natgillin/translations-raw huggingface dataset:
Atazanavir Mylan 150 mg hard capsules Atazanavir Mylan 200 mg hard capsules Atazanavir Mylan 300 mg hard capsules atazanavir
Atazanavir Mylan 150 mg tvrde kapsule Atazanavir Mylan 200 mg tvrde kapsule Atazanavir Mylan 300 mg tvrde kapsule atazanavir
(atazanavir 400 mg once daily)
(atazanavir 400 mg jedanput na dan)
How to take Atazanavir Mylan
Kako uzimati Atazanavir Mylan
Hyperbilirubinaemia (an increase in the level of bilirubin in the blood) has occurred in patients receiving atazanavir.
U bolesnika koji uzimaju atazanavir može nastati hiperbilirubinemija (povišena razina bilirubina u krvi).
Atazanavir Mylan 200 mg capsules are blue and greenish-blue opaque hard shell gelatin capsules filled with white to pale yellow powder and approximately 21.4 mm in length.
Atazanavir Mylan 200 mg kapsule su plave i zelenkastoplave neprozirne tvrde želatinske kapsule punjene bijelim do blijedožutim praškom i duljine približno 21,4 mm.
however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Međutim, vrijeme prijave pojave tih bolesti je vrlo varijabilno jer se mogu dogoditi i više mjeseci nakon početka liječenja.
Iron oxide yellow (E172) Iron oxide red (E172) Titanium dioxide (E171) Gelatin
Žuti željezov oksid (E172) Crveni željezov oksid (E172) Titanijev dioksid (E171) Želatina
Tel: +386 1 236 31 85
GSP Proizvodi d.o.o. Tel: +386 1 236 31 85
Atazanavir Mylan 300 mg capsules are red and greenish-blue opaque hard shell gelatine capsules filled with white to pale yellow powder and approximately 23.5 mm in length.
Atazanavir Mylan 300 mg kapsule su crvene i zelenkastoplave neprozirne tvrde želatinske kapsule punjene bijelim do blijedožutim praškom i duljine približno 23,5 mm.
Treatment-Naive Atazanavir Capsules/ritonavir (300 mg/100 mg once daily) n=16
Bolesnici koji prethodno nisu bili liječeni kapsulama atazanavira i ritonavirom (300 mg/100 mg jedanput na dan) n=16
No dosage adjustment is needed in patients with renal impairment.
U bolesnika s oštećenjem bubrega nije potrebna prilagodba doze.
Pravastatin is not metabolised by CYP3A4.
Pravastatin se ne metabolizira putem enzima CYP3A4.
Atazanavir Mylan 200 mg hard capsules are blue and greenish-blue opaque capsules with ‘MYLAN' over ‘AR200' printed in black ink on cap and body.
Atanazavir Mylan 200 mg tvrde kapsule su plave i zelenkastoplave neprozirne kapsule na kojima je otisnuto „MYLAN” iznad „AR200” crnom tintom na kapici i tijelu.
The mechanism of the clarithromycin/atazanavir interaction is CYP3A4 inhibition.
Mehanizam interakcije klaritromicin/atazanavir je inhibicija CYP3A4.
It inhibits CYP3A4.
Atazanavir inhibira enzim CYP3A4.
* In a combined analysis, atazanavir 300 mg and ritonavir 100 mg (n=33) was compared to
* U kombiniranoj analizi, atazanavir 300 mg s ritonavirom 100 mg (n=33) uspoređen je s atazanavirom 400 mg bez ritonavira (n=28).
Atazanavir Mylan 150 mg hard capsules Atazanavir Mylan 200 mg hard capsules Atazanavir Mylan 300 mg hard capsules
Atazanavir Mylan 150 mg tvrde kapsule Atazanavir Mylan 200 mg tvrde kapsule Atazanavir Mylan 300 mg tvrde kapsule
The capsule shell and printing ink contain iron oxide red (E172), titanium dioxide (E171), patent blue V (E131), gelatin, shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E172), potassium hydroxide.
