qanastek/EMEA-V3 huggingface dataset:
Common: nausea Uncommon: weight loss, loss of appetite, abdominal pain, diarrhoea, low blood sugar, drowsiness.
Komuni: nawżja, Mhux komuni: telf tal- piż, telf ta ’ l- aptit, uġigħ addominali, dijarrea, zokkor baxx fid- demm, ħedla.
Some patients have experienced stomach discomfort when starting the combination of sitagliptin and metformin together.
Xi pazjenti esperjenzaw skumdità fl- istonku meta bdew jieħdu l- kombinazzjoni ta ’ sitagliptin u metformin flimkien.
Some patients have experienced the following side effects while taking Januvia in combination with a sulphonylurea:
Xi pazjenti kellhom dawn l- effetti sekondarji meta kienu qed jieħdu Januvia flimkien ma ’ sulphonylurea:
Very common: low blood sugar
Komuni ħafna: livell baxx ta ’ zokkor fid- demm
Some patients have experienced the following side effects while taking Januvia in combination with a sulphonylurea and metformin:
Xi pazjenti kellhom dawn l- effetti sekondarji meta kienu qed jieħdu Januvia flimkien ma ’ sulphonylurea u metformin:
Some patients have experienced the following side effects while taking Januvia and pioglitazone:
Xi pazjenti kellhom dawn l- effetti sekondarji meta kienu qed jieħdu Januvia u pioglitazone:
Common: low blood sugar and flatulence.
Komuni: zokkor baxx fid- demm u tfewwieq.
In addition, some patients have reported foot swelling while taking Januvia and pioglitazone.
Ukoll, xi pazjenti kienu rrappurtaw sieq minfuħa waqt it - teħid ta ’ Januvia u pioglitazone.
These side effects may be seen with sitagliptin and any glitazone (e. g., rosiglitazone).
Dawn l- effetti sekondarji jistgħu jiġu osservati ma ’ sitagliptin u kull glitazone (ngħidu aħna rosiglitazone).
Some patients have experienced the following side effects while taking Januvia alone:
Xi pazjenti kellhom dawn l- effetti oħra meta kienu qed jieħdu Januvia waħdu:
Common: low blood sugar, headache Uncommon: dizziness, constipation
Komuni: zokkor baxx fid- demm, uġigħ ta ’ ras, Mhux komuni: sturdament, stitikezza
Common: upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain.
Ukoll, xi pazjenti rrappurtaw dawn l- effetti sekondarji waqt li kienu qed jieħdu Januvia Komuni: infezzjoni fil- parti ta ’ fuq ta ’ l- apparat respiratorju, mnieħer misdud jew iqattar u griżmejn iffjammati ostjoartrite u uġigħ fid- dirgħajn jew ir- riġjejn.
During post-marketing experience the following side effects have also been reported (frequency not known): allergic reactions, which may be serious, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Waqt l- esperjenza ta ’ wara t- tqegħid fis- suq ġew irrappurtati wkoll l- effetti sekondarji li ġejjin (il - frekwenza mhix magħrufa): reazzjonijiet allerġiċi li jistgħu jkunu serji nkluż raxx, ħmura tal- ġilda, u nefħa tal- wiċċ, xofftejn, ilsien, u l- gerżuma li jistgħu jikkawżaw diffikultà fit- teħid tan- nifs jew biex wieħed jibla ’.
If you have an allergic reaction, stop taking Januvia and call your doctor right away.
Jekk għandek reazzjoni allerġika, tibqax tieħu Januvia u sejjaħ lit- tabib tiegħek minnufih.
Your doctor may prescribe a medication to treat your allergic reaction and a different medication for your diabetes.
It- tabib tiegħek jista ’ jippreskrivi medikazzjoni sabiex jitratta r- reazzjoni allerġika tiegħek u mediċina differenti biex jittratta d- dijabete tiegħek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi effett minn dawn isir serju, jew jekk tinduna b ’ xi effetti sekondarji li mhux imniżżlin f’ dan il - fuljett, jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE JANUVIA
KIF TAĦŻEN JANUVIA
Do not use Januvia after the expiry date which is stated on the blister and the carton.
M’ għandekx tuża Januvia wara d- data ta’ skadenza li tidher fuq il- folja u l- kartuna.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tkun l- aħħar ġurnata ta ’ dak ix- xahar.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali m’ għandux bżonn kondizzjonijiet speċjali għall- ħażna.
Medicines should not be disposed of via wastewater or household waste.
55 Il- mediċini m’ għandhomx jintremew ma ’ l - ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu jipproteġu l- ambjent.
What Januvia contains
X’ fih Januvia
- The active substance is sitagliptin.
- Is- sustanza attiva hija sitagliptin.
Each film-coated tablet contains sitagliptin phosphate
Kull pillola miksija b’ rita fiha sitagliptin phosphate
monohydrate, equivalent to 25 mg sitagliptin.
monohydrate, ekwivalenti għal 25 mg ta ’ sitagliptin.
- The other ingredients are: microcrystalline cellulose (E460), calcium hydrogen phosphate,
- L- ingredjenti l- oħra huma: microcrystalline cellulose (E460), calcium hydrogen phosphate,
The tablet film coating contains: polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).
anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b), u sodium stearyl fumarate. Ir- rita li tiksi l- pillola fiha: polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), u yellow iron oxide (E172).
What Januvia looks like and contents of the pack
Id- Dehra ta ’ Januvia u l- kontenuti tal- pakkett:
Packs of 14, 28, 56, 84 or 98 film-coated tablets and 50 x 1 film-coated tablets in perforated unit dose blisters.
