qanastek/EMEA-V3 huggingface dataset:
changes in blood test results (such as blood chemistry and blood count)
deni uġigħ tnaqqis fil- piż riżultati tat- testijiet tal- laboratorju: tibdil fir- riżultati tat- testijiet tad- demm (bħal kimika tad- demm u add ta ’ ċelloli fid demm)
Uncommon side effects (affects 1 to 10 uses in 1,000):
Effetti sekondarji mhux komuni (jaffetwaw minn 1 sa 10 pazjenti minn kull 1, 000):
dehydration (thirst) • hepatitis (inflammation of the
deidratazzjoni (għatx) dijabete
hepatitis (inflammation of the liver)
epatite (infjammazzjoni tal- fwied) riżultati tat- testijiet tal- laboratorju: tibdil fir- riżultati tat- testijiet tad- demm
diabetes • laboratory test re
suffejra (sfurija fil- ġilda jew fl- abjad ta ’ l - għajnejn)
laboratory test results:
(bħal kimika tad- demm u add ta ’ ċelloli fid demm)
jaundice (yellowing of the skin or whites of eyes muscle pain, tenderness or weakness
uġigħ fil- muskoli, sensittività jew dgħjufija
Rare side effects (affects 1 to 10 users in 10,000):
Effetti sekondarji rari (jaffetwaw minn 1 sa 10 pazjenti minn kull 10, 000):
severe or life threatening skin • serious allergic reaction (anaphy
reazzjonijiet fil- ġilda severi jew li jpoġġu l -
serious allergic reaction (anaphylaxis)
reazzjonijiet allerġiċi serji (anafilassi)
reaction including blisters (Stevens Johnson syndrome)
ħajja fil- periklu, inklużi bżieżaq (is - sindromu Stevens Johnson)
low
•
levels of blood platelets, kidney failure,
livelli għoljin ta ’ zokkor fid- demm
seizures (fits), fainting and feeling faint when getting up, abnormally heavy periods.
Ġew irrapportati effetti sekondarji oħra ta ’ Norvir: livelli baxxi tad- diski żgħar fid- demm (platelets), insuffiċjenza tal- kliewi, attakki ta ’ l- epilessija, ħass ħazin u tħossok stordut meta tqum minn bil - qiegħda, menstrwazzjoni esaġerata.
It is not known how frequently these effects may occur.
Il- frekwenza ta ’ dawn l- effetti sekondarji għadha m’ hijiex magħrufa.
Tell your doctor if you fee sick (nauseous), are vomiting, or have stomach pain, because these may be signs of an inflamed pancreas.
Għid lit- tabib tiegħek jekk tħossok imdardar, jekk qieġħed tirremetti, jew għandek uġigħ fl- istonku, għax dawn jistgħu jkunu sinjali ta ’ infjammazzjoni tal- frixa.
Also tell your doctor if you experience joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty moving, as this may be a sign of osteonecrosis.
Għid lit- tabib tiegħek ukoll jekk tesperjenza uġigħ fil- ġogi, weġgħat u uġigħ (speċjalment tal- ġenbejn, ta ’ l- irkoppa u ta ’ l- ispalla) u diffikultà biex tiċċaqlaq, għax dan jista ’ jkun sinjal ta ’ nekrosi ta ’ l- għadam.
See also section 2 Before you take Norvir.
Ara ukoll sezzjoni 2 Qabel ma tieħu Norvir.
Side effects associated with combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
Effetti sekondarji assoċjati mat- terapija antiretrovirali kombinata jistgħu jikkawżaw tibdil fil - forma tal- ġisem minħabba tibdil fid- distribuzzjoni tax- xaħam.
These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and internal organs, breast enlargement and fatty lumps on the back of the neck ("buffalo hump").
Dawn jistgħu jinkludu telf ta ’ xaħam mir- riġlejn, mid- dirgħajn u mill- wiċċ, żieda ta ’ xaħam fiż- żaqq u fl- organi interni, tkabbir fis- sider u ħotob ta ’ xaħam fuq in- naħa ta ’ wara ta ’ l- għonq (“ buffalo hump ”).
The cause and long-term health effects of these conditions are not known.
Il- kawża u l- effetti fit- tul fuq is - saħħa ta ’ dawn il- kundizzjonijiet għadhom m’ humiex magħrufa.
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, increased fats in the blood and resistance to insulin (insulin will not work as effectively).
It- terapija antiretrovirali kombinata tista ’ ukoll tikkawża żieda fl- aċidu laktiku u zokkor fid- demm, żieda ta ’ xaħmijiet fid- demm u reżistenza għall- insulina (l- insulina ma tkunx effettiva kemm sippost).
In patients with haemophilia type A and B, there have been reports of increased bleeding while taking this treatment or another protease inhibitor.
82 F’ pazjenti li jbatu mill- emofilja tip A u B, kien hemm rapporti ta ’ żieda fit- telf ta ’ demm waqt li kienu qegħdin jieħdu dan it- trattament jew impeditur protejaż iehor.
Should this happen to you, seek immediate advice from your doctor.
Jekk jiġrilek hekk, fittex immedjatament il- parir tat- tabib tiegħek.
Cases of diabetes mellitus or increased blood sugars have been reported in patients receiving Norvir or other protease inhibitors.
Każi ta ’ dijabete mellitus jew żieda taz- zokkor fid- demm ġew rapportati f’ pazjenti li kienu qegħdin jieħdu Norvir jew impedituri protejaż oħra.
Abnormal liver function tests, hepatitis (inflammation of the liver), and rarely jaundice, have been reported in patients taking Norvir.
Testijiet abnormali tal- funzjoni tal- fwied, epatite (infjammazzjoni tal- fwied) u rarament is- suffejra, ġew rapportati f’ pazjenti li jieħdu Norvir.
Some people had other illnesses or were taking other medicines.
Xi nies oħra kellhom mard ieħor jew kienu qegħdin jieħdu mediċini oħra.
People with liver disease or hepatitis may have worsening of liver disease.
Persuni li jbatu minn mard tal- fwied jew mill- epatite jista ’ jkollhom aggravament tal - mard tal- fwied.
