qanastek/EMEA-V3 huggingface dataset:
A controlled study completed in 1996 with ritonavir as add-on therapy in HIV-1 infected patients extensively pre-treated with nucleoside analogues and baseline CD4 cell counts ≤ 100 cells/μl showed a reduction in mortality and AIDS defining events.
Studju kkontrollat komplet fl- 1996 li sar b’ ritonavir bħala terapija addizzjonali fuq pazjenti infettati bl- HIV- 1 u li kienu preċedentement ikkurati estensivament b’ analogi ta ’ nukleòside u b’ għadd ta ’ ċellulli tal- linja bażi CD4 ≤ 100 ċelluli / µl, urew tnaqqis fil- mortalità u fl- avvenimenti li jiddefinixxu l- AIDS.
The mean average change from baseline over 16 weeks for HIV RNA levels was -0.79 log10 (maximum mean decrease:
It- tibdil medju mill- linja bażi għal- livelli HIV RNA fuq perijodu ta’ 16 – il ġimgħa kien ta ’ 0. 79 log10 (medja ta ’ tnaqqis massimu:
1.29 log10) in the ritonavir group versus -0.01 log10 in the control group.
1. 29 log10) fil- grupp ta ’ ritonavir kontra - 0. 01 log10 fil- grupp ta ’ kontroll.
The mean average change from baseline over 48 weeks 50 for HIV RNA levels was -0.88 log10 in the ritonavir group versus -0.66 log10 in the ritonavir + zidovudine group versus -0.42 log10 in the zidovudine group.
It- tibdil medju mill- linja bażi għal- livelli HIV RNA fuq perijodu ta ’ 48 ġimgħa kien ta ’ - 0. 88 log10 fil- grupp ta ’ ritonavir kontra - 0. 42 log10 fil- grupp ta ’ zidovudine.
In an open label trial completed in 1998 in HIV infected, clinically stable children there was a significant difference (p = 0.03) in the detectable RNA levels in favour of a triple regimen (ritonavir, zidovudine and lamivudine) following 48 weeks treatment.
55 Fi prova open label kompleta fl- 1998 fuq tfal klinikament stabbli infettati bl- HIV, kien hemm, wara kura ta ’ 48 ġimgħa, differenza sinifikanti (p = 0. 03) fil- livelli traċċabbli ta ’ RNA favur dożaġġ triplu (ritonavir, zidovudine u lamivudine).
There is no parenteral formulation of ritonavir, therefore the extent of absorption and absolute bioavailability have not been determined.
M’ hemm l- ebda formulazzjoni parenterali ta ’ ritonavir, għalhekk l- ammont ta ’ kemm ritanovir jiġi assorbit u ta ’ kemm huwa assolutament bijodisponibbli għadhom ma ġewx stabbiliti.
Trough concentrations of ritonavir decrease over time, possibly due to enzyme induction, but appeared to stabilise by the end of 2 weeks.
Il- konċentrazzjoni fl- êrja baxxa bejn żewġ għoljiet ta ’ ritonavir jonqsu mal- mgħodija taż- żmien, possibilment minħabba induzzjoni tal- enzimi, imma dehru jistabilliżaw ruħhom wara ġimagħtejn.
The time to maximum concentration (Tmax) remained constant at approximately 4 hours with increasing dose.
Maż- żieda fid- doża, il- ħin biex tintlaħaq il- konċentrazzjoni massima (Tmax) baqa ’ l- istess, ta ’ bejn wieħed u ieħor 4 sigħat.
Tissue to plasma ratios of
56 Studji fuq id- distribuzzjoni fit- tessuti b’ ritonavir tikkettat 14C li saru fuq il- firien, urew li l- fwied, l - adrenali, il- frixa, il- kliewi u t- tirojde kellhom l- ogħla konċentrazzjoni ta ’ ritonavir.
51 approximately 1 measured in rat lymph nodes suggests that ritonavir distributes into lymphatic tissues.
Il- proporzjon ta ’ bejn it - tessuti u l- plażma ta ’ bejn wieħed u ieħor 1 imkejjel fin- nodi limfatiċi tal- firien jindika li ritonavir jinfirex fit- tessuti limfatiċi.
Animal studies as well as in vitro experiments with human hepatic microsomes indicated that ritonavir primarily underwent oxidative metabolism.
Studji fuq l - annimali, kif ukoll esperimenti in vitro b’ mikrosomi epatiċi tal- bniedem urew li primarjament ritonavir għadda minn metaboliżmu ossidattiv.
The isopropylthiazole oxidation metabolite (M-2) is the major metabolite and has antiviral activity similar to that of parent drug.
Il- metabolit ta ’ ossidifikazzjoni ta ’ isopropylthiazole (M- 2) huwa l- metabolit prinċipali u għandhu attività antiretrovirali simili għal dik tal- mediċina prinċipali (parent drug).
However, the AUC of the M-2 metabolite was approximately 3% of the AUC of parent drug.
Iżda l- AUC tal - metabolit M- 2 kien bejn wieħed u ieħor 3% ta ’ l- AUC tal- mediċina prinċipali.
In these studies renal elimination was not found to be a major route of elimination of ritonavir.
F’ dawn l- istudji ġie misjub li l- eliminazzjoni permezz tal- kliewi m’ hijiex ir- rotta prinċipali għal - eliminazzjoni ta ’ ritonavir.
Ritonavir pharmacokinetic parameters were not statistically significantly associated with body weight or lean body mass.
Il- parametri farmakokinetiċi ta ’ ritonavir ma kienux statistikament assoċjati b’ mod sinifikanti mal- piż tal- ġisem jew mal- massa tal- ġisem bla xaħam.
Paediatric patients:
Pazjenti Pedjatriċi:
Across dose groups, ritonavir oral clearance (CL/F/m2) was approximately 1.5 to 1.7 times faster in paediatric patients above 2 years of age than in adult subjects.
Bejn il- gruppi ta’ doża differenti it- tneħħija ta ’ ritonavir mill- ħalq (CL/ F/ m2) kienet ta ’ bejn wieħed u ieħor minn 1. 5 sa 1. 7 drabi aktar mgħaġġla f’ pazjenti pedjatriċi li kellhom iżjed minn sentejn, milli minn suġġetti adulti.
Across dose groups, ritonavir oral clearance (CL/F/m2) declined with age with median values of 9.0 L/h/m2 in children less than 3 months of age, 7.8 L/h/m2 in children between 3 and 6 months of age and 4.4 L/h/m2 in children between 6 and 24 months of age.
Bejn il- gruppi ta’ doża differenti, it- tneħħija ta ’ ritonavir mill- ħalq (CL/ F/ m2) naqqset ma ’ l- età, 57 b’ valuri medji ta ’ 9. 0 L/ h/ m2 fi tfal ta ’ inqas minn 3 xhur fl- età, 7. 8 L/ h/ m2 fi tfal ta’ l- età ta ’ bejn it- 3 xhur u s- 6 xhur u 4. 4 L/ h/ m2 fi tfal ta ’ età ta ’ bejn is- 6 xhur u l- 24 xhar.