Pakketti ta ’ 14, 28, 56, 84 or 98 pillola miksija b’ rita u 50 x 1 pillola miksija b’ rita f’ folji perforati ta ’ dożi uniċi
The Marketing Authorisation Holder is:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq huwa:
The Manufacturer is:
Il- Manufattur tal- Prodott huwa:
Via Emilia, 21 27100 - Pavia Italy
Via Emilia, 21 27100 - Pavia L- Italja
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok agħmel kuntatt mar- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
Belgique/ België/ Belgien Merck Sharp & Dohme B. V.
56 Belgique/ België/ Belgien Merck Sharp & Dohme B. V.
España Merck Sharp & Dohme de España, S. A.
57 España Merck Sharp & Dohme de España, S. A.
56 This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- aħħar f ’ [data]
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott mediċinali tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) sit: http: // www. emea. europa. eu /.
Do not pass it on to others.
M ’ għandekx tgħadd lil persuni oħra.
if their symptoms are the same as yours.
ħsara, anki jekk ikollom l- istess sintomi bħal tiegħek.
please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew spiżjar tiegħek.
Possible side effects 5.
X’ effetti oħra jista ’ jkollu Kif taħżen Januvia 5.
Januvia is used in combination with certain other medicines that lower blood sugar, which you will already be taking for your diabetes together with a food and exercise plan.
Januvia jintuża ma ’ ċerti mediċini oħra li jnaqqsu l- livell taz- zokor fid- demm, li tkun diġà qed tieħu minħabba d- dijabete flimkien ma ’ ma ’ pjan ta ’ ikel u t a ’ eżerċizzju fiżiku.
58
kliewi, Januvia jista ’ ma jkunx il- mediċina adattata għalik.
Tell your doctor or pharmacist about all the medicines you take or have recently taken.
Għid lit- tabib jew lill- ispiżjar tiegħek dwar kull mediċina li qed tieħu jew li ħadt dan l- aħħar.
Driving and using machines Januvia is not expected to interfere with your ability to drive or to use machines.
M’ hemm l- ebda informazzjoni li tindika li Januvia mhux mistenni li jaffettwa l- ħila tiegħek li ssuq fis - sewqan jew biex tħaddem il- magni.
The usual dose is: − one 100 mg film-coated tablet − once a day − by mouth
Id- doża normali tkun: pillola waħda miksija b’ rita tal- 100 mg
59 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)
Effetti sekondarji komuni ħafna (iktar minn 1 kull 10 pazjenti) Effetti sekondarji komuni (inqas minn 1 kull 10 imma iktar minn 1 kull 100 pazjent) Effetti sekondarji mhux komuni (inqas minn 1 kull 100 imma iktar minn 1 kull 1000 pazjent)
The expiry date refers to the last day of that month.
Id- data ta’ skadenza tkun l- aħħar ġurnata ta ’ dak ix- xahar.
This medicinal product does not require any special storage conditions.
61 Dan il- prodott mediċinali m’ għandux bżonn kondizzjonijiet speċjali għall- ħażna.
monohydrate, equivalent to 50 mg sitagliptin.
monohydrate, ekwivalenti għal 50 mg ta ’ sitagliptin.
Round, light beige film-coated tablet with “ 112” on one side.
Pillola tonda u beige ċara miksija b’ rita bi “ 112 ” fuq naħa waħda.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok agħmel kuntatt mar- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
Belgique/ België/ Belgien Merck Sharp & Dohme B. V.
62 Belgique/ België/ Belgien Merck Sharp & Dohme B. V.
Tel.: +420 233 010 111 msd_cr@merck. com
Tel.: +420 233 010 111 Msd_ cr@ merck. com
Ísland Icepharma hf.
63 Ísland Icepharma hf.
62 This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- aħħar f ’ [data]
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Iinformazzjoni dettaljata dwar dan il- prodott mediċinali tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) sit: http: // www. emea. europa. eu /.
63 PACKAGE LEAFLET:
64 FULJETT TA ’ TAGĦRIF:
Do not pass it on to others.
M ’ għandekx tgħaddiha lil persuni oħra.
Januvia is used in combination with certain other medicines that lower blood sugar, which you will already be taking for your diabetes together with a food and exercise plan.
Januvia jintuża ma ’ ċerti mediċini oħra li jnaqqsu l- livell taz- zokor fid- demm, li tkun diġà qed tieħu minħabba d- dijabete flimkien ma ’ pjan ta’ ikel u ta ’ eżerċizzju fiżiku.
Do not take Januvia
Tihux Januvia:
- if you are allergic (hypersensitive) to sitagliptin or any of the other ingredients of Januvia.
- jekk inti allerġiku/ a (tbati minn sensittivita eċċessiva).
- any kidney problems, or any past or present medical problems.
- xi problemi bil- kliewi, jew problemi mediċi fil- pass jew fil- preżent..
64
kliewi, Januvia jista ’ ma jkunx il- mediċina adattata għalik.
However, when driving or operating machinery, it should be taken into account that dizziness and drowsiness have been reported.
Madankollu, meta ssuq jew tkun tħaddem il- magni, għandek tikkunsidra l- fatt li sturdament u - ngħas ġew irrappurtati.
If you forget to take Januvia If you miss a dose, take it as soon as you remember.
66 Jekk tinsa tieħu Januvia Jekk taqbeż doża, ħudha malli tiftakar.
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)
Effetti sekondarji komuni ħafna (iktar minn 1 kull 10 pazjenti) Effetti sekondarjikomuni (inqas minn 1 kull 10 imma iktar minn 1 kull 100 pazjent) Effetti sekondarji mhux komuni (inqas minn 1 kull 100 imma iktar minn 1 kull 1000 pazjent)
- The active substance is sitagliptin.
- L- ingredjenti attiva hija sitagliptin.
monohydrate, equivalent to 100 mg sitagliptin.
monohydrate, ekwivalenti għal 100 mg ta ’ sitagliptin.
