qanastek/EMEA-V3 huggingface dataset:
For patients requiring 30 – 60 mg doses, please follow these instructions to ensure proper dosing.
Għall- pazjenti li għandhom bżonn dożi ta ’ 30 – 60 mg, jekk jogħġbok segwi dawn l- istruzzjonijiet biex ikun assigurat dożaġġ xieraq.
Hold one Tamilfu 75 mg capsule over a small bowl, carefully pull the capsule open and pour the powder into the bowl.
Żomm kapsula ta ’ Tamilfu 75 mg fuq skutella żgħira, b’ attenzjoni iftaħ il- kapsula( i) billi tiġbed u ferra ’ it- trab ġol- iskutella.
Add 5 ml water to the powder using a syringe with markings (called a “graduated syringe”) to show how much fluid has been drawn up.
Żid 5 ml ilma mat- trab permezz ta ’ siringa b’ marki tal- kejl (imsejħa “ siringa bi gradwazzjonijiet ”) biex turi kemm qed tiġbed likwidu.
Stir for about two minutes.
Ħawwad għal madwar żewġ minuti.
Draw up into the syringe the correct amount of mixture from the bowl.
Fis- siringa iġbed l- ammont tajjeb ta ’ taħlita mill- iskutella.
See the table below to determine the correct amount of mixture, based upon the patient’s weight.
Ara t- tabella taħt biex ikun determinat l- ammont xieraq ta ’ taħlita skond il- piż tal- pazjent.
It is not necessary to draw up any undissolved white powder as this is inert material.
M’ hemmx bżonn li tneħħi t- trab abjad li ma jkunx inħall għax dan ma jikkawża l- ebda reazzjoni.
Push down on the plunger of the syringe, to empty its entire contents into a second bowl.
Imbotta l- planġer tas- siringa biex tferra ’ l- kontenut kollu fi skutella oħra.
Discard any unused mixture.
Armi kull taħlita li ma ntużatx.
Amount of Tamiflu
Ammont ta ’ taħlita ta ’ Tamiflu għal doża waħda
Recommended dose
Doża rrakkomandata
mixture for one dose
15- il kg jew anqas
Less than or equal to 15 kg
minn 15- il kg u sa 23 kg
More than 15 kg and up to 23 kg More than 23 kg and up to 40 kg
Aktar minn 23 kg u sa 40 kg
The recommended dose is 30 mg, 45 mg or 60 mg twice daily for 5 days for treatment, and once daily for prevention 5.
Id- doża rrakkomandata hija 30 mg, 45 mg jew 60 mg darbtejn kuljum għal ħamest ijiem għall - kura, u darba kuljum għall- prevenzjoni.
In the second bowl, add a suitable, small amount (1 teaspoon maximum) of sweetened food product to the mixture (to mask the bitter taste) and mix well.
Fit- tieni skutella, żid ammont żgħir (massimu ta ’ kuċċarina), xieraq ta ’ prodott ta ’ l- ikel b’ togħma ħelwa (biex tgħatti t- togħma qarsa) u ħawwad sew.
Stir this mixture and give the entire contents of the second bowl to the patient.
Ħawwad din it- taħlita u għati l- kontenut kollu tat- tieni skutella lill- pazjent.
This mixture must be swallowed immediately after its preparation.
Wara li tiġi ppreparata din it- taħlita għandha tittieħed minnufih.
If there is some mixture left inside the bowl, rinse the bowl with a small amount of water and have the patient drink this remaining mixture.
Jekk jibqa ’ xi taħlita fl- iskutella, laħlaħ l - iskutella b’ ammont żgħir ta ’ ilma u ġiegħel lill- pazjent jixrob din it- taħlita li jkun fadal.
For patients requiring 75 mg dose, please follow these instructions.
Għall- pazjenti li għandhom bżonn doża ta ’ 75 mg, jekk jogħġbok segwi dawn l- istruzzjonijiet.
Hold one 75 mg capsule over a small bowl, carefully pull the capsule open and pour the powder into the bowl.
Żomm kapsula waħda ta ’ 75 mg fuq skutella żgħira, b’ attenzjoni iftaħ il- kapsula( i) billi tiġbed u ferra ’ it- trab ġol- iskutella.
Repeat this procedure every time you need to take the medicine.
86 Irrepeti din il- proċedura kull darba li għandek bżonn tieħu l- mediċina.
82 If you have forgotten to take Tamiflu
Jekk tinsa tieħu Tamiflu
The most common side effects of Tamiflu are nausea, vomiting, diarrhoea, stomach ache and headache.
L- aktar effetti oħra komuni ta ’ Tamiflu huma, dardir, rimettar dijarea, uġigħ fl- istonku u uġigħ ta ’ ras.
Adults and adolescents (children aged 13 years and older) Other less common side effects, which may also be caused by influenza, are upper abdominal fullness, bleeding in the gastrointestinal tract, bronchitis, upper respiratory tract infections, dizziness, tiredness, sleeping difficulties, skin reactions, mild to severe liver function disorders, visual disturbances and heart rhythm abnormalities.
Adulti u adoloxxenti (tfal ta 'etajiet' il fuq minn 13- il sena) Effetti oħrajn anqas komuni, li jistgħu jkunu kkawżati wkoll mill- influwenza, huma imbulmar tal- parti addominali ta ’ fuq, fsada fl- apparat gastro- intestinali, bronkite, infezzjonijiet ta ’ l- apparat respiratorju ta ’ fuq, isturdament, għeja, diffikultajiet biex wieħed jorqod, reazzjonijiet fil- ġilda, disturbi ħfief sa severi fil- funzjoni tal- fwied, disturbi fil- vista u anormalitajiet fir- ritmu tal- qalb.
Children (aged 1 to 12 years) Other less common side effects, which may also be caused by influenza, are ear inflammation, inflammation of the lungs, sinusitis, bronchitis, aggravation of pre-existing asthma, nose bleeding, ear disorders, inflammation of the skin, swelling of the lymph nodes, conjunctivitis, visual disturbances and heart rhythm abnormalities.
Tfal (ta 'etajiet minn sena sa 12- il sena) Effetti oħrajn anqas komuni, li jistgħu jkunu kkawżati wkoll mill- influwenza, huma infjammazzjoni fil- widnejn, infjammazzjoni fil- pulmuni, sinusite, bronkite, ażżma li kienet diġà teżisti taggrava, fsada mill- imnieħer, disturbi fil- widnejn, infjammazzjoni tal- ġilda, nefħa tal- glandoli limfatiċi konġuntivite, disturbi fil- vista u anormalitajiet fir- ritmu tal- qalb.
