qanastek/EMEA-V3 huggingface dataset:
Take special care with CRIXIVAN You should know that CRIXIVAN is not a cure for HIV infection and that you may continue to develop infections or other illnesses associated with HIV disease.
Oqgħod attent ħafna bi CRIXIVAN Għandek tkun taf li CRIXIVAN mhux kura għall- infezzjoni ta ’ l- HIV u li tista ’ tkompli tiżviluppa infezzjonijiet jew mard marbut mal- marda ta ’ l- HIV.
You should, therefore, remain under the care of your doctor while taking CRIXIVAN.
Għalhekk, għandek tibqa ’ taħt il- kura tat- tabib tiegħek meta qed tieħu CRIXIVAN.
HIV infection is a disease spread by contact with blood or sexual contact with an infected individual.
L- infezzjoni ta ’ l- HIV hija marda li tinfirex bil- kuntatt bid- demm jew bil- kuntatt sesswali ma ’ bniedem infettat.
Treatment with CRIXIVAN has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination.
Il- kura bi CRIXIVAN ma werietx li tnaqqas it- trażmissjoni ta ’ l- HIV lil oħrajn permezz ta ’ kuntatt sesswali jew kontaminazzjoni tad- demm.
Please speak with your doctor if you have a history of liver disease.
Jekk jogħġbok kellem lit- tabib tiegħek jekk għandek storja ta ’ mard fil- fwied.
Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require blood tests for control of liver function.
Pazjenti b’ epatite B jew C kronika u li qed jiġu kkurati b’ aġenti antiretrovirali għandhom riskju ikbar għal ġrajjiet avversi severi u potenzjalment fatali tal- fwied u jista ’ jkollhom bżonn testijiet tad- demm biex tiġi kkontrollata l- funzjoni tal- fwied.
Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy.
Ir- ridistribuzzjoni, l- akkumulu u t- telfien tax- xaħam tal- ġisem jista ’ jseħħ f’ pazjenti li qed jingħataw terapija antiretrovirali kombinata.
Contact your doctor if you notice changes in body fat.
Ikkuntattja lit- tabib tiegħek jekk tinduna b’ bidliet fix- xaħam tal - ġisem.
Bone problems Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Problemi fl- għadam Xi pazjenti li jieħdu terapija antiretrovirali kombinata jistgħu jiżviluppaw marda fl- għadam imsejħa ostejonekrożi (mewt tat- tessut ta ’ l- għadam minħabba n- nuqqas ta ’ demm li jmur lejn l- għadma).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Xi wħud mill- fatturi ta ’ riskju li jistgħu iwasslu għal din il- marda jinkludu, fost oħrajn, t- tul tat- terapija antiretrovirali kombinata, użu tal- kortikosterojdi, konsum ta ’ l- alkolħol, immunosoppressjoni severa u indiċi ogħla tal- massa tal- ġisem.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Is- sinjali ta ’ l- ostejonekrożi jinkludu ebusija fil- ġogi, uġigħ (speċjalment fil- ġenb, l- irkoppa u l- ispalla) u diffikultà fil- moviment.
If you notice any of these symptoms please inform your doctor.
Jekk tinnota xi wieħed minn dawn is- sintomi jekk jogħġbok informa lit- tabib tiegħek.
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
F’ xi pazjenti b’ infezzjoni avvanzata ta ’ l- HIV (AIDS) u storja ta ’ infezjoni opportunistika, jistgħu jidhru s- sinjali u sintomi ta ’ infajammazzjoni minn infezzjonijiet ta ’ qabel ftit wara li tinbeda l- kura kontra l- HIV.
It is believed that these symptoms are due to an improvement in the body’ s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Huwa maħsub li dawn is- sintomi huma minħabba titjib fir- rispons immunitarju tal - ġisem, u hekk il- ġisem ikun jista ’ jiġġieled infezzjonijiet li setgħu kienu preżenti mingħajr sintomi ovvji.
If you notice anysymptoms of infection, please inform your doctor immediately.
Jekk tara xi sintomu ta ’ infezzjoni, għarraf mal- ewwel lit- tabib tiegħek.
- about any past or present medical problems, including liver disease due to cirrhosis;
Għid lit- tabib tiegħek dwar problemi mediċi fil- passat jew fil- preżent, inkluż mard tal- fwied minħabba ċirrożi;
- if you have kidney problems (including back pain with or without blood in your urine);
- jekk għandek problemi fil- kliewi (inkluż uġigħ fid- dahar bid- demm fl- urina jew mingħajru);
- if you have allergies;
- jekk għandek allerġiji;
- if you have high cholesterol and if you are taking cholesterol− lowering medicines called
- jekk għandek livell għoli tal- kolesterol u jekk qed tieħu mediċini li jbaxxu l- livell tal- kolesterol
“ statins”;
li jissejħu “ statini ”;
- if you have diabetes;
- jekk għandek id- dijabete;
- if you have haemophilia;
- jekk għandek l- emofilja;
- if you are intolerant to lactose because each hard capsule contains 37.4 mg lactose (anhydrous).
- jekk m’ għandekx tolleranza għal lactose billi kull kapsula iebsa fiha 37. 4 mg ta ’ lactose
Children CRIXIVAN can be taken by children 4 years of age and older who are able to swallow hard capsules.
Tfal CRIXIVAN jista ’ jittieħed minn tfal ta ’ 4 snin jew ikbar li jistgħu jibilgħu kapsuli ibsin.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
98 Konsum ta ’ mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anke dawk mingħajr riċetta.
There are some medicines that should not be taken with CRIXIVAN with or without ritonavir (see Do not take CRIXIVAN) or that require dosage changes of that medicine or CRIXIVAN (e. g., itraconazole, ketoconazole, cyclosporine, nevirapine, delavirdine and efavirenz).
Hemm xi mediċini li m’ għandhomx jittieħdu ma ’ CRIXIVAN bi jew mingħajr ritonavir (ara Tiħux CRIXIVAN) jew li jeħtieġu tibdil fid- doża tagħhom jew ta ’ CRIXIVAN (eż. itraconazole, ketoconazole, cyclosporine, nevirapine, delavirdine u efavirenz).