Hyperplasia of the retinal pigment epithelium (RPE) and retinal degeneration have been seen in all of the rodent studies conducted with ritonavir, but have 52 not been seen in dogs.
L- iperplasija ta ’ l - epiteljum pigmentali tar- retina (RPE) u deġenerazzjoni fir- retina ġew osservati fl- istudji kollha li saru b’ ritonavir fuq l- annimali gerriema, iżda ma ġewx innutati fil- klieb.
Developmental toxicity observed in rats (embryolethality, decreased foetal body weight and ossification delays and visceral changes, including delayed testicular descent) occurred mainly at a maternally toxic dosage.
Tossiċità li hija relatata ma ’ l- iżvilupp li ġiet osservata fil- firien (mewt tal- embriju, tnaqqis fil- massa tal- ġisem tal- fetu u dewmin fl- ossifikazzjoni, u tibdil vixxerali, li jinkludi dewmin fl- inżul tat- testikoli fil- borża) irrevelat ruħha prinċiparjament f’ dożaġġ tossiku għall- omm.
Developmental toxicity in rabbits (embryolethality, decreased litter size and decreased foetal weights) occurred at a maternally toxic dosage.
Tossiċità li hija relatata ma ’ l - iżvilupp li ġiet osservata fil- fniek (mewt tal- embriju, tnaqqis fin- numru tal- boton u tnaqqis fil- massa tal- ġisem tal- fetu) irrevelat ruħha prinċiparjament f’ dożaġġ tossiku għall- omm.
Capsule contents: alcohol, butylated hydroxytoluene (E321), oleic acid, polyoxyl 35 castor oil.
Kontenut tal- kapsula: alcoħol, butylated hydroxytoluene (E321), aċidu oleiku, polyoxyl 35 żejt ir- riġnu
Capsule shell: gelatine, “sorbitol special” (ie sorbitol sorbitolanhydrides and mannitol), glycerine, titanium dioxide (white colour), medium chain triglycerides, lecithin, black ink containing: propylene glycol, black iron oxide, polyvinyl acetate phthalate, polyethylene glycol 400 and ammonium hydroxide.
Il- qoxra ta ’ barra tal- kapsula: ġelatina, “ sorbitol special ” (ie sorbitol sorbitolanhydrides u mannitol), gliċerina, titanium dioxide (ta ’ kulur abjad), triglycerides b’ katini ta ’ tul medju, leċitina, linka sewda li fiha: propylene glycol, iron oxide iswed, polyvinyl acetate phthalate, polyethylene glycol 400 u ammonium hydroxide.
Not applicable
58 Ma jgħoddx f’ dan il- każ.
Store in a refrigerator (2ºC - 8ºC) until they are dispensed to the patient.
Aħżen fi friġġ (2ºC - 8ºC) sakemm tagħtihom lill- pazjent.
Refrigeration by the patient is not required if used within 30 days and stored below 25°C.
Il- pazjent m’ għandux għalfejn jagħmilhom fil- friġġ jekk jużahom fi żmien 30 ġurnata u jaħżinhom f’ temperatura taħt 25ºC.
Avoid exposure to freezing and excessive heat.
Evita esponiment għall- iffriżar u sħana eċċessiva.
53 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Norvir soft capsules are supplied in white high density polyethylene (HDPE) bottles closed with polypropylene caps containing 84 capsules.
Il- kapsuli rotob Norvir huma fornuti fi fliexken bojod high density polyethylene (HDPE), magħluqa b’ għotjin polyethylene, u li fihom 84 kapsula.
Two pack sizes are available for Norvir soft capsules: − 1 bottle of 84 capsules (84 capsules) − 4 bottles of 84 capsules (336 capsules)
4 fliexken ta ’ 84 kapsula (336 kapsula).
Not all pack sizes may be marketed.
Mhux il- qisien kollha tal- pakketti jistgħu jinbiegħu.
26 August 1996 Date of last renewal:
26 ta ’ Awissu 1996 Data tat- tiġdid ta ’ l- awtorizzazzjoni:
54 ANNEX II
59 ANNESS II
CONDITIONS OF THE MARKETING AUTH ORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Soft capsules and oral solution
Kapsuli rotob u soluzzjoni orali
Aesica Queenborough Limited, Queenborough, Kent, ME11 5EL, United Kingdom
Aesica Queenborough Limited, Queensborough, Kent, ME11 5EL, Renju Unit
Soft capsules only
Kapsuli rotob biss
Abbott Laboratories S.A., Avenida de Burgos, 91, E-28050 Madrid, Spain
Abbott Laboratories S. A., Avenida de Burgos, 91, E- 28050 Madrid, Spanja
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
56 ANNEX III
61 ANNESS III
58 PARTICULARS TO APPEAR ON THE OUTER PACKAGING NORVIR ORAL SOLUTION CARTON TEXT
63 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA TEST TAL- KARTUNA TAS- SOLUZZJONI ORALI NORVIR
Norvir 80 mg/ml oral solution Ritonavir
Norvir 80 mg/ ml soluzzjoni orali Ritonavir
Each ml of oral solution contains 80 mg of ritonavir.
Kull ml ta’ soluzzjoni orali fih 80 mg ritonavir.
Also contains: alcohol (43% by volume), polyoxyl 35 castor oil, propylene glycol, saccharin sodium, sunset yellow E110.
Fih ukoll: alcoħol (b’ volum ta ’ 43%), Polyoxyl 35 żejt ir- riġnu, propylene glycol, sakkarina tas- sodju, isfar lewn inżul ix- xemx (E110).
450 ml oral solution (5 bottles of 90 ml oral solution each)
450 ml soluzzjoni orali (5 fliexken ta ’ 90 ml soluzzjoni orali kull wieħed)
Child resistant closure.
Għatu li ma jinfetaħx mit- tfal.
Use within the expiry date.
Uża sad- data ta ’ meta jiskadi.
Shake well before each use.
Ħawwad sew qabel kull darba li tużah.
If, after shaking, particles or precipitate can be seen in the solution, take the next dose and see your doctor about a fresh supply.
Jekk wara li tħawwad, ikunu jidhru partiċelli jew materja soda fis- soluzzjoni, ħu d- doża li jkun imiss u kellem lit- tabib dwar provvista ġdida.
Avoid exposure to excessive heat.
64 Evita l- esponiment għal sħana eċċessiva.
Abbott Laboratories Limited Queenborough Kent ME11 5EL, United Kingdom
Abbott Laboratories Limited Queenborough Kent ME11 5EL, Renju Unit
Norvir 80 mg/ml oral solution
Norvir 80 mg/ ml soluzzjoni orali
60 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
65 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT IMMEDJAT
NORVIR ORAL SOLUTION BOTTLE LABEL TEXT
TEST TAT- TABELLA TAL- FLIXKUN TAS- SOLUZZJONI ORALI NORVIR
90 ml oral solution
90 ml soluzzjoni orali
Avoid exposure to excessive heat.