If you or your child are often sick, you should inform your doctor.
87 Jekk int jew ibnek/ bintek spiss tħossukhom ma tifilħux, għandek tgħarraf lit- tabib tiegħek.
Keep out of the reach and sight of children.
Żommu fejn ma ’ jintlaħaqx u ma jidhirx mit- tfal.
- The active substance is oseltamivir phosphate (75 mg oseltamivir in each hard capsule).
- Is- sustanza attiva hi oseltamivir phosphate (75 mg oseltamivir f' kull kapsula iebsa).
capsule contents: pregelatinised starch, talc, povidone, croscarmellose sodium and sodium stearyl fumarate capsule shell: gelatin, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) and titanium dioxide (E171) printing ink: shellac (E904), titanium dioxide (E171) and indigocarmine (E132).
kontenut tal- kapsula: pregelatinized starch, talc, povidone, croscarmellose sodium, u sodium stearyl fumarate qoxra tal- kapsula: gelatin, iron oxide isfar (E172), iron oxide aħmar (E172), iron oxide iswed (E172) u titanium dioxide (E171) linka għall- istampar: shellac (E904), titanium dioxide (E171) u indigocarmine, (E132).
What Tamiflu looks like and contents of the pack
Id- Dehra ta ’ Tamiflu u l- kontenuti tal- pakkett
The hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “75 mg”.
Il- kapsula iebsa hija magħmula minn ġisem griż u opak li għandu stampat “ ROCHE ” u għatu isfar ċar u opak li għandu stampat “ 75 mg ”.
Tamiflu 75 mg hard capsules are available in blister packs of 10.
L- kapsuli ibsin ta ’ Tamiflu 75 mg huma disponibbli f’ folji ta ’ 10.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
88 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
85 This leaflet was last approved in {MM/YYYY}.
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
86 PACKAGE LEAFLET:
90 FULJETT TA ’ TAGĦRIF:
- If you have further questions, ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- spiżjar tiegħek.
Take special care with Tamiflu Before you take Tamiflu, make sure your prescribing doctor knows if you
Qabel tieħu Tamiflu, aċċerta ruħek li t- tabib li qiegħed jordnaħulek ikun jaf jekk inti:
- have problems with your kidneys
- għandek problemi bil- kliewi
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk ġejt mgħarraf mit- tabib tiegħek li għandek intolleranza għal xi zokkrijiet, kellem lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
Tamiflu can be taken with paracetamol, ibuprofen or acetylsalicylic acid (Aspirin).
91 Tamiflu jista 'jittieħed ma ’ paracetamol, ibuprofen jew acetylsalicylic acid (Aspirin).
87 Are there any interactions with an influenza vaccination?
Tilqima kontra l- influwenza tikkawża xi bidla fuq l- effett farmaċewtiku tal- prodott?
Taking Tamiflu with food and drink Tamiflu oral suspension can be taken with or without food, although it is recommended to take Tamiflu with food to reduce the chance of feeling or being sick (nausea or vomiting).
Meta tieħu Tamiflu ma ’ l- ikel u max- xorb Ibla 'l- kapsula ta ’ Tamiflu bl- ilma.
It can also be taken with a drink of water.
Tamiflu jista 'jittieħed kemm ma' l- ikel kif ukoll fuq stonku vojt, għalkemm huwa rrakkomandat li tieħu Tamiflu ma 'l- ikel sabiex tnaqqas il- possibiltà li tħoss dardir jew tirremetti. Tista' tieħdu wkoll ma 'tazza ilma.
Driving and using machines Tamiflu has no effect on your ability to drive or use machines.
Sewqan u tħaddim ta ’ magni Tamiflu m’ għandu l - ebda effett fuq il- ħila tiegħek biex issuq jew tħaddem magni.
Important information about some of the ingredients of Tamiflu Before you take Tamiflu, make sure your prescribing doctor knows if you have hereditary fructose intolerance.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Tamiflu Qabel ma tieħu Tamiflu, kun ċert li t- tabib tiegħek jaf jekk għandek intolleranza ereditarja għal - fructose.
This medicine contains sorbitol which is a form of fructose.
Din il- mediċina fiha sorbitol li huwa forma ta 'fructose.
How Much Tamiflu should be given to infants 1 year of age and older and Children 2 to 12 years of age)
L- ammont ta 'Tamiflu li għandu jingħata lit- trabi minn sena' l fuq u lit- tfal (b’ età minn sentejn sa 12- il sena)
Treatment You must give the amount of oral suspension to your child as prescribed by your doctor.
Għall- kura Għandek tagħti l- ammont tas- suspensjoni orali lit- tifel/ tifla tiegħek skond ir- riċetta tat- tabib tiegħek.
30 mg and 45 mg capsules can be used as an alternative to suspension.
Kapsuli ta ’ 30 mg u ta ’ 45 mg jistgħu jintużaw bħala alternattiva.
The usual dose for treatment of influenza in children depends on the body weight of the child (see table below):
92 Id- doża li normalment tingħata lit- tfal sabiex tiġi kkurata l- influwenza tiddependi mill- piż tat- tifel/ tifla (ara t- tabella ta 'hawn taħt):
Recommended dose for 5 days (Treatment)
Doża rrakommandata għal ħamest ijiem (ta 'kura)
Less than or equal to 15 kg
15 kg jew anqas
30 mg twice daily
30 mg darbtejn kuljum
More than 15 kg and up to 23 kg More than 23 kg and up to 40 kg More than 40 kg
Aktar minn 15 kg sa 23 kg Aktar minn 23 kg sa 40 kg Aktar minn 40 kg
45 mg twice daily 60 mg twice daily 75 mg twice daily
45 mg darbtejn kuljum 60 mg darbtejn kuljum 75 mg darbtejn kuljum
(75 mg is made up of a 30 mg dose plus a 45 mg dose)
(75 mg hija magħmula minn doża ta '30 mg miżjuda ma' doża ta '45 mg)
Prevention
Għall- prevenzjoni
Tamiflu can also be used to prevent influenza following exposure to an infected individual, such as family members.
Wara espożizzjoni għall- individwu infettat, bħal membri tal- familja, Tamiflu jista 'jintuża wkoll sabiex jipprevjeni l- influwenza.
88 30 mg and 45 mg capsules can be used as an alternative to suspension.
Kapsuli ta ’ 30 mg u ta ’ 45 mg jistgħu jintużaw bħala alternattiva għas- suspensjoni.
It is best to take this dose in the mornings with breakfast.
L- aħjar ħin biex tieħu din id- doża huwa fil - għodu mal- kolazzjon.
