qanastek/EMEA-V3 huggingface dataset:
The syringe should be washed after each dose.
Is- siringa għandha tiġi maħsula wara kull doża.
Pull the plunger out of the syringe and wash both parts in warm soapy water.
Iġbed il- planġer minn ġos- siringa u aħsel iż - żewġ partijiet f' ilma sħun bis- sapun.
Then rinse with water.
Imbagħad laħlaħ bl- ilma.
Dry the two parts.
Ixxotta ż- żewġ partijiet.
Push the plunger back in to the syringe.
Imbotta l- planġer mill- ġdid ġos- siringa.
Keep it in a clean safe place with the medicine.
Żommha f' post nadif fiż- żgur mal- mediċina.
-Fever -Rash -Nausea, vomiting, diarrhoea -Headache -Swelling of the extremities -Stomach pains
- Dardir, rimettar, dijarea
Common side effects (occurring in at least 1 in 100 patients) are:
137 Effetti sekondarji komuni (iseħħu f' mill- anqas 1 f' 100 pazjent) huma:
-Flu-like symptoms, sinusitis, chills, weakness -Anaemia, low numbers of cells called platelets that help the blood to clot, low numbers of some types of white blood cells or of all types of blood cells, red or purple discoloration of the skin which may be caused by low platelet count, other blood cell changes -Low blood sugar, low blood potassium -Anxiety, depression, tingling, confusion, dizziness, agitation, trembling, hallucinations and other nervous symptoms -Low blood pressure, inflammation of a vein (which may be associated with the formation of a blood clot) -Breathing difficulty, chest pain, fluid accumulation in the lungs -Jaundice, redness of the skin -Swelling of the lips or face -Allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reaction following exposure to light or sun -Itchiness -Hair loss -Back pain
ammonti baxxi ta 'ċerti tipi ta' ċelloli bojod tad- demm jew ta 'kull tip ta' ċelloli tad- demm, tbajja 'ħomor jew vjola tal- ġilda li jistgħu jkunu kkawżati minn għadd baxx ta' pjastrini, bidliet oħra fiċ- ċelloli tad- demm
131 -Kidney failure, blood in the urine, changes in blood tests of kidney function -Changes in blood tests of liver function
- Ansjetà, depressjoni, tnemnim, konfużjoni, sturdament, aġitazzjoni, alluċinazzjonijiet bir- rogħda
Uncommon side effects (occurring in at least 1 in 1,000 patients) are:
- Reazzjonijiet allerġiċi (kultant severi), fosthom raxx mifrux bl- infafet u tqaxxir tal- ġilda,
-Enlarged lymph glands (sometimes painful) -Increase in a type of white blood cell which may be associated with allergic reaction, disorder of blood clotting system -Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting -Depressed function of the adrenal gland -Problem with coordination -Swelling of the brain -Double vision pain and inflammation of the eyes and eyelids, involuntary movement of the eye -Decreased sensitivity to touch -Constipation, inflammation of upper small intestine, dyspepsia, pancreatitis, peritonitis -Gingivitis, -Swelling and inflammation of the tongue -Enlarged liver, hepatitis, liver failure, gallbladder disease, gallstones -Joint pain -Inflammation of the kidney, proteins in the urine -Abnormal electrocardiogram (ECG) -Blood chemistry changes
- Bidliet fit- testijiet tad- demm tal- funzjoni tal- fwied
Rare side effects (occurring in at least 1 in 10,000 patients) are:
Effetti sekondarji mhux komuni (iseħħu f' mill- anqas 1 f' 1, 000 pazjent) huma:
- Inability to sleep
- Ġenġivite
-Hearing difficulties, ringing in the ears -Abnormal sense of taste -Increase in muscle tone, muscle weakness caused by an abnormal immune system response -Abnormal brain function, Parkinson-like symptoms, convulsion
- Fwied akbar, epatite, insuffiċjenza tal- fwied, mard tal- bużżieqa tal- marrara, ġebel fil- marrara
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
138 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Powder for oral suspension: store at 2°C - 8°C (in a refrigerator) before constitution.
Trab għal suspensjoni orali: aħżen f' temperatura ta '2°C - 8°C (fi friġġ) qabel rikostituzzjoni.
For the constituted suspension:
Għas- suspensjoni kostitwita:
Do not store above 30°C.
Taħżinx f' temperatura 'il fuq minn 30°C Tpoġġix fi friġġ jew friża.
Do not refrigerate or freeze.
Aħżen fil- kontenitur oriġinali.
Store in the original container Keep the container tightly closed.
Żomm ir- reċipjent magħluq sewwa.
Ask your pharmacist how to 132 dispose of medicines no longer required.
Staqsi lill - ispiżjar tiegħek dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
What VFEND contains:
X' fih VFEND:
- The active substance is voriconazole.
- Is- sustanza attiva hi voriconazole.
Each bottle contains 45 g of powder providing 70 ml of
- Kull flixkun fih 45 g trab li jipprovdu 70 ml ta 'suspensjoni meta jiġu kostitwiti bl- ilma kif
suspension when constituted with water as recommended.
rakkomandat.
One ml of the constituted suspension contains 40 mg voriconazole.
1 ml tas- suspensjoni kostitwita fih 40 mg ta 'voriconazole.
(See section 3 ‘ How to take VFEND’).
(Ara sezzjoni 3 ‘ Kif għandek tieħu VFEND ’).
- The other ingredients are sucrose; silica colloidal; titanium dioxide; xanthan gum; sodium
- Is- sustanzi l- oħra huma sucrose; silica, colloidal; titanium dioxide; xanthan gum; sodium
citrate; sodium benzoate; citric acid; natural orange flavour.
citrate; sodium benzoate; aċidu ċitriku; togħma naturali tal- larinġ.
What VFEND looks like and contents of the pack VFEND is supplied as a white to off-white powder for oral suspension providing a white to off-white, orange flavoured suspension when constituted with water.
