qanastek/EMEA-V3 huggingface dataset:
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet spe cjali li ghandhom jittiehdu meta jintrema u ghal immaniggar ie hor
Each vial of ATryn contains a lyophilised powder of 1750 IU antithrombin alfa and is intended for single use only.
Kull kunjett ta 'ATryn fih trab lajofillizzat ta' 1750 IU ta 'antithrombin alfa u hu intenzjonat ghall- uzu ta' darba biss.
Vials should be brought to room temperature prior to reconstitution and kept no longer than 3 hours.
Il- kunjetti g handhom jingabu ghat- temperatura tal- kamra qabel ir - rikostituzzjoni u ma jinzammux iktar minn 3 sighat.
The powder should be reconstituted with 10 ml of Sterile Water for Injection (WFI) injected along the side wall of the vial and g swirled (not shaken) to prevent foaming.
It- trab ghandu jkun rikostitwit b' 10 ml ta 'Ilma Sterili ghall- Injezzjoni (Sterile Water for Injection - WFI) li jkun injettat fuq il- genb tal - kunjett u mdawwar bil- mod (mhux imhawwad) biex tigi evitata r- raghwa.
The reconstituted product should be inspected
Il- prodott rikostitwit ghandu jigi ezaminat vizwalment ghall- materjal f’ sura ta ’ partikuli u tibdil fil- kulur qabel ma jinghata.
visually for particulate matter and discolouration prior to administration.
Is- soluzzjoni ghandha tkun cara jew xi ftit opalexxenti.
The solution should be clear or slightly opalescent.
Tuzax soluzzjonijiet li jkunu m cajprin jew li jkollhom xi depoziti fil- qiegh.
Do not use solutions that are cloudy or have deposits.
Wara li jkun inhall
Upon complete dissolution, the reconstituted product may be drawn up into a sterile disposable syringe.
7 kompletament, il- prodott rikostitwit jista 'jingibed f' siringa sterili li tintrema wara li tintuza.
The reconstituted product should be administered by intravenous infusion using a sterile disposable syringe or an infusion bag wit h a 0.22 micron pore size in-line filter.
Il- prodott rikostitwit ghandu jinghata permezz ta 'infuzjoni gol- vina bl- uzu ta' siringa li tintrema wara li tintuza jew borza ta 'l infuzjoni b' filtru in- line bid- daqs tal- pori ta' 0. 22
Normal sodium chloride solution 9 mg/ ml (0.9%) may be added to dilute to a concentration convenient for administration.
Soluzzjoni normali ta '9 mg/ ml (0. 9%) ta' sodium chloride tista 'tizdied mad- dilwit biex tintla haq koncentrazzjoni konvenjenti ghall- ghoti.
The contents of infusion syringes or diluted solution prepared in infusion bags should be administered within 8 hours of preparation.
Il- kontenut tas- siringi ta 'l - infuzjoni jew tas- soluzzjoni dilwita fil- boroz ta' l infuzjoni ghandu jinghata fi zmien 8 sighat mill -
Compatibility with PVC infusion lines with in-line filters has been established.
Il- kompatibilità mal- linji ta 'l- infuzjoni PVC ma' filtri in- line kienet stabbilita.
MARKETING AUTHORISATION HOLDER
L- ENTITÀ LI GHANDHA L- AWTORIZZAZZJONI TAL- KUMMERC
LEO Pharma A/ S Industriparken 55 DK-2750 Ballerup Denmark
LEO Pharma A/ S Industriparken 55 DK- 2750 Ballerup Danimarka
EU/ 1/ 06/ 355/ 001-003
EU/ 1/ 355/ 064/ 001
DATE OF FIRST AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI
28/ 07/ 2006
28/ 07/ 06
DATE OF REVISION OF THE TEXT
DATA TA ’ META GIET RIVEDUTA L- KITBA
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOGIKA ATTIVA U SID/ SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUG TAL- LOTT
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GHALL- KUMMERC
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGAZZJONIJIET SPECIFICI LI GHANDHOM JIGU SODISFATTI MID- DETENTUR TA ’ L- AWTORIZZAZZJONI GHAT- TQEGHID FIS - SUQ
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOGIKA ATTIVA U SID/ SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL - HRUG TAL- LOTT
Name and address of the manufacturer of the biological active substance
Isem u indirizz tal- manifattur tas - sustanza bijologika attiva
97 South Street Hopkinton, MA 01748-2204 USA
97 South Street Hopkinton, MA 01748- 2204 Stati Uniti ta ’ l- Amerika
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur responsabbli ghall- hrug tal- lott
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L - UZU IMPOSTI FUQ SID L- AWTORIZZAZZJONI GHALL- KUMMERC
Medicinal product subject to restricted medical prescription (See Annex I:
Sommarju tal
Summary of Product Characteristics, section 4.2).
Karatteristici tal- Prodott, sezzjoni 4. 2).
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L - UZU MINGHAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDICINALI
Not applicable
Ma jghoddx f’ dan il- kaz
• OTHER CONDITIONS
• KUNDIZZJONIJIET OHRA
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
L- MAH jrid jizgura li s- sistema ta 'farmakovigilanza tkun implimentata u tkun tahdem qabel ma l- prodott jibda jinbiegh.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
L- MAH huwa obbligat li jwettaq l- istudji u attivitajiet ta 'farmakovigilanza addizzjonali deskritti fil- Pjan tal- Farmakovigilanza.
An updated risk management plan should be provided as per the CHMP guideline on risk management systems for medicinal products for human use.
Pjan aggornat dwar l- Immaniggjar tar- Riskju ghandu jkun ipprovdut skond il- Linja Gwida tal- CHPM dwar is- Sistemi ta 'l- Immaniggjar tar- Riskji ghal prodotti medicinali ghall- uzu uman.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGAZZJONIJIET SPECIFICI LI GHANDHOM JIGU SODISFATTI MID- DETENTUR TA ’ L- AWTORIZZAZZJONI GHAT- TQEGHID FIS- SUQ
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Id- Detentur ta ’ l- Awtorizzazzjoni ghat- Tqeghid fis- Suq ghandu jlesti l- programm ta ’ studji li gej fiz- zmien stipulat, li r- rizultati tieghu jridu jiffurmaw il- bazi ta ’ evalwazzjoni annwali tal - profil tal- beneficcju/ riskju.
10 Clinical aspects
10 Aspetti klinici:
A Multicenter, Multinational Study to Assess the Safety and Efficacy of Antithrombin alfa in Hereditary Antithrombin (AT) Deficient Patients in High- Risk Situations for Thrombosis.
