qanastek/EMEA-V3 huggingface dataset:
Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).
Żomm il- labra f’ linja dritta mal- pinna, u żommha dritta waqt li tqabbadha (bil- kamin jew b’ għafsa, skond it- tip ta ’ labra).
• If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or the needle can be bent.
• Jekk il- labra ma tinżammx dritta waqt li tkun qed tqabbadha, din tista ’ tagħmel ħsara l- woxer tal- lastku, u bħala riżultat ta ’ dan, il- pinna tibda tqattar, jew il- labra titgħawweġ.
This ensures that you get an accurate dose by: • making sure that pen and needle work properly • removing air bubbles If you are using a new OptiSet the initial safety test must be done with the 8 units preset by the manufacturer, otherwise the pen will not function properly.
Jekk qed tuża OptiSet ġdida t- test inizjali ta ’ sigurtà għandu jsir bi 8 unitajiet kif inhu s- settjat mill - manifattur, altrimenti l- pinna mhux ser taħdem sew.
Select the dose for the Safety Test. • New and unused OptiSet: a dose of 8 units is already preset by the manufacturer for the first safety test. • In-use OptiSet: select a dose of 2 units by turning the dosage selector forward till the dose arrow points to 2.
Agħżel id- doża għat- Test tas- Sigurtà. • Għal OptiSet ġdida u mhux użata: doża ta ’ 8 unitajiet diġa tkun issettjata mill- manifattur għall - ewwel test ta ’ sigurtà. • Għal OptiSet li ntuża: agħżel doża ta ’ 2 unitajiet billi ddawwar is- selettur tad- dożaġġ ’ il quddiem sakemm il- vleġġa tipponta lejn in- numru 2.
C.
134 Ċ.
discard keep
armi żomm
You can set the dose in steps of 2 units, from a minimum of 2 units to a maximum of 40 units.
Tista ’ tissettja d- doża f’ qabżiet ta ’ 2 unitajiet, minn minimu ta ’ 2 unitajiet sa massimu ta ’ 40 unità.
If you need a dose greater than 40 units, you should give it as two or more injections.
Jekk għandek bżonn ta ’ doża akbar minn 40 unità, din trid taqsamha f’ żewġ injezzjonijiet jew aktar.
• If the black plunger is at the beginning of the coloured bar, then there are approximately 40 units of insulin available.
135 • Jekk il- planġer iswed qiegħed fil- bidu ta ’ l- istrixxa ikkulurita, allura hemm madwar 40 unità ta ’ insulina disponibbli.
• If the black plunger is at the end of the coloured bar, then there are approximately 20 units of insulin available.
• Jekk il- planġer iswed qiegħed fit- tarf ta ’ l- istixxa ikkulurita, allura hemm madwar 20 unità ta ’ insulina disponibbli.
Note that the injection button only goes out as far as the amount of insulin that is left in the reservoir. • The injection button must be held out under tension during this check. • The last thick line visible on the injection button shows the amount of insulin loaded.
Innota li l- buttun ta ’ l- injezzjoni joħroġ ’ il barra sa l - ammont ta ’ insulina li fadal fir- riżervwar. • Waqt li qed isir dan l- iċċekkjar il- buttun ta ’ l- injezzjoni għandu jinżamm miġbud ’ il barra.
When the injection button is held out only the top part of this thick line can be seen. • In this example, 12 units are loaded.
L - aħħar linja ħoxna viżibbli fuq il- buttun ta ’ l- injezzjoni turi l- ammont ta ’ insulina li telgħet.
if you have selected 12 units you can inject your dose. if you have selected more than 12 units then only 12 units of your total insulin dose can be injected with this pen.
Meta l- buttun ta ’ l- injezzjoni jkun miġbud ’ il barra l- parti ta ’ fuq biss ta ’ din il- linja ħoxna tkun tidher. • Nieħdu eżempju fejn 12- il unità ttellgħet. jekk int għażilt 12- il unità tista ’ tinjetta d- doża tiegħek. o Jekk int għażilt aktar minn 12- il unità allura 12- il unità biss mid- doża sħiħa tiegħek ta ’ l - o insulina tista ’ tkun injettata b’ din il- pinna.
In this case what should you do: • either you can inject what is remaining in the pen and complete your dose with a new OptiSet. • or use a new OptiSet for your full dose..
F’ każ bħal dan x’ għandek tagħmel: • jew tinjetta dak li fadal fil- pinna u tkompli tieħu li fadallek għad- doża sħiħa minn OptiSet ġdida. • jew tuża OptiSet ġdida għad- doża sħiħa.
B.
136 B.
132 C.
Ċ.
Always remove the needle after each injection and store OptiSet without a needle attached.
Dejjem neħħi l- labra wara kull injezzjoni u aħżen l- OptiSet mingħajr labra mwaħħla.
This helps prevent: • Contamination and/ or infection • Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
Dan jgħin biex tevita: • Il- kontaminazzjoni u/ jew l- infezzjoni • Id- dħul ta ’ l- arja fir- riżervwar ta ’ l- insulina u li l- insulina tqattar mill- pinna, li jistgħu jikkawżaw dożaġġ li mhux eżatt.
Follow recommended safety measures for removal and disposal of needles (e. g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Segwi l- miżuri rakkomandati ta ’ sigurtà għat - tneħħija u r- rimi tal- labar (e. ż. tintuża id waħda biex tpoġġi l- kappa lura fuq il- labra) biex b’ hekk jonqos ir- riskju li wieħed iweġġa ’ aċċidentalment bil- labra u jkun trasmess l- mard infettiv.
Storage Instructions
Struzzjonijiet dwar il- Ħażna
Please check Section 5 - How to store Apidra- of the reverse (insulin) side of this leaflet for OptiSet storage instructions.
Jekk jogħġbok, ara sezzjoni 5 - Kif taħżen Apidra -, fuq il- faċċata ta ’ wara (ta ’ l- insulina) ta ’ dan il - fuljett għal struzzjonijiet dwar il- ħażna ta ’ OptiSet.
If your OptiSet is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up to room temperature.
Jekk l- OptiSet tiegħek hija maħzuna fil- kesħa, oħroġha minn siegħa sa sagħtejn qabel tinjetta biex tħalliha tisħon u tilħaq it- temperatura tal- kamra.
Protect your Optiset from dust and dirt.
137 Żomm l- Optiset tiegħek ’ il bogħod mit- trab u l- ħmieġ.
You can clean the outside of your OptiSet by wiping it with a damp cloth.