Id- dehra ta 'VFEND u l- kontenut tal- pakkett VFEND huwa pprovdut bħala trab abjad għal offwajt għal suspensjoni orali li jipprovdi suspensjoni bajda għal offwajt b' togħma ta' larinġ meta jiġi kostitwit bl- ilma.
The information in this leaflet is about VFEND 40 mg/ ml powder for oral suspension only.
It- tagħrif f' dan il- fuljett huwa dwar VFEND 40 mg/ ml trab għal suspensjoni orali biss.
For further information on VFEND 50 mg and 200 mg film-coated tablets or VFEND 200 mg powder for solution for infusion, please see the User Package Leaflets for these products.
Għal aktar tagħrif dwar il- pilloli VFEND 50 mg u 200 mg miksijin b' rita jew VFEND 200 mg trab għal soluzzjoni għal infużjoni, jekk jogħġbok ara l- Fuljett ta 'Tagħrif għal dawn il- prodotti.
België / Belgique/ Belgien Pfizer S. A. / N. V.
139 België / Belgique/ Belgien Pfizer S. A. / N. V.
134
141
What is Viagra?
X’ inhi Viagra?
Viagra is a medicine that contains the active substance sildenafil.
Viagra hija mediċina li fiha s- sustanza attiva sildenafil.
It is available as blue, diamond- shaped tablets (25, 50 or 100 mg).
Tiġi bħala pillola blu forma ta ’ maqrut (25, 50 jew 100 mg).
What is Viagra used for?
Għalxiex tintuża Viagra?
Viagra is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Viagra tintuża fit- trattament ta ’ rġiel adulti b’ disfunzjoni fl- erezzjoni (xi drabi magħrufa bħala impotenza), meta ma jkunx jista ’ jkollhom jew ma jkunux jistgħu jżommu erezzjoni (pene iebes) biex ikollhom attività sesswali sodisfaċenti.
For Viagra to be effective, sexual stimulation is required.
Biex Viagra tkun effettiva, hemm bżonn ta ’ stimulazzjoni sesswali.
How is Viagra used?
Kif tintuża Viagra?
The recommended dose of Viagra is 50 mg taken as needed about one hour before sexual activity.
Id- doża rakkomandata ta ’ Viagra hija 50 mg meħuda skont il- bżonn madwar siegħa qabel l- attività sesswali.
If Viagra is taken with food, the onset of activity may be delayed compared with taking Viagra without food.
Jekk Viagra tittieħed mal- ikel, il- bidu tal- attività tista ’ titressaq ’ il quddiem meta mqabbla ma ’ meta Viagra tittieħed mingħajr l- ikel.
The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects.
Id- doża tista ’ tiżdied għal massimu ta ’ 100 mg jew titnaqqas għal 25 mg skont l- effikaċja u l- effetti mhux mixtieqa.
Patients with liver problems or severe kidney problems should start treatment with the 25-mg dose.
Il- pazjenti bi problemi fil- fwied jew bi problemi severi tal- kliewi għandhom jibdew it- trattament b’ doża ta ’ 25 mg.
The maximum recommended dosing frequency is one tablet per day.
Il- frekwenza massima tad - doża hija ta ’ pillola waħda kuljum.
How does Viagra work?
Kif taħdem Viagra?
The active ingredient in Viagra, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Is- sustanza attiva f’ Viagra, sildenafil, tagħmel parti mill- grupp ta ’ mediċini magħrufin bħala inibituri tal- phosphodiesterase tip 5 (PDE5).
It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Taħdem bl- imblokk tal- enzim phosphodiesterase, li normalment ikisser sustanza magħrufa bħala cyclic guanosine monophosphate (cGMP).
During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection.
Waqt l- istimulazzjoni sesswali normali, cGMP jiġi prodott fil- pene, fejn jikkawża lill- muskolu fit- tessut artab tal- pene (il - corpora cavernosa) jirrilassa, jippermeti l- fluss tad- demm fil- corpora, u jipproduċi erezzjoni.
By blocking the breakdown of cGMP, Viagra restores erectile function.
Bit - tkissir tas- cGMP, Viagra treġġa ’ l- funzjoni tal- erezzjoni għan- normal.
Sexual stimulation is still needed to produce an erection.
L- istimulazzjoni sesswali xorta tkun għadha meħtieġa biex tipproduċi erezzjoni.
How has Viagra been studied?
Kif ġiet studjata Viagra?
Viagra has been studied in four main studies including 1,690 men aged 19 to 87 years, where it was compared with placebo (a dummy treatment) for between 12 and 26 weeks.
Viagra ġiet studjata f’ erba ’ studji ewlenin li fihom b’ kollox ħadu sehem 1, 690 raġel ta ’ bejn id- 19 u s - 87 sena, fejn tqabblet ma ’ plaċebo (trattament finta) għal bejn 12 u 26 ġimgħa.
In addition, there were 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Tnejn minn dawn l - istudji użaw dożi fissi (pazjenti allokati għal doża ta ’ 25, 50 jew 100 mg) u żewġ studji kienu flessibbli 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
The main measure of effectiveness was based on the ability of the men to get and maintain an erection.
(pazjenti mibdija fuq doża ta ’ 25 mg u jistgħu jinqalbu fuq doża ta ’ 50 jew 100 mg skont ir- rispons).
This was recorded in a special questionnaire completed at home using a scoring system on a five-point scale, where a score of 5 represents the best result.
Dan ġie rreġistrat fi kwestjonarju speċjali mimli d- dar bl- użu ta ’ sistema ta ’ punteġġ fuq skala ta ’ ħames punti, fejn il - punteġġ ta ’ 5 jirrappreżenta l- aqwa riżultat.
What benefit has Viagra shown during the studies?
Liema benefiċċju uriet Viagra waqt l- istudji mwettqa?
Viagra was significantly more effective than placebo in all studies.
Viagra kienet ferm iktar effikaċi mill- plaċebo fl- istudji kollha.
