qanastek/EMEA-V3 huggingface dataset:
ris area again before injecting.
Terġax tmiss din il- parti qabel tagħti l- injezzjoni.
With your other
B’ id waħda żomm il- pinna mimlija għal- lest bl- għatu l- griz (1) iħares ’ l isfel.
tho hand, pull the grey cap (1) straight off and discard cap.
Bl- id l- oħra, neħħi l- għatu l- griż (1) u armih.
Do not try to touch the needle housed in the barrel.
Tippruvax tmiss il- labra li jkun ’ g ħ hemm fil- bettija.
DO NOT RECAP as you may damage the
TERĠAX TLIBBES L- GĦATU għax tista ’ tagħmel ħsara lil- labra.
Pull the plum safety cap (labelled ‘2’) st raight off to expose the plum coloured activation button at the top.
Neħħi l- għatu tas- sigurtà ta ’ kulur l- għanbaqra (immarkat ‘ 2 ’) biex tikxef il- buttuna ta ’ kulur l - im
The pre-filled pen is now ready to use.
għanbaqra li tattiva, u li qiegħda fuq nett.
Do not press the plum activation button until
Sakemm issib il- pożizzjoni t- tajba, tafasx il- buttuna ta ’ kulur l- għanbaqra li tattiva, għax inkella toħroġ il- medikazzjoni.
DO NOT RECAP as this
TERĠAX TLIBBES L- GĦATU, għax dan jista jikkawża l- ħruġ tal - medikazzjoni mill- unità. li l
ge could cause the unit to discharge.
Biex tagħti l- injezzjoni ina
Place the white end of the pre-filled pen at a right angle (90 degrees) to the skin, so that you can see the window. no
Poġġi t- tarf l- abjad tal- pinna mimlija għal- lest f’ angolu rett (90 grad) mill- ġilda, biex inti tkun diċ
Holding the barrel of the pre-filled pen, press down slightly on to the injection site (holding in place without moving).
Żomm il- bettija tal- pinna mimlija għal- lest, u agħfas ftit ’ l isfel fuq il- post fejn se tingħata l - injezzjoni (żommha f’ postha mingħajr ma ċċaqlaqha).
With your index finger or your thumb, press the plum coloured button on top once you are ready t
Kif inti tkun lest biex tagħti l- injezzjoni, bis- suba ’ l- werrej jew il- kbir, agħfas il- buttuna ta ’ me
to begin the injection (see below).
kulur l- għanbaqra li tinsab fuq nett (ara hawn taħt).
You will then hear a ‘click’ as the needle is released, and you uc
Hekk kif il- labra tkun meħlusa, inti tisma ’ ‘ klick ’, u tħoss tingiża żgħira kif il- labra tidħol.
Do not remove the pre-filled pen while the injection is rod
Tneħħix il- pinna ott
being given. lP i na dic Me
mimlija għal- lest waqt li tkun qiegħda tingħata l- injezzjoni. od Pr
6.
166 at zz ori t aw 6.
157 7.
ux 7.
The white ne edle sleeve will move down over the needle and lock into place over the needle tip.
Il- biċċa l- bajda li tgħatti l- labra tinżel fuq il- labra u tissakkar f’ postha, fuq il- ponta tal- labra.
Do not t ry to touch the needle.
Tippruvax tmiss il- labra.
ed ris tho
ad ’ g ħ im li l ina diċ
You can press a cotton ball or a piece of
Jista ’ jkun li inti tinnota taqtira demm fil- post ta ’ l- injezzjoni.
ge gauze over the injection site for 10 seconds.
Tista ’ tagħfas ballun tat- tajjar jew garża fuq il- post ta ’ l- injezzjoni għal 10 sekondi.
Use a plaster if you want to. lon Throwing away supplies
Biex tarmi l- affarijiet li użajt me
• Do not put either of the caps back on the pre-filled pen. • Put used pre-filled pen immediately into the special container as instructed by your doctor, nurse or pharmacist. no
• Terġax tlibbes xi wieħed mill- għotjin fuq il- pinna mimlija għal- lest. • Poġġi l- pinna mimlija għal- lest użata f’ kontenitur speċjali immedjatament, kif qallek it- tabib, l - infermier jew l- ispiżjar tiegħek. ott
• Keep this container out of the reach and sight of children. • Never put the pre-filled pens that you have used into your normal household rubbish bin. • Only use each pre-filled pen for one injection. t uc
• Żomm dan il- kontenitur fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Qatt tarmi l- pinen mimlijin għal- lest użati fit- tank taż- żibel fejn inti tarmi l- fdalijiet ta ’ kuljum. • Uża l- pinna mimlija għal- lest għal injezzjoni waħda biss. od
If you use more Trudexa than you should:
Jekk tuża Trudexa aktar milli suppost Pr
If you accidentally inject Trudexa more frequently than told to by your doctor, you should call your rod
Jekk inti aċċidentalment tinjetta Trudexa aktar frekwentament milli ordnalek it- tabib tiegħek, inti għandek iċċempel lit- tabib tiegħek u tgħidlu li ħadt aktar milli suppost.
If you forget to take Trudexa: lP
167 Jekk tinsa tieħu Trudexa
Then take your next dose as you would have on your originally scheduled day, had you na
Imbagħad ħu d- doża ta ’ wara fil- ħin li inti suppost toħodha f’ ġurnata normali, daqs li kieku ma ’ nsejtx doża.
If you have any further questions on the use of this product, ask your doctor or pharmacist. i dic
at Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
4.
zz 4.
Like all medicines, Trudexa can have side effects, although not everybody gets them.
ori Bħal kull mediċina oħra, Trudexa jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Most side Me
Madanakollu, uħud minnhom jistgħu
However, some may be serious and require treatment.
t jkunu serji u jirrikjedu l- kura.
Side effects may occur at least up to 5 months after the last treatment.
L- effetti sekondarji jistgħu ifeġġu sa mill- inqas 5 xhur wara l- aħħar
Tell your doctor immediately if you notice any of the following: • Severe rash, hives or other signs of allergic reaction; • Swollen face, hands, feet; • Trouble breathing, swallowing; 158 • Shortness of breath with exertion or upon lying down or swelling of the feet; • Signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness.
