qanastek/EMEA-V3 huggingface dataset:
BOX OF 1 VIAL AND 1 PRE-FILLED SYRINGE BOX OF 4 VIALS AND 4 PRE-FILLED SYRINGES BOX OF 12 VIALS AND 12 PRE-FILLED SYRINGES
KAXXA TA ’ VJALA WA} DA U SIRINGA MIMLIJA LESTA G} ALL- U_BAR_U KAXXA TA ’ 4 VJALI U 4 SIRINGI MIMLIJIEN LESTI GĦALL- UŻU KAXXA TA ’ 12 VJALI U 12 SIRINGI MIMLIJIEN LESTI GĦALL- UŻU
Raptiva 100 mg/ ml powder and solvent for solution for injection Efalizumab
Raptiva 100 mg/ ml trab u solvent g] al soluzzjoni għall- injezzjoni Efalizumab
One vial of powder contains a retrievable amount of 125 mg of efalizumab.
Vjala waħda ta ’ trab fiha 125mg ta ’ efalizumab bħala ammont li jista ’ jittieħed
Polysorbate 20, histidine, histidine hydrochloride monohydrate and sucrose.
Polysorbat 20, histidine, histidine hydrochloride monohydrate u sukrozju.
Solvent: water for injections.
Solvent: ilma g] all- injezzjoni.
1 vial of powder for solution for injection.
Vjala waħda ta ’ trab għal soluzzjoni għall- injezzjoni.
1 pre-filled syringe of 1.3 ml solvent.
Siringa waħda mimlija lesta ta ’ 1. 3ml ta ’ solvent.
1 needle for injection.
EasyMIX adaptor għal rikostituzzjoni, Labra waħda għall- injezzjoni.
4 vials of powder for solution for injection.
4 vjali ta ’ trab għal soluzzjoni għall- injezzjoni.
4 EasyMIX adapters for reconstitution.
4 siringi mimlijien lesti ta ’ 1. 3ml ta ’ solvent.
4 needles for injection.
4 EasyMIX adaptors għal rikostituzzjoni, 4 labar għall- injezzjoni.
12 vials of powder for solution for injection.
12 vjali ta ’ trab għal soluzzjoni għall- injezzjoni.
12 pre-filled syringes of 1.3 ml solvent.
12 siringi mimlijien lesti ta ’ 1. 3ml ta ’ solvent.
12 needles for injection.
12 EasyMIX adaptor għal rikostituzzjoni, 12 labar għall- injezzjoni.
Subcutaneous use.
Għall- użu taħt il- ġilda.
Use immediately after reconstitution.
JISS Għall- użu immedjat wara ir- rikostituzzjoni
Discard any unused solution.
Soluzzjoni li ma jintużax jrid jintrema.
RAPTIVA 100 mg/ ml VIAL LABEL
TIKKETTA TA ’ VJALA TA ’ RAPTIVA 100mg/ ml
Raptiva 100 mg/ ml Powder for solution for injection Efalizumab Subcutaneous use
Raptiva 100mg/ ml Trab g] al soluzzjoni għall- injezzjoni Efalizumab Għall- użu taħt il- ġilda
125 mg retrievable
125mg li jista jittieħed
SOLVENT PRE-FILLED SYRINGE LABEL
TIKKETTA TAS- SIRINGA MIMLIJA LESTA G} ALL- U_BAR_U
Solvent for use with Raptiva Water for injections
Solvent għall- użu ma ’ Raptiva Ilma għal injezzjoni
1.3 ml in pre-filled syringe
1. 3ml fi siringa lesta għall- użu
Raptiva 100 mg/ ml powder and solvent for solution for injection Efalizumab
Raptiva 100 mg/ ml trab u solvent għal soluzzjoni għall- injezzjoni Efalizumab
What Raptiva is and what it is used for 2.
X’ inhu Raptiva u għalxiex jintuża 2.
Before you use Raptiva 3.
Qabel ma tuża Raptiva 3.
How to use Raptiva 4.
Kif għandek tuża Raptiva 4.
Possible side effects 5 How to store Raptiva 6.
Effetti sekondarji li jista ’ jkollu 5.
Further information
Kif taħżen Raptiva 6.
WHAT RAPTIVA IS AND WHAT IT IS USED FOR
X’ INHU RAPTIVA U GĦALXIEX JINTUŻA
Raptiva is a systemic psoriasis medicine.
Raptiva huwa mediċina sistemika għal psorjażi.
Systemic therapies are medicines taken orally or administered by injection and thus will be present in and affect the whole body.
Terapiji sistemiċi huma mediċini li jittieħdu oralment jew huma amministrati b’ injezzjoni u għalhekk huma prezenti u jaffettwaw il- ġisem kollu.
Raptiva is a medicine containing efalizumab, made by means of biotechnology.
Raptiva huwa mediċina li fiha efalizumab, li huwa magħmul permezz ta ’ bioteknoloġija.
It is produced by genetically engineered mammalian cells.
Huwa prodott fiċ- ċelloli mammalian li għandhom materjal ġenetiku mibdul.
Efalizumab is a monoclonal antibody.
Efalizumab huwa monoclonal antikorpu.
Monoclonal antibodies are proteins that recognise and bind to other specific proteins of the human body.
Dawn huma proteini li jagħrfu u jintrabtu ma ’ proteini speċifiċi oħra tal- ġisem uman.
Efalizumab reduces inflammation of the psoriatic lesions which results in improvement of the affected areas of the skin.
Efalizumab jonqos l- infiammazjoni tal- lezjoni psorjatiċi li jirriżulta fil- miljorament tal- partijiet tal- ġisem li huma affetwati.
Therapeutic indications Treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA.
Indikazjonijiet terapewti`i Kura ta ’ pazjienti adulti bi psorjażi kronika plaque moderata għal severa, li ma kellhomx risposta għal, jew għandhom xi kontraindikazzjoni għal, jew huma intoleranti għal kuri sistemiċi oħra inkluz ċiklosporina, methotrexate u PUVA.
This restriction of the indication of Raptiva is based on the present efficacy data and limited long-term experience with Raptiva.
Din ir- ristrizzjoni ta ’ l- indikazzjoni ta ’ Raptiva huwa bbasat fuq l- inforamazzjoni prezenti ta l - effikaċja u esperjenza fit- tul illimitat ma ’ Raptiva.
BEFORE YOU USE RAPTIVA
QABEL MA TUŻA RAPTIVA
Ask your doctor or pharmacist for advice before taking any medicine.
Saqsi it- tabib lit- tabib jew lill- ispiżjar tiegħek għal parir qabel tieħu xi mediċina.
Do not use Raptiva:
Tużax Raptiva:
- If you are allergic (hypersensitive) to efalizumab or any of the other ingredients of Raptiva.
