natgillin/translations-raw huggingface dataset:
Č eská republika Merck Sharp & Dohme IDEA, Inc., org. sl.
61 Česká republika Merck Sharp & Dohme IDEA, Inc., org. sl.
62 This leaflet was last approved in {MM/ YYYY}.
Navodilo je bilo odobreno {MM/ LLLL}.
65 Very common side effects (more than 1 per 10 patients) Common side effects (less than 1 per 10 but more than 1 per 100 patients) Uncommon side effects (less than 1 per 100 but more than 1 per 1000 patients)
Občasni neželeni učinki (pri manj kot 1 od 100, vendar več kot 1 od 1. 000 bolnikov).
Do not use Januvia after the expiry date which is stated on the blister and the carton.
66 Zdravila Januvia ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli.
monohydrate, equivalent to 100 mg sitagliptin.
monohidrat, ki ustreza 100 mg sitagliptina.
Č eská republika Merck Sharp & Dohme IDEA, Inc., org. sl.
67 Česká republika Merck Sharp & Dohme IDEA, Inc., org. sl.
68 This leaflet was last approved in {MM/ YYYY}.
Navodilo je bilo odobreno {MM/ LLLL}.
Kaletra is a medicine containing two active substances, lopinavir and ritonavir.
Kaletra je zdravilo, ki vsebuje dve zdravilni učinkovini, lopinavir in ritonavir.
It is available as orange capsules (133.3 mg lopinavir and 33.3 mg ritonavir), an oral solution (80 mg lopinavir and 20 mg ritonavir per millilitre) and tablets (pale yellow:
Na voljo je v obliki oranžnih kapsul (133, 3 mg lopinavirja in 33, 3 mg ritonavirja), peroralne raztopine (80 mg lopinavirja in 20 mg ritonavirja na mililiter) ter tablet (bledorumenih:
100 mg lopinavir and 25 mg ritonavir; yellow:
100 mg lopinavirja in 25 mg ritonavirja; rumenih:
200 mg lopinavir and 50 mg ritonavir).
200 mg lopinavirja in 50 mg ritonavirja).
Kaletra is an antiviral medicine.
Zdravilo Kaletra je protivirusno zdravilo.
It is used together with other antiviral medicines to treat adults and children over two years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Uporablja se skupaj z drugimi protivirusnimi zdravili pri zdravljenju odraslih in otrok, starejših od dveh let, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV- 1), virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
Treatment with Kaletra should be prescribed by a doctor who has experience in the management of HIV infection.
Zdravljenje z zdravilom Kaletra mora predpisati zdravnik z izkušnjami pri zdravljenju okužb s HIV.
The recommended dose of Kaletra is three capsules, 5 ml of the oral solution, or two 200/ 50 mg tablets twice a day.
Priporočeni odmerek zdravila Kaletra je tri kapsule, 5 ml peroralne raztopine ali dve tableti po 200/ 50 mg dvakrat na dan.
This dose is suitable for adults and children provided that they weigh more than 40 kg and have a body surface area (calculated using the child ’ s height and weight) over 1.4 m2.
Ta odmerek je primeren za odrasle in otroke, če tehtajo vsaj 40 kg in imajo vsaj 1, 4 m2 telesne površine (izračunano na podlagi otrokove višine in telesne mase).
The dose for smaller children depends on the child’ s body surface area and the other medicines that the child is taking.
Odmerek za manjše otroke je odvisen od njihove telesne površine in drugih zdravil, ki jih že jemljejo.
The oral solution is for patients who cannot take the tablets or capsules.
Peroralna raztopina je namenjena bolnikom, ki ne morejo jemati tablet ali kapsul.
The capsules and oral solution must be taken with food, but the tablets can be taken with or without food.
Kapsule in peroralna raztopina se morajo jemati s hrano, medtem ko lahko tablete bolniki jemljejo s hrano ali brez nje.
Kaletra tablets should be swallowed whole and not chewed, broken or crushed.
Tablete Kaletra je treba pogoltniti cele; ne smejo se žvečiti, prelomiti ali pregristi.
Kaletra should not be taken by patients with severe liver disease.
Zdravila Kaletra ne smejo uporabljati bolniki z resnimi obolenji jeter.
