qanastek/EMEA-V3 huggingface dataset:
Injecting Water For Injections Into Fuzeon Powder
Kif Tinjetta l- Ilma għall- Injezzjonijiet fit- Trab Fuzeon
● Gently tap the vial of Fuzeon to loosen the powder.
● Tektek il- kunjett ta ’ Fuzeon bil- mod biex it- trab ma jibqax magħqud.
● Hold the water-filled syringe by the barrel and push the needle through the rubber top of the vial at a slight angle.
● Żomm is- siringa mimlija bl- ilma miċ- ċilindru u mbotta l- labra, ftit angolata, minn ġol- wiċċ tal - gomma tal- kunjett.
59 Press the syringe plunger in slowly.
Agħfas il- plunġer tas- siringa bil- mod.
Allow the water to flow slowly down the inside of the vial.
Ħalli l- ilma jiġri bil- mod ġewwa l- kunjett.
Be careful not to forcefully shoot water into the powder, since this can cause foaming.
Ara li ma tisparax l- ilma bis- saħħa fit- trab għax dan jista ’ jifforma r- rgħawa.
If foaming occurs, it may take longer for the powder to dissolve completely.
Jekk ikun hemm ir- rgħawa, t- trab jista ’ jieħu aktar żmien biex jinħall għal kollox.
● After all of the sterile water for injections has been added to the vial of Fuzeon, remove the syringe from the vial.
● Wara li l- ilma sterili għall- injezzjonijiet kollu jkun ġie miżjud mal- kunjett ta ’ Fuzeon, neħħi s - siringa mill- kunjett.
● Hold the barrel of the syringe with one hand and gently press the coloured needle protection device down on a flat surface until it covers the needle.
● B’ id waħda żomm is- siringa miċ- ċilindru u bil- mod imbotta l- apparat tas- sigurtà kkulurit ’ l isfel fuq wiċċ ċatt sakemm jgħatti l- labra.
You will hear a click.
Se tisimgħu ifaqqa ’.
Do not use your free hand to press the device over the needle.
Tużax idek l- oħra biex tagħfas l - apparat fuq il- labra.
● Throw away the syringe into a dedicated waste container.
● Armi s- siringa fil- kontenitur maħsub apposta għall- iskart.
Mixing the Water with the Fuzeon Powder
It- Taħlit ta ’ l- Ilma mat- Trab Fuzeon
● Gently tap the vial with your fingertip until the powder begins to dissolve.
● Tektek il- kunjett bil- mod bil- ponta ta ’ subgħajk sakemm it- trab jibda jinħall.
Never shake the vial or turn it upside down to mix—this will cause excessive foaming.
Qatt m’ għandek tħawwad it- taħlita, jew iddawwarha rasha 'l isfel – dawn iwasslu biex tifforma ħafna rgħawa.
After the powder begins to dissolve you can set the vial aside to allow it to completely dissolve.
Wara li t- trab jibda jinħall, tista ’ tħalli l- kunjett waħdu biex ikompli jinħall għal kollox.
The powder may take up to 45 minutes to dissolve in to solution.
It- trab jista 'jieħu sa 45 minuta biex jinħall f’ soluzzjoni.
The vial can also be gently rolled between your hands after adding the water for injections until it is fully dissolved and this may reduce the time it takes for the powder to dissolve.
Wara li żżid l- ilma għall - injezzjonijiet tista ’ ukoll tgerbeb il- kunjett bejn idejk sakemm jinħall għal kollox u dan jista ’ jnaqqas il- ħin li t- trab jieħu biex jinħall.
● If you accidentally touch the rubber stopper, be sure to clean it again with a new alcohol swab.
● Jekk bi żball tmiss it- tapp tal- gomma, ara li tnaddfu għal darb’ oħra b’ imselħa bl- alkoħol ġdida.
● Make sure the powder has dissolved completely, allowing any bubbles that may have formed to settle.
● Ara li t- trab inħall għal kollox, u li xi bżieżaq li seta ’ kien hemm ikunu qagħdu.
If bubbles still exist, gently tap the side of the vial to help settle them.
Jekk għad hemm xi bżieżaq, tektek il- ġenb tal- kunjett bil- mod biex tgħinhom joqgħodu.
● As with all injectable medicines, it is important to inspect the solution for particles.
60 ● Bħal kull mediċina li tiġi injettata, huwa importanti li tispezzjona s- soluzzjoni għal xi frak.
If you notice any particles in the solution, do not use it.
Jekk tara xi frak fis- soluzzjoni, tużahiex.
You should throw away the vial into the dedicated waste container with a lid or return it to the pharmacy.
Għandek tarmi l- kunjett fil- kontenitur bl- għatu maħsub apposta għar- rimi jew teħodha lura l- ispiżerija.
Start again with a new vial of Fuzeon powder.
Erġa ’ ibda b’ kunjett ġdid ta ’ trab Fuzeon.
● Once a dose is mixed with water for injections, it must be used immediately or stored in a refrigerator and used within 24 hours.
● Meta doża titħallat ma ’ l- ilma għall- injezzjonijiet, din għandha tintuża minnufih jew tinħażen fi friġġ u tintuża fi żmien 24 siegħa.
Allow the solution to return to room temperature before using.
Ħalli s- soluzzjoni terġa ’ tiġi għat- temperatura tal- kamra qabel ma tużha.
● If you are preparing both of your daily doses at one time, be sure to use new syringes, water for injections, and Fuzeon for each dose.
● Jekk qed tipprepara ż- żewġ dożi ta ’ kuljum fl- istess ħin, ara li tuża siringi, ilma għall - injezzjonijiet, u Fuzeon ġodda għal kull doża.
60 STEP 3:
IT- TIELET PASS:
PREPARING FOR THE INJECTION
PREPARAZZJONI GĦALL- INJEZZJONI
Where to Inject
Fejn għandek Tinjetta
Injection sites include the abdomen, upper thighs, and upper arms.
Postijiet għall- injezzjoni jinkludu l- addome, n- naħa ta ’ fuq tal- koxox, u n- naħa ta ’ fuq tad- driegħ.
Each injection should be given at a site different from the last place you injected and never where there is still an injection site reaction from an earlier dose.
Kull injezzjoni għandha tingħata f’ post different mill- aħħar post użat għall- injezzjoni u qatt fejn għad hemm reazzjoni għall- injezzjoni minn doża ta ’ qabel.
You should not inject your medicine into moles, scar tissue, bruises or your navel.
M’ għandekx tinjetta l- mediċina f’ xi għazza, tessut taċ- ċikatriċi, tbenġil jew fiż- żokra.
Choose a different area from where you last injected yourself, and then check for any places where you may have a reaction (press the skin to see if there are any hard bumps).
Agħżel post differenti minn dak fejn injettajt ruħek id- darba ta ’ qabel, u ara jekk għandekx xi reazzjoni f’ xi postijiet (agħfas il- ġilda biex tara jekk hemmx xi għoqiedi iebsin).