- The other ingredients are: microcrystalline cellulose (E460), calcium hydrogen phosphate,
- Is- sustanzi l- oħra huma: microcrystalline cellulose (E460), calcium hydrogen phosphate,
What Januvia looks like and contents of the pack
Kif tidher Januvia u l- kontenut tal- pakk.
Round, beige film-coated tablet with “ 277” on one side.
Pillola tonda u beige miksija b’ rita bi “ 277 ” fuq naħa waħda.
Packs of 14, 28, 56, 84 or 98 film-coated tablets and 50 x 1 film-coated tablets in perforated unit dose blisters.
Pakketti ta ’ 14, 28, 56, 84 or 98 pillola miksija b’ rita u 50 x 1 pillola miksija b’ rita f’ folji perforati ta ’ dożi uniċi (għall- użu fl- isptar).
Belgique/ België/ Belgien Merck Sharp & Dohme B. V.
68 Belgique/ België/ Belgien Merck Sharp & Dohme B. V.
Ísland Icepharma hf.
69 Ísland Icepharma hf.
68 This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- aħħar f ’ [data]
What is Kaletra?
X' inhu Kaletra?
Kaletra is a medicine containing two active substances, lopinavir and ritonavir.
Kaletra huwa mediċina li fiha żewġ sustanzi attivi, lopinavir u 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:
Jiġi f' kapsuli oranġjo (133. 3 mg lopinavir u 33. 3 mg ritonavir), soluzzjoni orali (80 mg lopinavir u 20 mg ritonavir kull millilitru) u pilloli (sofor ċari:
100 mg lopinavir and 25 mg ritonavir; yellow:
100 mg lopinavir u 25 mg ritonavir; sofor:
200 mg lopinavir and 50 mg ritonavir).
200 mg lopinavir u 50 mg ritonavir;).
What is Kaletra used for?
Għalxiex jintuża Kaletra?
Kaletra is an antiviral medicine.
Kaletra huwa mediċina antivirali.
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).
Huwa jintuża flimkien ma 'mediċini antivirali oħra għat- trattament ta' persuni adulti u tfal ta '' l fuq minn sentejn li jkunu infettati bil- vajrus tal- immunodefiċjenza uman tat- tip 1 (HIV- 1), vajrus li jikkawża s- sindromu minn immunodefiċjenza akkwiżita (AIDS).
The medicine can only be obtained with a prescription.
Din il- mediċina tista 'tinkiseb biss b' riċetta.
How is Kaletra used?
Kif jintuża Kaletra?
Treatment with Kaletra should be prescribed by a doctor who has experience in the management of HIV infection.
It- trattament b' Kaletra għandu jkun ordnat minn tabib li jkollu esperjenza fil- ġestjoni ta 'infezzjoni bl - HIV.
The recommended dose of Kaletra is three capsules, 5 ml of the oral solution, or two 200/ 50 mg tablets twice a day.
Id- doża rakkomandata ta 'Kaletra hija tliet kapsuli, 5 ml tas- soluzzjoni orali, jew żewġ pilloli tal - 200/ 50 mg darbtejn kuljum.
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.
Din id- doża hija adatta għal persuni adulti u tfal bil- kundizzjoni li jiżnu aktar minn 40 kg u għandhom erja tas- superfiċje tal- ġisem (ikkalkulata bl- użu tat- tul u l- piż tat - tifel/ tifla) ta '' l fuq minn 1. 4 m2.
The dose for smaller children depends on the child’ s body surface area and the other medicines that the child is taking.
Id- doża għat- tfal iżgħar fid- daqs jiddependi mill- erja tas- superfiċje tal- ġisem tat- tifel/ tifla u fuq il- mediċini l- oħra li jkunu qegħdin jingħataw.
The oral solution is for patients who cannot take the tablets or capsules.
Is- soluzzjoni orali hija għal dawk il- pazjenti li ma jistgħux jieħdu pilloli jew kapsuli.
The capsules and oral solution must be taken with food, but the tablets can be taken with or without food.
Il- kapsuli u s- soluzzjoni orali għandhom jittieħdu mal- ikel, iżda l- pilloli jistgħu jittieħdu mal- ikel jew waħedhom.
Kaletra tablets should be swallowed whole and not chewed, broken or crushed.
Il- pilloli ta ’ Kaletra għandhom jinbelgħu sħaħ u l- pazjent ma għandux jomgħodhom, ikissirhom jew ifarrakhom.
Kaletra should not be taken by patients with severe liver disease.
Kaletra m' għandux jittieħed minn pazjenti li jkollhom mard gravi fil- fwied.
Caution is needed in patients with severe kidney disease.
Tinħtieġ kawtela fil- każ ta 'pazjenti b' mard gravi fil- kliewi.
For more information, see the Package Leaflet.
Għal aktar informazzjoni, ara l- Fuljett ta 'Tagħrif.
How does Kaletra work?
Kif jaħdem Kaletra?
Kaletra contains two active substances, lopinavir and ritonavir.
Kaletra fih żewġ sustanzi attivi, lopinavir u ritonavir.
Both substances are protease inhibitors: they block an enzyme called protease that is involved in the reproduction of HIV.
Iż- żewġ sustanzi huma inibituri tal- proteażi: huma jimblokkaw enzima msejħa proteażi li hija involuta fir- riproduzzjoni tal- HIV.
When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Meta l- enzima tiġi imblukkata, il- vajrus ma jirriproduċix ruħu b' mod normali, li jittardja l- firxa tal- infezzjoni.
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.
F' Kaletra, lopinavir jipprovdi l- attività u ritonavir jintuża bħala 'booster' li jnaqqas ir- rata li biha lopinavir jiġi dekompost mill- fwied.
This increases the levels of lopinavir in the blood, allowing a lower dose of lopinavir to be used for the same antiviral effect.
Dan iżid il- livelli ta 'lopinavir fid- demm, li jippermetti li tintuża doża aktar baxxa ta' lopinavir għall- istess effett antivirali.