92 Consult your doctor before taking certain cholesterol– lowering medicines (e. g., atorvastatin, rosuvastatin, pravastatin, fluvastatin), antifungals (e. g., fluconazole), anticonvulsants (e. g., phenobarbital, phenytoin, carbamazepine), steroids (e. g., dexamethasone), protease inhibitors (e. g., amprenavir, saquinavir), medicines for impotence (e. g., sildenafil), blood thinners (e. g., warfarin), calcium channel blockers (e. g., amlodipine, felodipine– class of medicinal products used for the treatment of hypertension and some specific heart disorders), sedative agents (e. g. midazolam administered by injection), antidepressants (e. g., venlafaxine), oral contraceptives (e. g. "the Pill"), medicines for asthma (e. g., theophylline) or any other medicines.
Midazolam mogħti b’ injezzjoni), antidipressanti (eż. venlafaxine), kontraċettivi orali (eż. “ il- Pillola ”), mediċini għall - ażżma (eż. theophylline) jew kwalunkwe mediċina oħra.
CRIXIVAN may be taken with a number of medicines that are commonly used in HIV infection (zidovudine, didanosine, lamivudine, stavudine, quinidine, cimetidine, clarithromycin, isoniazid, fluconazole, trimethoprim/ sulfamethoxazole, methadone).
CRIXIVAN jista ’ jittieħed ma ’ numru ta ’ mediċini li s- soltu jintużaw għall- infezzjoni ta ’ l- HIV (zidovudine, didanosine, lamivudine, stavudine, quinidine, cimetidine, clarithromycin, isoniazid, fluconazole, trimethoprim/ sulfamethoxazole, methadone).
Some medications may interact with CRIXIVAN taken in combination with ritonavir.
Xi medikazzjonijiet jistgħu jinteraġġixu ma ’ CRIXIVAN meħud f’ kombinazzjoni ma ’ ritonavir.
Please consult with your physician regarding taking medications with CRIXIVAN and ritonavir.
Jekk jogħġbok ikkonsulta mat- tabib tiegħek dwar it- teħid ta ’ medikazzjonijiet ma ’ CRIXIVAN u ritonavir.
Taking CRIXIVAN with food and drink CRIXIVAN should be taken without food but with water.
Meta tieħu CRIXIVAN ma ’ l- ikel u max- xorb CRIXIVAN m’ għandux jittieħed ma ’ l- ikel imma jista ’ jittieħed ma ’ l- ilma.
If co-administered with ritonavir, CRIXIVAN may be administered with or without food.
Jekk mogħti fl- istess ħin ma ’ ritonavir, CRIXIVAN jista ’ jingħata bi jew mingħajr ikel.
If water is not preferred, CRIXIVAN can be taken with skimmed or low– fat milk, juice, coffee, or tea.
Jekk l- ilma mhux ippreferut, CRIXIVAN jista ’ jittieħed mal- ħalib skremat jew b’ xaħam imnaqqas, meraq tal- frott, kafe` jew te`.
If CRIXIVAN cannot be taken without food, a low– fat light meal, such as dry toast with jam or fruit conserve, juice and coffee with skimmed or low– fat milk and sugar, or a light meal such as corn flakes with skimmed or low– fat milk and sugar is acceptable.
Jekk CRIXIVAN ma jistax jittieħed mingħajr l- ikel, jista ’ jittieħed ma ’ ikla li għandha ftit xaħam, bħal ħobż mixwi bil- ġamm jew bil- frott ikkonservat, meraq tal- frott u kafe` bil- ħalib skremat jew b’ xaħam imnaqqas, u zokkor jew ikla ħafifa bħal ‘ cornflakes ’ bil- ħalib skremat jew b’ xaħam imnaqqas.
Taking CRIXIVAN with a meal that is high in calories, fat, and protein reduces your body’ s ability to absorb the medicine and in turn reduces its effectiveness.
Jekk CRIXIVAN jittieħed ma ’ ikla li għandha livell għoli ta ’ kaloriji, xaħam u proteini, dan inaqqas il - ħila tal- ġisem li jassorbi l- mediċina li jnaqqas l- effettivita` tagħha.
Pregnancy and breast-feeding Tell your doctor if you are pregnant or intend to become pregnant.
Tqala u treddiegħ Għarraf lit- tabib tiegħek jekk int tqila jew jekk beħsiebek toħroġ tqila.
If you are pregnant, you should take CRIXIVAN only if your doctor decides it is clearly needed.
Jekk int tqila, għandek tieħu CRIXIVAN biss jekk it- tabib tiegħek jiddeċiedi li żgur għandek bżonnu.
It is not known whether CRIXIVAN is harmful to an unborn baby when taken by a pregnant woman.
Mhux magħruf jekk CRIXIVAN jagħmilx ħsara lit- tarbija li għadha fil- ġuf meta jittieħed minn mara tqila.
Tell your doctor if you are breast− feeding.
Għarraf lit- tabib tiegħek jekk qed tredda ’.
It is recommended that HIV-infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Huwa rakkomandat li nisa nfettati bl- HIV taħt l- ebda ċirkustanza ma jreddgħu lit- trabi biex jevitaw it - trażmissjoni ta ’ l- HIV.
Driving and using machines There is no specific information to suggest that CRIXIVAN affects your ability to drive and use machinery.
Sewqan u tħaddim ta ’ magni M’ hemmx informazzjoni speċifika li tissuġġerixxi li CRIXIVAN jaffettwa l- ħila tiegħek li ssuq u li tħaddem il- magni.
However, dizziness and blurred vision have been reported during treatment with CRIXIVAN.
Madankollu, ġew irrapurati sturdament u viżta mċajpra waqt il- kura bi CRIXIVAN.
Do not drive or operate machines if you experience these symptoms.
Jekk tħoss dawn is- sintomi m’ għandekx issuq jew tħaddem il- magni.
Important information about some of the ingredients of CRIXIVAN This medicinal product contains 299.2 mg of lactose in each 800-mg dose (maximum single dose).
Informazzjoni importanti dwar xi ingredjenti ta ’ CRIXIVAN Dan il- prodott mediċinali fih 299. 2 mg ta ’ lactose f’ kull doża ta ’ 800- mg (doża singola massima).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
Always take Crixivan exactly as your doctor has told you.
KIF JITTIEĦED CRIXIVAN 99 Dejjem għandek tieħu CRIXIVAN eżatt skond kif qallek it- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat - tabib jew ma ’ l- ispiżjar tiegħek jekk m’ intix ċert.
The usual dose for adults is 800 mg every 8 hours.
Id- doża normali għall- adulti hija 800 mg kull 8 sigħat.
An alternative dosing schedule for adults is CRIXIVAN 400 mg with ritonavir 100 mg both administered orally twice a day.
