qanastek/EMEA-V3 huggingface dataset:
Decreased platelets in the blood, increased or decreased white cells in the blood, tendency to bleed.
Tnaqqis tal- plejtlits fid- demm, żieda jew tnaqqis ta ’ ċelloli bojod tad- demm, tendenza ta ’ fsada.
Decreased sense of touch, abnormal sense of taste, migraine.
Tnaqqis fis- sens tal- mess, sens abnormali tat- togħma, emigranja.
Eyestrain, eye pain, inner ear problems.
Sforz ta ’ l- għajnejn, uġigħ fl- għajnejn, problemi fil- widna interna.
Shortness of breath.
Qtugħ ta ’ nifs.
Dry mouth, increased saliva, tooth problems, hemorrhoids.
Ħalq xott, żieda fis- saliva, problemi fis- snien, murliti.
Blood in the urine, protein in the urine, increased urine, kidney problems.
Demm fl- awrina, proteina fl- awrina, żieda fl- awrina, problemi fil- kliewi.
Facial swelling, dry skin, tendency to bruise, night sweats.
Nefħa fil- wiċċ, ġilda xotta, tendenza ta ’ tbenġil, għaraq bil- lejl.
Increased fatty substances in the blood, decreased blood glucose.
Żieda fis- sustanzi xaħmija fid- demm, tnaqqis fil- glucose fid- demm.
Fever, weakness, feeling abnormal, impaired healing.
Deni, dgħjufija, sensazzjoni ta ’ anormalità, fejqan imfixkel.
Anger, lack of interest, feeling confused, increased sex drive, panic attack, loss of memory.
Rabja, telf ta ’ l- interess, sensazzjoni ta ’ konfużjoni, żieda fl- impuls sesswali, attakk ta ’ paniku, telf tal- memorja.
About 17% of patients will develop antibodies to growth hormone during treatment.
Madwar 17% tal- pazjenti jiżviluppaw antikorpi għall- ormon tat- tkabbir matul it- trattament.
The antibodies do not seem to stop SOMAVERT from working.
L - antikorpi ma jidhrux li jwaqqfu lil SOMAVERT milli jaħdem.
HOW TO STORE SOMAVERT
KIF TAĦŻEN SOMAVERT
Do not use SOMAVERT after the expiry date which is stated on the vial and the carton after EXP.
Tużax SOMAVERT wara d- data ta ’ skadenza li tidher fuq il- kunjett u l- kartuna wara JIS.
Keep the vials in the outer carton in order to protect from light.
Żomm il- kunjetti fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
After preparing the SOMAVERT solution it must be used immediately.
Wara li tipprepara s- soluzzjoni ta ’ SOMAVERT, din trid tintuża immedjatament.
Carefully dispose of any SOMAVERT solution that has not been injected.
Armi b’ attenzjoni kull soluzzjoni ta ’ SOMAVERT li ma tkunx ġiet injettata.
Do not use SOMAVERT if you notice that the solution is cloudy or contains particulate matter.
Tużax SOMAVERT jekk tinnota li s- soluzzjoni tkun imdardra jew fiha l- frak.
What SOMAVERT contains
X’ fih SOMAVERT
- The active substance is pegvisomant.
- Is- sustanza attiva hi pegvisomant.
- One vial of powder contains either 10 mg, 15 mg, or 20 mg.
- Kunjett wieħed ta ’ trab fih 10 mg, jew 15mg jew 20mg.
After reconstitution with 1 ml of
Wara rikostituzzjoni b’ 1 ml ta ’ solvent, 1
solvent, 1 ml of the clear solution contains either 10 mg, 15 mg or 20 mg pegvisomant.
ml tas- soluzzjoni ċara jkun fih 10 mg, jew 15mg, jew 20mg pegvisomant.
- The other ingredients are glycine, mannitol (E421), sodium phosphate dibasic anhydrous and
- Is- sustanzi l- oħra huma glycine, mannitol (E421), sodium phosphate dibasic anhydrous u sodium
sodium phosphate monobasic monohydrate.
phosphate monobasic monohydrate.
- The solvent is water for injections.
- Is- solvent hu ilma għall- injezzjonijiet.
One vial of solvent contains 8 ml water for injections.