Jekk inti allerġika għal efalizumab jew għal xi wieħed mis- sustanzi oħra li fih Raptiva.
- If you have or have had any cancer.
- Jekk għandhek jew kellek xi tip ta ’ kanċer.
- If you have active tuberculosis or other severe infections.
- Jekk għandek tuberkulosi attiv jew infezzjonijiet severi oħrajn.
Symptoms that might indicate that
Sintomi li jistgħu jindikaw li
you have an infection are fever, wounds, feeling tired, dental problems, a bad cough that lasts longer than 2 weeks, pain in the chest or coughing up blood or sputum.
għandhek infezzjoni huma d- deni, ferita, tħossok għajjien, problemi bi snien, sogħla li jdum aktar minn ġimgħatejn, uġigħ f’ sidrek jew tisgħol bid- demm jew sputum.
- If you have forms of psoriasis other than plaque psoriasis (for instance other more severe forms
- Jekk għandek forma ta ’ psorjażi li mhiejiex plaque psorjażi (per ezempju formi oħrajn ta ’
of psoriasis, as diagnosed by your doctor).
psorjażi li huma aktar severi, kif inhu dianostikat mitt- tabib tiegħek).
- If you have been diagnosed as having a disorder of your immune system.
- Jekk ġejt dianostikat bi diżordni tas- sistemi immuni.
24 Take special care with Raptiva:
24 Huwa importanti illi tgħd lit- tabib tiegħek jekk għandhek jew kellek xi wieħed minn dawn il- problemi.
- If you experience hypersensitivity or allergic reactions such as overall body itching, hives, skin
- Jekk ikollhok reazzjoni allerġika jew ta ’ sensittivita żejda bħal ħakk f’ ġismek kollu, hives, jekk
flushing or rash tell your doctor immediately or go to the local casualty.
il- ġilda tiegħek titħmar jew jkollok xi raxx, għid litt- tabib immedjatament jew mur l- isptar.
- You might get infections more easily.
- tkellem litt- tabib.
If you develop a new infection or notice any new or
Huwa jkun jista ’ jgħid jekk hemm bżonn li tiġi monitorjat jew jekk hemm
He/ she will determine whether to monitor your treatment or whether it is necessary for you to stop using Raptiva.
bżonn li l- kura tiegħek jrid jittwaqqaf.
- If you develop cancer while undergoing treatment, please contact your doctor who will
- Jekk jkollhok xi kanċer waqt li qed tieħu l- kura, jekk jogġħbok tkellem mat- tabib tiegħek li jkun
determine if it is necessary for you to stop using Raptiva.
jista ’ jgħidlek jekk hemm bżonn li jitwaqqaf il- kura.
- If you develop signs and symptoms associated with anaemia (a reduction in red blood cells
- Jekk tiżviluppa xi sinjali jew sintomi li huma assoċjati ma ’ anemia (riduzzjoni fiċ- ċelluli ħomor
which can make the skin pale and cause weakness or breathlessness) while undergoing treatment, please contact your doctor who will determine if it is necessary for you to stop using Raptiva.
tad- demm li jista jikkawża li l- ġilda tiegħek issir pallidu u jista jikkawżalek li tħossok għajjien u ming] ajr nifs) waqt li qed tiegħu l- kura, jekk jogġħbok għamel kuntatt matt- tabib tiegħek li jkun jista ’ jgħidlek jekk hemm bżonn li jitwaqqaf il- kura ta ’ Raptiva.
- If you develop any of the signs and symptoms associated with a decrease in blood platelets,
- Jekk tiżviluppa xi sinjali jew sintomi li huma assoċjati ma ’ nuqqas fil- plajtlits tad- demm, bħal
such as easy bleeding from the gums, bruising or pinpoint red spots on the skin, please tell your doctor immediately.
titlief tad- demm mill- ħanek, tbenġil jew punti ħomor zgħar bħal labra fuq il- ġilda, tkellem immedjatament mat- tabib tiegħek.
He/ she will determine whether to monitor your treatment or whether it is necessary for you to stop using Raptiva.
Huwa jkun jista ’ jgħid jekk hemm bżonn li tiġi monitorjat jew jekk hemm bżonn li l- kura tiegħek jrid jittwaqqaf.
- Some patients had reactions including headache, fever, nausea and vomiting within two days of
- Xi pazjienti kellhom reazzjonijiet bħal uġigħ ta ’ ras, deni, nawsea u remettar fi 2 ġranet taż -
each of the first two injections.
żewġ injezzjonijiet.
These reactions were largely mild to moderate.
Dawn ir- reazzjonijiet kienu fl- akbar parti, ħfif għal moderati.
If you notice that any of these reactions do not vanish after the second injection, tell your doctor.
Jekk tinnota li xi wieħed minn dawn ir- reazzjonijiet ma jagħddiex wara t- tieni injezzjoni, għid litt- tabib tiegħek.
- If you discontinue Raptiva treatment (and this applies especially to patients not responding to
- Jekk twaqqaf il- kura Raptiva (u dan japlikka għal pazjienti li mhumiex qegħdin jirrispondu għal
treatment) your psoriasis may significantly worsen.
kura) l- psorjażi jista ’ jsir sinifikamenti għar.
Your doctor may wish to monitor you and provide effective treatment.
It- tabib jista jixtieq li jżommok taħt osservazzjoni u itik kura effettiva.
- If you experience a worsening of your psoriasis or you develop arthritis, please inform your
- Jekk il- psorjażi issir għar jew tiżviluppa l- artrite, jekk jogġħbok informa litt- tabib tiegħek.
He/ she will determine whether to stop using Raptiva or continue treatment with closer observation.
Huwa jkun jista ’ jgħid jekk hemm bżonn li twaqqaf milli tuża Raptiva jew tkompli l- kura u tiġi monitorjat minn viċin.
- If you are going to receive any vaccine, please check with your doctor.
- Jekk ħa tieħu xi tilqima, jekk joġgħbok iċċekja mat- tabib tiegħek.
You must not receive
Ma tistax tieħu ċerti tipi ta ’
certain types of vaccines during Raptiva treatment.
tilqima waqt il- kura ma ’ Raptiva.
It may be necessary to discontinue Raptiva treatment 8 weeks before a vaccination.
Jista ’ jkun il- kas li twaqqaf Raptiva 8 ġimgħat qabel xi tilqima.
He/ she will calculate the
- Jekk titlef jew tiżdied fil- piż li mhuwiex mistenni, jekk joġgħbok tkellem mat- tabib tiegħek.
correct dosage based on your new weight.
Huwa jista ’ jikkalkula id- doża li trid tieħu bbasat fuq il- piż li tkun.
Tell your doctor if you have renal or hepatic impairment.
Għid lit- tabib jekk għandek indeboliment tal- kliewi jew tal- fwied.