It is much better to avoid these areas.
Ħafna aħjar li tevita dawn il- postijiet.
Also avoid areas that could become irritated by your belt or the waistline of your clothing.
Evita ukoll postijiet li jistgħu jkunu rritati minħabba ċ- ċinturin jew il- qadd tal - ħwejjeġ.
Cleansing the Injection Site
It- Tindif tal- Post ta ’ l- Injezzjoni
Cleanse the area for injection thoroughly with an alcohol swab in a circular motion, working outward.
Naddaf sew il- post ta ’ l- injezzjoni b’ imselħa bl- alkoħol b’ moviment ċirkolari, minn ġewwa għal barra.
Allow to air-dry completely.
Ħalli l- post jinxef għal kollox waħdu.
Drawing Up Fuzeon into the 1 ml Syringe
Ġbid ta ’ Fuzeon fis- siringa tal- 1 ml
● Wipe the top of the Fuzeon vial again with a new alcohol swab.
● Erġa ’ imsaħ in- naħa ta ’ fuq tal- kunjett Fuzeon b’ imselħa bl- alkoħol ġdida.
Pick up the 1 ml small syringe.
Iġbor is- siringa ż- żgħira tal- 1 ml.
Using your index finger, push back the coloured needle protection device towards the syringe.
B’ subgħek il- werrej, imbotta l- apparat tas- sigurtà kkulurit tal- labra lura lejn is- siringa.
To remove the clear plastic cap push towards the syringe and then pull the cap off.
Biex tneħħi l- għatu trasparenti tal- plastik imbotta lejn is- siringa u wara iġbed u aqla ’ t- tapp.
Draw back 1 ml of air.
61 Iġbed 1 ml arja.
Be careful not to pull the plunger too fast past the 1 ml marker and/or out of the barrel.
Oqgħod attent li ma tiġbidx il- planġer malajr iżżejjed u tgħaddi l- marka ta '1 ml u/ jew tiġbdu ’ l barra mis- siringa.
Insert the syringe needle into the rubber top of the Fuzeon vial and press the plunger, injecting the air.
Daħħal is- siringa minn ġol- wiċċ tal- gomma tal- kunjett Fuzeon u injetta l- arja billi tagħfas il- plunġer.
Gently turn the vial upside down.
Bil- mod dawwar il- kunjett rasu 'l isfel.
Make sure the tip of the needle is always below the surface of the solution to help keep air bubbles from entering the syringe.
Ara li l- ponta tal- labra tibqa ’ dejjem taħt il- wiċċ tas- soluzzjoni biex tgħin biex bżieżaq ta ’ l- arja ma jidħlux fis- siringa.
Slowly pull back the plunger until the solution reaches the 1.0 ml mark.
Iġbed lura il- plunġer bil- mod sakemm is- soluzzjoni tilħaq il- marka ta ’ 1 ml.
Be careful not to pull the plunger too fast past the 1 ml marker and/or out of the barrel.
Oqgħod attent li ma tiġbidx il- planġer malajr iżżejjed u tgħaddi l- marka ta '1 ml u/ jew tiġbidha ’ l barra mis- siringa.
61 ● Tap the syringe gently to make any air bubbles rise to the top.
● Tektek is- siringa bil- mod biex jekk hemm xi bżieżaq ta ’ l- arja jitilgħu fil- wiċċ
● If excess air enters the syringe, gently press the plunger to inject the air back into the vial and withdraw the solution again, making sure you have 1.0 ml of solution in the syringe (whatever volume your doctor prescribed, if different).
● Jekk arja żejda tidħol fis- siringa, agħfas il- plunġer bil- mod biex tinjetta lura l- arja fil- kunjett u mbagħad erġa ’ iġbed is- soluzzjoni, u kun żgur li għandek 1. 0 ml ta ’ soluzzjoni fis- siringa (jew il- volum li ordnalek it- tabib tiegħek, jekk differenti).
This step may be repeated until the correct amount of solution is in the syringe.
Dan il- pass jista ’ jiġi ripetut sakemm fis - siringa jkun hemm l- ammont tajjeb ta ’ soluzzjoni.
● Remove the syringe from the vial.
● Neħħi s- siringa minn mal- kunjett.
STEP 4:
IR- RABA ’ PASS:
INJECTING FUZEON
INJEZZJONI TA ’ FUZEON
Tip:
Parir:
Your healthcare provider may suggest different injection techniques that will work best for you.
Min jagħtik s- servizzi tas- saħħa jista ’ jissuġġerixxi metodi għall- injezzjoni differenti li
Pinch as much of a skin fold as possible without making yourself uncomfortable.
Oqros kemm tista ’ ġilda mingħajr ma tħossok skomdu/ a
● Pierce the skin at a 45-degree angle.
● Taqqab il- ġilda b’ angolu ta ’ 45 grad
When the needle is in, release the skin, and using the same hand, hold on to the syringe barrel to help steady it and prevent shifting.
62 Meta tidħol il- labra, ħalli l- ġilda u, bl- istess id, żomm iċ- ċilindru tas- siringa biex tgħinha żżomm sod u biex ma tkunx tista ’ tiċċaqlaq.
● Using the thumb, depress the plunger in to inject the solution.
● B’ subgħajk il- kbir, injetta s- soluzzjoni billi tagħfas il- plunġer.
After the dose is fully delivered, remove the needle from the skin.
Wara li tingħata d- doża kollha, neħħi l- labra mill- ġilda.
62 ● Throw away the syringe into a dedicated waste container with a lid.
● Armi s- siringa f’ kontenitur bl- għatu maħsub apposta għall- iskart.
● Cover the injection site with a sticking plaster if any blood is present.
● Jekk ikun hemm xi demm, għatti l- post ta ’ l- injezzjoni b’ impastru li jeħel.
STEP 5:
IL- ĦAMES PASS:
DISPOSING OF USED SUPPLIES
IR- RIMI TA ’ OĠĠETTI UŻATI
Throw away all used syringes directly into the dedicated waste container with a lid.
Armi s- siringi użati kollha direttament fil- kontenitur bl- għatu maħsub apposta għall- iskart.
Keep the cover of this container tight and keep the dedicated waste container with a lid out of the reach of children.
Żomm l - għatu ta ’ dan il- kontenitur magħluq sew u żomm il- kontenitur b’ għatu maħsub apposta għall- iskart fejn ma jintlaħaqx mit- tfal.
Check with your doctor or pharmacist about proper disposal of the container.
Tkellem mat- tabib jew spiżjar tiegħek dwar ir- rimi xieraq tal- kontenitur.
In addition, you should safely dispose of all used alcohol swabs and vials, even if the vials contain unused amounts of medicine or water for injections.