In the questionnaire, scores for the question on how often the patient was able to achieve intercourse went from about 2 without treatment to 3 or 4 with Viagra 50 mg.
Fil- kwestjonarju, il- punteġġi għall - mistoqsija fuq kemm spiss jirnexxilu jagħmel l- att sesswali l- pazjent telgħet minn 2 mingħajr trattament għal 3 jew 4 b’ Viagra 50 mg.
In the fixed-dose studies, the proportions of patients reporting that treatment improved their erections were 62% (25 mg), 74% (50 mg) and 82% (100 mg), compared with 25% on placebo.
Fl- istudji b’ doża fissa, il- proporzjonijiet ta ’ pazjenti li rrapportaw li t- trattament tejjeb l- erezzjoni kienu 62% (għad- doża ta ’ 25 mg), 74% (għad- doża ta ’ 50 mg) u 82% (għad- doża ta ’ 100 mg), meta mqabbel ma ’ 25% għal dawk li kienu qed jieħdu plaċebo.
What is the risk associated with Viagra?
X’ inhu r- riskju assoċjat ma ’ Viagra?
The most common side effect with Viagra (seen in more than 1 patient in 10) is headache.
L- effett mhux mixtieq l- iktar komuni b’ Viagra (li deher f’ iktar minn pazjent wieħed minn kull 10) huwa l- uġigħ ta ’ ras.
For the full list of all side effects reported with Viagra, see the Package Leaflet.
Għal- lista sħiħa tal- effetti kollha mhux mixtieqa rrapportati b’ Viagra, ara l - Fuljett ta ’ Tagħrif.
Viagra should not be used in people who may be hypersensitive (allergic) to sildenafil or any of the other ingredients, or where sexual activity is inadvisable (e. g. men with severe heart disease such as unstable angina or severe heart failure).
Viagra m’ għandhiex tingħata lil persuni li jistgħu jkunu allerġiċi għal sildenafil jew għas- sustanzi l - oħrajn, jew fejn ma jkunx rakkomandat li ssir attività sesswali (eż. irġiel b’ mard sever tal- qalb bħal anġina instabbli jew indeboliment sever tal- qalb).
It should also not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy or NAION).
Ma għandhiex tittieħed ukoll minn pazjenti li xi darba kellhom telf tal- viżta minħabba problema bil- fluss tad- demm lejn in- nervitura tal- għajn (newropatija iskemika anterjuri mhux arteritika jew NAION).
Viagra should not be taken with nitrates (medicines used to treat angina).
Viagra m’ għandhiex tittieħed man - nitrati (mediċini użati fit- trattament tal- anġina).
Because Viagra has not been studied in patients with severe liver disease, hypotension (low blood pressure), recent stroke or myocardial infarction (heart attack), or a hereditary eye disease, such as retinitis pigmentosa, these patients should not use it.
Minħabba li Viagra ma ġietx studjata f’ pazjenti b’ mard sever tal- fwied, pressjoni għolja, puplesija iskemika jew attakk tal- qalb, jew mard tal- għajnejn ereditarju, bħar- retinitis pigmentosa, dawn il- pazjenti m’ għandhomx jiħduha.
Why has Viagra been approved?
Għaliex ġiet approvata Viagra?
The Committee for Medicinal Products for Human Use (CHMP) decided that Viagra’ s benefits are greater than its risks for the treatment of men with erectile dysfunction.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Viagra fit- trattament ta ’ rġiel b’ diżfunzjoni tal- erezzjoni huma ikbar mir- riskji tagħha.
The Committee recommended that Viagra be given marketing authorisation.
Il- Kumitat irrakkomanda li Viagra tingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Viagra:
Informazzjoni oħra dwar Viagra:
The European Commission granted a marketing authorisation valid throughout the European Union for Viagra to Pfizer Limited on 14 September 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Ewropa kollha għal Viagra lil Pfizer Limited fl- 14 ta ’ Settembru 1998.
The marketing authorisation was renewed on 14 September 2003 and on 14 September 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq iġġeddet fl - 14 ta ’ Settembru 2003 u fl- 14 ta ’ Settembru 2008.
The full EPAR for Viagra is available here.
L- EPAR sħiħ għal Viagra jista ’ jinstab hawn.
Number
Numru ta ’ l- EU
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (PVC/ alu) in a carton blister (PVC/ alu) in a carton blister (PVC/ alu) in a carton blister (PVC/ alu) in a carton blister (PVC/ alu) in a carton blister (PVC/ alu) in a carton blister (PVC/ alu) in a carton blister (PVC/ alu) in a carton blister (PVC/ alu) in a carton blister (PVC/ alu) in a carton blister (PVC/ alu) in a carton blister (PVC/ alu) in a carton blister (PVC/ alu) in a card blister (PVC/ alu) in a card blister (PVC/ alu) in a card blister (PVC/ alu) in a card
folji (PVC/ alu) f ’ kaxxa tal- kartun folji (PVC/ alu) f ’ kaxxa tal- kartun folji (PVC/ alu) f ’ kaxxa tal- kartun folji (PVC/ alu) f ’ kaxxa tal- kartun folji (PVC/ alu) f ’ kaxxa tal- kartun folji (PVC/ alu) f ’ kaxxa tal- kartun folji (PVC/ alu) f ’ kaxxa tal- kartun folji (PVC/ alu) f ’ kaxxa tal- kartun folji (PVC/ alu) f ’ kaxxa tal- kartun folji (PVC/ alu) f ’ kaxxa tal- kartun folji (PVC/ alu) f ’ kaxxa tal- kartun folji (PVC/ alu) f ’ kaxxa tal- kartun folji (PVC/ alu) f ’ kartuna folji (PVC/ alu) f ’ kartuna folji (PVC/ alu) f ’ kartuna folji (PVC/ alu) f ’ kartuna
VIAGRA 25 mg film-coated tablets
VIAGRA 25 mg Pilloli miksija b’ rita.