Please check with your doctor if you are planning to receive any vaccine (see “ Take special care with Raptiva”).
Jekk joġgħbok iċċekja mat- tabib tiegħek jekk għandek f’ moħħok biex tieħu xi tilqima.
When taking Raptiva you might be more vulnerable to infections (see Take special care with Raptiva) this effect might be enhanced by other medicines that are used to treat psoriasis and that also make you more vulnerable to infections.
(ara ‘ Qogħod attent ma ’ Raptiva ’) Meta qed tieħu Raptiva, tista jsir iktar vulnerabbli għal infezzjonijiet (ara ‘ Qogħod attent ma ’ Raptiva).
Please check with your doctor if you receive other medicines to treat your psoriasis.
Dan l- effett jista ’ jkun akbar meta tieħu mediċini oħra li jintużaw għal kura ta ’ psorjażi li ukoll jagħmlulek aktar vulnerabbli għal infezzjonijiet.
Raptiva can be used in combination with topical corticosteroids.
Raptiva jista ’ jintuża ma ’ cotrticosterojdi topikali.
Pregnancy It is not known whether Raptiva can cause harm to your baby if you are pregnant or whether it can affect your ability to become pregnant.
Tqala Mhuwiex magħruf jekk Raptiva jista ’ jikkawza danni għat- tarbija tiegħek jekk inti tqila, jew jekk huwa jista jkollu xi effett fuq l- abilita sabiex issir tqila.
Therefore, if you are pregnant, consult with your doctor immediately.
Għalhekk, jekk inti tqila, tkellem mat- tabib tiegħek immedjatament.
If you are a woman of childbearing potential, you are advised not to become pregnant and to use adequate contraception while using Raptiva.
Jekk inti mara ta ’ l- eta fejn tista jkollok tfal, inti avvisata li ma ssirx tqila u li tuża kontraċezzjoni adeguata waqt li qegħda fuq Raptiva.
Breast-feeding It is possible that efalizumab is excreted in human milk.
25 Treddigħ Huwa possibli li efalizumab huwa eskrejjat fil- ħalib uman.
If you are breastfeeding, your doctor will advise you either to discontinue breastfeeding or to discontinue Raptiva while breastfeeding.
Jekk inti qed treddigħ, it- tabib tiegħek se javvisak sabiex jew tieqaf treddigħ jew inkella li tieqaf il- kura ta ’ Raptiva sa meta tkun qed treddigħ.
25 Driving and using machines The use of Raptiva is not expected to affect your ability to drive and use machines.
Sewqan u tħaddim ta ’ magni L- użu ta ’ Raptiva mhuwiex mistenni li jkollu effett fuq l- abilita ’ tiegħek biex issuq u tħaddem magni.
HOW TO USE RAPTIVA
KIF GĦANDEK TUŻA RAPTIVA
Always take Raptiva exactly as your doctor has told you.
Dejjem għandek tieħu Raptiva skond il- parir tat- tabib.
Dosing for adults (18-64 years) and the elderly (≥ 65 years) The usual dose is an initial single injection of 0.7 mg/ kg followed by weekly injections of 1.0 mg/ kg.
Doża għal adulti (18- 64 snin) u l- anżjani (≥ 65 sena) Id- doża li ssoltu tingħata bħala injezzjoni iniżjali singolari hija ta ’ 0. 7mg/ kg issegwit minn injezzjonijiet ta ’ kull ġimgħa ta ’ 1. 0mg/ kg.
Your doctor will tell you how much you should inject.
Lit- tabib tiegħek jgħidlek kemm trid tinjetta.
The duration of therapy is 12 weeks.
It- tul tal- kura hija ta ’ 12 ġimgħat.
Therapy may be continued only in patients who responded to treatment, your doctor will discuss with you the extent of your response to treatment.
Il- kura tista titkompla f’ dawk il- pazjienti li jirrispondu għalija; it- tabib tiegħek jista ’ jgħidlek kif inti qed tirrispondi għal kura.
Method and route of administration Raptiva is injected just under the skin (subcutaneous).
Metodu ta ’ kif għandu jingħata Raptiva jingħata minn taħt il- ġilda.
It is for single use only.
Huwa għall- użu singolari biss.
The injection can be self-administered or given by another person, for example a family member or your doctor.
L- injezzjoni jista ’ jingħata mill - pazjient stess jew minn xi ħadd ieħor, per eżempju xi membru mill- familja jew it- tabib tieħek.
You should continue to inject Raptiva as long as instructed to do so by your doctor.
Trid tibqa ’ tieħu Raptiva għal żmien kif jgħidlek it- tabib tiegħek.
The vial of powder is designed to be reconstituted (mixed) with the solvent.
Il- vjala ta ’ trab irid jkun rikkostitut mas- solvent.
If you administer Raptiva, please read the following instructions carefully and follow then step by step: • Wash your hands.
Jekk tieħu Raptiva waħdek, jekk jogħġbok aqra sew dawn l- istruzzjonijiet segwenti imbagħad seqwihom waħda waħda. • Aħsel idejk.
It is important that your hands and items you use be as clean as possible. • Take the Raptiva out of the refrigerator and lay out on a clean surface everything you need: o one vial containing the Raptiva powder o one pre-filled syringe containing the solvent o one EasyMIX adapter for reconstitution o two alcohol swabs o one needle for subcutaneous injection, and o a sharps container
Sib post nadif u ifrex kollox o Vjala waħda bit- trab ta ’ Raptiva o Siringa mimlija lesta bis- solvent o EasyMIX wiehed ghal rikostituzzjoni o żewġ ċraret bl- alkoħol, o labra fina għall- injezzjoni taħt il- ġilda o kontenitur għar- rimi b’ sigurtà tal- ħġieġ u s- siringi.
• Remove the protective cap from the Raptiva vial and from the solvent pre-filled syringe.
• Neħħi l- għatu protettiv mill- vjala u mil siringa mimlija lesta ta ’ solvent.
Wipe the top of the vial with an alcohol swab. • Holding the EasyMIX outer cover, carefully peel back and remove the protective film using the tab.
Naddaf il- wiċċ tal- vjala bil ċarruta ta ’ l- alkoħol. • Zomm il- kisi ta barra tal- EasyMIX, u bil- mod aqla il- kisi protettiv billi tuza it- tab.
This will expose a plastic spiked end that you will use to pierce the vial.
Meta tnehhi dan il- kisi tara bicca tal- plastik ippuntata li se tintuza biex inti ttaqqab il- vjala.
You should not touch this area. • Holding the EasyMIX outer cover, place it on top of the vial, then press down so that the plastic spiked end pierces the rubber stopper on the vial. • Ensure the EasyMIX adapter is firmly attached to the vial, before removing the outer cover.