Barra minn dan għandek tarmi l- imsielaħ bl- alkoħol u l- kunjetti kollha, anke jekk il- kunjetti jkollhom xi ammonti mhux użat ta ’ mediċina jew ilma għall- injezzjonijiet.
The vials of Fuzeon and water for injections should only be used once.
Il- kunjetti ta ’ Fuzeon u ta ’ l- ilma għall- injezjzonijiet għandhom jintużaw darba biss.
Used supplies other than syringes (alcohol swabs and empty vials) may be disposed of into the rubbish as long as no blood is visible.
Oġġetti użati li m’ humiex siringi (msielaħ bl - alkoħol u kunjetti vojta) jistgħu jintremew fiż- żibel sakemm m’ hemmx xi demm viżibli.
If blood is visible, dispose of the items into the dedicated waste container with a lid.
Jekk hemm xi demm viżibli, armi l- oġġetti fil- kontenitur b’ għatu maħsub apposta għall- iskart.
If you have any questions or concerns about the safe disposal of these materials, please call your doctor or pharmacist.
Jekk għandek xi mistoqsijiet dwar ir- rimi mingħajr riskju ta ’ dawn l- oġġetti, jekk jogħġbok tkellem mat- tabib jew ma ’ l- ispiżjar tiegħek.
63 PACKAGE LEAFLET:
63 FULJETT TA ’ TAGĦRIF:
Fuzeon 90 mg/ml powder for solution for injection Enfuvirtide
Fuzeon 90 mg/ ml trab għal soluzzjoni għall- injezzjoni Enfuvirtide
them, even if their symptoms are the same as yours.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollom l- istess sintomi bħall tiegħek.
What Fuzeon is and what it is used for 2.
X’ inhu Fuzeon u għal xiex jintuża 2.
How to store Fuzeon 6.
Kif taħżen lFuzeon 6.
This means that the HIV cannot enter the cell and then it cannot multiply.
Dan ifisser li l- HIV ma jkunx jista jidħol fiċ- ċellula u għalhekk ma jkunx jista jitkattar.
Your doctor has prescribed Fuzeon to help control your HIV infection.
It- tabib tiegħek ordnalek Fuzeon biex jgħinek tikkontrolla l - infezzjoni ta ’ l- HIV tiegħek.
BEFORE YOU USE FUZEON
QABEL MA TIEĦU FUZEON
- if you are allergic (hypersensitive) to enfuvirtide or any of the other ingredients of Fuzeon (see
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal enfuvirtide jew sustanzi oħra ta ’
section 6).
Fuzeon (ara sezzjoni 6).
64 In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
64 F’ xi pazjenti b’ infezzjoni ta ’ l- HIV avvanzata (AIDS) u b’ passat ta ’ infezzjonijiet opportunistiċi, jistgħu jseħħu sinjali u sintomi ta ’ infjammazjoni minn infezzjonijiet ta ’ qabel ftit wara li tinbeda l - kura anti- HIV.
It is believed that these symptoms are due to a recovery of the body’s immune system.
Huwa maħsub li dawn is- sintomi jseħħu minħabba rkupru tas- sistema immuni tal - ġisem.
The usual dose is 90 mg twice a day, given as a l ml subcutaneous (just below the skin) injection.
Id- doża normali hija ta '90 mg darbtejn kuljum, mogħtija permezz ta ’ injezzjoni ta ’ 1 ml minn taħt il- ġilda (eżatt taħt il- ġilda).
If you forget to take Fuzeon Take the dose as soon as you remember and then take your next dose at its regular time.
65 Jekk tinsa tieħu Fuzeon: Ħu d- doża malli tiftakar u wara ħu d- doża li jmiss f' ħinha.
Like all medicines, Fuzeon can cause side effects, although not everybody gets them.
Bħall kull mediċina oħra, Fuzeon jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
It is important for you to tell your doctor if you develop a cough with a high temperature, very fast breathing and/or shortness of breath as these symptoms may mean you are developing pneumonia.
Huwa importanti li tgħarraf lit- tabib tiegħek jekk taqbdek xi sogħla bid- deni, nifs mgħaġġel ħafna u/ jew qtugħ ta ’ nifs peress li dawn is- sintomi jistgħu jfissru li qed tiżviluppa pnewmonja.
Common side effects (affects 1 to 10 users in 100) are: ● inflammation of the sinuses (cavities in the forehead), ● local swelling on the skin, ● reactions at injection sites ● pneumonia, ● ear infection, ● swollen glands, ● decreased appetite, ● anorexia, ● increased blood fat values, ● diabetes, ● feeling anxious or irritated, ● nightmares, ● feeling dizzy, ● lack of concentration, ● tremor (shaking), ● inflamed eye lids, ● nasal congestion, ● inflammation of the pancreas, ● heart burn, ● dry skin, ● eczema, ● redness of the skin,
Effetti sekondarji komuni (jaffettwaw persuna waħda sa 10 minn kull 100 li qed jużawh) huma • infjammazzjoni tas- sinusis (spazji fil- ġbin), • nefħa lokalizzata fil- ġilda, • reazzjonijiet fil- post tal- injezzjoni, • pnewmonja, • infezzjoni tal- widnejn, • glandoli minfuħin, • nuqqas ta ’ aptit, • anoreksja, • żieda fil- valuri tax- xaħam fid- demm, • dijabete, • tħossok ansjuż jew irritat, • inkubi, • sturdament, • nuqqas ta ’ konċentrazzjoni, • rogħda (tregħid), • nefħa ta 'tebqet il- għajn, • imnieħer miżdud,
● ● ● ● ● ●
• • • • • • • • • • •
acne, muscle pain, kidney stones, 'flu-like' symptoms, feeling weak blood in the urine.
infjammazzjoni tal- frixa, ħruq ta ’ stonku, ġilda xotta, ekżema, ħmura fil- ġilda, akne, uġigħ fil- muskoli, ġebla fil- kliewi, sintomi ‘ jixbħu lill- influwenza ’, tħossok dgħajjef, demm fl- urina.
HOW TO STORE FUZEON
KIF TAĦŻEN FUZEON.
Do not use Fuzeon after the expiry date which is stated on the label of the Fuzeon Vials after EXP.
Tużax Fuzeon wara d- data ta ’ skadenza li tidher fuq it- tikketta tal- kunjett ta ’ Fuzeon wara JIS.
Do not use Fuzeon if you notice any particles in the powder or the solution once the water for injections has been added.
Tużax Fuzeon jekk tara xi frak fit- trab jew fis- soluzzjoni wara li tkun żidt l- ilma għall- injezzjoni.
with the solvent 1 ml of reconstituted solution contains 90 mg enfuvirtide.
Is- sustanzi l- oħra huma:
Sodium Carbonate, anhydrous Mannitol Sodium Hydroxide Hydrochloric Acid
Sodium Carbonate, anhydrous Mannitol Sodium Hydroxide Hydrochloric Acid
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.
