 6 hours of your normal dosing time, take your missed dose as soon as possible, and then continue with your normal dose at the regular time as prescribed by your doctor.
- Ako unutar 6 sati od vremena kada ste trebali uzeti lijek primijetite da ste propustili uzeti jednu dozu, što prije uzmite propuštenu dozu, a potom nastavite uzimati lijek prema uobičajenom rasporedu kako Vam je propisao Vaš liječnik.
The efficacy data favouring the twice-daily regimen are reinforced by a differential in pharmacokinetic parameters significantly favouring the twice-daily regimen (see section 5.2).
Podaci o učinkovitosti govore u prilog doziranju dvaput na dan kao i razlike u farmakokinetičkim parametrima koji značajno govore u prilog doziranju dvaput na dan
Increased plasma concentrations of amiodarone and dronedarone.
Povišena koncentracija amiodarona i dronedarona u plazmi.
HIV-1 isolates with reduced susceptibility to lopinavir have been selected in vitro.
Izdvojeni su izolati HIV-a 1 sa smanjenom osjetljivošću na lopinavir in vitro.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Oral solution - Carton containing 120 ml (2 bottles x 60 ml) oral solution
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Oralna otopina - Kutija koja sadrži 120 ml (2 boce x 60 ml) oralne otopine
Increased plasma concentrations of avanafil (see sections 4.4 and 4.5).
Povišena koncentracija avanafila u plazmi (vidjeti dijelove 4.4 i 4.5).
Phenytoin:
Fenitoin:
Colchicine
Kolhicin
Concentrations may be decreased due to CYP3A induction by carbamazepine and phenobarbital.
Koncentracije mogu biti smanjene zbog indukcijskog učinka karbamazepina i fenobarbitala na CYP3A.
Steady-state concentrations was moderately decreased due to CYP2C9 and CYP2C19 induction by lopinavir/ritonavir.
Koncentracije u stanju dinamičke ravnoteže umjereno su se smanjile zbog indukcijskog učinka lopinavira/ritonavira na CYP2C9 i CYP2C19.
Caution should be exercised in administering afatinib with Kaletra.
Potreban je oprez kada se afatinib primjenjuje zajedno s lijekom Kaletra.
The concomitant administration with lurasidone is contraindicated (see section 4.3).
Istodobna primjena s lurasidonom je kontraindicirana (vidjeti dio 4.3).
Increased plasma concentrations of venetoclax.
Povišena koncentracija venetoklaksa u plazmi.
• nausea;
• mučnina;
Increased plasma concentrations of quetiapine which may lead to coma.
Povišena koncentracija kvetiapina u plazmi, što može dovesti do kome.
Table 6
Tablica 6
It is not recommended to co-administer Kaletra and sofosbuvir/velpatasvir/ voxilaprevir.
Ne preporučuje se istodobna primjena lijeka Kaletra i sofosbuvira/velpatasvira/voksilapre vira.
Includes: alcohol (42 % v/v see leaflet), high fructose corn syrup, propylene glycol, glycerol, polyoxyl 40 hydrogenated castor oil, potassium (as acesulfame potassium).
Sadrži: alkohol (42 % V/V vidjeti uputu o lijeku), kukuruzni sirup bogat fruktozom, propilenglikol, glicerol, polioksil 40 hidrogenirano ricinusovo ulje, kalij (u obliku acesulfamkalija).
Ethinyl Oestradiol: ↓
Etinilestradiol: ↓
The pharmacokinetics of Kaletra oral solution 300/75 mg/m2 twice daily and 230/57.5 mg/m2 twice daily have been studied in a total of 53 paediatric patients, ranging in age from 6 months to 12 years.
Farmakokinetika Kaletra oralne otopine u dozi od 300/75 mg/m² dvaput na dan i 230/57,5 mg/m² dvaput na dan ispitana je u ukupno 53 pedijatrijska bolesnika u dobi od 6 mjeseci do 12 godina.
Adultc a. Kaletra oral solution 230/57.5 mg/m2 twice daily regimen without nevirapine b. Kaletra oral solution 300/75 mg/m2 twice daily regimen with nevirapine c. Kaletra film-coated tablets 400/100 mg twice daily at steady state
Režim liječenja Kaletra oralnom otopinom u dozi od 230/57,5 mg/m2 dvaput na dan bez nevirapina b. Režim liječenja Kaletra oralnom otopinom u dozi od 300/75 mg/m2 dvaput na dan u kombinaciji s nevirapinom c. Kaletra filmom obložene tablete u dozi od 400/100 mg dvaput na dan u stanju dinamičke ravnoteže
• weight gain.
• povećanje tjelesne težine.
300 ml (5 bottles x 60 ml) oral solution with five 5 ml oral dosing syringes.
300 ml (5 boca x 60 ml) oralne otopine i 5 štrcaljki od 5 ml za primjenu kroz usta.
Erectile dysfunction, menstrual disordersamenorrhoea, menorrhagia
Erektilna disfunkcija, poremećaj menstrualnog ciklusa - amenoreja, menoragija