Ovojnica kapsule i tinta za označavanje sadrže crveni željezov oksid (E172), titanijev dioksid (E171), boju patent blue V (E131), želatinu, šelak, propilenglikol, koncentriranu otopinu amonijaka, crni željezov oksid (E172), kalijev hidroksid.
Co-administration with atazanavir may result in increased concentrations of salmeterol and an
Istovremena primjena s atazanavirom može rezultirati povišenim koncentracijama salmeterola i pojačanim nuspojavama povezanima sa salmeterolom.
The mechanism of this interaction is CYP3A4 inhibition.
Mehanizam ove interakcije je inhibicija enzima CYP3A4.
Body Weight (kg)
(kg)
How to store Atazanavir Mylan
Kako čuvati Atazanavir Mylan
The mechanism of interaction between atazanavir and ritonavir is CYP3A4 inhibition.
Mehanizam interakcije između atazanavira i ritonavira je inhibicija enzima CYP3A4.
Nephrolithiasis has been reported in patients receiving atazanavir (see section 4.8).
U bolesnika koji primaju atazanavir zabilježena je nefrolitijaza (vidjeti dio 4.8).
Cholelithiasis has been reported in patients receiving atazanavir (see section 4.8).
U bolesnika koji primaju atazanavir zabilježena je kolelitijaza (vidjeti dio 4.8).
Co-administration of alfuzosin with atazanavir is contraindicated (see section 4.3)
Istovremena primjena alfuzosina i atazanavira je kontraindicirana (vidjeti dio 4.3)
3) and the mean baseline plasma HIV-1 RNA level was 4.4 log10 copies/ml (range: 2.6 to 5.88 log10 copies/ml).
3), a prosječna početna vrijednost HIV 1 RNK u plazmi bila je 4,67 log10 kopija/ml (raspon: 3,70 do 5,00 log10 stanica/ml).
CARDIOVASCULAR AGENTS Antiarrhythmics
KARDIOVASKULARNI LIJEKOVI
Atazanavir Mylan 300 mg hard capsules are red and greenish-blue opaque capsules with ‘MYLAN' over ‘AR300' printed in black ink on cap and body.
Atanazavir Mylan 300 mg tvrde kapsule su crvene i zelenkastoplave neprozirne kapsule na kojima je otisnuto „MYLAN” iznad „AR300” crnom tintom na kapici i tijelu.
The capsules are axially printed with ‘MYLAN' over ‘AR150' in black ink on cap and body.
Na kapsulama je uzduž osi otisnuto „MYLAN” iznad „AR150” crnom tintom na kapici i tijelu.
Ritonavir is used as a booster of atazanavir pharmacokinetics (see sections 4.5 and 5.1).
Ritonavir se koristi kao pojačivač farmakokinetike atazanavira (vidjeti dijelove 4.5 i 5.1). (Vidjeti i 'Prekid primjene ritonavira samo pod restriktivnim uvjetima' u dijelu 4.4).
Atazanavir Mylan 150 mg hard capsules are greenish-blue and blue opaque capsules with ‘MYLAN' over ‘AR150' printed in black ink on cap and body.
Atanazavir Mylan 150 mg tvrde kapsule su zelenkastoplave i plave neprozirne kapsule na kojima je otisnuto „MYLAN” iznad „AR150” crnom tintom na kapici i tijelu.
Hepatic impairment
• bubrežni bolovi
Tacrolimus
Salmeterol
METHOD AND ROUTE OF ADMINISTRATION
NAČIN I PUT PRIMJENE LIJEKA
Stevens-Johnson syndrome (SJS), erythema multiforme, toxic skin eruptions and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported in patients receiving atazanavir.
U bolesnika koji primaju atazanavir zabilježeni su Stevens-Johnsonov sindrom (SJS), multiformni eritem, toksične kožne erupcije i medikamentozni osip s eozinofilijom i sistemskim simptomima (DRESS).
Serum concentrations of verapamil may be increased by atazanavir due to CYP3A4 inhibition.
