natgillin/translations-raw huggingface dataset:
Through 360 weeks of treatment, the proportion of patients with HIV RNA < 400 (< 50) copies/ ml was 61% (59%), and the corresponding mean increase in CD4 cell count was 501 cells/ mm3.
Vsebuje: propilenglikol, makrogolglicerol ricinolat 35, anhidrirani tekoči sorbitol (mešanica sorbitola, sorbitolovih anhidridov in manitola), glicerol in oranžno FCF (E110).
Patients with prior antiretroviral therapy
FARMACEVTSKA OBLIKA IN VSEBINA
Median baseline CD4 cell count was 349 cells/ mm3 (range 72 to 807 cells/ mm3) and median baseline plasma HIV-1 RNA was 4.0 log10 copies/ ml (range 2.9 to 5.8 log10 copies/ ml).
180 mehkih kapsul (2 plastenki po 90 kapsul)
Median baseline CD4 cell count was 220 cells/ mm3 (range 13 to 1030 cells/ mm3).
POSTOPEK IN POT( I) UPORABE ZDRAVILA
Paediatric Use
Za peroralno uporabo Pred uporabo preberite priloženo navodilo.
All patients were non-nucleoside reverse transcriptase inhibitor naïve.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
Naïve patients also received nucleoside reverse transcriptase inhibitors.
Zdravilo shranjujte nedosegljivo otrokom!
Safety, efficacy and pharmacokinetic profiles of the two dose regimens were assessed after 3 weeks of therapy in each patient.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
Subsequently, all patients were continued on the 300/ 75 mg per m2 dose.
Za otroke varna zaporka.
Mean baseline CD4 cell count was 838 cells/ mm3 and mean baseline plasma HIV-1 RNA was 4.7 log10 copies/ ml.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Through 48 weeks of therapy, the proportion of patients with HIV RNA < 400 copies/ ml was 84% for antiretroviral naïve patients and 75% for antiretroviral experienced patients and the mean increases from baseline in CD4 cell count were 404 cells/ mm3 and 284 cells/ mm3 respectively.
{MM/ LLLL}
5.2 Pharmacokinetic properties
POSEBNA NAVODILA ZA SHRANJEVANJE
Lopinavir is essentially completely metabolised by CYP3A.
Shranjevanje med uporabo:
Ritonavir inhibits the metabolism of lopinavir, thereby increasing the plasma levels of lopinavir.
Če zdravila ne hranite v hladilniku, ga shranjujte na temperaturi do 25 °C, vso neporabljeno količino pa zavrzite po 42 dneh (6 tednih).
Across studies, administration of Kaletra 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.
Na ovojnino je priporočljivo zapisati datum, ko ste zdravilo vzeli iz hladilnika.
The plasma levels of ritonavir are less than 7% of those obtained after the ritonavir dose of 600 mg twice daily.
Ne izpostavljajte čezmerni vročini.
The in vitro antiviral EC50 of lopinavir is approximately 10-fold lower than that of ritonavir.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
Therefore, the antiviral activity of Kaletra is due to lopinavir.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
The mean steady-state trough concentration prior to the morning dose was 5.5 ± 4.0 μ g/ ml.
Abbott Laboratories Limited Queenborough Kent ME11 5EL Velika Britanija
The absolute bioavailability of lopinavir co-formulated with ritonavir in humans has not been established.
ŠTEVILKA( E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
Effects of food on oral absorption:
EU/ 1/ 01/ 172/ 001
At least 13 lopinavir oxidative metabolites have been identified in man.
ŠTEVILKA SERIJE
The 4-oxo and 4-hydroxymetabolite epimeric pair are the major metabolites with antiviral activity, but comprise only minute amounts of total plasma radioactivity.
{številka}
Unchanged lopinavir accounted for approximately 2.2% and 19.8% of the administered dose in urine and faeces, respectively.