There have been reports of muscle pain, tenderness or weakness, particularly when taking medicines to lower cholesterol in combination with antiretroviral therapy, including protease inhibitors and nucleoside analogues.
Kien hemm rapporti ta ’ uġigħ fil- muskoli, sensittività jew dgħjufija, partikolarment meta jkunu qegħdin jittieħdu prodotti mediċinali biex jitbaxxa l- livell tal- kolosterol, flimkien ma ’ terapija antiretrovirali, inklużi impedituri protejaż u analogi nuklèoside.
On rare occasions these muscle disorders have been serious (rhabdomyolysis).
F’ okkażjonijiet rari dawn id- disturbi muskolari kienu ta ’ natura serja (rabdomijolożi).
In the event of unexplained or continual muscle pain, tenderness, weakness or cramps, stop taking the medicine, contact your doctor as soon as possible or go to the Accident and Emergency Department of your nearest hospital.
Fil- każ ta ’ uġigħ fil- muskoli, sensittività, dgħjufija, bugħawwieġ li ma tafx minn fejn ġejjin jew li jkunu kontinwi, waqqaf il- mediċina, ikkuntattja lit- tabib tiegħek mill- aktar fis possibbli jew mur fid- Dipartiment ta ’ l- Aċċidenti u l- Emerġenza ta ’ l- eqreb sptar.
Inform your doctor as soon as possible if you experience any symptoms that suggest an allergic reaction after taking Norvir such as rash, hives or breathing difficulties.
Għarraf lit- tabib tiegħek mill- aktar fis possibbli, jekk wara li tkun ħadt Norvir inti tħoss xi sintomi li jissuġerixxu reazzjoni allerġika bħal raxx, urtikarja jew diffikultajiet biex tieħu n- nifs.
77 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, contact your doctor, pharmacist, Accident and Emergency department or if it is urgent get immediate medical help.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, ikkuntattja lit- tabib jew lill- ispiżjar tiegħek, jew lid- Dipartiment ta ’ l- Aċċidenti u ta ’ l- Emerġenza, jew jekk hu każ ta ’ urġenza ġib għajnuna medika immedjatament.
HOW TO STORE NORVIR
KIF TAĦŻEN NORVIR
Do not use Norvir oral solution after the expiry date on the bottle.
Tużax is- soluzzjoni orali Norvir wara d- data ta ’ skadenza li tidher fuq il- flixkun.
The expiry date refers to the last day of the month.
Id- Data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
Bottles of Norvir oral solution should be stored below 25°C.
Il- fliexken tas- soluzzjoni oral Norvir għandhom jinħażnu f’ temepratura taħt 25°C.
Do not store Norvir oral solution in the refrigerator, or in extreme heat or cold (such as in a car during hot or very cold weather, or in your freezer).
Tagħmilx is - soluzzjoni orali Norvir fil- friġġ, jew fi sħana jew kesħa estrema (bħal ġo karozza f’ temp sħun jew kiesaħ ħafna, jew fil- friża)
It is important to keep Norvir in the bottle it came in.
Huwa importanti li żżomm Norvir fil- flixkun oriġinali.
Don't transfer it to any other container.
Titfgħux f’ kontenitur ieħor
What Norvir contains
X’ fih Norvir:
− The active substance is ritonavir.
- Is- sustanza attiva hi ritonavir.
Each ml of Norvir contains 80 mg ritonavir. − The other ingredients are alcohol, purified water, polyoxyl 35 castor oil, propylene glycol, saccharin sodium, anhydrous citric acid, peppermint oil, creamy caramel flavouring and sunset yellow E110.
- Is- sustanzi l- oħra huma alkoħol, ilma ppurifikat, polyoxyl 35 żejt ir- riġnu, propylene glycol,
What Norvir looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett:
Norvir oral solution comes in an amber bottle containing 90 ml of liquid.
Is- soluzzjoni orali Norvir tiġi fi flixkun ta ’ aktar minn doża waħda li jesa ’ 90 ml, u hu ta ’ kulur l - ambra.
Five bottles are provided in one package together with a dosage cup.
Pakkett wieħed ikollu 5 flixkien flimkien ma ’ tazza għall- kejl tad- doża.
Each ml of Norvir contains 80 mg of ritonavir.
Kull ml Norvir fih 80 mg ritonavir.
Norvir is also supplied as a capsule containing 100 mg of ritonavir.
83 Norvir huwa fornut ukoll bħala kapsula li fiha 100 mg ritonavir.
Aesica Queenborough Limited Queenborough Kent ME11 5EL United Kingdom
Aesica Queenborough Limited Queenborough Kent ME11 5EL Renju Unit
Бизнес Парк София, сгр.8С ет.7 София 1766 Teл.: + 359 2 489 1950
Бизнес Парк София, сгр. 8С ет. 7 София 1766
H-1139 Budapest Tel.: +36 1 465 2100
Tel.: +36 1 465 2100
Eesti Abbott Laboratories Baltics Vienības 87h LV-1004 Rīga Läti Tel: + 371 67605580
Eesti Abbott Laboratories Baltics Vienības 87h LV- 1004 Rīga
Estrada de Alfragide, nº 67 Alfrapark, Edifício D, P-2610-008 Amadora Tel: + 351 (0) 21 472 7100
Estrada de Alfragide, nº 67 Alfrapark, Edifício D, P- 2610- 008 AmadoraTel: + 351 (0) 21 472 7100
France Abbott France 10, rue d’Arcueil BP 90233 F-94528 Rungis Cedex Tél: + 33 (0) 1 45 60 25 00
France România Abbott France 10, rue d’ Arcueil BP 90233 F- 94528 Rungis Cedex Tél: + 33 (0) 1 45 60 25 00
United Kingdom Abbott Laboratories Ltd Abbott House Vanwall Business Park Maidenhead Berkshire SL6 4XE-UK Tel: + 44 (0) 1628 773355
United Kingdom Abbott Laboratories Ltd Abbott House Vanwall Business Park Maidenhead Berkshire SL6 4XE- UK
80 PACKAGE LEAFLET:
86 FULJETT TA ’ TAGĦRIF:
NORVIR 100 mg soft capsules ritonavir
NORVIR 100 mg kapsuli rotob Ritonavir
Do not pass it on to others.