Inti mhux suppost tmiss din il- parti. • Zomm il- kisi ta ’ barra tal- EasyMIX, poggija fuq il- vjala, u ghafas l- isfel sabiex il- bicca plastic ippuntata ttaqqab l- istopper tal- gomma fuq il- vjala. • Kun zgur li l- adapter tal- EasyMIX huwa mwahhal sew mal- vjala, qabel ma tnehhi il- kisi ta ’ barra.
26 • Pull off the cap covering the pre-filled syringe tip. • Attach the pre-filled syringe containing the solvent to the EasyMIX adapter with a ‘ push and twist’ action.
26 • Neħħi l- kap li jiksi l- punta tas- siringa mimlija lesta • Waħħal is- sirniga mimlija lesta bis- solvent ma ’ l- adaptor EasyMIX b’ azzjoni ta ’ ‘ għafas u iddur ’.
• Very slowly push down on the syringe plunger to inject all the solvent into the Raptiva vial. • Without removing the syringe, gently rotate the vial to dissolve the medicine in the solvent.
• Bil- mod afán gafas l- isfel fuq il- plunger sabiex tinjetta is- solvent kollu fil- vjala tar- Raptiva. • Mingħajr ma tneħħi s- siringa, dawwar il- vjala bil- mod sabiex sabiex il- mediċina tinħal fis - solvent
Do not shake (Shaking will cause foaming of the Raptiva solution).
Iddawarx bis- saħħa (dan jista ’ jikkawza r- ragħwa tas- soluzzjoni ta ’ Raptiva).
Generally reconstitution takes less than 5 minutes.
Ġeneralment, rikostituzzjoni jdum inqas minn 5 minuti.
After the powder has dissolved, check the resulting solution for particles and discoloration.
Wara li tinħal it- trab, iċċekja is- soluzzjoni għal biċċiet u kulur.
The reconstituted solution should be clear to pale yellow and free of particles.
Dan irid jkun ċar għal isfar u mingħajr biċċiet.
No other medicines should be added to the solution containing Raptiva and Raptiva should not be reconstituted with other solvents. • Turn the vial upside down, with the syringe still attached.
Ma jistgħux jitħalltu mediċini oħra mas - soluzzjoni ta ’ Raptiva u Raptiva ma tistax tiġi rrikosituta ma ’ solventi oħra.) • Aqleb il- kunjett rasu l- isfel u, bis- siringa għadha mwaħħla..
Withdraw the solution slowly into the syringe, taking more than the dose you need.
Iġbed is- soluzzjoni lura fis- siringa, u iġbed iktar milli għandek bżonn bħala doża.
Some foam or bubbles may remain in the vial.
Xi ragħwa jew bżieżaq jistgħu jibqgħu fil- vjala.
With the syringe still attached to the vial, check the syringe for air bubbles. • Gently tap the syringe to make any bubbles rise to the top of the syringe.
Bis- siringa imwaħħla mal- vjala, iċċekja s- siringa għal bżieżaq ta ’ l- arja. • Bil- mod ifflikkja s- siringa sakemm l- arja tinġabar fuq ħdejn il- labra
• Gently push the plunger up until the dose to be given remains in the syringe.
• Bil- mod ibbotta il- plunġer sakemm jkollok id- doża li għandek bżonn.
This will also push the bubbles out of the syringe and into the vial.
Dan ineħħi il- bżieżaq barra mis- siringa u fil- vjala.
If you eject too much Raptiva back into the vial, simply repeat the drawing up process and continue.
Jekk tneħħi wisq Raptiva, sempliċement terġa tirrepeti l- proċedura biex tieħu d- doza u kompli.
• Check you have the right dose, then remove the syringe from the EasyMIX adapter using a ‘ twist and pull’ action.
• Iċċekja li għandek id- doza tajba u neħħi s- siringa mill- EasyMIX adaptor, billi ddawru u tiġbed.
27 You are now ready to attach the injection needle. • Take the injection needle and, with its shield still in place, carefully screw it on to the syringe tip.
27 Issa inti lest li twaħħal il- labra ta ’ l- injezzjoni. • Ħu l- labra ta ’ l- injezzjoni, u bil- kisi tiegħu għadu f’ postu, waħħlu mat- tip tas- siringa billi ddawru bil- mod.
You are now ready to select and prepare your injection site.
Issa inti lest sabiex tagħzel u tipprepara s- sit ta ’ l- linjezzjoni.
Your doctor or nurse will have already advised you where to inject.
It- tabib jew l- infiermiera tiegħek se jkunu diġà avżawk fejn tinjetta.
Sites for self-injection include the buttocks, thigh, abdomen or upper arm.
Siti għal injezzjoni jinkludu s- sorm, il- koxxa, żaqq jew driegħ.
The injection sites should be rotated. • Wipe the chosen area with an alcohol swab.
Is- siti ta ’ l- injezzjoni jridu jinbidlu. • Imsaħ il- parti magħżula b’ ċarruta bl- alkoħol.
Remove the shield from the injection needle. • Immediately inject the solution as follows:
Neħħi l- kisi mis- siringa ta ’ l- injezzjoni. • Immedjatament injetta s- soluzzjoni kif segwenti:
Firmly pinch the skin together and insert the needle at a 45° to 90° angle using a dart-like motion.
Agħfas sew il- ġilda u daħħal il- labra f’ anglu ta ’ 45° sa 90° isek qed twaddab dart.
Pull back the plunger very slightly.
Iġbed ftit lura l- planġer.
If blood comes into the syringe, the needle has entered a blood vessel.
Jekk jidħol ftit demm fis- siringa, il- labra tkun daħħlet f’ xi vina.
Do not inject but withdraw the needle and repeat the injection procedure.
Tinjettax u neħħi l- labra u erġa rrepeti l- proċedura ta ’ l- injezzjoni.
Inject the solution by pushing gently on the plunger.
Injetta s - soluzzjoni billi tibbota bil- mod il- planġer.
Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
Neħħi l- labra mill- ewwel u naddaf il- ġilda b’ ċarruta ta ’ l- alkoħol b’ moviment ċirkulari.
Once you have finished your injection, immediately discard all needles and empty glass containers in a sharps container.
Hekk kif tkun lestejt l- injezzjoni tiegħek, armi l- labar u l - kontenituri tal- ħġieġ vojta fil- kontenitur provdut.
Any unused solution must be discarded.
Kull taħlita likwida mhux użata għandha tintrema.
If you use more Raptiva than you should If you have injected more Raptiva than told by your doctor, please contact your doctor or pharmacist.
Jekk tieħu Raptiva aktar milli suppost Jekk injettajt aktar Raptiva milli qallek it- tabib, jekk jogħġbok għamel kuntatt mat- tabib jew lill - ispiżjar tiegħek.
It is recommended that you are monitored for any signs or symptoms of adverse effects and that you are given appropriate symptomatic treatment immediately.