NAČIN IZDAJANJA ZDRAVILA
After multiple dosing, less than 3% of the lopinavir dose is excreted unchanged in the urine.
Izdaja zdravila je le na recept.
Special Populations
NAVODILA ZA UPORABO
Paediatrics:
IME ZDRAVILA
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.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Gender, Race and Age:
Ena mehka kapsula vsebuje:
Kaletra pharmacokinetics have not been studied in the elderly.
133, 3 mg lopinavirja in 33, 3 mg ritonavirja (farmakokinetični stopnjevalec).
80 Renal Insufficiency:
SEZNAM POMOŽNIH SNOVI
Kaletra pharmacokinetics have not been studied in patients with renal insufficiency; however, since the renal clearance of lopinavir is negligible, a decrease in total body clearance is not expected in patients with renal insufficiency.
Vsebuje: propilenglikol, makrogolglicerol ricinolat 35, anhidrirani tekoči sorbitol (mešanica sorbitola, sorbitolovih anhidridov in manitola), glicerol in oranžno FCF (E110).
Hepatic Insufficiency:
FARMACEVTSKA OBLIKA IN VSEBINA
The steady state pharmacokinetic parameters of lopinavir in HIV-infected patients with mild to moderate hepatic impairment were compared with those of HIV-infected patients with normal hepatic function in a multiple dose study with lopinavir/ ritonavir 400/ 100 mg twice daily.
90 mehkih kapsul
5.3 Preclinical safety data
POSTOPEK IN POT( I) UPORABE ZDRAVILA
Hepatic changes indicated cellular swelling with focal degeneration.
Za peroralno uporabo Pred uporabo preberite priloženo navodilo.
Coombs-negative anisocytosis and poikilocytosis were observed in rats, but not in mice or dogs.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
Enlarged spleens with histiocytosis were seen in rats but not other species.
Zdravilo shranjujte nedosegljivo otrokom!
Serum cholesterol was elevated in rodents but not dogs, while triglycerides were elevated only in mice.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
Lower concentrations of lopinavir/ ritonavir did not produce significant potassium (HERG) current blockade.
Za otroke varna zaporka.
These effects have been assumed to be caused by electrolyte disturbance.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
The clinical relevance of these preclinical data is unknown, however, the potential cardiac effects of this product in humans cannot be ruled out (see also sections 4.4 and 4.8).
POSEBNA NAVODILA ZA SHRANJEVANJE
In rats, embryofoetotoxicity (pregnancy loss, decreased foetal viability, decreased foetal body weights, increased frequency of skeletal variations) and postnatal developmental toxicity (decreased survival of pups) was observed at maternally toxic dosages.
Če zdravila ne hranite v hladilniku, ga shranjujte na temperaturi do 25 °C, vso neporabljeno količino pa zavrzite po 42 dneh (6 tednih).
The systemic exposure to lopinavir/ ritonavir at the maternal and developmental toxic dosages was lower than the intended therapeutic exposure in humans.
Ne izpostavljajte čezmerni vročini.
Long-term carcinogenicity studies of lopinavir/ ritonavir in mice revealed a nongenotoxic, mitogenic induction of liver tumours, generally considered to have little relevance to human risk.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
Carcinogenicity studies in rats revealed no tumourigenic findings.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
81 reverse mutation assay, the mouse lymphoma assay, the mouse micronucleus test and chromosomal aberration assays in human lymphocytes.
Abbott Laboratories Limited Queenborough Kent ME11 5EL Velika Britanija
PHARMACEUTICAL PARTICULARS
ŠTEVILKA( E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
Tablet contents:
ŠTEVILKA SERIJE
Film-coating:
Serija:
Polyvinyl alcohol Titanium dioxide Talc Macrogols type 3350 (Polyethylene glycol 3350) Yellow ferric oxide E172
{številka}
6.2 Incompatibilities
NAČIN IZDAJANJA ZDRAVILA
Not applicable.
Izdaja zdravila je le na recept.