The usual dose for prevention of influenza in children depends on the body weight of the child (see table below):
Id- doża tas- soltu għall- prevenzjoni tal- influwenza fit- tfal tiddependi mill- piż tat- tifel/ tifla (ara t- tabella taħt):
Recommended dose for 10 days (Prevention)
Doża rrakkomandata għal għaxart ijiem (Prevenzjoni)
30 mg once daily
30 mg darba kuljum
45 mg once daily 60 mg once daily 75 mg once daily
45 mg darba kuljum 60 mg darba kuljum 75 mg darba kuljum magħmula minn doża ta ’ 30 mg
(75 mg is made up of a 30 mg dose plus a 45 mg dose)
miżjuda ma ’ doża ta ’ 45 mg)
Children weighing more than 40 kg and can swallow capsules may take a 75 mg dose of Tamiflu capsules once daily for 10 days.
Tfal li jiżnu aktar minn 40 kg u li jistgħu jibilgħu l- kapsuli jistgħu jieħdu doża ta ’ kapsuli Tamiflu ta ’ 75 mg darba kuljum għal għaxart ijiem.
How Much Tamiflu should be given to Adolescents (13 to 17 years of age) and Adults
L- ammont ta 'Tamiflu li għandu jingħata lill- Adoloxxenti (b’ età minn 13 sa 17- il sena) u lill - Adulti
The suspension can be used by adults and adolescents instead of the capsule.
Is- suspensjoni tista ’ tintuża mill- adulti u l- adoloxxenti minflok il- kapsula.
30 mg and 45 mg capsules can be used as an alternative to suspension.
Kapsuli ta ’ 30 mg u ta ’ 45 mg jistgħu jintużaw bħala alternattiva għas- suspensjoni.
Treatment Usually, your doctor will prescribe a 75 mg dose of Tamiflu twice daily for 5 days.
Għall- kura Normalment, it- tabib tiegħek jordnalek doża ta '75 mg ta' Tamiflu darbtejn kuljum għal ħamest ijiem.
Prevention Usu ally, your doctor will prescribe a 75 mg dose of Tamiflu once daily for 10 days.
Għall- prevenzjoni Normalment, it- tabib tiegħek jordnalek doża ta '75 mg ta' Tamiflu darba kuljum għal għaxart ijiem.
Your doctor will recommend the length of time you will need to take Tamiflu.
It - tabib jirrakkomandalek għal kemm tul ta 'żmien ikollok bżonn tieħu Tamiflu.
A single 75 mg dose of Tamiflu requires two doses of the suspension: one 30 mg dose and one 45 mg dose.
Doża waħda ta '75 mg ta' Tamiflu ssir minn żewġ dożi tas- suspensjoni: doża waħda ta '30 mg flimkien ma' oħra ta '45 mg.
a) HOW TO PREPARE THE ORAL SUSPENSION:
93 a) KIF TĦEJJI S- SUSPENSJONI ORALI:
Your pharmacist may have prepared the oral suspension for you when you collected your prescription.
Jista 'jkun li l- ispiżjar tiegħek ħejjielek s- suspensjonili orali meta ġbart il- mediċina.
However, if they have not done this, then you can do it easily yourself.
Madankollu, jekk dan ma sarx, tista 'tħejjiha faċilment inti stess.
You only need to prepare the suspension once, at the beginning of your course.
Is- suspensjoni hemm bżonn li titħejja darba biss, fil - bidu tal- kors tal- kura tiegħek.
After that, all you need to do is shake the suspension well and draw up the appropriate recommended dose.
Tapp
Cap ←Bottle Adapter Measuring Cup ← To the indicated level
← Adapter għall- flixkun
Figure 1
Illustrazzjoni 1
Tap the closed bottle gently several times to loosen the powder.
Tektek bil- mod fuq il- flixkun magħluq għal diversi drabi ħalli t- trab jintreħa.
Measure 52 ml of water by filling the measuring cup to the indicated level (measuring cup included in the box).
Kejjel 52 ml ilma billi timla t- tazza għall- kejl sal- livell indikat (it- tazza għall- kejl tinsab fil- kaxxa).
You should always use 52 ml of water, irrespective of the recommended dose you are taking.
Dejjem għandek tuża 52 ml ilma, hi x’ inhi d- doża rrakkomandata li qed tieħu.
Add all 52 ml of water into the bottle, recap the bottle and shake the closed bottle well for 15 seconds.
Żid il- 52 ml ilma kollu fil- flixkun, għalaq mill- ġdid il- flixkun u ħawwad sew il- flixkun magħluq għal 15- il sekonda.
Remove the cap and push the bottle adapter into the neck of the bottle.
Neħħi t- tapp u daħħal l- adapter tal- flixkun f' għonq il- flixkun.
Place the cap tightly over the top of the bottle, which now includes the bottle adapter.
Issikka t- tapp fuq il- flixkun, li issa jinkludi l- adapter tal- flixkun.
This will make sure that the bottle adapter fits in the bottle in the right position.
B' hekk taċċerta li l- adapter tal - flixkun jiffitja fil- flixkun fil- pożizzjoni kif suppost.
b) HOW TO MEASURE AND GIVE A DOSE OF ORAL SUSPENSION
b) KIF TKEJJEL U TAGĦTI DOŻA TA 'SUSPENSJONI ORALI
Always shake Tamiflu oral suspension well before use!
Dejjem ħawwad is suspensjoni orali ta ’ Tamiflu sew qabel tużaha!
Oral Dispenser Plunger
Illustrazzjoni 2
Figure 3
Illustrazzjoni 3
How to measure the correct amount of suspension:
Kif tkejjel l- ammont korrett ta 'likwidu b’ ħafna partiċelli żgħar:
Shake the closed bottle of Tamiflu oral suspension well before use.
Ħawwad sew il- flixkun magħluq bis- suspensjoni orali ta ’ Tamiflu qabel tużaha.
Take the dispenser (see figure 2) and push the plunger completely down toward the tip of the dispenser.
Aqbad id- dispenser (ara illustrazzjoni 2) u mbotta l- planġer s' isfel nett lejn il- ponta tad - dispenser.
The dispenser provided with your medicine must always be used to measure to correct dose.
Għandek dejjem tuża d- dispenser ipprovvdut mal- mediċina tiegħek biex tkejjel id - doża korretta.
Remove the cap from the bottle of oral suspension.
Neħħi t- tapp mill- flixkun tas- suspensjoni orali.
Insert the tip of the dispenser into the bottle adapter.