Studju Multicentre, Multinazzjonali biex Jevalwa s- Sigurtà u l- Effikacja ta 'Antithrombin alfa f' Pazjenti b' Deficjenza Ereditarja ta' Antithrombin (AT) f' Sitwazzjonijiet ta 'Riskju Qawwi ta' Trombozi.
The results of ongoing study GTC AT HD 012-04 and in particular the results of investigations in pregnant women treated during the peri-partum period will be submitted when enrollment is completed (total of 17 patients, a mix of surgical and pregnant women).
Ir- rizultati ta 'studju GTC AT HD 012- 04 li ghadu ghaddej, u b' mod partikulari, ir- rizultati ta' investigazzjonijiet f' nisa tqal ikkurati matul il- perjodu tal- peri- partum ser ikunu sottomessi meta titlesta r- registrazzjoni, (total ta '17 il- pazjent, tahlita ta' nisa li kellhom operazzjoni u nisa tqal).
Assuming positive results of the trial, a marketing authorization variation will be submitted to expand the indication and dosing of pregnant women.
Jekk wiehed jassumi rizultati pozittivi tal- prova, varjazzjoni ta 'l- awtorizzazzjoni tal- kummerc ser tkun sottomessa biex tespandi l- indikazzjoni u d- dozagg f' nisa tqal.
An update on the status of the trial will be submitted on an annual basis until such time as the study is completed.
Aggornament dwar l- istatus tal- prova ser ikun sottomess kull sena sakemm l- istudju jitlesta.
2. Post-marketing surveillance a) Prior to launch in any EU Member State, the MAH will set up a post-marketing surveillance programme to collect the following information about congenital AT deficient patients treated with ATryn
Sorveljanza ta ’ wara t- tqeghid fis- suq a) Qabel it- tnedija fi kwalunkwe Stat Membru ta 'l- UE, il- MAH ser iwaqqaf programm ta' sorveljanza ta 'warat- tqeghid fis- suq biex jigbor l- informazzjoni li gejja dwar pazjenti li ghandhom deficjenza ta' l- AT ikkurati b' ATryn
Demographics Indication Posology Length of treatment Prior treatment with ATryn Use of anti-coagulants Adverse drug reactions including lack of efficacy Development of antibodies
Demografija Indikazzjoni Pozologija Tul ta ’ zmien tal- kura Kura fil- passat b' ATryn Uzu ta 'medicini li jinaghtaw biex ma jaghadx id- demm Reazzjonijiet avversi tal- medicina li jinkludu nuqqas ta' effikacja L- izvilupp ta 'anti- korpi
Physicians should be encouraged to enrol patients in the surveillance programme and results of the surveillance should be provided in the update to the EU-RMP or at the time of the annual reassessment, whichever comes first.
It- tobba ghandhom jigu mhegga biex jirregistraw il- pazjenti fil- programm ta 'sorveljanza u r- rizultati tas- sorveljanza ghandhom jigu pprovduti fl- aggornament tal - UE- RMP jew fiz- zmien ta' - evalwazzjoni mill- gdid li ssir kull sena, skond liema l wiehed minnhom jigi l- ewwel.
b) Prior to launch in any EU Member State, the MAH will set up an immunosurveillance programme and provide antibody testing for anti-ATryn antibodies to physicians.
b) Qabel it- tnedija fi kwalunkwe Stat Membru ta 'l- UE, il- MAH ser iwaqqaf programm ta' immunosorveljanza u jipprovdi ittestjar ghall- anti- korpi ta 'l- anti- ATryn lit- tobba.
This antibody testing should be provided upon request of a physi cian and when the MAH receives a report suggestive of a possible immune reaction or lack of efficacy.
Dan l- ittestjar ghall- anti- korpi ghandu jigi pprovdut meta jintalab minghand tabib u meta l- MAH jircievi rapport li jissuggerixxi reazzjoni immunologika possibbli jew nuqqas ta 'effikacja.
c) The MAH will ensure that material provided to physicians provides information on the post-marketing surveillance programme and the immunosurveillance programme.
c) L- MAH ser jizgura li l- materjal ipprovdut lit- tobba jipprovdi informazzjoni dwar il - programm ta 'sorveljanza ta' warat- tqeghid fis- suq u l- programm ta 'l - immunosorveljanza.
This post-marketing surveillance will run up until such time as 40 patients are enrolled.
Din is- sorveljanza ta ’ wara t- tqeghid fis- suq tibqa ’ sejra sa dak iz- zmien li jigu arwolati 40 pazjent.
LABELLING AND PACKAGE LEAFLET
TIKKETTA U L- FULJETT TA ’ TAGHRIF FIL- PAKKETT
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
13 TAGHRIF LI GHANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON (1 VIAL)
PAKKETT TA ’ BARRA (KUNJETT WIEHED)
ATryn 1750 IU powder for solution for infusion Antithrombin alfa
ATryn 1750 IU trab ghas- soluzzjoni ghall- infuzjoni Antithrombin alfa
Approximately 175 IU/ml antithrombin alfa when reconstituted with 10 ml of WFI.
Madwar 175 IU/ ml ta 'antithrombin alfa meta rikostitwit ma' 10 ml ta 'WFI.
Glycine Sodium chloride Sodium citrate
Glycine Sodium chloride Sodium citrate
PHARMACEUTICAL FORM AND CONTENTS
GHAMLA FARMACEWTIKA U KONTENUT
1 Vial
1 kunjett
METHOD AND ROUTE(S) OF ADMINISTRATION
METODU U MOD( I) TA 'AMMINISTRAZZJONI
For intravenous use.
Jinghata gol- vina.
Read the package leaflet before use.
Aqra l- fuljett ta 'taghrif fil- pakkett qabel l- uzu.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPECJALI LI L- PRODOTT MEDICINALI GHANDU JINZAMM FEJN MA JINTLAHAQX U MA JIDHIRX MIT- TFAL
Keep out of the reach and sight of children.
Zomm fejn ma jintlahaqx u ma jidhirx mit- tfal.
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA/ IET SPECJALI OHRA, JEKK MEHTIEGA
EXP IRY DATE
DATA TA 'META JISKADI
EXP {MM/YYYY)
JIS {XX/ SSSS}
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPECJALI TA 'KIF JINHAZEN
Store in a refrigerator.
Ahzen fil- frigg.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPECJALI GHAR- RIMI TA ’ PRODOTTI MEDICINALI MHUX UZATI JEW SKART MINN DAWN IL- PRODOTTI MEDICINALI, JEKK HEMM BZONN
For single use only.
Ghall- uzu ta ’ darba biss.
Any unused solution should be discarded.
Kwalunkwe soluzzjoni li ma tintuzax ghandha tintrema.
LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark
LEO Pharma A/ S Industriparken 55 DK- 2750 Ballerup Danimarka
EU/1/06/355/001
EU/ 1/ 00/ 355/ 001
GENERAL CLASSIFICATION FOR SUPPLY
KLASSIFIKAZZJONI GENERALI TA ’ KIF JINGHATA
Medicinal product subject to medical prescription.
Prodott medicinali jinghata bir- ricetta tat- tabib.
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
STRUZZJONIJIET DWAR L- UZU
OUTER CARTON (10 VIALS)
15 TAGHRIF LI GHANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
10 Vials
10 kunjetti
EU/1/06/355/002
EU/ 1/ 99/ 355/ 002
INSTRUCTIONS ON USE
STRUZZJONIJIET DWAR L- UZU
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
17 TAGHRIF LI GHANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON (25 VIALS)
KARTUNA TA ’ BARRA (PAKKETT TA ’ 25 KUNJETT)
25 Vials
25 Kunjett
EU/1/06/355/003
EU/ 1/ 99/ 355/ 003
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
19 TAGHRIF MINIMU LI GHANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ZGHAR
NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
ISEM TAL- PRODOTT MEDICINALI U, JEKK NECESSARJU, IR- ROTTA (ROTOT) TA ’ MINN FEJN JINGHATA
ATryn 1750 IU powder for solution for infusion Antithrombin alfa For intravenous use.
ATryn 1750 IU trab ghas- soluzzjoni ghall- infuzjoni Antithrombin alfa Jinghata gol- vina.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKOND IL- PIZ, VOLUM, JEW PARTI INDIVIDWALI
Approximately 175 IU/ml antithrombin alfa when reconstituted with 10 ml of WFI
Madwar 175 IU/ ml antithrombin alfa meta rikostitwit ma '10 ml ta' WFI
LEO Pharma A/S, DK-2750 Ballerup, Denmark.
LEO Pharma A/ S, DK- 2750 Ballerup, Danimarka.
PACKAGE LEAFLET
FULJETT TA 'TAGHRIF FIL- PAKKETT
21 PACKAGE LEAFLET:
21 FULJETT TA ’ TAGHRIF:
ATryn 1750 IU powder for solution for infusion Antithrombin alfa.
ATryn 1750 IU trab ghas - soluzzjoni ghall- infuzjoni Antithrombin alfa.
Read all of this leaflet carefully before you start using this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tuza din il- medicina
- Keep this leaflet.
- Zomm dan il- fuljett.
You may need to read it again.
Jista ’ jkollok bzonn terga ’ taqrah.
- If you have any further questions, ask your doctor.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib tieghek.
- If any of the side effects get serious or if you notice any side effects not listed in the
- Jekk xi wiehed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li
leaflet, please tell your doctor.
mhumiex imnizzlin f’ dan il- fuljett, jekk joghgbok ghid lit- tabib tieghek.
What ATryn is and what it is used for 2.
X’ inhu ATryn u ghalxiex jintuza 2.
Before you use ATryn 3.
Qabel ma tuza ATryn 3.
How to use ATryn 4.
Kif ghandek tuza ATryn 4.
Possible side effects 5 How to store ATryn 6.
Effetti sekondarji li jista ’ jkollu 5 Kif tahzen ATryn 6.
Further information
Aktar taghrif
WHAT ATryn IS AND WHAT IT IS USED FOR
X’ INHU ATryn U GHALXIEX JINTUZA
ATryn is an anti-clotting agent and contains antithrombin alfa which is similar to human antithrombin.
ATryn hija medicina li ma thallix id- demm jaghqad u fiha antithrombin alfa li hu simili ghal antithrombin uman.
Antithrombin alfa is produced by recombinant DNA technology from the milk of goats.
Antithrombin alfa hu prodott minn teknologija rikombinanti mid- DNA? mill- halib tal- moghoz.
If you have congenital antithrombin deficiency, your blood level of antithrombin is lower than normal, which may result in a reduced anti-clotting capacity of your blood.
Jekk ghandek deficjenza kongenitali ta 'l- antithrombin, il- livell ta' l - antithrombin fid- demm tieghek ikun iktar baxx min- normal, u dan jista 'jirrizulta fi tnaqqis tal- kapacità ta' kontra t- taghqid tad- demm fid- demm tieghek.
If your anti-clotting capacity is reduced, there is an increased risk of the formation of clots in the vessels of your legs (deep vein thrombosis) or in other vessels of your body (thromboembolism) during major surgery.
Jekk il- kapacità tieghek biex ma jaqghadx id- demm hija baxxa, ikun hemm riskju oghla tal- formazzjoni ta 'emboli fil- vini jew arterji f' riglejk (trombozi profonda tal- vini) jew f' vini jew arterji ohrajn ta' gismek (tromboembolizmu) waqt xi operazzjoni magguri.
Therefore, it is important that your antithrombin blood level be maintained at sufficient levels in these situations.
Ghalhekk, hu importanti li l- livell ta 'antithrombin fid- demm tieghek jinzamm f' livelli sufficjenti f' dawn is- sitwazzjonijiet.
BEFORE YOU USE ATryn
QABEL MA TUZA ATryn
Do not use ATryn If you are allergic (hypersensitive) to antithrombin alfa or any of the other ingredients of ATryn.
Tuzax ATryn Jekk inti allergiku/ a (ghandek sensittività eccessiva) ghal antithrombin jew ghal xi wahda mis- sustanzi l- ohra ta ’ ATryn.
Take special care with ATryn If you are allergic to goat products, please tell your treating physician since you should not use ATryn.
Oqghod attent hafna b’ ATryn Jekk inti allergiku/ a ghall- prodotti li gejjin mill- moghoz, jekk joghgbok ghid lit- tabib li qed jikkurak, ghax m' ghandekx tuza ATryn.
As with any intravenous protein product, allergic reactions are possible.
gol- vina, reazzjonijiet allergici huma possibbli.
If you experience hives, itchy welts or wheals all over the skin, tightness of the chest, wheezing (difficulty breathing), you should immediately contact your physician since these might be symptoms of a severe allergic reaction.
Jekk ikollok urtikarja, partijiet tal- gilda li jkollok il- hakk fihom jew tbengil fuq il- gilda kollha, sensazzjoni ta 'dwejjaq fis- sider, tharhir (diffikultà biex tie hu n- nifs), ghandek tikkuntattja immedjatament lit- tabib tieghek ghax dawn jistghu jkunu sintomi ta' reazzjoni allergika qawwija.
To test for the occurrence of an allergic reaction, blood will be collected and tested before and some time after you have been treated with ATryn.