6.3 Shelf life
NAVODILA ZA UPORABO
6.4 Special precautions for storage
PODATKI V BRAILLOVI PISAVI
This medicinal product does not require any special storage conditions.
96 PODATKI NA ZUNANJI OVOJNINI
6.5 Nature and content of container
PAKIRANJE S 180 (5 ŠKATEL S 6 PRETISNIMI OMOTI PO 6 KAPSUL)
6.6 Special precautions for disposal
IME ZDRAVILA
No special requirements.
Kaletra 133, 3 mg/ 33, 3 mg mehke kapsule lopinavir/ ritonavir
MARKETING AUTHORISATION HOLDER
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Abbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom
133, 3 mg lopinavirja in 33, 3 mg ritonavirja (farmakokinetični stopnjevalec).
MARKETING AUTHORISATION NUMBERS
SEZNAM POMOŽNIH SNOVI
EU/ 1/ 01/ 172/ 00
Vsebuje: propilenglikol, makrogolglicerol ricinolat 35, anhidrirani tekoči sorbitol (mešanica sorbitola, sorbitolovih anhidridov in manitola), glicerol in oranžno FCF (E110).
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
FARMACEVTSKA OBLIKA IN VSEBINA
Date of first authorisation:
Vsebuje:
20 March 2006
180 mehkih kapsul (5 škatel s 6 pretisnimi omoti po 6 kapsul)
DATE OF REVISION OF THE TEXT
POSTOPEK IN POT( I) UPORABE ZDRAVILA
{MM/ YYYY}
6.
83 ANNEX II
Zdravilo shranjujte nedosegljivo otrokom!
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
B.
8.
CONDITIONS OF THE MARKETING AUTHORISATION
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
84 A.
EXP:
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
{MM/ LLLL}
Name and address of the manufacturer(s) responsible for batch release
POSEBNA NAVODILA ZA SHRANJEVANJE
Kaletra oral solution, Kaletra soft capsules, Kaletra film-coated tablets:
Shranjevanje med uporabo:
Aesica Queenborough Limited, Queenborough, Kent ME11 5EL, United Kingdom
Če zdravila ne hranite v hladilniku, ga shranjujte na temperaturi do 25 °C, vso neporabljeno količino pa zavrzite po 42 dneh (6 tednih).
Abbott GmbH & Co.
Na ovojnino je priporočljivo zapisati datum, ko ste zdravilo vzeli iz hladilnika.
KG, Knollstrasse, 67061 Ludwigshafen, Germany
Ne izpostavljajte čezmerni vročini.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
CONDITIONS OF THE MARKETING AUTHORISATION
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Abbott Laboratories Limited Queenborough Kent ME11 5EL Velika Britanija
Medicinal product subject to restricted medical prescription (See Annex I:
12.
Summary of Product Characteristics, 4.2).
ŠTEVILKA( E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
Not applicable.
ŠTEVILKA SERIJE
• OTHER CONDITIONS
{številka}
Pharmacovigilance system
NAČIN IZDAJANJA ZDRAVILA
Risk Management Plan
Izdaja zdravila je le na recept.
Periodic Safety Update Reports
NAVODILA ZA UPORABO
The Marketing Authorisation Holder will submit Periodic Safety Update Reports on an annual cycle.
PODATKI V BRAILLOVI PISAVI
85 86 ANNEX III
98 PODATKI NA ZUNANJI OVOJNINI
LABELLING AND PACKAGE LEAFLET
ŠKATLA S 36 KAPSULAMI (6 PRETISNIH OMOTOV PO 6 KAPSUL)
LABELLING
IME ZDRAVILA
88 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Kaletra 133, 3 mg/ 33, 3 mg mehke kapsule lopinavir/ ritonavir
STATEMENT OF ACTIVE SUBSTANCE(S)
Ena mehka kapsula vsebuje:
Each soft capsule contains: lopinavir 133.3 mg and ritonavir 33.3 mg (pharmacokinetic enhancer).