Għarraf lit- tabib tiegħek immedjatament jekk inti tinnota xi wieħed minn dawn li ġejjin: • Raxx sever, urtikarja jew sinjali oħra ta ’ reazzjoni allerġika;
Tell your doctor as soon as possible if you notice any of the following: • Signs of infection such as fever, malaise, wounds, dental problems, burning on urination;
ux • Nefħa fil- wiċċ, fl- idejn u fis- saqajn; • Diffikultà biex tieħu n- nifs, biex tibla ’; • Qtugħ ta ’ nifs meta tagħmel l- eżeċizzju jew meta timtedd jew nefħa fis- saqajn;
ed • Feeling weak or tired; • Coughing; • Tingling;
ad • Sinjali u sintomi li għandhom x’ jaqsmu ma’ disturbi tad- demm bħal deni persistenti, tbenġil, ħruġ ta ’ demm, tkun pallidu. ’ g ħ Għarraf lit- tabib tiegħek mill- aktar fis possibbli jekk inti tinnota xi wieħed minn dawn li ġejjin: • Sinjali ta ’ infezzjoni bħal deni, telqa tal- ġisem mingħajr l- ebda sinjali ta ’ mard, feriti, problemi tas- snien, ħruq waqt għamil ta ’ l- awrina; im
ris • Numbness; • Double vision;
• Tħossok dgħajjef jew għajjien; • Sogħla; • Tnemnim; • Tirżiħ; li l
tho • A rm or leg weakness.
• Tara doppju; • Dgħufija fl- idejn jew fir- riġlejn. ina
The symptoms described above can be signs of the below listed side effects, which have been observed with Trudexa:
Is- sintomi deskritti hawn fuq jistgħu jkunu sinjali ta ’ l- effetti sekondarji mniżżlin hawn taħt, li ġew osservati b’ Trudexa: diċ
au Very common (≥ 1/10 patients): • injection site reactions (including pain, swelling, redness or itching).
Komuni ħafna (≥ 1/ 10 pazjent): • reazzjonijiet fil- post ta ’ l- injezzjoni (li jinkludu uġigħ, nefħa, ħmura jew ħakk). me
r Common (≥ 1/100 and < 1/10 patients):
Komuni (≥ 1/ 100 u < 1/ 10 pazjent): • infezzjonijiet fin- naħa t’ isfel tas- sistema respiratorja (bħal bronkite, pnewmonja); • infezzjonijiet fin- naħa ta ’ fuq tas- sistema respiratorja (li jinkludu riħ, flisjoni, infezzjoni fis - sinus); • infezzjoni fis- sistema urinarja, infafet kiesħa, ħruq ta ’ Sant’ Antnin; ott
ge • lower respiratory tract infections (such as bronchitis, pneumonia); • upper respiratory tract infections (including cold, runny nose, sinus infection); • urinary tract infection, cold blisters, shingles; lon • dizziness, including vertigo, headache; • eye inflammation; • cough, sore throat; • nausea, diarrhoea, abdominal pain, mouth ulcers; no
• sturdament, li jinkludi vertigo, uġigħ ta ’ ras; • infjammazzjoni fl- għajnejn; • sogħla, uġigħ fil- griżmejn; od
• elevated liver enzymes; • rash, itching, hair loss; • fatigue; • fever. t uc
• raxx, ħakk, taqa ’ x- xagħar; • għeja kbira; • deni.
Uncommon (≥ 1/1000 and < 1/100 patients): • serious infections (such as sepsis [blood poisoning]), joint infection, fungal infections; rod
Mhux komuni (≥ 1/ 1000 u < 1/ 100 pazjent):
• skin wart; • anaemia, low white blood cell counts; • allergic reactions; • increased lipid values, appetite disorders; lP
168 • infezzjonijiet serji (bħal fil- pene [avvelenament tad- demm]), infezzjoni fil- ġogi, infezzjonijiet tal- fungu; • felul fil- ġilda; • anemija, għadd baxx taċ- ċelluli bojod fid- demm; • reazzjonijiet allerġiċi;
• anxiety, depression, feeling sleepy and difficulty sleeping; • nerve disorders (such as multiple sclerosis and eye nerve inflammation), taste disturbances; • vision disturbances; • ear discomfort; na
zz • disturbi fin- nervituri (bħal sklerosi multipla u infjammazzjoni fin- nervituri ta ’ l- għajnejn), disturbi tat- togħma; • disturbi tal- vista;
• sensation of heart beating rapidly, high blood pressure; • asthma, shortness of breath; • abdominal symptoms (such as vomiting, indigestion, constipation), rectal bleeding; i dic
ori • skonfort fil- widnejn; • sensazzjoni ta ’ taħbit mgħaġġel tal- qalb, pressjoni għolja tad- demm;
• skin disorders (such as psoriasis, eczema or infections)itchy rash, slow wound healing; • muscle weakness; • urinary disturbances (such as blood in urine, increas ed urinary frequency); • increased menstrual bleeding; Me
aw • sintomi addominali (bħal rimettar, indiġestjoni, stitikezza), ħruġ ta ’ demm mir- rektum; • disturbi fil- ġilda (bħal psorjasi, ekżema jew infezzjonijiet), raxx li jqabbdek il- ħakk, dewmien biex ifiqu l- feriti; • dgħufija tal- muskoli;
• flu like symptoms, chest pain, swelling of the feet.
ux • dirstubi fis- sistema urinarja (bħal demm fl- awrina, tagħmel l- awrina aktar frekwentament); • żieda fil- ħruġ ta ’ demm tal- mestrwazzjoni; • sintomi li jixbħu lil dawk ta ’ l- influwenza, uġigħ fis- sider, nefħa fis- saqajn.