66 Evita l- esponiment għal sħana eċċessiva.
Abbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom
Abbott Laboratories Limited Queenborough Kent ME11 5EL, Renju Unit
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
67 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Norvir 100 mg soft capsules Ritonavir
Norvir 100 mg kapsuli rotob Ritonavir
Each soft capsule contains 100 mg ritonavir
Kull kapsula ratba fiha 100 mg ritonavir
Also contains: mannitol, polyoxyl 35 castor oil, propylene glycol, butylated hydroxytoluene (E321), ethanol (12% w/w) (see package leaflet)
Fih ukoll: mannitol, polyoxyl 35 żejt ir- riġnu, propylene glycol, butylated hydroxytoluene (E321), ethanol (12% w/ w) (ara l- fuljett ta ’ tagħrif)
84 soft capsules
84 kapsula ratba
Store in a refrigerator until dispensed to the patient.
Aħżen fi friġġ sakemm tagħtih lill- pazjent.
Refrigeration by the patient is not required if used within 30 days and stored below 25°C.
Il- pazjent m’ għandux għalfejn jagħmlu fil- friġġ jekk jużah fi żmien 30 ġurnata, u jaħżnu f’ temperatura taħt 25°C.
Avoid exposure to freezing and to excessive heat.
Evita l- esponiment għall- iffriżar u sħana eċċessiva.
NORVIR SOFT CAPSULES CARTON TEXT – 4 BOTTLES
TEST TAL- KARTUNA TAL- KAPSULI ROTOB NORVIR – 4 FLIEXKEN
336 soft capsules (4 bottles of 84 capsules each)
336 kapsula ratba (4 fliexken ta ’ 84 kapsula kull wieħed)
66 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
71 TAGĦRIF LI GĦANDU JIDHER FUQ IL- FLIXKUN TA ’ ĠEWWA
NORVIR SOFT CAPSULES BOTTLE LABEL TEXT
TEST TAT- TABELLA TAL- FLIXKUN TAL- KAPSULI ROTOB NORVIR
NORVIR 80 mg/ml oral solution ritonavir
NORVIR 80 mg/ ml soluzzjoni orali ritonavir
Read all of this leaflet carefully before you start taking this medicine. − Keep this leaflet.
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina
You may need to read it again. − If you have any further questions, please ask your doctor or pharmacist. − This medicine has been prescribed for you.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Do not pass it onto others.
Tagħtihiex lil persuni oħra.
What Norvir is and what it is used for 2.
X’ inhu Norvir u għalxiex jintuża 2.
Before you take Norvir 3.
Qabel ma tieħu Norvir 3.
How to take Norvir 4.
Kif għandek tieħu Norvir 4.
How to store Norvir 6.
Kif taħżen Norvir 6.
WHAT NORVIR IS AND WHAT IT IS USED FOR
X’ INHU NORVIR U GĦALXIEX JINTUŻA
Norvir contains ritonavir which is a protease inhibitor used to control HIV infection.
Norvir fih ritonavir li huwa impeditur protejaż użat biex jikkontrolla l- infezzjoni ta ’ l- HIV.
Norvir is used in combination with other anti-HIV medicines (antiretrovirals) to control your HIV infection.
Norvir huwa wżat flimkien ma ’ mediċini oħra għal kontra l- HIV (antiretrovirali) biex jikkontrollalek l - infezzjoni ta ’ l- HIV.
Your doctor will discuss with you the best combination of medicines for you.
It- tabib tiegħek jiddiskuti miegħek liema taħlita ta ’ mediċini hija l- aħjar għalik.
Norvir can be used at full dose on its own, or at lower doses (called booster doses) with other medicines.
Norvir jista ’ jintuża bħala doża sħiħa meta jittieħed waħdu, jew f’ dożi iżgħar (imsejħa dożi buster) flimkien ma ’ mediċini oħra.
BEFORE YOU TAKE NORVIR
QABEL MA TIEĦU NORVIR
If Norvir is taken in combination with other antiretroviral medicines, it is important that you also carefully read the leaflets that are provided with these other medicines.
Jekk Norvir jittieħed flimkien ma ’ mediċini antiretrovirali oħra, huwa importanti li inti taqra b’ attenzjoni wkoll il- Fuljett ta ’ Tagħrif li jkunu pprovduti ma ’ dawn il- mediċini l- oħra.
There may be additional information in those leaflets about situations when Norvir should be avoided.
F’ dawk il - fuljetti jista ’ jkun hemm informazzjoni addizzjonali dwar dawk il- każijiet fejn Norvir għandu jiġi evitat.
If you have any further questions about Norvir (ritonavir) or the other medicines prescribed, please ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar Norvir (ritonavir) jew dwar il- mediċini l- oħra li ġew mogħtija lilek mit- tabib, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek.
Do not take Norvir
Tieħux Norvir
− if you are allergic (hypersensitive) to ritonavir or any of the other ingredients of Norvir (see section 6).
- jekk inti allerġiku (tbati minn sensittività eċċessiva) għal ritonavir jew sustanzi oħra ta ’ Norvir
− if you have severe liver disease.
- jekk inti għandek mard serju tal- fwied.
− if you are currently taking any of the following medicines:
- jekk bħalissa qiegħed tieħu xi waħda minn dawn il- mediċini segwenti:
astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines may be available without prescription);
- astemizole jew terfenadine (issoltu użata biex tikkura sintomi ta ’ allergija – dawn il -
−
mediċini jistgħu jiġu akkwistati mingħajr riċetta tat- tabib);
amiodarone, bepridil, encainide, flecainide, propafenone, quinidine (used to correct irregular heartbeats);
- amiodarone, bepridil, encainide, flecainide, propafenone, quinidine (użati sabiex jikkoreġu
− −
- dihydroergotamine, ergotamine (użati għall- kura tal- migranja);
dihydroergotamine, ergotamine (used to treat migraine headache); ergonovine, methylergonovine (used to stop excessive bleeding that may occur following childbirth or an abortion);
- ergonovine, methylergonovine (użati biex iwaqqfu ħruġ eċċessiv ta ’ demm li jista ’ jkun
70
hemm wara l- ħlas jew wara abort);
−
- clorazepate, diazepam, estazolam, flurazepam, triazolam jew midazolam orali (mittieħed
clorazepate, diazepam, estazolam, flurazepam, triazolam or oral (taken by mouth) midazolam (used to help you sleep and/or relieve anxiety);
mill- ħalq) (użati biex jgħinuk torqod u/ jew inaqqsu l- ansjetà);
clozapine, pimozide, (used to treat abnormal thoughts or feelings); meperidine, piroxicam, propoxyphene (used to relieve pain); cisapride (used to relieve certain stomach problems); rifabutin (used to prevent/treat certain infections)*; voriconazole (used to treat fungal infections)*; simvastatin, lovastatin (used to lower blood cholesterol); alfuzosin (used to treat enlarged prostate gland); fusidic acid (used to treat bacterial infections); rifampicin co-administered with saquinavir (used to treat co-infections with HIV and tuberculosis);
clozapine, pimozide (użati biex jikkuraw ħsibijiet jew emozzjonijiet li m’ humiex normali); meperidine, piroxicam, propoxyphene (użati biex itaffu l- uġigħ); cisapride (użat biex itaffi ċerti problemi fl- istonku); rifabutin (użat biex jippreveni / jikkura ċerti infezzjonijiet) *; voriconazole (użat biex jikkura infezzjonijiet tal- fungu) *; simvastatin, lovastatin (użati biex inaqqsu l- kolesterol fid- demm); alfuzosin (użati biex jikkuraw it- tkabbir tal- glandola tal- prostata); fusidic acid (użat biex jikkura infezzjonijiet bil- batterji); rifampicin mittieħed flimkien ma ’ saquinavir (użat biex jikkura infezzjonijiet eżistenti flimkien ma ’ l- HIV u t- tuberkulosi);
sildenafil for impotence (erectile dysfunction) if you also suffer from a lung disease call pulmonary arterial hypertension that makes breathing difficult.