133, 3 mg lopinavirja in 33, 3 mg ritonavirja (farmakokinetični stopnjevalec).
Includes: propylene glycol, polyoxyl 35 castor oil, anhydrized liquid sorbitol (mixture of sorbitol, sorbitol anhydrides and mannitol), glycerol and sunset yellow (E110).
Vsebuje: propilenglikol, makrogolglicerol ricinolat 35, anhidrirani tekoči sorbitol (mešanica sorbitola, sorbitolovih anhidridov in manitola), glicerol in oranžno FCF (E110).
180 soft capsules (2 bottles of 90 capsules each)
36 mehkih kapsul (6 pretisnih omotov po 6 kapsul)
Store in a refrigerator In use storage:
Shranjevanje med uporabo:
If kept outside of the refrigerator, do not store above 25°C and discard any unused contents after 42 days (6 weeks).
Če zdravila ne hranite v hladilniku, ga shranjujte na temperaturi do 25 °C, vso neporabljeno količino pa zavrzite po 42 dneh (6 tednih).
90 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
100 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
CAPSULES - BOTTLE
PRETISNI OMOT S 6 KAPSULAMI
Kaletra 133.3 mg/ 33.3 mg soft capsules lopinavir/ ritonavir
Kaletra 133, 3 mg/ 33, 3 mg mehke kapsule lopinavir/ ritonavir
STATEMENT OF ACTIVE SUBSTANCE(S)
ŠKATLA - 300 ML RAZTOPINE (5 STEKLENIČK PO 60 ML)
Each soft capsule contains: lopinavir 133.3 mg and ritonavir 33.3 mg (pharmacokinetic enhancer).
80 mg lopinavirja in 20 mg ritonavirja (farmakokinetični stopnjevalec).
Includes: propylene glycol, polyoxyl 35 castor oil, anhydrized liquid sorbitol (mixture of sorbitol, sorbitol anhydrides and mannitol), glycerol and sunset yellow (E110).
Vsebuje: alkohol (42% v/ v, glejte navodilo za uporabo), visokofruktozni koruzni sirup, propilenglikol, glicerol, makrogolglicerol hidroksistearat 40, kalij (kot kalijev acesulfamat).
90 soft capsules
300 ml raztopine (5 stekleničk po 60 ml)
Child resistant closure.
Za otroke varna zaporka.
92 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
103 PODATKI NA PRIMARNI OVOJNINI
CAPSULES - PACK OF 180 (5 CARTONS OF 6 BLISTERS OF 6 CAPSULES)
STEKLENIČKA
Kaletra 133.3 mg/ 33.3 mg soft capsules lopinavir/ ritonavir
Kaletra (80 mg + 20 mg) / ml peroralna raztopina (lopinavir + ritonavir)
Each soft capsule contains: lopinavir 133.3 mg and ritonavir 33.3 mg (pharmacokinetic enhancer).
En ml vsebuje 80 mg lopinavirja in 20 mg ritonavirja (farmakokinetični stopnjevalec).
Contains:
60 ml raztopine
{MM/ YYY}
{MM/ LLLL}
94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
105 PODATKI NA ZUNANJI OVOJNINI
CAPSULES - CARTON OF 36 CAPSULES (6 BLISTERS OF 6 CAPSULES)
ŠKATLA Z 1 PLASTENKO
Kaletra 133.3 mg/ 33.3 mg soft capsules lopinavir/ ritonavir
Kaletra 200 mg/ 50 mg filmsko obložene tablete lopinavir/ ritonavir
Each soft capsule contains: lopinavir 133.3 mg and ritonavir 33.3 mg (pharmacokinetic enhancer).
Ena filmsko obložena tableta vsebuje 200 mg lopinavirja, koformuliranega s 50 mg ritonavirja kot farmakokinetičnim stopnjevalcem.
36 soft capsules (6 foil blisters of 6 capsules)
120 filmsko obloženih tablet
Avoid exposure to excessive heat.