Dan il- prodott mediċinali fih inqas minn 1 mmol sodju (23 mg) kull doża, jiġġiefieri essenzjalment ‘ mingħajr sodju ’.
What Fuzeon looks like and contents of the pack
Id- Dehra ta ’ Fuzeon u l- kontenuti tal- pakkett:
Fuzeon powder for solution for injection comes in a carton containing 60 vials of your medicine.
Fuzeon trab għal soluzzjoni għall- injezzjoni jiġu f’ pakkett li fih 60 kunjett tal- mediċina tiegħek.
67 Marketing Authorisation Holder
67 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
HOW TO USE FUZEON
KIF TUŻA FUZEON
The usual dose is 90 mg twice a day, given as a 1 ml subcutaneous (just below the skin) injection into the upper arm, anterior thigh or abdomen.
Id- doża tas- soltu hija ta ’ 90 mg darbtejn kuljum, mogħtija bħala injezzjoni ta ’ 1 ml minn taħt il - ġilda fin- naħa ta ’ fuq tad- driegħ, fin- naħa ta ’ quddiem tal- koxxa jew fl- addome.
Each injection should be given at a site different from the last place you injected and never where there is still an injection site reaction from an earlier dose.
Kull injezzjoni għandha tingħata f’ post differenti minn tad- darba ta ’ qabel u qatt fil- post fejn għad hemm reazzjoni għall- injezzjoni minħabba doża ta ’ qabel.
When to take Fuzeon It is best to take Fuzeon at the same time each day if you can.
Meta għandek tieħu Fuzeon Huwa aħjar li tieħu Fuzeon fl- istess ħin kuljum jekk tista ’.
How long should you take Fuzeon For?
Għal kemm żmien għandek tieħu Fuzeon?
This is when your
Hawn it -
69 doctor may decide to no longer keep treating you with Fuzeon.
69 tabib tiegħek jista ’ jiddeċiedi li ma jkomplix jikkurak aktar b’ Fuzeon.
● When handling syringes, do not touch the needle.
● Meta qed timmanniġġja s- siringi, tmissx il- labra.
● Make sure none of the items that you need for your injection have been opened.
● Kun ċert li l- ebda wieħed mill- oġġetti li għandek bżonn għall- injezzjoni tiegħek ma kienu miftuħa.
Do not use opened materials.
Tużax oġġetti miftuħa.
● Never mix your medicine with tap water.
● Qatt m’ għandek tħallat il- mediċina tiegħek ma ’ l- ilma tal- vit.
● Discard used syringes into your dedicated container with a lid for the safe disposal of waste materials.
● Armi s- siringi użati fil- kontenitur b’ għatu maħsub għall- iskart, għar- rimi sikur ta ’ materjal ta ’ skart.
STEP 1:
L- EWWEL PASS:
Gather all of the following supplies that you will need to prepare and give yourself an injection.
Iġbor l- oġġetti kollha li ser ikollok bżonn biex tipprepara u tagħti l- injezzjoni lilek innifsek.
You need to ask your pharmacist or doctor if you need to find out where to get the water for injections, the 3 ml and 1 ml syringes, alcohol swabs and dedicated waste container with a lid:
Għandek tistaqsi lill- ispiżjar jew lit- tabib tiegħek jekk għandek bżonn tkun taf minn fejn se ġġib l- ilma għall - injezzjonijiet, is- siringi ta '3 ml u 1 ml, imsielaħ bl- alkoħol u kontenitur b’ għatu maħsub biex tarmi l - iskart fih:
● One vial of Fuzeon
● Kunjett ta ’ Fuzeon
● One vial of water for injections
● Kunjett ta 'l- ilma għall- injezzjonijiet
● One 1 ml syringe (smaller syringe) with a 13 mm needle
● Siringa tal- 1 ml (is- siringa ż- żgħira) b’ labra ta ’ 13 mm
● 3 alcohol swabs
● 3 imsielaħ bl- alkoħol
● Dedicated waste container with a lid for the safe disposal of the waste materials.
70 ● Kontenitur b’ għatu maħsub għall- iskart għar- rimi sikur tal- materjal ta ’ skart
Open Syringe Packages and Remove Vial Caps
Iftaħ il- Pakketti tas- Siringa u l- Għotjien tal- Kunjett
70 ● Place syringes and vials onto a clean surface.
● Poġġi s- siringi u l - kunjetti fuq wiċċ nadif.
Let the tops air-dry.
● Imsaħ in- naħa ta ’ fuq ta ’ kull kunjett b’ imselħa bl- alkoħol ġdida.
● Be sure not to touch the rubber tops after cleaning them.
Ħalli l- kunjetti jinxfu b’ mod naturali. ● Kun ċert li ma tmissx l- uċuħ tal- gomma wara li tnaddafhom.
Remove the plastic cap and draw back 1.1 ml of air.
Neħħi t- tapp tal- plastik u iġbed lura 1. 1 ml arja.
Make sure the tip of the needle is always below the surface of the sterile water to help keep any air bubbles from entering the syringe.
Ara li l- ponta tal- labra tibqa ’ dejjem taħt il- wiċċ ta ’ l- ilma sterili għall - injezzjonijiet sabiex tgħin biex bżieżaq ta ’ l- arja ma jidħlux fis- siringa.
Slowly pull back the plunger until the water for injection reaches the 1.1 ml mark.
Iġbed il- plunġer lura bil- mod sakemm l- ilma għall- injezzjonijiet jilħaq is- sinjal ta ’ 1. 1 ml.
If excess air enters the syringe, gently press the plunger to force any air back into the vial and withdraw the water for injections again, making sure you have 1.1 ml of water for injections in the syringe.
Jekk arja żejda tidħol fis- siringa, agħfas il- plunġer bil- mod biex timbotta l- arja lura fil- kunjett u mbagħad iġbed l- ilma għall- injezzjonijiet għal darb’ oħra, u tkun żgur li jkollok 1. 1 ml ilma għall - injezzjonijiet fis- siringa.
● Remove the needle from the vial, making sure you never touch the needle with your fingers or any other object.
71 ● Neħħi l- labra mill- kunjett, u ara li qatt ma tmiss il- labra b’ subgħajk jew xi oġġett ieħor.
● Throw away the water for injections vial into the rubbish.
● Armi l- kunjett ta ’ l- ilma għall- injezzjonijiet fiż- żibel.
The water for injections vial is intended for single use only.
Il- kunjett ta ’ l- ilma għall- injezzjonijiet huwa maħsub għall- użu ta ’ darba biss.
Injecting Water for Injections Into the Fuzeon Powder
Kif - Tinjetta l- Ilma għall- Injezzjonijiet fit- Trab Fuzeon
71 ● Gently tap the vial of Fuzeon to loosen the powder.
● Tektek il- kunjett ta ’ Fuzeon bil- mod biex it- trab ma jibqax magħqud.