Huwa rakkomandat li tkun monitorjat għal xi sinjali jew sintomi ta ’ effetti avversi u li tingħata kura simtomatika addatata immedjatament.
If you forget to use Raptiva Do not take a double dose to make up for a forgotten dose.
Jekk tinsa ’ tieħu Rapriva M’ għandekx tieħu doża doppja, sabiex tikkompensi għad- doża li insejt tieħu.
Please contact your doctor if you forget to take 2 or more doses of Raptiva.
Jekk jogħġbok kellem lit- tabib tiegħek jekk tinsa tieħu aktar minn 2 jew iktar dożi.
If you stop using Raptiva If you discontinue treatment with Raptiva without substitution treatment, your psoriasis may significantly worsen.
Jekk tieqaf tuża Raptiva Jekk tieqaf il- kura ta ’ Raptiva mingħajr ma tieħu kura ieħor, il- psorjażi tiegħek jista jsir għar.
(See “ Take special care with Raptiva”)
(ara ‘ Qogħod attent ma ’ Raptiva).
In case re-treatment with Raptiva is needed you should follow the guidance of your doctor.
Fil- każ li jkollok terġa tuża Raptiva, trid issegwi dak li jgħidlek it- tabib.
Re- treatment may be associated with lower or inadequate response to Raptiva than in the earlier treatment periods.
Dan jista ’ jkun assoċjat ma ’ risposta inqas jew inadeguata meta tikkompara ma ’ kuri li ttieħdu qabel.
Therapy should be continued only when adequate response is observed.
Il- kura jrid jkun komplut biss meta hemm risposta adeguata jew jekk il- psorjażi tiegħek qed jsir iktar għar.
Your doctor will advise you what to do when insufficient response to treatment or worsening of your disease is observed.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Raptiva can cause side effects, although not everybody gets them.
Bħall- mediċini l- oħra kollha, Raptiva jista ’ jkollu effetti oħra, għalkemm ma jidhrux fuq kulħadd.
The side effects in this section are given with an estimation of the frequency with which they may occur.
28 F’ din is- sezzjoni, l- effetti oħra ingħatu b’ estimu tal- frekwenza kif jiġru.
Side effects that may occur in less than 1 out of 10,000 patients;
Għalhekk is- segwenti klassikazzjoni intuża: • Komuni ħafna: effetti oħra li jistgħu jseħħu f’ iktar minn pazjient wieħed minn 10; • Komuni: effetti oħra li jistgħu jseħħu fi 1- 10 pazjienti minn 100; • Mhux komuni: effetti oħra li jistgħu jseħħu fi 1- 10 pazjienti minn 1, 000; • Rari: effetti oħra li jistgħu jseħħu fi 1- 10 pazjienti minn 10, 000; • Rari ħafna: effetti oħra li jistgħu jseħħu f’ inqas minn pazjient minn 10, 000;
Raptiva may cause mild to moderate flu-like symptoms including headache, chills, nausea, muscle aches and occasionally fever within 48 hours of an injection of Raptiva.
Raptiva jista jikkawża simptomi moderati bħal ta ’ l- influenza inkluż uġigħ ta ’ ras, sirdat, nawsea, uġigħ fil- muskoli u xi kultant deni fi 48 sigħat ta ’ injezzjoni ta ’ Raptiva.
These symptoms are very common and occur most often after the first two doses and decrease with continued use.
Dawn is- sintomi huma komuni ħafna u fl- aktar każi jseħħu wara l- ewwel żewġ dożi u jonqsu ma ’ aktar użu tal- mediċina.
If any of these symptoms are severe or persist, you should contact your doctor.
Jekk hemm xi sintomi minn dawn li huma severi jew li jippersisti, għamel kuntatt mat- tabib tiegħek.
In clinical trials, visible side effects at the injection site and injection site pain were uncommon.
Fi studji kliniċi, effetti oħrajn fis- sit ta ’ injezzjoni w uġigħ fis- sit ta ’ l- injezzjoni ma kienux komuni.
Tell your doctor or go to the local casualty and stop using Raptiva immediately if you: • Notice serious hypersensitivity or allergic reactions, such as anaphylaxis.
Tkellem lit- tabib tiegħek jew inkella mur l- isptar u ieqaf tuża Raptiva immedjatament jekk inti: • Tinnota ipersensittivita ’ eċċessiva jew reazzjonijiet allerġiċi, bħal anafilassi.
Symptoms of an allergic reaction are common and generally include overall body itching, hives, skin flushing or rash.
Sintomi ta ’ reazzjoni allerġika huma komuni u ġeneralment jinkludu hakk madwar il- ġisem kollu, hives, il - ġilda li titħmar jew raxx.
Anaphylaxis is a more serious allergic reaction that may involve dizziness, vomiting, low blood pressure, and difficulty with breathing.
Anafilassi huwa reazzjoni allerġika iktar serja u jista jinvolvi sturdament, rimettar, pressjoni baxxa, u diffikolta ’ fin- nifs.
Prompt medical care is needed since serious allergic reactions may be potentially life-threatening. • Notice symptoms of low blood platelet counts, such as easy bleeding from the gums, bruising or pinpoint red spots on the skin.
Kura immedjata huwa neċċessarju peress illi reazzjonijiet allerġiċi serji jistgħu jkunu potenzjalment periklu għal ħajja. • Tinnota sintomi ta ’ ammont baxx ta ’ plajtlits, bħal titlief tad- demm mill- ħanek, tbenġil jew punti ħomor żgħar fuq il- ġilda.
These symptoms are uncommon. • Notice signs of nerve disorder such as tingling or onset of weakness in legs or arms or new or sudden change in thinking, balance, strength, talking, walking or vision. • Notice severe headache accompanied with nuchal rigidity.
Dawn is- sintomi mhumiex komuni. • Tinnota sinjali ta ’ diżordni tan- nervi bħal tingling jew debbulizza fis- saqajn jew driegħi jew bdil ġdid jew għarrieda fil- ħsieb, fil- bilanċ, fis- saħħa, fil- mixi jew fil- vista. • Tinnota uġigħ ta ’ ras akkompanjat minn ibbies nuchal.
This may occur rarely in particular at the beginning of the treatment. • Are diagnosed with cancer. • Develop a diffuse skin rash or blisters in your oral cavity.
Rarament, dan jista jseħħ partikolarment fil- bidu tal- kura. • Tkun dijanjostikat bi kankru. • Tiżviluppa raxx tal- ġilda diffusa jew nuffatta f’ ħalqek.
Tell your doctor and discuss with him your general health if you notice any of the following: • Back pain, joints pain, headache, vomiting, weakness, fatigue or rash.
Tkellem mat- tabib tiegħek u ddiskuti miegħu is- saħħa tiegħek ġenerali jekk tinnota xi ħaġa minn: • Uġigħ f’ darek, uġigħ ta ’ ras, rimettar, debbulizza, għas jew raxx.