POSEBNA NAVODILA ZA SHRANJEVANJE
INFORMATION IN BRAILLE
FARMACEVTSKA OBLIKA IN VSEBINA
96 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Za peroralno uporabo Pred uporabo preberite priloženo navodilo.
CAPSULES - BLISTER OF 6 CAPSULES
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
NAME OF THE MEDICINAL PRODUCT
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
Kaletra 133.3 mg/ 33.3 mg soft capsules lopinavir/ ritonavir
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Abbott Laboratories Limited
Abbott Laboratories Limited Queenborough Kent ME11 5EL Velika Britanija
EXPIRY DATE
ŠTEVILKA SERIJE
EXP:
Serija:
{MM/ YYYY}
{številka}
BATCH NUMBER
NAČIN IZDAJANJA ZDRAVILA
{number}
NAVODILA ZA UPORABO
OTHER
PODATKI V BRAILLOVI PISAVI
97 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
109 PODATKI NA ZUNANJI OVOJNINI
ORAL SOLUTION CARTON - 300 ML OF SOLUTION (5 BOTTLES OF 60 ML EACH)
PAKIRANJE S 120 (3 ŠKATLE S 5 PRETISNIMI OMOTI PO 8 FILMSKO OBLOŽENIH TABLET)
Kaletra (80 mg + 20 mg) / ml oral solution (lopinavir + ritonavir)
Kaletra 200 mg/ 50 mg filmsko obložene tablete lopinavir/ ritonavir
Each ml contains: lopinavir 80 mg and ritonavir 20 mg (pharmacokinetic enhancer).
Ena filmsko obložena tableta vsebuje 200 mg lopinavirja, koformuliranega s 50 mg ritonavirja kot farmakokinetičnim stopnjevalcem.
300 ml of solution (5 bottles of 60 ml each).
120 filmsko obloženih tablet (3 škatle s 5 pretisnimi omoti po 8 tablet).
98 9.
110 9.
{number]
{številka}
Kaletra
Kaletra 200 mg/ 50 mg tablete
99 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
111 PODATKI NA ZUNANJI OVOJNINI
ORAL SOLUTION - BOTTLE LABEL
NOTRANJA ŠKATLA S 40 FILMSKO OBLOŽENIMI TABLETAMI (5 PRETISNIH OMOTOV PO 8 FILMSKO OBLOŽENIH TABLET)
Each ml contains lopinavir 80 mg and ritonavir 20 mg (pharmacokinetic enhancer).
Ena filmsko obložena tableta vsebuje 200 mg lopinavirja, koformuliranega s 50 mg ritonavirja kot farmakokinetičnim stopnjevalcem.
60 ml of solution
Vsebuje:
Important to open
Za peroralno uporabo Pred uporabo preberite priloženo navodilo.
{MM/ YYYY}
{/ MM/ LLLL}
100 9.
112 9.
101 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PRETISNI OMOT Z 8 FILMSKO OBLOŽENIMI TABLETAMI
Kaletra 200 mg/ 50 mg film-coated tablets lopinavir/ ritonavir
Kaletra 200 mg/ 50 mg filmsko obložene tablete lopinavir/ ritonavir
STATEMENT OF ACTIVE SUBSTANCE(S)
114 PODATKI NA ZUNANJI OVOJNINI
Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.
Ena filmsko obložena tableta vsebuje 100 mg lopinavirja, koformuliranega s 25 mg ritonavirja kot farmakokinetičnim stopnjevalcem.