Skeda ta ’ dożaġġ alternattiv għall- adulti hija CRIXIVAN 400 mg ma ’ ritonavir 100 mg it- tnejn li huma mogħtija mill- ħalq darbtejn kuljum.
The dose for children and adolescents will be determined by the doctor.
Id- doża għat- tfal u l- adoloxxenti jiddeċidieha t- tabib.
For all dosages, use a combination of the 100 mg, 200 mg or 400 mg hard capsules, as appropriate.
Għad- dożi kollha, uża kombinazzjoni tal- kapsuli iebsin tal- 100 mg, 200 mg jew 400 mg, kif xieraq.
93 CRIXIVAN must be taken at regular intervals of 8 hours for full effectiveness and either 1 hour before or 2 hours after a meal.
CRIXIVAN irid jingħata f’ intervalli regolari ta ’ 8 sigħat biex jittieħed l- effett kollu tiegħu, jew siegħa qabel jew sagħtejn wara l- ikel.
CRIXIVAN should be swallowed unchewed together with water.
CRIXIVAN għandu jinbela bl- ilma mingħajr ma jintmagħad.
It is important for adults to drink at least 1.5 litres (approximately 48 fluid ounces) of liquids during each day while taking CRIXIVAN to help reduce the risk of forming kidney stones.
Importanti li l- adulti jixorbu mill- inqas litru u nofs (bejn wieħed u ieħor 48 uqija fluwida) ta ’ likwidi kuljum waqt li qed jieħdu CRIXIVAN biex inaqqsu r- riskju li jiffurmaw ġebel fil- kliewi.
It is also important for children and adolescents to drink enough liquids during the course of the day.
Importanti wkoll li t- tfal u l- adoloxxenti jixorbu biżżejjed likwidi matul il- ġurnata.
The doctor will tell you the amount of liquids your child should drink.
It- tabib jgħidlek kemm it - tifel/ tifla tiegħek għandu/ ha bżonn jixrob/ tixrob.
Your doctor will tell you how long the treatment with CRIXIVAN will last.
It- tabib jgħidlek kemm iddum il- kura bi CRIXIVAN.
If you take more CRIXIVAN than you should In clinical studies, doses higher than 800 mg every 8 hours have not been shown to have any better effect.
Jekk tieħu CRIXIVAN aktar milli suppost għandek Fi studji kliniċi, dożi ikbar minn 800 mg kull 8 sigħat ma kellhomx effetti aħjar.
Contact your doctor if you have taken more than the prescribed dose of CRIXIVAN.
Kellem lit- tabib jekk ħadt iktar mid- doża preskritta ta ’ CRIXIVAN.
The most common signs and symptoms of overdose are: nausea, vomiting, diarrhoea, back pain and blood in the urine.
L- iktar sinjali u sintomi komuni ta ’ doża eċċessiva huma: tqallih, rimettar, dijarrea, uġigħ fid- dar u demm fl- urina.
There is at present little information on the treatment of overdosage.
Bħalissa ftit hemm informazzjoni dwar il- kura ta ’ doża eċċessiva.
If you forget to take CRIXIVAN If you have missed a dose, do not take it later in the day.
Jekk tinsa tieħu CRIXIVAN Jekk qbiżt doża, teħodhiex iktar tard matul il- jum.
Simply continue to follow your usual schedule.
Kemm tkompli bl- iskeda normali tiegħek.
If you stop taking CRIXIVAN It is important that you take CRIXIVAN exactly as your doctor prescribes.
Jekk tieqaf tieħu CRIXIVAN Importanti li tieħu CRIXIVAN eżatt kif jgħidlek it- tabib.
Do not stop taking it because reducing or missing doses will increase the risk of the HI– Virus becoming resistant to CRIXIVAN, in which case treatment with this medicine will become ineffective.
Tieqafx tieħdu għax jekk tnaqqas jew taqbeż id- dożi jkollok riskju ikbar li l- Virus- HI isir reżistenti għal CRIXIVAN; f’ dan il- każ il- kura b’ din il - mediċina ma tibqax effettiva.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek iktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, CRIXIVAN can cause side effects, although not everybody gets them.
Bħall- kull mediċina oħra, CRIXIVAN jista ’ jikkawża effetti oħra, għalkemm ma jidhrux fuq kulħadd l- effetti.
The following terms are used to describe how often side effects have been reported.
It- termini li ġejjin jintużaw biex jiddeskrivu kemm ‚ il darba ġew irrapurtati l- effetti sekondarji.
Very common (occurring in at least 1 in 10 patients treated) Common (occurring in at least 1 of 100 and less than 1 of 10 patients treated) Not known (cannot be estimated from the available data)
(ma tistax issir stima mit- tagħrif preżenti)
Blood and the lymphatic disorders:
Disturbi tad- demm u tas- sistema limfatika:
Not known: low red blood cell count
Mhux magħruf: għadd baxx taċ- ċelluli ħomor tad- demm
Not known: allergic reactions (sometimes severe, including shock)
Mhux magħruf: reazzjonijiet allerġiċi (xi kultant severi, inkluż xokk)
Very common: dizziness; headache; Common: inability to sleep decreased or abnormal skin sensation Not known: numbness of the mouth
100 Komuni ħafna: sturdament; uġigħ ta ’ ras Komuni: ma tistax torqod jew sensazzjoni tal- ġilda anormali Mhux magħruf: tirżiħ tal- ħalq
Gastrointestinal disorders:
Disturbi fis- sistema gastro- intestinali:
Very common: nausea; vomiting; diarrhoea; an uncomfortable feeling in the stomach or belching after eating Common: wind; dry mouth; acid regurgitation Not known: inflammation of the pancreas
Komuni ħafna: nawżja; remettar; dijarrea; sensazzjoni skomda fl- istonku jew tfewwieq wara l- ikel Komuni: gass; ħalq niexef; rigurġitazzjoni ta ’ l- aċidu Mhux magħruf: infjammazzjoni tal- frixa
94 Skin and subcutaneous tissue disorders:
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda:
Very common: dry skin; rash Not known: severe skin reactions; hair loss; darkening skin colour; ingrown toenails with or without infection
Komuni ħafna: ġilda niexfa; raxx Mhux magħruf: reazzjonijiet severi tal- ġilda; waqgħa tax- xahar; il- kulur tal- ġilda jiskura; dwiefer tas - saqajn imdaħħlin ’ il ġewwa b’ infezzjoni jew mingħajrha
Musculoskeletal connective tissue and bone disorders:
Disturbi muskolu- skeltrali u tal- connective tissue:
Common: muscle pain
Komuni: uġigħ fil- muskoli
Common: pain on urination Not known: infection of the kidneys, decreased kidney function, loss of renal function.