Kunjett wieħed ta ’ solvent fih 8 ml ilma għall -
What SOMAVERT looks like and contents of the pack
46 Id- dehra ta ’ SOMAVERT u l- kontenuti tal- pakkett
SOMAVERT is presented as a powder and a solvent for injection, in a vial.
SOMAVERT huwa ppreżentat bħala trab u solvent għal injezzjoni.
Powder in a vial (either 10 mg, 15 mg, or 20 mg pegvisomant) and solvent in a vial (8 ml).
Trab f’ kunjett (10mg jew 15mg, jew 20mg pegvisomant) u solvent f’ kunjett (8ml).
Pack sizes of 1 and 30.
Il- pakketti fihom 1 jew 30.
Not all pack sizes are marketed.
Jista jkun li mhux il - pakketti kollha huma għall- bejgħ.
The powder is white and the solvent is clear and colourless.
It- trab huwa abjad u s- solvent hu ċar u mingħajr kulur.
Marketing Authorisation holder:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
43 Manufacturer:
Il- Manifattur:
Pfizer Manufacturing Belgium NV Rijksweg 12 2870 Puurs Belgium
Pfizer Manufacturing Belgium NV Rijksweg 12 2870 Puurs Il- Belġju
Tel: +351 21 423 5500
Tel: +351 21 423 5500 47
Ísland Vistor Sími: + 354 535 7000
Ísland Vistor Simi: + 354 535 7000
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 Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
45 INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF SOMAVERT
48 STRUZZJONIET SABIEX TIĠI PPREPARATA U MOGĦTIJA INJEZZJONI TA ’ SOMAVERT
The following instructions explain how to prepare and inject SOMAVERT.
L- istruzzjonijiet li jsegwu jispjegaw kif wieħed għandu jipprepara u jinjetta SOMAVERT.
You will be instructed by your doctor or his/her assistant on the technique of self-injection.
Inti se tiġi muri mit- tabib tiegħek u/ jew l - assistent/ a tiegħu/ tagħha t- teknika kif tinjetta lilek innifsek.
Do not attempt to self-inject until you are sure that you understand how to prepare and give an injection.
Tippruvax tinjetta lilek innifsek qabel ma tkun ċert/ a li fhimt sew kif tipprepara u tagħti l- injezzjoni.
The powder must be dissolved with the solvent before use.
Qabel jintuża, it- trab għandu jiġi maħlul bis- solvent.
This injection should not be mixed in the same syringe or vial with any other medicine.
Din l- injezzjoni m’ għandhiex tiġi mħallta fl- istess siringa jew kunjett ma ’ xi mediċina oħra.
STEP 1.
L- EWWEL PASS.
CHOOSING THE METHOD FOR PREPARING THE SOMAVERT SOLUTION
KIF TAGĦŻEL IL- METODU BIEX TIPPREPARA S- SOLUZZJONI TA ’ SOMAVERT
There are 2 methods for preparing the SOMAVERT solution.
Hemm 2 metodi biex tipprepara s- soluzzjoni ta ’ SOMAVERT.
Please discuss with your healthcare professional which method is best for you: a) The Vial Adapter Method (MIXJECT™), b) The Non-Vial Adapter Method.
Jekk jogħġbok iddiskuti mal - professjonist tal- kura tas- saħħa tiegħek liema huwa l- aħjar metodu għalik: a) Il- Metodu ta ’ l- Adapter tal- Kunjett (MIXJECT™), b) Il- Metodu Mingħajr Adapter tal- Kunjett.
a) VIAL ADAPTER METHOD (MIXJECT™)
a) METODU BL- ADAPTER TAL- KUNJETT (MIXJECT™)
GETTING STARTED
IL- BIDU
• Wash your hands thoroughly. • Collect:
• Aħsel idejk sew. • Iġbor:
1 vial of powder (SOMAVERT), 1 vial of solvent (Water for Injections), 1 luer-lock syringe of 1ml (for both reconstituting the SOMAVERT solution and giving the injection) is recommended.
1 kunjett ta ’ trab (SOMAVERT), 1 kunjett ta ’ solvent (Ilma għall- Injezzjonijiet), 1 siringa luer- lock ta ’ 1 ml (kemm biex tirrikostitwixxi s- soluzzjoni ta ’ SOMAVERT kif ukoll biex tagħti l- injezzjoni) hija rakkomandata.
However, other sizes and types of syringes can be used for the preparation and injection of SOMAVERT.