Tista ’ tnaddaf l- OptiSet tiegħek minn barra billi timsaħha b’ ċaruta niedja.
133 Questions and Answers
Mistoqsijiet u Tweġibiet
If the safety test is successful OptiSet is ready for use.
Jekk it- test ta sigurtà jirnexxi l- OptiSet hija lesta għall- użu. ’ il ġewwa, mingħajr ma Jekk it- test ta sigurtà ma jirrnexxiex, il- pinna tista ’ tkun bil- ħsara.
• You are turning forward while the injection button is pulled out.
Qiegħed iddawwar ’ il quddiem waqt li l- buttun ta ’ l- injezzjoni huwa miġbud ’ il barra.
• Difference is more than 2 units OptiSet is damaged, use a new OptiSet.
M’ hemmx biżżejjed insulina fir- riżervwar. •
The amount indicated on the injection button is lower than the dose selected
il- buttun ta ’ l- injezzjoni huwa anqas mid- doża magħzula.
134 Insulin is leaking from the pen.
Ma tismax iċ- ċekċik waqt li qed tinjetta.
Needle may have been attached imprecisely (e.g. at a slant).
Jista ’ jagħti l- każ li l- labra twaħħlet ħażin (e. ż. immejjla).
Remove needle and replace with a new needle attaching it on straight.
Neħħi l - L- insulina qed tqattar labra, biddilha ma oħra ġdida u waħħalha dritta.
Perform the safety test.
Agħmel it- test ta ’ mill- pinna.
Air bubbles are present in the reservoir.
138 sigurtà.
OptiSet has been dropped or subjected to impact.
Jekk int fid- dubju jekk il- pinna hix taħdem sew uża OptiSet ġdida.
135 PACKAGE LEAFLET:
139 FULJETT TA ’ TAGĦRIF:
Read carefully all of this leaflet including the Instructions for Use of Apidra, pre -filled pen, SoloStar before using this medicine.
Aqra bir- reqqa dan il- fuljett kollu inklużi l- Istruzzjonijiet dwar l- Użu ta’ Apidra, pinna mimlija għal- lest, SoloStar qabel tibda tuża din il- mediċina.
Possible side effects 5.
Effetti sekondarji li jista ’ jkollu Kif taħżen Apidra 5.
Follow closely the instructions for dosage, monitoring (blood tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
Segwi bil- preċiż l- istruzzjonijiet dwar id- dożaġġ, l- immoniterjar (testijiet tad- demm), id- dieta u l - attività fiżika (xogħol fiżiku u eżerċizzju), kif spjegalek it- tabib tiegħek.
If you have liver or kidney problems, speak to your doctor as you may need a lower dose.
140 Jekk għandek problemi fil- fwied jew fil- kliewi, tkellem mat- tabib tiegħek għax jista ’ jkollok bżonn tnaqqis fid- doża.
Before travelling consult your doctor.
Safar Qabel tivjaġġa tkellem mat- tabib tiegħek.
- the availability of your insulin in the country you are visiting,
– id- disponibbiltà ta ’ l- insulina tiegħek fil- pajjiż li qiegħed iżżur, – il- forniment ta ’ l- insulina, siringi eċċ – il- ħażna korretta ta ’ l- insulina tiegħek waqt l- ivvjaġġar – il- ħin ta ’ l- ikel u t- teħid ta ’ l- insulina waqt l- ivvjaġġar, – l- effetti possibbli fit- tibdil minn żona ta ’ ħin għal oħra differenti – il- possibiltà ta ’ riskji ġodda għal saħħtek fil- pajjiż li tkun qiegħed żżur, – – x’ għandek tagħmel f’ sitwazzjonijiet ta ’ emerġenza meta ma tħossokx tajjeb jew timrad.
- diazoxide (used to treat high blood pressure),
141
- diuretics(used to treat high blood pressure or excessive fluid retention),
- -
- oestrogens and progestogens (such as in the contraceptive pill used for birth control),
diazoxide (użat għall- kura ta ’ pressjoni għolja fid- demm), id- dijuretiċi (użati għall- kura ta ’ pressjoni għolja fid- demm jew l- akkumulazzjoni eċċessiva ta ’ fluwidi),
137 Your blood sugar level may either rise or fall if you take:
Il- livell taz- zokkor f’ demmek jista ’ jogħla jew jinżel jekk tieħu
Important information about some of the ingredients of Apidra
142 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Apidra
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free’.
Għal kull doża dan il- prodott mediċinali fih inqas minn 1 mmol (23 mg) ta ’ sodium, i. e tista ’ tgħid li huwa ‘ ħieles minn sodium ’.
138 If you switch from another insulin to insulin glulisine, your dosage may have to be adjusted by your doctor.
Jekk taqleb minn insulina oħra għall- insulina glulisine, id- dożaġġ tiegħek jista ’ jkollu jiġi aġġustat mit- tabib tiegħek.
See the box at the end of this leaflet for further information.
Ara l- informazzjoni f’ kaxxa li ssib fi tmiem ta ’ dan il- fuljett, għal aktar dettalji.
Method of administration Apidra is injected under the skin (subcutaneously).
Apidra huwa injettat taħt il- ġilda (b’ mod subkutaneju).
As for all insulins, injection sites and infusion sites within an-injection area (abdomen, thigh or upper arm) must be rotated from one injection to the next.
Bħal ma jsir fl- insulini kollha, s- siti ta ’ l- injezzjonijiet u l - infużjonijiet, f’ żona partikolari (żaqq, koxxa u l- parti ta ’ fuq tad- driegħ), għandhom jinbidlu minn injezzjoni għall- oħra.
How to handle SoloStar
Kif timmaniġġa SoloStar
SoloStar is a pre-filled disposable pen containing insulin glulisine.
SoloStar hija pinna li hija mimlija għal- lest, li tintrema wara li tinħela u li fiha l- insulina glulisine.
Read carefully the "SoloStar Instructions for Use" included in this package leaflet.
Aqra sew “ Struzzjonijiet dwar l- Użu ta ’ SoloStar ” li jinsabu f’ dan il- fuljett ta ’ tagħrif.
Only use needles that are compatible for use with SoloStar (see “SoloStar Instructions for Use”).
Uża biss labar li huma approvati għall- użu b’ SoloStar (ara “ Struzzjonijiet dwar l- Użu ta ’ SoloStar ”).
Look at the cartridge sealed in the disposable pen injector before you use it.
Eżamina l- iskartoċċ issiġillat fil- pinna, li tintrema wara li tinħela, fil- parti tagħha li ttaqqab, qabel ma tużaha.