Daħħal il- ponta tad- dispenser fl- adapter tal- flixkun.
Turn the entire unit (bottle and dispenser) upside down (see figure 3).
Aqleb il- flixkun bid- dispenser b' kollox rasu 'l- isfel (ara illustrazzjoni 3).
Slowly pull out the plunger to the graduation which marks the dose you need.
Iġbed il- planġer bil- mod 'il barra sal- gradazzjoni li turi d- doża li għandek bżonn.
Turn the entire unit upright.
Dawwar kollox rasu 'l fuq.
Slowly remove the dispenser from the bottle.
Neħħi bil- mod id- dispenser minn ġol- flixkun.
Push the suspension directly into the mouth by pushing down the plunger of the dispenser.
Itfa 's- suspensjoni direttament fil- ħalq billi timbotta l- isfel il- planġer tad- dispenser.
Swallow the medicine.
Ibla 'l - mediċina.
You may drink and eat something after taking the medicine.
Tista 'tixrob jew tiekol xi ħaġa wara li tieħu l- mediċina.
Immediately after administration, take the dispenser apart and rinse both parts of the dispenser under running tap water.
Hekk kif tieħu l- mediċina, żarma d- dispenser u laħlaħ iż- żewġ partijiet tiegħu taħt il- vit.
If you take more Tamiflu, than you should
94 Jekk tieħu Tamiflu aktar milli suppost
Adults and adolescents (children aged 13 years and older) Other less common side effects, which may also be caused by influenza, are upper abdominal fullness, bleeding in the gastrointestinal tract, bronchitis, upper respiratory tract infections, dizziness, tiredness, sleeping difficulties, skin reactions, mild to severe liver function disorders, visual disturbances and heart rhythm abnormalities.
Adulti u adoloxxenti (tfal ta 'etajiet' l fuq minn 13- il sena) Effetti oħrajn anqas komuni, li jistgħu jkunu kkawżati wkoll mill- influwenza, huma imbulmar tal- parti addominali ta ’ fuq, fsada fl- apparat gastro- intestinali, bronkite, infezzjonijiet ta ’ l- apparat respiratorju ta ’ fuq, isturdament, għeja, diffikultajiet biex wieħed jorqod, reazzjonijiet fil- ġilda, disturbi ħfief sa severi fil- funzjoni tal- fwied, disturbi fil- vista u anormalitajiet fir- ritmu tal- qalb.
Children (aged 1 to 12 years) Other less common side effects, which may also be caused by influenza, are ear inflammation, inflammation of the lungs, sinusitis, bronchitis, aggravation of pre-existing asthma, nose bleeding, ear disorders, inflammation of the skin, swelling of the lymph nodes ,conjunctivitis, visual disturbances and heart rhythm abnormalities.
Tfal (ta 'etajiet minn sena sa 12- il sena) Effetti oħrajn anqas komuni, li jistgħu jkunu kkawżati wkoll mill- influwenza, huma infjammazzjoni fil- widnejn, infjammazzjoni fil- pulmuni, sinusite, bronkite, ażżma li kienet diġà teżisti taggrava, fsada mill- imnieħer, disturbi fil- widnejn, infjammazzjoni tal- ġilda, nefħa tal- glandoli limfatiċi, konġuntivite, disturbi fil- vista u anormalitajiet fir- ritmu tal- qalb.
If you or your child are often sick, you should inform your doctor.
95 Jekk int jew ibnek/ bintek spiss tħossukhom ma tifilħux, għandek tgħarraf lit- tabib tiegħek.
Do not use Tamiflu powder for oral suspension after the expiry date which is stated on the carton and bottle after EXP.
Tużax Tamiflu trab għal suspensjoni orali wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- flixkun wara {abbrevjazzjoni li tintuża għad- data ta ’ skadenza}.
After reconstitution, the suspension can be stored either at room temperature (not above 25°C) for 10 days or in a refrigerator (2°C - 8°C) for 17 days.
Wara r- rikostituzzjoni, s- suspensjoni tista ’ tinħażen f’ temperatura tal- kamra (mhux aktar minn 25°C) għal għaxart ijiem jew fi friġġ (2°C - 8°C) għal 17- il ġurnata.
91 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
- The active substance is oseltamivir phosphate (12 mg/ml oseltamivir after reconstitution).
- Is- sustanza attiva hi oseltamivir phosphate (12 mg/ ml oseltamivir wara r- rikostituzzjoni).
- The other ingredients are sorbitol (E420), sodium dihydrogen citrate (E331[a]), xanthan gum
- Is- sustanzi l- oħra huma sorbitol (E420), sodium dihydrogen citrate (E331[ a]), xanthan gum
(E415), sodium benzoate (E211), saccharin sodium (E954), titanium dioxide (E171) and flavour.
(E415), sodium benzoate (E211), saccharin sodium (E954), titanium dioxide (E171) u togħma.
What Tamiflu looks like and contents of the pack
Id- Dehra ta ’ Tamiflu u l- kontenuti tal- pakkett:
The powder is a granulate or clumped granulate with a white to light yellow colour.
It- trab huwa mrammel jew mrammel iżda magħqud, b’ kulur abjad sa isfar ċar.
Tamiflu 12 mg/ml powder for oral suspension is available in a bottle containing 30 g powder for mixing with 52 ml of water.
Tamiflu 12 mg/ ml trab għal suspensjoni orali huwa disponibli fi flixkun li fih 30 g trab biex jitħallat ma ’ 52 ml ilma.
The box also contains 1 plastic measuring cup (52 ml), 1 plastic bottle adapter (to help get the drug into the dispenser) and 1 plastic oral dispenser (to give the correct amount of medicine via the mouth).
Il- kaxxa fiha wkoll tazza tal- plastik għall- kejl (52 ml), adapter tal- plastik għall- flixkun (li jgħin sabiex il- mediċina tingħadda għal ġod- dispenser), u dispenser orali tal- plastik (biex tagħti l- ammont korrett ta 'mediċina mill- ħalq).
Shown on the oral dispenser are marks for 30 mg, 45 mg and 60 mg of the medicine (see figures 1 and 2 above).
Fuq id- dispenser orali hemm marki għal 30 mg, 45 mg, u 60 mg tal- mediċina (ara illustrazzjonijiet 1 u 2 fuq).
For details on how to prepare the oral suspension and how to measure and take the medicine, read section 3, “How to take Tamiflu”.
Għal dettalji dwar kif tħejji s- suspensjoni u kif tkejjel u tieħu l- mediċina, aqra Sezzjoni 3. “ Kif jittieħed Tamiflu. ”
Marketing Authorisation Holder and Manufacturer
96 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
Ireland Roche Products (Ireland) Ltd.