sildenafil għall- impotenza (disfunzjoni erettili) jekk int tbati ukoll minn marda tal- pulmun li tissejjaħ pressjoni għolja fl- arterji pulmonari li tagħmilha diffiċli biex tieħu n- nifs.
Patients without this disease may use sildenafil under their doctor’s supervision (see the section on Taking other medicines);
(ara s- sezzjoni dwar Meta tieħu mediċini oħra);
products containing St John’s wort (Hypericum perforatum) as this may stop Norvir from working properly.
prodotti li fihom l- fexfiex tar- raba ’ (Hypericum perforatum) peress li din tista ’ twaqqaf lil Norvir milli jaħdem kif sippost.
St John’s wort is often used in herbal medicines that you can buy yourself.
Il- fexfiex tar- raba ’ huwa użatt ta ’ spiss f’ mediċini tal - ħxejjex li tista ’ tixtrihom inti stess.
* Your doctor may decide that you can take rifabutin and/or voriconazole with a booster (lower dose) of Norvir but a full dose of Norvir must not be taken together with these two medicines.
It- tabib tiegħek jista ’ jiddeċiedi li int tista ’ tieħu rifabutin u/ jew voriconazole b’ buster (doża * iżgħar) ta ’ Norvir, iżda m’ għandhiex tittieħed doża sħiħa ta ’ Norvir flimkien ma ’ dawn iż- żewġ mediċini.
If you are currently taking any of these medicines, ask your doctor about switching to a different medicine while you are taking Norvir.
Jekk preżentament inti qiegħed tieħu xi waħda minn dawn il- mediċini, staqsi lit- tabib tiegħek dwar jekk tistax taqleb fuq mediċina oħra waqt li inti qiegħed tieħu Norvir.
Often, there are other medicines you can take instead.
Ħafna drabi jkun hemm mediċini oħra li inti tista ’ tieħu minflok.
Also read the list of medicines other ‘Taking other medicines’ for use with certain other medicines which require special care.
Aqra ukoll il- lista ta ’ mediċini taħt is- sezzjoni ‘ Meta tieħu mediċini oħra ’ meta tkun se tieħu Norvir flimkien ma ’ ċerti mediċini oħra li jeħtieġu attenzjoni speċjali.
Take special care with Norvir
Oqgħod attent ħafna b’ Norvir
Important information
Informazzjoni Importanti
− Norvir is not a cure for HIV infection or AIDS. − People taking Norvir may still develop infections or other illnesses associated with HIV infection or AIDS.
- Persuni li jkunu qegħdin jieħdu Norvir xorta jistgħu jiżviluppaw infezzjonijiet jew mard ieħor
It is therefore important that you remain under the supervision of your doctor while taking Norvir. − Norvir does not lower the risk of passing HIV to others.
Għalhekk huwa importanti li int tibqa ’ taħt is - superviżjoni tat- tabib tiegħek waqt li tkun qiegħed tieħu Norvir.
Appropriate precautions should be taken to prevent passing the disease through sexual contact (e.g. use of a condom) or blood contamination (you should not give blood or share needles).
prekawzjonijiet xierqa biex tiġi evitata t- trasmissjoni tal- marda minn kuntatt sesswali (eż. uża l - kondom) jew minn kontaminazzjoni tad- demm (int m’ għandekx tagħti demm jew taqsam labar ma ’ ħaddieħor).
Tell your doctor if you have/had:
Għid lit- tabib tiegħek jekk int għandek/ kellek:
− A history of liver disease.
- Storja ta ’ mard tal- fwied.
− Hepatitis B or C and are being treated with a combination of antiretroviral agents, as you are at a greater risk of a severe and potentially l ife threatening reaction because of the effect on the liver.
- Epatite B jew C u qiegħed tiġi kkurat b’ taħlita ta ’ aġenti antiretrovirali, peress li int tinsab
Regular blood tests may be required to check your liver is working properly.
f’ riskju akbar ta ’ reazzjoni avversa severa li tista ’ tkun ta ’ periklu għal ħajtek minħabba l- effett fuq il- fwied.
− Haemophilia, as there have been reports of increased bleeding in patients with haemophilia who are taking this type of medicine (protease inhibitors).
- Emofilja, peress li kien hemm rapporti ta ’ żieda fil- ħruġ ta ’ demm f’ pazjenti li jbatu mill -
The reason for this is not known.
Il- kaġun ta ’ dan għadu mhux magħruf.
You may need additional medicine to help your blood clot (factor VIII), in order to control any bleeding.
- Dijabete, peress li f’ każ ta ’ xi pazjenti li kienu qegħdin jieħdu l- impedituri protejaż, kien hemm
− Diabetes, as there have been reports of worsening of or the development of diabetes (diabetes mellitus) in some patients taking protease inhibitors.
rapporti ta ’ istanzi fejn id- dijabete marret għall- agħar jew fejn żviluppat id- dijabete (dijabete mellitus).
71 Tell your doctor if you experience:
Għid lit- tabib tiegħek jekk int tesperjenza:
− Changes in the distribution of the fat on your body, or a build up or loss of body fat (see section 4.
- Tibdil fid- distribuzzjoni tax- xaħam ta ’ ġismek, jew jekk jifformalek xaħam jew titlef ix -
Possible side effects).
Effetti sekondarji li jista ’ jkollu).
− Diarrhoea or vomiting that is not improving (persistent), as this may reduce how well the medicines you are taking work.
- Dijarea jew rimettar li mhux qiegħed imur ’ il quddiem (persistenti), għaliex dan jista ’ jnaqqas
− Feeling sick (nausea), vomiting or have stomach pain, because these may be signs of inflammation of the pancreas (pancreatitis).
- Dardir (nawseja), rimettar jew jekk għandek uġigħ fl- istonku, għax dawn jistgħu jkunu sinjali
Some patients taking Norvir can develop serious problems with their pancreas.
Xi pazjenti li jieħdu Norvir jistgħu jiżviluppaw problemi severi fil- frixa.
Tell your doctor as soon as possible if this applies to you.
Għid lit- tabib tiegħek malajr kemm jista ’ jkun jekk dan japplika għalik.