Only use it if the solution is clear, colourless and has no visible particles in it.
Użaha biss jekk is- soluzzjoni hija ċara, mingħajr kulur u m’ għandhiex frak vizibbli fiha.
Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse.
143 Dejjem uża pinna ġdida jekk tinnota li l- kontroll taz- zokkor f’ demmek qed jiggrava bla mistenni.
If you think you may have a problem with SoloStar, please consult your Health Care Professional.
Jekk taħseb li jista ’ jkun hemm problema b’ SoloStar, jekk jogħġbok, kellem lill- Professjonist tiegħek fil - Qasam tas- Saħħa.
- If you have missed a dose of Apidra or if you have not injected enough insulin, your blood
- Jekk tlift doża ta ’ Apidra jew jekk ma injettajtx biżżejjed insulina, il- livell tiegħek taz- zokkor fid -
sugar level may become too high (hyperglycaemia).
demm jista ’ jogħla wisq (ipergliċemija).
139 If you stop using Apidra This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Dan jista ’ jwassal għal ipergliċemija severa (livell għoli ħafna ta ’ zokkor fid- demm) u ketoaċidożi (jogħla l- livell ta ’ aċidu fid- demm minħabba li l- ġisem qiegħed ikisser x- xaħam minflok iz- zokkor).
If you experience the following symptoms, contact your doctor immediately: large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.These could be symptoms of generalised allergy to insulin, including anaphylactic reaction, which may be life-threatening.
Dawn jistgħu jkunu sintomi ta ’ allerġija ġeneralizzata għall- insulina, inkluża r- reazzjoni anafilattika, li tista ’ tkun fatali.
140 Other side effects include:
Effetti sekondarji oħrajn jinkludu:
• Hyperglycaemia (high blood sugars) means there is too much sugar in the blood If your blood sugar level is too high, this tells you that you could have needed more insulin than you injected.
Ara l- kaxxa fit- tmiem ta ’ dan il- fuljett, għal aktar informazzjoni.
Do not use Apidra after the expiry date, which is stated on the carton and on the label of the pen.
Tużax Apidra wara d- data ta ’ skadenza, li tidher fuq il- kaxxa u fuq it- tikketta tal- pinna.
Not in-use pens Store in a refrigerator (2°C-8°C).
Pinen mhux fl- użu:
Do not freeze.
Aħżen fi friġġ (2°Ċ – 8°Ċ).
Do not put SoloStar next to the freezer compartment or a freezer pack.
Tagħmilhomx fil- friża. Tagħmilx SoloStar viċin il- kompartiment tal- friża jew viċin pakkett tal- friża.
In use pens
Pinen fl- użu:
Pre-filled pens in use (or carried as a spare) may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
145 Pinen mimlijin għal- lest (fl- użu: jew li qed jinġarru bħala riżerva) jistgħu jinħażnu għal massimu ta ’ erba ’ ġimgħat f’ temperatura mhux ’ il fuq minn 25°C u ’ l bogħod mis- sħana diretta jew mid- dawl dirett.
The pen in use must not be stored in a refrigerator.
Il- pinna m’ għandhiex tinħażen fi friġġ.
Apidra 100 Units/ml, solution for injection in a pre-filled pen, SoloStar.It is a clear, colourless solution with no particles visible.
Hija soluzzjoni ċara, mingħajr kulur u bla frak viżibbli.
Each pen contains 3 ml solution (300 Units).
Kull pinna fiha soluzzjoni ta ’ 3 ml (300 Unità).
141 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
Manufacturer:
Il- Manifattur huwa:
Sanofi-Aventis Deutschland GmbH Industriepark Höchst, D- 65926 Frankfurt Germany
Sanofi- Aventis Deutschland GmbH Industriepark Höchst, D- 65926 Frankfurt Il- Ġermanja
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- Suq.
Danmark sanofi-aventis Denmark A/S Tlf: +45 45 16 70 00
146 Danmark sanofi- aventis Denmark A/ S Tlf: +45 45 16 70 00
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 /
143 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
147 IPERGLIĊEMIJA U IPOGLIĊEMIJA
Warning symptoms of hyperglycaemia Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beatand glucose and ketone bodies in urine.
Sintomi ta ’ twissija ta ’ ipergliċemija Għatx, il- bżonn akbar biex tgħaddi l- awrina, għeja, ġilda xotta, ħmura tal- wiċċ, nuqqas ta ’ aptit, pressjoni baxxa tad- demm, il- qalb tħabbat mgħaġġla u glukosju u ketoni fl- awrina.
substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates),
sustanzi simili għaz- zokkor jissejjħu jissejjħu karboidrati; madankollu, l- ħlewwiet artifiċjali M’ HUMIEX karboidrati),
SoloStar.
149 Apidra soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, SoloStar.
Talk with your healthcare professional about proper injection technique before using SoloStar.
Kellem lill - professjonist tiegħek fil- qasam tas- saħħa dwar it- teknika adatta ta ’ l- injezzjoni qabel tuża SoloStar.
You can set doses from 1 to 80 units in steps of 1 unit.
Int tista ’ tissettja d- doża minn unità waħda sa 80 unità f’ qabżiet ta ’ unita waħda.
If you have any questions about SoloStar or about diabetes, ask your healthcare professional or call the local sanofi-aventis number on the front of this leaflet.
Jekk għandek xi mistoqsijiet dwar SoloStar jew dwar id- dijabete, staqsi lill- professjonist tal- kura tas - saħħa tiegħek jew ċempel in- numru lokali ta ’ sanofi- aventis li hemm fuq quddiem ta ’ dan il- fuljett.
Only use needles that are compatible for use with SoloStar. • Always perform the safety test before each injection. • This pen is only for your use.
Uża biss labar li huma konpatibbli ma ’ l- użu ta ’ SoloStar. • Dejjem agħmel test ta ’ sigurtà qabel kull injezzjoni. • Din il- pinna hija għall- użu tiegħek biss.
Do not share it with anyone else. • If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection. • Never use SoloStar if it is damaged or if you are not sure that it is working properly. • Always have a spare SoloStar in case your SoloStar is lost or damaged.
Taqsamhiex ma ’ ħaddieħor. • Jekk l- injezzjoni tiegħek tingħata minn persuna oħra, għandha tittieħed il- kawtela speċjali minn din il- persuna biex tevita li tweġġa ’ aċċidentalment bil- labra u titrasmetti l- infezzjoni. • Qatt m’ għandek tuża SoloStar jekk tkun bil- ħsara jew jekk m’ intix ċert li qed taħdem sew. • Dejjem żomm SoloStar żejda f’ każ li s- SoloStar tiegħek tintilef jew jiġrilha l- hsara.