Tista ’ tagħmlilhom il- ħsara,
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 jikkontrollalalek l - infezzjoni ta ’ l- HIV.
clorazepate, diazepam, estazolam, flurazepam, triazolam or oral (taken by mouth) midazolam (used to help you sleep and/or relieve anxiety);
clorazepate, diazepam, estazolam, flurazepam, triazolam jew midazolam orali (mittieħed mill- ħalq) (użati biex jgħinuk torqod u/ jewinaqqsu l- ansjetà);
− 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 life 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
You may need additional medicine to help your blood clot (factor VIII), in order to control any bleeding.
Jista ’ jkollok bżonn mediċina addizzjonali biex tgħin lid- demm jagħqad (fattur VIII) sabiex tikkontrolla l- ħruġ ta ’ demm.
− Diabetes, as there have been reports of worsening of or the development of diabetes (diabetes mellitus) in some patients taking protease inhibitors.
- Dijabete, peress li f’ każi ta ’ xi pazjenti li kienu qegħdin jieħdu l- impedituri protejaż, kien
82 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, jekk jekk jifformalek xaħam jew titlef ix -
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
There are some other medicines that can only be used under certain circumstances as described below.
Dawn kienu mniżżla qabel f’ sezzjoni 2, taħt ‘ Tieħux Norvir ’. Hemm mediċini oħra li jistgħu jintużaw biss f’ ċerti cirkostanzi 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 reċentement xi mediċini oħra, inklużi mediċini li jiġu akkwistati mingħajr riċetta tat- tabib.
You may also notice irregular uterine bleeding if you are taking 83 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.
− 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.
- warfarina, li traqqaq id- demm.
There are some medicines you cannot take at all with Norvir.
90 Hemm ċerti mediċini li int assolutament ma tistax toħodhom ma ’ Norvir.
84 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.
It is not known if Norvir p asses into breast milk.
M’ huwiex magħruf jekk Norvir jgħaddix ġol- ħalib tas- sider.
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per maximum dose of 600 mg.
Dan il- prodott mediċinali fih ammonti żgħar ta ’ ethanol (alkoħol), inqas minn 100 mg kull doża massima ta ’ 600 mg.
• if Norvir is used to boost the effects of certain other anti-HIV medicines the typical dose for adults is 1 to 2 capsules once or twice daily.
• jekk Norvir huwa użat biex iżid l- effetti ta ’ ċerti mediċini oħra għal kontra l- HIV, id- doża tipika għall- adulti hi minn 1 sa 2 kapsuli darba jew darbtejn kuljum.
For more detailed dose recommendations, including those for children, see the Package Leaflet of the anti-HIV medicines Norvir is given in combination with.
Għal aktar rakkomandazzjonijiet 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 capsules in the morning and 3 capsules 12 hours later, gradually increasing over a period of up to 14 days to the full dose of 6 capsules twice daily.
• jekk it- tabib tiegħek jagħtik doża sħiħa, l- adulti jistgħu jibdew fuq doża ta ’ 3 kapsuli filgħodu u 3 kapsuli 12 - il siegħa wara, u bil- mod il- mod iżidu, fuq perijodu ta ’ żmien sa 14 - il ġurnata, għal doża sħiħa ta ’ 6 kapsuli darbtejn kuljum.
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 as directed, tell your doctor straight away.
Jekk xi effett sekondarju qiegħed iżommok milli tieħu Norvir bil- mod kif ordnat lilek, 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.
91 Dejjem żomm biżżejjed Norvir biex inti qatt ma tispiċċa mingħajru.
85 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 ”.
• stomach ache •
uġigħ fl- istonku
a tingling sensation or numbness in
sensazzjoni ta ’ tnemnim jew tirżiħ fl- idejn, fis- saqajn jew madwar ix- xofftejn u l- ħalq
vomiting diarrhoea feeling sick (nausea) • headache •
rimettar dijarea tħossok imdardar (nawseja) uġigħ ta ’ ras
the hands, feet or around the lips and mouth feeling weak/tired bad taste in the mouth
tħossok dgħajjef/ għajjien ikollok togħma ħażina fil- ħalq
dizziness inability to sleep (insomnia) anxiety sleepiness numbness unusual sensitivity of the skin heartburn
sturdament ma tkunx tista ’ torqod (nuqqas ta ’ rqad) ansjetà ngħas tirżiħ sensittività mhux tas- soltu tal- ġilda ħruq ta ’ stonku
pain weight loss laboratory test results: changes in blood test results (such as blood chemistry and blood count)
deni uġigħ tnaqqis fil- piż riżultati tat- testijiet tal- laboratorju: tibdil fir- riżultati tat- testijiet tad- demm (bħal kimika tad- demm u add ta ’ ċelloli fid demm)
high levels of sugar in the blood
livelli għoljin ta ’ zokkor fid- demm
Other side effects that have been reported with Norvir: low levels of blood platelets, kidney failure, seizures (fits), fainting and feeling faint when getting up, abnormally heavy periods.
Ġew irrapportati effetti sekondarji oħra ta ’ Norvir: livelli baxxi tad- diski żgħar fid- demm (platelets), insuffiċjenza tal- kliewi, attakki ta ’ l- epilessija, ħass ħazin u tħossok stordut meta tqum minn bil - qiegħda, menstrwazzjoni esaġerata.
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 li jbatu mill- emofilja tip A u B, kien hemm rapporti ta ’ żieda fit- telf ta ’ demm waqt li kienu qegħdin jieħdu dan it- trattament jew impeditur protejaż iehor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, contact your doctor, pharmacist, Accident and Emergency department or if it is urgent get immediate medical help.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, ikkuntattja lit- tabib jew lill- ispiżjar tiegħek, jew lid- Dipartiment ta ’ l - Aċċidenti u ta ’ l- Emerġenza, jew jekk hu każ ta ’ urġenza ġib għajnuna medika immedjatament..
Do not use Norvir after the expiry date on the bottle or from a bottle which has been stored unrefrigerated for more than 30 days.
Tużax Norvir wara d- data ta ’ skadenza li tidher fuq il- flixkun, jew minn flixkun li kien maħżun mhux fil- friġġ għal aktar minn 30 ġurnata.