97 Ireland Roche Products (Ireland) Ltd.
93 This leaflet was last approved in {MM/YYYY}.
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
What is Tandemact?
X' inhu Tandemact?
Tandemact is a medicine that contains two active substances, pioglitazone and glimepiride.
Tandemact huwa mediċina li fiha żewġ sustanzi attivi, pioglitazone u glimepiride.
It is available as white, round tablets (30 mg pioglitazone and 2 or 4 mg glimepiride, or 45 mg pioglitazone and 4 mg glimepiride).
Hija disponibili f' pilloli tondi bojod (30 mg pioglitazone u 2 jew 4 mg glimepiride, jew 45 mg pioglitazone u 4 mg glimepiride).
What is Tandemact used for?
Għal xiex jintuża Tandemact?
Tandemact is used to treat adult patients who have type 2 diabetes (also known as non-insulin- dependent diabetes).
Tandemact jintuża għat- trattament ta 'pazjenti adulti li jbatu mid- dijabete tat- tip 2 (magħrufa wkoll bħala dijabete mhux dipendenti fuq l- insulina).
It is used in patients for whom metformin (a type of anti-diabetes medicine) is not suitable and who are already being treated with a combination of tablets containing the two active substances, pioglitazone and glimepiride.
Jintuża f' pazjenti li għalihom il- metformina (tip ta 'mediċina kontra d- dijabete), mhijiex adatta u li diġà qegħdin jiġu ttrattati b' kombinazzjoni ta' pilloli li fihom żewġ sustanzi attivi, pioglitazone u glimepiride.
The medicine can only be obtained with a prescription.
Il- mediċina tista 'tinkiseb biss permezz ta' riċetta ta 'tabib.
How is Tandemact used?
Kif jintuża Tandemact?
The usual dose of Tandemact is one tablet once a day, taken just before or with the first meal of the day.
Id- doża tas- soltu ta 'Tandemact hija pillola waħda darba kuljum, meħuda ftit qabel jew ma' l- ewwel ikla tal- jum.
The tablet should be swallowed whole with a little water.
Il- pillola għandha tinbela 'sħiħa bi ftit ilma.
Patients who are receiving pioglitazone together with another medicine in the same class as glimepiride (i. e. another sulphonylurea) should first be switched from this other sulphonylurea to glimepiride before they can transfer to Tandemact.
Pazjenti li qed jirċievu pioglitazone flimkien ma 'mediċina oħra fl- istess klassi bħal glimepiride (jiġifieri sulfonilurea oħra) għandhom l- ewwel jgħaddu minn fuq din is- sulfonilurea l- oħra għal glimepiride qabel ma jkunu jistgħu jaqilbu għal Tandemact.
Patients who experience hypoglycaemia (low blood sugar levels) while taking Tandemact may need to use a lower dose of the medicine or to return to using separate tablets.
Pazjenti li jesperjenzaw ipogliċemija (livelli ta 'zokkor baxxi fid- demm) waqt li qed jieħdu Tandemact jistgħu jkunu meħtieġa li jużaw doża aktar baxxa ta' mediċina jew imorru lura għal li jużaw pilloli separati.
Tandemact cannot be used in patients who have severe kidney problems, or in patients who have liver problems.
Tandemact ma jistax jintuża f' pazjenti li għandhom problemi serji tal- kliewi, jew f' pazjenti li għandhom problemi tal- fwied.
How does Tandemact work?
Kif jaħdem Tandemact?
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Id- dijabete tat- tip 2 hija marda fejn il- frixa (pankreas) ma tipproduċix biżżejjed insulina biex tikkontrolla l- livell ta 'glukożju (zokkor) fid- demm jew meta l- ġisem mhuwiex kapaċi juża l- insulina b' mod effikaċi.
Tandemact contains two active substances, each of which has a different mode of action.
Tandemact fih żewġ sustanzi attivi, li kull waħda għandha mod ta 'kif taħdem b' mod differenti.
Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Pioglitazone tagħmel iċ- ċelluli (xaħam, muskolu u fwied) aktar sensittivi għall- insulina, li jfisser li l- ġisem jagħmel użu aħjar mill- insulina li jipproduċi.
Glimepiride is a sulphonylurea: it stimulates the pancreas to produce more insulin.
Glimepiride hija sulfonilurea: hija tistimola lill- frixa biex tipproduċi aktar insulina.
As a result of the action of both active substances, the blood glucose level is reduced and this helps to control type 2 diabetes.
Bħala riżultat ta 'l- azzjoni taż- żewġ sustanzi attivi, il - livell ta' glukożju fid- demm huwa mnaqqas u dan jgħin biex jikkontrolla d- dijabete tat- tip 2.
How has Tandemact been studied?
Kif ġie studjat Tandemact?
Because pioglitazone has been approved in the European Union (EU) since 2000 under the name Actos, and glimepiride is already used in authorised medicines in the EU, the company presented data obtained in earlier studies and from the published literature.
Minħabba li pioglitazone kien ġie approvat fl- Unjoni Ewropea (UE) mis- sena 2000 bl- isem ta 'Actos, u glimepiride diġà tintuża f' mediċini awtorizzati fl- UE, il- kumpanija ppreżentat dejta miksuba minn studji li kienu saru aktar kmieni u mil- letteratura ippubblikata.
Actos is approved for use with a sulphonylurea in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Actos huwa approvat għal użu ma 'sulfonilurea f' pazjenti b' dijabete tat- tip 2 li mhumiex ikkontrollati b' mod sodisfaċenti fuq metformina waħedha.
The company used three studies to support the use of Tandemact in the same indication.
Il- kumpanija użat tliet studji biex tappoġġa l- użu ta 'Tandemact fl- istess indikazzjoni.
The studies included 1,390 patients who added pioglitazone to their existing treatment with a sulphonylurea.
L- istudji inkludew b' 1, 390 pazjent li żiedu pioglitazone mat- trattament eżistenti tagħhom b' sulfonilurea.
The studies lasted between four months and two years and measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
L- istudji damu bejn erba 'xhur u sentejn u kejlu l- livell ta' sustanza fid- demm imsejħa emoglobina glikosilata (HbA1c), li tagħti indikazzjoni fuq kemm ikun ikkontrollat sewwa l- livell ta 'glukożju fid- demm.
These studies used pioglitazone and sulphonylureas given as separate tablets.
Dawn l- istudji użaw pioglitazone u sulfonilurej mogħtija bħala pilloli separati.