Kaletra does not cure HIV
Kaletra ma jfejjaqx infezzjoni tal- HIV jew l- AIDS,
Reproduction is authorised provided the source is acknowledged. infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Reproduction is authorised provided the source is acknowledged. iżda jista 'jittardja l- ħsara fis- sistema immunitarja u l- iżvilupp ta' infezzjonijiet u mard assoċjati mal - HIV.
How has Kaletra been studied?
Kif ġie studjat Kaletra?
There were two main studies of Kaletra in adults and one in children.
Kien hemm żewġ studji prinċipali ta 'Kaletra fl- adulti u wieħed fit- tfal.
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).
L- ewwel studju kien jinkludi 653 pazjent adult 'naïve għat- trattament' (pazjenti li ma kinux ġew ittrattati għall- infezzjoni tal- HIV qabel), fejn Kaletra tqabbel ma 'nelfinavir (mediċina antivirali oħra).
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.
It- tieni studju kien jinkludi 118- il pazjent adult li kienu ħadu inibitur tal- proteażi ieħor fil- passat, fejn Kaletra tqabbel ma 'inibitur tal - proteażi ieħor magħżul mill- investigatur tal- istudju fuq bażi ta' pazjent pazjent.
The third study involved 100 children, who were given one of two doses of Kaletra.
It- tielet studju kien jinvolvi 100 tifel/ tifla, li ngħataw waħda minn żewġ dożi ta 'Kaletra.
For all three studies, Kaletra and the comparator medicines were combined with other antiviral medicines.
Fit- tliet studji, Kaletra u l - mediċini tat- tqabbil kienu kkombinati ma 'mediċini antivirali oħrajn.
The main measure of effectiveness was the number of patients who had undetectable levels of HIV-1 in their blood (viral loads) after treatment.
Il- kejl prinċipali tal- effikaċja kien in- numru ta 'pazjenti li kellhom livelli mhux indentifikabbli ta' HIV- 1 fid- demm tagħhom (tagħbijiet virali) wara t- trattament.
What benefit has Kaletra shown during the studies?
X' benefiċċju wera Kaletra matul l- istudji?
In all of the studies, Kaletra reduced viral loads.
Fl- istudji kollha, Kaletra naqqas it- tagħbijiet virali.
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).
Fl- istudju tal- pazjenti adulti naïve għat- trattament, 79% mill- pazjenti li kienu qegħdin jieħdu Kaletra (259 minn 326) kellhom tagħbijiet virali taħt 400 kopja/ ml wara 24 ġimgħa, meta mqabbla mal- 71% mill- pazjenti li kienu qegħdin jieħdu nelfinavir (233 minn 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).
Fl- istudju tal- pazjenti li kienu ħadu inibitur tal- proteażi qabel, 73% mill- pazjenti li kienu qegħdin jieħdu Kaletra (43 minn 59) kellhom tagħbijiet virali taħt 400 kopja/ ml wara 16- il ġimgħa, meta mqabbla mal- 54% mill- pazjenti li kienu qegħdin jieħdu mediċini tat- tqabbil (32 minn 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.
Riżultati simili dehru biż- żewġ dożi ta 'Kaletra fl- istudju tat- tfal: madwar 70% kellhom tagħbijiet virali taħt 400 kopja/ ml wara 12- il ġimgħa ta' trattament.
What is the risk associated with Kaletra?
X' inhu r- riskju assoċjat ma 'Kaletra?
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).
L- aktar effetti sekondarji komuni fl- adulti (jidhru f' aktar minn 1 minn kull 10 pazjenti) huma dijarrea, u bidliet fil- livelli tax- xaħam fid- demm (kolesterol u trigliċeridi) u tal- enzimi fil- fwied (GGT).
The side effect profile is similar in children.
Il - profil tal- effetti sekondarji huwa simili fit- tfal.
For the full list of all side effects reported with Kaletra, see the Package Leaflet.
Għal- lista kompleta tal- effetti sekondarji kollha rrapportati b' Kaletra, ara l- Fuljett ta 'Tagħrif.
Kaletra should not be used in people who may be hypersensitive (allergic) to lopinavir, ritonavir or any of the other ingredients.
Kaletra m' għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal lopinavir, ritonavir jew xi sustanzi oħra.
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.
Kaletra m' għandux jintuża minn pazjenti b' mard tal- fwied sever jew dawk li jkunu qegħdin jieħdu xi waħda mill- mediċini li ġejjin: • mediċini li jitkissru (jiddekomponu) fl- istess mod bħal Kaletra u li jikkawżaw ħsara f' livelli għoljin fid- demm.
See the Package Leaflet for a full list of these medicines; • St John’ s wort (a herbal preparation used to treat depression).
Ara l- Fuljett ta 'Tagħrif għal- lista sħiħa ta' dawn il- mediċini; • fexfiexa tar- raba '(St John' s wort) (preparazzjoni tal- ħxejjex għat- trattament tad- depressjoni), rifampicin (użat għall- kura tat- tuberkulosi).
Caution is also needed by patients taking Kaletra at the same time as other medicines.
Tinħtieġ ukoll kawtela minn pazjenti li jkunu qegħdin jieħdu Kaletra fl- istess ħin ma 'mediċini oħra.
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).
Bħal fil- każ ta 'kull mediċina oħra kontra l- HIV, il- pazjenti li jkunu qegħdin jieħdu Kaletra jistgħu jkunu f' riskju ta' lipodistrofija (tibdil fid- distribuzzjoni tax- xaħam tal- ġisem), osteonekrosi (mewt tat - tessut tal- għadam) jew is- sindromu tar- rijattivazzjoni immuni (sintomi ta 'infezzjoni kkawżati mis - sistema immunitarja li tkun qiegħda tirkupra).
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.