Hold the water-filled syringe by the barrel and push the needle through the rubber top of the Fuzeon vial at a slight angle.
Żomm is- siringa mimlija bl- ilma miċ- ċilindru u mbotta l- labra, ftit angolata, minn ġol- wiċċ tal- gomma tal- kunjett ta ’ Fuzeon.
Press the syringe plunger in slowly.
Agħfas il- plunġer tas- siringa bil- mod.
If foaming occurs, it may take longer for the powder to dissolve completely.
Jekk ikun hemm r- rgħawa, t- trab jista ’ jieħu aktar żmien biex jinħall għal kollox.
● After all of the water for injections has been added to the vial of Fuzeon, throw the syringe into a dedicated waste container.
● Wara li l- ilma għall- injezzjonijiet kollu jkun ġie miżjud mal- kunjett ta ’ Fuzeon, armi s- siringa f’ kontenitur bl- għatu maħsub għar- rimi ta ’ skart.
Mixing the Water For Injections with the Fuzeon Powder
It- Taħlit ta ’ l- Ilma għall- Injezzjonijiet mat- Trab ta ’ Fuzeon
Never shake the vial or turn it upside down to mix—this will cause excessive foaming.
Qatt m’ għandek tħawwad it- taħlita, jew iddawwarha rasha ‘ l isfel – dawn iwasslu biex tifforma ħafna rgħawa.
● As with all injectable medicines, it is important to inspect the solution for particles.
● Bħal kull mediċina li tiġi injettata, huwa importanti li tispezzjona s- soluzzjoni għal xi frak.
Start again with a new vial of Fuzeon Powder.
Erġa ’ ibda b’ kunjettġdid ta ’ Trab Fuzeon.
● Once a dose is mixed with water for injections, it must be used immediately or stored in a refrigerator and used within 24 hours.
● Meta d- doża titħallat ma ’ l- ilma għall- injezzjonijiet, din għandha tintuża minnufih jew tinħażen fi friġġ u tintuża fi żmien 24 siegħa.
● If you are preparing both of your daily doses at one time, be sure to use new syringes, water for injections and Fuzeon for each dose.
● Jekk qed tipprepara ż- żewġ dożi ta ’ kuljum fl- istess ħin, ara li tuża siringi, ilma għall - injezzjonijiet, u Fuzeon ġodda għal kull doża.
STEP 3:
72 IT- TIELET PASS:
Injection sites include the abdomen, upper thighs, and upper arms.
Fejn għandek Tinjetta Postijiet għall- injezzjoni jinkludu l- addome, n- naħa ta ’ fuq tal- koxox, u n- naħa ta ’ fuq tad- driegħ.
72 Choose a different area from where you last injected yourself, and then check for any places where you may have a reaction (press the skin to see if there are any hard bumps).
Agħżel post differenti minn dak fejn injettajt ruħek id- darba ta ’ qabel, u ara jekk għandekx xi reazzjoni f’ xi postijiet (agħfas il- ġilda biex tara jekk hemmx xi għoqiedi iebsin).
Drawing Up Fuzeon into the 1 ml syringe
Ġbid ta ’ Fuzeon fis- siringa tal- 1 ml
● Wipe the top of the Fuzeon vial again with a new alcohol swab.
● Erġa ’ imsaħ in- naħa ta ’ fuq tal- kunjett ta ’ Fuzeon b’ imselħa bl- alkoħol ġdida.
Remove the plastic cap and draw back 1 ml of air.
Neħħi t- tapp tal- plastik u iġbed lura 1 ml ta ’ arja.
Insert the syringe needle into the rubber top of the Fuzeon vial and press the plunger, injecting the air.
Daħħal is- siringa minn ġol- wiċċ tal- gomma tal- kunjett ta ’ Fuzeon u injetta l- arja billi tagħfas il - plunġer.
Slowly pull back the plunger until the solution reaches the 1.0 ml mark.
Iġbed lura l- plunġer bil- mod sakemm is- soluzzjoni tilħaq il- marka ta ’ 1 ml.
● Tap the syringe gently to make any air bubbles rise to the top.
● Tektek is- siringa bil- mod biex jekk hemm xi bżieżaq ta ’ l- arja jitilgħu fil- wiċċ
● If excess air enters the syringe, gently press the plunger to inject the air back into the vial and withdraw the solution again, making sure you have 1.0 ml of solution in the syringe (whatever volume your doctor prescribed, if different).
● Jekk arja żejda tidħol fis- siringa, agħfas il- plunġer bil- mod biex tinjetta lura l- arja fil- kunjett u mbagħad erġa ’ iġbed is- soluzzjoni, u kun żgur li għandek 1. 0 ml ta ’ soluzzjoni fis- siringa (jew, il- volum li ordnalek it- tabib tiegħek, jekk differenti).
This step may be repeated until the correct amount of solution is in the syringe.
Dan il- pass jista ’ jiġi rripetut sakemm fis - siringa jkun hemm l- ammont tajjeb ta ’ soluzzjoni.
STEP 4:
73 IR- RABA ’ PASS:
Your healthcare provider may suggest different injection techniques that will work best for you.
Min jagħtik s- servizzi tas- saħħa jista ’ jissuġġerixxi metodi għall- injezzjoni differenti li jkunu aħjar għalik.
Pinch as much of a skin fold as possible without making yourself uncomfortable.
Oqros kemm tista ’ ġilda mingħajr ma tħossok skomdu/ a.
73 When the needle is in, release the skin, and using the same hand, hold on to the syringe barrel to help steady it and prevent shifting.
Meta tidħol il- labra, ħalli l- ġilda u, bl- istess id, żomm iċ- ċilindru tas- siringa biex tgħinha żżomm sod u biex ma tkunx tista ’ tiċċaqlaq.
● Using the thumb, depress the plunger in to inject the medicine.
● B’ subgħajk il- kbir, injetta s- soluzzjoni billi tagħfas il- plunġer.
After the dose is fully delivered remove the needle from the skin.
Wara li tingħata d- doża kollha, neħħi l- labra mill- ġilda.
● Discard the syringe into a dedicated waste container with a lid.
● Armi s- siringa f’ kontenitur bl- għatu maħsub apposta għall- iskart.
Keep the cover of this container tight and keep the container out of the reach of children.
Żomm l - għatu ta ’ dan il- kontenitur magħluq sew u żomm il- kontenitur fejn ma jintlaħaqx mit- tfal żgħar.
Check with your doctor or pharmacist about proper disposal of the container.
Tkellem mat- tabib jew l- ispiżjar tiegħek dwar ir- rimi xieraq tal- kontenitur.
In addition, you should safely dispose of all used alcohol swabs and vials, even if the vials contain unused amounts of medicine or water for injections.
Barra minn dan għandek tarmi l- imsielaħ bl- alkoħol u l- kunjetti kollha, anke jekk il- kunjetti jkollhom xi ammonti mhux użati ta ’ mediċina jew ilma għall- injezzjonijiet.
