qanastek/EMEA-V3 huggingface dataset:
b) Sterile techniques to minimize risk of infection c) Use of antibiotics d) Use of povidone iodine e) Performing lid scrubs f) Use of anesthetic to ensure patient comfort g) Techniques for the intravitreal injection h) Management of intraocular pressure (IOP) i) Management of endophthalmitis j) Understanding the risk factors involved in developing endophthalmitis k) Reporting of serious adverse events • An educational plan for patients which is aimed at risk minimisation and to support safe and effective use for the product.
Dan il- pjan għandu jkun iffurmat minn miżuri mmirati sabiex inaqqsu l- episodji avversi marbuta mal- proċedura ta 'injezzjoni ġol- vitriju (p. e. endophthalmitis) permezz ta' edukazzjoni xierqa dwar: a) Il- proċedura għal ġol- vitriju kif saret fl- istudji kliniċi pivitali b) Tekniki sterili biex jitnaqqas ir- riskju ta 'infezzjoni c) Użu ta' antibijotiċi d) Użu ta 'povidone iodine e) Twettiq ta' għarik tal- kappell ta 'l- għajn f) Użu ta' anestetiku biex tiġi żgurata l- kumdità tal- pazjent g) Tekniki għall- injezzjoni ġol- vitriju h) Ġestjoni tal- pressjoni fl- għajn (IOP - intraocular pressure) i) Ġestjoni ta 'l- endophthalmitis j) Fehim tal- fatturi ta' riskju involuti fl- iżvilupp ta 'l- endophthalmitis k) Rappurtar ta' episodji avversi serji • Pjan edukattiv għall- pazjenti li jkun immirat sabiex jitnaqqas ir- riskju u biex jappoġġja l- użu bla periklu u effettiv tal- prodott.
This plan shall consist of measures to provide adequate education on: l) Key signs and symptoms of serious adverse events associated with the intravitreal injection procedure m) When to seek urgent attention from the health care provider
Dan il- pjan se jkun jikkonsisti minn miżuri sabiex tingħata edukazzjoni xierqa dwar: l) Sinjali u sintomi prinċipali ta 'episodji avversi serji assoċjati mal- proċedura ta' l- injezzjoni ġol - vitriju m) Meta għandu wieħed ifittex attenzjoni urġenti mill- fornitur tal- kura tas- saħħa
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.1 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Sistema tal- Farmakoviġilanza Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jassigura li is- sistema tal - Farmakoviġilanza, kif inhu deskritt f’ verżjoni 1. 1 ppreżentata f’ Module 1. 8. 1 ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, hija f’ postha u mħaddma qabel u waqt li il- prodott qiegħed fis- suq.
13 Risk Management Plan The Marketing Authorisation Holder has committed to performing the studies and monitoring which are detailed in the risk management plan, as part of the Pharmacovigilance plan.
13 Pjan ta ’ Ġestjoni tar- Riskju Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq impenja ruħu li jwettaq l- istudji u l- monitoraġġ li hemm dettaljati fil- pjan ta' ġestjoni tar- riskju, bħala parti mill- pjan ta 'Farmakoviġilanza.
In addition, the Marketing Authorisation Holder committed to provide a proposal for a methodology to assess the effectiveness of risk minimisation measures across the EU, including milestones for such assessment.
Barra minn hekk, id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq impenja ruħu li jipprovdi proposta għal metodoloġija biex tiġi evalwata l- effikaċja tal- miżuri għat- tnaqqis tar- riskju madwar l - UE, fosthom miri importanti għal tali valutazzjoni.
This should be in line with the CHMP Guideline on Risk Management Systems for Medicinal Products for Human use and should be submitted within 30 days after the Commission Decision.
Din għandha tkun skond il- Linja Gwida tal- CHMP dwar Sistemi ta 'Ġestjoni tar- Riskju għal Prodotti Mediċinali li Jintużaw fil- Bniedem u trid tiġi ppreżentata fi żmien 30 ġurnata wara d- Deċiżjoni tal- Kummissjoni.
Carton
KARTUNA
Macugen 0.3 mg solution for injection pegaptanib sodium
Macugen 0. 3 mg soluzzjoni għall- injezzjoni pegaptanib sodium
ST ATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA
A single dose pre-filled syringe delivers 1.65 mg pegaptanib sodium, corresponding to 0.3 mg of the free acid form of the oligonucleotide, in a nominal volume of 90 microlitres.
Siringa ta 'doża waħda mimlija lesta tagħti 1. 65 mg pegaptanib sodium, li jikkorrispondu għal 0. 3 mg tal- forma ta' aċidu liberu ta 'l- oligonucleotide, f' volum nominali ta' 90 mikrolitru.
Sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, sodium hydroxide, hydrochloric acid, water for injections.
Sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, sodium hydroxide, hydrochloric acid, ilma għall- injezzjonijiet
Solution for injection, 90 µl.
Soluzzjoni għall- injezzjoni, 90 µl.
This pack contains one pre-filled syringe, a plunger stopper and a pre-attached plunger rod and is supplied without a needle.
Dan il- pakkett fih siringa mimlija għal- lest, stopper tal- plunġer u qasba tal- plunġer mwaħħla lesta u huwa fornut mingħajr labbra.
Intravitreal use.
Għal użu ġol- vitriju.
{MM/YYYY}
JIS {XX/ SSSS}
Pfizer Ltd Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom
Pfizer Ltd Ramsgate Road Sandwich, Kent CT13 9NJ Ir- Renju Unit
Pre-filled syringe
SIRINGA MIMLIJA GĦALL- LEST
Macugen 0.3mg injection pegaptanib
Macugen 0. 3mg Injezzjoni Pegaptanib
Pouch containing pre-filled syringe, a plunger stopper and a pre-attached plunger rod
BORŻA LI FIHA SIRINGA MIMLIJA GĦAL- LEST, STOPPER TAL- PLUNĠER U QASBA TAL- PLANĠER MWAĦĦLA LESTA
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINSTRATION
ISEM TAL- PRODOTT MEDIĊINALI U MNEJN GĦANDU JINGĦATA
Macugen 0.3 mg solution for injection pegaptanib sodium Intravitreal use
Macugen 0. 3 mg soluzzjoni għall- injezzjoni pegaptanib sodium Użu għal ġol- vitriju
The pouch must not be opened until the patient has been prepared for injection.