These common side effects have not been clearly associated with Raptiva but have been observed when using it.
Dawn l- effetti oħra komuni ma ġewx assoċjati ċarament ma ’ Raptiva imma ġew osservati waqt li ntuża.
Your doctor may want to examine you more closely and ask you to have blood tests. • Fever or if you think that you have an infection.
It- tabib tiegħek jista jixtieq li jezaminak iktar mill- viċin u jsaqsik biex ikollok testijiet tad- demm. • Deni jew taħseb li għandek infezzjoni.
Raptiva acts on the immune system, which may potentially increase your risk of infectious diseases or may reactivate old infections.
Raptiva jaħdem fuq is- sistema immuni, li jista jizdied ir - riskju ta ’ mardi ta’ infezzjoni jew jista jerġa jattiva infezzjoni qadim.
Infections are very common. • A relapse or flare or strong worsening of psoriasis or red, inflamed psoriatic plaques, sometimes with swelling of your arms or legs or joint inflammation, especially after stopping Raptiva.
Infezzjonijiet huma komuni ħafna. • Jerġa joħroġ il- psorjażi jew issir iktar għar, jew joħorgu plaques ħomor tal- psorjażi, xi kultant bin- nefħa tas- saqajn jew driegħi jew infiammazzjoni tal - ġonti, speċjalment wara li jitwaqqaf Raptiva.
These side effects are common. • Shortness of breath or any persistent respiratory difficulties. • Signs of facial paralysis usually on one side of the face (such as weakness of face muscles and dribbling) possibly preceded by pain in the ear area.
Dawn l- effetti oħra huma komuni ħafna. • Tuħ fin- nifs u problemi respiratorji persistenti. • Sinjali ta ’ paralazi tal- wiċċ issoltu fuq naħa waħda tal- wiċċ (bħal djufija tal- muskoli tal- wiċċ u ħruġ ta ’ bzieq minn naħat tal- ħalq minħabba illi x- xuftejn ma jingħalqux sewwa (dribbling)), bil- possibilta ’ li jkun hemm min qabel uġigħ fiz- zona tal- widna.
Generally patients with facial paralysis recover within a few weeks without any specific treatment.
Ġeneralment pazjienti bi paralazi tal- wiċċ jirkupraw fi żmien ta ’ ftit ġimgħat, mingħajr il- bżonn ta ’ xi kura speċifika.
Certain laboratory tests may change, such as the number of white or red blood cells (including leukocytes and lymphocytes) as well as alkaline phosphatase and ALT values (blood laboratory values).
Ċerti tesijiet tal- laboratorju jistgħu jitbiddlu, bħal in- numru ta ’ ċelluli bojod u ħomor (inklużi il - leukoċiti u limfoċiti) kif ukoll il- valuri ta ’ alkaline phosphatase u ALT (valuri laboratorji tad- demm).
These changes, which may be associated with the use of Raptiva, can usually only be detected with blood tests.
Dawn il- bidliet, li jistgħu jkunu assoċjati ma ’ l- użu ta ’ Raptiva, is- soltu jistgħu jinstabu permez ta ’ testijiet tad- demm.
HOW TO STORE RAPTIVA
KIF TAĦŻEN RAPTIVA
Do not freeze.
Taħżinx fi friża.
Do not use Raptiva after the expiry date which is stated on the label and carton after EXP.
M’ ghandekx tuża Raptiva wara id- data li jiskadi li tidher fuq il- kunjetti wara JISS.
Do not use if you notice that the solution is not clear or contains particles.
Tużaħx jekk tinnota li s- soluzzjoni mhiex ċara jew fiha xi frak.
To maintain sterility, Raptiva must be used immediately after first opening and reconstitution.
Sabiex jinżamm l- isterilita ’, Raptiva jrid jintuża immedjatament wara li jinfetaħ u jiġi rrikostitut.
What Raptiva contains • The active substance is efalizumab, each vial contains a deliverable dose of 125 mg efalizumab. • The other ingredients are polysorbate 20, histidine, histidine hydrochloride monohydrate and sucrose. • Each pre-filled syringe of solvent contains sufficient water for injections to make up the solution for injection.
X’ fih Raptiva • Is- sustanza attiva hi efalizumab, kull vjala fiha doża li jista ’ jingħata ta ’ 125mg efalizumab. • Is- sustanzai l- oħra huma polysorbat 20, histidine, histidine hydrochloride monohydrate u sukrożju. • Kull siringa mimlija lesta ta ’ solvent fiha ilma għal injezzjoni li hija biżżejjed sabiex tagħmel is - soluzzjoni għal injezzjoni.
What Raptiva looks like and contents of the pack Raptiva is presented as a powder and solvent for solution for injection.
Id- Dehra tal- prodott u d- daqs tal- pakkett Raptiva huwa ppresentat bħala trab u solvent għal soluzzjoni għall - injezzjoni.
The powder is a white to off-white cake and the solvent is a colourless liquid.
It- trab huwa abjad għal off- white kejk u s- solvent huwa liqwiku mingħajr kulur.
The product is supplied in packs of 1 vial of powder, 1 pre-filled syringe of solvent, 1 EasyMIX adapter for reconstitution, 1 needle for injection; in packs of 4 vials of powder, 4 pre-filled syringes of solvent, 4 EasyMIX adapters for reconstitution, 4 needles for injection and in packs of 12 vials of powder, 12 pre-filled syringes of solvent, 12 EasyMIX adapters for reconstitution and 12 needles for injection.
Il- prodott huwa xxuplit f’ pakketti ta ’ vjala waħda ta ’ trab, siringa mimlija lesta għall- użu ta ’ solvent, EasyMIX adaptor għal rikostituzzjoni, labra oħra għall- injezzjoni, pakketti ta ’ 4 vjali ta ’ trab, 4 siringi mimlijien lesti għall- użu, 4 EasyMIX adaptors għal rikostituzzjoni, 4 labar oħra għall- injezzjoni u pakketti ta ’ 12 vjali ta ’ trab, 12 siringi mimlijien lesti għal l- użu ta ’ solvent, 12 EasyMIX adaptors għal rikostituzzjoni u 12 labar għall - injezzjoni.
Not all pack sizes may be available in each country.
Mux id- daqsijiet kollha tal- prodott jistgħu jkun disponibbli f’ kull pajjiż.
Manufacturer Merck Serono S. p. A.
Maniffatur Merck Serono S. p. A.
Via Luigi Einaudi 11 00012 Guidonia Montecelio/ Rome Italy
Via Luigi Einaudi 11 00012 Guidonia Montecelio/ Rome Italy
What is Rasilez?
X' inhu Rasilez?
Rasilez is a medicine containing the active substance aliskiren.