Each tablet contains 25 mg of sildenafil(as citrate)
Kull pillola fiha 25 mg ta ’ sildenafil (bħala citrate).
Blue rounded diamond-shaped tablets, marked “ PFIZER ” on one side and “ VGR 25 ” on the other.
Pilloli blu, ittundjati forma ta ’ djamant, immarkati “ PFIZER ” fuq naħa waħda u “ VGR 25 ” fuq l- oħra.
Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
Dan jirreferi għall- diffikultà biex wieħed jilħaq jew iżomm erezzjoni għal tul ta ’ żmien biżżejjed biex l- att sesswali iseħħ b’ mod sodisfaċenti.
In order for VIAGRA to be effective, sexual stimulation is required.
Biex VIAGRA tkun effettiva, jkun hemm bżonn ta ’ stimulazzjoni sesswali.
For oral use.
Biex jittieħed mill- ħalq.
Use in adults:
Użu fl- adulti:
The recommended dose is 50 mg taken as needed approximately one hour before sexual activity.
Id- doża rakkomandata hija 50 mg meħuda kif meħtieġ bejn wieħed u ieħor siegħa qabel attività sesswali.
Based on efficacy and toleration, the dose may be increased to 100 mg or decreased to 25 mg.
Bażata fuq effiċjenza u tolleranza, id- doża tista ’ tiżdied għal 100 mg jew titnaqqas għal 25 mg.
The maximum recommended dose is 100 mg.
Id- doża massima rakkomandata hija 100 mg.
The maximum recommended dosing frequency is once per day.
Il- frekwenza tad- dożaġġ massimu rakkomandat huwa ta ’ darba kuljum.
If VIAGRA is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).
Jekk VIAGRA tittieħed ma ’ l- ikel, jista ’ jdum aktar biex jibda jaħdem meta mqabbel ma ’ meta jittieħed fuq stonku vojt (ara sezzjoni 5. 2).
Use in the elderly:
Użu fl- anzjani:
Dosage adjustments are not required in elderly patients.
M’ hemm ebda ħtieġa għal arranġament fid- doża għal pazjenti anzjani.
Use in patients with impaired renal function:
Użu f’ pazjenti b’ indeboliment fil- funzjoni tal- kliewi:
The dosing recommendations described in ‘ Use in adults ’ apply to patients with mild to moderate renal impairment (creatinine clearance = 30 - 80 ml/ min).
Ir- rakkomandazzjonijiet ta ’ dożaġġi mfissra f ’ “ Użu fl- adulti ” japplikaw għal pazjenti b’ indeboliment ħafif għal moderat tal- kliewi (clearance tal- creatinine = 30- 80ml/ min).
Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 ml/ min) a 25 mg dose should be considered.
Minħabba li l- clearance ta ’ sildenafil titnaqqas f’ pazjenti b’ indeboliment sever tal- kliewi (clearance ta ’ creatinine < 30ml / min) doża ta ’ 25 mg għandha tiġi kunsidrata.
Based on efficacy and toleration, the dose may be increased to 50 mg and 100 mg.
Bażata fuq effiċjenza u tolleranza, d - doża tista ’ tiżdied għal 50 mg u 100 mg.
2 Use in patients with impaired hepatic function:
Użu f’ pazjenti b’ indeboliment tal- fwied:
Since sildenafil clearance is reduced in patients with hepatic impairment (e. g. cirrhosis) a 25 mg dose should be considered.
Minħabba li l- clearance ta ’ sildenafil f’ pazjenti b’ indeboliment tal- fwied (eż. ċirrożi) titnaqqas, doża ta ’ 25 mg għandha tiġi kunsidrata.
Based on efficacy and toleration, the dose may be increased to 50 mg and 100 mg.
Bażata fuq effiċjenza u tolleranza, d- doża tista ’ tiżdied għal 50 mg u 100 mg.
Use in children and adolescents:
2 Użu fi tfal u adoloxxenti:
VIAGRA is not indicated for individuals below 18 years of age.
VIAGRA mhix indikata għal individwi taħt l- età ta ’ 18 sena.
Use in patients using other:
Użu f’ pazjenti fuq mediċini oħra:
With the exception of ritonavir for which co-administration with sildenafil is not advised (see section 4.4) a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5).
Bl- eċċezzjoni ta ’ ritonavir li miegħu ma maqbilx li jingħata li jingħata sildenafil (ara sezzjoni 4. 4) doża tal- bidu ta ’ 25 mg għandha tiġi kunsidrata f’ pazjenti li fl- istess ħin ikunu fuq kura ta ’ inibituri ta ’ CYP3A4 (ara sezzjoni 4. 5).
In order to minimise the potential for developing postural hypotension, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment.
Biex jitnaqqas ir- riskju li jiżviluppaw pressjoni baxxa posturali, pazjenti għandhom jiġu stabilizzati fuq kura b’ alfa blockers qabel ma jinbeda trattament b’ sildenafil.
In addition, initiation of sildenafil at a dose of 25 mg should be considered (see sections 4.4 and 4.5).
Barra minn hekk, għandu jiġi kkunsidrat li tinbeda kura b’ sildenafil b’ doża ta ’ 25mg (ara sezzjonijiet 4. 4 u 4. 5).
Agents for the treatment of erectile dysfunction, including sildenafil, should not be used in men for whom sexual activity is inadvisable (e. g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure).
Sustanzi għal kura ta ’ problemi ta ’ l- erezzjoni, fosthom sildenafil, m’ għandhomx jintużaw f’ irġiel li għalihom l- attività sesswali mhix rakkomandata (eż. pazjenti bi problemi severi kardjovaskulari bħal anġina mhux stabbli jew insuffiċjenza kardijaka severagravi tal- qalb).
VIAGRA is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
VIAGRA huwa kontra- indikat f’ dawk il- pazjenti li tilfu l- vista f’ għajn waħda minħabba newropatija anterjuri iskimika, mhux arterika ta ’ l- għajn (NAION), sew jekk dan l- episodju ġara wara espożizzjoni għal inibitur ta ’ PDE5 kif ukoll jekk le.