Il- borża m' għandhiex tinfetaħ qabel ma l- pazjent ikun ġie mħejji għall- injezzjoni.
Macugen 0.3 mg solution for injection Pegaptanib sodium
Macugen 0. 3 mg soluzzjoni għall- injezzjoni Pegaptanib sodium
Read all of this leaflet carefully before your treatment with Macugen begins
Aqra dan il- fuljett kollu qabel tibda tuża din il- mediċina
You may need to read it again If you have any further questions, please ask your doctor or pharmacist
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
What Macugen is and what it is used for 2.
X’ inhu Macugen u għalxiex jintuża 2.
Before Macugen is used 3.
Qabel ma tuża Macugen 3.
How the intravitreal injection of Macugen is administered 4.
Kif għandek tieħu Macugen 4.
How to store Macugen 6.
Kif taħżen Macugen 6.
WHAT MACUGEN IS AND WHAT IT IS USED FOR
X’ INHU X U GĦALXIEX JINTUŻA
Macugen is an ophthalmic product, which means it is for eye treatment only.
Macugen hu prodott oftalmiku, jiġifieri għall- kura ta 'l- għajnejn biss.
It is a solution for injection contained within a glass pre-filled syringe.
Huwa soluzzjoni għall- injezzjoni kontenuta f' siringa tal- ħġieġ mimlija lesta.
Your doctor will administer the injection.
It- tabib tiegħek se jagħti l- injezzjoni.
Macugen is used for the treatment of the wet form of age-related macular degeneration (AMD).
Macugen jintuża għall- kura tal- forma mxarrba tad- deġenerazzjoni makulari relatata ma 'l- eta' (AMD).
This disease leads to vision loss resulting from damage to the central part of the retina (called the macula), at the back of the eye.
Din il- marda twassal għal telf tal- vista li jirriżulta minn ħsara fil- parti ċentrali tar- retina (imsejħa l - makula), fuq wara ta 'l- għajn.
The macula enables the eye to provide the fine central vision that is needed for activities such as driving a car, reading fine print and other similar tasks.
Il- makula tippermetti lill- għajn tipprovdi l- vista ċentrali fina li hija meħtieġa għal attivitajiet bħal sewqan ta 'karrozza, qari ta' tipa rqiqa u attivitajiet oħra simili.
In the wet form of AMD, abnormal blood vessels grow under the retina and macula.
Fil- forma mxarrba ta 'AMD, vini u arterji abnormali jikbru taħt ir- retina u l- makula.
These new blood vessels may bleed and leak fluid, causing the macula to bulge or lift up, thus distorting or destroying central vision.
Dawn il- vini u arterji ġodda jistgħu jinfasdu u jnixxu fluwidu, jikkawżaw il- makula tintefaħ jew togħla, u b' hekk jgħawġu jew jeqirdu l- vista ċentrali.
Under these circumstances vision loss may be rapid and severe.
Taħt dawn iċ- ċirkostanzi t- telf tal- vista jista 'jkun rapidu u sever.
Macugen works by inhibiting the growth of these abnormal blood vessels and by stemming the bleeding and leakage.
Macugen jaħdem billi jimpedixxi t- tkabbir ta 'dawn il- vini u arterji abnormali u billi jwaqqaf il- fsada u t- tnixxija.
Macugen is used for the treatment of all types of abnormal blood vessels growth in AMD patients.
Macugen jintuża għall- kura ta 'kull tip ta' tkabbir ta 'vini u arterji abnormali f' pazjenti bl - AMD.
Each pack of Macugen contains one pre-filled syringe, an elastomeric plunger stopper, and a pre- attached plunge-rod inside a sealed pouch.
Kull pakkett ta 'Macugen fih siringa mimlija għal- lest, stopper tal- plunġer elastomeriku u qasba tal - plunġer mwaħħla lesta, ġo borża ssiġillata.
The pre-filled syringe will be used once and then thrown away.
Is- siringa mimlija għal- lest għandha tintuża darba u mbagħad tintrema.
BEFORE MACUGEN IS USED
QABEL MA TUŻA MACUGEN
Macugen must not be used:
Tużax Macugen:
If you are hypersensitive (allergic) to pegaptanib sodium or any of the other ingredients.
- Jekk int allerġiku (tbagħti minn sensittività eċċessiva) għal pegaptanib sodium jew sustanzi oħra
If you have an infection in or around the eye.
- Jekk għandek infezzjoni fi jew madwar l- għajn
Take special care with Macugen:
22 Oqgħod attent ħafna b’ Macugen:
Please contact your doctor if you are allergic to any substance.
- Jekk jogħġbok ikkuntattja lit- tabib tiegħek jekk int allerġiku għal xi sustanza.
Macugen is given as an injection into the eye.
- Macugen jingħata bħala injezzjoni fl- għajn.
Occasionally, an infection in the internal portion of the eye can occur after Macugen treatment (in the next two weeks).
l- għajn wara kura b' Macugen (fil- ġimagħtejn ta 'wara).
It is important to identify and treat this type of infection as soon as possible.
Huwa importanti li din it- tip ta 'infezzjoni tiġi identifikata u kkurata mill- aktar fis.
Please tell your doctor immediately if you notice any of the following symptoms: eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, increased sensitivity to light, increased number of small particles in your vision.
Jekk jogħġbok avża lit- tabib tiegħek immedjatament jekk tinnota xi wieħed mis- sintomi li ġejjin: uġigħ jew diqa akbar fl- għajn, taħżin tal- ħmura fl- għajn, vista mċajpra jew imnaqqsa, sensittività akbar għad- dawl, numru akbar ta 'partikoli żgħar fil- vista tiegħek.
If your doctor cannot be reached for any reason, an alternate should be contacted immediately.
Jekk għal xi raġuni ma tkunx tista 'ssib lit- tabib tiegħek, għandek tikkuntattja tabib floku immedjatament.
In some patients the pressure inside the treated eye may increase for a short period directly after the injection.
- F' xi pazjenti, il- pressjoni ġewwa l- għajn ikkurata tista 'tiżdied għal perjodu qasir direttament wara
Your doctor may monitor this after each injection.
It- tabib tiegħek jista 'jimmonitorja dan wara kull injezzjoni
22 Taking other medicines:
Meta tieħu mediċini oħra:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra li jinkisbu mingħajr riċetta.