Disturbi tal- kliewi u fis- sistema urinarja Komuni: uġigħ waqt li qed tagħmel l- awrina Mhux magħruf: infezzjoni fil- kliewi, tnaqqis fil- funzjoni tal- kliewi, telfien tal- funzjoni renali.
Very common: weakness/ fatigue; taste perversion; abdominal pain/ swelling.
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Komuni ħafna: bla saħħa/ għejja kbira; perverżjoni fit- togħma, uġigħ/ nefħa addominali.
Ask your doctor or pharmacist for more information about side effects.
Saqsi lit- tabib jew lill- ispiżjar tiegħek għal iktar informazzjoni dwar effetti sekondarji.
Both have a more complete list of side effects.
It- tnejn ikolhom lista sħiħa ta ’ l- effetti sekondarji.
There have been reports of inflammation of the kidneys and kidney stones.
Kien hemm rapporti ta ’ infjamazzjoni tal- kliewi u ġebla fil- kliewi.
In some of these patients, this led to more severe kidney problems including kidney failure.
F’ xi pazjenti, dan wassal għal problemi fil- kliewi iktar severi, inkluż insuffiċenza tal- kliewi.
In most cases, kidney impairment and kidney failure were reversible.
F’ ħafna mill- każijiet, l- indeboliment fil - kliewi u l- insuffiċenza fil- kliewi huma reversibbli.
Call your doctor if you develop sudden severe back pain, with or without blood in the urine, caused by kidney stones.
Kellem lit- tabib jew ikollok uġigħ f’ daqqa f’ dahrek, bid- demm fl- urina jew mingħajru, li ġej minn ġebel fl- kliewi.
Your doctor will want to test your blood regularly to detect possible abnormalities such as rapid breakdown of red blood cells (anaemia), elevation of liver enzyme levels, impairment of kidney function, changes in blood sugar levels (hyperglycaemia).
It- tabib tiegħek ikun irid jittestja d- demm tiegħek regolarment biex jara jekk hemmx irregolaritajiet bħal m’ huma tifrik taċ- ċelluli ħomor tad- demm (anemija), livelli ogħla ta ’ enzimi fil- fwied, indeboliment tal- kliewi, bidliet fil- livelli taz- zokkor fid- demm (ipergliċemija).
In patients with haemophilia type A and B, there have been reports of increased bleeding while taking this treatment or another protease inhibitor.
F’ pazjenti b’ emofilija tip A jew B, hemm rapporti ta ’ żieda fid- dmija waqt din il- kura jew b’ inibitur ieħor tal- protease.
Should this happen to you, seek immediate advice from your doctor.
Jekk dan jiġri lilek, saqsi parir mal- ewwel mit- tabib tiegħek.
Inform your doctor as soon as possible if you develop severe muscle pain or weakness.
Informa lit- tabib tiegħek kemm jista ’ jkun maljar jekk ikollok uġigħ sever fil- muskoli jew indeboliment.
Severe muscle pain and weakness have occurred in patients taking protease inhibitors, including CRIXIVAN, together with cholesterol– lowering medicines called “ statins”.
Uġigħ sever fil- muskoli jew indeboliment seħħew f’ pazjenti li kienu qed jieħdu inibituri tal- protease, inkluż CRIXIVAN, flimkien ma ’ mediċini msejħa « statini » li jbaxxu l- livell tal - kolesterol.
There have also been reports of muscle pain, tenderness or weakness, particularly with combination antiretroviral therapy including protease inhibitors and nucleoside analogues in patients not taking statins.
Kien hemm ukoll rapporti ta ’ uġigħ, sensittivita` jew indeboliment fil- muskoli, speċjalment bit- terapija kombinata antiretrovirali inkluż inibituri tal- protease u analogi tan- nukleosidi lil pazjenti li mhux qed jieħdu statini.
On rare occasions these muscle disorders have been serious (rhabdomyolysis).
F’ okkażjoni rari dan il- mard fil- muskoli kien serju (rabdomajlożis).
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
It- terapija kombinata antiretrovirali tista ’ twassal għal bidliet fil- forma tal- ġisem minħabba bidliet fid - distribuzzjoni tax- xaħam.
These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘ buffalo hump’).
Dan jista ’ jinkludi nuqqas ta ’ xaħam fir- riġlejn, id- dirgħajn u l- wiċċ, żieda fix- xaħam fiż- żaqq u organi oħra interni, tkabbir tas- sider u boċċi tax- xaħam fuq wara ta ’ l- għonq (ħotba ta ’ buflu).
The cause and long-term effects of these conditions are not known at this time.
Il- kawża u l- effetti fit- tul ta ’ dawn il- kondizzjonijiet mhux magħrufa bħalissa.
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipidaemia (increased fats in the blood) and resistance to insulin.
It - terapija kombinata antiretrovirali tista ’ tikkawża livelli ogħla ta ’ aċidu lattiku u zokkor fid- demm, iperlipidimija (livelli ogħla ta ’ xaħam fid- demm) u reżistenza għall- insulina.
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 wieħed mill- effetti sekondarji jiggrava, jew jekk tinduna b ’ xi effetti oħrajn li mhux imniżżlin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE CRIXIVAN
KIF TAĦŻEN CRIXIVAN
Keep out of the reach and sight of children.
Żomm ‘ il bogħod mit- tfal.
Do not use CRIXIVAN after the expiry date stated on the bottle or carton.
Tużax CRIXIVAN wara d- data ta ’ iskadenza li ssib fuq il- flixkun jew il- kartuna.
The expiry date refers to the last day of the month.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
95 Store CRIXIVAN in the original bottle.
Żomm CRIXIVAN fil- flixkun oriġinali.
Keep the bottle tightly closed in order to protect from moisture.
Żomm il- flixkun magħluq sew biex tipproteġi mill- umdita`.
The bottles contain desiccant canisters that should remain in the bottle.
Il- fliexken fihom bottijiet żgħar tad- dessikant għandhom jibqgħu fil- flixkun.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għal protezzjoni ta ’ l- ambjent
What CRIXIVAN contains
X’ FIH CRIXIVAN
- The active substance is indinavir sulphate.
- Is- sustanza attiva hi indinavir sulphate.
Each hard capsule contains indinavir sulphate
Kull kapsula iebsa fiha indinavir sulphate li
corresponding to 100 mg of indinavir.
jokkorrispondi għal 100 mg ta ’ indinavir.