Kaletra 200 mg/ 50 mg tablets
kaletra 100 mg/ 25 mg tablete
103 PARTICULARS TO APPEAR ON THE ON THE IMMEDIATE PACKAGING
116 PODATKI NA PRIMARNI OVOJNINI
200 MG/ 50 MG TABLETS - BOTTLE
PLASTENKA
Kaletra 200 mg/ 50 mg film-coated tablets lopinavir/ ritonavir
Kaletra 100 mg/ 25 mg filmsko obložene tablete lopinavir/ ritonavir
105 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
NAVODILO ZA UPORABO
200 MG/ 50 MG TABLETS - PACK OF 120 (3 CARTONS OF 5 FOIL BLISTERS OF 8 FILM- COATED TABLETS)
KALETRA 133, 3 mg/ 33, 3 mg mehke kapsule lopinavir/ ritonavir
NAME OF THE MEDICINAL PRODUCT
Pred začetkom jemanja natančno preberite navodilo!
Kaletra 200 mg/ 50 mg film-coated tablets lopinavir/ ritonavir
Morda ga boste želeli ponovno prebrati.
STATEMENT OF ACTIVE SUBSTANCE(S)
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.
Njim bi lahko celo
LIST OF EXCIPIENTS
škodovalo, čeprav imajo znake bolezni, podobne vašim.
PHARMACEUTICAL FORM AND CONTENTS
omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Contains:
Navodilo vsebuje:
120 film-coated tablets (3 cartons of 5 foil blisters of 8 tablets).
Možni neželeni učinki 5.
METHOD AND ROUTE(S) OF ADMINISTRATION
KAJ JE ZDRAVILO KALETRA IN ZA KAJ GA UPORABLJAMO
Oral use Read the package leaflet before use
Zdravilo Kaletra je zaviralec proteaze; proteaza je encim virusa človeške imunske pomanjkljivosti (HIV).
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Zdravilo Kaletra se uporablja pri odraslih in otrocih (od 2. leta dalje), okuženih s HIV, virusom, ki povzroča AIDS.
Keep out of the reach and sight of children
Vaš zdravnik bo presodil, katera zdravila so za vas najprimernejša.
OTHER SPECIAL WARNING(S), IF NECESSARY
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO KALETRA
EXPIRY DATE
Ne jemljite zdravila Kaletra
{MM/ YYY}
- če imate hude težave z jetri.
SPECIAL STORAGE CONDITIONS
astemizol ali terfenadin (pogosto se uporabljata za zdravljenje simptomov alergije – ti zdravili sta lahko na voljo brez recepta);
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
peroralni (zaužiti) midazolam, triazolam (uporabljata se za lajšanje tesnobnosti in/ ali težav s spanjem);
106 11.
- - -
Abbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom
pimozid (uporablja se za zdravljenje shizofrenije); cisaprid (uporablja se za lajšanje določenih težav z želodcem); ergotamin, dihidroergotamin, ergonovin, metilergonovin (uporabljajo se za zdravljenje glavobolov);
MARKETING AUTHORISATION NUMBER(S)
amiodaron (uporablja se za zdravljenje motenj srčnega ritma); vardenafil (uporablja se za zdravljenje erektilne disfunkcije).
EU/ 1/ 01/ 172/ 005
Če trenutno jemljete katero od teh zdravil, se za čas, ko jemljete zdravilo Kaletra, z zdravnikom pogovorite o zamenjavi s kakšnim drugim zdravilom.
BATCH NUMBER
Bodite posebno pozorni pri uporabi zdravila Kaletra
{number}
posledice.
GENERAL CLASSIFICATION FOR SUPPLY
- Zdravilo Kaletra lahko medsebojno deluje z zdravili za zdravljenje erektilne disfunkcije (npr.
Medicinal product subject to medical prescription.
sildenafilom in tadalafilom).
INSTRUCTIONS ON USE
Vaš zdravnik vas bo redno
INFORMATION IN BRAILLE
kontroliral, če jemljete digoksin in zdravilo Kaletra.
Kaletra 200 mg/ 50 mg tablets
- Jemanje določenih zdravil z zdravilom Kaletra lahko zveča koncentracijo teh zdravil v telesu in
107 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
zveča ali podaljša njihovo delovanje in/ ali neželene učinke.