Biex tkun itttestjat/ a ghall- okkorrenza ta 'reazzjoni allergika, jittehidlek id- demm u dan ser jigi ttestjat qabel u xi hin wara li inti tkun gejt ikkurat/ a b' ATryn.
Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tie hu medicini ohra Jekk joghgbok ghid lit- tabib tieghek jekk qieghed tiehu jew hadt dan l- ahhar xi medicini ohra, anki dawk minghajr ricetta.
When ATryn is used together with heparin (an anti-clotting drug), or some other anti-clotting drugs, this may increase the risk of bleeding.
22 Meta ATryn jintuza flimkien ma 'l- eparina (medicina li ma thallix id- demm jaghqad), jew xi medicini ohrajn li jinghataw biex ma jaghqadx id- demm, dan jista' jzid ir- riskju ta 'hrug ta' demm.
Therefore your doctor will carefully monitor the use of ATryn when administered together with these anti-clotting drugs.
Ghalhekk it- tabib tieghek ser jimmonitorja bl- attenzjoni l- uzu ta 'ATryn meta jinghata flimkien ma' dawn il- medicini li jinghataw biex ma jaghqadx id- demm.
22 Using ATryn with food and drink No special precautions should be taken while eating or drinking.
Meta tuza ATryn ma ’ l- ikel u max- xorb L- ebda prekawzjonijiet specjali m' ghandhom jittiehdu meta tkun qed tiekol jew tixrob.
Pregnancy ATryn is not indicated for use in pregnant patients.
Tqala ATryn mhuwiex indikat ghall- uzu f' pazjenti waqt it- tqala.
Breast-feeding It is unknown whether ATryn is present in breast milk.
Jekk qed tredda 'Mhux maghruf jekk ATryn jinstabx fil- halib tas- sider.
Therefore it is not recommended to breastfeed whilst being treated with ATryn.
Ghalhekk, mhux rakkomandat li mara tredda 'waqt li tkun qed tigi kkurata b' ATryn.
Driving and using machines Not relevant.
Sewqan u thaddim ta ’ magni Mhux rilevanti.
Important information about some of the ingredients of ATryn Not relevant.
Taghrif importanti dwar xi whud mis- sustanzi ta ’ ATryn Mhux rilevanti.
HOW TO USE ATryn
KIF TUZA ATryn
Your health care provider will prepare a solution of ATryn to be administered through an infusion directly into a blood vessel.
Il- persuna li tipprovdilek is- servizz tal- kura tas- sahha ser tipprepara soluzzjoni ta 'ATryn li tinghata permezz ta' infuzjoni direttament go vina jew arterja.
Blood levels of antithrombin will be regularly checked in the blood and a change of dose may be necessary.
Il- livelli fid- demm ta 'antithrombin ser ikunu ccekkjati regolarment u jista' jkun hemm bzonn tibdil fid- doza.
If you use more ATryn than you should
Jekk tie hu aktar ATryn milli suppost
The doctor will treat you, as appropriate, if you have any particular ill effects.
It- tabib ser jikkurak, kif ikun xieraq, jekk ikollok kwalunkwe effetti partikulari hziena.
If you stop using ATryn
Jekk tieqaf tuza ATryn
Please discuss possibility of stopping the treatment with your doctor.
Jekk joghgbok iddiskuti l- possibbiltà li twaqqaf il- kura mat- tabib tieghek.
If you have any further questions on the use of this product, ask your doctor.
Jekk ikollok aktar mistoqsijiet dwar l- uzu ta 'dan il- prodott, staqsi lit- tabib tieghek.
Like all medicines, ATryn may cause side effects, although not everybody gets them.
Bhal kull medicina ohra, ATryn jista ’ jkollu effetti sekondarji, ghalkemm ma jidhrux fuq kulhadd.
Some side effects such as bleeding, bruises, redness, or pain at the site of injection, nausea, headache, feeling hot, dizziness, bruising and increased bleeding may occur during treatment with ATryn.
Xi effetti sekondarji bhal hrug ta 'demm, tbengil, hmura, jew ugigh fis- sit ta' l- injezzjoni, dardir, ugigh ta ’ ras, thoss is- shana, sturdament, tbengil u zieda fil- hrug tad- demm jistghu isehhu waqt il- kura b' ATryn.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Jekk xi wiehed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imnizzlin f' dan il- fuljett, jekk joghgbok ghid lit- tabib tieghek.
HOW TO STORE ATryn
KIF TAHZEN ATryn
Store in a refrigerator (2°C – 8°C).
23 Ahzen fil- frigg (2°C – 8°C).
Do not use ATryn after the expiry date stated on the labelling after the letters EXP.
Tuzax ATryn wara d- data li jiskadi li tidher fuq it- tikketta wara l- ittri JIS.
The product should be used immediately.
Il- prodott medicinali ghandu jintuza immedjatament.
What ATryn contains
X’ fih ATryn
- The active substance is antithrombin alfa
- Is- sustanza attiva hi antithrombin alfa
- The other ingredients are: glycine, sodium chloride, sodium citrate
- Is- sustanzi l- ohra huma: glycine, sodium chloride, sodium citrate
What ATryn looks like and contents of the pack
Id- dehra ta 'ATryn u l- kontenut tal- pakkett
Package size:
Trab ta ’ lewn abjad jew abjad jaghti fil- griz.
1, 10 or 25 vials per carton.
Daqs tal- pakkett; 1, 10 jew 25 kunjett f' kull kaxxa tal- kartun.
Each vial of ATryn contains a nominal value of 1750 IU of recombinant antithrombin alfa.
Kull kunjett ta 'ATryn fih valur nominali ta' 1750 IU ta 'antithrombin alfa rikombinanti..
The powder will be dissolved before it can be infused.
Il- trab irid jinhall qabel ikun jista 'jkun uzat ghall- infuzjoni.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni ghat- Tqeghid fis- Suq u l- Manifattur
Marketing authorisation Holder LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark.
Sid l- ta ’ l- Awtorizzazzjoni ghat- Tqeghid fis- Suq LEO Pharma A/ S, Industriparken 55, DK- 2750 Ballerup, Danimarka.
Manufacturer authorisation holder responsible for batch release LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark.
Sid l- awtorizzazzjoni tal- manifattura responsabbli ghall- hrug tal- lott LEO Pharma A/ S, Industriparken 55, DK- 2750 Ballerup, Danimarka.
This leaflet was last approved in
Dan il- fuljett kien approvat l- ahhar fi:
This medicinal product has been authorized under “Exceptional Circumstances”.
Dan il- prodott medicinali kien awtorizzat taht “ Cirkustanzi Eccezzjonali ”.