The vials of Fuzeon are intended for single use only.
Il- kunjetti ta ’ Fuzeon huma maħsuba għall- użu ta ’ darba biss.
Used supplies other than syringes (alcohol swabs and empty vials) may be disposed of into the rubbish as long as no blood is visible.
Oġġetti użati li m’ humiex siringi (msielaħ bl- alkoħol u kunjetti vojta) jistgħu jintremew fiż- żibel sakemm m’ hemmx xi demm viżibli.
If you have any questions or concerns about the safe disposal of these materials, please call your doctor or pharmacist.
Jekk għandek xi mistoqsijiet dwar ir- rimi mingħajr riskju ta ’ dawn l- oġġetti, jekk jogħġbok tkellem mat- tabib jew ma ’ l- spiżjar tiegħek.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l - Fuljett ta ’ Tagħrif (ukoll parti mill- EPAR) ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is Galvus?
X’ inhu Galvus?
Galvus is a medicine containing the active substance vildagliptin.
Galvus huwa mediċina li fiha s- sustanza attiva vildagliptin.
It is available as round, pale yellow tablets (50 mg).
Hija disponibbli bħala pilloli tondi, sofor ċari (50 mg).
What is Galvus used for?
Għal x’ hiex jintuża Galvus?
Galvus is used to treat type 2 diabetes mellitus (non-insulin-dependent diabetes).
Galvus jintuża biex jittratta dijabete mellitus tat- 2 tip (dijabete mhux dipendenti fuq l- insulina).
It is used together with another antidiabetes medicine (as ‘ dual therapy’) when the patient ’ s diabetes is insufficiently controlled by this other medicine taken alone.
Jintuża flimkien ma ’ mediċina oħra kontra d- dijabete (bħala ‘ terapija doppja ’) meta d- dijabete tal - pazjent ma tkunx ikkontrollata biżżejjed minn din il- mediċina l- oħra meħuda waħidha.
Galvus can be used with metformin, a thiazolidinedione or a sulphonylurea, but it is only used in combination with a sulphonylurea in patients who cannot take metformin.
Galvus jista ’ jintuża ma ’ metformin, thiazolidinedione jew sulphonylurea, iżda jintuża biss f’ kombinazzjoni ma ’ sulphonylurea f’ pazjenti li ma jistgħux jieħdu metformin.
How is Galvus used?
Kif jintuża Galvus?
In adults, the recommended dose of Galvus is: • one tablet in the morning and another in the evening when used with metformin or a thiazolidinedione, • one tablet in the morning when taken with a sulphonylurea.
Fl- adulti, id- doża rakkomandata ta ’ Galvus hija: • Pillola waħda filgħodu u waħda filgħaxija meta wżat ma ’ metformin jew ma ’ thiazolidinedione. • Pillola waħda filgħodu meta meħuda ma ’ sulphonylurea.
The daily dose should not exceed two tablets (100 mg).
Din id- doża tinkiseb meta tittieħed pillola ta ’ 50 mg filgħodu.
Galvus can be taken with or without food.
Galvus jista ’ jittieħed jew ma ’ l- ikel jew mhux ma ’ l - ikel.
Galvus is not recommended for patients who have moderate or severe problems with their kidneys, including those on haemodialysis (a blood clearance technique) with end-stage renal disease.
Galvus m’ huwiex rakkomandat għal pazjenti bi problemi moderati jew severi fil- kliewi tagħhom, inkluż dawk fuq emodijaliżi (tekniki ta ’ tisfija tad- demm) b’ mard renali ta ’ tmiem il- fażi.
Galvus is not recommended for patients with liver problems.
Galvus mhuwiex rakkomandat ukoll għal pazjenti bi problemi severi tal- fwied.
It should be used with caution in patients aged over 75 years.
Għandu jintuża b’ kawtela f’ pazjenti li għandhom aktar minn 75 sena.
How does Galvus work?
Kif jaħdem Galvus?
The active substance in Galvus, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Is- sustanza attiva f’ Galvus, vildagliptin, hija inibitur dipeptidyl peptidase 4 (DPP- 4).
It works by blocking the breakdown of ‘ incretin’ hormones in the body.
Taħdem billi timblokka t- tkissir ta ’ l- ormoni ta ’ ‘ inkretin ’ fil- ġisem.
By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Billi jżid il- livelli ta ’ l- ormoni ta ’ incretin fid- demm, vildagliptin jistimula lill- frixa biex tipproduċi aktar insulina meta l- livelli tal- glukosju fid - demm ikunu għoljin.
Vildagliptin does not work when the blood glucose is low.
Vildagliptin ma jaħdimx meta l- livell ta ’ glukosju fid- demm ikun wieħed baxx.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Vildagliptin inaqqas ukoll l- ammont ta ’ glukosju magħmul mill- fwied, billi jżid il- livelli ta ’ l- insulina 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. u billi jnaqqas il- livelli ta ’ l- ormon glucagon.
How has Galvus been studied?
Kif ġie studjat Galvus?
The effects of Galvus were first tested in experimental models before being studied in humans.
Għall- ewwel, l- effetti ta ’ Galvus ġew ittestjati f’ mudelli esperimentali qabel ma ġew studjati fuq il - bniedem.
Galvus has also been studied in seven main studies involving a total of over 4,000 patients with type 2 diabetes and insufficient control of blood glucose levels.
Galvus ġie studjat ukoll f’ seba ’ studji prinċipali li kienu jinvolvu total ta ’ aktar minn 4, 000 pazjent b’ dijabete ta ’ tip 2 u b’ kontroll insuffiċjenti tal- livelli ta ’ glukosju fid- demm.
Three of these studies looked at the effects of Galvus taken alone in a total of 2,198 patients who had not taken diabetes treatment before, comparing it to placebo (a dummy treatment), metformin or rosiglitazone (a thiazolidinedione).
Tlieta minn dawn l- istudji analizzaw l- effetti ta ’ Galvus meta meħud waħdu f’ total ta ’ 2, 198 pazjent li ma ħadux trattament għad- dijabete qabel, u dan tqabbel ma ’ plaċebo (trattament finta), metformin jew rosiglitazone (thiazolidinedione).
The other four studies compared the effects of Galvus, taken at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used as an add-on to existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients).
L- erba ’ studji l- oħrajn qabblu l- effetti ta ’ Galvus, meħud f’ dożi ta ’ 50 jew 100 mg kuljum għal 24 ġimgħa, ma ’ dawk ta ’ plaċebo, meta wżat bħala addizzjoni għat- trattament eżistenti b’ metformin (544 pazjenti), pioglitazone (thiazolidinedione, 463 pazjent), glimepiride (sulphonylurea, 515- il pazjent) jew insulina (296 pazjent).