There is no experience of using Macugen in pregnant women; therefore the potential risks are unknown.
Tqala u Treddigħ M' hemmx esperjenza dwar l- użu ta 'Macugen f' nisa tqal; għalhekk ir- riskji potenzjali mhumiex magħrufa.
If you are pregnant or planning to become pregnant, please discuss this with your doctor before Macugen treatment.
Jekk inti tqila jew qed tippjana biex tinqabad tqila, jekk jogħġbok iddiskuti dan mat- tabib tiegħek qabel kura b' Macugen.
Macugen is not recommended during breast-feeding.
Macugen mhux rakkomandat waqt it- treddigħ.
Ask your doctor or pharmacist for advice before Macugen treatment.
Itlob il- parir tat- tabib jew ta 'l- ispiżjar tiegħek qabel kura b' Macugen.
You may experience temporary visual blurring after receiving Macugen.
Issuqx għax tista 'tesperjenza tiċpir temporanju tal- vista wara li tirċievi Macugen.
If you are affected you should not drive or use machines until this resolves.
M’ għandekx tagħmel użu minn għodda jew tħaddem magni qabel ma jitlaq l- effett.
HOW THE INTRAVITREAL INJECTION OF MACUGEN IS ADMINISTERED
KIF GĦANDEK TUŻA MACUGEN
All injections of Macugen will be admin istered by your doctor.
L- injezzjonijiet kollha ta 'Macugen għandhom jingħataw mit- tabib tiegħek.
9 times per year).
Macugen jingħata bħala injezzjoni waħda f' għajnek f' intervalli ta 'ġimgħat (jiġifieri 9 darbiet fis- sena).
The injection is given into the vitreous of the eye, which is the jelly-like substance inside the eye.
L- injezzjoni tingħata ġol- vitriju ta 'l- għajn, li hija s- sustanza tixbah lill- ġeli ġewwa l- għajn.
Your doctor will monitor your condition and recommend how long you should be treated with Macugen.
It- tabib tiegħek se jimmonitorja l- kondizzjoni tiegħek u jirrakkomanda kemm iddum tiġi kkurat b' Macugen.
Before the treatment is given your doctor may ask you to use antibiotic eye drops, or to wash your eyes carefully.
Qabel ma tingħata l- kura t- tabib tiegħek jista 'jistaqsik biex tuża qtar antibijotiku għall- għajnejn, jew biex taħsel għajnejk sewwa.
Please tell your doctor if you are known to be allergic to any substance.
Jekk jogħġbok għid lit- tabib tiegħek jekk huwa magħruf li int allerġiku/ a għal xi sustanza.
Please follow these instructions carefully.
Jekk jogħġbok segwi dawn l- istruzzjonijiet b' attenzjoni.
Before the injection, your doctor will give you some local anaesthetic (numbing medication).
Qabel l- injezzjoni, it- tabib tiegħek se jagħtik ftit anestetiku lokali (medikazzjoni ta 'tħeddil).
This will reduce or prevent any pain you might have with the injection, which is a simple and rapid procedure.
Dan għandu jnaqqas jew jevita kwalunkwe uġigħ li jista 'jkollok bl- injezzjoni, li hija proċedura sempliċi u veloċi.
After each injection you might be asked to use antibiotic eye drops (or another type of antibiotic treatment) to guard against eye infection.
Wara kull injezzjoni inti tista 'tiġi mitlub/ a tuża qtar antibijotiku għall- għajnejn (jew tip ieħor ta' trattament antibijotiku) biex tipproteġi kontra infezzjoni fl- għajn.
If you forget to attend an appointment:
Jekk tinsa tmur għal appuntament:
Contact the hospital or clinic as soon as possible to re-schedule your appointment.
Ikkuntattja l- isptar jew il- klinika mill- aktar fis biex terġa 'tirranġa l- appuntament tiegħek.
Like all medicines, Macugen can have side effects although not everybody gets them.
Bħal kull mediċina oħra, Macugen jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The most commonly reported side effects (occurring in more than one of 10 patients in clinical trials) are most probably caused by the injection procedure rather than the drug, and include: eye inflammation eye pain, increased pressure inside the eye, small marks on the eye surface (punctate keratitis), small particles or spots in your vision (vitreous floaters or opacities).
L- aktar effetti sekondarji komuni rrapportati (iseħħu f' aktar minn 1 minn kull 10 pazjenti fi provi kliniċi) wisq probabbli huma kkawżati mill- proċedura ta 'l- injezzjoni aktar milli l- mediċina, u jinkludu: infjammazzjoni ta' l- għajn, uġigħ fl- għajnejn, pressjoni għolja fl- għajnejn, marki żgħar fuq is - superfiċje ta 'l- għajn (punctate keratitis), partikoli żgħar jew tikek fil- vista tiegħek (floaters jew opaċitajiet fil- vitriju).
Occasionally, an infection in the internal portion of the eye can occur after Macugen treatment in the next two weeks.
Kultant, tista 'titfaċċa infezzjoni fil- porzjon intern ta' l- għajn wara kura b' Macugen fil- ġimagħtejn li jmiss.
The symptoms you might experience are described in Section 2 of this leaflet ("Take special care with Macugen").
Is- sintomi li tista 'tesperjenza huma deskritti f' Sezzjoni 2 ta' dan il- fuljett ("Oqgħod attent ħafna b' Macugen").
Please read Section 2.
Jekk jogħġbok aqra Sezzjoni 2.
It tells you what to do if you have any of these symptoms.