Check the label on your SoloStar to make sure you have the correct insulin.
Iċċekkja t- tikketta tas- SoloStar tiegħek biex tiżgura ruħek li għandek l- insulina adatta.
The Apidra Solostar is blue.
L- Apidra SoloStar hija ta ’ kulur ikħal.
It has a dark blue injection button with a raised ring on the top.
Għandha buttun ta ’ l- injezzjoni ikħal skur b’ ċirku imqabbeż fil - parti ta’ fuq.
Apidra is a clear insulin.
Apidra hija insulina ċara.
Do not use this SoloStar if the insulin is cloudy, coloured or has particles.
Tużax din is- SoloStar jekk l - insulina hija mdardra, ikkulurita jew għandha xi frak.
Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).
Żomm il- labra f’ linja dritta mal- pinna, u żommha dritta waqt li qed tqabbadha (bil- kamin jew b’ għafsa, skond it- tip ta ’ labra).
• If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.
• Jekk il- labra ma tinżammx dritta waqt li tkun qed tqabbadha, din tista ’ tagħmel ħsara l- woxer tal- lastku, u bħala riżultat ta ’ dan, il- pinna tibda tqattar, jew il- labra titgħawweġ.
Perform a Safety test
Agħmel test ta ’ sigurtà
This ensures that you get an accurate dose by: • ensuring that pen and needle work properly • removing air bubbles
Dan jiżgura li d- doża tkun preċiza billi: • tkun żgur li l- pinna u l- labra qed jaħdmu sew. • tneħħi l- bżieżaq ta ’ l- arja.
Take off the outer needle cap and keep it to remove the used needle after injection.
Neħħi l- kappa ta ’ barra tal- labra u żommha biex tkun tista ’ tneħħi l- labra użata biha wara l - injezzjoni.
147 You may have to perform the safety test several times before insulin is seen.
151 f
• If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them. • If still no insulin comes out, the needle may be blocked.
Għandu mnejn ikollok tagħmel it- test ta ’ sigurta ’ diversi drabi qabel ma titfaċċa l- insulina. • Jekk ebda insulina ma toħroġ, iċċekkja għall- preżenza ta ’ bżieżaq ta ’ l- arja u irrepeti t- test ta ’ sigurtà darbtejn jew aktar biex tneħħihom. • Jekk xorta ma toħroġx l- insulina, l- labra tista ’ tkun miżduda.
You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units.
Tista ’ tissettja d- doża f’ qabżiet ta ’ unità waħda, minn minimu ta ’ unità waħda sa massimu ta ’ 80 unità.
If you need a dose greater than 80 units, you should give it as two or more injections.
Jekk tinħtieġ doża akbar minn 80 unità, trid teħodha f’ żewġ injezzjonijiet jew aktar.
Select your required dose (in the example below, the selected dose is 30 units).
Agħżel id- doża meħtieġa (fl- eżempju hawn taħt, id- doża magħżula hija 30 unità).
If you turn past your dose, you can turn back down.
Jekk tiskorri B. d- doża tiegħek waqt li qed iddawwar, tista ’ terġa tiġi lura.
Use the injection method as instructed by your healthcare professional.
ta ’ l- injezzjoni li urik il- professjonist tiegħek fil- qasam tas- saħħa.
148 C.
Ċ.
Always remove the needle after each injection and store SoloStar without a needle attached.
Dan jgħin biex
This helps prevent: • Contamination and/or infection, • Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
• Il- kontaminazzjoni u/ jew l- infezzjoni • Id- dħul ta ’ l- arja fir- riżervwar ta ’ l- insulina u li l- insulina tqattar mill- pinna, li jistgħu jikkawżaw dożaġġ li mhux eżatt.
To reduce the risk of accidental needle injury, never replace the inner needle cap. • If your injection is given by another person, special caution must be taken by this person when removing and disposing the needle.
• Jekk l- injezzjoni tiegħek ser tingħata minn persuna oħra, għandha tittieħed il- kawtela speċjali minn din il- persuna waqt li tneħħi u tarmi l- labra.
Follow recommended safety measures for removal and disposal of needles (e.g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Segwi l- miżuri rakkomandati ta’ sigurtà għat - tneħħija u r- rimi tal- labar (e. ż. tintuża id waħda biex tpoġġi l- kappa lura fuq il- labra) biex b’ hekk jonqos ir- riskju li wieħed iweġġa ’ aċċidentalment bil- labra u jkun trasmess l- mard infettiv.
Always put the pen cap back on the pen, then store the pen until your next injection.
Qiegħed il- kappa tal- pinna lura f’ postha, u wara aħżen il- pinna sa l- injezzjoni li jmissek tieħu.
If your SoloStar is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up.
Jekk is- SoloStar tiegħek hija maħzuna fil- kesħa, oħroġha minn siegħa sa sagħtejn qabel tinjetta biex tħalliha tisħon u tilħaq it- temperatura tal- kamra.
Discard your used SoloStar as required by your local authorities.
Armi s- SoloStar użata tiegħek kif jitolbu l- liġijiet lokali.
You can clean the outside of your SoloStar by wiping it with a damp cloth.
Tista ’ tnaddaf is- SoloStar tiegħek minn barra billi timsaħħa b’ ċaruta niedja.
149
153
What is Aprovel?
X’ inhu Aprovel?
Aprovel is a medicine that contains the active substance irbesartan.
Aprovel hija mediċina li fiha s- sustanza attiva irbesartan.
What is Aprovel used for?
Għal x' hiex jintuża Aprovel?
Aprovel is used in patients who have essential hypertension (high blood pressure). ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
Aprovel huwa wżat għall- pazjenti li jbatu minn pressjoni għolja essenzjali (pressjoni għolja tad - demm). ‘ Essenzjali ’ tfisser li l- pressjoni għolja fid- demm ma tkunx ikkawżata minn xi kundizzjoni oħra.
Aprovel is also used to treat renal (kidney) disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes).
Aprovel huwa użat ukoll fit- trattament tal- mard renali (tal- kliewi) f’ pazjenti li jbatu minn ipertensjoni u d- dijabete tat- tip 2 (dijabete li mhix dipendenti fuq l- insulina).
Aprovel is not recommended for use in patients below 18 years of age.
Aprovel m’ għandux jintuża fuq pazjenti ta ’ anqas minn 18 - il sena.
How is Aprovel used?
Kif jintuża Aprovel?
Aprovel is taken by mouth, with or without food.