Il- pazjenti li jkollhom problemi bil- fwied tagħhom (inkluża infezzjoni bl- epatite B jew Ċ) jistgħu jkunu f' riskju għoli ta 'ħsara fil- fwied meta jieħdu Kaletra.
Why has Kaletra been approved?
Għaliex ġie approvat Kaletra?
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.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu fil- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Kaletra huma akbar mir- riskji tiegħu għat- trattament ta' persuni adulti u tfal ta '' l fuq minn sentejn infettati bl- HIV- 1, flimkien ma 'aġenti antiretrovirali oħra.
The Committee recommended that Kaletra be given marketing authorisation.
Huwa rrakkomanda li Kaletra jingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
Kaletra was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval.
Oriġinarjament Kaletra kien awtorizzat f '"Ċirkostanzi Eċċezzjonali", minħabba li, għal raġunijiet xjentifiċi, kienet disponibbli informazzjoni limitata fil- ħin tal- approvazzjoni.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 12 November 2002.
Billi l- kumpanija kienet ipprovdiet it- tagħrif addizzjonali mitlub, iċ - "Ċirkostanzi Eċċezzjonali" spiċċaw fit- 12 ta 'Novembru 2002.
Which measures are being taken to ensure the safe use of Kaletra?
2/ 3 X' miżuri qegħdin jittieħdu biex jiġi assigurat l- użu bla periklu ta '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.
Billi qabel, Kaletra kien jiġi biss bħala kapsuli u soluzzjoni orali, il- kumpanija li tipproduċi Kaletra se tipprovdi ittra għall- persuni involuti fit- trattament ta 'pazjenti li jkunu qegħdin jieħdu l- mediċina.
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.
Din se tispjega d- differenzi bejn il- kapsuli u l- pilloli Kaletra, biex tiġi evitata l- konfużjoni dwar l- ammont ta 'pilloli li l- pazjenti għandhom jieħdu waqt li jkunu qegħdin jiġu introdotti l- pilloli.
2/ 3 Other information about Kaletra:
Tagħrif ieħor dwar Kaletra:
The European Commission granted a marketing authorisation valid throughout the European Union for Kaletra to Abbott Laboratories Limited on 20 March 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Kaletra lil Abbott Laboratories Limited fl- 20 ta 'Marzu 2001.
The marketing authorisation was renewed on 20 March 2006.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fl- 20 ta 'Marzu 2006.
The full EPAR for Kaletra can be found here.
L- EPAR sħiħ għal Kaletra jista 'jiġi kkonsultat hawn.
This summary was last updated in 07-2008.
Dan is- sommarju kien approvat l- aħħar fi:
Invented name
Isem inventat Qawwa
Pharmaceutical Form
Għamla farmaċewtika Mnejn
Route of Administration
jingħata
133.3 mg / 33.3 mg 133.3 mg / 33.3 mg
Kaletra 133. 3 mg / 33. 3 mg Kaletra 133. 3 mg / 33. 3 mg
Capsule, soft Capsule, soft
Kapsula, ratba Kapsula, ratba
Oral use Oral use
Użu mill- ħalq Użu mill- ħalq
bottle (HDPE) blister (PVC)
Flixkun (HDPE) Folja (PVC)
180 capsules 180 capsules
180 kapsula 180 kapsula
(80 mg + 20 mg) / ml 200 mg/ 50 mg 200 mg / 50 mg 100 mg / 25 mg
Kaletra (80 mg + 20 mg) / ml Kaletra 200 mg / 50 mg
Oral solution film-coated tablets film-coated tablets film-coated tablets
Soluzzjoni orali Pilloli miksijin b’ rita
Oral use Oral use Oral use Oral use
Użu mill- ħalq Użu mill- ħalq
bottle (PET) bottle (HDPE) blister (PVC) bottle (HDPE)
Flixkun (PET) Flixkun (HDPE)
5 bottles + 5 x 5 ml syringes 120 tablets 120 tablets 60 tablets
5 fliexken + 5 x 5 ml siringi 120 pillola
Kaletra 133.3 mg/ 33.3 mg soft capsules
Kaletra 133. 3 mg/ 33. 3 mg kapsuli, rotob
Each Kaletra soft capsule contains 133.3 mg of lopinavir co-formulated with 33.3 mg of ritonavir as a pharmacokinetic enhancer.
Kull kapsula ratba Kaletra fiha 133. 3 mg lopinavir ko- formulata ma ’ 33. 3 mg ritonavir bħala qanqiel farmakokinetiku.
Name of the
Isem ta ’
Quantity per capsule
Kwantita f’ kull kapsula
- active substance
- sustanza attiva
- excipient (s) capsule fill
- sustanza( i) mhux attiva( i) fil- mili tal -
Propylene glycol Castor Oil Polyoxyl 35
Propylene glycol Castor Oil Polyoxyl 35
- excipient (s) capsule shell
- sustanza( i) mhux attiva( i) fil- kappa tal -
Anhydrized liquid sorbitol – glycerol blend Sunset yellow (E110)
Anhydrized liquid sorbitol – glycerol blend Sunset yellow (E110)
132.2 mg 0.8 mg
132. 2 mg 0. 8 mg
For a full list of excipients, see section 6.1.
Għall- lista ta ’ sustanzi mhux attivi, ara Sezzjoni 6. 1.
Soft capsule
Kapsula, ratba
The capsules are orange with a black ink imprint of [Abbott logo] and “ PK”.
Il- kapsuli huma oranġjo b’ impronta ta ’ inka sewda ta ’ [l- arma Abbott] u “ 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.
Kaletra huwa indikat għat- trattament ta ’ adulti u tfal ’ il fuq minn sentejn infettati b’ HIV- 1, ikkombinat ma aġenti antiretrovirali oħra.
Most experience with Kaletra is derived from the use of the product in antiretroviral therapy naïve patients.