- The other excipients are anhydrous lactose, magnesium stearate, gelatin, silicon dioxide, sodium
- Is- sustanzi l- oħra huma anhydrous lactose, magnesium stearate, ġelatina, silicon dioxide,
lauryl sulphate and titanium dioxide (E 171).
sodium lauryl sulphate u titanium dioxide (E 171).
The capsules are printed with printing ink containing titanium dioxide (E 171), indigo carmine (E 132) and iron oxide (E 172).
Il- kapsuli huma stampati b’ inka ta ’ l - istampar li fiha titanium dioxide (E 171), indigo carmine (E 132) u iron oxide (E 172).
What CRIXIVAN look like and content of the pack
Kif jidher CRIXIVAN u l- kontenut tal- pakkett
CRIXIVAN 100 mg hard capsules are supplied in HDPE bottles with a polypropylene cap and a foil induction cap containing 180 capsules.
Il- kapsuli ibsin ta ’ CRIXIVAN 100 mg jiġu fi fliexken HDPE li jkun fihom 180 kapsula b’ tapp ta ’ polypropylene u tapp ta ’ l- induzzjoni tal- fojl.
The capsules are semi-translucent white and coded CRIXIVAN TM 100 mg in green.
Il- kapsuli huma bojod semi- trasparenti u l- kliem CRIXIVANTM 100 mg huma ħodor.
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU United Kingdom
Merck Sharp & Dohme Limitel, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, Ir- Renju Unit
Merck Sharp & Dohme B. V., Waarderweg 39, Postbus 581, 2003 PC Haarlem The Netherlands
Merck Sharp & Dohme B. V., Waarderweg 39, Postbus 581, 2003 PC Haarlem, L- Olanda
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtorizzazzjoni għall- Kummerċ.
Č eská republika Merck Sharp & Dohme IDEA, Inc., org. sl.
102 Česká republika Merck Sharp & Dohme IDEA, Inc., org. sl.
Norge MSD (Norge) A/ S Tlf: +47 32 20 73 00 msdnorge@ msd. no
Tel: +31 (0) 23 5153153 msdbvnl@ merck. com Norge MSD (Norge) A/ S Tlf: +47 32 20 73 00 msdnorge @ msd. no
Ireland Merck Sharp and Dohme Ireland (Human Health) Limited Tel: +353 (0)1 299 8700 medinfo_ireland@merck. com
Ireland Merck Sharp and Dohme Ireland (Human Health) Limited Tel: +353 (0) 1 2998700 medinfo_ ireland@ merck. com
Τηλ: +357 22866700 info_cyprus@merck. com
Τηλ: +357 22866700
Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 (0) 8 626 1400 medicinskinfo@merck. com
Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 (0) 8 626 1400
Latvija SIA “ Merck Sharp & Dohme Latvija”.
103 Latvija SIA “ Merck Sharp & Dohme Latvija ”.
98 PACKAGE LEAFLET:
104 FULJETT TA ’ TAGĦRIF:
CRIXIVAN 200 mg hard capsules indinavir
CRIXIVAN 200 mg kapsuli ibsin Indinavir
How to store CRIXIVAN 6.
Kif taħżen CRIXIVAN 6.
Signs and symptoms of an allergic reaction may include: itchy skin, redness of the skin, wheals or hives, swelling of the face, lips, tongue and/ or throat, or difficulty breathing.
CRIXIVAN. Is- sinjali u s- sintomi ta ’ reazzjoni allerġika jistgħu jkunu: ħakk fil- ġilda, ħmura fil- ġilda, tbenġil jew urtkarja, nefħa fil- wiċċ, xofftejn, ilsien u/ jew gerżuma, u diffikulta` biex tieħu n- nifs.
encainide, flecanide, propafenone, quinidine, fusidic acid, clozapine, clorazepate, diazepam, estazolam, and flurazepam.
encainide, lecanide, propafenone, quinidine, fusidic acid, clozapine, clorazepate, diazepam, stazolam, u flurazepam.
When CRIXIVAN is used with ritonavir, please tell your doctor and refer to the package leaflet for ritonavir for more information.
Meta jintuża CRIXIVAN ma ’ ritonavir, jekk jogħġbok għid lit- tabib tiegħek u rreferi għall- fuljett ta ’ tagħrif għal ritonavir għal aktar informazzjoni.
If you notice any symptoms of infection, please inform your doctor immediately.
Jekk tara xi sintomu ta ’ infezzjoni, għarraf mal- ewwel lit- tabib tiegħek.
- if you are intolerant to lactose because each hard capsule contains 74.8 mg lactose (anhydrous).
- jekk m’ għandekx tolleranza għal lactose billi kull kapsula iebsa fiha 74. 8 mg ta ’ lactose
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
106 Konsum ta ’ mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anke dawk mingħajr riċetta.
100 Consult your doctor before taking certain cholesterol– lowering medicines (e. g., atorvastatin, rosuvastatin, pravastatin, fluvastatin), antifungals (e. g., fluconazole), anticonvulsants (e. g., phenobarbital, phenytoin, carbamazepine), steroids (e. g., dexamethasone), protease inhibitors (e. g., amprenavir, saquinavir), medicines for impotence (e. g., sildenafil), blood thinners (e. g., warfarin), calcium channel blockers (e. g., amlodipine, felodipine– class of medicinal products used for the treatment of hypertension and some specific heart disorders), sedative agents (e. g. midazolam administered by injection), antidepressants (e. g., venlafaxine), oral contraceptives (e. g. "the Pill"), medicines for asthma (e. g., theophylline) or any other medicines.
Midazolam mogħti b’ injezzjoni), antidipressanti (eż. venlafaxine), kontraċettivi orali (eż. “ il- Pillola ”), mediċini għall - ażżma (eż. theophylline) jew kwalunkwe mediċina oħra.
HOW TO TAKE CRIXIVAN
KIF JITTIEĦED CRIXIVAN
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek tieħu CRIXIVAN eżatt kif qallek tat- tabib.
The usual dose for adults is 800 mg every 8 hours.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk m’ intix ċert Id- doża normali għall- adulti hija 800 mg kull 8 sigħat.
For all dosages, use a combination of the 100– mg, 200– mg or 400– mg hard capsules, as appropriate.
Għad- dożi kollha, uża kombinazzjoni tal- kapsuli iebsin tal- 100 mg, 200 mg jew 400 mg, kif xieraq.