Caution is needed in patients with severe kidney disease.
Previdnost je potrebna tudi pri bolnikih z resnimi obolenji ledvic.
Both substances are protease inhibitors: they block an enzyme called protease that is involved in the reproduction of HIV.
Obe učinkovini sta zaviralca proteaz: blokirata encim, imenovan proteaza, ki sodeluje pri razmnoževanju virusa HIV.
In Kaletra, lopinavir provides the activity and ritonavir is used as a ‘ booster ’ that slows down the rate at which lopinavir is broken down by the liver.
Lopinavir v zdravilu Kaletra zagotavlja učinkovanje, ritonavir pa služi kot „ stopnjevalec “, ki upočasni razgradnjo lopinavirja v jetrih.
This increases the levels of lopinavir in the blood, allowing a lower dose of lopinavir to be used for the same antiviral effect.
To poveča koncentracijo lopinavirja v krvi, kar omogoča uporabo manjšega odmerka lopinavirja za isti protivirusni učinek.
Kaletra does not cure HIV
Zdravilo Kaletra ne ozdravi okužbe s HIV ali AIDS- a, vendar pa lahko upočasni slabšanje imunskega sistema in razvoj okužb in bolezni, povezanih z AIDS- om.
There were two main studies of Kaletra in adults and one in children.
Z zdravilom Kaletra sta bili izvedeni dve glavni študiji pri odraslih in ena pri otrocih.
The first study included 653 ‘ treatment-naïve’ adults (patients who had not taken treatment for HIV infection before), comparing Kaletra with nelfinavir (another antiviral medicine).
Prva študija, v kateri so zdravilo Kaletra primerjali z nelfinavirjem (drugim protivirusnim zdravilom), je vključevala 653 odraslih bolnikov, pri katerih okužba s HIV predhodno še ni bila zdravljena.
The second study included 118 adults who had taken another protease inhibitor in the past, comparing Kaletra with a protease inhibitor chosen by the study investigator on a patient-by-patient basis.
Druga študija, v kateri so primerjali zdravilo Kaletra z zaviralcem proteaz, ki ga je izbral raziskovalec za vsakega bolnika posebej, je vključevala 118 odraslih, ki so v preteklosti prejemali drugačnega zaviralca proteaz.
The third study involved 100 children, who were given one of two doses of Kaletra.
Tretja študija je vključevala 100 otrok, ki so prejemali enega od obeh odmerkov zdravila Kaletra.
For all three studies, Kaletra and the comparator medicines were combined with other antiviral medicines.
V vseh treh študijah so bili zdravilo Kaletra in primerjalna zdravila kombinirani z drugimi protivirusnimi zdravili.
The main measure of effectiveness was the number of patients who had undetectable levels of HIV-1 in their blood (viral loads) after treatment.
Glavno merilo učinkovitosti je bilo število bolnikov, ki so imeli po zdravljenju v krvi nezaznavno koncentracijo HIV- 1 (virusno breme).
In all of the studies, Kaletra reduced viral loads.
V vseh študijah je zdravilo Kaletra zmanjšalo virusno breme.
In the study of treatment-naïve adults, 79% of the patients taking Kaletra (259 out of 326) had viral loads below 400 copies/ ml after 24 weeks, compared with 71% of the patients taking nelfinavir (233 out of 327).
V študiji s predhodno nezdravljenimi odraslimi bolniki je pri 79% bolnikih, ki so prejemali zdravilo Kaletra (259 od 326), prišlo po 24 tednih do zmanjšanja virusnega bremena pod 400 kopij/ ml, v primerjavi z 71% bolnikov, ki so prejemali nelfinavir (233 od 327).
In the study of adults who had previously taken a protease inhibitor, 73% of the patients taking Kaletra (43 out of 59) had viral loads below 400 copies/ ml after 16 weeks, compared with 54% of the patients taking the comparator medicines (32 out of 59).
V študiji z odraslimi bolniki, ki so predhodno prejemali zaviralca proteaz, je pri 73% bolnikov, ki so prejemali zdravilo Kaletra (43 od 59), prišlo po 16 tednih do zmanjšanja virusnega bremena pod 400 kopij/ ml, v primerjavi s 54% bolnikov, ki so prejemali primerjalna zdravila (32 od 59).