− Symptoms of infection – inform your doctor immediately.
- Sintomi ta ’ infezzjoni – informa lit- tabib tiegħek immedjatament.
Some patients with advanced HIV infection (AIDS) who then start anti-HIV treatment may develop the symptoms of infections they have had in the past even if they didn’t know they had had them.
infezzjoni ta ’ l- HIV fi stadju avanzat (AIDS) li mbagħad jibdew l- kura għal kontra l- HIV jistgħu jiżviluppaw is- sintomi ta ’ infezzjonijiet li huma kellhom fil- passat anke jekk huma lanqas kienu jafu li huma qatt kellhom dawn l- infezzjonijiet.
It is believed that this happens because the body's immune response improves and helps the body to fight these infections.
- Ebusija tal- ġogi, weġgħat u uġigħ (speċjalment tal- ġenbejn, ta ’ l- irkoppa u ta ’ l- ispalla) u
− Joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty moving, tell your doctor, as this may be a sign of a problem that can destroy bone (osteonecrosis).
diffikultà biex tiċċaqlaq, għid lit- tabib tiegħek għax dan jista ’ jkun sinjal ta ’ problema li tista ’ teqred l- għadam (nekrosi ta ’ l- għadam).
Some patients taking a number of antiretroviral medicines may develop this disease.
Xi pazjenti li jieħdu numru ta ’ mediċini antiretrovirali jistgħu jiżviluppaw din il- marda.
− Muscle pain, tenderness or weakness, particularly in combination with antiretroviral therapy including protease inhibitors and nucleoside analogues.
- Uġigħ fil- muskoli, sensittività̀ jew dgħjufija, speċjalment jekk int qiegħed tieħu Norvir
On rare occasions these muscle disorders have been serious.
flimkien ma ’ terapija antiretrovirali li tinkludi impedituri protejaż u analogi ta ’ nukleòside.
(See section 4 Possible side effects)
F’ każi rari, dawn id- disturbi kienu serji (Ara sezzjoni 4 Effetti sekondarji li jista ’ jkollu).
− if you have any other health concerns, discuss these with your doctor as soon as you can.
- jekk għandek xi diffikultajiet oħra relatati mas- saħħa, iddiskutihom mat- tabib tiegħek mill- aktar
Children under 2 years of age should not take Norvir.
Tfal ta ’ taħt is- sentejn m’ għandhomx jieħdu Norvir.
There are some medicines you cannot take at all with Norvir.
Hemm ċerti mediċini li inti assolutament ma tistax tieħu ma ’ Norvir.
These are listed earlier in Section 2, under ‘Do not take Norvir’.
Dawn kienu mniżżla qabel f’ sezzjoni 2, taħt ‘ Tieħux Norvir ’.
There are some other medicines that can only be used under certain circumstances as described below.
Hemm mediċini oħra li jistgħu jintużaw biss f’ ċerti ċirkostanzi kif deskritt hawn taħt.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk joġgħbok għid lit- tabib jew lill- ispiżjar tiegħek jekk inti qiegħed tieħu jew ħadt riċentement xi mediċini oħra, inklużi mediċini li jiġu akkwistati mingħajr riċetta tat- tabib.
The following warnings apply when Norvir is taken as a full dose.
It- twissijiet li ġejjin japplikaw meta Norvir jittieħed bħala doża sħiħa.
However, these warnings may also apply when Norvir is used in lower doses (a booster) with other medicines.
Madanakollu, dawn it- twissijiet jistgħu japplikaw ukoll meta Norvir jintuża f’ dożi iżgħar (buster) flimkien ma ’ mediċini oħra.
Tell your doctor if you are taking any of the medicines listed below, as special care should be taken.
Jekk int qiegħed tieħu xi waħda mill- mediċini mniżżlin hawn taħt, għid lit- tabib tiegħek, għax hemm bżonn li tittieħed attenzjoni speċjali.
− Sildenafil, tadalafil, vardenafil for impotence (erectile dysfunction).
- Sildenafil, tadalafil, vardenafil għall- impotenza (disfunsjoni erettili).
You should reduce the dose of these medicines to avoid damage to the penis.
doża ta ’ dawn il- mediċini biex tevita li tikkawża ħsara lill- pene.
You must not take Norvir with sildenafil if you also suffer from pulmonary arterial hypertension (see also section 2.
M’ għandekx tieħu Norvir ma ’ sildenafil jekk int tbati wkoll minn pressjoni għolja fl- arterji pulmonari (ara wkoll sezzjoni 2.
Before you take Norvir).
Qabel ma ’ tieħu Norvir).
− Digoxin (heart medicine).
- Digoxin (mediċina għall- qalb).
Your doctor may need to adjust the dose of digoxin and monitor you while you are taking digoxin and Norvir in order to avoid heart problems.
Jista ’ jkun li t- tabib tiegħek ikollu bżonn jaġġusta d- doża ta ’
− Hormonal contraceptives containing ethinyl oestradiol as Norvir may reduce the effectiveness of these medicines.
- Kontraċettivi li fihom l- ormoni li fihom ethinyl oestradiol għax Norvir jista ’ jnaqqas l -
It is recommended that a condom or other non-hormonal method of contraception is used instead.
Huwa rrakkomandat li minflok, jintuża kondom jew metodu ieħor ta ’ kontraċezzjoni li ma fihx ormoni.
You may also notice irregular uterine bleeding if you are taking 72 this type of hormonal contraceptive with Norvir.
Jista ’ jkun ukoll li tinnota ħruġ ta ’ demm irregolari mill- ġuf jekk int tieħu dan it- tip ta ’ kontraċettiv li fih l- ormoni flimkien ma ’ Norvir.
− Atorvastatin or rosuvastatin (for high cholesterol) as Norvir may raise the blood levels of these medicines.
- Atorvastatin jew rosuvastatin (għall- kolesterol għoli) għax Norvir jista ’ jżid il- livelli fid -
Talk to your doctor before you take any cholesterol-reducing medicines with Norvir (see also ‘Do not take Norvir’ above).
Tkellem mat- tabib tiegħek qabel tieħu mediċini li jnaqqsu l - kolesterol flimkien ma ’ Norvir (ara ukoll ‘ Tieħux Norvir ’ hawn fuq).
− Steriods (eg dexamethasone, fluticasone propionate, prednisolone) as Norvir may raise the blood levels of these medicines which may lead to Cushing’s syndrome (development of a rounded face) and reduce production of the hormone cortisol.
livelli fid- demm ta ’ dawn il- mediċini li jista ’ jwassal għas- sindromu Cushing (Cushing’ s syndrome) (żvilupp ta ’ wiċċ tond) u jnaqqas il- produzzjoni ta ’ l- ormon cortisol.
Your doctor may wish to reduce the steroid dose or monitor your side effects more closely.
Jista ’ jkun li t - tabib tiegħek ikun irid inaqqaslek id- doża ta ’ l- isterojd jew josserva l- effetti avversi aktar mill - qrib.