Din tgħidlek x' għandek tagħmel jekk ikollok xi wieħed minn dawn is- sintomi;
23 Other common eye side effects reported to be possibly caused by the drug or by the injection procedure include (occurring in more than one in 100 patients in clinical trials): blurred vision, visual disturbance, eye discomfort, decreased vision, increased sensitivity to light, appearance of flashing lights, bleeding that occurs around the eye (periorbital bleeding), bloodshot eye (conjunctival haemorrhage), disorder of the jelly portion inside the eye (vitreous disorder), such as displacement or tear (vitreous detachment), clouding of the lens (cataract), disorder of the surface of the eye (cornea),, swelling or inflammation of the eyelid, swelling of the area on the inside of the eyelid or the outer surface of the eye (conjunctiva), eye inflammation, tears, inflammation of the conjunctiva (conjunctivitis), dryness, eye discharge, eye irritation, itching of the eye, eye redness or enlargement of the pupil,
Effetti sekondarji oħra komuni fl- għajnejn li ġew irrapportati bħala li jistgħu jkunu kkawżati mill - mediċina jew mill- proċedura ta 'l- injezzjoni jinkludu (iseħħu f' aktar minn 1 minn kull 100 pazjent fi provi kliniċi): vista mċajpra, disturb viżwali, diqa fl- għajn, vista mnaqqsa, sensittività akbar għad- dawl, dehra ta' dwal ileħħu, fsada li sseħħ madwar l- għajn (fsada madwar l- orbita), għajnejn ħomor (emorraġija konġunktivali), disturb tal- porzjon tal- ġelli ġewwa l- għajn (disturb tal- vitriju), bħal spostament jew tiċrit (stakkar tal- vitriju), tidnis tal- lenti (katarretta), disturb tas- superfiċje ta 'l- għajn (kornea), nefħa jew infjammazzjoni tal- kappell ta' l- għajn, nefħa ta 'l- arja fuq in- naħa ta' ġewwa tal - kappell ta 'l- għajn jew is- superfiċje ta' barra ta 'l- għajn (konġuntiva), infjammazzjoni ta ’ l- għajn, dmugħ, infjammazzjoni tal- konġuntiva (konġuntivite), nixfa, tnixxija mill- għajn, irritazzjoni ta' l - għajn, ħakk fl- għajn, ħmura ta ’ l- għajn jew tkabbir tal- pupilla
Other common non-visual side effects reported to be possibly caused by the drug or by the injection procedure includes (occurring in more than one in 100 patients in clinical trials): headache or nasal discharge.
Effetti sekondarji oħra komuni li mhumiex viżwali li ġew irrapportati li jistgħu jkunu kkawżati mill - mediċina jew mill- proċedura ta 'l- injezzjoni (iseħħu f' aktar minn 1 minn kull 100 pazjent fi provi kliniċi): uġigħ ta' ras jew tnixxija mill- imnieħer.
Uncommon eye side effects reported to be possibly caused by the drug or by the injection procedure include (occurring in less than one in 100 but more than one in 1000 patients in clinical trials): inflammation of your eye or of the outer surface of the eye, bleeding in the eye or the internal portion of the eye (vitreous), eye strain, inflammation of the central part of the surface of the eye (keratitis), small deposits on the eye or on the surface of the eye (cornea), deposits in the back of the eye, itching of the eyelids, disturbance in your eye’s reaction to the light (pupillary reflex impaired), small erosion on the central part of the surface of the eye (cornea), drooping eyelid, scar inside the eye (retinal scar), small lump on your eyelid due to inflammation (chalazion), decreased pressure inside the eye, injection site reaction, injection site vesicles, displacement or tear of a layer in the back of the eye (retina), disorder of the pupil, of the coloured part of the eye (iris), retinal artery occlusion, eversion of the eyelid, eye movement disorder, eyelid irritation, blood in your eye, discoloured eye, deposit eye, inflammation of the eye (iritis), optic nerve cupping, deformation of the pupil, occlusion of the vein at the back of the eye, discharge of inner jelly of the eye.
Effetti sekondarji mhux komuni fl- għajnejn li ġew irrapportati bħala li jistgħu jkunu kkawżati mill - mediċina jew mill- proċedura ta 'l- injezzjoni jinkludu (iseħħu f' inqas minn 1 minn kull 100 imma iktar minn 1 minn kull 1000 pazjent fi provi kliniċi): infjammazzjoni ta' l- għajn jew tas- superfiċje ta 'barra ta' l- għajn, fsida fl- għajn jew tal- porzjon ta ’ ġewwa ta ’ l- għajn (vitriju), sforz ta ’ l- għajn, infjammazzjoni tal- parti ċentrali tas- superfiċje ta 'l- għajn (keratite), depożiti żgħar fuq l- għajn jew fuq is- superfiċje ta' l- għajn (kornea), depożiti fuq in- naħa ta 'wara ta' l- għajn, ħakk fil- kpiepel ta 'l- għajn, disturb fir- reazzjoni ta' għajnejk għad- dawl (indeboliment tar- rifless pupillari), erużjoni żgħira fuq il - parti ċentrali tas- superfiċje ta 'l- għajn (kornea), kappell ta' l- għajn imniżżel 'l isfel, marka ġewwa l - għajn (marka fir- retina), nefħa żgħira fuq il- kappell ta' l- għajn minħabba infjammazzjoni (chalazion), tnaqqis tal- pressjoni ġewwa l- għajn, reazzjoni fil- post ta 'l- injezzjoni, infafet fil- post ta' l- injezzjoni, spostament jew tiċrit ta 'saff fin- naħa ta' wara ta 'l- għajn (retina), disturb tal- pupilla, tal- parti bil- kulur ta' l- għajn (ħabba ta 'l- għajn), okklużjoni ta' l- arterja tar- retina, qlib tal- kappell ta 'l- għajn, disturb fil - moviment ta' l- għajn, irritazzjoni fil- kappell ta 'l- għajn, demm f' għajnek, għajn bla kulur, depożitu fl - għajn, infjammazzjoni ta' l- għajn (irite), cupping tan- nerv ottiku, deformazzjoni tal- pupilla, okklużjoni tal- vina fuq in- naħa ta 'wara ta' l- għajn, tnixxija tal- ġeli intern ta 'l- għajn.
(occurring in less than one in 100 but more than one in 1000 patients in clinical trials): nightmare, depression, deafness, vertigo, palpitations, high blood pressure, dilatation of the aorta (the main blood vessel), inflammation of the higher respiratory tract, vomiting, indigestion, irritation and inflammation of the skin, hair colour changes, rash, itching night sweats, back pain, fatigue, shivering, tenderness, chest pain, sudden fever, generalised aches and pains, elevation of the liver enzymes, abrasion.