159 Rare (< 1/1000) • glaucoma; • skin cancer; • thyroid disorders; • protein in urine.
ad Rari (< 1/ 1000) • glawkoma; ’ g ħ • kanċer tal- ġilda; • distrubi fit- tirojde; • proteina fl- awrina. im
ed • Other side effects that have been observed in patients taking Trudexa: • tuberculosis and other opportunistic infections (infections that occur when resistance to disease is lowered);
Effetti sekondarji oħra li ġew osservati f’ pazjenti li jieħdu Trudexa: tuberkulosi u infezzjonijiet opportunistiċi oħra (infezzjonijiet li jiġu kkawżati meta r- reżistenza għall - mard tiddgħajjef); li l
ris • lung disease.
mard tal- pulmun.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex ina
tho tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek. diċ
Keep out of the reach and sight of children.
Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal. me
r Do not use the Trudexa pre-filled pen after the expiry date stated on the label/blister/carton after EXP:.
Tużax il- pinna mimlija għal- lest ta ’ Trudexa wara d- data ta ’ skadenza li tidher fuq it- tikketta/ il- folja/ il - pakkett wara JIS:.
ge The expiry date refers to the last day of that month.
Id- Data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
FURTHER INFORMATION
AKTAR TAGĦRIF od
Trudexa 40 mg solution for injection in pre-filled pen is supplied as a sterile solution of 40 mg no
Pr
What Trudexa contains t uc
X’ fih Trudexa:
The other ingredients are mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium rod
169 Is- sustanzi l- oħra huma mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide u ilma għall- injezzjoni.
hydroxide and water for injections.
Id- Dehra tal- prodott u d- daqs tal- pakkett:
What the Trudexa pre-filled pen looks like and contents of the pack lP
at Il- pinna ta ’ Trudexa mimlija għal- lest hijia pinna ta ’ kulur griż u kulur l- għanbaqra, li tintuża darba
The Trudexa pre-filled pen is a single-use grey- and plum-coloured pen which contains a glass syringe with Trudexa.
zz biss, li fiha siringa tal- ħġieġ b’ Trudexa.
There is a window on each side of the pen through which you can see the Trudexa solution inside the na
Hemm tieqa fuq kull ġenb tal- pinna, li minnha tista ’ tara s - soluzzjoni Trudexa ta’ ġos- siringa.
The Trudexa pre-filled pen is available in packs containing 1, 2, 4, and 6 pre-filled pens.
ori Il- pinna ta ’ Trudexa mimlija għal- lest tista ’ tinxtara f’ pakketti ta ’ 1, 2, 4 jew 6 pinen mimlijin għal - lest.
Each pre- i
Jista ’ jkun li mhux il -
Trudexa is also available as dic
t pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali. Trudexa jista ’ tinxtara ukoll bħala kunjett
a vial or pre-filled syringe.
aw jew siringa mimlija għal- lest.
Marketing Authorisation Holder Me
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur:
Abbott Laboratories Ltd Queenborough Kent ME11 5EL Unit ed Kingdom
Abbott Laboratories Ltd
160 Manufacturer
Abbott Biotechnology Deutschland GmbH im
Abbott Biotechnology Deutschland GmbH Max-Planck-Ring 2 D – 65205 Wiesbaden Germany
Max- Planck- Ring 2 D – 65205 Wiesbaden Ġermanja li l
ed For any information about this medicine, please contact the local representative of the Marketing
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq: ina
tho Abbott SA Parc Scientifique Rue du Bosquet, 2 B-1348 Ottignies/Louvain-la-Neuve
België/ Belgique/ Belgien Abbott SA Parc Scientifique diċ
au Tél/Tel: + 32 10 475311
Rue du Bosquet, 2 Rue du Bosquet, 2 B- 1348 Ottignies/ Louvain- la- Neuve B- 1348 Ottignies/ Louvain- la- Neuve Belgique/ Belgien Tél/ Tel: + 32 10 475311 me
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Deutschland lP
at Norge Deutschland
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zz Abbott Norge AS Abbott GmbH & Co.
D-65205 Wiesbaden Tel: + 49 (0) 6122 58-0 i
ori Tlf: + 47 81 55 99 20 Tel: + 49 (0) 6122 58- 0
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at Θεοτόκη 4Β 1055 Λευκωσία
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ori Abbott Laboratories Ltd Abbott Laboratories Baltics Abbott House Vienibas 87h Unit 2, Vanwall Road LV- 1004 Rīga
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t Vanwall Business Park Tel: + 371 7605580
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162 This leaflet was last approved in {MM/YYYY}
ad LV- 1004 Rīga Latvia Tel: + 371 7605580 ’ g ħ Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS} im li l ina diċ me ott od Pr
Film-coated tablet Film-coated tablet
Pilloli miksija b’ rita Pilloli miksija b’ rita
Oral use Oral use
Użu orali.
Bottle (HDPE) Bottle (HDPE)
Flixkun (HDPE) Flixkun (HDPE)
30 tablets 3 x 30 tablets
30 pilloli 3 x 30 pilloli
Truvada 200 mg/ 245 mg film-coated tablets.
Truvada 200 mg/ 245 mg pilloli miksija b’ rita.
Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).
Kull pillola miksija b’ rita fiha 200 mg ta ’ emtricitabine u 245 mg ta ’ tenofovir disoproxil (ekwivalenti għal 300 mg ta ’ tenofovir disoproxil fumarate, jew 136 mg ta ’ tenofovir).
Each tablet contains 80 mg lactose monohydrate.
Kull pillola fiha 80 mg ta ’ lactose monohydrate.
Blue, capsule-shaped, film-coated tablet, debossed on one side with “ GILEAD” and on the other side with “ 701”.
Pillola miksija b’ rita, blu, forma ta ’ kapsula, b ’ “ GILEAD ” imnaqqxa fuq naħa waħda u “ 701 ” fuq in - naħa l- oħra.
Truvada is a fixed dose combination of emtricitabine and tenofovir disoproxil fumarate.
4. 1 Indikazzjonijiet terapewtiċi
It is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.
Hija indikata f’ terapija antiretrovirali kombinata għal trattament ta ’ adulti infettati b’ HIV- 1.