L- aktar esperjenza b’ Kaletra hija derivata mill- użu ta ’ dan il- prodott f’ terapija antiretrovirali f ’ pazjenti novizzi għal din it- terapija.
Data in heavily pretreated protease inhibitor experienced patients are limited.
Data f’ pazjenti prettratati bil- qawwa bi inibituri tal- protease hija limitata.
There are limited data on salvage therapy on patients who have failed therapy with Kaletra.
Hemm data limitata fuq terapija ta ’ salvataġġ f’ pazjenti li fallew it- terapija b’ Kaletra.
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).
Ix- xelta li tuża Kaletra biex tittrata pazjenti infettati b’ HIV- 1 prettratati bil- qawwa b’ inibituri tal - protease għandha tkun ibbażżata fuq testijiet ta ’ reżistenza virali individwali u storja ta ’ trattament tal - pazjenti (ara sezzjonijiet 4. 4 u 5. 1).
4.2 Posology and method of administration
2 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
Kaletra should be prescribed by physicians who are experienced in the treatment of HIV infection.
Kaletra għandu jiġi preskritt minn tobba li għandhom esperjenza fi trattamenti ta ’ infezzjoni ta ’ HIV.
Adult and adolescent use: the recommended dosage of Kaletra is three capsules twice daily taken with food.
Użu fl- Adulti u fl- adoloxxenti: id- doża rrikmandata ta ’ Kaletra hija ta ’ tlett kapsuli darbtejn kuljum ma ’ l- ikel.
Oral solution is available to patients who have difficulty swallowing.
Soluzzjoni orali hija disponibbli għall- pazjenti li għandhom diffikulta biex jibilgħu.
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).
Użu Pediatriku (sentejn u fuqhom): is- soluzzjoni orali hija l- għażla irrikandata għall- aktar dużaġġ akkurat fi tfal ibbażat fuq l- arja tal- wiċċ tal- ġisem * (jekk jogħġbok irreferi għall- Karatteristiċi tal - Prodott fil qosor tas- Soluzzjoni Orali ta ’ 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.
Minkejja dan, jekk jiġi meqjus neċessarju rikorriment għall- kapsuli rotob fi tfal, il- kapsuli għandhom jiġu wżati b’ kawtiela partikulari għaliex huma assoċċjati ma preċiżjoni inqas fil- kapaċitajiet ta ’ dużaġġ.
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).
Għalekk, tfal li jirċievu kapsuli rotob jistgħu ikunu iktar esposti (bir- riskju ta’ aktar tossiċita) jew ikollhom esposizzjoni sub- ottimali (bir - riskju ta ’ effikaċja li ma tkunx biżżejjed).
Consequently when dosing children with soft capsules, therapeutic drug monitoring may be a useful tool to ensure appropriate lopinavir exposure in an individual patient.
Għal din ir- raġuni meta tfal jieħdu dużaġġ ta ’ kapsuli rotob, monitoraġġ terapewtiku tal- mediċina jista jgħin biex tiġi assigurata esposizzjoni appropjata ta ’ lopinavir f’ pazjent individwali.
Paediatric Dosing Guidelines with Soft Capsules
Gwida ta ’ Dożaġġ b’ kapsuli rotob f’ pazjenti pedjatriċi
Body Surface Area* (m2)
Arja ta ’ wiċċ tal- ġisem * (m2)
Twice Daily Dose (dose in mg)
Dużaġġ darbtejn kuljum (doża f’ mg)
0.40 – 0.75 0.80 – 1.3
0. 40 − 0. 75 0. 80 − 1. 3
1 soft 2 soft
1 2
capsule (133.3/ 33.3 mg) capsules (266.6/ 66.6 mg)
kapsula ratba (133. 3/ 33. 3 mg) kapsuli rotob (266. 6/ 66. 6 mg)
1.4 – 1.75
1. 4 − 1. 75
3 soft capsules (400/ 100 mg)
3 kapsuli rotob (400/ 100 mg)
* Body surface area can be calculated with the following equation
* L- arja tal- wiċċ tal- ġisem tista tiġi kkalkulata bill- fomula li jmiss
BSA (m2) = √ (Height (cm) X Weight (kg) / 3600)
BSA (m2) = √ (Tul (ċentimetri) X Piż (kilogrammi) / 3600)
Children less than 2 years of age:
Tfal li għandhom inqas minn sentejn:
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).
Kaletra mhux irrikmandat għal użu fi tfal li għandhom inqas minn sentejn minħabba data limitata ta ’ sigurtà u effikaċja (ara sezzjoni 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).
F’ pazjenti infettati b’ HIV u b’ indeboliment tal- fwied ħafif għal moderat, ġiet osservata żieda approssimattiva ta ’ 30% ta ’ esposizzjoni għal lopinavi, imma mhix mistennija li tkun klinikament ta ’ importanza (ara sezzjoni 5. 2).
No data are available in patients with severe hepatic impairment.
Ma hawnx informazzjoni ta ’ użu f ’ pazjenti b’ indeboliment serju ħafna tal- fwied.
Kaletra should not be given to these patients (see section 4.3).
Kaletra ma għandux jingħata lil dawn il pazjenti (ara sezzjoni 4. 3).
Renal impairment: no dose adjustment is necessary in patients with renal impairment.
L- ebda aġġustament fid- doża m’ hu neċessarju f’ pazjenti b’ indeboliment tal - kliewi.
Caution is warranted when Kaletra is used in patients with severe renal impairment (see section 4.4).
Kawtiela hija neċċeserja meta Kaletra jintuża f ’ indeboliment tal- kliewi serju ħafna (ara sezzjoni 4. 4).
Patients with known hypersensitivity to lopinavir, ritonavir or any of the excipients.
Pazjenti sensittivi għal lopinavir, ritonavir jew għal xi sustanzi mhux attivi.