Effetti sekondarji mhux komuni li mhumiex viżwali li ġew irrapportati li jistgħu jkunu kkawżati mill - mediċina jew mill- proċedura ta 'l- injezzjoni (iseħħu f' anqas minn 1 minn kull 100 pazjent iżda f' aktar minn 1 minn kull 1000 pazjent fi provi kliniċi): ħmar il- lejl, depressjoni, truxija, vertigo, palpitazzjonijiet, pressjoni tad- demm għolja, twessigħ ta' l- aorta (l- arterja prinċipali tad- demm), infjammazzjoni ta 'l- apparat respiratorju ta' fuq, rimettar, indiġestjoni, irritazzjoni u infjammazzjoni tal- ġilda, bidliet fil- kulur tax- xagħar, raxx, tagħriq eċċessiv li jqabbdek il- ħakk matul il- lejl, uġigħ fid - dahar, għeja, rogħda, sensibilità, uġigħ tas- sider, deni għal għarrieda, uġigħ ġeneralizzat, żieda fl - enzimi tal- fwied, brix.
In some rare cases, serious allergic reaction has been reported soon after the injection.
24 F' xi każijiet rari, ġiet irrappurtata reazzjoni allerġika serja ftit wara l- injezzjoni.
Please seek immediate medical help if you experience any of the following soon after the injection: sudden onset of breathing difficulty or wheezing, swollen mouth, face, hands or feet, itching skin, fainting, rapid pulse, stomach cramps, nausea, vomiting or diarrhoea.
Jekk jogħġbok fittex għajnuna medika mill- ewwel jekk tesperjenza xi waħda minn dawn li ġejjin ftit wara l- injezzjoni: bidu għal għarrieda ta 'diffikulta' biex tieħu nifs jew tħarħir, ħalq, wiċċ, idejn jew saqajn minfuħin, ġilda tieklok, ħass ħażin, polz mgħaġġel, uġigħ qawwi fl- istonku, dardir, rimettar jew dijarea.
If you notice other side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Jekk tinnota xi effetti sekondarji oħra li mhumiex imsemmija f' dan il- fuljett, jekk jogħġbok informa lit - tabib jew lill- ispiżjar tiegħek.
HOW TO STORE MACUGEN
KIF TAĦŻEN X
Store in a refrigerator (2oC -8oC).
Aħżen fi friġġ (2oC - 8oC).
Macugen should be discarded if kept at room temperature for more than two weeks.
Macugen għandu jintrema jekk ikun inżamm f' temperatura tal- kamra għal aktar minn ġimagħtejn
Do not use after the expiry date stated which is on the label and carton.
Tużax Macugen wara d- data ta ’ skadenza li tidher fuq it- tikketta u il- kaxxa
What MACUGEN contains
X’ fih X:
- The active substance is pegaptanib sodium.
- Is- sustanza attiva hija pagaptinib sodium.
Each single dose pre-filled syringe delivers a dose of
Kull siringa ta ’ doża waħda mimlija lesta tagħti doża ta '
0.3 mg pegaptanib sodium.
0. 3 mg pegaptinib sodium
- The other ingredients are sodium chloride, monobasic sodium phosphate monohydrate, dibasic
- Is- sustanzi l- oħra huma huma sodium chloride, monobasic sodium phosphate monohydrate,
sodium phosphate heptahydrate, sodium hydroxide, hydrochloric acid and water for injections.
dibasic sodium phosphate heptahydrate, sodium hydroxide, hydrochloric acid u ilma għall - injezzjonijiet
What MACUGEN looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett:
Macugen is supplied in a single dose pack.
Macugen huwa fornut f' pakkett ta 'doża waħda.
Each pack contains a pouch in a carton, containing a 1 ml pre-filled syringe, Type I glass, sealed with an elastomeric plunger stopper and a pre-attached plunger rod, held by a plastic clip.
Kull pakkett fih borża f' kaxxa li fiha siringa ta '1 ml mimlija lesta, tal- ħġieġ tat- Tip 1, issiġillata bi stopper tal- planġer elastomeriku u qasba tal- planġer mwaħħla lesta miżmuma b’ molla tal- plastik.
The syringe has a pre-attached polycarbonate plastic .luer lock adaptor and the tip is sealed with an elastomeric tip cap.
Is - siringa għandha adapter tal- plastik tal- lukkett luer, u t- tap huwa issiġillat b’ kappa elastomerika.
The pack is supplied without a needle.
Il - pakkett huwa fornut mingħajr labbra.
Marketing Authorisation Holder Pfizer Limited Ramsgate Road Sandwich CT13 9NJ United Kingdom
Pfizer Limited Ramsgate Road Sandwich CT13 9NJ Ir- Renju Unit
Manufacturer Pfizer Ireland Pharmaceuticals Pottery Road Dun Laoghaire Co Dublin Ireland
25 Il- Manifattur Pfizer Ireland Pharmaceuticals Pottery Road Dun Laoghaire Co Dublin L- Irlanda
25 For any information about this medicinal product, 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.
España Pfizer S.A.
España Pfizer Hellas A. E.
Tel: +34 91 490 99 00
Τηλ: +34 91 490 99 00
Slovenija Pfizer Luxembourg SARL, Pfizer podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Slovenija Pfizer Luxembourg SARL, Pfizer Podružnica za zvestovanje s področja farmacevtske dejavnosti, Ljubljana
This leaflet was last approved in 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 > < Hemm ukoll links għall- websites oħra dwar mard rari u kura.
EU Number
Numru ta 'l- UE
Content
6000 unità (30
Package size
1 kunjett +
6000 units (30 mg)
(30 mg)
Powder and solvent for solution for injection
solvent: siringa mimlija
Intravenous use
6 ml (1000 U/ ml- 5
powder: vial (glass); solvent: pre-filled syringe (cycloolefine- copolymer)
għal- lest (cycloolefinecopolymer)
6000 units (30 mg)/ 6 ml; 6 ml (1000 U/ ml-5 mg/ ml)
mg/ ml) 8000 unità (40
1 vial + 1 pre-filled syringe + 1 vial adapter + 1 needle
1 adapter tal- kunjett 1 labra 1 kunjett +
8000 units (40 mg)
(40 mg)
Intravenous use
8 ml (1000 U/ ml- 5
8000 units (40 mg)/ 8 ml; 8 ml (1000 U/ ml-5 mg/ ml)
mg/ ml)
1 vial + 1 pre-filled syringe + 1 vial adapter + 1 needle
1 adapter tal- kunjett 1 labra
powder: vial (glass); solvent: pre-filled syringe (cycloolefine- copolymer)
Trab: kunjett (ħġieġ) solvent: siringa mimlija għal- lest (cycloolefinecopolymer)
10000 units (50 mg)/ 10 ml; 10 ml (1000 U/ ml-5 mg/ ml)
10000 unità (50 mg) / 10 ml; 10 ml (1000 U/ ml- 5 mg/ ml)
1 vial + 1 pre-filled syringe + 1 vial adapter + 1 needle
1 kunjett + 1 siringa mimlija għal- lest 1 adapter tal- kunjett 1 labra
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk tixtieq aktar taħriġ dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l - Fuljett ta 'Tagħrif (huwa parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is Micardis?