The demonstration of the benefit of the combination emtricitabine and tenofovir disoproxil fumarate in antiretroviral therapy is based solely on studies performed in treatment-naïve patients (see section 5.1).
Id- dimostrazzjoni tal- benefiċċju tat- taħlita ta ’ emtricitabine u tenofovir disoproxil fumarate fit- terapija antiretrovirali hi bbażata biss fuq studji li saru fuq pazjenti li qatt ma kienu ħadu din it- terapija qabel (ara sezzjoni 5. 1).
Posology Adults:
Pożoloġija Adulti:
The recommended dose of Truvada is one tablet, taken orally, once daily.
Id- doża rakkomandata ta ’ Truvada hija ta ’ pillola waħda, orali, meħuda darba kuljum.
In order to optimise the absorption of tenofovir, it is recommended that Truvada should be taken with food.
Sabiex ikun hemm l- aħjar assorbiment ta ’ tenofovir, hu rakkomandat li Truvada tittieħed ma ’ l- ikel.
Even a light meal improves absorption of tenofovir from the combination tablet (see section 5.2).
Anke ikla ħafifa ttejjeb l- assorbiment ta ’ tenofovir mill- pillola kombinata taż- żewġ mediċini (ara sezzjoni 5. 2).
Where discontinuation of therapy with one of the components of Truvada is indicated or where dose modification is necessary, separate preparations of emtricitabine and tenofovir disoproxil fumarate are available.
Meta t- twaqqif tat- terapija b’ wieħed mill- komponenti ta ’ Truvada jkun indikat, jew meta tibdil fid - doża jkun meħtieġ, preparazzjonijiet separati ta ’ emtricitabine u tenofovir disoproxil fumarate huma disponibbli.
Please refer to the Summary of Product Characteristics for these medicinal products.
Jekk jogħġbok irreferi għas- Sommarju tal- Karatteristiċi tal- Prodott għal dawn il- prodotti mediċinali.
Truvada is not recommended for use in children below the age of 18 years due to insufficient data on safety and efficacy (see section 5.2).
Truvada mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 2).
No data are available on which to make a dose recommendation for patients over the age of 65 years.
M’ hemmx informazzjoni fuqhiex wieħed jista ’ jagħti rakkomandazzjoni għall- pazjenti ta ’ ’ l fuq minn 65 sena.
2 (creatinine clearance 50-80 ml/ min).
2 Insuffiċjenza renali:
Therefore, in patients with renal impairment Truvada should only be used if the potential benefits of treatment are considered to outweigh the potential risks.
Hemm dejta limitata dwar is- sigurtà u l- effikaċja ta ’ Truvada f’ pazjenti b’ indeboliment renali moderat u sever (tneħħija tal - krejatinina ta ’ < 50 ml/ min) u dejta dwar is- sigurtà fuq tul ta ’ żmien ma kinitx evalwata għal indeboliment renali ħafif (tneħħija tal- krejatinina ta ’ 50- 80 ml/ min).
Patients with renal impairment may require close monitoring of renal function (see section 4.4).
Pazjenti b’ indeboliment renali jista ’ jkollhom bżonn monitoraġġ mill- qrib tal- funzjoni renali (ara sezzjoni 4. 4).
Dose interval adjustments are recommended for patients with creatinine clearance between 30 and 49 ml/ min.
Aġġustamenti ta ’ l- intervall tad- dożi huma rakkomandati għal pazjenti bi tneħħija tal- krejatinina bejn 30 u 49 ml/ min.
These dose adjustments have not been confirmed in clinical studies and the clinical response to treatment should be closely monitored in these patients (see sections 4.4 and 5.2).
Dawn l- aġġustamenti fid - dożi ma kienux ikkonfermati fl- istudji kliniċi u r- rispons kliniku għat- trattament għandu jkun immonitorjat mill- qrib f’ dawn il- pazjenti (ara sezzjonijiet 4. 4 u 5. 2).
Mild renal impairment (creatinine clearance 50-80 ml/ min):
Indeboliment renali ħafif (tneħħija tal- krejatinina ta ’ 50- 80 ml/ min):
Limited data from clinical studies support once daily dosing of Truvada in patients with mild renal impairment (see section 4.4).
Dejta limitata minn studji kliniċi tjissapportja dożaġġ ta ’ darba kuljum ta ’ Truvada f’ pazjenti b’ indeboliment renali ħafif (ara sezzjoni 4. 4).
Moderate renal impairment (creatinine clearance 30-49 ml/ min):
Indeboliment renali moderat (tneħħija tal- krejatinina ta ’ 30- 49 ml/ min):
Administration of Truvada every 48 hours is recommended, based on modelling of single-dose pharmacokinetic data for emtricitabine and tenofovir disoproxil fumarate in non-HIV infected subjects with varying degrees of renal impairment (see section 4.4). Severe renal impairment (creatinine clearance < 30 ml/ min) and haemodialysis patients:
L- għoti ta ’ Truvada kull 48 siegħa hu rakkomandat ibbażat fuq l- immudellar ta ’ tagħrif farmakokinetiku ta ’ doża waħda għal emtricitabine u tenofovir disoproxil fumarate f’ individwi li ma kienux infettati bl- HIV b’ livelli differenti ta ’ indeboliment renali (ara sezzjoni 4. 4).
Truvada is not recommended for patients with severe renal impairment (creatinine clearance < 30 ml/ min) and in patients who require haemodialysis because appropriate dose reductions cannot be achieved with the combination tablet.
Truvada mhiex rakkomandata għal pazjenti b’ indeboliment renali sever (tneħħija tal- krejatinina < 30 ml/ min) u f’ pazjenti li jeħtieġu dijaliżi tad- demm minħabba li tnaqqis xieraq tad- doża ma jistax isir bil- pillola kombinata taż- żewġ mediċini.
The pharmacokinetics of Truvada and emtricitabine have not been studied in patients with hepatic impairment.
Il- farmakokinetiċi ta ’ Truvada u emtricitabine ma ġewx studjati f’ pazjenti b’ indeboliment epatiku.