− Trazodone (a medicine for depression) as, unwanted effects like nausea, dizziness, low blood pressure and fainting can occur when taken with Norvir.
nawseja, sturdament, pressjoni baxxa fid- demm u jagħtik ħass ħażin meta dan jittieħed flimkien ma ’ Norvir.
− Rifampicin and saquinavir (used for tuberculosis and HIV, respectively) as serious liver damage can occur when taken with Norvir.
- Rifampicin u saquinavir (użati għat- tuberkulosi u għall- HIV, rispettivament) għax tista ’ tiġi
There are medicines that may not mix with Norvir because their effects could increase or decrease when taken together.
Hemm mediċini li ma jistgħux jitħalltu flimkien ma ’ Norvir għax l- effetti tagħhom jistgħu jiżdiedu jew jonqsu meta dawn jittieħdu flimkien.
In some cases your doctor may need to perform certain tests, change the dose or monitor you regularly.
F’ ċerti każi, it- tabib tiegħek ikollu bżonn jagħmillek ċerti testijiet, ibiddel id- doża jew josservak regolarment.
This is why you should tell your doctor if you are taking any medicines, including those you have bought yourself or herbal products, but it is especially important to mention these:
Din hi r- raġuni għaliex int għandek tgħid lit- tabib tiegħek jekk int qiegħed tieħu xi mediċini, inklużi dawk li xtrajt int stess mingħajr riċetta tat- tabib jew prodotti tal- ħxejjex, iżda hu partikolarment importanti li ssemmi dawn:
− amphetamine or amphetamine derivatives; − antibiotics (eg erythromycin, clarithromycin); − anticancer treatments (eg vincristine, vinblastine); − antidepressants (eg amitriptyline, desipramine, fluoxetine, imipramine, nortriptyline, paroxetine, sertraline, trazodone); − antifungals (eg ketoconazole, itraconazole); − antihistamines (eg loratidine, fexofenadine); − antiretroviral medicines including HIV-protease inhibitors and Non-nucleoside reverse transcriptase inhibitors( NNRTI); − anxiety medicine, buspirone; − asthma medicine, theophylline; − atovaquone, a medicine used to treat a certain type of pneumonia and malaria; − buprenorphine, a medicine used for the treatment of chronic pain; − bupropion, a medicine used to help you stop smoking; − epilepsy medicines (eg carbamazepine, divalproex, lamotrigine, phenytoin); − heart medicines (eg digoxin, disopyramide, mexiletine and calcium channel antagonists such as amlodipine, diltiazem and nifedipine); − immune system (eg cyclosporine, tacrolimus, everolimus); − morphine and morphine-like medicines used to treat severe pain (eg methadone, fentanyl); − sleeping pills (eg alprazolam, zolpidem) and also midazolam administered by injection; − tranquillisers (eg haloperidol, risperidone, thioridazine); − warfarin, that thins the blood.
Norvir m’ għandux jittieħed ma ’ disulfiram (mediċina użata għall- kura ta ’ l- alkoħoliżmu) u ma ’
Norvir should not be used with disulfiram (a medicines used to treat alcoholism) and metronidazole (a medicines used for certain bacterial infections) as they can interact with the alcohol contained in the oral solution.
78 metronidazole (mediċina użata għal ċerti infezzjonijiet bil- batterji) għax dawn jistgħu jikkawżaw reazzjoni ma ’ l- alkoħol li hemm fis- soluzzjoni orali.
There are some medicines you cannot take at all with Norvir.
Hemm ċerti mediċini li int assolutament ma tistax toħodhom ma ’ Norvir.
These are listed earlier in section 2, under ‘Do not take Norvir’.
Dawn huma mniżżla aktar ’ il fuq f’ sezzjoni 2, taħt ‘ Tieħux Norvir ’.
Taking Norvir with food and drink
Meta tieħu Norvir ma ’ l- ikel u max- xorb
73 Norvir should preferably be taken with food.
Preferibbilment, Norvir għandu jittieħed ma ’ l- ikel.
The bitter taste of Norvir oral solution may be better if it is mixed with chocolate milk.
It- togħma morra tas- soluzzjoni orali Norvir tista ’ tittejjeb billi tħallat Norvir mal- ħalib taċ- ċikkulata.
Do not mix with water.
Tħallatx ma ’ l- ilma.
Eating salty food or drinking fluids before or after taking Norvir oral solution can help clear the aftertaste from your mouth.
Jekk tiekol ikel mielaħ jew tixrob qabel jew wara li tieħu s- soluzzjoni orali Norvir, dan jista ’ jgħinek tneħħi t- togħma ħażina minn ħalqek.
If you think you are pregnant or you are planning to become pregnant, it is very important that you discuss this with your doctor.
Jekk taħseb li int tqila jew jekk qiegħda tippjana biex tinqabad tqila, huwa importanti ħafna li int tiddiskuti dan mat- tabib tiegħek.
There is very little information on the use of ritonavir (the active ingredient in Norvir) during pregnancy.
Teżisti ftit wisq informazzjoni dwar l- użu ta ’ ritonavir (is- sustanza attiva f’ Norvir) waqt it- tqala.
In general, the pregnant mothers received ritonavir after the first three months of pregnancy at a lower dose (booster) along with other protease inhibitors.
B’ mod ġenerali, nisa tqal ingħataw ritonavir wara l- ewwel tliet xhur tat- tqala f’ doża iżgħar milli sippost (buster), flimkien ma ’ impedituri protejaż oħra.
Norvir did not appear to increase the chance of developing birth defects compared to the general population.
Ma deherx li Norvir iżid iċ- ċans ta ’ żvilupp ta ’ difetti tat- twelid meta pparagunat mal- popolazzjoni ġenerali.
It is not known if Norvir passes into breast milk.
M’ huwiex magħruf jekk Norvir jgħaddix ġol- ħalib tas- sider.
To avoid transmitting the infection, mothers with HIV should not breast feed their babies.
Biex jevitaw li jgħaddu l- infezzjoni lit - tarbija, l- ommijiet li għandhom l- HIV m’ għandhomx ireddgħu lit- trabi tagħhom.
Norvir can cause sleepiness and dizziness.
Norvir jista ’ jikkawża ngħas u sturdament.
If you are affected do not drive or use machinery.
Jekk int tkun affetwat, issuqx u tħaddimx magni.
Important information about some of the ingredients of Norvir
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Norvir
Norvir contains 43 vol% ethanol (alcohol), ie up to 258 mg per maximum dose of 600 mg, equivalent to 65 ml beer, 27 ml wine per dose.
Norvir fih 43 vol% ethanol (alkoħol), jiġifieri sa 258 mg kull doża massima ta ’ 600 mg, ekwivalenti għal 65 ml birra, 27 ml inbid kull doża.
This can be harmful to pregnant or breast-feeding women, children and people with liver disease, epilepsy or alcoholism.
Dan jista ’ jkun ta ’ dannu għal nisa tqal jew li jkunu qegħdin ireddgħu, għat - tfal u għal persuni b’ mard tal- fwied, bl- epilessija jew bl- alkoħoliżmu..