Norvir soft capsules should be stored in a refrigerator (2º - 8ºC) until they are dispensed.
Sakemm jingħataw lil pazjent, il- kapsuli rotob Norvir għandhom jinħażnu fi friġġ (2° - 8°C).
Refrigeration is not required if used within 30 days and stored below 25°C.
M’ hemmx għalfejn taħżen fi friġġ jekk tkun ħa tużahom fi żmien 30 ġurnata u jkunu maħżuna f’ temperatura taħt 25°C.
Do not store Norvir soft capsules in extreme heat or cold (such as in a car during hot or very cold weather, or in your freezer).
Taħżinx il- kapsuli rotob Norvir fi sħana jew kesħa estrema (bħal ġo karozza f’ temp sħun jew kiesaħ ħafna, jew fil- friża).
Don't transfer it to any other container.
Titfgħux f’ kontenitur ieħor.
Each capsule contains 100 mg ritonavir.
Kull kapsula fiha 100 mg ritonavir.
− The other ingredients are alcohol, oleic acid, butylated hydroxytoluene (E321) and polyoxyl 35 castor oil.
- Is- sustanzi l- oħra huma alkoħol, aċidu oleiku, butylated hydroxytoluene (E321) u polyoxyl 35
− The capsule shell is composed of: gelatine, “sorbitol special” (sorbitol, sorbitolanhydrides and mannitol), glycerine, titanium dioxide (white colour), medium chain triglycerides lecithin and black ink containing: propylene glycol, black iron oxide, polyvinyl acetate phthalate, polyethylene glycol 400 and ammonium hydroxide.
sorbitolanhydrides u mannitol), glyċerina, titanium dioxide (kulur abjad), trigliċeridi b’ katina medja, leċitina u linka sewda li fiha: propylene glycol, ossidu tal- ħadid iswed, polyvinyl acetate phthalate, polyethylene glycol 400 u ammonium hydroxide.
Norvir soft capsules are white with “Abbott A” and the code “DS100” imprinted on the shell in black ink.
Il- kapsuli rotob Norvir huma bojod b ’ “ Abbott A ” u l- kodiċi “ DS100 ” stampati fuq il- qoxra ta ’ barra b’ linka sewda.
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).
Norvir is also supplied as an oral solution containing 80 mg/ml of ritonavir
Norvir huwa fornut ukoll bħala soluzzjoni orali li fiha 80 mg/ ml ritonavir
Manufacturers
Manifattur:
Aesica Queenborough Limited Queenborough Kent ME11 5EL United Kingdom
Aesica Queenborough Limited Queenborough Kent ME11 5EL
Abbott Laboratories S.A.
94 Renju Unit
Бизнес Парк София, сгр.8С ет.7 София 1766 Teл.: + 359 2 489 1950
Бизнес Парк София, сгр. 8С ет. 7 1766
France Abbott France 10, rue d’Arcueil BP 90233 F-94528 Rungis Cedex Tél: + 33 (0) 1 45 60 25 00
95 France România Abbott France 10, rue d’ Arcueil BP 90233 F- 94528 Rungis Cedex Tél: + 33 (0) 1 45 60 25 00
I-04010 Campoverde di Aprilia (Latina) Tel: + 39 06 928921
Italia Abbott S. r. l. I- 04010 Campoverde di Aprilia (Latina) Tel: + 39 06 928921
90
96
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abbażi tar- rakkommandazzjonijiet tas- CHMP, aqra d- diskussjoni xjentifika (ukoll parti mill- EPAR).
What is NovoMix?
X’ inhu NovoMix?
NovoMix is a range of white suspensions for injection.
NovoMix huwa firxa ta ’ sospensjonijiet bojod għal injezzjoni.
It is available in cartridges or in prefilled pens.
Huwa jinstab fi skrataċ jew f’ pinen mimlija minn qabel.
NovoMix contains the active substance insulin aspart 100 units (U) per millilitre: • NovoMix 30:
NovoMix fih is- sustanza attiva insulina aspart 100 junit (U) kull millilitru: • NovoMix 30:
30% soluble insulin aspart (rapid acting) and 70% protamine-crystallised insulin aspart (long acting), • NovoMix 50:
30% insulina aspart solubbli (taħdem b’ mod rapidu) u 70% protamine- crystallised insulina aspart (taħdem fit- tul), • NovoMix 50:
50% soluble insulin aspart (rapid acting) and 50% protamine-crystallised insulin aspart (long acting), • NovoMix 70:
50% insulina aspart solubbli (taħdem b’ mod rapidu) u 50% protamine- crystallised insulina aspart (taħdem fit- tul), • NovoMix 70:
70% soluble insulin aspart (rapid acting) and 30% protamine-crystallised insulin aspart (long acting).
70% insulina aspart solubbli (taħdem b’ mod rapidu) u 30% protamine- crystallised insulina aspart (taħdem fit- tul).
What is NovoMix used for?
Gal xiex jintuża NovoMix?
NovoMix is used to treat patients who have diabetes.
NovoMix jintuża biex jittratta pazjenti li għandhom id- dijabete.
How is NovoMix used?
Kif jintuża NovoMix?
NovoMix is administered subcutaneously (under the skin) by injection in the abdominal wall (tummy), or the thigh.
NovoMix huwa amministrat taħt il- ġilda permezz ta ’ injezzjoni fil- ħajt addominali (iż- żaqq), jew fil - koxxa.
The deltoid region (shoulder) or the gluteal region (buttocks) may also be used.
Ir- reġjun deltojd (l- ispalla) jew ir- reġjun glutejali (il- warrani) jistgħu jintużaw ukoll.
The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.
Il - glukożju fid- demm (zokkor) tal- pazjent għandu jiġi ittestjat regolarment biex tinstab l- aktar doża baxxa effettiva.
NovoMix is given immediately before a meal, but may be given after a meal if necessary.
NovoMix jingħata immedjatament qabel l- ikel, iżda jista ’ jingħata wara l- ikel jekk meħtieġ.
The usual dose is between 0.5 and 1.0 U per kilogram body weight per day.
Id- doża tas- soltu hija bejn 0. 5 u 1. 0 U kull kilogramm piż korporali kuljum.