In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Fl- istudji kollha, il- miżura prinċipali ta ’ l- effikaċja kienet il- bidla fil- livelli tad- demm ta ’ sustanza msejħa glycosylated haemoglobin (HbA1c), li tagħti indikazzjoni ta ’ kemm il - glukosju fid- demm huwa kkontrollat tajjeb.
What benefit has Galvus shown during the studies?
X’ benefiċċju wera Galvus matul l- istudji?
Galvus reduced levels of HbA1c in all studies.
Galvus naqqas il- livelli ta ’ HbA1c fl- istudji kollha.
When used alone, it caused a reduction in HbA1c levels by approximately 1% from a starting level of around 8% after 24 weeks, but it was not as effective as metformin or rosiglitazone.
Meta wżat waħdu, ikkawża tnaqqis fil- livelli ta ’ HbA1c b’ bejn wieħed u ieħor 1% mil- livell tal- bidu ta ’ madwar 8% wara 24 ġimgħa, iżda ma kienx effettiv daqs metformin jew rosiglitazone.
When used as an add-on to existing treatment for type 2 diabetes, Galvus was more effective than placebo in reducing HbA1c levels.
Meta wżat bħala żjieda għal trattament eżistenti għal dijabete ta ’ tip 2, Galvus kien aktar effettiv minn plaċebo fit- tnaqqis tal- livelli ta ’ HbA1c.
With metformin and with pioglitazone, the 100-mg daily dose was more effective than the 50 mg daily dose, with a reduction in HbA1c levels of between 0.8 and 1.0%.
Ma ’ metformin u ma ’ pioglitazone, id- doża ta ’ 100- mg kuljum kienet aktar effettiva mid- doża ta ’ 50 mg kuljum, bi tnaqqis fil- livelli ta ’ HbA1c ta ’ bejn 0. 8 u 1. 0%.
In combination with glimepiride, both 50 mg and 100 mg daily doses caused a reduction of around 0.6%.
Flimkien ma ’ glimepiride, iż- żewġ dożi, kemm ta ’ 50 mg kif ukoll ta ’ 100 mg li jittieħdu kuljum ikkawżaw tnaqqis ta ’ madwar 0. 6%.
In contrast, patients adding placebo to their existing treatment showed smaller changes in HbA1c levels, ranging from a fall of 0.3% to a rise of 0.2%.
B’ kuntrast għal dan, il- pazjenti li jieħdu plaċebo mat - trattament eżistenti tagħhom urew bidliet iżgħar fil- livelli ta ’ HbA1c, li varjaw minn tnaqqis ta ’ 0. 3% għal żjieda ta ’ 0. 2%.
Although adding Galvus to existing insulin therapy caused a greater reduction in HbA1c levels than placebo, the size of this effect was too small to be considered meaningful for patients.
Għalkemm iż- żieda ta ’ Galvus għal terapija eżistenti bl- insulina ikkawżat tnaqqis ikbar fil- livelli ta ’ HbA1c minn plaċebo, id- daqs ta ’ l- effett kien żgħir wisq biex jitqies sinjifikanti għall- pazjenti.
The company withdrew its application for the use of Galvus on its own and as an add-on to insulin during the assessment of the medicine.
Il- kumpanija irtirat l- applikazzjoni tagħha għall- użu ta ’ Galvus waħdu u bħala żjieda għall- insulina matul il- valutazzjoni tal- mediċina.
What is the risk associated with Galvus?
X’ inhu r- riskju assoċjat ma ’ Galvus?
The most common side effect with Galvus (seen in between 1 and 10 patients in 100) is dizziness.
L- aktar effett sekondarju komuni b’ Galvus (li deher f’ bejn pazjent 1 u 10 minn kull 100) kien l - isturdament.
For the full list of all side effects reported with Galvus, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b’ Galvus, ara l- Fuljett ta ’ Tagħrif.
Galvus should not be used in people who may be hypersensitive (allergic) to vildagliptin or any of the other ingredients.
Galvus m’ għandux jintuża fuq persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal vildagliptin jew għal xi sustanza oħra tiegħu.
Because vildagliptin has been associated with liver problems, patients should have tests to check their liver before treatment with Galvus and at regular intervals during treatment.
L- użu tiegħu f’ pazjenti b’ mard tal- qalb għandu jkun limitat għal pazjenti b’ mard ħafif. ecause vildagliptin has been associated with liver problems, patients should have tests to check their liver before treatment with Galvus and at regular intervals during treatment.
Why has Galvus been approved?
Għaliex ġie approvat Galvus?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Galvus’ s benefits in the treatment of type 2 diabetes mellitus are greater than its risks when used as dual oral therapy in combination with metformin, a sulphonylurea or a thiazolidinedione.
Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) ikkonkluda li l- benefiċċji ta ’ Galvus fit- trattament ta ’ dijabete mellitus tat- 2 tip huma akbar mir- riskji tiegħu meta wżat bħala terapija orali dupliċi flimkien ma ’ metformin, sulphonylurea jew thiazolidinedione.
The Committee recommended that Galvus be given marketing authorisation.
Il- Kumitat irrakkomanda li Galvus jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Galvus:
Tagħrif ieħor dwar Galvus:
The European Commission granted a marketing authorisation valid throughout the European Union for Galvus to Novartis Europharm Limited on 26 September 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea għal Galvus lil Novartis Europharm Limited fit- 26 ta ’ Settembru 2007.
The full EPAR for Galvus can be found here.
L- EPAR sħiħ għal Galvus jista ’ jinstab hawn.
This summary was last updated in 02-2008.
Dan is- sommarju ġie aġġornat l- aħħar f’ 02- 2008.
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola
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
Blister (PA/ Al/ PVC/ /Al) Blister (PA/ Al/ PVC/ /Al) Blister (PA/ Al/ PVC/ /Al) Blister (PA/ Al/ PVC/ /Al) Blister (PA/ Al/ PVC/ /Al) Blister (PA/ Al/ PVC/ /Al) Blister (PA/ Al/ PVC/ /Al) Blister (PA/ Al/ PVC/ /Al) Blister (PA/ Al/ PVC/ /Al) Blister (PA/ Al/ PVC/ /Al) Blister (PA/ Al/ PVC/ /Al)
Folja (PA/ Al/ PVC // Al) Folja (PA/ Al/ PVC // Al) Folja (PA/ Al/ PVC // Al) Folja (PA/ Al/ PVC // Al) Folja (PA/ Al/ PVC // Al) Folja (PA/ Al/ PVC // Al) Folja (PA/ Al/ PVC // Al) Folja (PA/ Al/ PVC // Al) Folja (PA/ Al/ PVC // Al) Folja (PA/ Al/ PVC // Al) Folja (PA/ Al/ PVC // Al)
7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 60 tablets 90 tablets 112 tablets 180 tablets 336 tablets 336 (3x112) tablets
7 pilloli 14- il pillola 28 pillola 30 pillola 56 pillola 60 pillola 90 pillola 112- il pillola 180 pillola 336 pillola 336 (3x112) pillola
Galvus 50 mg tablets
Galvus 50 mg pilloli
Each tablet contains 50 mg of vildagliptin.