Atazanavir može povisiti koncentracije verapamila u serumu zbog inhibicije enzima CYP3A4.
Atazanavir Mylan 150 mg capsules are greenish-blue and blue opaque hard shell gelatin capsules filled with white to pale yellow powder and approximately 19.3 mm in length.
Atazanavir Mylan 150 mg kapsule su zelenkastoplave i plave neprozirne tvrde želatinske kapsule punjene bijelim do blijedožutim praškom i duljine približno 19,3 mm.
The combination of Atazanavir Mylan with atorvastatin is not recommended (see section 4.5).
Ne preporučuje se istovremena primjena lijeka Atazanavir Mylan s atorvastatinom (vidjeti dio 4.5).
Co-administration of nevirapine and atazanavir is not recommended (see section 4.4)
Ne preporučuje se istovremena primjena nevirapina i atazanavira (vidjeti dio 4.4)
(400 mg/ 100 mg twice daily) n=123
100 mg dvaput na dan) n=123
The Summary of Product Characteristics for ritonavir must be consulted before initiation of therapy with Atazanavir Mylan and ritonavir.
Prije početka terapije lijekom Atazanavir Mylan i ritonavirom potrebno je pročitati Sažetak opisa svojstava lijeka za ritonavir.
Ritonavir may decrease plasma levels of phenytoin and/or phenobarbital due to CYP2C9 and
Zbog indukcije CYP2C9 i CYP2C19, primjena ritonavira može sniziti razine fenitoina i/ili fenobarbitala u plazmi.
Nephrolithiasis
Nefrolitijaza
For patients who are taking tenofovir disoproxil fumarate,
Kod bolesnika koji ne uzimaju tenofovir, ako se atazanavir
The mechanism of interaction is CYP3A4 inhibition.
Mehanizam interakcije je inhibicija enzima CYP3A4.
Co-administration of efavirenz and atazanavir is not recommended (see section 4.4)
Ne preporučuje se istovremena primjena efavirenza i atazanavira (vidjeti dio 4.4)
In HIV-infected patients with atazanavir/ritonavir at the recommended dose 300/100 mg once daily
Primjena atazanavira/ritonavira u preporučenoj dozi od 300/100 mg jedanput na dan u bolesnika zaraženih HIV-om
The capsules are axially printed with ‘MYLAN' over ‘AR200' in black ink on cap and body.
Na kapsulama je uzduž osi otisnuto „MYLAN” iznad „AR200” crnom tintom na kapici i tijelu.
Voriconazole 200 mg twice daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Vorikonazol 200 mg dvaput na dan (atazanavir 300 mg i ritonavir 100 mg jedanput na dan)
Capsule shell body 150 mg
Želatina Tijelo kapsule od 150 mg
Atazanavir Mylan with ritonavir must not be used in patients with moderate to severe hepatic impairment (see sections 4.3, 4.4, and
Atazanavir Mylan s ritonavirom ne smije se primjenjivati u bolesnika s umjerenim do teškim oštećenjem funkcije jetre (vidjeti dijelove 4.3, 4.4 i 5.2).
OPA/Aluminium/PVC - Aluminium blisters containing 30, 30 x 1 (unit dose) capsules.
OPA/aluminij/PVC - aluminijski blisteri koji sadrže 30, 30 x 1 (jedinična doza) kapsula.
The capsules are axially printed with ‘MYLAN' over ‘AR300' in black ink on cap and body.
Na kapsulama je uzduž osi otisnuto „MYLAN” iznad „AR300” crnom tintom na kapici i tijelu.
Clarithromycin Cmin ↑160%
Klaritromicin Cmin ↑160% (↑135%
Co-administration of salmeterol with atazanavir is not recommended (see section 4.4).
Ne preporučuje se istovremena primjena salmeterola i atazanavira (vidjeti dio 4.4).
OPA/Aluminium/PVC - Aluminium blisters containing 60, 60 x 1 (unit dose) capsules.
OPA/aluminij/PVC - aluminijski blisteri koji sadrže 60, 60 x 1 (jedinična doza) kapsula.