The pharmacokinetics of tenofovir have been studied in patients with hepatic impairment and no dose adjustment is required for tenofovir disoproxil fumarate in these patients.
Il- farmakokinetiċi ta ’ tenofovir ġew studjati f’ pazjenti b’ indeboliment epatiku u l- ebda aġġustament fid- doża mhux meħtieġ għal tenofovir disoproxil fumarate f’ dawn il- pazjenti.
Based on minimal hepatic metabolism and the renal route of elimination for emtricitabine, it is unlikely that a dose adjustment would be required for Truvada in patients with hepatic impairment (see sections 4.4 and 5.2).
Ibbażat fuq il- metaboliżmu epatiku minimu u r- rotta ta ’ l- eliminazzjoni renali ta ’ emtricitabine, huwa improbabbli li jkun meħtieg aġġustament tad- doża ta ’ Truvada f’ pazjenti b’ indeboliment epatiku (ara sezzjonijiet 4. 4 u 5. 2).
If Truvada is discontinued in patients co-infected with HIV and HBV, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Jekk Truvada jitwaqqaf f’ pazjenti infettati kemm bl- HIV kif ukoll bl- HBV, dawn il- pazjenti għandhom ikunu immonitorjati mill- qrib għal evidenza jekk l- epatite tmur għall- agħar (ara sezzjoni 4. 4).
Method of administration If patients have difficulty in swallowing, Truvada can be disintegrated in approximately 100 ml of water, orange juice or grape juice and taken immediately.
Kif jingħata Jekk il- pazjenti jsibuha diffiċli biex jibilgħu, Truvada tista ’ tinħall f’ madwar 100 ml ta ’ ilma, meraq tal- larinġ jew meraq ta ’ l- għeneb u għandha tittieħed immedjatament.
Hypersensitivity to the active substances emtricitabine, tenofovir, tenofovir disoproxil fumarate or to any of the excipients.
Sensittività eċċessiva għas- sustanzi attivi emtricitabine, tenofovir, tenofovir disoproxil fumarate jew għal xi sustanzi mhux attivi.
Truvada should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil (as fumarate) or other cytidine analogues, such as lamivudine and zalcitabine (see section 4.5).
Truvada m’ għandhiex tingħata fl- istess ħin ma ’ prodotti mediċinali oħrajn li fihom emtricitabine, tenofovir disoproxil (bħala fumarate) jew analogi ta ’ cytidine oħrajn, bħal lamivudine u zalcitabine (ara sezzjoni 4. 5).
Triple nucleoside therapy:
Terapija tan- nukleoside tripla:
There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when tenofovir disoproxil fumarate was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
Kien hemm rapporti ta ’ rata għolja ta ’ ħsara viroloġika, u ta ’ reżistenza li titfaċċa, li seħħew it- tnejn li huma fi stadju bikri, meta tenofovir disoproxil fumarate ngħata flimkien ma ’ lamivudine u abacavir, kif ukoll ma ’ lamivudine u didanosine bħala kors ta ’ għoti ta ’ darba kuljum.
There is close structural similarity between lamivudine and emtricitabine and similarities in the pharmacokinetics and pharmacodynamics of these two agents.
Hemm xebħ struttuali qawwi bejn lamivudine u emtricitabine u xebħ fil- farmakokinetiċi u fil -
Therefore, the same problems may be seen if Truvada is administered with a third nucleoside analogue.
Għalhekk, l- istess problemi jistgħu jseħħu meta Truvada tingħata mat- tielet analogu tan- nukleosidi.
Patients receiving Truvada or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Pazjenti li jieħdu Truvada jew terapija antiretrovirali oħra jistgħu jkomplu jiżviluppaw infezzjonijiet opportunistiċi u kumplikazzjonijiet oħra ta ’ l- infezzjoni ta ’ l- HIV u għalhekk għandhom jibqgħu taħt osservazzjoni klinika mill- qrib minn tobba b’ esperjenza fit- trattament ta ’ pazjenti b’ mard konness ma ’ l- HIV.
Patients must be advised that antiretroviral therapies, including Truvada, have not been proven to prevent the risk of transmission of HIV to others through sexual contact or contamination with blood.
Il- pazjenti għandhom jiġu avżati li t- terapiji antiretrovirali, fosthom Truvada, ma ġewx ippruvati li jeliminaw ir- riskju ta ’ trasmissjoni ta ’ HIV lil ħaddieħor minn kuntatt sesswali jew tniġġiż tad- demm.
Appropriate precautions must continue to be used.
Prekawzjonijiet adegwati għandhom jibqgħu jittieħdu.
3 Renal impairment:
Indeboliment renali:
Emtricitabine and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion.
Emtricitabine u tenofovir jitneħħew primarjament mill- kliewi permezz ta ’ filtrazzjoni glomerulari u sekrezzjoni tubulari attiva.
Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil fumarate in clinical practice (see section 4.8).
Kollass renali, indeboliment renali, krejatinina għolja, ipofosfatimja u tubulopatija prossimali (inkluż is- sindromu ta ’ Fanconi) kienu rrappurtati bl - użu ta ’ tenofovir disoproxil fumarate fl- użu kliniku (ara sezzjoni 4. 8).
It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with Truvada and renal function (creatinine clearance and serum phosphate) is also monitored every four weeks during the first year and then every three months.
Hu rakkomandat li t- tneħħija tal- krejatinina tkun ikkalkulata fil- pazjenti kollha qabel ma tinbeda t - terapija bi Truvada u l- funzjoni renali (tneħħija tal- krejatinina u phosphate fis- serum) tkun wkoll immonitorjata kull erba ’ ġimgħat matul l- ewwel sena, u mbagħad kull tliet xhur.
In patients at risk for renal impairment, including patients who have previously experienced renal events while receiving adefovir dipivoxil, consideration should be given to more frequent monitoring of renal function.