The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure < 90/ 50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Is- sigurtà ta ’ sildenafil ma ġietx studjata f’ dawn is- sotto gruppi ta ’ pazjenti li ġejjin, u għalhekk l- użu tiegħu huwa kontra- indikat: indeboliment sever tal- fwied, pressjoni baxxa (pressjoni tad- demm < 90/ 50 mmHg), passat reċenti ta ’ puplesija jew attakk tal- qalb u mard magħruf ereditarju ta ’ deġenerazzjoni tar- retina bħal retinitis pigmentosa (minoranza ta ’ dawn il- pazjenti għandhom mard ġenetiku ta ’ phosphodiesterases retinali).
A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.
Għandu jitqies il- passat mediku tal- pazjent u jsir eżami fiżiku, biex issir dijanjożi tal- problema ta ’ l - erezzjoni u jiġu determinati raġunijiet oħra li jista ’ jkun hemm, qabel ma tinbeda kura farmakoloġika.
Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.
Qabel ma tibda xi kura għal problema ta ’ l- erezzjoni, t- tabib għandu jikkunsidra l- istat kardjuvaskulari tal- pazjent, minħabba li hemm grad ta ’ riskju għal qalb assoċjat ma ’ attività sesswali.
Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1).
Sildenafil għandu karatteristiċi vażodilatatorji, li jirriżultaw fi tnaqqis ħafif u temporanju tal- pressjoni tad- demm (ara sezzjoni 5. 1).
Prior to prescribing sildenafil, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, especially in combination with sexual activity.
Qabel ma jikteb riċetta għal sildenafil, it- tabib għandu jikkunsidra bir- reqqa jekk pazjent li jkollu kundizzjonijiet oħra hux ser jiġi affettwat ħażin minn dawn l- effetti ta ’ vażodilatazzjoni, speċjalment waqt l- attività sesswali.
Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (e. g., aortic stenosis, hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure.
Pazjenti li jistgħu jintlaqtu ħażin bl- użu ta ’ sustanzi vażodilatatorji jinkludu dawk li jsofru minn sadda tal- ħrug ventikulari tax- xellug (eż. stenożi ta ’ l- aorta, hypertrophic obstructive cardiomyopathy), jew dawk bis- sindromu rari ta ’ atrofija ta ’ sistemi diversi li jidher bħala kontroll awtonomu tal- pressjoni tad- demm li jkollu ħsara severa.
VIAGRA potentiates the hypotensive effect of nitrates (see section 4.3).
VIAGRA issaħħaħ l- effett ipotensiv tan- nitrati (ara sezzjoni 4. 3).
3 Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of VIAGRA.
Wara li tqiegħedet fuq is- suq, ġew rappurtati każi kardjuvaskulari serji marbuta ma ’ l- użu fl- istess waqt ta ’ VIAGRA, fosthom infart mijokardijaku, anġina instabbli, mewt għal għarrieda tal- qalb, arritmja ventrikulari, emorraġija ċerebrovaskulari, attakk iskimiku transitorju, pressjoni għolja u pressjoni baxxa.
Most, but not all, of these patients had pre-existing cardiovascular risk factors.
Il- biċċa l- kbira ta ’ dawn l- pazjenti, iżda mhux kollha, kellhom fatturi ta ’ riskju kardjuvaskulari minn qabel.
Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of VIAGRA without sexual activity.
3 ftit ġew rappurtati li ġraw wara l- użu ta ’ VIAGRA mingħajr attività sesswali.
Agents for the treatment of erectile dysfunction, including sildenafil, should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’ s disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Sustanzi għal kura ta ’ problema ta ’ l- erezzjoni fosthom sildenafil, għandhom jintużaw b’ kawtela f’ pazjenti b’ deformazzjoni anatomika tal- pene (bħal angulazzjoni, fibrosi fil- korpus kavernożum jew il- marda ta 'Peyronie), jew f’ pazjenti li għandhom kundizzjonijiet li jagħmluhom predisposti għal prijapiżmu (bħal anemija tas- sickle cell, majeloma multipla jew lewkimja).
The safety and efficacy of combinations of sildenafil with other treatments for erectile dysfunction have not been studied.
Is- sigurtà u effiċjenza ta ’ taħlit ta ’ sildenafil ma ’ kuri oħra għal problemi ta ’ l- erezzjoni ma ġewx studjati.
Therefore the use of such combinations is not recommended.
Għalhekk l- użu ta ’ dan it- taħlit, mhux rakkomandat.
The patient should be advised that in case of sudden visual defect, he should stop taking VIAGRA and consult a physician immediately (see section 4.3).
Il- pazjent għandu jkun avżat li f’ każ li f’ daqqa waħda jiżviluppa difett fil- vista, dan għandu jwaqqaf il- VIAGRA u jkellem tabib immedjatament (ara sezzjoni 4. 3).
Co-administration of sildenafil with ritonavir is not advised (see section 4.5).
Il- ko- amministrazzjoni ta ’ sildenafil ma ’ ritonavir mhix rakkomandata (ara sezzjoni 4. 5).
Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the coadministration may lead to symptomatic hypotension in a few susceptible individuals (see section 4.5).
Sildenafil għandu jintuża b’ kawtela minn dawk li qed jużaw alpha- blockers għax ko- amministrazzjoni tista ’ twassal għal pressjoni baxxa sintomatika f’ xi pazjenti (ara sezzjoni 4. 5).
This is most likely to occur within 4 hours post sildenafil dosing.
Huwa probabbli li dan iseħħ fi żmien 4 sigħat wara li tittieħed id- doża ta ’ sildenafil.
In order to minimise the potential for developing postural hypotension, patients should be hemodynamically stable on alpha- blocker therapy prior to initiating sildenafil treatment.