Rasilez hu mediċina li fiha s- sustanza attiva aliskiren.
What is Rasilez used for?
Għal x' hiex jintuża Rasilez?
Rasilez is used to treat essential hypertension (high blood pressure). ‘ Essential ’ means that no specific cause for the hypertension can be found.
Rasilez jintuża fit- trattament tal- pressjoni għolja essenzjali. ‘ Essenzjali 'tfisser li ma tkunx tista' tinstab kawża speċifika għall- pressjoni għolja.
How is Rasilez used?
Kif jintuża Rasilez?
The recommended dose of Rasilez is 150 mg once a day, either taken alone or in combination with other medicines for hypertension.
Id- doża rrakkomandatata ta 'Rasilez hi 150 mg darba kuljum, jew waħedha jew flimkien ma' mediċini oħra għall- pressjoni għolja.
Rasilez is not recommended for children, due to a lack of information on safety and effectiveness in this group.
Rasilez mhux rakkomandat għat- tfal, minħabba nuqqas ta 'tagħrif dwar is - sigurtà u l- effikaċja f' dan il- grupp.
How does Rasilez work?
Kif jaħdem Rasilez?
The active substance in Rasilez, aliskiren, is a renin inhibitor.
Is- sustanza attiva f' Rasilez, aliskiren, hi inibitur tar- renin.
How has Rasilez been studied?
Kif ġie studjat Rasilez?
The effects of Rasilez were first tested in experimental models before being studied in humans.
L- effetti ta 'Rasilez għall- ewwel ġew ittestjati f' mudeli esperimentali qabel ma ġew studjati fil - bnedmin.
Rasilez was studied in 14 main studies involving over 10,000 patients with essential hypertension.
Rasilez ġie studjat f' 14- il studju ewlieni li fihom ħadu sehem iktar minn 10, 000 pazjent bi pressjoni għolja essenzjali.
In five of the studies, the effects of Rasilez taken alone were compared with those of placebo (a dummy treatment).
F' ħamsa mill - istudji, l- effetti ta 'Rasilez meħud waħdu tqabblu ma' dawk ta 'plaċebo (trattament finta).
Rasilez, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Rasilez, meħud waħdu jew flimkien ma 'mediċini oħra, tqabbel ma' mediċini oħra għall- pressjoni għolja.
Combination studies looked at Rasilez used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L - istudji kombinatorji ħarsu lejn l- effett ta 'Rasilez użat flimkien ma' inibitur ta 'enzim li jikkonverti l - angiotensin (ramipril), ma' sustanza li timblokka r- riċettur ta 'l- angiotensin (valsartan), ma' beta - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
What benefit has Rasilez shown during the studies?
X' inhu l- benefiċċju ta 'Rasilez li ntwera f' dawn l- istudji?
Rasilez on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Rasilez waħdu kien iktar effettiv mill- plaċebo u kien effettiv daqs it- trattamenti komparattivi fit - tnaqqis tal- pressjoni.
When the results of the five studies comparing Rasilez taken alone with placebo were looked at together, patients aged under 65 had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Rasilez, from an average of 99.4 mmHg at the start of the study.
Meta r- riżultati tal- ħames studji li qabblu Rasilez meħud waħdu ma 'plaċebo ġew studjati flimkien, il- pazjenti li kellhom inqas minn 65 sena kellhom tnaqqis medju fil- pressjoni dijastolika ta' 9. 0 mmHg wara tmien ġimgħat jieħdu 150 mg Rasilez, minn medja ta '99. 4 mmHg fil - bidu tat- trattament.
Larger falls were seen in patients aged 65 or over and those taking higher doses of Rasilez.
Fil- pazjenti li kellhom 65 sena jew iktar u f' dawk li kienu qed jieħdu dożi ogħla ta 'Rasilez kien hemm tnaqqis ikbar fil- pressjoni.
Rasilez also reduced blood pressure in patients with diabetes, patients who were overweight, and those who were over 65 years of age.
Rasilez ġab ukoll tnaqqis fil- pressjoni fil - pazjenti bid- dijabete, pazjenti b' piż eċċessiv, u f' dawk li kellhom iktar minn 65 sena.
The studies also showed that Rasilez, when taken in combination with other medicines (especially hydrochlorothiazide), can produce additional decreases in blood pressure compared with those produced by these medicines taken without Rasilez.
L- istudji wrew ukoll li Rasilez, meta meħud flimkien ma 'mediċini oħra (speċjalment hydrochlorothiazide), jista' jwassal għal iktar tnaqqis fil- pressjoni meta mqabbel mat- tnaqqis fil - pressjoni kkawżat minn dawn il- mediċini meħuda mingħajr Rasilez.
What is the risk associated with Rasilez?
X' inhu r- riskju assoċjat ma 'Rasilez?
The most common side effect with Rasilez (seen in between 1 and 10 patients in 100) is diarrhoea.
L- iktar effett sekondarju komuni ta 'Rasilez (li deher f' bejn pazjent wieħed u 10 minn kull 100) hi d - dijarea.
For the full list of all side effects reported with Rasilez, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati ma' Rasilez, ara l- Fuljett ta 'Tagħrif.
Rasilez should not be used by people who may be hypersensitive (allergic) to aliskiren or any of the other ingredients.
Rasilez m' għandux jintuża minn persuni li huma sensittivi żżejjed (allerġiċi) għal aliskiren jew għal xi sustanza oħra tiegħu.
Why has Rasilez been approved?
Għaliex ġie approvat Rasilez?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Rasilez are greater than its risks for the treatment of essential hypertension.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Rasilez fit- trattament tal- pressjoni għolja essenzjali huma ikbar mir- riskji tiegħu.
The Committee recommended that Rasilez be given marketing authorisation.
Il- Kumitat irrakkomanda li Rasilez jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Rasilez:
Tagħrif ieħor dwar Rasilez:
The European Commission granted a marketing authorisation valid throughout the European Union for Rasilez to Novartis Europharm Limited on 22 August 2007.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Rasilez lil Novartis Europharm Limited fl- 22 ta 'Awwissu ta' l- 2007.
The full EPAR for Rasilez can be found here.
L- EPAR sħiħ għal Rasilez jinsab hawn.
Form
Għamla farmaċewtika
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Rasilez 150 mg film-coated tablets
Rasilez 150 mg pilloli miksijin b’ rita
The recommended dose of Rasilez is 150 mg once daily.
Id- doża irrikkmandata ta ’ Rasilez hija 150 mg darba kuljum.
Rasilez may be used alone or in combination with other antihypertensive agents (see sections 4.4 and 5.1).
Rasilez jista ’ jintuża waħdu jew ma ’ aġenti oħra li jbaxxu l- pressjoni (ara sezzjonijiet 4. 4 u 5. 1).