101 CRIXIVAN must be taken at regular intervals of 8 hours for full effectiveness and either 1 hour before or 2 hours after a meal.
CRIXIVAN irid jingħata f’ intervalli regolari ta ’ 8 sigħat biex jittieħed l- effett kollu tiegħu, jew siegħa qabel jew sagħtejn wara l- ikel.
Nervous system disorders:
108 Disturbi fis- sistema nervuża:
Very common: dizziness; headache; Common: inability to sleep decreased or abnormal skin sensation Not known: numbness of the mouth
Komuni ħafna: sturdament; uġigħ ta ’ ras; Komuni: ma tistax torqod jew sensazzjoni tal- ġilda anormali Mhux magħruf: tirżiħ tal- ħalq
Very common: nausea; vomiting; diarrhoea; an uncomfortable feeling in the stomach or belching after eating Common: wind; dry mouth; acid regurgitation Not known: inflammation of the pancreas 102 Skin and subcutaneous tissue disorders:
Komuni ħafna: nawżja; remettar; dijarrea; sensazzjoni skomda fl- istonku jew tfewwieq wara l- ikel Komuni: gass; ħalq niexef; rigurġitazzjoni ta ’ l- aċidu Mhux magħruf: infjammazzjoni tal- frixa
In some of these patients, this led to more severe kidney problems including kidney failure.
F’ xi pazjenti, dan wassal għal problemi fil- kliewi ikrar severi, inkluż insuffiċenza tal- kliewi.
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.
109 Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinduna b ’ xi effetti oħrajn li mhux imniżżlin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
103 Store CRIXIVAN in the original bottle.
Żomm CRIXIVAN fil- flixkun oriġinali.
corresponding to 200 mg of indinavir.
jokkorrispondi għal 200 mg ta ’ indinavir.
The capsules are printed with printing ink containing indigo carmine (E 132).
Il- kapsuli huma stampati b’ inka ta ’ l - istampar li fiha indigo carmine (E 132).
CRIXIVAN 200 mg hard capsules are supplied in HDPE bottles with a polypropylene cap and a foil induction cap containing 180, 270 or 360 capsules.
Il- kapsuli ibsin ta ’ CRIXIVAN 200 mg jiġu fi fliexken HDPE li jkun fihom 180, 270 jew 360 kapsula u li jkunu b’ tapp ta ’ polypropylene u tapp ta ’ l- induzzjoni tal- fojl.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad - daqsijiet kollha jkunu għal skop kummerċjali TM Il- kapsuli huma bojod semi- trasparenti u l- kliem CRIXIVAN
The capsules are semi-translucent white and coded CRIXIVANTM 200 mg in blue.
200 mg huma blu.
България Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3740 info-msdbg@merck. com
110 България Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3740 info- msdbg@ merck. com
Ι talia Merck Sharp & Dohme (Italia) S. p. A.
111 Ιtalia Merck Sharp & Dohme (Italia) S. p. A.
106 PACKAGE LEAFLET:
Katja
INFORMATION FOR THE USER
112 FULJETT TA ’ TAGĦRIF INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU
CRIXIVAN 400 mg hard capsules indinavir
CRIXIVAN 400 mg kapsuli ibsin Indinavir
- if you are intolerant to lactose because each hard capsule contains 149.6 mg lactose (anhydrous).
- jekk m’ għandekx tolleranza għal lactose billi kull kapsula iebsa fiha 149. 6 mg ta ’ lactose
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Konsum ta ’ mediċini oħra 114 Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anke dawk mingħajr riċetta.
108 Consult your doctor before taking certain cholesterol– lowering medicines (e. g., atorvastatin, rosuvastatin, pravastatin, fluvastatin), antifungals (e. g., fluconazole), anticonvulsants (e. g., phenobarbital, phenytoin, carbamazepine), steroids (e. g., dexamethasone), protease inhibitors (e. g., amprenavir, saquinavir), medicines for impotence (e. g., sildenafil), blood thinners (e. g., warfarin), calcium channel blockers (e. g., amlodipine, felodipine– class of medicinal products used for the treatment of hypertension and some specific heart disorders), sedative agents (e. g. midazolam administered by injection), antidepressants (e. g., venlafaxine), oral contraceptives (e. g. "the Pill"), medicines for asthma (e. g., theophylline) or any other medicines.
Midazolam mogħti b’ injezzjoni), antidipressanti (eż. venlafaxine), kontraċettivi orali (eż. “ il- Pillola ”), mediċini għall - ażżma (eż. theophylline) jew kwalunkwe mediċina oħra.
3.
115 3.
Always take Crixivan exactly as your doctor has told you.
Dejjem għandek tieħu CRIXIVAN eżatt skond kif qallek tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk m’ intix ċert.
109 CRIXIVAN must be taken at regular intervals of 8 hours for full effectiveness and either 1 hour before or 2 hours after a meal.
CRIXIVAN irid jingħata f’ intervalli regolari ta ’ 8 sigħat biex jittieħed l- effett kollu tiegħu, jew siegħa qabel jew sagħtejn wara l- ikel.
48 fluid ounces) of liquids during each day while taking CRIXIVAN to help reduce the risk of forming kidney stones.
Importanti li l- adulti jixorbu mill- inqas litru u nofs (bejn wieħed u ieħor 48 uqija fluwida) ta ’ likwidi kuljum waqt li qed jieħdu CRIXIVAN biex inaqqsu r- riskju li jiffurmaw ġebel fil- kliewi.
Nervous system disorders:
116 Disturbi fis- sistema nervuża:
Very common: dizziness; headache; Common: inability to sleep decreased or abnormal skin sensation Not known: numbness of the mouth
Komuni ħafna: sturdament; uġigħ ta ’ ras Komuni: ma tistax torqod jew sensazzjoni tal- ġilda anormali Mhux magħruf: tirżiħ tal- ħalq
110 Skin and subcutaneous tissue disorders:
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda:
These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘ buffalo hump’).
Dan jista ’ jinkludi nuqqas ta ’ xaħam fir- riġlejn, id- dirgħajn u l- wiċċ, żieda fix- xaħam fiż- żaqq u organi oħra interni, tkabbir tas- sider u boċċi tax- xaħam fuq wara ta ’ l- għonq 117 (ħotba ta ’ buflu).
111 Store CRIXIVAN in the original bottle.
Żomm CRIXIVAN fil- flixkun oriġinali.
corresponding to 400 mg of indinavir.
jokkorrispondi għal 400 mg ta ’ indinavir.
lauryl sulphate and titanium dioxide (E 171).
sodium dioxide, sodium lauryl sulphate u titanium dioxide (E 171).