X' inhu Micardis?
Micardis is a medicine that contains the active substance telmisartan.
Micardis huwa mediċina li fih s- sustanza attiva telmisartan.
It is available as white tablets (round:
Huwa disponibbli f' pilloli bojod (tondi:
20 mg; oblong:
20 mg; oblongi:
What is Micardis used for?
Għal xiex jintuża Micardis?
Micardis is used in adults who have essential hypertension (high blood pressure). ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
Micardis jintuża f' adulti li jbatu minn ipertensjoni essenzjali (pressjoni tad- demm għolja).
The medicine can only be obtained with a prescription.
'Essenzjali' tfisser li l- pressjoni għolja ma tkunx ikkawżata minn xi kundizzjoni oħra.
How is Micardis used?
Kif jintuża Micardis?
Micardis is taken by mouth, with or without food.
Micardis jittieħed b' mod orali, anki fuq stonku vojt.
The recommended dose is 40 mg once a day, but some patients may benefit from using a 20-mg dose.
Id- doża rakkomandata hija 40 mg darba kuljum, iżda xi pazjenti jistgħu jieħdu benefiċċju billi jużaw doża ta '20 mg.
If the target blood pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Jekk il- pressjoni tad- demm baxxa li tkun immirata li tintlaħaq ma tintlaħaqx, id- doża tista 'tiżdied għal 80 mg, jew mediċina oħra għall - ipertensjoni bħal idroklorotijażide (hydrochlorothiazide) li tista' tiġi miżjuda.
How does Micardis work?
Kif jaħdem Micardis?
The active substance in Micardis, telmisartan, 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' Micardis, telmisartan, hija tip ta '' antagonist tar- riċetturi tal- anġjotensina II 'li tfisser li jimblokka l- azzjoni tal- ormon fil- ġisem imsejjaħ anġjotensina II.
By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Billi jimblokka r- riċetturi li magħhom l - anġjotensina II teħel normalment, telmisartan iwaqqaf l- ormon milli jkollu effett, b' hekk iħalli l- arterji u l- vini jitwessgħu.
This allows the blood pressure to drop, reducing the risk caused by high blood pressure, such as having a stroke.
Dan jippermetti li titbaxxa l- pressjoni tad- demm u b' hekk jitnaqqas ir- riskju kkawżat mill- pressjoni tad- demm għolja, bħal ma hi l- puplesija.
How has Micardis been studied?
Kif ġie studjat Micardis?
Micardis has been studied in 1,647 patients who were treated with telmisartan either alone or in combination with hydrochlorothiazide.
Micardis ġie studjat f' 1, 647 pazjent li ġew ittrattati b' telmisartan waħdu jew f' kombinazzjoni ma 'idroklorotijażide.
Micardis was compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine).
Micardis tqabbel ma 'plaċebo (trattament finta) jew ma' mediċini oħra għall - ipertensjoni (atenolol, lisinopril, enalapril, amlodipina).
The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Il- kejl ewlieni tal- effikaċja kien it- tnaqqis tal - pressjoni tad- demm dijastolika (pressjoni tad- demm mkejla bejn żewġ taħbitiet tal- qalb).
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged X' benefiċċju wera Micardis matul l- istudji mwettqa?
Micardis was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Micardis irriżulta aktar effikaċi mill- plaċebo biex inaqqas il- pressjoni tad- demm dijastolika u kellu effetti simili għal mediċini oħra għall- ipertensjoni.
What is the risk associated with Micardis?
X' inhu r- riskju assoċjat ma 'Micardis?
Side effects with Micardis are not common.
L- effetti sekondarji b' Micardis m’ humiex komuni.
For the full list of all side effects reported with Micardis, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati b' Micardis, ara l- Fuljett ta 'Tagħrif.
Micardis should not be used in people who may be hypersensitive (allergic) to telmisartan or any of the other ingredients.
Micardis ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal telmisartan jew għal xi ingredjent ieħor tiegħu.
Micardis must not be used in people who have severe liver problems or bile problems.
Micardis ma għandux jintuża f' persuni li jkollhom problemi gravi fil- fwied jew problemi biljari.
Why has Micardis been approved?
Għaliex ġie approvat Micardis?
The Committee for Medicinal Products for Human Use (CHMP) decided that Micardis’ s benefits are greater than its risks for the treatment of essential hypertension in adults.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Micardis huma ogħla mir- riskji tiegħu fit- trattament tal- ipertensjoni essenzjali fl- adulti.
The Committee recommended that Micardis be given marketing authorisation.
Il- Kumitat irrakkomanda li Micardis jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Micardis:
Aktar tagħrif dwar Micardis:
The European Commission granted a marketing authorisation valid throughout the European Union for Micardis to Boehringer Ingelheim International GmbH on 16 December 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Micardis lil Boehringer Ingelheim International GmbH fis- 16 ta 'Diċembru 1998.
The marketing authorisation was renewed on 16 December 2003 and on 16 December 2008.
L - awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 16 ta 'Diċembru 2003 u fis- 16 ta ’ Diċembru 2008.
The full EPAR for Micardis is available here.
L- EPAR sħiħ dwar Micardis jista 'jiġi kkonsultat hawn.
Micardis 20 mg tablets
Micardis 20 mg pilloli
In patients with mild to moderate hepatic impairment, the posology should not exceed 40 mg once daily (see section 4.4).
F’ pazjenti b’ indeboliment epatiku minn ħafif sa moderat, il- pożoloġija m’ għandhiex taqbeż 40 mg darba kuljum (ara sezzjoni 4. 4).
Paediatric patients Micardis is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Pazjenti pedjatriċi Micardis mhuwiex rakkomandat għall- użu fit- tfal taħt it- 18- il sena, minħabba nuqqas ta ’ dejta dwar is - sigurtà u l- effikaċja.
Micardis is not to be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment (see section 4.3) since telmisartan is mostly eliminated with the bile.