BOTTLE LABEL FOR 150 MG HARD CAPSULES
NALJEPNICA NA BOCI ZA TVRDE KAPSULE OD 150 MG
(atazanavir 400 mg once daily with ritonavir 200 mg once daily)
(atazanavir 400 mg jedanput na dan s ritonavirom 200 mg jedanput na dan)
Capsule shell cap 150 mg
Kapica kapsule od 150 mg
Voriconazole 50 mg twice daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Vorikonazol 50 mg dvaput na dan (atazanavir 300 mg i ritonavir 100 mg jedanput na dan)
• dyspnoea (shortness of breath)
• otežano disanje (nedostatak zraka)
Co-administration of atazanavir and elbasvir/grazoprevir is contraindicated because of a significant increase in grazoprevir plasma concentrations and an associated
Istodobna primjena atazanavira i elbasvira/grazoprevira je kontraindicirana zbog značajnog povišenja koncentracije grazoprevira u plazmi te povezanim mogućim povećanjem rizika povišenja ALT-a (vidjeti dio 4.3).
BLISTER CARTON FOR 200 MG HARD CAPSULES
KUTIJA BLISTERA ZA TVRDE KAPSULE OD 200 MG
Atazanavir Mylan 150 mg hard capsules atazanavir
Atazanavir Mylan 150 mg tvrde kapsule atazanavir
Atazanavir Mylan 200 mg hard capsules
Atazanavir Mylan 200 mg tvrde kapsule
BLISTER CARTON FOR 150 MG HARD CAPSULES
KUTIJA BLISTERA ZA TVRDE KAPSULE OD 150 MG
Capsule shell body 300 mg
Tijelo kapsule od 300 mg
Atazanavir Mylan 150 mg hard capsules
Atazanavir Mylan 150 mg tvrde kapsule
Atazanavir Mylan with ritonavir is contraindicated in patients with moderate hepatic insufficiency (see sections 4.2, 4.4 and 5.2).
Primjena lijeka Atazanavir Mylan u kombinaciji s ritonavirom kontraindicirana je u bolesnika s umjerenom insuficijencijom jetre (vidjeti dijelove 4.2, 4.4 i 5.2).
BOTTLE CARTON FOR 150 MG HARD CAPSULES
KUTIJA BOCE ZA TVRDE KAPSULE OD 150 MG
Capsule shell cap 200 mg
Kapica kapsule od 200 mg
Atazanavir Mylan with ritonavir is not recommended in patients undergoing haemodialysis (see sections 4.4 and 5.2).
Ne preporučuje se primjenjivati Atazanavir Mylan s ritonavirom u bolesnika na hemodijalizi (vidjeti dijelove 4.4 i 5.2).
Capsule shell body 200 mg
Tijelo kapsule od 200 mg
PVC/PVDC/Aluminium blisters containing 30, 60, 60 x 1 (unit dose) capsules.
PVC/PVDC/aluminijski blisteri koji sadrže 30, 60, 60 x 1 (jedinična doza) kapsula.
Kidney stones have been reported in patients taking atazanavir.
U bolesnika koji uzimaju atazanavir zabilježeni su bubrežni kamenci.
Atazanavir Mylan 200 mg hard capsules atazanavir
Atazanavir Mylan 200 mg tvrde kapsule atazanavir
Atazanavir Mylan 300 mg hard capsules
Atazanavir Mylan 300 mg tvrde kapsule
Iron oxide red (E172) Titanium dioxide (E171) Patent blue V (E131) Gelatin
Crveni željezov oksid (E172) Titanijev dioksid (E171) Boja Patent blue V (E131) Želatina
Iron oxide yellow (E172) Titanium dioxide (E171) Patent blue V (E131) Gelatin
Žuti željezov oksid (E172) Titanijev dioksid (E171) Boja Patent blue V (E131) Želatina
The mechanism of nevirapine/atazanavir interaction is CYP3A4 induction.
Mehanizam interakcije između nevirapina i atazanavira je indukcija enzima CYP3A4.