In type 2 diabetes (also known as non-insulin dependent diabetes), NovoMix can be given on its own or together with metformin.
Fid- dijabete tip 2 (magħrufa ukoll bħala dijabete mhux dipendenti fuq l- insulina), NovoMix jista ’ jingħata waħdu jew flimkien ma ’ metformin.
NovoMix 30 can also be used with other antidiabetic medicines that can be taken by mouth in combination with insulin, but it should only be used with pioglitazone once the patient ’ s risk of fluid-related side effects has been evaluated.
NovoMix 30 jista ’ jintuża ukoll ma ’ mediċini kontra d - dijabete oħra li jistgħu jittieħdu mill- ħalq f’ kumbinazzjoni ma ’ l- insulina, iżda għandu jintuża ma ’ pioglitazone biss kemm- il darba r- riskju ta ’ effetti sekondarji relatati mal- fluwidi jkun ġie evalwat.
How does NovoMix work?
Kif jaħdem NovoMix?
Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose.
Id- dijabete hija marda fejn il- ġisem ma jipproduċix biżżejjed insulina biex jikkontrolla l- glukożju fid - demm.
NovoMix is a replacement insulin which is very similar to the insulin made by the pancreas.
NovoMix hija insulina ta ’ skambjament li hija simili għall- insulina magħmula mill- frixa.
The active ingredient of NovoMix, insulin aspart, is produced by a method known as ‘ recombinant DNA technology’: it is made by a yeast that has received a gene (DNA), which makes it able to produce 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Is - sustanza attiva ta ’ NovoMix, insulina aspart, hija magħmula permezz ta ’ metodu magħruf bħal ‘ teknoloġija rekombinanti DNA ’: hija magħmula minn ħmira li irċeviet ġene (DNA), li tagħmilha 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 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 insulin aspart.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 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 kapaċi tipproduċi insulina aspart.
Insulin aspart is very slightly different from human insulin, and the change means that it is absorbed faster by the body, and can therefore act faster than human insulin.
Insulina aspart hija ftit differenti mill- insulina umana, u l- bidla tfisser li hija assorbita aktar malajr mill- ġisem, u għaldaqstant taħdem aktar malajr mill- insulina tal - bniedem.
NovoMix contains insulin aspart in two forms: the soluble form, which acts quickly (within 10 minutes of injection) and the crystallised form, which is absorbed much more slowly during the day.
NovoMix fiha insulina aspart f’ żewġ forom: il- forma solubbli, li taħdem malajr (fi żmien 10 minuti mill- injezzjoni) u l- forma ikkristallizzata, li hija assorbita ħafna aktar bil- mod matul il- jum.
This gives NovoMix a longer duration of action.
Dan jagħti NovoMix żmien ta ’ azzjoni itwal.
The replacement insulin acts in the same way as naturally produced insulin and helps glucose enter cells from the blood.
L- insulina ta ’ skambjament taħdem bl- istess mod bħall - insulina magħmula naturalment u tgħin lil glukożju jidħol fiċ- ċelloli mid- demm.
By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Is- sintomi u l - kumplikazzjonijiet tad- dijabete jitnaqqsu billi jiġi kkontrollat il- glukożju fid- demm.
How has NovoMix been studied?
Kif ġie studjat NovoMix?
NovoMix 30 has been studied in patients with type 1 or type 2 diabetes (294 patients) where it was compared with human insulin over 12 weeks.
NovoMix 30 ġie studjat f’ pazjenti b’ dijabete tip 1 jew tip 2 (294 pazjent) fejn ġie mqabbel ma ’ insulina tal- bniedem fuq 12- il ġimgħa.
NovoMix 50 and NovoMix 70 injected three times a day have been compared in 664 patients (with type 1 or type 2 diabetes) to human insulin 30 injected twice a day.
NovoMix 50 u NovoMix 70 injettati tlett darbiet ġew imqabbla f’ 664 pajent (b’ dijabete tip 1 jew tip 2) ma ’ insulina 30 tal- bniedem injettata darbtejn kuljum.
The effects of adding NovoMix 30 to other antidiabetic medicines taken by mouth (metformin, sulphonylureas and pioglitazone) have also been studied in four studies involving a total of 905 patients.
L- effetti taż- żieda ta ’ NovoMix 30 ma ’ mediċini kontra d- dijabete oħra meħuda mill- ħalq (metformin, sulphonylureas u pioglitazone) ġew studjati ukoll f’ 4 studji li involvew total ta ’ 905 pazjent.
In all studies, the main measure of effectiveness was the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, before and at the end of the study.
Fl- istudji kollha, il- miżura ewlenija ta ’ effettività kienet il- livell ta ’ sustanza fid- demm imsejħa glycosylated haemoglobin (HbA1c), li tagħti indikazzjoni ta ’ kemm huwa ikkontrollat tajjeb il- glukożju fid- demm, qabel u fi tmiem l- istudju.
What benefit has NovoMix shown during the studies?
X’ benefiċċju wera NovoMix waqt l- istudji?
NovoMix 30 gave almost identical results to human insulin at the end of the study.
Fi tmiem l- istudju, NovoMix 30 kważi ta riżultati identiċi għall- insulina umana.
NovoMix 50 and NovoMix 70 gave better overall control of blood glucose than human insulin 30.
NovoMix 50 u NovoMix 70 taw kontroll ta ’ glukożju fid- demm totali aħjar mill- insulina 30 umana.
Adding NovoMix 30 to other antidiabetic medicines resulted in better control of blood glucose than the other medicines taken alone.
Iż- żieda ta ’ NovoMix 30 ma ’ mediċini kontra d- dijabete oħra irriżultat f’ kontroll aħjar tal- glukożju fid- demm milli l- mediċini l- oħra meħuda waħedhom.
What is the risk associated with NovoMix?
X’ inhu r- riskju assoċjat ma ’ NovoMix?
As with other insulins, NovoMix may cause hypoglycaemia (low blood glucose).
Bħal b’ insulini oħra, NovoMix jista ’ jikkaġuna ipogliċemija (zokkor baxx fid- demm).
For the full list of all side effects reported with NovoMix, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha irrapportati b’ NovoMix, ara l- Fuljett ta ’ Taħgrif.