Patients with severe hepatic insufficiency.
Pazjenti b’ insuffiċjenza serja ħafna tal- fwied.
Kaletra contains lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A.
Kaletra fih lopinavir u ritonavir, it- tnejn li huma inibituri ta ’ l- iżoforma ta ’ P450 - CYP3A.
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.
Kaletra m’ għandux jiġi ko- amministrat ma prodotti mediċinali dipendenti fuq CYP3A għat- tneħħija mill- ġisem u prodotti mediċinali li konċentrazzjoni elevata fil- plażma tagħhom hija assoċjata ma avvenimenti serji li huma ta ’ periklu għall- ħajja.
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.
3 midazolam li jittieħed mill- ħalq (sabiex tiġi eżerċitata kawtela meta midazolam jiġi mgħoti parenteralment, ara sezzjoni 4. 5), triazolam, cisapride, pimozide, amiodarone, ergot alkaloids (eż. ergotamine, dihydroergotamine, ergonovine u methylergonovine) u 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).
Preparazzjonijiet mill- ħxejjex li fihom St John’ s wort (Hypericum perforatum) m’ għandhomx jintużaw waqt it- teħid ta ’ lopinavir u ritonavir minħabba r- riskju ta’ tnaqqis fil - konċentrazzjoni fil- plażma u tnaqqis fl- effetti kliniċi ta ’ lopinavir u ritonavir (ara sezzjoni 4. 5).
Patients with coexisting conditions
Pazjenti b ’ kundizzjonijiet ko- eżistenti
Hepatic impairment: the safety and efficacy of Kaletra has not been established in patients with significant underlying liver disorders.
Indeboliment tal- fwied: is- sigurtà u l- effikaċja ta ’ Kaletra ma ġietx stabbilita f’ pazjenti bi problemi tal - fwied sottostanti.
Kaletra is contraindicated in patients with severe liver impairment (see section 4.3).
Kaletra huwa kontra- indikat f’ pazjenti b’ indeboliment tal- fwied serju ħafna (ara sezzjoni 4. 3).
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Pazjenti b’ epatite B jew Ċ u ttratati b’ taħlita ta ’ terapija antiretrovirali qiegħdin f’ riskju akbar ta ’ reazzjonijiet avversi serji ħafna u potenzjalment fatali għall- fwied.
In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products.
F’ każ li terapiji antiretrovirali jittieħdu flimkien għal epatite B jew Ċ, jekk jogħġbok irreferi għall- informazzjoni tal - prodott għal dawn il- prodotti mediċinali.
Patients with pre-existing liver dysfunction including chronic hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Pazjenti b’ disfunzjoni tal- fwied ġa eżistenti, inkluża l- epatite kronika għandhom żieda fil- frekwenza funzjoni tal- fwied mhux normali waqt terapija kkombinata antiretrovirali, u għandhom ikunu monitorati kif titlob il- pratika standard.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment should be considered.
Jekk hemm evidenza ta ’ aggravar ta ’ mard fil- fwied f’ dawn il- pazjenti, l - interuzzjoni jew it- twaqqif tat- trattament għandu jkun ikkunsidrat.
Renal impairment: since the renal clearance of lopinavir and ritonavir is negligible, increased plasma concentrations are not expected in patients with renal impairment.
Indeboliment renali: peress li t- tneħħija mill- kliewi ta ’ lopinavir u ritonavir huwa negliġibli, żidiet fil - konċentrazzjoni fil- plażma mhumiex mistennija f’ pazjenti b’ indeboliment tal- kliewi.
Because lopinavir and ritonavir are highly protein bound, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis.
Minħabba li lopinavir u ritonavir jingħaqdu ħafna mall- proteini, aktarx li ma jitneħħewx bid- dijaliżi tad- demm jew bid- dijaliżi peritoneali.
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.
Emofilija: kien hemm rapporti ta ’ żieda fit- telf ta ’ demm, li jinkludu ematomi spontanji fil- ġilda u artrożi tad- demm f’ pazjenti b’ emofilija tip A u B li ġew ittratati b’ inibituri tal- protease.
In some patients additional factor VIII was given.
F’ xi ftit pazjenti ġie mogħti ukoll il- fattur VIII.
In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
F’ iżjed min- nofs il- każi rappurtati, t- trattament b’ inibituri tal - protease tkompla jew ġie re- introdott jekk it- trattament kien twaqqaf.
A causal relationship had been evoked, although the mechanism of action had not been elucidated.
Relazzjoni kawżali kienet evokata, avolja il- mekkaniżmu ta ’ azzjoni ma ġietx eluċidata.
Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Pazjenti emofiliċi għandhom ikunu magħrrfa bill- possibilita ta ’ żieda fit- telf ta ’ demm.
Lipid elevations
Elevazzjonijiet fil- lipidi
Treatment with Kaletra has resulted in increases, sometimes marked, in the concentration of total cholesterol and triglycerides.
It- trattament b’ Kaletra irriżulta f’ żieda, xi kultant markata, fil- konċentrazzjoni tal- kolesterol totali u trigliċeridi.
Triglyceride and cholesterol testing is to be performed prior to initiating Kaletra therapy and at periodic intervals during therapy.
Testijiet tat- trigliċeridi u tal- kolesterol għandhom isiru qabel ma tinbeda t- terapija b’ Kaletra u f’ intervalli perjodiċi waqt it- trattament.
Particular caution should be paid to patients with high values at baseline and with history of lipid disorders.
Għandha tintwera kawtiela partikolari lill- pazjenti b’ valuri għolja fil- linja bażi u bi storja ta ’ problemi tal- lipidi.
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).
Problemi tal- lipidi għandhom jiġu mmaneġjati b’ modd kliniku approprjat (ara anke sezzjoni 4. 5 għal aktar informazzjoni dwar interazzjonijiet potenzali ma inibituri HMG- CoA reductase).