The company provided evidence that the levels of the active substances in the blood were the same in people taking Tandemact and people taking the separate tablets.
Il- kumpanija pprovdiet evidenza li l- livelli ta 'sustanzi attivi fid- demm kienu l- istess f' nies li qed jieħdu Tandemact u nies li qed jieħdu pilloli separati.
What benefit has Tandemact shown during the studies?
X' benefiċċju wera Tandemact?
In all three studies, patients who used a combination of pioglitazone and a sulphonylurea had an improvement in the control of their blood glucose.
Fit- tliet studji, pazjenti li jużaw kombinazzjoni ta 'pioglitazone u sulfonilurea kellhom titjib fil- kontroll tal- glukożju fid- demm tagħhom.
The patients’ HbA1c levels fell from a baseline of over 7.5% by between 1.22 and 1.64%.
Il- livelli ta 'HbA1c tal- pazjenti waqgħu mil- linja bażi ta' 'l fuq minn 7. 5% b' madwar 1. 22 u 1. 64%.
At least 64% of the patients treated were classified as ‘ responders’, since their HbA1c levels either fell by at least 0.6% from the baseline value over the course of the studies, or their HbA1c levels were 6.1% or less at the end of the studies.
Ta 'l- anqas 64% tal- pazjenti ttrattati kienu kklassifikati bħala' responders ', peress li l- livell tal- HbA1c tagħhom waqa' b' ta 'l- inqas 0. 6% mill- valur tal- linja bażi matul iż- żmien ta' l- istudji, jew l- livelli ta 'HbA1c tagħhom kienu 6. 1% jew inqas fi tmiem l- istudji.
What is the risk associated with Tandemact?
X' inhu r- riskju assoċjat ma 'Tandemact?
The most common side effects with Tandemact (seen in between 1 and 10 patients in 100) are weight gain, dizziness, flatulence (gas) and oedema (swelling).
L- aktar effetti sekondarji komuni b' Tandemact (li jidhru f' madwar pazjent 1 u 10 minn kull 100) huma żieda fil- piż, sturdament, flatulenza (gass) u edema (nefħa).
For the full list of all side effects reported with Tandemact, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha irrapportati b' Tandemact, ara l- Fuljett ta' Tagħrif.
Tandemact should not be used in people who may be hypersensitive (allergic) to pioglitazone, glimepiride or any of the other ingredients, or to other sulphonylureas or to sulphonamides.
Tandemact m' għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal pioglitazone, glimepiride jew għal xi sustanza oħra tiegħu, jew għal sulfonilurej oħra jew għas- sulfonamidi.
It should not be used in patients who have heart failure, problems with their liver or severe problems with their kidneys.
M' għandux jintuża f' pazjenti li għandhom insuffiċjenza kardijaka, problemi bil- fwied tagħhom jew problemi serji bil- kliewi tagħhom.
It should not be used in patients with type 1 diabetes (insulin-dependent diabetes), patients who have complications of diabetes (diabetic ketoacidosis or diabetic coma), or women who are pregnant or breast-feeding.
M' għandux jintuża f' pazjenti b' dijabete tat- tip 1 (dijabete dipendenti fuq l- insulina), pazjenti li għandhom kumplikazzjonijiet tad- dijabete (ketoaċidożi dijabetika jew koma dijabetika), jew nisa li huma tqal jew qed irreddgħu.
Doses of Tandemact may need to be adjusted when given with some other medicines.
Id- dożi ta 'Tandemact jistgħu jeħtieġu li jiġu aġġustati meta mogħtija ma' xi mediċini oħra.
The full list of these medicines is available in the Summary of Product Characteristics, which is also part of the EPAR.
Il- lista sħiħa ta 'dawn il- mediċini tinsab fis- Sommarju tal- Karatteristiċi tal- Prodott, li hija ukoll parti mill - EPAR.
Why has Tandemact been approved?
Għaliex ġie approvat Tandemact?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the effectiveness of pioglitazone and glimepiride in type 2 diabetes had been shown, and that Tandemact simplifies treatment and improves the ability of patients to stick to their treatment when a combination of the two active substances is needed.
Il- Kumitat għal Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) ikkonkluda li l- effikaċja ta 'pioglitazone u glimepiride f' dijabete tat- tip 2 intweriet, u li Tandemact jissimplifika t- trattament u jtejjeb il- kapaċità tal- pazjenti li jżommu mat- trattament tagħhom meta tkun meħtieġa kombinazzjoni ta' żewġ sustanzi attivi.
The Committee decided that Tandemact’ s benefits are greater than its risks for the treatment of type 2 diabetes in patients who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.
Il- Kumitat iddeċieda li l- benfiċċji ta 'Tandemact huma akbar mir- riskji tiegħu għat- trattament tad- dijabete tat- tip 2 f' pazjenti li juru intolleranza għal metformina jew li għalihom il - metformina hija kontraindikata u li huma diġà ttrattati b' kombinazzjoni ta' pioglitazone u glimepiride.
The Committee recommended that Tandemact be given marketing authorisation.
Il- Kumitat irrakkomanda li Tandemact jingħata awtorizzazzjoni għat- Tqegħid fis- Suq.
Other information about Tandemact:
Tagħrif ieħor dwar Tandemact:
The European Commission granted a marketing authorisation valid throughout the EU for Tandemact to Takeda Global Research and Development Centre (Europe) Ltd on 8 January 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Tandemact valida fl- Unjoni Ewropea kollha lil Takeda Global Research and Development Centre (Europe) Ltd fit- 8 ta 'Jannar 2007.
The full EPAR for Tandemact is available here.
L- EPAR sħiħ għal Tandemact jista 'jiġi kkonsultat hawn.
Route of Administration
Għamla farmaċewtika Mnejn jingħata Il- pakkett
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Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu) Pillola Użu orali Folja (alu/ alu)
Tandemact 30 mg/ 2 mg tablets.
Pilloli Tandemact 30 mg/ 2 mg.
Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 2 mg of glimepiride.
Kull pillola fiha 30 mg ta ’ pioglitazone (bħala hydrochloride) u 2 mg glimepiride.
Excipient:
Sustanzi oħra:
Each tablet contains approximately 125 mg lactose monohydrate.
Kull pillola fiha madwar 125 mg lattosju monohydrate.
White to off-white, round, convex and embossed ‘ 4833 G’ on one face and ‘ 30/ 2’ on the other.
Il- pilloli huma bojod għal abjad maħmuġ, tondi, konvessi u mmarkati b ’ ‘ 4833 G ’ fuq naħa u b ’ ‘ 30/ 2 ’ fuq in- naħa l- oħra.