NovoMix should not be used in people who may be hypersensitive (allergic) to insulin aspart or to any of the other ingredients, or in patients with hypoglycaemia.
NovoMix m’ għandux jintuża f’ persuni li huma sensittivi b’ mod eċċessiv (allerġiċi) għall- insulina aspart jew ghal kwalunkwe mis- sustanzi l- oħra, jew f’ pazjenti b’ ipogliċemija.
NovoMix doses might also need to be adjusted when given with a number of other medicines which can have an effect on blood glucose.
Jista ’ jkun meħtieġ li dożi ta ’ NovoMix jiġu aġġustati meta mogħtija ma ’ numru ta ’ mediċini oħra li għandhom effett fuq il - glukożju fid- demm.
For the full list, see the Package Leaflet.
Għal- lista sħiħa ara l- Fuljett ta ’ Tagħrif.
Why has NovoMix been approved?
Għal xiex ġie approvat NovoMix?
The Committee for Medicinal products for Human Use (CHMP) decided that NovoMix’ s benefits are greater than its risks for the treatment of diabetes mellitus.
Il- Kumitat għal Prodotti Mediċinali għal Użu tal- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ NovoMix huma akbar mir- riskji tiegħu fit- trattament tad- dijabete mellitus.
The Committee recommended that NovoMix be given marketing authorisation.
Il- Kumitat irrakkommanda li NovoMix jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about NovoMix:
Tagħrif ieħor dwar NovoMix:
The European Commission granted a marketing authorisation valid throughout the European Union for NovoMix to Novo Nordisk A/ S on 1 August 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal NovoMix valida fl- Unjoni Ewropea kollha lil Novo Nordisk A/ S fl- 1 ta ’ Awwissu 2000.
The marketing authorisation was renewed on 1 August 2005.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 1 ta ’ Awwissu 2005.
The full EPAR for NovoMix can be found here.
L- EPAR sħiħ għal NovoMix jinsab hawnhekk.
This summary was last updated in 08-2007.
Dan is- sommarju ġie aġġornat l- aħħar f' 08- 2007.
NovoMix 30 Penfill 100 U/ ml, suspension for injection in a cartridge.
NovoMix 30 Penfill 100 U/ ml, suspensjoni g all- injezzjoni fi skarto.
Soluble insulin aspart*/ protamine-crystallised insulin aspart*……... 100 U/ ml in the ratio of 30/ 70
Insulin aspart * li jin all / insulin aspart * ikkristallizzat bi protamine …….. 100 U/ ml f’ proporzjon ta ’ 30/ 70
* produced by recombinant DNA technology in Saccharomyces cerevisiae.
* prodott minn teknolo ija rikombinanti tad- DNA f’ Saccharomyces cerevisiae.
One unit of insulin aspart corresponds to 6 nmol, 0.035 mg salt-free anhydrous insulin aspart.
Unità wa da ta ’ insulin aspart tikkorrispondi g al 6 nmol, 0. 035 mg ta ’ insulin aspart anidru ming ajr mel.
1 cartridge contains 3 ml equivalent to 300 U.
Skarto fih 3 ml ekwivalenti g al 300 U.
NovoMix 30 is a white suspension.
NovoMix 30 hu suspensjoni bajda.
NovoMix 30 has a faster onset of action than biphasic human insulin and should generally be given immediately before a meal.
NovoMix 30 jibda ja dem aktar malajr minn insulina umana bifa ika, u eneralment g andu jing ata immedjatament qabel l- ikel.
When necessary, NovoMix 30 can be given soon after a meal.
Meta jkun me tie, NovoMix 30 jista ’ jing ata dritt wara l- ikel.
NovoMix 30 is administered subcutaneously in the thigh or in the abdominal wall.
NovoMix 30 jing ata ta t il - ilda fil- koxxa jew fil - ajt addominali.
If convenient, the gluteal or deltoid region may be used.
Jekk ikun konvenjenti, jistg u jintu aw i - oni gluteali jew tad- deltojd.
Injection sites should be rotated within the same region.
Is- siti ta ’ l- injezzjoni g andhom jinbidlu b’ sistema ta ’ rotazzjoni fl- istess ona.
As with all insulins the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
B all- insulini kollha, it- tul ta ’ l- azzjoni ser ivarja skond id- do a, is- sit ta ’ l - injezzjoni, il- fluss tad- demm, it- temperatura u l- livell ta ’ attività fi ika.
The influence of different injection sites on the absorption of NovoMix 30 has not been investigated.
L- influwenza ta ’ siti differenti ta ’ l- injezzjoni fuq l- assorbiment ta ’ NovoMix 30 ma ietx investigata.
NovoMix 30 should never be administered intravenously.
NovoMix 30 m’ g andu qatt jing ata ol- vini.
Renal or hepatic impairment may reduce the patient’ s insulin requirements.
L- indeboliment tal- kliewi jew tal- fwied jista ’ jnaqqas il - ti ijiet tal- pazjent g all- insulina.
NovoMix 30 can be used in children and adolescents aged 10 years and above when premixed insulin is preferred.
Novomix 30 jista ’ jintu a fit- tfal u fl- adolexxenti minn 10 snin ’ il fuq, meta huwa meqjus li jkun a jar li tintu a insulina m allta bil- lest.
For children 6-9 years limited clinical data exists (see section 5.1).
G al tfal bejn 6- 9 snin l- informazzjoni klinika hija limitata (ara sezzjoni 5. 1).
No studies have been performed in children under the age of 6 years.
Ma sarux studji fit- tfal ta t is- 6 snin.
Dose recommendation:
Rakkomandazzjoni tad- do a:
Dosage of NovoMix 30 is individual and determined in accordance with the needs of the patient.
ta ’ NovoMix 30 hu individwali u ji i stabbilit skond il- b onnijiet tal- pazjent.
In patients with type 2 diabetes, NovoMix 30 can be given in monotherapy or in combination with oral antidiabetic drugs for which the combination with insulin is approved, when the blood glucose is inadequately controlled with those oral antidiabetic drugs alone.
b’ dijabete ta ’ tip 2, NovoMix 30 jista ’ jing ata f’ monoterapija jew flimkien ma ’ medi ini
For patients with type 2 diabetes, the recommended starting dose of NovoMix 30 is 6 U at breakfast and 6 U at dinner (evening meal).