The European Medicines Agency (EMEA) will review any new information which may become available every year and this leaflet will be updated as necessary.
L- Agenzija Ewropeja Dwar il- Medicini (EMEA) ser tevalwa kwalunkwe taghrif gdid li jista 'jsir disponibbli kull sena u dan il- fuljett ser ikun aggornat kif mehtieg.
Detailed information is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu --------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
Informazzjoni dettaljata dwar din il- medicina tinsab fuq il- website ta ’ l- Agenzija Ewropea dwar il- medicini (EMEA): http: // www. emea. europa. eu --------------------------------------------------------------------------------------------------------------------- It- taghrif li jmiss qed jinghata biss ghall- professjonisti fil- qasam mediku u fil- kura tas- sahha:
Each vial of ATryn contains a lyophilised powder of 1750 IU antithrombin alfa and is intended for single use only.
Kull kunjett ta 'ATryn fih trab lajofilizzat ta' 1750 IU ta 'antithrombin alfa u hu intenzjonat ghall- uzu ta' darba biss.
The powder should be reconstituted with 10 ml of Sterile Water for Injection (WFI) injected along the side wall of the vial and gently swirled (not shaken) to prevent foaming.
It- trab ghandu jkun rikostitwit b' 10 ml ta 'Ilma Sterili ghall- Injezzjoni (Sterile Water for Injection - WFI) li jkun injettat fuq il- genb tal - kunjett u mdawwar bil- mod (mhux imhawwad) biex tigi evitata r- raghwa.
The reconstituted product should be inspected visually for particulate matter and discolouration prior to administration.
Is- soluzzjoni g
The solution should be clear or slightly opalescent.
Tuzax soluzzjonijiet li
Do not use solutions that are cloudy or have deposits.
jkunu mcajprin jew li jkollhom xi depoziti fil- qiegh.
Upon complete dissolution, the reconstituted product may be drawn up into a sterile disposable syringe.
Wara li jkun inhall kompletament, il - prodott rikostitwit jista 'jingibed f' siringa sterili li tintrema wara li tintuza.
The reconstituted product should be administered by intravenous infusion using a sterile disposable syringe or an infusion bag with an in-line filter e.g. a methylcellulose filter with a 0.2 micron pore size.
Il- prodott rikostitwit ghandu jinghata permezz ta 'infuzjoni gol- vina bl- uzu ta' siringa sterili li tintrema wara li tintuza jew borza ta 'l- infuzjoni b' filtru in- line, ez. filtru tal- methylcellulose bid- daqs
Normal sodium chloride solution 9 mg/ml (0.9%) may be added to dilute to a concentration convenient for administration.
Soluzzjoni normali ta '9 mg/ ml (0. 9%) ta' sodium chloride tista 'tizdied mad- dilwit biex tintla haq koncentrazzjoni konvenjenti ghall- ghoti.
The contents of infusion syringes on diluted solution prepared in infusion bags should be administered within 8 hours of preparation.
Il- kontenut tas- siringi ta 'l - infuzjoni jew is- soluzzjoni dilwita fil- boroz ta' l- infuzjoni ghandu jinghata fi zmien 8 sighat mill- preparazzjoni.
Compatibility with PVC infusion lines with in-line filters has been established.
Il- kompatibilità mal - linji ta '- infuzjoni PVC ma' filtri in- line kienet l stabbilita.
24 Any unused product or waste material should be disposed of in accordance with local requirements.
Kull prodott mhux uzat jew materjal ghar- rimi ghandu jintrema skond il- ligijiet lokali.
The therapeutic goal of treatment with ATryn is to increase to, and maintain antithrombin activity between 80 – 120% (0.8 – 1.2 IU/ml) for the duration of treatment.
Il- ghan terapewtiku tal- kura b' ATryn hija biex izzid, u zzomm l- attività ta 'l- antithrombin bejn 80 – 120% (0. 8 – 1. 2 IU/ ml) ghal kemm iddum il- kura.
Initial treatment starts with a loading dose of ATryn targeting an antithrombin activity level of 100%.
Il- kura inizjali tibda b' doza qawwija tal- bidu ta 'ATryn biex jintlahaq livell ta' attività ta 'l - antithrombin ta' 100%.
The required loading dose is determined using the following formula:
Id- doza qawwija tal- bidu mehtiega tigi stabbilita billi tintuza l- formula li gejja:
Loading Dose (IU) = [(100 – patient’s pre -treatment AT activity level in%) /2.28] x Body Weight in kg
Doza qawwija tal- bidu (IU) = [(100 – il- livell ta 'l- attività AT ta' qabel il- kura tal - pazjent f '%) / 2. 28] x il- piz tal- gisem f' kg
The usual loading dose in surgical patients (baseline AT activity 50%, bodyweight 75 kg) with congenital antithrombin deficiency in clinical risk situations is 20-25 IU/kg bodyweight.
Id- doza qawwija tal- bidu normali f' pazjenti kirurgici (50% attività AT fil- linja bazi, piz tal - gisem 75 kg) b’ deficjenza kongenitali ta 'l- antithrombin f' sitwazzjonijiet ta' riskju kliniku hi ta '20- 25 IU/ kg ta' piz tal- gisem.
The loading dose should be given as a 15 minute infusion immediately followed by initiation of the maintenance infusion.
Id- doza qawwija tal- bidu ghandha tinghata bhala infuzjoni ta '15- il minuta segwita immedjatament mill- bidu ta' l- infuzjoni tal- manutenzjoni.
Maintenance Dose (IU/hour) = [(100 – patient’s pre -treatment AT activity level in%) /10.22] x Body Weight in kg
Doza tal- manutenzjoni (IU/ siegha) = [(100 – il- livell ta 'l- attività AT ta' qabel il- kura f '%) / 10. 22] x il- piz tal- gisem f' kg
The usual maintenance dose in surgical patients with congenital antithrombin deficiency in clinical risk situations is 4-5 IU/kg/h.
Matul l istati tal- konsum
During consumptive states (e.g. major surgery, concomitant use of heparin) the actual dose may be higher.
(ez. operazzjoni magguri, uzu fl- istess hin ta 'l- eparina), id- doza attwali tista' tkun oghla.
See therapeutic monitoring and dose adjustment recommendations below.
Ara l- monitoragg terapewtiku r- rakkomandazzjonijiet ghall- bdil tad- doza hawn taht.
The dosage should be adjusted on the basis of laboratory measurements of antithrombin activity.
Id- dozagg ghandu jigi mibdul fuq il- bazi tal- kejl tal- laboratorju ta 'l- attività ta' l- antithrombin.