Tandemact is indicated for the treatment of patients with type 2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.
Tandemact huwa ndikat għall- kura ta ’ pazjenti b’ dijabete mellitus tat- tip 2 li juru ntolleranza għal metformin jew għal dawk li metformin huwa kontra- indikat u li diġà huma kkurati b’ taħlita ta ’ pioglitazone u glimepiride.
The tablets are taken orally once daily shortly before or with the first main meal.
Il- pilloli huma meħuda mill- ħalq ftit qabel jew ma ’ l- ewwel ikla prinċipali.
The tablets should be swallowed whole with some liquid.
Il- pilloli għandhom jinbelgħu sħaħ ma ’ ftit likwidu.
If patients report hypoglycaemia, the dose of Tandemact should be reduced or free combination therapy should be considered.
Jekk il- pazjenti jirrappurtaw ipogliċemija, id- doża ta ’ Tandemact għandha titnaqqas jew għandha tiġi kkunsidrata terapija kombinata ħielsa.
If patients are receiving pioglitazone in combination with a sulphonylurea other than glimepiride, patients should be stabilised with concomitant pioglitazone and glimepiride before switching to Tandemact.
Jekk il- pazjenti qed jirċievu pioglitazone f’ taħlita ma ’ sulphonylurea minbarra glimepiride, il- pazjenti għandhom jiġu stabbilizzati b’ terapija ta ’ pioglitazone u glimepiride fl- istess ħin qabel ma jinqalbu fuq Tandemact.
Tandemact should not be used in patients with severe renal function disorders (creatinine clearance < 30 ml/ min, see section 4.3).
Tandemact m’ għandux jintuża f’ pazjenti b’ disturbi serji fil- funzjoni renali (tneħħijja ta ’ creatinine < 30 ml/ min, ara sezzjoni 4. 3).
Tandemact should not be used in patients with hepatic impairment (see section 4.3).
Tandemact m’ għandux jintuża f’ pazjenti b’ indeboliment epatiku (ara sezzjoni 4. 3).
Tandemact is not recommended for use in patients below age 18 due to insufficient data on safety and efficacy.
Tandemact mhux rakkomandat għall- użu f’ pazjenti taħt l- eta ’ ta ’ 18- il sena minħabba tagħrif insuffiċjenti dwar is- sigurtà u l- effikaċja.
Tandemact is contraindicated in patients with:
Tandemact huwa kontra- indikat f’ pazjenti b ’:
- Hypersensitivity to the active substances, or to any of the excipients, or other sulphonylureas or
- Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi, jew għal
sulphonamides
sulphonylureas jew sulphonamides oħra
- Type 1 diabetes mellitus
- Dijabete mellitus tat- tip I
- Diabetic coma
- Koma dijabetika
- Diabetic ketoacidosis
- Ketoaċidożi dijabetika
- Severe renal function disorders
- Disturbi severi fil- funzjoni renali
- Pregnancy
- Tqala
There is no clinical trial experience of other oral anti-hyperglycaemic agents added to treatment with Tandemact or concomitantly administered glimepiride and pioglitazone.
M’ hemmx esperjenza minn prova klinika ta ’ aġenti anti- ipergliċemiċi oħra miżjuda ma ’ kura b’ Tandemact jew ma ’ l- għotja fl- istess ħin ta ’ glimepiride u pioglitazone.
When meals are taken at irregular hours or skipped altogether, treatment with Tandemact may lead to hypoglycaemia due to the sulphonylurea component.
Meta l- ikliet jittieħdu f’ sigħat irregolari jew jinqabżu għal kollox, kura b’ Tandemact tista ’ twassal għal ipogliċemija minħabba l- komponent ta ’ sulphonylurea.
Symptoms can almost always be promptly controlled by immediate intake of carbohydrates (sugar).
Is- sintomi jistgħu jiġu kkontrollati minnufih kważi dejjem b’ teħid immedjat ta ’ karboidrati (żokkor).
Artificial sweeteners have no effect.
Sweeteners arifiċjali m’ għandhom l- ebda effett.
It is known from other sulphonylureas that, despite initially successful countermeasures, hypoglycaemia may recur.
Minn sulphonylureas oħra, huwa magħruf li minkejja li l- miżuri ta ’ kontroll li jittieħdu, ikollhom suċċess fil- bidu, ipogliċemija tista ’ terġa sseħħ.
Severe hypoglycaemia or prolonged hypoglycaemia, only temporarily controlled by the usual amounts of sugar, require immediate medical treatment and occasionally hospitalisation.
Ipogliċemija severa jew ipogliċemija mtawwla, kkontrollata temporanjament biss mill- kwantitajiet tas- soltu ta ’ żokkor, jinħtieġu kura medika immedjata u kull tant żamma l- isptar.
Treatment with Tandemact requires regular monitoring of glycaemic control.
Kura b’ Tandemact tinħtieġ sorveljanza regolari tal- kontroll gliċemiku.
When treating patients who have at least one risk factor for development of congestive heart failure (e. g. prior myocardial infarction or symptomatic coronary artery disease), physicians should start with the lowest available dose of pioglitazone and increase the dose gradually.
Meta jiġu kkurati pazjenti li għandhom ta ’ l- inqas fattur ta ’ riskju wieħed għall- iżvilupp ta ’ insuffiċjenza tal- qalb konġestiva (e. ż. infart mijokardijaku minn qabel jew marda sintomatika ta ’ l - arterji koronarji), it- tobba għandhom jibdew bl- inqas doża disponibbli ta ’ pioglitazone u jżidu d- doża bil- mod.
Patients should be observed for signs and symptoms of heart failure, weight gain or oedema, particularly those with reduced cardiac reserve.
Il- pazjenti għandhom jiġu osservati għal sinjali u sintomi ta ’ insuffiċjenza tal- qalb, żieda fil - piż jew edima, speċjalment dawk b’ riserva kardijaka mnaqqsa.
There have been cases of cardiac failure reported from the market when pioglitazone was used in combination with insulin. or in patients with a history of cardiac failure.
Kien hemm każijiet ta ’ insuffiċjenza kardijaka rrappurtati mis- suq meta pioglitazone intuża flimkien ma ’ l- insulina jew f’ pazjenti b’ passat ta ’ insuffiċjenza kardijaka.
Since insulin and pioglitazone are associated with fluid retention, concomitant administration may increase the risk of oedema.
Minħabba li insulina u pioglitazone huma assoċjati ma ’ żamma ta ’ fluwidu, l- għotja flimkien tista ’ żżid ir- riskju ta ’ edema.