F’ pazjenti li qegħdin f’ riskju għal indeboliment renali, li jinkludu pazjenti li fil- passat kellhom avvenimenti renali waqt li kienu qed jirċievu adefovir dipivoxil, għandha tingħata konsiderazzjoni għal monitoraġġ iktar frekwenti tal- funzjoni renali.
Patients with renal impairment (creatinine clearance < 80 ml/ min), including haemodialysis patients:
Pazjenti b’ indeboliment renali (tneħħija tal- krejatinina ta ’ < 80 ml/ min), li jinkludu pazjenti fuq id - dijaliżi tad- demm:
Renal safety with Truvada has only been studied to a very limited degree in patients with impaired renal function (creatinine clearance < 80 ml/ min).
Is- sigurtà renali bi Truvada kienet studjata biss b’ mod limitat ħafna f’ pazjenti b’ indeboliment tal- funzjoni renali (tneħħija tal- krejatinina ta ’ < 80 ml/ min).
Dose interval adjustments are recommended for patients with creatinine clearance 30-49 ml/ min (see section 4.2).
Aġġustamenti ta ’ l - intervall tad- dożi huma rakkomandati għal pazjenti bi tneħħija tal- krejatinina ta ’ 30- 49 ml/ min (ara sezzjoni 4. 2).
Limited clinical study data suggest that the prolonged dose interval is not optimal and could result in increased toxicity and possibly inadequate response.
Informazzjoni limitata minn studji kliniċi tissuġġerixxi li intervall tad- dożi mtawwal mhuwiex l- aħjar għażla, u jista ’ jirriżulta f’ żieda fit- tossiċità u possibbilment f’ rispons inadegwat.
Furthermore, in a small clinical study, a subgroup of patients with creatinine clearance between 50 and 60 ml/ min who received tenofovir disoproxil fumarate in combination with emtricitabine every 24 hours had a 2-4-fold higher exposure to tenofovir and worsening of renal function (see section 5.2).
Flimkien ma ’ dan, fi studju kliniku żgħir, sotto- grupp ta ’ pazjenti bi tneħħija tal- krejatinina ta ’ bejn 50 u 60 ml/ min li rċivew tenofovir disoproxil fumarate flimkien ma ’ emtricitabine kull 24 siegħa, kellhom esponiment ogħla ta ’ 2- 4 darbiet aktar għal tenofovir u l- funzjoni renali marret għall- agħar (ara sezzjoni 5. 2).
Therefore, a careful benefit-risk assessment is needed when Truvada is used in patients with creatinine clearance < 60 ml/ min, and renal function should be closely monitored.
Għalhekk, hi meħtieġa evalwazzjoni bir- reqqa tal- benefiċċju- riskju meta Truvada tintuża f’ pazjenti bi tneħħija tal- krejatinina ta ’ < 60 ml/ min, u l- funzjoni renali għandha tkun immonitorjata mill- qrib.
In addition, the clinical response to treatment should be closely monitored in patients receiving Truvada at a prolonged dosing interval.
Flimkien ma ’ dan, ir- rispons kliniku għat- trattament għandu jkun immonitorjat mill- qrib f’ pazjenti li jkunu qed jirċievu Truvada b’ intervall tad- dożaġġ imtawwal.
The use of Truvada is not recommended in patients with severe renal impairment (creatinine clearance < 30 ml/ min) and in patients who require haemodialysis since appropriate dose reductions cannot be achieved with the combination tablet (see sections 4.2 and 5.2).
L- użu ta ’ Truvada mhuwiex rakkomandat f’ pazjenti b’ indeboliment renali sever (tneħħija tal- krejatinina ta ’ < 30 ml/ min) u f’ pazjenti li jeħtieġu dijaliżi tad- demm minħabba li tnaqqis xieraq tad- doża ma jistax isir bil- pillola kombinata taż- żewġ mediċini (ara sezzjonijiet 4. 2 u 5. 2).
If serum phosphate is < 1.5 mg/ dl (0.48 mmol/ l) or creatinine clearance is decreased to < 50 ml/ min in any patient receiving Truvada, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Jekk il- phosphate fis- serum huwa < 1. 5 mg/ dl (0. 48 mmol/ l) jew it- tneħħija tal- krejatinina tonqos għal < 50 ml/ min, fi kwalunkwe pazjent li qed jirċievi Truvada, il- funzjoni renali għandha tkun evalwata mill- ġdid fi żmien ġimgħa, inkluż il- kejl tal- konċentrazzjonijiet tal- glucose fid- demm, tal- potassium fid- demm u tal- glucose fl- awrina (ara sezzjoni 4. 8, tubulopatija prossimali).
Consideration should also be given to interrupting treatment with Truvada in patients with creatinine clearance decreased to < 50 ml/ min or decreases in serum phosphate to < 1.0 mg/ dl (0.32 mmol/ l).
Konsiderazzjoni għandha tingħata wkoll għall- waqfien tat- trattament bi Truvada f’ pazjenti bi tneħħija tal- krejatinina mnaqqsa għal < 50 ml/ min jew tnaqqis tal- phosphate fis- serum għal < 1. 0 mg/ dl (0. 32 mmol/ l).
Use of Truvada should be avoided with concurrent or recent use of a nephrotoxic medicinal product (see section 4.5).
L- użu ta ’ Truvada flimkien ma ’ jew fi żmien qasir minn meta jkun ttieħed prodott mediċinali nefrotossiku, għandu jiġi evitat (ara sezzjoni 4. 5).
Truvada should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation (see section 5.1).
Truvada għandha tkun evitata f’ pazjenti li kellhom infezzjoni HIV- 1 bil- mutazzjoni K65R (ara sezzjoni 5. 1).
Bone effects:
Effetti fuq l- għadam:
In a 144-week controlled clinical study that compared tenofovir disoproxil fumarate with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in bone mineral density of the hip and spine were observed in both treatment groups.
Fi studju kliniku kkontrollat ta ’ 144 ġimgħa fejn tqabblu tenofovir disoproxil fumarate ma ’ stavudine mogħti flimkien ma ’ lamivudine u efavirenz f’ pazjenti li qatt ma ’ kienu ngħataw mediċini antiretrovirali qabel, tnaqqis żgħir fid- densità minerali ta ’ l- għadam tal- ġenbejn u
Decreases in bone mineral density of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil fumarate treatment group at 144 weeks.