Aprovel jittieħed b’ mod orali, ma ’ l- ikel jew fuq stonku vojt.
In patients with hypertension and type 2 diabetes, Aprovel is added to other treatments for hypertension.
F ’ pazjenti li jbatu b’ ipertenzjoni u dijabete tat- tip 2, Aprovel huwa miżjud mat- trattamenti l- oħra għall- ipertensjoni.
How does Aprovel work?
Kif jaħdem Aprovel?
The active substance in Aprovel, irbesartan, is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Is- sustanza attiva f’ Aproval, ibresartan hija ‘ antagonista tar- riċettur l- anġjotensina II ’ li jfisser li jimblokka l- azzjoni ta ’ ormon fil- ġisem imsejjaħ anġjotensina II.
Reproduction is authorised provided the source is acknowledged. hypertension (atenolol, enalapril or amlodipine) in 823 patients.
Oriġinarjament Aprovel ġie studjat fi 11 – il prova għall- effetti tiegħu fuq il- pressjoni tad- demm.
Its use in combination with hydrochlorothiazide was also examined in 1,736 patients.
Ġie eżaminat ukoll l- użu tiegħu flimkien ma ’ hydrochlorothiazide f’ 1, 736 pazjent.
For the treatment of kidney disease, Aprovel was studied in two large studies involving a total of 2,326 patients with type 2 diabetes.
Aprovel ġie studjat ukoll f’ żewġ studji kbar dwar il- mard tal- kliewi f’ 2, 326 pazjent li għandhom dijabete tat- tip 2.
Aprovel was used for two years or more.
Aprovel ġie studjat għal sentejn jew aktar.
The second study looked at whether Aprovel increased the time taken until the patients ’ blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died.
It - tieni studju ħares lejn jekk Aprovel żiedx il- ħin meħud mill- pazjenti biex jesperjenzaw irduppjar tal - livelli tagħhom tal- livell ta ’ krejatinina fid- demm (indikatur ta ’ mard fil- kliewi), sakemm ikollhom bżonn trapjant tal- kliewi jew dijaliżi, jew sakemm mietu.
In this study, Aprovel was compared with placebo and with amlodipine.
F’ dan l- istadju Aprovel tqabbel mal- plaċebo u ma ’ l- amlodipina.
What benefit has Aprovel shown during the studies?
Liema benefiċċju wera Aprovel waqt l- istudji li ġew mwettqa?
In the blood pressure studies, Aprovel was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Fl- istudji dwar il- pressjoni għolja, irriżulta li Aprovel kien ferm aktar effettiv mill- plaċebo biex inaqqas il- pressjoni tad- demm dijastolika u kellu effetti simili għal mediċini għall- ipertensjoni.
In the first kidney disease study, Aprovel was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
Fl- ewwel studju dwar il- mard tal- kliewi irriżulta li Aprovel kien ferm aktar effettiv mill- plaċebo biex inaqqas ir- riskju li ssir ħsara lill- kliewi kif ġiet imkejla t- tneħħija tal- proteini.
In the second kidney disease study, Aprovel reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo.
Fit- tieni studju dwar il - mard tal- kliewi, Aprovel naqqas ir- riskju relattiv b ’ 20% meta mqabbel mal- plaċebo li jintlaħaq fl - irduppjar tal- livelli tal- krejatinina fid- demm, li jeħtieġu li jsir trapjant tal- kliewi jew il- bżonn ta ’ dijaliżi jew li jkunu mietu waqt l- istudju.
What is the risk associated with Aprovel?
X’ inhu r- riskju assoċjat ma ’ Aprovel?
The most common side effects with Aprovel (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, fatigue (tiredness) and increases in blood creatine kinase levels (an enzyme found in muscles).
L- aktar effetti sekondarji komuni b ’ Approvel (dehru f’ madwar pazjent 1 u 10 pazjenti f’ 100) huma sturdament, nawżea (dardir) jew remettar, għejja (ħedla) u żjieda fil- livelli ta ’ kinażju ta ’ krejatinina fid- demm (enzima li tinsab fil- muskoli).
For the full list of all side effects reported with Aprovel, see the Package Leaflet.
Għal lista sħiħa ta ’ l- effetti sekondarji rrapportati b’ Aprovel, ara l- Fuljett ta ’ Tagħrif.
Aprovel should not be used in people who may be hypersensitive (allergic) to irbesartan or any of the other ingredients.
Aprovel m ’ għandux jintuża min- nies li jista ’ jkollhom ipersensittività eċċessiva (allerġiċi) għall - irbesartan jew għal xi sustanzi oħra tiegħu.
Why has Aprovel been approved?
Għaliex ġie approvat Aprovel?
The Committee for Medicinal Products for Human Use (CHMP) decided that Aprovel’ s benefits are greater than its risks for the treatment of essential hypertension and of renal disease in patients with hypertension and type 2 diabetes mellitus.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Aprovel huma akbar mir- riskji tiegħu għat- trattament ta 'pazjenti għat- trattament ta ’ ipertensjoni essenzjali u għat- trattament ta ’ mard tal- kliewi f ’ pazjenti li jbatu minn pressjoni għolja u dijabete mellitus tat- tip 2.
The Committee recommended that Aprovel be given marketing authorisation.
Huma irrakkomandaw li Aprovel jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Aprovel:
Informazzjoni oħra dwar Aprovel:
The European Commission granted a marketing authorisation valid throughout the European Union for Aprovel to Sanofi Pharma Bristol-Myers Squibb SNC on 27 August 1997.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Aprovel lil Sanofi Pharma Bristol- Myers Squibb SNC fis- 27 ta ’ Awissu 1997.
The full EPAR for Aprovel is available here.
L- EPAR sħiħ dwar Aprovel jista ’ jiġi konsultat hawnhekk.
Aprovel 75 mg tablets.
Aprovel 75 mg pilloli.
Aprovel at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Aprovel b’ doża ta ’ 150 mg darba kuljum ġeneralment jipprovdi kontroll aħjar matul l- 24 siegħa għall- pressjoni tad- demm minn 75 mg.
In patients insufficiently controlled with 150 mg once daily, the dose of Aprovel can be increased to 300 mg, or other anti-hypertensive agents can be added.
F’ pazjenti li mhumiex ikkontrollati biżżejjed b’ 150 mg darba kuljum, id- doża ta ’ Aprovel tista ’ tiżdied għal 300 mg, jew jistgħu jiġu miżjudin mediċini oħrajn ta ’ kontra l- pressjoni għolja.
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Aprovel (see section 4.5).