200 MG/ 50 MG TABLETS - INNER CARTON OF 40 FILM-COATED TABLETS (5 FOIL BLISTERS OF 8 FILM-COATED TABLETS)
- Če za preprečevanje nosečnosti jemljete peroralne kontraceptive ali kontraceptive v obližu,
1.
Bolnike s
NAME OF THE MEDICINAL PRODUCT
prerazporeditev, kopičenje ali izgubljanje telesnega maščevja.
Kaletra 200 mg/ 50 mg film-coated tablets lopinavir/ ritonavir
- Nosečnice ali doječe matere ne smejo jemati zdravila Kaletra, če tega posebej ne naroči
STATEMENT OF ACTIVE SUBSTANCE(S)
zdravnik (glejte tudi "Nosečnost in dojenje").
Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.
- Zdravilo Kaletra se ne sme uporabljati pri otrocih, mlajših od 2 let, če tega posebej ne naroči
LIST OF EXCIPIENTS
zdravnik.
PHARMACEUTICAL FORM AND CONTENTS
Osebe, ki jemljejo zdravilo Kaletra, lahko
Contains:
121 zdravnika.
40 film-coated tablets (5 foil blisters of 8 film-coated tablets).
Upoštevati morate ustrezne previdnostne ukrepe.
METHOD AND ROUTE(S) OF ADMINISTRATION
- Pri nekaterih bolnikih z napredovalo okužbo s HIV (AIDS) in z oportunistično okužbo v
Oral use Read the package leaflet before use
Pri nekaterih bolnikih, ki jemljejo kombinirano protiretrovirusno zdravljenje,
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Znaki osteonekroze so togost sklepa, bolečine (zlasti v kolku, kolenu in rami) in težave z gibljivostjo.
Keep out of the reach and sight of children
Jemanje drugih zdravil
7.
Zdravniku morate pred uporabo zdravila Kaletra povedati za vsa zdravila, ki jih jemljete ali jih nameravate jemati, tudi za tista brez recepta.
OTHER SPECIAL WARNING(S), IF NECESSARY
Za dodatne informacije glejte poglavje 2, KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO KALETRA.
EXPIRY DATE
Zdravilo Kaletra je mogoče uporabljati z zdravili, ki zmanjšajo izločanje kisline (npr. z omeprazolom ali ranitidinom), ne da bi bilo treba prilagoditi odmerek.
{MM/ YYYY}
Gastrorezistenten pripravek didanozina je treba uporabiti najmanj dve uri po jedi.
SPECIAL STORAGE CONDITIONS
Te simptome vam lahko razloži zdravnik.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Če za preprečevanje nosečnosti jemljete peroralne kontraceptive, morate uporabiti dodatno ali drugačno kontracepcijsko zaščito, kajti zdravilo Kaletra lahko zmanjša učinkovitost peroralnih kontraceptivov.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Abbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom
Jemanje zdravila Kaletra skupaj s hrano in pijačo
MARKETING AUTHORISATION NUMBER(S)
Pomembno je, da zdravilo Kaletra jemljete s hrano.
EU/ 1/ 01/ 172/ 005
Nosečnost in dojenje
BATCH NUMBER
122 Vpliv na sposobnost upravljanja vozil in strojev
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Zdravila Kaletra niso posebej preizkušali glede možnih učinkov na sposobnost za upravljanje vozil oz. delo s stroji.
GENERAL CLASSIFICATION FOR SUPPLY
Pomembne informacije o nekaterih sestavinah zdravila Kaletra
Medicinal product subject to medical prescription.
Alergija je pogostejša pri osebah, alergičnih na acetilsalicilno kislino (Aspirin).
INSTRUCTIONS ON USE
KAKO JEMATI ZDRAVILO KALETRA
INFORMATION IN BRAILLE
Kako in kdaj naj uporabim zdravilo Kaletra
Kaletra 200 mg/ 50 mg tablets
Pomembno je, da vse odmerke zdravila Kaletra vzamete s hrano.