Biex jitnaqqas ir- riskju ta ’ pressjoni baxxa posturali, pazjenti għandhom ikunu emodinamikament stabbli fuq kura ta ’ alpha blockers qabel ma jinbeda t- trattament b’ sildenofil.
Initiation of sildenafil at a dose of 25 mg should be considered (see section 4.2).
Għandu jiġi kkunsidrat li tinbeda kura b’ sildenafil b’ doża ta ’ 25mg (ara sezzjoni 4. 2).
In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms.
Barra minn hekk, tobba għandhom jgħarrfu lill- pazjenti tagħhom fuq il- passi li jridu jieħdu f’ każ li jkollhom sintomi ta ’ pressjoni baxxa posturali.
Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro.
Studji bi plejtlets umani jindikaw li sildenafil isaħħaħ l- effett kontra l- aggregazzjoni ta ’ sodium nitroprusside in vitro.
The film coating of the VIAGRA tablet contains lactose.
Il- kisja b’ rita tal- pillola tal- VIAGRA fiha lactose.
VIAGRA should not be administered to men with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
VIAGRA m’ għandhiex tingħata lill- irġiel li għandhom problemi ereditarji ta ’ intolleranza għall- galactose, defiċjenza fil- Lapp lactase jew li għandhom problemi fl- assorbiment ta ’ glucose- galactose.
VIAGRA is not indicated for use by women.
VIAGRA mhix indikata għal użu fin- nisa.
Effects of other medicinal products on sildenafil
Effetti ta ’ prodotti mediċinali oħra fuq sildenafil
Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance.
Għalhekk, l- inibituri ta ’ dawn l- iżo- enżimi jistgħu jnaqqsu il - clearance ta ’ sildenafil.
Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, cimetidine).
Analiżi farmakokinetika ta ’ tagħrif minn provi kliniċi fuq grupp ta ’ pazjenti tindika tnaqqis fil - clearance ta ’ sildenafil meta ko- amministrat ma ’ inibituri ta ’ CYP3A4 (bħal ketoconazole, erythromycin, cimetidine).
Although no increased incidence of adverse events was observed in these patients, when sildenafil is administered concomitantly with CYP3A4 inhibitors, a starting dose of 25 mg should be considered.
Għalkemm ma ġietx osservata żieda fl- inċidenza ta ’ reazzjonijiet avversi f’ dawn il- pazjenti, doża tal- bidu ta ’ 25 mg għandha tiġi kunsidrata meta sildenafil jiġi amministrat fl - istess ħin ma ’ inibituri ta ’ CYP3A4.
4 Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma AUC.
F’ 24
At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/ ml, compared to approximately 5 ng/ ml when sildenafil was administered alone.
4 siegħa, l- livelli tal- plażma ta ’ sildenafil kienu għadhom bejn wieħed u ieħor 200ng/ ml, imqabblin ma ’ bejn wieħed u ieħor 5ng/ ml meta sildenafil ingħata waħdu.
Sildenafil had no effect on ritonavir pharmacokinetics.
Sildenafil ma kellux effett fuq il - farmakokinetiċi ta ’ ritonavir.
Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is not advised (see section 4.4) and in any event the maximum dose of sildenafil should under no circumstances exceed 25 mg within 48 hours.
Bażata fuq dawn ir- riżultati farmakokinetiċi il- ko- amministrazzjoni ta ’ sildenafil ma ’ ritonavir mhix rakkomandata (ara sezzjoni 4. 4) u f’ kull eventwalità l- ogħla doża ta ’ sildenafil taħt l- ebda ċirkustanza ma għandha tkun iżjed minn 25 mg fi żmien 48 siegħa.
Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.
Ko- amministrazzjoni ta ’ l- inibitur ta ’ HIV protease saquinavir, inibitur ta ’ CYP3A4, fi stat stabbli (1200 mg tlett darbiet kuljum) ma ’ sildenafil (100 mg doża waħda) irriżultat f’ żieda ta ’ 140% fis- Cmax ta ’ sildenafil u żieda ta ’ 210% fl- AUC ta ’ sildenafil.
Sildenafil had no effect on saquinavir pharmacokinetics (see section 4.2).
Sildenafil ma kellux effett fuq il- farmakokinteċi ta ’ saquinavir (ara sezzjoni 4. 2).
Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects.
Inibituri ta ’ CYP3A4 aktar b’ saħħithom bħal ketoconazole u itraconazole jkunu mistennija li jkollhom effetti akbar.
When a single 100 mg dose of sildenafil was administered with erythromycin, a specific CYP3A4 inhibitor, at steady state (500 mg twice daily. for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC).
Meta doża waħda ta ’ 100 mg sildenafil ġiet amministrata ma ’ erythromycin, inibitur ta ’ CYP3A4 speċifiku, fi stat stabbli (500 mg darbtejn kuljum għal 5 jiem), kien hemm żieda ta ’ 182% fis- systemic exposure (AUC) ta ’ sildenafil.
In normal healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, tmax, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite.
F’ voluntiera normali rġiel b’ saħħithom, ma kienx hemm evidenza ta ’ xi effett ta ’ azithromycin (500 mg kuljum għal 3 jiem) fuq ir- rata ta ’ l- eliminazzjoni fissa ta ’ l- AUC, Cmax u tmax, jew il- half life ta ’ wara ta ’ sildenafil jew il- metabolu prinċipali tiegħu fiċ- ċirkolazzjoni.
Cimetidine (800 mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers.
Cimetidine (800 mg), inibitur ta ’ ċitokromju P450 u inibitur ta ’ CYP3A4 mhux speċifiku, wassal għal żieda ta ’ 56% fil- konċentrazzjonijiet tal- plażma ta ’ sildenafil meta ko- amministrat ma ’ sildenafil (50 mg) fuq voluntiera b’ saħħithom.
Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil.
Il- meraq tal- grapefruit huwa inibitur dgħajjef tal- metaboliżmu ta ’ CYP3A4 li jseħħ fis- superfiċje ta ’ ġewwa tal- musrana u jista ’ jwassal għal żidiet żgħar fil- livelli tal- plażma ta ’ sildenafil.