G all- pazjenti b’ dijabete ta ’ tip 2, id- do a tal- bidu rakkomandata ta ’ NovoMix 30 hi ta ’ 6 U waqt il- kolazzjon u ta ’ 6 U waqt il- pranzu (l- ikla ta ’ filg axija).
When using
NovoMix 30 jista ’ wkoll jinbeda darba kuljum bi 12 U waqt il- pranzu (l- ikla ta ’ filg axija).
2 NovoMix 30 once daily, it is generally recommended to move to twice-daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses.
Meta tu a NovoMix 30 darba kuljum, eneralment hu rakkomandat li malli til aq 30 unità tmur g al do a ta ’ darbtejn kuljum billi taqsam id- do a f ’ ew do i ndaqs wa da waqt il- kolazzjon u l- o ra waqt il- pranzu.
NovoMix 30 dose adjustment
Jekk do a ta ’ darbtejn kuljum b’ NovoMix 30 jirri ulta f’ episodji frekwenti ta ’ ipogli emija matul il- jum, id- do a ta ’ filg odu tista ’ tinqasam f’ do i ta ’ filg odu u ta ’ waqt l- ikla ta ’ nofsinhar (do a ta ’ tliet darbiet kuljum).
6.2 – 7.8 mmol/ l 7.9 – 10 mmol/ l > 10 mmol/ l
B ala linja gwida fl- a ustamenti fid- do a huwa rakkomandat li ssegwi din it- tabella:
111 – 140 mg/ dL 141 – 180 mg/ dL > 180 mg/ dL
Livell ta ’ glucose fid- demm qabel l - ikel < 4. 4 mmol/ l < 80 mg/ dL 4. 4 – 6. 1 mmol/ l 80 – 110 mg/ dL 6. 2 – 7. 8 mmol/ l 111 – 140 mg/ dL 7. 9 – 10 mmol/ l 141 – 180 mg/ dL > 10 mmol/ l > 180 mg/ dL
+2U +4U +6U
A ustament fid- do a ta ’ NovoMix 30 - 2U 0 +2U +4U +6U
The lowest of three previous days’ pre-meal levels should be used.
G andu jintu a l- inqas mil- livelli ta ’ qabel l- ikel tat- tlitt ijiem ta ’ qabel.
The dose should not be increased if hypoglycaemia occurred within these days.
Id- do a m’ g andhiex ti died jekk l- ipogli emija tkun se et f’ dawn il- jiem.
Dose adjustments can be made once a week until target HbA1c is reached.
A ustamenti fid- do a jistg u jsiru darba f ’ img a sakemm tintla aq il- mira ta ’ HbA1c.
Pre-meal blood glucose levels should be used to evaluate the adequacy of the preceding dose.
G andhom jintu aw il- livelli tal- glucose fid- demm qabel l- ikel sabiex ji i evalwat jekk id- do a ta ’ qabel kinitx suffi jenti.
The combination of NovoMix 30 with pioglitazone should only be considered following clinical evaluation of the patient’ s risk of developing signs or symptoms of fluid-related adverse events.
It- te id flimkien ta ’ NovoMix 30 u pioglitazone g andha ti i kkunsidrata biss wara evalwazzjoni kliniku tar- riskju li l- pazjent jista ’ ji viluppa sinjali jew sintomi ta ’ avvenimenti avversi konnessi mal - fluwidi.
The initiation of NovoMix 30 should be undertaken cautiously titrating to the lowest dose required to achieve glycaemic control (see section 4.4)
(ara sezzjoni 4. 4)
In patients with type 1 diabetes the individual insulin requirement is usually between 0.5 and 1.0 Units/ kg/ day.
F’ pazjenti b’ dijabete ta ’ tip 1, il - tie a individwali ta ’ l- insulina normalment hi ta ’ bejn 0. 5 u 1. 0 Unitajiet/ kg/ kuljum.
NovoMix 30 may fully or partially meet this requirement.
NovoMix 30 jista ’ jil aq din il - tie a b’ mod s i jew b’ mod parzjali.
The daily insulin requirement may be higher in patients with insulin resistance (e. g. due to obesity), and lower in patients with residual endogenous insulin production.
Il - tie a ta ’ l- insulina ta ’ kuljum tista ’ tkun og la f’ pazjenti b’ re istenza g all- insulina (e. min abba obe ità) u iktar baxxa f’ pazjenti bi produzzjoni residwa ta ’ insulina endo enika.
When transferring a patient from biphasic human insulin to NovoMix 30, start with the same dose and regimen.
Meta taqleb pazjent minn insulina umana bifa ika g al NovoMix 30, ibda bl- istess do a u frekwenza ta ’ do a.
Then titrate according to individual needs (See titration guidelines in table above).
Imbag ad g amel l- a ustamenti skond il- b onnijiet ta ’ l- individwu.
NovoMix 30 can be used in elderly patients; however there is limited experience with the use of NovoMix 30 in combination with OADs in patients older than 75 years.
NovoMix 30 jista ’ jintu a f’ pazjenti anzjani; madankollu l- esperjenza hija limitata fl- u u ta ’ NovoMix 30 flimkien ma ’ OADs f’ pazjenti ikbar minn 75 sena.
• Hypersensitivity to the active substance or to any of the excipients • Hypoglycaemia.
• Sensittività e essiva g as- sustanza attiva jew g al xi sustanzi mhux attivi. • Ipogli emija
The use of dosages which are inadequate or discontinuation of treatment, especially in insulin- dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
L- u u ta ’ do i li huma inadegwati jew it- twaqqif tal- kura, spe jalment f’ pazjenti dijabeti i li huma dipendenti fuq l- insulina, jista ’ jwassal g al ipergli emija u ketoa idosi dijabetika; kundizzjonijiet li huma potenzjalment letali.
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia (see section 4.8 and section 4.9).
Ikla maqbu a jew e er izzju fi iku li je tie sforz qawwi, jistg u jwasslu g al ipogli emija (ara sezzjoni 4. 8 u sezzjoni 4. 9).
Compared with biphasic human insulin, NovoMix 30 may have a more pronounced glucose lowering effect up to 6 hours after injection.