Similar results were seen with both doses of Kaletra in the study of children: around 70% had viral loads below 400 copies/ ml after 12 weeks of treatment.
V študiji z otroki so pri obeh odmerkih zdravila Kaletra zabeležili podobne rezultate: po 12 tednih zdravljenja jih je imelo okrog 70% virusno breme pod 400 kopij/ ml.
The most common side effects in adults (seen in more than 1 patient in 10) are diarrhoea, and changes in the blood levels of fat (cholesterol and triglycerides) and liver enzymes (GGT).
Najpogostejši neželeni učinki pri odraslih (opaženi pri več kot 1 bolniku od 10) so driska ter spremembe ravni maščob v krvi (holesterola in trigliceridov) in jetrnih encimov (GGT).
The side effect profile is similar in children.
Pri otrocih je profil neželenih učinkov podoben.
For the full list of all side effects reported with Kaletra, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Kaletra, glejte navodilo za uporabo.
Kaletra should not be used in people who may be hypersensitive (allergic) to lopinavir, ritonavir or any of the other ingredients.
Zdravila Kaletra ne smejo uporabljati osebe, ki utegnejo biti preobčutljivi za (alergični na) lopinavir, ritonavir ali katero koli drugo sestavino zdravila.
Kaletra should not be used by patients with severe liver disease or those who are taking any of the following medicines: • medicines that are broken down in the same way as Kaletra and are harmful at high levels in the blood.
Zdravila Kaletra ne smejo uporabljati bolniki z resnimi obolenji jeter oziroma tisti, ki jemljejo katero od naslednjih zdravil: • zdravila, ki se presnavljajo enako kot zdravilo Kaletra in so škodljiva pri visokih koncentracijah v krvi.
See the Package Leaflet for a full list of these medicines; • St John’ s wort (a herbal preparation used to treat depression).
Za celoten seznam teh zdravil glejte navodilo za uporabo, • šentjanževko (rastlinski pripravek za zdravljenje depresije).
Caution is also needed by patients taking Kaletra at the same time as other medicines.
Previdnost je potrebna tudi pri drugih zdravilih, ki jih bolniki jemljejo sočasno z zdravilom Kaletra.
As with all anti-HIV medicines, patients taking Kaletra may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Enako kot pri drugih zdravilih proti virusu HIV obstaja pri bolnikih, ki prejemajo zdravilo Kaletra, tveganje za lipodistrofijo (spremembe v porazdelitvi telesne maščobe), osteonekrozo (odmiranje kostnega tkiva) ali sindrom imunske reaktivacije (simptomi okužbe, ki jih povzroči imunski sistem med okrevanjem).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Kaletra.
Pri bolnikih, ki imajo težave z jetri (vključno z okužbo s hepatitisom B ali C), obstaja pri jemanju zdravila Kaletra povečano tveganje za poškodbe jeter.
The Committee for Medicinal Products for Human Use (CHMP) decided that Kaletra’ s benefits are greater than its risks for the treatment of HIV-1 infected adults and children above the age of two years, in combination with other antiretroviral agents.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Kaletra za zdravljenje odraslih in otrok, starejših od dveh let, okuženih s HIV- 1, večje od z njim povezanih tveganj.
The Committee recommended that Kaletra be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Kaletra odobri dovoljenje za promet.
Kaletra was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval.
Zdravilo Kaletra je bilo prvotno odobreno v „ izjemnih okoliščinah “, ker so bile zaradi znanstvenih razlogov v času odobritve na voljo le omejene informacije.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 12 November 2002.
Ker je družba predložila dodatne zahtevane informacije, so „ izjemne okoliščine “ prenehale veljati 12. novembra 2002.
Which measures are being taken to ensure the safe use of Kaletra?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Kaletra?
As Kaletra was previously available only as capsules and oral solution, the company that makes Kaletra will supply a letter for people involved in the care of patients taking the medicine.
Ker je bilo zdravilo Kaletra predhodno na voljo le v obliki kapsul in kot peroralna raztopina, bo družba, ki proizvaja zdravilo Kaletra, pripravila dopis za osebe, ki skrbijo za bolnike, ki jemljejo zdravilo.