Single doses of antacid (magnesium hydroxide/ aluminium hydroxide) did not affect the bioavailability of sildenafil.
Doża waħda ta ’ mediċina kontra l- aċidu fl- istonku (magnesium hydroxide / aluminium hydroxide) ma effettwatx il- biodisponiblità ta ’ sildenafil.
Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant medication on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors (such as tolbutamide, warfarin, phenytoin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP450 metabolism (such as rifampicin, barbiturates).
Għalkemm ma sarux studji speċifiċi ta ’ interazzjoni għal prodotti mediċinali kollha, analiżi farmakokinetiċi tal- popolazzjoni ma juru l- ebda effett ta ’ medikazzjoni konkomitanti fuq il - farmakokinetiċi ta ’ sildenafil meta miġbura fi gruppi bħala inibituri ta ’ CYP2C9 (bħal tolbutamide, warfarin, phenytoin), inibituri ta ’ CYP2D6 (bħal selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide u dijuretiċi relatati, dijuretiċi loop u potassium- sparing, inibituri ta ’ l- enżima li tikkonverti l- angiotensin, channel blockers tal- kalċju, antagonisti beta- adrenoreceptor jew inducers tal- metaboliżu CYP450 (bħal rifampicin, barbiturate).
Due to the nitrate component it has the potential to have serious interaction with sildenafil.
Minħabba il- komponent ta ’ nitrate, hemm potenzjal ta ’ interazzjoni serja ma ’ sildenofil.
Effects of sildenafil on other medicinal products
Effetti ta ’ sildenafil fuq prodotti mediċinali oħra
Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 µM).
Sildenafil huwa inibitur dgħajjef ta ’ ċitokromju P450 iżoformi 1A2, 2C9, 2C19, 2D6, 2E1 u 3A4 (1C50 > 150 µM).
Given sildenafil peak plasma concentrations of approximately 1 µM after recommended doses, it is unlikely that VIAGRA will alter the clearance of substrates of these isoenzymes.
Bl- ogħla konċentrazzjonijiet ta ’ plażma ta ’ sildenafil ta ’ bejn wieħed u ieħor 1µM wara dożi rakkomandati, mhux probabli li VIAGRA tbiddel il- clearance tas- sustrati ta ’ dawn l- iżo - enżimi.
Consistent with its known effects on the nitric oxide/ cGMP pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see section 4.3).
B’ mod konformi ma ’ l- effetti magħrufin ta ’ sildenafil fuq in- nitric oxide/ cGMP pathway (ara sezzjoni 5. 1), intwera li sildenofil iżid l- effett tan- nitrates li jnaqqsu l- pressjoni, u għaldaqstant il- ko - amministrazzjoni ta ’ sildenofil u donaturi ta ’ nitric oxide jew nitrates hija kontraindikata (ara sezzjoni 4. 3).
5 Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible individuals.
5 Amministrazzjoni ta ’ sildenofil lil pazjenti taħt il- kura b’ alpha blockers tista ’ tirriżulta fi pressjoni baxxa sintomatika fi ftit individwi suxxettibbli.
This is most likely to occur within 4 hours post sildenafil dosing (see sections 4.2 and 4.4).
Dan jista ’ jseħħ l- aktar sa 4 sigħat wara li tittieħed id - doża ta ’ sildenofil (ara sezzjonijiet 4. 2 u 4. 4).
In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.
Fi tlett studji speċifiċi għal interazzjoni bejn żewġ prodotti mediċinali, alpha blocker doxazocin (4mg u 8mg) u sildenafil (25mg, 50mg u 100mg) ġew amministrati fl- istess ħin lil pazjenti bi tkabbir benin tal- prostata (BPH), stabilizzati fuq kura ta ’ doxazocin.
In these study populations, mean additional reductions of supine blood pressure of 7/ 7 mmHg, 9/ 5 mmHg, and 8/ 4 mmHg, and mean additional reductions of standing blood pressure of 6/ 6 mmHg, 11/ 4 mmHg, and 4/ 5 mmHg, respectively, were observed.
F’ dawn il- popolazjonijiet ta ’ l- istudji, kien osservat tnaqqis addizzjonali medju tal - pressjoni meta kienu mimdudin ta ’ 7/ 7mmHg, 9/ 5mmHg u 8/ 4mmHg rispettivament u tnaqqis addizzjonali medju ta ’ 6/ 6mmHg, 11/ 4mmHg u 4/ 5nnHg.
When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension.
Meta sildenafil u doxazocine ingħataw fl - istess ħin lil pazjenti stabilizzati fuq kura ta ’ doxazocin kien hemm rapporti mhux spissi ta ’ pazjenti li kellhom pressjoni baxxa posturali sintomatika.
These reports included dizziness and light-headedness, but not syncope.
Fost dawn ir- rapporti kien hemm stordament qawwi u stordament ħafif imma mhux sinkope.
No significant interactions were shown when sildenafil (50 mg) was co-administered with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9.
Ma kienx hemm interazzjonijiet sinifikanti meta sildenafil (50 mg) kien ko- amministrat ma ’ tolbutamide (250 mg) jew warfarin (40 mg), li t- tnejn li huma jiġu metabolizzati minn CYP2C9.
Sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid (150 mg).
Sildenafil (50 mg) ma saħħaħx iż- żieda fil- ħin tal- fsada kaġunat mill- aċidu acetyl salicyclic (150 mg).
Pooling of the following classes of antihypertensive medication: diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and centrally- acting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor blockers, showed no difference in the side effect profile in patients taking sildenafil compared to placebo treatment.