Meta mqabbel ma ’ insulina umana bifa ika, NovoMix 30 jista ’ jkollu effett li jbaxxi l- livell ta ’ glucose b’ mod aktar qawwi sa 6 sig at wara l- injezzjoni.
This may have to be compensated for in the individual patient, through adjustment of insulin dose and/ or food intake.
Dan jista ’ jkollu ji i kkumpensat fil- pazjent individwali, permezz ta ’ a ustament fid- do a ta ’ l- insulina u/ jew tat- te id ta ’ l- ikel.
Patients, whose blood glucose control is greatly improved, e. g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly.
3 Dawk il- pazjenti, li l- kontroll taz- zokkor fid- demm tag hom jitjieb bil- kbir, e. permezz ta ’ terapija intensifikata bl- insulina, jista ’ jkollhom bidla fis- sintomi normali ta ’ twissija tag hom ta ’ l - ipogli emija, u g andhom jing ataw parir dwar dan il- fatt.
3 Tighter control of glucose levels can increase the potential for hypoglycaemic episodes and therefore require special attention during dose intensification as outlined in section 4.2.
Kontroll iktar strett tal- livelli ta ’ glucose jista ’ j id il- potenzjal g al episodji ipogli emi i u g alhekk te tie attenzjoni spe jali matul l- intensifikazzjoni tad- do a kif spjegat fil- qosor f’ sezzjoni 4. 2.
NovoMix 30 should be administered in immediate relation to a meal.
NovoMix 30 g andu jing ata b’ rabta immedjata ma ’ l- ikel.
The rapid onset of action should therefore be considered in patients with concomitant diseases or treatment with other medicinal products where a delayed absorption of food might be expected.
G alhekk, il- fatt li jibda ja dem malajr g andu jkun ikkunsidrat f’ pazjenti li fl- istess in ikollhom mard ie or jew ikunu qed jir ievu kura bi prodotti medi inali o rajn u jkun mistenni li jista ’ jkun hemm xi dewmien fl- assorbiment ta ’ l- ikel.
Concomitant illness, especially infections, usually increases the patient’ s insulin requirements.
Mard fl- istess mien, spe jalment infezzjonijiet, is- soltu j idu l - ti ijiet tal- pazjent g all- insulina.
When patients are transferred between different types of insulin products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with their previous insulin.
Meta l- pazjenti jkunu ttrasferiti bejn tipi differenti ta ’ prodotti ta ’ l- insulina, is- sintomi bikrija ta ’ twissija ta ’ ipogli emija jistg u jinbidlu jew isiru inqas prominenti minn dawk li kien ikollhom bl - insulina ta ’ qabel tag hom.
Transferring a patient to a new type or brand of insulin should be done under strict medical supervision.
It- trasferiment ta ’ pazjent g al tip jew marka dida ta ’ insulina g andu jsir ta t supervi joni medika stretta.
Changes in strength, brand (manufacturer), type, origin (animal, human, human insulin analogue), and/ or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dosage.
Tibdil fil- qawwa, marka (manifattur), tip, ori ini (mill- annimali, mill- bniedem, analogu ta ’ l - insulina umana) u/ jew fil- metodu ta ’ manifattura (DNA rikombinanti kontra insulina li ejja minn sors ta ’ l- annimali) jista ’ jirri ulta fil - tie a ta ’ tibdil fid- do a.
Patients taking NovoMix 30 may need a change in dosage from that used with their usual insulin.
Pazjenti li jkunu qed jie du NovoMix 30 jista ’ jkollhom b onn ta ’ tibdil fid- do a minn dak u at bl- insulina normali tag hom.
If dosage adjustment is needed, it may be done with the first dose or during the first few weeks or months.
Jekk ikun me tie xi a ustament fid- do a, dan jista ’ jsir ma ’ l- ewwel do a jew matul l- ewwel ftit img at jew xhur.
Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet.
L- a ustament fid- do a jista ’ jkun ne essarju wkoll jekk il- pazjenti j idu l- attività fi ika tag hom jew jibdlu d- dieta normali tag hom.
Exercise taken immediately after a meal may increase the risk of hypoglycaemia.
L- e er izzju li jsir dritt wara xi ikla jista ’ j id ir- riskju ta ’ ipogli emija.
Insulin suspensions are not to be used in insulin infusion pumps.
Suspensjonijiet ta ’ l- insulina m’ g andhomx jintu aw f’ pompi ta ’ l- infu joni ta ’ l- insulina.
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
B al kull terapija o ra bl- insulina, jista ’ jkun hemm xi reazzjonijiet fil- post ta ’ l- injezzjoni u dawn jinkludu u ig, aqq, urtikarja, nef a u infjammazzjoni.
Reactions usually resolve in a few days to a few weeks.
Li fl- istess ona partikulari jkun hemm tibdil kontinwu tal- post ta ’ l- injezzjoni jista ’ jg in biex inaqqas jew jimpedixxi dawn ir - reazzjonijiet. Normalment dawn ir- reazzjonijiet imorru wara xi ftit ranet jew img at.
On rare occasions, injection site reactions may require discontinuation of NovoMix 30.
F’ okka jonijiet rari, min abba r- reazzjonijiet fil- post ta ’ l- injezzjoni jista ’ jkun hemm il- b onn li NovoMix 30 jitwaqqaf
Combination of NovoMix 30 with pioglitazone:
Te id ta ’ NovoMix 30 flimkien ma ’ pioglitazone:
There have been cases of cardiac failure reported from the market when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure.
Kien hemm rapporti mill- u u fis- suq ta ’ ka ijiet ta ’ insuffi jenza tal- qalb meta pioglitazone intu a flimkien ma ’ l- insulina, spe jalment f’ pazjenti b’ fatturi ta ’ riskju li jkollhom insuffi jenza tal- qalb.
Patients should be observed for signs and symptoms of heart failure, weight gain and oedema when NovoMix 30 is used in combination with pioglitazone.
Il - pazjenti g andhom ikunu osservati g al sinjali jew sintomi ta ’ insuffi jenza tal- qalb, jieda fil- pi u edima meta NovoMix 30 jintu a flimkien ma ’ pioglitazone.