This will explain the differences between Kaletra capsules and tablets, to avoid confusion over the number of tablets that patients should take while the tablets are being introduced.
V dopisu bodo pojasnjene razlike med kapsulami in tabletami Kaletra, da ne bi prišlo do zmede glede števila tablet, ki jih mora bolnik vzeti v obdobju uvajanja tablet.
2/ 3 Other information about Kaletra:
2/ 3 Druge informacije o zdravilu Kaletra:
The European Commission granted a marketing authorisation valid throughout the European Union for Kaletra to Abbott Laboratories Limited on 20 March 2001.
Evropska komisija je dovoljenje za promet z zdravilom Kaletra, veljavno po vsej Evropski uniji, odobrila družbi Abbott Laboratories Limited dne 20. marca 2001.
The marketing authorisation was renewed on 20 March 2006.
Dovoljenje za promet z zdravilom je bilo obnovljeno 20. marca 2006.
The full EPAR for Kaletra can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Kaletra je na voljo tukaj.
Capsule, soft Capsule, soft
kapsula, mehka kapsula, mehka
Oral use Oral use
peroralna uporaba peroralna uporaba
bottle (HDPE) blister (PVC)
plastenka (HDPE) pretisni omot (PVC)
180 capsules 180 capsules
180 kapsul 180 kapsul
EU/ 1/ 01/ 172/ 003 EU/ 1/ 01/ 172/ 004 EU/ 1/ 01/ 172/ 005 EU/ 1/ 01/ 172/ 006
EU/ 1/ 01/ 172/ 003
Kaletra Kaletra Kaletra Kaletra
Kaletra
(80 mg + 20 mg) / ml 200 mg/ 50 mg 200 mg / 50 mg 100 mg / 25 mg
(80 mg + 20 mg) / ml
Oral solution film-coated tablets film-coated tablets film-coated tablets
peroralna raztopina
Oral use Oral use Oral use Oral use
peroralna uporaba
bottle (PET) bottle (HDPE) blister (PVC) bottle (HDPE)
plastenka (PET)
5 bottles + 5 x 5 ml syringes 120 tablets 120 tablets 60 tablets
5 plastenk + 5 x 5 ml brizg
Kaletra 133.3 mg/ 33.3 mg soft capsules
Kaletra 133, 3 mg/ 33, 3 mg mehke kapsule
Each Kaletra soft capsule contains 133.3 mg of lopinavir co-formulated with 33.3 mg of ritonavir as a pharmacokinetic enhancer.
Ena mehka kapsula Kaletra vsebuje 133, 3 mg lopinavirja, koformuliranega s 33, 3 mg ritonavirja kot farmakokinetičnim stopnjevalcem.
Name of the
Ime
Quantity per capsule
Količina v kapsuli
- active substance
- učinkovine
- excipient (s) capsule fill
- pomožnih snovi v kapsuli
Propylene glycol Castor Oil Polyoxyl 35
propilenglikol makrogolglicerol ricinolat 35
- excipient (s) capsule shell
- pomožnih snovi v ovojnici kapsule
Anhydrized liquid sorbitol – glycerol blend Sunset yellow (E110)
oranžno FCF (E110)
The capsules are orange with a black ink imprint of [Abbott logo] and “ PK”.
Kapsule so oranžne in na njih je s črnim barvilom natisnjen [Abbottov logo] in "PK".
Kaletra is indicated for the treatment of HIV-1 infected adults and children above the age of 2 years, in combination with other antiretroviral agents.
Zdravilo Kaletra je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje odraslih in otrok, starejših od 2 let, okuženih s HIV- 1.
Most experience with Kaletra is derived from the use of the product in antiretroviral therapy naïve patients.
Večina izkušenj z zdravilom Kaletra izvira iz njegove uporabe pri bolnikih, ki še niso prejemali protiretrovirusnih zdravil.
Data in heavily pretreated protease inhibitor experienced patients are limited.
Podatkov o bolnikih, izkušenih z intenzivnim predzdravljenjem z zaviralci proteaz, je malo.
There are limited data on salvage therapy on patients who have failed therapy with Kaletra.