Kull pillola fiha 50 mg ta ’ vildagliptin.
Each tablet contains 47.82 mg anhydrous lactose.
Kull pillola fiha 47. 82 mg anhydrous lactose.
White to light yellowish, round (8 mm diameter), flat-faced, bevelled-edge tablet.
Pillola bajda tagħti ftit fl- isfar, tonda (8 mm dijametru), wiċċ ċatt, b ’ xifer imżerżaq.
One side is debossed with “ NVR”, and the other side with “ FB”.
Naħa waħda mnaqqxa b ’ “ NVR ”, u n- naħa l- oħra b ’ “ FB ”.
Vildagliptin is indicated in the treatment of type 2 diabetes mellitus:
Vildagliptin jintuża għall- kura ta ’ dijabete mellitus tat- tip 2:
As dual oral therapy in combination with
Bħala terapija bi tnejn f’ kombinazzjoni ma ’
- metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of
- metformin, f’ pazjenti li ma jkollhomx kontroll suffiċjenti taz- zokkor fid- demm minkejja li jkunu
monotherapy with metformin,
qed jieħdu l- ogħla doża tollerata ta ’ metformin waħdu,
- a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose
- sulphonylurea, f’ pazjenti li ma jkollhomx kontroll suffiċjenti taz- zokkor fid- demm minkejja li
of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance,
jkunu qed jieħdu l- ogħla doża tollerata ta ’ sulphonylurea u li ma jistgħux jieħdu metformin minħabba li hu kontra- indikat jew għax ma jittollerawhx,
- a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a
- thiazolidinedione, f’ pazjenti li ma jkollhomx kontroll suffiċjenti taz- zokkor fid- demm u għal
thiazolidinedione is appropriate.
min l- użu ta ’ thiazolidinedione huwa adattat.
Adults When used in dual combination with metformin or a thiazolidinedione, the recommended daily dose of vildagliptin is 100 mg, administered as one dose of 50 mg in the morning and one dose of 50 mg in the evening.
Adulti Meta jintuża f’ kombinazzjoni doppja ma ’ metformin, jew ma ’ thiazolidinedione, id- doża ta ’ vildagliptin rakkomandata hija ta ’ 100 mg kuljum mogħtija bħala doża waħda ta ’ 50 mg filgħodu u doża waħda ta ’ 50 mg filgħaxija.
When used in dual combination with a sulphonylurea, the recommended dose of vildagliptin is 50 mg once daily administered in the morning.
Meta jintuża f’ kombinazzjoni doppja ma ’ sulphonylurea, id- doża ta ’ vildagliptin rakkomandata hija 50 mg kuljum mogħtija filgħodu.
In this patient population, vildagliptin 100 mg daily was no more effective than vildagliptin 50 mg once daily.
F’ din il- popolazzjoni ta ’ pazjenti, vildagliptin 100 mg kuljum ma kienitx aktar effettiva minn vildagliptin 50 mg darba kuljum.
Doses higher than 100 mg are not recommended.
Dożi ogħla minn 100 mg mhumiex rakkomandati.
The safety and efficacy of vildagliptin as triple oral therapy in combination with metformin and a thiazolidinedione or with metformin and a sulphonylurea has not been established.
Is- sigurtà u l- effikaċja ta ’ vildagliptin bħala terapija trippla orali f’ kombinazzjoni ma ’ metformin u thiazolidinedione jew ma ’ metformin u sulphonylurea ma ġietx stabbilita.
Galvus can be administered with or without a meal (see also section 5.2).
Glavus jista ’ jingħata ma ’ ikla jew waħdu (ara wkoll sezzjoni 5. 2).
2 Additional information on special populations Renal impairment No dose adjustment is required in patients with mild renal impairment (creatinine clearance ≥ 50 ml/ min).
2 Aktar informazzjoni fuq popolazzjonijiet speċjali Indeboliment renali M’ hemmx bżonn ta ’ aġġustamenti fid- doża f’ pazjenti b’ indeboliment ħafif renali (tneħħija tal - krejatinina ≥ 50 ml/ min).
The use of Galvus is not recommended in patients with moderate or severe renal impairment or in haemodialysis patients with end-stage renal disease (ESRD) (see also sections 4.4 and 5.2).
L- użu ta ’ Galvus mhux rakkomandat f’ pazjenti b’ indeboliment renali moderat jew sever jew pazjenti fuq emodijalisi b’ mard renali fl- aħħar stadju (ESRD) (ara wkoll sezzjonijiet 4. 4 u 5. 2).
Hepatic impairment Galvus should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN) (see also sections 4.4 and 5.2).
Indeboliment tal- fwied Galvus mgħandux jintuża f’ pazjenti b’ indeboliment tal- fwied, inklużi pazjenti li jkollhom alanine aminotransferase (ALT) jew aspartate aminotransferase (AST) qabel il- kura > 3 darbiet il- limitu ta ’ fuq tan- normal (ULN) (ara wkoll sezzjonijiet 4. 4 u 5. 2).
Elderly (≥ 65 years) No dose adjustments are necessary in elderly patients.
Anzjani (≥ 65 sena) M’ hemmx bżonn ta ’ aġġustar tad- doża f’ pazjenti anzjani.
Experience in patients aged 75 years and older is limited and caution should be exercised when treating this population (see also sections 5.1 and 5.2).
L- esperjenza f’ pazjenti li għandhom 75 sena u iktar hija limitata u għandha ssir attenzjoni meta tkun qed tiġi kkurata din il- popolazzjoni (ara wkoll sezzjonijiet 5. 1 u 5. 2).
Paediatric population (< 18 years) Galvus is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Popolazzjoni pedjatrika (< 18- il sena) Galvus mhux irrakkomandat għall- użu fit- tfal u adolexxenti peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
General Galvus is not a substitute for insulin in insulin-requiring patients.
Ġenerali Galvus mhux sostitut ta ’ l- insulina f’ pazjenti li jeħtieġu l- insulina.
Galvus should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Galvus m’ għandux jintuża f’ pazjenti b’ dijabete tat- tip 1 jew għall- kura ta ’ ketoaċidożi dijabetika.
Renal impairment There is limited experience in patients with moderate to severe renal impairment or in patients with ESRD on haemodialysis.
Indeboliment renali Hemm esperjenza limitata f’ pazjenti b’ indeboliment renali moderat għal sever jew f’ pazjenti b’ ESRD fuq emodijalisi.
Therefore, the use of Galvus is not recommended in these patients.
Għalhekk, l- użu ta ’ Galvus mhux rakkomandat f’ dawn il- pazjenti.