Tnaqqis fid- densità minerali ta ’ l - għadam tas- sinsla tad- dahar u tibdil fil- bijomarkaturi mil- linja bażi kienu ogħla b’ mod sinifikanti fil - grupp tat- trattament ta ’ tenofovir disoproxil fumarate fil- 144 ġimgħa.
Decreases in bone mineral density of hip were significantly greater in this group until 96 weeks.
Tnaqqis fid- densità minerali ta ’ l- għadam tal- ġenbejn kienu ogħla b’ mod sinifikanti f’ dan il- grupp sa 96 ġimgħa.
However, there was no increased risk of fractures or evidence for clinically relevant bone abnormalities over 144 weeks.
Madankollu, ma kienx hemm riskju akbar ta ’ ksur jew evidenza ta ’ anormalitajiet fl- għadam klinikament rilevanti matul 144 ġimgħa.
Bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy (see section 4.8).
Anormalitajiet fl- għadam (li b’ mod mhux frekwenti jikkontribwixxu għal ksur) jistgħu jkunu assoċjati ma ’ tubulopatija renali prossimali (ara sezzjoni 4. 8).
If bone abnormalities are suspected then appropriate consultation should be obtained.
Jekk ikun hemm suspett ta ’ xi anormalitajiet fl - għadam, konsultazzjoni xierqa għandha tinkiseb.
4 Patients with HIV and hepatitis B or C virus co-infection:
Pazjenti infettati kemm bl- HIV kif ukoll bil- virus ta ’ l- epatite B jew Ċ:
Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Pazjenti b’ epatite kronika B jew Ċ u li huma ttrattati b’ terapija antiretrovirali huma f’ riskju akbar għal reazzjonijiet avversi epatiċi severi u potenzjalment fatali.
Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with hepatitis B virus (HBV).
It- tobba għandhom jirreferu għal- linji gwida kurrenti tat- trattament ta ’ l- HIV għall- aħjar immaniġġjar ta ’ infezzjoni bl- HIV f’ pazjenti li huma infettati ukoll bil- virus ta ’ l- epatite B (HBV).
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Fil- każ ta ’ terapija antivirali konkomitanti għall- epatite B jew Ċ, jekk jogħġbok irreferi wkoll għas - Sommarju tal- Karatteristiċi tal- Prodott rilevanti għal dawn il- prodotti mediċinali.
The safety and efficacy of Truvada have not been established for the treatment of chronic HBV infection.
Is- sigurtà u l- effikaċja ta ’ Truvada ma ġewx stabbiliti għat- trattament ta ’ infezzjoni kronika bl- HBV.
Emtricitabine and tenofovir individually and in combination have shown activity against HBV in pharmacodynamic studies (see section 5.1).
Emtricitabine u tenofovir meħuda individwalment u flimkien urew attività kontra HBV fi studji farmakokinetiċi (ara sezzjoni 5. 1).
Limited clinical experience suggests that emtricitabine and tenofovir disoproxil fumarate have anti-HBV activity when used in antiretroviral combination therapy to control HIV infection.
Esperjenza klinika limitata tissuġġerixxi li emtricitabine u tenofovir disoproxil fumarate għandhom attività kontra l- HBV meta użati f’ terapija antiretrovirali kombinata biex jikkontrollaw infezzjoni bl- HIV.
Discontinuation of Truvada therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
It- twaqqif tat- trattament bi Truvada f’ pazjenti infettati kemm bl- HIV kif ukoll bl- HBV jistgħu jkunu assoċjati ma ’ epatite li tmur għall- agħar severa u akuta.
Patients co-infected with HIV and HBV who discontinue Truvada should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Pazjenti infettati kemm bl- HIV kif ukoll bl - HBV li jwaqqfu Truvada għandhom jiġu mmonitorjati mill- qrib b’ eżaminazzjonijiet kemm kliniċi u kemm tal- laboratorju almenu għal diversi xhur wara li jitwaqqaf it- trattament.
If appropriate, resumption of hepatitis B therapy may be warranted.
Jekk ikun xieraq, it - tkomplija mill- ġdid tat- trattament kontra l- epatite B tista ’ tkun meħtieġa.
In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.
F’ pazjenti b’ mard avvanzat tal- fwied jew ċirrożi, it- twaqqif tat- trattament mhuwiex rakkomandat għax li l- epatite tmur għall- agħar wara t- trattament jista ’ jwassal għal dikumpens epatiku.
The safety and efficacy of Truvada have not been established in patients with significant underlying liver disorders.
Is- sigurtà u l- effikaċja ta ’ Truvada ma kienux stabbiliti f’ pazjenti b’ disturbi tal- fwied sinifikanti.
The pharmacokinetics of tenofovir have been studied in patients with hepatic impairment and no dose adjustment is required in these patients.
Il- farmakokinetiċi ta ’ tenofovir ġew studjati f’ pazjenti b’ indeboliment epatiku u l- ebda aġġustament fid- doża mhu meħtieġ f’ dawn il- pazjenti.
Based on minimal hepatic metabolism and the renal route of elimination for emtricitabine, it is unlikely that a dose adjustment would be required for Truvada in patients with hepatic impairment (see section 5.2).
Ibbażat fuq il- metaboliżmu epatiku minimu u r - rotta ta ’ l- eliminazzjoni renali ta ’ emtricitabine, huwa improbabbli li aġġustament tad- doża ta ’ Truvada jkun meħtieġ f’ pazjenti b’ indeboliment epatiku (ara sezzjoni 5. 2).
Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Pazjenti li diġà jbatu minn disfunzjoni tal- fwied li tinkludi epatite kronika attiva, għandhom żieda fil - frekwenza ta ’ anormalitajiet tal- fwied waqt it- terapija antiretrovirali kombinata u jeħtieġ li jiġu monitorjati skond il- prattika normali.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Jekk ikun hemm xi evidenza li l- mard tal- fwied qed imur għall - agħar f’ pazjenti bħal dawn, l- interruzzjoni jew it- twaqqif tat- trattament għandhom ikunu kkunsidrati.