Talk to your doctor immediately if you get symptoms of kidney stones which may include, pain in your low back or low stomach-area, blood in your urine or pain when you urinate.
• Manje često mogu se pojaviti bubrežni kamenci u osoba koje uzimaju Atazanavir Mylan . Odmah se obratite liječniku ako razvijete simptome bubrežnih kamenaca mogu uključivati bol u donjem dijelu leđa ili donjem dijelu trbuha, krv u mokraći ili bol pri mokrenju.
Atazanavir Mylan 300 mg hard capsules atazanavir
Atazanavir Mylan 300 mg tvrde kapsule atazanavir
Co-administration with bepridil is contraindicated (see section 4.3)
Istovremena primjena s bepridilom je kontraindicirana (vidjeti dio 4.3)
(atazanavir 300 mg/ritonavir 100 mg once daily)
(atazanavir 300 mg / ritonavir 100 mg jednom dnevno)
PVC/PVDC/Aluminium blisters containing 30, 30 x 1 (unit dose) capsules.
PVC/PVDC/aluminijski blisteri koji sadrže 30, 30 x 1 (jedinična doza) kapsula.
BLISTER CARTON FOR 300 MG HARD CAPSULES
KUTIJA BLISTERA ZA TVRDE KAPSULE OD 300 MG
BOTTLE LABEL FOR 300 MG HARD CAPSULES
NALJEPNICA NA BOCI ZA TVRDE KAPSULE OD 300 MG
• if you have type A or B haemophilia
• ako imate hemofiliju tipa
Capsules/ritonavir (300 mg/100 mg once daily) n=25
Bolesnici koji su prethodno bili liječeni kapsualama atazanavira i ritonavirom (300 mg/100 mg jedanput na dan) n=25
Caution should be exercised when verapamil is co-administered with atazanavir.
Potreban je oprez kad se verapamil primjenjuje istovremeno s atazanavirom.
Haemophiliac patients
Bolesnici s hemofilijom
PVC/PVDC/Aluminium blisters containing 60, 60 x 1 (unit dose) capsules.
PVC/PVDC/aluminijski blisteri koji sadrže 60, 60 x 1 (jedinična doza) kapsula.
Diltiazem Cmax ↑98% (↑78%
Diltiazem Cmax ↑98% (↑78% ↑119%) Diltiazem Cmin ↑142% (↑114%
The frequency of this is unknown (see section 4.4).
Mehanizam ovog smanjenja nije poznat. (Vidjeti dijelove 4.2 i 4.4)
BOTTLE LABEL FOR 200 MG HARD CAPSULES
NALJEPNICA NA BOCI ZA TVRDE KAPSULE OD 200 MG
Ethinyloestradiol AUC ↓19%
Etinilestradiol AUC ↓19% (↓25%
(300 mg/ 100 mg once daily) n=120
100 mg jedanput na dan) n=120
(atazanavir 400 mg once daily with ritonavir 100 mg once daily)
(atazanavir 400 mg jedanput na dan s ritonavirom 100 mg jedanput na dan)
uncommon: dyspnoea
manje često: ginekomastija
BOTTLE CARTON FOR 300 MG HARD CAPSULES
KUTIJA BOCE ZA TVRDE KAPSULE OD 300 MG
Each hard capsule contains 150 mg atazanavir (as sulphate).
Jedna tvrda kapsula sadrži 150 mg atazanavira (u obliku atazanavirsulfata).
Each hard capsule contains 200 mg atazanavir (as sulphate).
Jedna tvrda kapsula sadrži 200 mg atazanavira (u obliku atazanavirsulfata).
Each hard capsule contains 300 mg atazanavir (as sulphate).
Jedna tvrda kapsula sadrži 300 mg atazanavira (u obliku atazanavirsulfata).
Atazanavir/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Atazanavir/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tableti, jedanput na dan).
Capsule shell cap 300 mg
Kapica kapsule od 300 mg
Co-administration of atorvastatin with atazanavir is not recommended.