Norvir contains polyoxyl 35 castor oil which may cause stomach upset and diarrhoea.
Norvir fih polyoxyl 35 żejt ir- riġnu, li jista ’ jikkawża taqlih fl- istonku u dijarea.
Norvir contains the colouring agent sunset yellow (E110) which may cause allergic reactions.
Norvir fih l- aġent li jagħti l- kulur isfar lewn inżul ix- xemx (E110), li jista ’ jikkawża reazzjonijiet allerġiċi.
HOW TO TAKE NORVIR
KIF GĦANDEK TIEĦU NORVIR
Always take Norvir exactly as your doctor has told you.
Dejjem għandek tieħu Norvir skond il- parir tat- tabib.
It is taken by mouth usually two times every day.
Jittieħed mill- ħalq, normalment darbtejn kuljum.
Norvir should preferably be taken with food.
Preferibbilment, Norvir għandu jittieħed ma ’ l- ikel.
Shake the bottle well before each use.
Ħawwad il- flixkun sewwa qabel kull darba li tużah.
If, after shaking, particles or solids can be seen in the solution, take the next dose and see your doctor or pharmacist about a fresh supply.
Jekk wara li tkun ħawwadt, ikunu jidhru partiċelli jew materja soda fis- soluzzjoni, ħu d- doża li jkun imiss u kellem lit- tabib dwar provvista ġdida.
Recommended doses of Norvir are:
Id- dożi rrakkomandati ta ’ Norvir huma:
• if Norvir is used to boost the effects of other anti-HIV medicines, the typical dose for adults is 1.25 to 2.5 ml once or twice daily.
Għal aktar rakkomandazzjonijiet
For more detailed dose recommendations, including those for children, see the Package Leaflet of the anti-HIV medicines Norvir is given in combination with.
79 fid- dettall dwar dożaġġ, inkluż id- dożaġġ għat- tfal, ara l- Fuljett ta ’ Tagħrif ta ’ dawk il- mediċini għal kontra l- HIV li Norvir ikun qiegħed jingħata magħhom.
• if your doctor prescribes a full dose, adults may be started on a dose of 3.75 ml in the morning and 3.75 ml 12 hours later, gradually increasing over a period of up to 14 days to the full dose of 7.5 ml twice daily.
• jekk it- tabib tiegħek jagħtik doża sħiħa, l- adulti jistgħu jibdew fuq doża ta ’ 3. 75 ml filgħodu u 3. 75 ml 12 - il siegħa wara, u bil- mod il- mod iżidu, fuq perijodu ta ’ żmien sa 14 - il ġurnata, għal doża sħiħa ta ’ 7. 5 ml darbtejn kuljum.
Children (2 – 12 years of age) will start with a dose smaller than this and continue up to the maximum allowed for their size.
Tfal (2 - 12 - il sena) jibdew b’ doża iżgħar minn din u jkomplu jżidu għal massimu skond id- daqs tagħhom.
Your doctor will advise you on the dosage to be taken.
It- tabib tiegħek jgħidlek id- dożaġġ li inti għandek tieħu.
74 Like all anti-HIV medications, Norvir should be taken every day to help control your HIV, no matter how much better you feel.
Bħall- mediċini kollha għal kontra l- HIV, Norvir għandu jittieħed kuljum biex jgħin biex jiġi kontrollat l- HIV, u dan irrispettivament minn kemm inti tħossok tajjeb.
If a side effect is preventing you from taking Norvir, tell your doctor straight away.
Jekk xi effett sekondarju qiegħed iżommok milli tieħu Norvir, għid lit- tabib tiegħek minnufih.
During episodes of diarrhoea your doctor may decide that extra monitoring is needed.
F’ perijodi fejn tkun qiegħda taqbdek id - dijarea, it- tabib tiegħek jista ’ jiddeċiedi illi hemm bżonn ta ’ aktar osservazzjoni.
Always keep enough Norvir on hand so you don't run out.
Dejjem żomm biżżejjed Norvir biex inti qatt ma tispiċċa mingħajru.
When you travel or need to stay in the hospital, make sure you have enough Norvir to last until you can get a new supply.
Meta tivjaġġa jew ikollok bżonn tmur l- isptar, kun ċert illi inti għandek Norvir biżżejjed biex iservik sakemm inti tkun tista ’ takkwista provvista ġdida.
Norvir oral solution has a lingering aftertaste.
Is- soluzzjoni orali Norvir tħalli ċerta togħma ħażina wara li toħodha.
You can take it alone or mix it with chocolate milk to improve the taste.
Tista ’ toħodha waħedha jew tħallatha mal- ħalib taċ- ċikkulata biex ittejjeb it- togħma.
Mix only one dose at a time, and be sure to take the whole dose right away.
Ħallat doża waħda kull darba, u kun ċert li tieħu d- doża kollha mill- ewwel.
Do not mix Norvir with anything else without talking to your doctor or pharmacist.
Int m’ għandekx tħallat Norvir ma ’ xi ħaġa oħra mingħajr ma ’ tkellem lit- tabib jew lill- ispiżjar tiegħek.
Eating salty foods or drinking fluids before or after taking Norvir oral solution may help clear the aftertaste from your mouth.
Jekk tiekol ikel mielaħ jew tixrob qabel jew wara li tieħu s- soluzzjoni orali Norvir, dan jista ’ jgħinek tneħħi t- togħma ħażina minn ħalqek.
Even if you feel better, do not stop taking Norvir without talking to your doctor.
Tiqafx tieħu Norvir mingħajr ma tkellem lit- tabib tiegħek, anke jekk tkun qiegħed tħossok aħjar.
Taking Norvir as recommended should give you the best chance of delaying resistance to the medicines.
Jekk tieħu Norvir kif irrakkomandat lilek, dan għandu jagħtik l- aħjar ċans biex inti tittardja l- iżvilupp tar - reżistenza għall- mediċini.
How do I measure the correct dose of the solution?
Kif inkejjel id- doża tas- soluzzjoni t- tajba?
Open the childproof cap by pushing down on it with your palm and twisting it anti-clockwise, or in the direction of the arrow.
Iftaħ l- għatu li ma jinfetaħx mit- tfal billi timbotta ‘ l isfel bil- pala ta ’ jdejk u ddawru lejn ix- xellug, jew fid- direzzjoni tal- vleġġa.
Talk to your pharmacist if you have difficulty opening the bottle.
Kellem lill- ispiżjar tiegħek jekk issib diffikultà biex tiftaħ il- flixkun.
The measuring cup provided has been especially designed to give you the right dose of Norvir oral solution.
It- tazza għall- kejl tad- doża provduta ġiet speċifikament magħmula biex tagħtik id- doża t- tajba tas - soluzzjoni orali Norvir.
This cup, which is attached to the bottle cap, is the only cup you should use to measure your dose.
Din it- tazza, li hija mwaħħla ma ’ l- għatu tal- flixkun, hija l- unika tazza illi inti għandek tuża biex tkejjel id- doża tiegħek.
Place the measuring cup on a flat surface at eye-level.