B' mod partikolari, iż- żjieda ta 'dijuretiku bħal hydrochlorothiazide ntwera li jkollha effett ta' tisħiħ ma 'Aprovel (ara sezzjoni 4. 5).
The demonstration of renal benefit of Aprovel in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see section 5.1).
Il- benefiċċju renali muri b’ Aprovel f’ pazjenti b’ dijabete ta ’ tip 2 li għandhom pressjoni għolja huwa bbażat fuq studji fejn irbesartan intuża flimkien ma ’ mediċini oħra ta ’ kontra l- pressjoni għolja kif meħtieġ, biex jintlaħaq il- livell mixtieq ta ’ pressjoni (ara sezzjoni 5. 1).
Such conditions should be corrected before the administration of Aprovel.
Dawn il- kondizzjonijiet għandhom jiġu kkoreġuti qabel tinbeda l- kura b’ Aprovel.
While this is not documented with Aprovel, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Għalkemm m’ hemm xejn dokumentat li dan isir b’ Aprovel, effetti simili għandhom ikunu antiċipati b’ antagonisti tar- riċetturi angiotensin- II.
Renal impairment and kidney transplantation: when Aprovel is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Indeboliment renali u trapjant tal- kliewi: meta Aprovel jintuża f’ pazjenti b’ indeboliment renali, hija irrikmandata osservanza perjodika tal- livelli tal- potassju u tal- krejatinina fis- serum.
There is no experience regarding the administration of Aprovel in patients with a recent kidney transplantation.
M’ hemmx esperjenza fuq l- għoti ta 'Aprovel lil pazjenti li reċentement kellhom trapjant tal- kliewi.
Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Aprovel, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/ or heart failure.
Iperkalimja: bħalma jiġri bi prodotti mediċinali oħra li jaffettwaw is- sistema ta ’ renin- angiotensin - aldosterone, iperkalimja tista ’ sseħħ waqt il- kura b’ Aprovel, speċjalment fil- preżenza t’ indeboliment renali, proteinuria ovvja minħabba mard renali dovut għad- dijabete, u/ jew insuffiċjenza tal- qalb.
Lithium: the combination of lithium and Aprovel is not recommended (see section 4.5).
Lithium: it- taħlit ta 'litju u Aprovel mhuwiex rakkomandat (ara sezzjoni 4. 5).
Therefore, the use of Aprovel is not recommended.
Għalhekk, l- użu ta ’ Aprovel mhuwiex irrikmandat.
Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Aprovel has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Dijuretiċi u mediċini oħra kontra l- pressjoni għolja: mediċini oħra kontra l- pressjoni għolja jistgħu jżidu l- effetti ta ’ tnaqqis fil- pressjoni ta ’ irbesartan; madankollu Aprovel ingħata mingħajr periklu ma ’ mediċini oħra ta ’ kontra l- pressjoni għolja, bħal beta- blockers, imblokkaturi tal- kanali ta ’ calcium li jaħdmu fit- tul, u dijuretiċi thiazides.
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Aprovel (see section 4.4).
Kura li ssir qabel b' dożi għoljin ta 'dijuretiċi tista' tirriżulta f' nuqqas fil- volum u riskju ta 'pressjoni baxxa meta tinbeda l- kura b' Aprovel (ara sezzjoni 4. 4).
Aprovel is contraindicated (see section 4.3) during breast-feeding.
Aprovel huwa kontra- indikat (ara sezzjoni 4. 3) waqt it- treddigħ.
No specific information is available on the treatment of overdose with Aprovel.
M’ hemmx biżżejjed informazzjoni speċifika disponibbli fuq il- kura tad- doża eċċessiva b’ Aprovel.
The blood pressure lowering effect of Aprovel is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
L- effett li għandu Aprovel li jbaxxi l- pressjoni jidher fi żmien 1- 2 ġimgħat, bl- effett massimu jseħħ f’ 4- 6 ġimgħat wara li tinbeda t- terapija.
The efficacy of Aprovel is not influenced by age or gender.
L- effikaċja ta ’ Aprovel ma hijiex influwenzata bl- età jew sess.
Hypertension and type 2 diabetes with renal disease The “ Irbesartan Diabetic Nephropathy Trial (IDNT )” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
Pressjoni għolja u dijabete tip 2 b’ mard renali L- istudju “ Irbesartan u n- Nefropatija bid- Diabete (IDNT) ” juri li irbesartan inaqqas il- progressjoni tal - mard renali fil- pazjenti b’ insuffiċjenza renali kronika u b’ proteinuria li tidher.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Aprovel, amlodipine and placebo.
IDNT kienet prova double blind, ikkontrollata, ta ’ morbożità u mortalità li qabblet Aprovel, amlodipine u plaċebo.
In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/ day and serum creatinine ranging from 1.0-3.0 mg/ dl, the long-term effects (mean 2.6 years) of Aprovel on the progression of renal disease and all-cause mortality were examined.
F’ 1, 715- il pazjent bi pressjoni għolja u b’ dijabete tip 2, proteinuria ≥ 900 mg/ jum u krejatinina fis - serum li tvarja minn 1. 0 - 3. 0 mg/ dl, ġew eżaminati l- effetti fit- tul (medja ta ’ 2. 6 sena) ta ’ Aprovel
Patients were titrated from 75 mg to a maintenance dose of 300 mg Aprovel, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Il- pazjenti ngħataw doża aġġustata minn 75 mg għal doża ta ’ manteniment ta ’ 300 mg ta ’ Aprovel, minn 2. 5 mg għal 10 mg ta ’ amlodipine, jew plaċebo skond kemm felħu.
8 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
L- istudju ta ’ “ L- effetti ta ’ Irbesartan fuq il- Mikroalbuminuria fil- Pazjenti bi Pressjoni Għolja b’ Tip 2 ta ’ Diabete Mellitus (IRMA) ” juri li irbesartan 300 mg jittardja il- progressjoni għal proteinuria li tidher f’ pazjenti b’ mikroalbuminuria.
The study examined the long-term effects (2 years) of Aprovel on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/ day, and an increase in UAER of at least 30% from baseline).
L- istudju eżamina l- effetti fit- tul (sentejn) ta ’ Aprovel fuq il- progressjoni għal proteinuria klinikali (li tidher) (ir- rata ta ’ tneħħija t’ albumina ma ’ l- urina (UAER) > 300 mg/ jum, u żjieda f ’ UAER ta ’ l- inqas 30% mill- linja bażi).
Regression to normoalbuminuria (< 30 mg/ day) was more frequent in the Aprovel 300 mg group (34%) than in the placebo group (21%).