Madankollu, daqsijiet u tipi oħra ta ’ siringi jistgħu jintużaw għall- preparazzjoni u l- injezzjoni ta ’ SOMAVERT.
Please consult your healthcare professional for further information.
Jekk jogħġbok ikkonsulta lill - professjonist tal- kura tas- saħħa tiegħek għal aktar informazzjoni.
2 MIXJECT™ vial adapters, 1 detachable needle (25 to 30 gauge), Alcohol or antiseptic swabs and a proper disposal container for used needles and syringes. • Inspect the expiry dates on both the vial label and the syringe label.
Swobbs ta ’ l- alkoħol jew antisettiċi u reċipjent adegwat għar- rimi ta ’ labar u siringi użati. • Ara d- dati ta ’ skadenza kemm fuq it- tikketta tal- kunjett u kemm fuq it- tikketta tas- siringa.
They should not be used after the month and year shown.
Ma għandux isir użu minnhom wara x- xahar u s- sena murija.
After reconstitution with 1 ml of solvent, 1 ml of the clear solution contains either 10 mg, 15 mg, or 20 mg pegvisomant.
Wara rikostituzzjoni b’ 1 ml ta ’ solvent, 1 ml tas- soluzzjoni ċara jkun fih 10 mg, jew 15mg, jew 20mg pegvisomant.
PREPARING THE SOMAVERT DOSE FOR INJECTION
IL- PREPARAZZJONI TAD- DOŻA TA ’ SOMAVERT GĦALL- INJEZZJONI
Remove the protective plastic caps from the tops of both vial of solvent and vial of SOMAVERT (Fig.
Neħħi l- għotjien protettivi tal- plastik mill- parti ta ’ fuq kemm tal- kunjett tas- solvent kif ukoll tal - kunjett ta ’ SOMAVERT (Fig.
Take care not to touch the rubber vial stoppers.
Oqgħod attent/ a li ma tmissx it- tappijiet tal- gomma tal- kunjetti.
At this point, the stoppers are clean.
F’ dan l- istadju t- tappijiet huma ndaf.
If the stoppers are touched or otherwise contaminated, you must clean them with an antiseptic or alcohol swab before inserting a vial adapter through the stopper.
Jekk it- tappijiet jintmessu jew jiġu kontaminati b’ xi mod ieħor, dawn iridu jitnaddfu bi swobb bl- alkoħol jew antisettika, qabel ma wieħed idaħħal adapter
Open only one of the vial adapters by peeling back the protective cover.
Iftaħ biss wieħed mill- adapters tal- kunjett billi tneħħi l- għatu protettiv.
Leave the adapter in the plastic packaging and do not touch the spike of the adapter.
Ħalli l- adapter fil- pakkett tal- plastik u tmissx il- ponta ta ’ l- adapter.
While holding the plastic adapter packaging, place the adapter over the solvent vial and insert the piercing spike of the vial adapter all the way in through the rubber stopper of the solvent vial, using a pushing motion.
Waqt li żżomm il- pakkett tal- plastik ta ’ l- adapter, poġġi l- adapter fuq il- kunjett tas- solvent u daħħal il- ponta li ttaqqab ta ’ l- adapter tal- kunjett kompletament minn ġot- tapp tal- gomma tal - kunjett tas- solvent, billi timbotta.
Remove the plastic packaging from the vial adapter and discard.
Neħħi l- pakkett tal- plastik mill- adapter tal- kunjett u armih.
Remove the syringe from the protective packaging.
Neħħi s- siringa mill- pakkett protettiv.
Pull the plunger of the syringe out to the 1 ml mark.
Iġbed il- planġer tas- siringa ’ l barra sal- marka ta ’ 1 ml.
Hold the solvent vial, placed on a flat surface, with one hand and connect the tip of the syringe to the vial adapter by twisting the syringe on the vial adapter clockwise (Fig.
Żomm il- kunjett tas- solvent, imqiegħed fuq wiċċ ċatt, b’ id waħda u qabbad it- tarf tas- siringa ma ’ l- adapter tal- kunjett billi ddawwar is- siringa fuq l- adapter tal- kunjett fid- direzzjoni tal- vleġġa (Fig.
Gently push the plunger until the air is injected into the vial.
Imbotta l- planġer b’ mod ġentili sakemm l- arja tkun injettata ġol- kunjett.