The capsules are printed with printing ink containing titanium dioxide (E 171), indigo carmine (E 132) and iron oxide (E 172).
Il- kapsuli huma stampati b’ inka ta ’ l- istampar li fiha titanium dioxide (E 171), indigo carmine (E 132) u iron oxide (E 172).
Not all pack sizes may be marketed.
Kif jidher CRIXIVAN u l- kontenut tal- pakkett Il- kapsuli ibsin ta ’ CRIXIVAN 400 mg jiġu fi fliexken HDPE li jkun fihom 18, 90 jew 180 kapsula u li jkunu b’ tapp ta ’ polypropylene u tapp ta ’ l- induzzjoni tal- fojl.
The capsules are semi-translucent white and coded CRIXIVANTM 400 mg in green.
Jista ’ jkun li mhux il- pakketti tad - daqsijiet kollha jkunu għal skop kummerċjali TM 400 mg huma ħodor.
Belgique/ België/ Belgien Merck Sharp & Dohme B. V.
118 Belgique/ België/ Belgien Merck Sharp & Dohme B. V.
What is Cubicin?
X’ inhu Cubicin?
Cubicin is a powder that is made up into a solution for infusion (drip into a vein).
Cubicin hu trab li jinħall f’ soluzzjoni għall- infużjoni (drip fil- vina).
It contains the active substance daptomycin.
Fih is- sustanza attiva daptomycin.
What is Cubicin used for?
Għal xiex jintuża Cubicin?
Cubicin is used to treat adults with the following bacterial infections: • complicated infections of the skin or in the layers of flesh under the skin (soft tissues), • right-sided infective endocarditis (infection of the lining or the valves of the right side of the heart) caused by the bacterium Staphylococcus aureus.
Cubicin jintuża għat- trattament ta ’ adulti b’ dawn l- infezzjonijiet batteriċi: • Infezzjonijiet ikkumplikati tal- ġilda jew f’ saffi tal- laħam taħt il- ġilda (tessuti rotob), • Endokardite infettiva tal- lemin (infezzjoni fil- kisi jew fil- valvoli fin- naħa tal- lemin tal- qalb) ikkawżata mill- batterju Staphylococcus aureus.
The decision to treat this type of infection with Cubicin should be based on the likelihood that the medicine will work against the infection and on advice from an expert, • bacteraemia (infection of the blood) caused by Staphylococcus aureus, associated with either of the two infections above.
Id- deċiżjoni li tiġi ttrattata din it- tip ta ’ infezzjoni b’ Cubicin għandha tkun ibbażata fuq il- probabilità li l- mediċina taħdem kontra l- infezzjoni u fuq parir minn espert, • Batteremja (infezzjoni tad- demm) ikkawżata minn Staphylococcus aureus, assoċjata ma ’ xi waħda miż- żewġ infezzjonijiet ta ’ hawn fuq.
Prescribers should consider official guidance on the use of antibacterial agents.
Min jagħti r- riċetta jrid jikkunsidra l- gwida uffiċjali fuq l- użu ta ’ l- aġenti antibatteriċi.
How is Cubicin used?
Kif jintuża Cubicin?
Cubicin powder is made up into a solution and is given by intravenous infusion by a doctor or a nurse over 30 minutes.
It- trab ta ’ Cubicin jinħall f’ soluzzjoni u jingħata b’ infużjoni intravenuża, li ddum 30 minuta, minn tabib jew infermier/ a.
For skin or soft tissue infections without bacteraemia, the recommended dose is 4 mg per kilogram body weight given once every 24 hours for seven to 14 days or until the infection is cleared.
Għal infezzjonijiet tal- ġilda jew tat- tessut artab mingħajr batteremja, id- doża rrakkomandata hi 4 mg għal kull kilogramma li jiżen il- pazjent mogħtija kull 24 siegħa għal bejn sebat ijiem u 14- il jum jew sakemm l- infezzjoni tiċċara.
The duration of treatment depends on the risk of complications and official recommendations.
Għall- endokardite u għall- infezzjonijiet tal- ġilda jew tat- tessut artab bil- batteremja, id- doża rrakkomandata hi 6 mg għal kull kilogramma li jiżen il - pazjent.
Cubicin at a lower dose should only be used in patients who have problems with their kidneys if the benefit of treatment is greater than its potential risk.
Cubicin f’ doża iżgħar għandu jintuża biss f’ pazjenti li jkollhom problemi fil- kliewi jekk il- benefiċċju tat- trattament ikun ikbar mir- riskju potenzjali tiegħu.
Depending on the type of infection being treated and whether or not a patient has more than one infection, other antibiotics may be given during treatment with Cubicin.
Skond it- tip ta ’ infezzjoni li tkun qed tiġi ttrattata u jekk il- pazjenti ikollhomx infezzjoni waħda jew iktar, jistgħu jingħataw antibijotiċi oħra waqt it - trattament b’ Cubicin.
How does Cubicin work?
Kif jaħdem Cubicin?
The active substance in Cubicin, daptomycin, is an antibiotic.
Is- sustanza attiva f’ Cubicin, daptomycin, hija antibijotiku.
It can stop the growth of certain types of bacteria, by binding to the membrane around each bacterial cell and upsetting the essential functions that keep the cell alive.
Tista ’ twaqqaf it- tkabbir ta ’ ċerti tipi ta ’ batterji, billi teħel mal- membrana ta ’ madwar kull ċellola batterika u tfixkel il- funzjonijiet essenzjali li jżommu ċ- ċellola ħajja.
The full list of bacteria against which Cubicin is active can be found in the Summary of Product Characteristics (also part of the EPAR).
Il- lista sħiħa ta ’ batterji li Cubicin hu attiv kontrihom tista ’ tinstab fis - Sommarju tal- Karatteristiċi tal- Prodott (ukoll parti mill- EPAR).
(44-20) 74 18 84 00 Fax (44-20) 74 18 85 45 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Cubicin been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 85 45 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Cubicin?
Cubicin has been studied in two large studies involving 1,118 patients with complicated skin and soft tissue infections (mainly wound infections and major abscesses) and in one study involving 246 patients with bacteraemia caused by Staphylococcus aureus, including 35 patients with right-sided infective endocarditis.