Micardis m’ għandux jingħata lil pazjenti b’ kolestasi, b’ disturbi ostruttivi tal- marrara jew li għandhom indeboliment sever epatiku (ara sezzjoni 4. 3), għax telmisartan huwa eliminat fil- biċċa l- kbira tiegħu mal- bili.
Micardis should be used only with caution in patients with mild to moderate hepatic impairment.
Micardis għandu jintuża biss bl- attenzjoni f’ pazjenti li għandhom indeboliment epatiku minn ħafif sa moderat.
When Micardis is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.
Meta Micardis jintuża f’ pazjenti li għandhom indeboliment fil- funzjoni renali, monitoraġġ perjodiku tal- livelli tal- potassium u tal- krejatinina tas- serum hu rakkomandat.
There is no experience regarding the administration of Micardis in patients with recent kidney transplantation.
M’ hemmx esperjenza dwar l - għoti ta ’ Micardis f’ pazjenti bi trapjant renali riċenti.
Symptomatic hypotension, especially after the first dose of Micardis, may occur in patients who are volume and/ or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting.
Pressjoni baxxa ħafna sintomatika, speċjalment wara l- ewwel doża ta ’ Micardis tista ’ sseħħ f’ pazjenti li għandhom volum u/ jew sodium li jkun tnaqqas minn terapija dijuretika vigoruża, restrizzjoni tal - melħ fid- dieta, dijarea jew rimettar.
Such conditions should be corrected before the administration of Micardis.
Dawn il- kundizzjonijiet għandhom jiġu kkoreġuti qabel l- għoti ta ’ Micardis.
Volume and/ or sodium depletion should be corrected prior to administration of Micardis.
It- tnaqqis tal- volum u/ jew tas- sodium għandu jiġi kkoreġut qabel l- għoti ta ’ Micardis.
In patients whose vascular tone and renal function depend predominantly on the activity of the renin- angiotensin-aldosterone system (e. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system such as telmisartan has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
F’ pazjenti fejn it- ton vaskulari u l- funzjoni renali jiddependu b’ mod predominanti mill- attività tas - sistema renin- angiotensin- aldosterone (eż. pazjenti b’ insuffiċjenza konġestiva severa tal- qalb jew li għandhom mard prinċipali renali, li jinkludi stenosi ta ’ l- arterja renali), il- kura bi prodotti mediċinali oħrajn li jaffettwaw din is- sistema bħal telmisartan, kienet assoċjata ma ’ pressjoni baxxa ħafna akuta, iperażotemija, oligurja, jew b’ mod rari ma ’ insuffiċjenza renali akuta (ara sezzjoni 4. 8).
Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Prodotti mediċinali jew klassijiet terapewtiċi ta ’ prodotti mediċinali li jistgħu jikkawżaw l- iperkalemija huma sostituti tal- melħ li fihom il- potassium, dijuretiċi li ma jneħħux potassium, inibituri ta ’ ACE, antagonisti tar- riċettur ta ’ angiotensin II, prodotti mediċinali mhux sterojdi kontra l- infjammazzjoni (NSAIDs, li jinkludu inibituri COX- 2 selettivi), eparina, immunosoppressuri (cyclosporin jew tacrolimus), u trimethoprim.
- Intercurrent events, in particular dehydratation, acute cardiac decompensation, metabolic
- Avvenimenti interkurrenti, b’ mod partikulari d- deidrazzjoni, dikumpensazzjoni akuta kardijaka,
acidosis, worsening of renal function, sudden worsening of the renal condition (e. g. infectious diseases), cellular lysis (e. g. acute limb ischemia, rhabdomyolysis, extend trauma).
aċidożi metabolika, funzjoni renali li tmur għall- agħar, kundizzjoni renali li tmur għall- agħar għal għarrieda (eż. mard infettiv), lisi ċellulari (eż. iskemija akuta fir- riġlejn jew fid- dirgħajn, rabdomijolosi, estensjoni tat- trawma).
Patients with rare hereditary problems of fructose intolerance should not take Micardis.
Pazjenti li għandhom problemi ereditarji rari ta ’ intolleranza għall- fructose m’ għandhomx jieħdu Micardis.
As with other medicinal products acting on the renin-angiotensin-aldosterone system, telmisartan may provoke hyperkalaemia (see section 4.4).
4 Bħal mediċini oħrajn li jaġixxu fuq is- sistema renin- angiotensin- aldosterone, telmisartan jista ’ jikkawża l- iperkalemija (ara sezzjoni 4. 4).
If concomitant use is indicated because of documented hypokalaemia, they should be used with caution and with frequent monitoring of serum potassium.
Jekk l- użu fl- istess ħin ikun indikat minħabba li jkun hemm ipokalemija dokumentata, dawn għandhom jintużaw bl- attenzjoni u b’ monitoraġġ frekwenti tal - potassium fis- serum.
Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion, and in a risk of hypotension when initiating therapy with telmisartan.
Il- kura fil- passat b’ dożi qawwija ta ’ dijuretiċi bħal furosemide (dijuretiku loop) u hydrochlorothiazide (dijuretiku thiazide) tista ’ tirriżulta fi tnaqqis tal- volum u f’ riskju ta ’ pressjoni tad- demm baxxa ħafna meta tibda t- terapija b’ telmisartan.
Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including telmisartan:
Ibbażat fuq il- proprjetajiet farmakoloġiċi tagħhom, jista ’ jkun mistenni li l - prodotti mediċinali li ġejjin jistgħu jżidu l- effetti ipotensivi tal- mediċini kollha kontra l- pressjoni għolja, li jinkludu telmisartan:
Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics, or antidepressants.
Flimkien ma ’ dan, pressjoni tad- demm baxxa ħafna meta wieħed ikun bilwieqfa tista ’ tiggrava permezz ta ’ l- alkoħol, barbiturates, mediċini narkotiċi jew anti- dipressanti.
There are no adequate data from the use of Micardis in pregnant women.
M’ hemmx tagħrif dwar l- użu ta ’ Micardis f’ nisa tqal.
The overall incidence of adverse events reported with telmisartan (41.4%) was usually comparable to placebo (43.9%) in placebo controlled trials.
L- inċidenza ta ’ l -
The incidence of adverse events was not dose related and showed no correlation with gender, age or race of the patients.
6 avvenimenti avversi ma ’ kinitx marbuta mad- doża u ma wriet l- ebda korrelazzjoni mas- sess, ma ’ l- età, jew mar- razza tal- pazjenti.