Response to ATryn may vary in individual patients, achieving different levels of in vivo recovery and different half-lives.
Ir- rispons ghal ATryn jista 'jvarja f' pazjenti individwali, u jilhaq livelli differenti ta' rkuprar in vivo u half- lives differenti.
After the start of the maintenance dose infusion, blood for AT activity levels should be drawn at 45 minutes after the start of the loading dose infusion.
Wara l- bidu ta 'l- infuzjoni tad- doza tal- manutenzjoni, biex jitkejlu l- livelli ta' attività ta 'l- AT id- demm ghandu jittiehed wara 45 minuta wara l bidu ta' l - infuzjoni tad- doza qawwija tal -
In case the AT activity level is between 80% and 120% (0.8- 1.2 IU/ml), no dose adjustment is needed.
F' kaz li l- livell ta 'attività ta' l- AT ikun bejn 80% u 120% (0. 8 - 1. 2 IU/ ml), l- ebda bdil fid- doza ma huwa mehtieg.
Check AT activity level 30 minutes after any change in infusion rate, or four hours after a value within the target range.
Iccekkja l- livell ta 'attività ta' l - AT 30 minuta wara kwalunke bidla fir- rata ta 'l- infuzjoni rata, jew erba' sighat wara valur li jkun fil- medda tal- valur mixtieq.
Subsequently, antithrombin activity should be checked 1 times a day and dose -2 adjustments made accordingly.
Il- livell ta '
The antithrombin activity level should be maintained above 80% for the duration of the treatment, unless clinical particulars would indicate a different effective level.
attività ta 'l- antithrombin ghandu jinzamm fuq it- 80% ghal kemm iddum il- kura, hlief jekk l - indikazzjonijiet klinici jkunu jindikaw livell effettiv differenti
The dose can be calculated utilizing the p loading dose formula above.
Fil- kaz li l - livell ta 'attività ikun taht 80%, infuzjoni bolus ta' 15- il minuta ta 'AT tista' tinghata biex tregga ’ lura ghan- normal malajr il- livell ta 'attività ta' l- AT.
ost-surgical AT activity in the
Id- doza tista 'tigi kkalkulata billi tintuza l- attività ta' l- AT ta 'wara l- operazzjoni fid- doza qawwija tal- bidu li ssemmiet hawn fuq.
25 There is no experience in children.
M' hemm l- ebda esperjenza fit- tfal.
What is Avaglim?
X' inhu Avaglim?
Avaglim is a medicine containing two active substances, rosiglitazone and glimepiride.
Avaglim huwa mediċina li fiha żewġ sustanzi attivi, rosiglitazone u glimepiride.
It is available as triangular tablets (pink:
Huwa disponibbli bħala pilloli f' forma ta 'trijangolu (roża:
4 mg rosiglitazone and 4 mg glimepiride; red:
4 mg rosiglitazone u 4 mg glimepiride; ħomor:
8 mg rosiglitazone and 4 mg glimepiride).
8 mg rosiglitazone u 4 mg glimepiride).
What is Avaglim used for?
Għal xiex jintuża Avaglim?
Avaglim is used to treat adult patients who have type 2 diabetes (non-insulin-dependent diabetes).
Avaglim jintuża għat- trattament ta 'pazjenti adulti li jbatu mid- dijabete ta' tip 2 (dijabete mhux dipendenti mill- insulina).
Avaglim is used in patients who cannot satisfactorily control their blood glucose (sugar) when using an adequate dose of a sulphonylurea (a type of antidiabetes medicine) on its own, and for whom metformin (another antidiabetes medicine) is not suitable.
Avaglim jintuża f' pazjenti li jirnexxilhomx jikkontrollaw b' mod suffiċjenti l - glukożju (zokkor) fid- demm b' doża adegwata ta 'sulfonilurea (sulphonylurea - tip ta' mediċina kontra d- dijabete) waħedha u li għalihom il- metformina (metformin - tip ieħor ta 'mediċina kontra d- dijabete) mhijiex adatta.
How is Avaglim used?
Kif jintuża Avaglim?
Avaglim is taken once a day, just before or during a meal, generally breakfast.
Avaglim jittieħed darba kuljum, immedjatament qabel jew ma 'l- ikel, is- soltu mal- kolazzjon (breakfast).
Doctors must be careful when switching patients who are at risk of developing hypoglycaemia (low blood sugar) to Avaglim, such as elderly patients, patients with low weight or those who have been taking certain other medicines.
It- tobba għandhom joqogħdu attenti meta jippreskrivu Avaglim lill- pazjenti b' riskju ta 'ipogliċemija (livell baxx ta' zokkor fid- demm), per eżempju pazjenti anzjani, pazjenti b' piż baxx jew pazjenti li ħadu ċerti mediċini oħra.
The patient can start with separate tablets containing only rosiglitazone or a sulphonylurea, before switching to the combination tablet once control is achieved.
It- terapija tista 'tinbeda b' pilloli separati li fihom rosiglitazone jew sulfonilurea biss u, wara li jiksbu l - kontroll, jaqilbu għall- pillola li fiha l- kombinazzjoni.
The dose should start with the 4 mg/ 4 mg tablet.
Id- doża inizjali hija pillola ta '4 mg/ 4 mg.
The dose can be increased to the 8 mg/ 4 mg tablets after eight weeks if needed, but this should be done with caution, due to the risk of fluid retention.
Id - doża tista 'tiżdied sa 8 mg/ 4 mg wara tmien ġimgħat, jekk dan ikun meħtieġ, iżda dan għandu jsir b' kawtela minħabba r- riskju ta' żamma ta 'fluwidi.
If the patient develops hypoglycaemia, then a return to separate tablets will be needed so that the dose of glimepiride can be adjusted.
Jekk il- pazjent jiżviluppa ipogliċemija, jeħtieġ li jmur lura għall- pillola separata biex id- doża ta 'glimepiride tiġi aġġustata.
How does Avaglim work?
Kif jaħdem Avaglim?
Avaglim contains two active substances, which have different modes of action.
Avaglim fih żewġ sustanzi attivi, kull waħda minnhom għandha azzjoni differenti.
Rosiglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Rosiglitazone jagħmel iċ- ċelluli (tax- xaħam, tal- muskoli u tal- fwied) aktar sensittivi għall- insulina, li jfisser li l- ġisem jagħmel użu aħjar mill- insulina li jipproduċi.
Glimepiride is a sulphonylurea.
Il- glimepiride hija sulfonilurea.
It stimulates the pancreas to produce more insulin.
Hija tistimula l- frixa biex tipproduċi aktar insulina.