Rigressjoni għal albuminuria normali (< 30 mg/ jum) kienet iktar frekwenti fil- grupp ta ’ Aprovel 300 mg (34%) milli fil- grupp tal - plaċebo (21%).
Aprovel 150 mg tablets.
Aprovel 150 mg pilloli.
Patients were titrated from 75 mg to a maintenance dose of 300 mg Aprovel, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Il- pazjenti ngħataw doża aġġustata minn 150 mg għal doża ta ’ manteniment ta ’ 300 mg ta ’ Aprovel, minn 2. 5 mg għal 10 mg ta ’ amlodipine, jew plaċebo skond kemm felħu.
18 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
L- istudju ta ’ “ L- effetti ta ’ Irbesartan fuq il- Mikroalbuminuria fil- Pazjenti bi Pressjoni Għolja b’ Tip 2 ta ’ Diabete Mellitus (IRMA) ” juri li irbesartan 300 mg jittardja il- progressjoni għal proteinuria li tidher f’ pazjenti b’ mikroalbuminuria.
Aprovel 300 mg tablets.
Aprovel 300 mg pilloli.
Patients were titrated from 75 mg to a maintenance dose of 300 mg Aprovel, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Il- pazjenti ngħataw doża aġġustata minn 300 mg għal doża ta ’ manteniment ta ’ 300 mg ta ’ Aprovel, minn 2. 5 mg għal 10 mg ta ’ amlodipine, jew plaċebo skond kemm felħu.
28 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
L- istudju ta ’ “ L- effetti ta ’ Irbesartan fuq il- Mikroalbuminuria fil- Pazjenti bi Pressjoni Għolja b’ Tip 2 ta ’ Diabete Mellitus (IRMA) ” juri li irbesartan 300 mg jittardja il- progressjoni għal proteinuria li tidher f’ pazjenti b’ mikroalbuminuria.
Aprovel 75 mg film-coated tablets.
Aprovel 75 mg pilloli miksijin b’ rita.
Aprovel is contraindicated (see section 4.3) during breast-feeding. It is not known whether irbesartan is excreted in human milk.
Mhux magħruf jekk irbesartan jitneħħiex fil- ħalib uman.
In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/ day and serum creatinine ranging from 1.0-3.0 mg/ dl, the long-term effects (mean 2.6 years) of Aprovel on the progression of renal disease and all-cause mortality were examined.
F’ 1, 715- il pazjent bi pressjoni għolja u b’ dijabete tip 2, proteinuria ≥ 900 mg/ jum u krejatinina fis - serum li tvarja minn 1. 0 - 3. 0 mg/ dl, ġew eżaminati l- effetti fit- tul (medja ta ’ 2. 6 sena) ta ’ Aprovel fuq l- avvanz ta ’ mard renali u l- kawżi kollha ta ’ mortalità.
38 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
L- istudju ta ’ “ L- effetti ta ’ Irbesartan fuq il- Mikroalbuminuria fil- Pazjenti bi Pressjoni Għolja b’ Tip 2 ta ’ Diabete Mellitus (IRMA) ” juri li irbesartan 300 mg jittardja il- progressjoni għal proteinuria li tidher f’ pazjenti b’ mikroalbuminuria.
Aprovel 150 mg film-coated tablets.
Aprovel 150 mg pilloli miksijin b’ rita.
48 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
L- istudju ta ’ “ L- effetti ta ’ Irbesartan fuq il- Mikroalbuminuria fil- Pazjenti bi Pressjoni Għolja b’ Tip 2 ta ’ Diabete Mellitus (IRMA) ” juri li irbesartan 300 mg jittardja il- progressjoni għal proteinuria li tidher f’ pazjenti b’ mikroalbuminuria.
Aprovel 300 mg film-coated tablets.
Aprovel 300 mg pilloli miksijin b’ rita.
58 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
L- istudju ta ’ “ L- effetti ta ’ Irbesartan fuq il- Mikroalbuminuria fil- Pazjenti bi Pressjoni Għolja b’ Tip 2 ta ’ Diabete Mellitus (IRMA) ” juri li irbesartan 300 mg jittardja il- progressjoni għal proteinuria li tidher f’ pazjenti b’ mikroalbuminuria.
Aprovel 75 mg tablets irbesartan
Aprovel 75 mg pilloli irbesartan
EU/ 1/ 97/ 046/ 010 14 tablets EU/ 1/ 97/ 046/ 001 28 tablets EU/ 1/ 97/ 046/ 002 56 tablets EU/ 1/ 97/ 046/ 013 56 x 1 tablets EU/ 1/ 97/ 046/ 003 98 tablets
EU/ 1/ 97/ 046/ 010 14- il pillola EU/ 1/ 97/ 046/ 001 28 pillola EU/ 1/ 97/ 046/ 002 56 pillola EU/ 1/ 97/ 046/ 013 56 x 1 pillola EU/ 1/ 97/ 046/ 003 98 pillola
Aprovel 150 mg tablets irbesartan
Aprovel 150 mg pilloli irbesartan
EU/ 1/ 97/ 046/ 011 14 tablets EU/ 1/ 97/ 046/ 004 28 tablets EU/ 1/ 97/ 046/ 005 56 tablets EU/ 1/ 97/ 046/ 014 56 x 1 tablets EU/ 1/ 97/ 046/ 006 98 tablets
EU/ 1/ 97/ 046/ 011 14- il pillola EU/ 1/ 97/ 046/ 004 28 pillola EU/ 1/ 97/ 046/ 005 56 pillola EU/ 1/ 97/ 046/ 014 56 x 1 pillola EU/ 1/ 97/ 046/ 006 98 pillola
Aprovel 300 mg tablets irbesartan
Aprovel 300 mg pilloli irbesartan
EU/ 1/ 97/ 046/ 012 14 tablets EU/ 1/ 97/ 046/ 007 28 tablets EU/ 1/ 97/ 046/ 008 56 tablets EU/ 1/ 97/ 046/ 015 56 x 1 tablets EU/ 1/ 97/ 046/ 009 98 tablets
EU/ 1/ 97/ 046/ 012 14- il pillola EU/ 1/ 97/ 046/ 007 28 pillola EU/ 1/ 97/ 046/ 008 56 pillola EU/ 1/ 97/ 046/ 015 56 x 1 pillola EU/ 1/ 97/ 046/ 009 98 pillola
Aprovel 75 mg film-coated tablets irbesartan
Aprovel 75 mg pilloli miksijin b' rita irbesartan