Upper respiratory tract infection including pharyngitis and sinusitis Urinary tract infection including cystitis
Infezzjoni fl- apparat ta ’ l- awrina li tinkludi ċistite
Blood uric acid increased, blood creatinine increased, hepatic enzyme increased, blood creatine phosphokinase increased
Żieda fil- uric acid fid- demm, żieda fil- krejatinina fid- demm, żieda fl- enzimi epatiċi, żieda fil - creatine phosphokinase fid- demm Tnaqqis fl- emoglobina
Haemoglobin decreased
Doża eċċessiva
The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia dizziness, increase in serum creatinine, and acute renal failure have also been reported.
L- iktar manifestazzjonijiet prominenti ta ’ doża eċċessiva ta ’ telmisartan kienu pressjoni tad - demm baxxa ħafna u takikardja; il- bradikardija, sturdament, żieda fil- livell tal- krejatinina fis- serum u insuffiċjenza renali akuta kienu osservati wkoll.
5.1 Pharmacodynamic properties
8 5. 1 Tagħrif farmakodinamiku
8 In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without affecting pulse rate.
F’ pazjenti bi pressjoni għolja, telmisartan inaqqas kemm il- pressjoni sistolika u dik dijastolika, mingħajr ma jaffettwa r- rata tal- polz.
When telmisartan is taken with food, the reduction in the area under the plasma concentration-time curve (AUC0-∞) of telmisartan varies from approximately 6% (40 mg dose) to approximately 19% (160 mg dose).
9 tnaqqis taż- żona taħt il- kurva tal- konċentrazzjoni tal- plażma- żmien (AUC0- ∞) ta ’ telmisartan tvarja minn madwar 6% (doża ta ’ 40 mg) sa madwar 19% (doża ta ’ 160 mg).
After oral (and intravenous) administration, telmisartan is nearly exclusively excreted with the faeces, mainly as unchanged compound.
Wara teħid mill- ħalq (u minn ġol- vina), telmisartan jiġi kważi eliminat kollu ma ’ l- ippurgar, primarjament bħala kompost mhux mibdul.
9 Elderly patients:
Pazjenti anzjani:
In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium in normotensive animals.
Fi studji dwar is- sigurtà ta ’ qabel l- użu kliniku, id- dożi li pproduċew esponiment li kien komparabbli għal dak fil- medda terapewtika klinika, ikkawżaw tnaqqis fil- parametri taċ- ċelluli ħomor tad- demm (eritroċiti, emoglobina, ematokrit), bidliet fl- emodinamiċi renali (żieda fin- nitrogen ta ’ l- urea u l -
10 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Aluminium/ aluminium blisters (PA/ Al/ PVC/ Al or PA/ PA/ Al/ PVC/ Al).
Folji tal- aluminju/ aluminju (PA/ PA/ Al/ PVC/ Al).
Boehringer Ingelheim International GmbH Binger Str.
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ 11 Boehringer Ingelheim International GmbH Binger Str.
173 D-55216 Ingelheim am Rhein Germany
173 D- 55216 Ingelheim am Rhein Il- Ġermanja
EU/ 1/ 98/ 090/ 009 (14 tablets) EU/ 1/ 98/ 090/ 010 (28 tablets) EU/ 1/ 98/ 090/ 011 (56 tablets) EU/ 1/ 98/ 090/ 012 (98 tablets)
EU/ 1/ 98/ 090/ 009 (14- il pillola) EU/ 1/ 98/ 090/ 010 (28 pillola) EU/ 1/ 98/ 090/ 011 (56 pillola) EU/ 1/ 98/ 090/ 012 (98 pillola)
Micardis 40 mg tablets
Micardis 40 mg pilloli
White oblong tablets engraved with the code number '51H 'on one side and the company logo on the other side.
Pilloli bojod b’ forma oblunga li fuqhom hemm imnaqqax in- numru tal- kodiċi ‘ 51H ’ fuq naħa waħda u l- logo tal- kumpanija fuq in- naħa l- oħra.
No dose adjustment is necessary for elderly patients.
Anzjani L- ebda aġġustament fid- doża mhu meħtieġ għal pazjenti anzjani.
12 • Second and third trimester of pregnancy (see sections 4.4 and 4.6) • Lactation (see section 4.6) • Biliary obstructive disorders • Severe hepatic impairment
• Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi (ara sezzjoni 6. 1) • It- tieni u t- tielet trimestru tat- tqala (ara sezzjonijiet 4. 4 u 4. 6) • Treddigħ (ara sezzjoni 4. 6) • Disturbi ostruttivi biljari • Indeboliment sever epatiku
Symptomatic hypotension, especially after the first dose of Micardis, may occur in patients who are volume and/ or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting.
Pressjoni baxxa ħafna sintomatika, speċjalment wara l- ewwel doża ta ’ Micardis, tista ’ sseħħ f’ pazjenti li għandhom volum u/ jew sodium li jkun tnaqqas minn terapija dijuretika vigoruża, restrizzjoni tal - melħ fid- dieta, dijarea jew rimettar.
Volume and/ or sodium depletion should be corrected prior to administration of Micardis.
It- tnaqqis tal- volum u/ jew tas- sodium għandu jiġi kkoreġut qabel l- għoti Micardis.
Primary aldosteronism:
14 Aldosteroniżmu primarju:
As with others drugs acting on the renin-angiotensin-aldosterone system, telmisartan may provoke hyperkalaemia (see section 4.4).
15 Bħal mediċini oħrajn li jaġixxu fuq is- sistema renin- angiotensin- aldosterone, telmisartan jista ’ jikkawża l- iperkalemija (ara sezzjoni 4. 4).
The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti- inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
Ir- riskju jista ’ jiżdied f’ każ li l- kura tingħata flimkien ma ’ prodotti mediċinali oħra li jistgħu jikkawżaw ukoll l- iperkalemija (sostituti tal- melħ li fihom il - potassium, dijuretiċi li ma jneħħux potassium, inibituri ta ’ ACE, antagonisti tar- riċettur ta ’ angiotensin II, prodotti mediċinali mhux sterojdi kontra l- infjammazzjoni (NSAIDs, li jinkludu inibituri COX- 2 selettivi), eparina, immunosoppressuri (cyclosporin jew tacrolimus) u trimethoprim).