As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Ir- riżultat ta 'l- azzjoni kombinata taż- żewġ sustanzi attivi huwa tnaqqis tal- glukożju fid- demm li jgħin fil- kontroll tad- dijabete tat- tip 2.
How has Avaglim been studied?
Kif ġie studjat Avaglim?
As rosiglitazone has been approved on its own in the European Union (EU) since 2000 as Avandia, studies of rosiglitazone on its own were used as the basis for Avaglim.
Billi rosiglitazone kien ġie approvat waħdu fl- Unjoni Ewropea (UE) sa mis- sena 2000 bħala Avandia, l- istudji ta 'rosiglitazone waħdu ntużaw bħala bażi għal Avaglim.
Glimepiride has also been available in the EU since 1995.
Il- glimepiride wkoll ilha disponibbli fl- UE mill- 1995.
For glimepiride, information from scientific publications was used.
Għall- glimepiride ntużat l- informazzjoni li ġejja minn pubblikazzjonijiet xjentifiċi.
In addition, four studies were carried out, comparing the combination of both active substances to each substance on its own, in patients who had never been treated, as well as in patients whose blood glucose levels were not controlled when treated with only one of the substances.
Barra minn dan, twettqu erba 'studji biex iqabblu l- kombinazzjoni taż- żewġ sustanzi attivi ma' kull waħda mis- sustanzi waħedhom, f' pazjenti li qatt ma kienu ġew ittrattati qabel, kif ukoll f' pazjenti li t - trattament tagħhom b' sustanza waħedha ma kienx irnexxielu jikkontrolla l- livelli ta 'glukożju fid - demm.
The studies measured the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Dawn l- istudji kejlu l- livell ta 'sustanza magħrufa bħala emoglobina glikosilata (HbA1c - glycosylated haemoglobin) fid- demm, li jagħti indikazzjoni ta' l- effikaċja tal- kontroll tal- glukożju fid - demm.
What benefit has Avaglim shown during the studies?
X' benefiċċju wera Avaglim matul l- istudji?
In all four studies, the combination of rosiglitazone and glimepride was shown to be more effective than either of its components used on its own in lowering the levels of HbA1c.
Fl- erba 'studji kollha, il- kombinazzjoni ta' rosiglitazone u glimepiride wriet ruħha aktar effikaċi minn kull wieħed mill- komponenti użat waħdu fit- tnaqqis tal- livelli ta 'l- HbA1C.
What is the risk associated with Avaglim?
X' inhu r- riskju assoċjat ma 'Avaglim?
The most common side effects of Avaglim (seen in more than 1 patient in 10) are hypoglycaemia and oedema (swelling).
L- aktar effetti sekondarji komuni ta 'Avaglim (li dehru f' aktar minn pazjent 1 minn 10) huma ipogliċemija u edema (nefħa).
For the full list of all side effects reported with Avaglim, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrapportata b' Avaglim, ara l- Fuljett ta' Tagħrif.
Avaglim should not be used in people who may be hypersensitive (allergic) to rosiglitazone, glimepiride or any of the other ingredients.
Avaglim ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal rosiglitazone, glimepiride jew għal xi ingredjent ieħor tiegħu.
It should not be used in patients who have heart failure, an ‘ acute coronary syndrome’ such as unstable angina (a severe type of chest pain that changes in intensity) or certain types of heart attack, problems with their liver, or severe problems with their kidneys.
Ma għandux jintuża f' pazjenti li jkollhom insuffiċjenza kardijaka, 'sindromu koronarju akut' bħal anġina instabbli (tip gravi ta 'wġigħ fis- sider li l- intensità tiegħu tinbidel) jew ċerti tipi ta' attakk tal- qalb, problemi bil- fwied jew problemi gravi bil- kliewi.
It should also not be used in patients with insulin-dependent diabetes or who have complications of diabetes (diabetic ketoacidosis or diabetic coma).
Ma għandux jintuża wkoll f' pazjenti li jbatu minn dijabete dipendenti mill- insulina jew li jkollhom kumplikazzjonijiet relatati mad- dijabete (ketoaċidożi djabetika jew koma djabetika).
Avaglim doses may need to be adjusted when given with certain other medicines such as gemfibrozil or rifampicin.
Huwa possibbli li d- dożaġġ ta 'Avaglim jiġi aġġustat meta jittieħed ma' mediċini oħra eż. gemfibrozil jew riframpiċina.
Why has Avaglim been approved?
Għaliex ġie approvat Avaglim?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the effectiveness of adding rosiglitazone to sulphonylureas, especially glimepiride, had been shown sufficiently.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li l- effikaċja taż - żieda ta 'rosiglitazone mas- sulfonilurej, speċjalment mal- glimepiride, intweriet b' mod suffiċjenti.
The Committee decided that Avaglim’ s benefits are greater than its risks for the treatment of type 2 diabetes in patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance.
Il - Kumitat iddeċieda li l- benefiċċji ta 'Avaglim huwa aktar mir- riskji tiegħu għat- trattament tad- dijabete tat- tip 2 fil- pazjenti li ma rnexxilhomx jiksbu kontroll gliċemiku suffiċjenti fuq id- dożaġġ ottimali tal - monoterapija bis- sulfonilurej, u li għalihom il- metformina mhijiex adatta minħabba kontroindikazzjoni jew intolleranza.
The Committee recommended that Avaglim be given marketing authorisation.
Il- Kumitat irrakkomanda li Avaglim jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Avaglim:
Informazzjoni oħra dwar Avaglim:
The European Commission granted a marketing authorisation valid throughout the EU for Avaglim to SmithKline Beecham plc on 27 June 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Avaglim lil SmithKline Beecham plc fis- 27 ta 'Ġunju 2006.
The full EPAR for Avaglim can be found here.
L- EPAR sħiħ għal Avaglim jista 'jiġi kkonsultat hawn.
AVAGLIM 4 mg/ 4 mg film-coated tablets.
AVAGLIM 4mg/ 4mg pilloli miksijin b’ rita
Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone and 4 mg glimepiride.
Kull pillola fiha rosiglitazone maleate li jikkorrispondi għal 4mg rosiglitazone u 4 mg glimepiride
- contains lactose (approximately 104 mg)
- fih lattosju (bejn wieħed u ieħor 104 mg)
Pink, rounded triangular tablet with “ gsk” debossed on one side and “ 4/ 4” on the other side.
Pillola roża, triangolari u magħmula fit- tond li għandha minqux “ gsk ” fuq naħa waħda u “ 4/ 4 ” fuq in - naħa l- oħra.
AVAGLIM is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance.