Cubicin ġie studjat f’ żewġ studji ewlenin li fihom ħadu sehem 1, 118- il pazjent b’ infezzjonijiet kumplikati tal- ġilda u tat- tessuti rotob (l- aktar infezzjonijiet fil- feriti u axxessi maġġuri) u fi studju ieħor bis- sehem ta ’ 246 pazjent bil- batteremja kkawżata mill- iStaphylococcus aureus, inklużi 35 pazjent b’ endokardite infettiva tal- lemin.
In all three studies, Cubicin was compared to standard treatments with other antibiotics used for such infections (either vancomycin or one of the penicillins, including oxacillin, cloxacillin, flucloxacillin and nafcillin).
Fit- tliet studji, Cubicin tqabbel mat- trattamenti standard b’ antibijotiċi oħra użati għal infezzjonijiet bħal dawn (jew vancomycin jew wieħed mill- peniċillini, inklużi oxacillin, cloxacillin, flucloxacillin u nafcillin).
The trials looked at cure and clinical improvement of the infections, after seven to 12 days in the studies of skin and soft-tissue infections, and, in the study of bacteraemia, after a length of time determined by each patient ’ s diagnosis and susceptibility of the bacteria causing their infection to the medicines being used.
L- istudji studjaw il- fejqan u t- titjib kliniku ta ’ l- infezzjonijiet, wara sebat ijiem u 12- il jum fl- istudji dwar infezzjonijiet tal- ġilda u tat- tessuti rotob, u, fl- istudju tal- batteremja, wara tul ta ’ żmien determinat mid- dijanjożi ta ’ kull pazjent u s- suxxettibilità tal- batterji li jikkawżaw l- infezzjoni għall- mediċini li jkunu qed jintużaw.
What benefit has Cubicin shown during the studies?
X’ inhu l- benefiċċju ta ’ Cubicin li ntwera f’ dawn l- istudji?
Cubicin was as effective as the standard treatments.
Cubicin kien effettiv daqs it- trattamenti standard.
In the studies of skin and soft tissue infections, the clinical success rates at seven to 12 days after the last injection for Cubicin were 67% in one study and 85% in the other.
Fl- istudji ta ’ l- infezzjonijiet tal- ġilda u tat- tessuti rotob, ir- rati ta ’ suċċess kliniku wara bejn sebgħa u 12- il jum wara l- aħħar injezzjoni għal Cubicin kienu 67% fi studju wieħed u 85% fl- ieħor.
These rates reflect differences between the two studies in the range of types of patients and infections that were being treated in each.
Dawn ir - rati jirriflettu d- differenzi bejn iż- żewġ studji fid- diversi tipi ta ’ pazjenti u infezzjonijiet li kienu qed jiġu ttrattati f’ kull wieħed.
For the treatment of bacteraemia in patients with right-sided infective endocarditis, 8 (42%) of the 19 patients given Cubicin were treated successfully, compared with 7 (44%) of the 16 given standard treatment.
Fit- trattament tal- batteremja fil- pazjenti bl- endokardite infettiva fuq il- lemin, 8 (42%) mid- 19- il pazjent li ngħataw Cubicin ġew ittrattati b’ suċċess, meta mqabbla ma ’ 7 (44%) mis- 16 li ngħataw trattament standard.
However, there was insufficient evidence to support the use of Cubicin to treat bacteraemia in patients who did not have either right-sided infective endocarditis or complicated skin and soft- tissue infections.
Madankollu, ma kienx hemm biżżejjed evidenza biex tappoġġja l- użu ta ’ Cubicin fit- trattament tal- batteremja fil- pazjenti li la kellhom endokardite infettiva tal- lemin u lanqas infezzjonijiet kumplikati tal- ġilda u tat- tessuti rotob.
What is the risk associated with Cubicin?
X’ inhu r- riskju assoċjat ma ’ Cubicin?
The most common side effects with Cubicin (seen in more than 1 patient in 10) are infections caused by fungi (moulds and yeasts), headache, nausea (feeling sick), vomiting, diarrhoea, rash, infusion site reactions, abnormal liver tests and raised levels in the blood of an enzyme called CPK (a marker of muscle damage).
L- iktar effetti sekondarji komuni b’ Cubicin (li dehru f’ iktar minn pazjent wieħed minn kull 10) huma infezzjonijiet ikkawżati minn fungi (moffa u ċelloli bħal tal- ħmira), uġigħ ta ’ ras, dardir, rimettar, dijarea, raxx, reazzjonijiet fis- sit ta ’ l- infezzjoni, testijiet anormali tal- fwied u livelli għoljin ta ’ enzim magħruf bħala CPK (markatur tal- ħsara muskolari) fid- demm.
For the full list of all side effects reported with Cubicin, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati b’ Cubicin, ara l- Fuljett ta ’ Tagħrif.
Cubicin should not be used in people who may be hypersensitive (allergic) to daptomycin or the other ingredient (sodium hydroxide).
Cubicin m’ għandux jingħata lil persuni allerġiċi għal daptomycin jew għal xi sustanza oħra tiegħu (sodium hydroxide).
Caution is needed when it is given to patients with kidney problems and the dose may need to be reduced.
Hemm bżonn tal- kawtela meta jingħata lil pazjenti bi problemi fil- kliewi u d - doża jista ’ jkollha bżonn titnaqqas.
All patients must have their CPK levels measured at regular intervals, particularly if they have any known risk factors for muscle damage.
Il- pazjenti kollha jrid jitkejlilhom il- livell ta ’ CPK fid- demm b’ mod regolari, speċjalment jekk ikollhom fatturi ta ’ riskju għall- ħsara muskolari.
For the full list of precautions, see the Package Leaflet.
Għal- lista sħiħa tal - prekawzjonijiet, ara l- Fuljett ta ’ Tagħrif.
Why has Cubicin been approved?
Għaliex ġie approvat Cubicin?
The Committee for Medicinal Products for Human Use (CHMP) decided that Cubicin’ s benefits are greater than its risks for the treatment of adults with complicated skin and soft-tissue infections and right-sided infectious endocarditis, and with bacteraemia due to Staphylococcus aureus associated with either of these infections.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Cubicin huma ikbar mir- riskji tiegħu meta użat għat- trattament ta ’ adulti b’ infezzjonijiet ikkumplikati tal- ġilda u tat- tessuti rotob u ta ’ l- endokardite infettiva tal- lemin, u b’ batteremja kkawżata mill - iStaphylococcus aureus assoċjat ma ’ waħda jew iktar minn dawn l- infezzjonijiet.
The Committee recommended that Cubicin be given marketing authorisation.
Il- Kumitat irrakkomanda li Cubicin jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.