Podatkov o rešilnem zdravljenju pri bolnikih, pri katerih zdravljenje z zdravilom Kaletra ni bilo uspešno, je malo.
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).
Izbira zdravila Kaletra za zdravljenje s HIV- 1 okuženih in z zaviralci proteaz izkušenih bolnikov mora temeljiti na individualnem preizkusu odpornosti virusa in anamnezi bolnikovega zdravljenja (glejte poglavji 4. 4 in 5. 1).
Adult and adolescent use: the recommended dosage of Kaletra is three capsules twice daily taken with food.
Uporaba pri odraslih in mladostnikih: priporočeni odmerek zdravila Kaletra so tri kapsule dvakrat na dan, zaužite s hrano.
Oral solution is available to patients who have difficulty swallowing.
Za bolnike, ki imajo težave s požiranjem, je na voljo peroralna raztopina.
2 Paediatric use (2 years of age and above): the oral solution is the recommended option for the most accurate dosing in children based on body surface area* (please refer to the Kaletra oral solution Summary of Product Characteristics).
Pediatrična uporaba (od 2. leta dalje): peroralna raztopina je priporočena možnost za najnatančnejše odmerjanje pri otrocih na podlagi telesne površine * (glejte povzetek glavnih značilnosti zdravila za peroralno raztopino zdravila Kaletra).
However, if it is judged necessary to resort to soft capsules in children, they should be used with particular caution since they are associated with less precise dosing capabilities.
Če pa se zdi potrebno uporabiti mehke kapsule pri otrocih, jih je treba uporabljati posebno previdno, ker je možnost natančnega odmerjanja z njimi manjša.
Therefore, children receiving soft capsules might have higher exposure (with the risk of increased toxicity) or sub optimal exposure (with the risk of insufficient efficacy).
Izpostavljenost pri otrocih, ki dobivajo mehke kapsule, je tako lahko večja (kar spremlja tveganje za večjo toksičnost) ali suboptimalna (kar spremlja tveganje za nezadostno učinkovitost).
Consequently when dosing children with soft capsules, therapeutic drug monitoring may be a useful tool to ensure appropriate lopinavir exposure in an individual patient.
Zato lahko terapevtsko nadziranje zdravila med uporabo mehkih kapsul pri otrocih koristi za zagotovitev primerne izpostavljenosti posameznega bolnika lopinavirju.
Paediatric Dosing Guidelines with Soft Capsules
Smernice za pediatrično odmerjanje mehkih kapsul
Body Surface Area* (m2)
telesna površina * (m2)
Twice Daily Dose (dose in mg)
odmerek dvakrat na dan (odmerek v mg)
3 soft capsules (400/ 100 mg)
1 mehka kapsula (133, 3/ 33, 3 mg) 2 mehki kapsuli (266, 6/ 66, 6 mg) 3 mehke kapsule (400/ 100 mg)
* Body surface area can be calculated with the following equation
* Telesno površino lahko izračunamo po naslednji enačbi
BSA (m2) = √ (Height (cm) X Weight (kg) / 3600)
telesna površina (m2) = √ (višina (cm) X telesna masa (kg) / 3600)
Kaletra is not recommended for use in children below 2 years of age due to insufficient data on safety and efficacy (see section 5.1).
Otroci do 2. leta starosti: zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila Kaletra pri otrocih pod 2 letoma ni priporočjiva (glejte poglavje 5. 1).
In HIV-infected patients with mild to moderate hepatic impairment, an increase of approximately 30% in lopinavir exposure has been observed but is not expected to be of clinical relevance (see section 5.2).
Okvara jeter: pri s HIV okuženih bolnikih z blago do zmerno jetrno okvaro so opazili za približno 30% večjo izpostavljenost lopinavirju, vendar ni pričakovati, da bi to bilo klinično pomembno (glejte poglavje 5. 2).
Kaletra should not be given to these patients (see section 4.3).
Ti bolniki ne smejo prejeti zdravila Kaletra (glejte poglavje 4. 3).
Renal impairment: no dose adjustment is necessary in patients with renal impairment.
Okvara ledvic: pri bolnikih z okvaro ledvic odmerka ni treba prilagoditi.