EU/ 1/ 97/ 046/ 016 14 tablets EU/ 1/ 97/ 046/ 017 28 tablets EU/ 1/ 97/ 046/ 034 30 tablets EU/ 1/ 97/ 046/ 018 56 tablets EU/ 1/ 97/ 046/ 019 56 x 1 tablets EU/ 1/ 97/ 046/ 031 84 tablets EU/ 1/ 97/ 046/ 037 90 tablets EU/ 1/ 97/ 046/ 020 98 tablets
EU/ 1/ 97/ 046/ 016 14- il pillola EU/ 1/ 97/ 046/ 017 28 pillola EU/ 1/ 97/ 046/ 034 30 pillola EU/ 1/ 97/ 046/ 018 56 pillola EU/ 1/ 97/ 046/ 019 56 x 1 pillola EU/ 1/ 97/ 046/ 031 84 pillola EU/ 1/ 97/ 046/ 037 90 pillola EU/ 1/ 97/ 046/ 020 98 pillola
Aprovel 150 mg film-coated tablets irbesartan
Aprovel 150 mg pilloli miksijin b' rita irbesartan
EU/ 1/ 97/ 046/ 021 14 tablets EU/ 1/ 97/ 046/ 022 28 tablets EU/ 1/ 97/ 046/ 035 30 tablets EU/ 1/ 97/ 046/ 023 56 tablets EU/ 1/ 97/ 046/ 024 56 x 1 tablets EU/ 1/ 97/ 046/ 032 84 tablets EU/ 1/ 97/ 046/ 038 90 tablets EU/ 1/ 97/ 046/ 025 98 tablets
EU/ 1/ 97/ 046/ 021 14- il pillola EU/ 1/ 97/ 046/ 022 28 pillola EU/ 1/ 97/ 046/ 035 30 pillola EU/ 1/ 97/ 046/ 023 56 pillola EU/ 1/ 97/ 046/ 024 56 x 1 pillola EU/ 1/ 97/ 046/ 032 84 pillola EU/ 1/ 97/ 046/ 038 90 pillola EU/ 1/ 97/ 046/ 025 98 pillola
Aprovel 300 mg film-coated tablets irbesartan
Aprovel 300 mg pilloli miksijin b' rita irbesartan
EU/ 1/ 97/ 046/ 026 14 tablets EU/ 1/ 97/ 046/ 027 28 tablets EU/ 1/ 97/ 046/ 036 30 tablets EU/ 1/ 97/ 046/ 028 56 tablets EU/ 1/ 97/ 046/ 029 56 x 1 tablets EU/ 1/ 97/ 046/ 033 84 tablets EU/ 1/ 97/ 046/ 039 90 tablets EU/ 1/ 97/ 046/ 030 98 tablets
EU/ 1/ 97/ 046/ 026 14- il pillola EU/ 1/ 97/ 046/ 027 28 pillola EU/ 1/ 97/ 046/ 036 30 pillola EU/ 1/ 97/ 046/ 028 56 pillola EU/ 1/ 97/ 046/ 029 56 x 1 pillola EU/ 1/ 97/ 046/ 033 84 pillola EU/ 1/ 97/ 046/ 039 90 pillola EU/ 1/ 97/ 046/ 030 98 pillola
INFORMATION FOR THE USER Aprovel 75 mg tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Aprovel 75 mg pilloli irbesartan
What Aprovel is and what it is used for 2.
X' inhu Aprovel u għalxiex jintuża 2.
Before you take Aprovel 3.
Qabel ma tieħu Aprovel 3.
How to take Aprovel 4.
Kif għandek tieħu Aprovel 4.
How to store Aprovel 6.
Kif taħżen Aprovel 6.
WHAT APROVEL IS AND WHAT IT IS USED FOR
X' INHU APROVEL U GĦALXIEX JINTUŻA
Aprovel belongs to a group of medicines known as angiotensin-II receptor antagonists.
Aprovel jappartjeni għall- grupp ta ’ mediċini magħrufa bħala antagonisti tar- riċetturi angiotensin- II.
Aprovel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Aprovel jipprevjeni li angiotensin- II tingħaqad ma ’ dawn ir- riċetturi, u jwassal il- vini tad- demm biex jirrilassaw u b’ hekk il- pressjoni tinżel.
Aprovel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Aprovel inaqqas ir- rata tat- tnaqqis tal- funzjoni tal- kliewi f’ pazjenti bi pressjoni għolja u b’ dijabete ta 'tip 2.
Aprovel is used to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
Aprovel jintuża biex jikkura pressjoni għolja tad- demm (pressjoni għolja) biex jipproteġi lill- kliewi f’ pazjenti bi pressjoni għolja ħafna, b’ dijabete ta ’ tip 2 u b’ evidenza mit- testijiet tal- laboratorju ta ’ indeboliment fil- funzjoni tal- kliewi.
BEFORE YOU TAKE APROVEL
QABEL MA TIEĦU APROVEL
Do not take Aprovel if you are allergic (hypersensitive) to irbesartan or any other ingredients of Aprovel during the last 6 months of pregnancy, see section Pregnancy and breastfeeding if you are breast-feeding
Tiħux Aprovel jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal irbesartan jew sustanzi oħra ta 'Aprovel matul l- aħħar sitt xhur tat- tqala, ara s- sezzjoni Tqala u Treddigħ jekk qegħda tredda ’
Aprovel should not be given to children and adolescents (under 18 years).
Aprovel m’ għandux jingħata lit- tfal u adoloxxenti (taħt it- 18- il sena).
Take special care with Aprovel Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Aprovel for diabetic kidney disease.
Oqgħod attent ħafna b' Aprovel Għid lit- tabib tiegħek jekk xi waħda minn dawn tapplika għalik: jekk ikollok rimettar jew dijarea eċċessiva jekk tbati minn problemi fil- kliewi jekk tbati minn problemi tal- qalb jekk tirċievi Aprovel għal mard tal- kliewi dijabetiku.
Aprovel is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section Pregnancy and breastfeeding.
Aprovel mhuwiex rakkomandat kmieni matul it- tqala u dan jista ’ jikkawża ħsara serja għat- tarbija tiegħek wara l- ewwel 3 xhur tat- tqala, ara s- sezzjoni Tqala u Treddigħ.
Aprovel does not usually interact with other medicines.
Ġeneralment, Aprovel ma għandux effetti ma ’ mediċini oħra.
Taking Aprovel with food and drink Aprovel can be taken with or without food.
Meta tieħu Aprovel ma 'l- ikel u max- xorb Aprovel jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.