Tandemact should be discontinued if any deterioration in cardiac state occurs.
Tandemact għandu jitwaqqaf jekk iseħħ xi deterjorament fl- istat kardijaku.
There have been rare reports of hepatocellular dysfunction during post-marketing experience with pioglitazone and glimepiride (see section 4.8).
Kien hemm rapporti rari ta ’ disfunzjoni epatoċellolari waqt l- esperjenza ta ’ wara t- tqegħid fis- suq b’ pioglitazone u glimepiride (ara sezzjoni 4. 8).
It is recommended, therefore, that patients treated with Tandemact undergo periodic monitoring of liver enzymes.
Għalhekk, huwa rakkomandat li, pazjenti kkurati b’ Tandemact jagħmlu sorveljanza perjodika ta ’ l- emżimi tal- fwied.
Liver enzymes should be checked prior to the initiation of therapy with Tandemact in all patients.
3 ċċekkjati qabel ma tinbeda terapija b’ Tandemact f’ kull pazjent.
Therapy with Tandemact should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 X upper limit of normal) or with any other evidence of liver disease.
Terapija b’ Tandemact m’ għandiex tinbeda f’ pazjenti b’ livelli ta ’ l- enżimi tal- fwied fil- linja bażika miżjuda (ALT > 2. 5 X l- għola limitu tan- normal) jew b’ xi evidenza oħra ta ’ mard tal- fwied.
3 Following initiation of therapy with Tandemact, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
Wara l- bidu tat- terapija b’ Tandemact, huwa rakkomandat li l- enżimi tal- fwied ikunu sorveljati perjodikament ibbażat fuq ġudizzju kliniku.
If ALT levels are increased to 3 X upper limit of normal during Tandemact therapy, liver enzyme levels should be reassessed as soon as possible.
Jekk il- livelli ta ’ ALT jiżdiedu sa 3 X l- għola limitu tan - normal waqt it- terapija b’ Tandemact, il- livelli ta ’ l- enżimi tal- fwied għandhom jerġu jiġu ċċekkjati mill- aktar fis possibli.
If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/ or dark urine, liver enzymes should be checked.
Jekk xi pazjent jiżviluppa sintomi li jissuġġerixxu disfunzjoni epatika, li jistgħu jinkludu tqallih mhux spjegat, rimettar, uġigħ addominali, għeja, anoressija u/ jew awrina skura, l - enżimi tal- fwied iridu jiġu ċċekkjati.
The decision whether to continue the patient on therapy with Tandemact should be guided by clinical judgement pending laboratory evaluations.
Id- deċiżjoni dwar jekk il- pazjent għandux jitkompla bit- terapija b’ Tandemact għandha tiġi ggwidata minn ġudiżżju kliniku sakemm isiru l- valutazzjonijiet tal - laboratorju.
If jaundice is observed, therapy with Tandemact should be discontinued.
Jekk tkun osservata s- suffejra, it- terapija b’ Tandemact għandha titwaqqaf.
Weight gain:
Żieda fil- piż:
In clinical trials with pioglitazone and sulphonylurea monotherapy or in combination there was evidence of dose related weight gain, which may be due to fat accumulation and in some cases associated with fluid retention.
Fi provi kliniċi b’ monoterapija jew b’ taħlita ta ’ pioglitazone u sulphonylurea kien hemm evidenza ta ’ żieda fil- piż relatata mad- doża, li tista ’ tkun minħabba akkumulazzjoni ta ’ xaħam u f’ xi każijiet assoċjata ma ’ żamma ta ’ fluwidu.
In some cases weight increase may be a symptom of cardiac failure therefore weight should be closely monitored.
F’ xi każijiet żieda fil- piż tista ’ tkun sintomu ta ’ insuffiċjenza kardijaka, għalhekk il- piż għandu jiġi sorveljat mill- viċin.
Part of the treatment of diabetes is dietary control.
Parti mill- kura ta ’ dijabete hija kontroll tad - dieta.
Rare changes in haematology have been observed with glimepiride treatment (see section 4.8).
Tibdiliet rari fl- ematoloġija kienu osservati b’ kura b’ glimepiride (ara sezzjoni 4. 8).
Treatment with Tandemact therefore requires regular haematological monitoring (especially leucocytes and platelets).
Għalhekk kura b’ Tandemact tinħtieġ sorveljanza ematoloġika regolari (speċjalment il- lewkoċiti u l- plejtlits).
During therapy with pioglitazone there was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction), consistent with haemodilution.
Kien hemm tnaqqis żgħir fil- medja ta ’ l- emoglobina (tnaqqis relattiv ta ’ 4%) u l- ematokrita (tnaqqis relattiv ta ’ 4. 1%) konsistenti ma ’ emodiluzzjoni, waqt terapija b’ pioglitazone.
Similar changes were seen in metformin (haemoglobin 3 - 4% and haematocrit 3.6 – 4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1 – 2% and haematocrit 1 – 3.2% relative reductions) treated patients in comparative controlled trials with pioglitazone.
Tibdiliet simili dehru fi provi komparattivi kkontrollati b’ pioglitazone f’ pazjenti kkurati b’ metformin (tnaqqis relattiv fl - emoglobina ta ’ 3 - 4% u fl- ematokrita ta ’ 3. 6 – 4. 1%) u fi kwantità inqas b’ sulphonylurea u insulina (tnaqqis relattiv fl- emoglobina ta ’ 1 – 2% u fl- ematokrita ta ’ 1 – 3. 2%).
Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to haemolytic anaemia.
Kura ta ’ pazjenti b’ nuqqas ta ’ G6PD b’ sustanzi minn sulfonylurea tista ’ twassal għal anemija emolitika.
Since glimepiride belongs to the chemical class of sulfonylurea drugs, caution should be used in patients with G6PD-deficiency and a non-sulfonylurea alternative should be considered.
Minħabba li glimepiride jagħmel parti mill- klassi kimika ta ’ mediċini minn sulfonylurea, ġħandha tittieħed kawtela f’ pazjenti b’ nuqqas ta ’ G6PD u għandha tiġi kkunsidrata alternattiva mhux sulfonylurea.
Eye disorders:
Mard fl- għajnejn:
Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Rapporti ta ’ wara t- tqegħid fis- suq ta ’ żvilupp ġdid jew irkadar ta ’ edema makulari dijabetika bi tnaqqis fl- akutezza viżiva kienu rrappurtati b’ thiazolidinediones, inkluż pioglitazone.
Many of these patients reported concurrent peripheral oedema.
Ħafna minn dawn il- pazjenti rrappurtaw edema periferali fl- istess ħin.