Cases of pancreatitis have been reported in patients receiving Kaletra, including those who developed hypertriglyceridaemia.
Każijiet ta ’ pankreatite ġew irrapurtati f’ pazjenti li qed jieħdu Kaletra, inklużi dawk li żvillupaw ipertrigliċeridimja.
In most of these cases patients have had a prior history of pancreatitis and/ or concurrent therapy with other medicinal products associated with pancreatitis.
F’ bosta minn dawn il- każijiet, il- pazjenti kellhom storja ta ’ pankreatite preċedenti jew/ u terapiji, meħudin flimkien, ta’ prodotti mediċinali oħra assoċċjati ma pankreatite.
Marked triglyceride elevation is a risk factor for development of pancreatitis.
Elevazzjoni markata trigliċerida huwa fattur ta ’ riskju ta ’ żvillup ta ’ pankreatite.
Patients with advanced HIV disease may be at risk of elevated triglycerides and pancreatitis
Pazjenti bill- marda ta ’ l- HIV avvanzata jista ’ jkollom riskju ta ’ trigliċeridi elevati u pankreatite.
Pancreatitis should be considered if clinical symptoms (nausea, vomiting, abdominal pain) or abnormalities in laboratory values (such as increased serum lipase or amylase values) suggestive of pancreatitis should occur.
4 Il- pankreatite għandha tkun ikkunsidrata jekk sintomi kliniċi (nawsja, rimettar, uġigħ addominali) jew valuri tal- laboratorju mhux normali (bħal żieda fis- serum lipase u valuri tal- amilase) suġġestivi ta ’ pankreatite iseħħu.
Patients who exhibit these signs or symptoms should be evaluated and Kaletra therapy should be suspended if a diagnosis of pancreatitis is made (see section 4.8).
Pazjenti li jkollhom dawn is- sinjali jew sintomi għandhom ikunu evalwati u it - terapija b’ Kaletra għandha tkun sospiża jekk issir dijanjosi ta ’ pankreatite (ara sezzjoni 4. 8).
New onset diabetes mellitus, hyperglycaemia or exacerbation of existing diabetes mellitus has been reported in patients receiving protease inhibitors.
Żvilupp ta ’ dijabete mellitus, ipergliċemija jew aggravar ta ’ diabete mellitus ġa eżistenti kien irrapurtat f’ pazjenti li qed jieħdu inibituri tal- proteajż.
In some of these the hyperglycaemia was severe and in some cases also associated with ketoacidosis.
F’ xi ftit minn dawn il- każi l- ipergliċemija kienet serja ħafna u f’ xi każi assoċjata anke b’ ketoaċidożi.
Many patients had confounding medical conditions some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycaemia.
Ħafna pazjenti kellhom kundizzjonijiet mediċi f’ konflitt li xi ftit minnhom kienu jinħtieġu terapija b’ aġenti li kienu assoċjati ma żvilupp ta ’ dijabete mellitus jew ipergliċemija.
4 Fat redistribution & metabolic disorders
Ridistribuzzjoni tax- xaħam u problemi metaboliċi
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients.
Terapija kkombinata antiretrovirali ġiet assoċjata mar- ridistribuzzjoni tax- xaħam (lipodistrofija) f’ pazjenti bl- HIV.
The long-term consequences of these events are currently unknown.
Il- konsegwenzi fit- tul ta ’ dawn l- avvenimenti huma ma humiex magħrufa preżentement.
Knowledge about the mechanism is incomplete.
Tagħrif dwar il- mekkaniżmu mhuwiex komplett.
A connection between visceral lipomatosis and protease inhibitors (PIs) and lipoatrophy and nucleoside reverse transcriptase inhibitors (NRTIs) has been hypothesised.
Konnessjoni bejn lipomatożi vixxerali u inibituri tal- protease (PIs) u lipoatrofija u inibituri ta ’ nucleoside reverse transcriptase (NRTIs) ġie ipotizzat.
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Riskju ogħla ta ’ lipodistrofija ġie assoċjat ma fatturi individwali bħax- xjuħija, u fatturi relatati mal- mediċini, bħal żieda fit- tul tat- trattament antiretrovirali u disturbi metaboliċi assoċjati.
Clinical examination should include evaluation for physical signs of fat redistribution.
Eżami kliniku għandu jinkludi evalwazzjoni għal sinjali fiżici ta ’ redistribuzzjoni tax- xaħam.
Consideration should be given to measurement of fasting serum lipids and blood glucose.
Għandu jiġi kkunsidrat il- kejl ta ’ lipidi fis- serum meta tkun sajjem u l- glukożju fid- demm.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Problemi tal- lipidi għandhom jiġu mmaniġjati b’ modd kliniku approprjat (ara sezzjoni 4. 8).
Immune Reactivation Syndrome
Sindromi ta ’ riattivazzjoni immunitarja
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymtomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
F’ pazjenti infettati bl- HIV, b’ immunodefiċenza serja ħafna meta tinbeda kombinazzjoni ta ’ trattament antiretrovirali (CART), reazzjoni inflammatorja għal patoġeni opportunistiċi asintomatiċi jew residwali tista toħroġ u tikkawża kundizzjonijiet kliniċi serji, jew aggravar tas- sintomi.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Tipikament, reazzjoniet bħal dawn ġew osservati matul l- ewwel ftit ġimgħat jew xhur mill- bidu tat- trattament ta ’ CART.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
Eżempji relevanti huma retinite ta ’ ċitomegalovirus, ġeneralizzata u/ jew infezzjonijiet mikobakterjali, u pulmonite Pneumocystis carinii.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Sintomi infjammatorji għandhom jiġu evalwati u t- trattamenti mogħtija meta jkun neċessarju.
Osteonecrosis
Ostjonekrożi