Poġġi t- tazza għall- kejl tad- doża fuq wiċċ ċatt li jkun fil- livell ta ’ l- għajnejn.
Fill it with Norvir oral solution to the line marked with your dose.
Imliha bis- soluzzjoni orali Norvir sal- linja markata bid- doża tieghek.
Do not fill the cup to any other dosing line.
Timliex it- taxxa sa l- ebda linja oħra li timmarka d - doża.
Do not overfill the cup.
Tfawwarx it- tazza.
To measure out the dose for children may require an oral syringe.
Biex tkejjel id- doża tat- tfal jista ’ jkun hemm bżonn ta ’ siringa tal- ħalq.
Obtain a syringe from your pharmacist.
Akkwista siringa mingħand l- ispiżjar tiegħek.
Ask your pharmacist for instructions on how to use the syringe correctly.
Staqsi lill- ispiżjar tiegħek biex jagħtik l- istruzzjonijiet ta ’ kif tuża s- siringa kif sippost.
Have I taken the correct dose?
80 Ħadt id- doża t- tajba?
75 Don't worry if a little Norvir oral solution is left in the measuring cup after you've taken your dose.
Tinkwetax jekk wara li tkun ħadt id- doża tiegħek, jibqa ’ xi ftit soluzzjoni orali Norvir fit- tazza għall - kejl tad- doża.
This is normal.
Dan hu normali.
You should always use this special cup to take your Norvir oral solution to make sure you take the right dose.
Int għandek dejjem tuża din it- tazza speċjali biex tieħu s- soluzzjoni orali Norvir biex int taċċerta ruħek li tieħu d- doża t- tajba.
W ash the measuring cup with soap and warm water as soon as you can.
Aħsel it- tazza għall- kejl tad- doża bis- sapun u bl- ilma sħun malajr kemm jista ’ jkun.
If you don't have soap and water, wipe the inside of the cup with a clean, dry tissue or cloth, and wash the cup with soap and warm water later.
Jekk ma jkollokx sapun u ilma, imsaħ it- tazza minn ġewwa b’ maktur tal- karti jew b’ biċċa xotta, u aħsel it- tazza bis - sapun u bl- ilma sħun aktar tard.
If Norvir is allowed to dry in the cup, it will turn white, which will make the dosing lines hard to see for your next dose.
Jekk tħalli Norvir tinxef fit- tazza, din issir bajda u jkun diffiċli li inti tara l- linji li jindikaw id- dożaġġ meta tiġi biex tieħu d- doża li jkun imissek.
The orange liquid left in the cup will also turn white when it touches water.
Il- likwidu ta ’ kulur oranġjo li jibqa ’ fit- tazza jsir abjad ukoll meta jmiss ma ’ l- ilma.
The dosing cup is not dishwasher-safe.
Ma tistax taħsel it- tazza għall- kejl tad- doża fid- dishwasher.
The same cleaning instructions apply to the syringe.
L- istess istruzzjonijiet ta ’ tindif japplikaw għas- siringa.
If you take more Norvir than you should
Jekk tieħu Norvir aktar milli suppost
Numbness, tingling, or a “pins and needles” sensation may occur if you take too much Norvir.
Jekk tieħu Norvir aktar milli sippost tista ’ tesperjenza sensazzjoni ta ’ tirżiħ, textix jew sensazzjoni bħal qisu “ xi ħadd qiegħed iniggżek bil- labar ”.
If you realise you have taken more Norvir than you were supposed to, contact your doctor or the Accident and Emergency Department of your nearest hospital straight away.
Jekk tinduna li inti ħadt aktar Norvir milli suppost, ikkuntatja lit- tabib tiegħek jew lid- Dipartiment ta ’ l- Aċċidenti u ta ’ l- Emerġenza ta ’ l- eqreb sptar minnufih.
If you forget to take Norvir
Jekk tinsa tieħu Norvir
If you miss a dose, take the missed dose as soon as possible.
Jekk tinsa tieħu doża, ħu d- doża li tkun insejt tieħu mill- aktar fis possibbli.
If it is nearly time for the next dose, just take that one.
Jekk ikun kważi wasal il - ħin biex tieħu d- doża li jmiss, ħu d- doża li jmiss.
Like all medicines, Norvir can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Norvir jista ’ jikkawża effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Also, the side effects of Norvir when used with other antiretroviral medicines are dependent on the other medicines.
Barra minn hekk, l- effetti sekondarji ta ’ Norvir meta jintuża ma ’ mediċini oħra antiretrovirali, huma dipendenti fuq dawn il- mediċini l- oħra.
So it is important that you carefully read the side effects section of the leaflets that are provided with these other medicines.
Għalhekk huwa importanti illi inti taqra b’ attenzjoni s- sezzjoni dwar l- effetti sekondarji tal- Fuljett ta ’ Tagħrif ipprovdut ma ’ dawn il- mediċini.
Very common side effects (affects more than 1 user in 10):
Effetti sekondarji komuni ħafna (jaffetwaw aktar minn 1 minn kull 10 pazjenti):
stomach ache • a tingling sensation or numbn
sensazzjoni ta ’ tnemnim jew tirżiħ fl- idejn, fis- saqajn jew madwar ix- xofftejn u l- ħalq
• stomach ache •
• • • •
a tingling sensation or numbness in
rimettar dijarea tħossok imdardar (nawseja) uġigħ ta ’ ras
vomiting diarrhoea feeling sick (nausea) • headache •
tħossok dgħajjef/ għajjien ikollok togħma ħażina fil- ħalq
the hands, feet or around the lips and mouth feeling weak/tired bad taste in the mouth
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Common side effects (affects 1 to 10 users in 100):
Effetti sekondarji komuni (jaffetwaw minn 1 sa 10 pazjenti minn kull 100):
allergic reactions including skin • sore
reazzjonijiet allerġiċi li jinkludu raxx fil -
sore throat
griżmejk juġgħawk
rashes (may be red, raised, itchy), severe swelling of the skin and other tissues
ġilda (tista ’ tkun ħamra, mqabbża u tqabbdek il- ħakk), nefħa severa tal- ġilda u ta ’ tessuti oħra
increased cough wind (flatulence) loss of appetite
żieda fis- sogħla gass fl- istonku u fl- imsaren telf ta ’ aptit
difficulty in breathing flushing of the skin (vasodilation) changes in fat distribution (see Side effects associated with combination antiretroviral therapy below)
diffikultà biex tieħu n- nifs ħmura fil- ħilda (vażodilazzjoni) tibdil fid- distribuzzjoni tax- xaħam (ara Effetti sekondarji assoċjati mat- terapija antiretrovirali kombinata hawn taħt)
dry mouth belching mouth ulcer sweating muscle aches fever
ħalq xott tifwiq ulċeri fil- ħalq ħruġ ta ’ għaraq weġgħat fil- muskoli
dizziness inability to sleep (insomnia) anxiety
sturdament ma tkunx tista ’ torqod (nuqqas ta ’ rqad) ansjetà ngħas tirżiħ sensittività mhux tas- soltu tal- ġilda ħruq ta ’ stonku