Ne preporučuje se istovremena primjena atorvastatina s atazanavirom.
OPIOIDS
LIJEKOVI
The mechanism of diltiazem/atazanavir interaction is CYP3A4 inhibition.
Mehanizam interakcije diltiazema s atazanavirom je inhibicija enzima CYP3A4.
Atazanavir Cmax ↑12% (↑1% ↑24%) Atazanavir Cmin ↑23% (↑13%
Atazanavir Cmax ↑12 % (↑1 % ↑24
In antiretroviral experienced adult patients
U odraslih bolesnika koji su prethodno bili liječeni antiretrovirusnim lijekovima
(atazanavir 300 mg once daily with ritonavir 100 mg once daily)
(atazanavir 300 mg jedanput na dan s ritonavirom 100 mg jedanput na dan)
Each capsule contains 200 mg atazanavir (as sulphate)
Jedna kapsula sadrži 200 mg atazanavira (u obliku atazanavirsulfata).
The mechanism of efavirenz/atazanavir interaction is CYP3A4 induction.
Mehanizam interakcije efavirenza s atazanavirom je indukcija CYP3A4.
Reporting of side effects
Preporuke kod istovremene primjene
25-O-desacetyl-rifabutin Cmax ↑677% (↑513% ↑883%) **
25-O-dezacetil -rifabutin Cmax ↑677%
Lopinavir/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Lopinavir/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tableti, jedanput na dan).
BOTTLE CARTON FOR 200 MG HARD CAPSULES
KUTIJA BOCE ZA TVRDE KAPSULE OD 200 MG
(atazanavir 300 mg and ritonavir 100 mg once daily)
(atazanavir 300 mg i ritonavir 100 mg jedanput na dan)
Each capsule contains 150 mg atazanavir (as sulphate)
Jedna kapsula sadrži 150 mg atazanavira (u obliku atazanavirsulfata).
ERECTILE DYSFUNCTION PDE5 Inhibitors Sildenafil, tadalafil, vardenafil
EREKTILNA DISFUNKCIJA Inhibitori PDE5
ATV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
ATV/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tabletama, jedanput na dan).
(range: 2 to 800 cells/ mm 3) and mean baseline plasma HIV 1 RNA was 4.67 log10 copies/ml (range: 3.70 to 5.00 log10 copies/ml).
(raspon od 2 do 810 stanica/mm i prosječna početna vrijednost HIV-1 RNK u plazmi bila je 4,94 log10 kopija/ml (raspon od 2,6 do 5,8 8 log10 kopija/ml)
Lactose monohydrate Crospovidone Magnesium stearate
Magnezijev stearat
Each capsule contains 300 mg atazanavir (as sulphate)
Jedna kapsula sadrži 300 mg atazanavira (u obliku atazanavirsulfata).
If indicated, elimination of unabsorbed atazanavir should be achieved by emesis or gastric lavage.
Uklanjanje neapsorbiranog atazanavira može se postići poticanjem povraćanja ili ispiranjem želuca, ako za to postoji indikacija.
With tenofovir disoproxil fumarate 300 mg once daily (equivalent to 245 mg tenofovir disoproxil) In HIV-infected patients with atazanavir/ritonavir at the recommended dose of 300/100 mg once daily
Primjena atazanavira/ritonavira u povišenoj dozi od 400/100 mg jedanput na dan u bolesnika zaraženih HIV-om Famotidin 20 mg dvaput na dan
Atazanavir is expected to increase plasma levels of lurasidone due to CYP3A4 inhibition.
Zbog inhibicije CYP3A4 očekuje se da će primjena atazanavira povisiti razine lurasidona u plazmi.
LPV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
LPV/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tabletama, jedanput na dan).
Atazanavir Mylan once daily dose ritonavir once daily dose a
Doza lijeka Atazanavir Mylan jedanput na dan
Raltegravir C12hr↑ 77%
Raltegravir AUC ↑41% Raltegravir Cmax ↑24% Raltegravir C12hr ↑77% Mehanizam je inhibicija UGT1A1.