ADDING SOLVENT
IŻ- ŻIEDA TAS- SOLVENT
Securely grasp the solvent vial, adapter and syringe assembly.
Aqbad sod il- kunjett tas- solvent, l- adapter u s- siringa fl- intier tagħha.
Carefully turn the vial, adapter and syringe assembly upside down.
Dawwar bl- attenzjoni l - kunjett, l- adapter u s- siringa ta ’ taħt fuq.
Bring to eye level (Fig.
Żommhom fil- livell ta ’ għajnejk (Fig.
Slide one hand carefully down the solvent vial so that with your thumb and forefinger you can securely grasp the neck of the vial, and with your other fingers, the upper part of the syringe.
Żerżaq ’ l isfel b’ attenzjoni id waħda tul il- kunjett tas- solvent b’ mod li b’ sebgħek il- kbir u sebgħek il- werrej inti tkun tista ’ taqbad sod għonq il- kunjett, u bis- swaba ’ l- oħra taqbad il- parti ta ’ fuq tas - siringa.
With the other hand, slowly pull the syringe plunger down to slightly past the 1 ml mark.
B’ idek l- oħra, iġbed ’ l isfel bil- mod il- planġer tas- siringa kemm taqbeż il- marka ta ’ 1 ml.
Examine the solution in the syringe for air bubbles.
Eżamina s- soluzzjoni fis- siringa għall- bżieżaq ta ’ l- arja.
If bubbles are present, tap the syringe barrel until the bubbles rise to the top of the syringe.
Jekk ikun hemm il- bżieżaq, tektek il - bettija tas- siringa sakemm il- bżieżaq jitilgħu fil- parti ta ’ fuq tas- siringa.
Carefully push the plunger up to eject only the air bubbles back into the vial.
Imbotta bl- attenzjoni l - planġer biex tixħet biss il- bżieżaq ta ’ l- arja lura għal ġol- kunjett.
Recheck that 1 ml of solvent remains in the syringe.
Erġa ’ iċċekkja li 1 ml ta ’ solvent jibqa ’ fis- siringa.
Carefully turn the solvent vial, adapter and syringe assembly and place them upright on a clean surface.
Dawwar b’ attenzjoni l- kunjett tas- solvent, l- adapter u s- siringa u poġġihom weqfin fuq wiċċ nadif.
Do not remove the syringe from the adapter at this point.
Tneħħix is- siringa minn ma ’ l- adapter f’ dan l- istadju.
As explained for the first vial adapter, open now the second vial adapter by peeling back the protective cover.
Kif spjegat għall- ewwel adapter tal- kunjett, issa iftaħ it- tieni adapter tal- kunjett billi tneħħi l- għatu protettiv.
Do not touch the vial adapter.
Tmissx l- adapter tal- kunjett.
Do not remove the adapter from the plastic packaging.
Tneħħix l- adapter mill- pakkett tal- plastik.
While holding the plastic adapter packaging, place the adapter over the SOMAVERT vial and insert the piercing spike of the vial adapter all the way in through the rubber stopper of the SOMAVERT vial, using a pushing motion (Fig.
Waqt li żżomm il- pakkett tal- plastik ta ’ l- adapter, poġġi l- adapter fuq il- kunjett ta ’ SOMAVERT u daħħal il- ponta li ttaqqab ta ’ l- adapter tal- kunjett sa ġewwa minn ġot- tapp tal- gomma tal- kunjett ta ’ SOMAVERT, billi timbotta ’ l isfel (Fig.
Disconnect the syringe from the solvent vial adapter and attach it to the vial adapter on the vial of SOMAVERT.
Neħħi s- siringa minn ma ’ l- adapter tal- kunjett tas- solvent u qabbadha ma ’ l- adapter tal- kunjett fuq il- kunjett ta ’ SOMAVERT.
Discard the solvent vial as directed by your healthcare provider.
Armi l- kunjett tas- solvent skond l- istruzzjonijiet tal- fornitur tal- kura tas- saħħa tiegħek.
Hold the vial of SOMAVERT with the adapter and syringe still attached upright between your hands and gently roll it to dissolve the powder (Fig.
Żomm il- kunjett ta ’ SOMAVERT bl- adapter u s- siringa għadhom imwaħħlin weqfin bejn idejk u irromblah b’ mod ġentili biex tħoll it- trab (Fig.