AVAGLIM hu indikat biss fit- trattament ta ’ pazjenti bid- dijabete mellitus tip 2 li ma jistgħux jiksbu kontroll gliċemiku biżżejjed bl- aħjar dożaġġ ta ’ monoterapija b’ sulphonylurea, u li għalihom il - metformin mhux adattat minħabba kontraindikazzjoni jew nuqqas ta ’ tolleranza.
AVAGLIM therapy should be individualised for each patient.
Terapija b’ AVAGLIM għandha tkun individwalizzata għal kull pazjent.
Before therapy is initiated with AVAGLIM appropriate clinical evaluation should be made to assess the patient’ s risk of developing hypoglycaemia (see section 4.4).
Qabel ma tinbeda t- terapija b’ AVAGLIM għandha ssir evalwazzjoni klinika xierqa biex ikun stabbilit ir- riskju ta ’ żvilupp ta ’ ipogliċemija (ara sezzjoni 4. 4).
AVAGLIM should be taken once daily shortly before or during a meal (usually the first main meal of the day).
AVAGLIM għandu jittieħed darba kuljum ftit qabel jew waqt l- ikel (normalment l- ewwel ikla sħiħa tal- ġurnata).
If a dose is forgotten, the following dose must not be increased.
Jekk tinqabeż xi doża m’ għandhiex tiżdied id- doża li jkun imiss.
For patients inadequately controlled on glimepiride monotherapy (typically 4 mg).
Dwar pazjenti mhux kontrollati adegwatament b’ monoterapija ta ’ glimepride (tipikament 4 mg.).
Concomitant administration should be considered before the patient is switched to AVAGLIM.
Għandu jiġi kkunsidrat l- għoti fl- istess ħin meta pazjent tinbdielu t- terapija b’ AVAGLIM.
Where clinically appropriate, direct change from glimepiride monotherapy to AVAGLIM may be considered.
Meta klinikament xieraq, tista ’ tiġi kkunsidrata bidla diretta minn terapija bi glimepiride għal dik b’ AVAGLIM.
The starting dose is 4 mg/ day rosiglitazone plus 4 mg/ day glimepiride (given as one tablet AVAGLIM 4 mg/ 4 mg).
Id- doża tal- bidu hi 4 mg/ kuljum rosiglitazone u 4 mg/ kuljum glimepiride (mogħtijin bħala pillola AVAGLIM waħda ta ’ 4 mg/ 4 mg).
Patients unable to achieve glycaemic control on at least half-maximum dose of other sulphonylurea monotherapy (except chlorpropamide, see section 4.4).
Pazjenti li ma jistgħux jiksbu kontroll gliċemiku b’ doża mill- anqas ta ’ nofs il- massimu ta ’ monoterapija oħra b’ sulphonylurea (ħlief chlorpropamide, ara sezzjoni 4. 4).
Rosiglitazone 4 mg should be administered concomitantly with the dose of sulphonylurea already being taken.
Rosiglitazone 4 mg għandu jingħata flimkien mad- doża ta ’ sulphonylurea li tkun ġa qed tittieħed.
Once glycaemic control is stable at these doses, AVAGLIM may be introduced at a starting dose of 4 mg rosiglitazone/ 4 mg glimepiride once daily.
Darba li kontroll gliċemiku jkun stabbli b’ dawn id- dożi, AVAGLIM jista ’ jinbeda b’ doża inizjali ta ’ 4 mg rosiglitazone/ 4 mg glimepiride darba kuljum.
AVAGLIM may be used to substitute concomitant sulphonylurea and rosiglitazone in established dual oral therapy providing the patient has achieved at least half-maximum dose of sulphonylurea.
AVAGLIM jista ’ jintuża minflok sulphonylurea u rosiglitazone flimkien f’ terapija stabbilita orali doppja basta li l- pazjent ikun kiseb għall- inqas id- doża ta ’ nofs massimu tas - sulphonylurea.
The dose of the rosiglitazone component can be increased after 8 weeks if required.
2 Id- doża tal- komponent tar - rosiglitazone tista ’ tiżdied wara 8 ġimgħat jekk ikun meħtieġ.
An increase in the rosiglitazone component to 8 mg/ day should be undertaken
Id- doża massima rakkomandata għal kuljum hi 8 mg rosiglitazone/ 4 mg glimepiride (mogħtija bħala pillola waħda AVAGLIM 8 mg/ 4mg, darba kuljum.).
2 cautiously following appropriate clinical evaluation to assess the patient’ s risk of developing adverse reactions relating to fluid retention (see 4.4 and 4.8).
Żjieda fil- komponent ta ’ rosiglitazone għal 8 mg/ 4 mg trid tiġi kkunsidrata b’ attenzjoni wara evalwazzjoni klinika xierqa li tistabbilixxi r- riskju li pazjent jista ’ jiżviluppa effetti mhux mixtieqa relatati ma ’ retenzjoni ta ’ fluwidi (ara sezzjoni 4. 4 u 4. 8).
If hypoglycaemic symptoms occur, the patient should revert to concomitant therapy and adjust the glimepiride dose as appropriate.
Jekk jitfaċċaw sintomi ipogliċemiċi, il- pazjent għandu jerġa ’ lura għal terapija konkomitanti u jaġġusta kif jixraq id- doża ta ’ glimepiride.
Elderly Due to the potential for decreased renal function the initiation and maintenance of therapy with AVAGLIM in elderly patients should be under close medical supervision due to an increased susceptibility to hypoglycaemia (see section 4.4).
Anzjani Minħabba l- possibilta` ta ’ tnaqqis fil- funzjonament tal- kliewi fil- bidu u fil- kontinwazjoni ta ’ terapija b’ AVAGLIM f’ pazjenti anzjani għandhom jibqgħu taħt sorveljanza medika b’ attenzjoni kbira minħabba żjieda fis- suxxettibilta` għal ipogliċemija (ara sezzjoni 4. 4).
Patients with renal impairment Mild or moderate renal impairment (creatinine clearance 30 to 80 ml/ min):
Pazjenti b’ indeboliment tal- kliewi Indeboliment ħafif jew moderat tal- kliewi (tneħħija ta ’ kreatinina ta ’ 30 sa 80 ml/ min):
- Patients changing to AVAGLIM from sulphonylurea therapies other than glimepiride may be at
- Pazjenti li jaqilbu għal terapiji b’ AVAGLIM minn dawk b’ terapiji b’ sulphonylurea għajr
an increased risk of hypoglycaemia (see section 4.4).
glimepiride jista ’ jiżdidilhom ir- riskju ta ’ ipogliċemija (ara sezzjoni 4. 4).
Appropriate monitoring is advised.
Hu rakkomandat monitoraġġ kif jixraq.