Each capsule contains 168 mg lactose monohydrate
Jedna kapsula sadrži 168 mg laktoza hidrata Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
SEDATIVES Benzodiazepines Midazolam
Benzodiazepini
Atazanavir Cmax ↓21% (↓36% ↓4%)
Atazanavir AUC ↓21% (↓34% ↓4%)
Norgestimate Cmin ↑102% (↑77%
Norgestimat Cmax ↑68% (↑51% ↑88%) Norgestimat Cmin ↑102% (↑77%
• fatigue (extreme tiredness)
• iscrpljenost (jaki umor)
Tel: +34 900 102 712
Mylan Pharmaceuticals, S.L. Tel: +34 900 102 712
Famotidine 20 mg twice daily Atazanavir AUC ↑18% (↑6.5%
Atazanavir AUC ↑18% (↑6.5%
eczema, vasodilatation
, vezikulobulozni osip, ekcem, vazodilatacija
(n=392
(n=392f)
Ritonavir 100 mg once daily
Elbasvir 50 mg jednom dnevno
Atazanavir should be discontinued if severe rash develops.
Ako se razvije teški osip, primjenu atazanavira treba prekinuti.
This summary was last updated in 11-2014.
Ovaj sažetak je posljednji put ažuriran u 11. 2014.
The recommended dose is 200 mg taken twice a day (around 12 hours apart).
Preporučena doza je 200 mg dva puta na dan (u razmaku od otprilike 12 sati).
The full EPAR and risk management plan summary for Vargatef can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Vargatef nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Vargatef is available as capsules (100 and 150 mg) to be taken by mouth, preferably with food.
Vargatef je dostupan kao kapsule (100 i 150 mg) koje se uzimaju peroralno, po mogućnosti sa hranom.
The European Commission granted a marketing authorisation valid throughout the European Union for Vargatef on 21 November 2014.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Vargatef na snazi u Europskoj uniji od 21. studenog 2014.
Vargatef must not be used in patients who are hypersensitive (allergic) to nintedanib, peanut or soya, or any of the other ingredients.
Vargatef se ne smije koristiti u bolesnika koji su preosjetljivi (alergični) must na nintedanib, kikiriki ili soju ili bilo koje druge sastojke.
If severe side effects persist, treatment should be permanently discontinued.
Ako se ozbiljne nuspojave nastave, liječenje treba odmah prekinuti.
This is a summary of the European public assessment report (EPAR) for Vargatef.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Vargatef.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vargatef's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučilo je da koristi od lijeka Vargatef nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
By blocking these enzymes, nintedanib helps to reduce the growth and spread of the cancer and to cut off the blood supply that keeps cancer cells growing.
Inhibirajući ove enzime, nintedanib pomaže u smanjivanju rasta i širenju raka, te prekida opskrbu krvlju koja održava rast stanica raka.
Other information about Vargatef
Ostale informacije o lijeku Vargatef
Why is Vargatef approved?
Zašto je Vargatef odobren?
What measures are being taken to ensure the safe and effective use of Vargatef?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vargatef?
What is Vargatef and what is it used for?
Što je Vargatef i za što se koristi?
In addition, the company that markets Vargatef will conduct studies to find ways to identify those patients who are most likely to benefit from treatment with the medicine.
Nadalje, tvrtka koja stavlja u promet lijek Vargatef provest će ispitivanje kako bi pronašla način za identificiranje onih bolesnika koji su najizgledniji da će imati koristi od liječenja ovim lijekom.
These enzymes can be found in certain receptors (such as VEGF, FGF and PDGF receptors) on the surface of cancer cells and on the cells of the surrounding tissue (e.g. blood vessel), where they activate several processes including cell division and the growth of new blood vessels.
Ovi se enzimi nalaze u određenim receptorima (poput receptora VEGF, FGF i PDGF) na površini stanica raka i u stanicama koje okružuju tkivo (primjerice krvne žile), pri čemu se aktivira nekoliko postupaka, uključujući diobu stanica i rast krvnih žila.