Ġbir ta ’ dawn il- każi li ġejjin ta ’ medikazzjoni ta ’ kontra l- pressjoni għolja: dijuretiċi, beta- blokers, inibituri ta ’ ACE, antagonisti ta ’ angiotensin II, prodotti mediċinali kontra l- pressjoni għolja (vażodilataturi u li jaħdmu fuq is- sistema ċentrali), adrenergic neurone blockers, channel blockers tal - kalċju u blokers alpha- adrenoceptor, ma wrew ebda differenza fil- profil ta ’ effetti f’ pazjenti li ħadu sildenafil mqabblin ma ’ kura bil- plaċebo.
In a specific interaction study, where sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg.
Fi studju speċifiku ta ’ interazzjoni, fejn sildenafil (100 mg) kien ko- amministrat ma ’ amlodipine f’ pazjenti bi pressjoni għolja, kien hemm aktar tnaqqis fil - pressjoni sistolika f’ pożizzjoni minduda tad- demm ta ’ 8 mmHg.
The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg.
It- tnaqqis korrispondenti fil- pressjoni dijastolika tad- demm f’ pożizzjoni minduda kienet 7 mmHg.
These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers (see section 5.1).
Dan it- tnaqqis ulterjuri fil- pressjoni tad - demm kien jixbah lil dak li seħħ meta sildenafil ġie amministrat waħdu lil voluntiera b’ saħħithom (ara sezzjoni 5. 1).
Sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.
Sildenafil (100 mg) ma affettwax il- farmakokinetiċi fi stat stabbli ta ’ l- inibituri ta ’ HIV protease, saquinavir u ritonavir, it- tnejn li huma sustrati CYP3A4.
VIAGRA is not indicated for use by women.
VIAGRA mhix indikata għal użu minn nisa.
No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil.
Ma nstabux effetti avversi fi studji riproduttivi f’ firien u fniek wara amministrazzjoni orali ta ’ sildenafil.
No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effett ta ’ sildenafil fuq il- ħila biex issuq jew tħaddem magni.
As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to VIAGRA, before driving or operating machinery.
Minħabba li ġew rappurtati sturdament u viżjoni mibdula fi provi kliniċi b’ sildenafil, il- pazjenti għandhom ikunu konxji ta ’ kif jirreaġġixxu għal VIAGRA, qabel ma jsuqu jew iħaddmu xi magni.
The safety profile of VIAGRA is based on 8691 patients who received the recommended dosing regimen in 67 placebo-controlled clinical studies.
Is- sigurta ’ ta ’ VIAGRA hija bbażata fuq 8691 pazjenti li ħadu d- dużaġġ irrakkomandat f’ 67 studji kliniċi kkontrollati bi plaċebo.
The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, visual disorders, nasal congestion, dizziness and visual colour distortion.
L- aktar reazzjonijiet avversi li ġew irrappurtati minn fost il- pazjenti li użaw sildenafil fl- istudji kliniċi kienu uġigħ ta ’ ras, fwawar, dispepsja, viżjoni mibdula, sadda tal - imnifsejn, sturdament u diffikulta` biex tagħraf il- kuluri.
6 Adverse reactions from post-marketing surveillance has been gathered covering an estimated period > 9 years.
Reazzjonijiet avversi ġew miġbura waqt is- sorveljanza ta ’ wara t- tqegħid tal- prodott fis- suq, fuq medda ta ’ > 9 snin.
Because not all adverse reactions are reported to the Marketing Authorisation Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined.
6 l- Awtorizzazzjoni għat- Tqegħid fis- Suq, u mniżżla fil- ġabra kumulattiva tad- dejta, il- frekwenzi ta ’ dawn ir- reazzjonijiet ma jistgħux ikunu magħrufa fiċ- ċert.
In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000).
Fit- tabella ta ’ hawn taħt, ir- reazzjonijiet avversi ta ’ importanza medika, li seħħew fl- istudji kliniċi b’ inċidenza iktar minn bil- plaċebo, huma mniżżla skond il- klassi ta ’ l- organi u l- frekwenzi (komuni ħafna (≥1/ 10), komuni (≥1/ 100 to < 1/ 10), mhux komuni (≥1/ 1, 000 to < 1/ 100), rari (≥1/ 10, 000 to < 1/ 1, 000).
In addition, the frequency of medically important adverse reactions reported from post-marketing experience is included as not known.
Barra minn hekk, il- frekwenza tar- reazzjonijiet avversi ta ’ importanza medika rrappurtati mill - esperjenza ta ’ wara t- tqegħid tal- prodott fis- suq hija mniżżla bħala mhux magħrufa.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull ġabra ta ’ frekwenzi, l- effetti mhux mixtieqa huma mniżżla bejn iktar serji għal dawk inqas serji.
Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through post- marketing surveillance
Reazzjonijiet avversi ta ’ importanza medika b’ inċidenza ta ’ rapporti akbar minn plaċebo fi studji kliniċi kkontrollati, u reazzjonijiet avversi ta ’ importanza medika rrappurtati minn sorveljanza ta ’ wara t- tqegħid tal- prodott fis- suq.
Adverse Reactions
Klassi tal- Organu Disturbi fis- sistema immuni
Immune system disorders
Reazzjonijiet Kuntrarji
Hypersensitivity reactions
Reazzjonijiet ta ’ ipersensittività
Very common Common Uncommon Rare Not known Eye disorders
Komuni ħafna Komuni Mhux komuni Rari Mhux magħruf Disturbi fl- għajnejn
Headache Dizziness Somnolence, Hypoaesthesia Cerebrovascular accident, Syncope Transient ischaemic attack, Seizure, Seizure recurrence
Uġigħ ta ’ ras Sturdament Ngħas tqil, ipostesja Aċċident ċerebrovaskulari, sinkope Attakk iskimiku temporanju, attakk ta ’ puplesija, attakki ripetuti ta ’ puplesija
Visual disorders, Visual colour distortion Conjunctival disorders, Eye Disorders, Lacrimation Disorders, Other Eye Disorders
Disturbi fil- vista, diffikulta` li tagħraf il- kuluri Disturbi fil- konġuntiva, disturbi fl- għajnejn, disturbi fil- ħruġ tad- dmugħ, disturbi oħra fl- għajnejn