Rasilez should be taken with a light meal once a day, preferably at the same time each day.
Rasilez għandu jittieħed ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin tal- ġurnata kuljum.
Grapefruit juice should not be taken together with Rasilez.
Il- meraq tal- grejpfrut m’ għandux jittieħed flimkien ma ’ Rasilez.
2 4.3 Contraindications
Pazjenti tfal (taħt it- 18- il sena) Rasilez mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 2).
Second and third trimesters of pregnancy (see section 4.6).
2 It- tieni u t- tielet trimestri tat- tqala (ara sezzjoni 4. 6).
In the event of severe and persistent diarrhoea, Rasilez therapy should be stopped.
F’ każ ta ’ dijarea severa u persistenti, it- terapija b’ Rasilez għandha titwaqqaf.
Sodium and/ or volume depleted patients In patients with marked volume- and/ or salt-depletion (e. g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Rasilez.
Pazjenti li għandhom nuqqas ta ’ sodium u/ jew volum F’ pazjenti li jkollhom nuqqas serju ta ’ volum u/ jew melħ (eż dawk li qed jingħataw dożi għoljin ta ’ dijuretiċi) jista ’ jkun hemm sintomi ta ’ pressjoni baxxa wara li tibda l- kura b’ Rasilez.
This condition should be corrected prior to administration of Rasilez, or the treatment should start under close medical supervision.
Din il - kundizzjoni għandha tiġi korretta qabel ma jingħata Rasilez, jew il- kura għandha tinbeda taħt superviżjoni medika stretta.
Renal impairment In clinical studies Rasilez has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μ mol/ l or 1.70 mg/ dl in women and ≥ 177 μ mol/ l or 2.00 mg/ dl in men and/ or estimated glomerular filtration rate (GFR) < 30 ml/ min), history of dialysis, nephrotic syndrome or renovascular hypertension.
Indeboliment renali Fil- provi kliniċi, Rasilez ma ġiex investigat f’ pazjenti li għandhom il- pressjoni għolja u li jbatu minn indeboliment renali sever (krejatinina fis- serum ≥ 150 μmol/ l jew 1. 70 mg/ dl fin- nisa u ≥ 177 μmol/ l jew 2. 00 mg/ dl fl- irġiel u/ jew rata ta ’ filtrazzjoni fil- glomeruli (GFR) stmata < 30 ml/ min), li kellhom dijalisi fil- passat, sindrome nefrotika jew pressjoni għolja renovaskulari.
Caution should be exercised in hypertensive patients with severe renal impairment due to the lack of safety information for Rasilez.
Għandu jkun hemm kawtela f’ pazjenti bil- pressjoni għolja b’ indeboliment renali sever minħabba n- nuqqas ta ’ tagħrif dwar is - sigurtà li hemm għal Rasilez.
Renal artery stenosis No data are available on the use of Rasilez in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Stenożi ta ’ l- arterja renali M’ hemmx tagħrif dwar l- użu ta ’ Rasilez f’ pazjenti bi stenożi ta ’ l- arterja renali unilaterali jew bilaterali, jew fi stenożi f’ kilwa waħda.
Rasilez has no known clinically relevant interactions with medicinal products commonly used to treat hypertension or diabetes.
Rasilez mhux magħruf li jagħmel interazzjonijiet li għandhom rilevanza klinika ma ’ prodotti mediċinali li jintużaw għall- kura ta ’ pressjoni għolja jew dijabete.
Co-administration of aliskiren with either valsartan (↓ 28%), metformin (↓ 28%), amlodipine (↑ 29%) or cimetidine (↑ 19%) resulted in between 20% and 30% change in Cmax or AUC of Rasilez.
Meta aliskiren jingħata ma ’ valsartan (↓28%), metformin (↓28%), amlodipine (↑29%) jew cimetidine (↑19%) is- Cmax jew AUC ta ’ Rasilez inbidlu b’ bejn 20% u 30%.
When administered with atorvastatin, steady-state Rasilez AUC and Cmax increased by 50%.
Meta ngħata ma ’ atorvastatin, l- AUC u Cmax fi stat fiss ta ’ Rasilez żdiedu b’ 50%.
Co- administration of Rasilez had no significant impact on atorvastatin, valsartan, metformin or
Meta Rasilez ingħata ma ’ atorvastatin, valsartan, metformin jew amlodipine dan ma kellux impatt sinifikanti fuq il- farmakokinetika tagħhom.
As a result no dose adjustment for Rasilez or these co-administered medicinal products is necessary.
3 Il- biodisponibilità ta ’ digoxin tista ’ titnaqqas xi ftit b’ Rasilez.
Preliminary data suggest that irbesartan may decrease Rasilez AUC and Cmax.
Tagħrif preliminari jindika li irbesartan jista ’ jnaqqas xi ftit l- AUC u s- Cmax ta ’ Rasilez.
In experimental animals, it has been shown that P-gp is a major determinant of Rasilez bioavailability.
F’ annimali esperimentali, intwera li P- gp jiddetermina bil- kbir il- biodisponibilità ta ’ Rasilez.
John’ s wort, rifampicin) might therefore decrease the bioavailability of Rasilez.
John’ s wort, rifampicin) għalhekk jistgħu jnaqqsu l- biodisponibilità ta ’ Rasilez.
John’ s wort, rifampicin) might therefore decrease the bioavailability of Rasilez.
John’ s Wort, rifampicin) għalhekk jistgħu jnaqqsu l- bijodisponibilità ta ’ Rasilez.
Furosemide When aliskiren was co-administered with furosemide, the AUC and Cmax of furosemide were reduced by 28% and 49%, respectively.
Furosemide Meta aliskiren ingħata ma ’ furosemide, l- AUC u Cmax ta ’ furosemide tnaqqsu b’ 28% u 49% rispettivament.
4 Potassium and potassium-sparing diuretics Based on experience with the use of other substances that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other substances that may increase serum potassium levels (e. g. heparin) may lead to increases in serum potassium.
4 sustanzi oħra li jistgħu jżidu l- livelli ta ’ potassium fis- serum (eż heparin) jistgħu jwasslu għal żidied tal- potassium fis- serum.
Warfarin The effects of Rasilez on warfarin pharmacokinetics have not been evaluated.
Warfarin L- effetti ta ’ Rasilez fuq il- farmakokinetika ta ’ warfarin ma kienux evalwati.
Food intake Meals with a high fat content have been shown to reduce the absorption of Rasilez substantially.
It- teħid ta ’ l- ikel Ikliet b’ kontenut ta ’ xaħam għoli ntwerew li jnaqqsu l- assorbiment ta ’ Rasilez b’ mod sostanzjali.
Rasilez was not teratogenic in rats or rabbits (see section 5.3).
Rasilez ma kienx teratoġeniku fi frien jew fniek (ara sezzjoni 5. 3).