Caution is warranted when Kaletra is used in patients with severe renal impairment (see section 4.4).
Previdnost je potrebna med uporabo zdravila Kaletra pri bolnikih s hudo okvaro ledvic (glejte poglavje 4. 4).
Patients with known hypersensitivity to lopinavir, ritonavir or any of the excipients.
Bolniki z znano preobčutljivostjo za lopinavir, ritonavir ali katerokoli pomožno snov.
Patients with severe hepatic insufficiency.
Bolniki s hudo insuficienco jeter.
Kaletra should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/ or life threatening events.
Zato se je ne sme uporabljati sočasno z zdravili, katerih očistek je močno odvisen od CYP3A in pri katerih je zvečana koncentracija v plazmi povezana z resnimi in/ ali smrtno nevarnimi učinki.
These medicinal products include astemizole, terfenadine, oral midazolam (for caution on parenterally administered midazolam, see section 4.5), triazolam, cisapride, pimozide, amiodarone, ergot alkaloids (e. g. ergotamine, dihydroergotamine, ergonovine and methylergonovine) and vardenafil.
Med takšna zdravila spadajo astemizol, terfenadin, peroralni midazolam (za previdnost pri uporabi parenteralnega midazolama glejte poglavje 4. 5), triazolam, cisaprid, pimozid, amiodaron in alkaloidi ergot (npr. ergotamin, dihidroergotamin, ergonovin in metilergonovin) in vardenafil.
Herbal preparations containing St John’ s wort (Hypericum perforatum) must not be used while taking lopinavir and ritonavir due to the risk of decreased plasma concentrations and reduced clinical effects of lopinavir and ritonavir (see section 4.5).
3 Med jemanjem lopinavirja in ritonavirja se ne sme uporabljati zeliščnih pripravkov šentjanževke (Hypericum perforatum), ker obstaja tveganje za zmanjšanje koncentracije lopinavirja in ritonavirja v plazmi in zmanjšanje njunih kliničnih učinkov (glejte poglavje 4. 5).
Hepatic impairment: the safety and efficacy of Kaletra has not been established in patients with significant underlying liver disorders.
Okvara jeter: varnost in učinkovitost zdravila Kaletra nista ugotovljeni pri bolnikih s pomembnimi osnovnimi boleznimi jeter.
Kaletra is contraindicated in patients with severe liver impairment (see section 4.3).
Zdravilo Kaletra je kontraindicirano pri bolnikih s hudo okvaro jeter (glejte poglavje 4. 3).
Renal impairment: since the renal clearance of lopinavir and ritonavir is negligible, increased plasma concentrations are not expected in patients with renal impairment.
Okvara ledvic: ledvični očistek lopinavirja in ritonavirja je zanemarljiv, zato pri bolnikih z okvaro ledvic ni pričakovati zvečane koncentracije v plazmi.
Haemophilia: there have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with protease inhibitors.
Hemofilija: pri bolnikih s hemofilijo tipa A in B, zdravljenih z zaviralci proteaz, so poročali o povečanju krvavitev, vključno s spontanimi kožnimi hematomi in hemartrozami.
Treatment with Kaletra has resulted in increases, sometimes marked, in the concentration of total cholesterol and triglycerides.
Zdravljenje z zdravilom Kaletra je zvečalo koncentracijo celokupnega holesterola in trigliceridov; zvečanje je bilo včasih izrazito.
Triglyceride and cholesterol testing is to be performed prior to initiating Kaletra therapy and at periodic intervals during therapy.
Pred začetkom zdravljenja z zdravilom Kaletra je treba opraviti laboratorijski pregled trigliceridov in holesterola ter ga med zdravljenjem v rednih intervalih ponavljati.
Particular caution should be paid to patients with high values at baseline and with history of lipid disorders.
Posebna previdnost je potrebna pri bolnikih, ki imajo že izhodiščno zvišane vrednosti in anamnezo lipidnih motenj.
Lipid disorders are to be managed as clinically appropriate (see also section 4.5 for additional information on potential interactions with HMG-CoA reductase inhibitors).
(Za dodatne informacije o možnem medsebojnem delovanju z zaviralci reduktaze HMG- CoA glejte tudi poglavje 4. 5).