Early symptoms (symptomatic hyperlactataemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/ or deep breathing) or neurological symptoms (including motor weakness).
Sintomi bikrija (l- iperlaktejtimja sintomatika) jinkludu sintomi diġestivi beninji (tqalligħ, rimettar u uġigħ addominali), ħass ħażin mhux speċifiku, nuqqas ta ’ aptit, tnaqqis fil - piż, sintomi respiratorji (nifs mgħaġġel u/ jew qawwi) jew sintomi newroloġiċi (fosthom indeboliment fil- moviment).
Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure or renal failure.
L- aċidożi lattika għandha mortalità għolja u tista ’ tkun assoċjata ma ’ pankreatite, kollass tal- fwied jew tal- kliewi.
Treatment with nucleoside analogues should be discontinued in the setting of symptomatic hyperlactataemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
5 It- trattament b’ analogi tan- nukleosidi għandu jitwaqqaf meta sseħħ l- iperlaktejtimja sintomatika u aċidożi lattika/ metabolika, epatomegalija progressiva jew meta l- livelli ta ’ aminotransferase jiżdiedu malajr.
A connection between visceral 5 lipomatosis and protease inhibitors and lipoatrophy and nucleoside reverse transcriptase inhibitors has been hypothesised.
Saret ipotesi dwar il- konnessjoni bejn lipomatożi vixxerali u impedituri ta ’ protease ma ’ lipoatrofija u impedituri ta ’ nucleoside reverse transcriptase.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Għandu jiġi kkunsidrat il- kejl tal- livell tal- lipidi fis- serum u glucose fid- demm fl- istat sajjem.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Disturbi fil- lipidi għandhom jiġu ttrattati kif ikun meħtieġ klinikament (ara sezzjoni 4. 8).
Tenofovir is structurally related to nucleoside analogues hence the risk of lipodystrophy cannot be excluded.
Tenofovir hu strutturalment relatat ma ’ analogi tan- nukleosidi u għalhekk ir- riskju ta ’ lipodistrofija ma jistax jiġi eskluż.
However, 144-week clinical data from antiretroviral-naïve patients indicate that the risk of lipodystrophy was lower with tenofovir disoproxil fumarate than with stavudine when administered with lamivudine and efavirenz.
Madankollu, tagħrif kliniku ta ’ 144 ġimgħa minn pazjenti li qatt ma kienu ngħataw mediċini antiretrovirali jindika li r- riskju ta ’ lipodistrofija kien inqas b’ tenofovir disoproxil fumarate milli bi stavudine meta jingħata ma ’ lamivudine u efavirenz.
Any child exposed in utero to nucleoside and nucleotide analogues, even HIV negative children, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms.
Kull tarbija esposta fl- utru għall- analogi tan- nukleosidi u tan- nukleotidi, anke trabi li huma negattivi għall- HIV, għandhom jiġu segwiti klinikament u b’ testijiet tal- laboratorju u jridu jiġu investigati kompletament għall- possibiltà ta ’ disfunzjoni tal- mitokondrija f’ każ ta ’ sinjali jew sintomi rilevanti.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis jiroveci pneumonia.
Eżempji rilevanti huma retinite ċitomegalovirus, infezzjonijiet mikobatterjali ġeneralizzati u/ jew fokali, u pulmonite tat- tip Pneumocystis jiroveci.
Co-administration of tenofovir disoproxil fumarate and didanosine: is not recommended.
6 L- għoti flimkien ta ’ tenofovir disoproxil fumarate u didanosine: mhuwiex rakkomandat.
Co-administration of tenofovir disoproxil fumarate and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse events (see section 4.5).
L- għoti ta ’ tenofovir disoproxil fumarate flimkien ma ’ didanosine jirriżulta f’ żieda ta ’ 40- 60% fl- esponiment sistemiku għad- didanosine, li jista ’ jżid ir- riskju ta ’ effetti avversi relatati ma ’ didanosine (ara sezzjoni 4. 5).
Rare cases of pancreatitis and lactic acidosis, sometimes fatal, have been reported.
Każijiet rari ta ’ pankreatite u aċidożi lattika, li kultant kienu fatali, ġew irrappurtati.
Co-administration of tenofovir disoproxil fumarate and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated (i. e. active) didanosine.
L - għoti flimkien ta ’ tenofovir disoproxil fumarate u didanosine f’ doża ta ’ 400 mg kuljum kien assoċjat ma ’ tnaqqis sinifikanti fl- għadd taċ- ċelluli CD4, possibbilment minħabba interazzjoni intraċellulari li żiedet didanosine fosforilat (jiġifieri attiv).
A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil fumarate therapy has been associated with reports of high rates of virological failure within several tested combinations.
Dożaġġ imnaqqas ta ’ 250 mg ta ’ didanosine mogħti flimkien ma ’ terapija b’ tenofovir disoproxil fumarate kien assoċjat ma ’ rapporti ta ’ rati għoljin ta ’ ħsara viroloġika f’ diversi kumbinazzjonijiet li kienu ttestjati.
Truvada contains lactose monohydrate.
Truvada fih lactose monohydrate.
Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Konsegwentement, pazjenti li għandhom problemi ereditarji rari ta ’ intolleranza għall- galactose, nuqqas ta ’ Lapp lactase jew għandhom problemi biex jassorbu l- glucose - galactose m’ għandhomx jieħdu dan il- prodott mediċinali.
6 The steady-state pharmacokinetics of emtricitabine and tenofovir were unaffected when emtricitabine and tenofovir disoproxil fumarate were administered together versus each medicinal product dosed alone.
Il- farmakokinetiċi fl- istat fiss ta ’ emtricitabine u tenofovir ma kienux affettwati meta emtricitabine u tenofovir disoproxil fumarate ngħataw flimkien meta mqabbla mal- prodott mediċinali meta ngħataw weħedhom.