qanastek/EMEA-V3 huggingface dataset:
The safety of TachoSil for use in human pregnancy or breastfeeding has not been established in controlled clinical trials.
Is- sigurtà ta ’ l- użu ta ’ TachoSil fit- tqala jew it- treddigħ tal- bniedem għadha ma ġietx stabbilita fi provi kliniċi kkontrollati.
Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation and peri- and postnatal development.
Studji sperimentali fuq l- annimali mhumiex biżżejjed sabiex jistmaw is- sigurtà fir - rigward tar- riproduzzjoni, l- iżvilupp ta ’ l- embriju jew il- fetu, il- proċess tat- tqala u l- iżviluppi ta ’ qabel u ta ’ wara t- twelid.
Therefore, TachoSil should be administered to pregnant and lactating women only if clearly needed.
3 Għalhekk, TachoSil għandha tiġi amministrata lil nisa tqal u li qed ireddgħu jekk dan ikun tassew meħtieġ biss.
Not relevant.
Mhux relevanti
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the application site, bronchospasm, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may occur in rare cases in patients treated with fibrin sealants/ haemostatics.
Reazzjonijiet ta ’ sensittività eċċessiva jew allerġika (li jistgħu jinkludu anġjodema, ħruq jew tingiż fis- sit tal- applikazzjoni, bronkospażmu, sirdat, ħmura, urtikarja ġenerali, uġigħ ta ’ ras, ħorriqija, pressjoni baxxa, letarġija, tqalligħ, irrekwitezza, takikardja, sider magħfus, tnemnim, remettar, tħarħir) jistgħu jseħħu f’ każijiet rari fil- pazjenti trattati b’ siġillanti tal- fibrin/ prodotti emostatiċi.
In isolated cases, these reactions may progress to severe anaphylaxis.
F’ każijiet iżolati dawn ir- reazzjonijiet jistgħu jibqgħu jipprogressaw għal anafilassi severa.
Such reactions may especially be seen, if the preparation is applied repeatedly, or administered to patients known to be hypersensitive to constituents of the product.
Dawn ir- reazzjonijiet jidhru speċjalment, jekk il- preparazzjoni tiġi applikata ripetutament, jew tiġi amministrata lil pazjenti li għandhom sensittivita` eċċessiva għal kostitwenti tal- prodott.
Antibodies against components of fibrin sealant/ haemostatic products may occur rarely.
Antikorpi kontra l- komponenti ta ’ siġillanti tal- fibrin / prodotti emostatiċi jistgħu jseħħu b’ mod rari.
Thromboembolic complications may occur if the preparation is unintentionally applied intravascularly (see section 4.4).
Kumplikazzjonijiet tromboembolitiċi jistgħu jseħħu jekk il- preparazzjoni tiġi applikata mhux intenzjonalment ġol- arterja/ vina (ara sezzjoni 4. 4).
For viral safety see section 4.4
Għas- sigurtà virali ara sezzjoni 4. 4
Frequency of undesirable effects for TachoSil based on all adverse event data from six clinical trials, two post-authorisation safety studies and spontaneous reporting.
Din it- taqsima hija bbażata fuq it- tagħrif kollu miġbur dwar effetti mhux mixtieqa ta ’ TachoSil minn sitt provi kliniċi, żewġ studji ta ’ wara l- awtorizzazzjoni u rapportaġġ spontanju.
Summary of the safety profile The safety data of TachoSil generally reflect the type of post-operative complications related to the surgical settings in which the trials were conducted and the underlying disease of the patients.
Ġabra fil- qosor dwar il- profil ta ’ sigurtà It- tagħrif dwar is- sigurtà fuq TachoSil ġeneralment jirrifletti t- tip ta ’ kumplikazzjonijiet ta ’ wara l- operazzjonijiet li huma relatati mal- ambjenti kirurġiċi li fihom saru l- provi u l- mard fis- sottofond tal- pazjenti.
Tabulated summary of adverse reactions Data from the six controlled clinical trials conducted by the MAH has been pooled into an integrated dataset and the frequencies of occurrence in this SmPC originate from this integrated dataset.
Ġabra fil- qosor f’ għamla ta ’ tabella tar- reazzjonijiet avversi It- tagħrif minn sitt kontrolli kliniċi bil- kontrolli li ġew mmexxija mid- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq ġie miġbur flimkien f’ dataset integrat u l- frekwenzi li bihom seħħew f’ dan is- Sommarju tal- Karatteristiċi tal- Prodott huma meħudin minn dan id- dataset integrat.
In the integrated analyses, 521 patients were treated with TachoSil and 511 patients were treated with comparator treatment.
Fl- analiżi integrata, 521 pazjent kienu trattati b’ TachoSil u 511- il pazjent kienu trattati b’ trattament komparatur.
Due to practical reasons (comparison to standard surgical and standard haemostatic treatment), blinding was not possible in the TachoSil trials.
Minħabba raġunijet prattiċi (tqabbil ta ’ kirurġija standard u trattament emostatiku standard), l- analiżi ma setgħetx issir fl- għama fil- provi ta ’ TachoSil.
Therefore the studies were performed as open-label studies.
Għalhekk l- istudji saru bit- tikketta tidher.
The following categories are used to rank the undesirable effects by frequency of occurrence: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); and very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Il- kategoriji li ġejjin qed jintużaw sabiex jiġu gradati l- effetti mhux mixtieqa skont kemm il- darba seħħew: komuni ħafna (> 1/ 10); komuni (> 1/ 100 sa < 1/ 10); mhux komuni (> 1/ 1000 sa < 1/ 100); rari (> 1/ 10, 000 sa < 1/ 1000); u rari ħafna (< 1/ 10, 000).
(< 1/ 10,000), not known
Disturbi fis- sistema immuni
Pyrexia*
Sensittività eċċessiva
(cannot be estimated from the available data) Thromboembolism (if applied intravascularly)
Tromboemboliżmu Disturbi vaskulari Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata
Immune system disorders
Deni *
Hypersensitivity
(jekk jiġi applikat ġol - vina/ arterja)
*Pyrexia occurred in 6.3% of the patients treated with TachoSil and in 5.9% of the patients treated with comparator treatment.
* Id- deni seħħ f’ 6. 3% tal- pazjenti trattati b’ TachoSil u f’ 5. 9% tal- pazjenti trattati b’ trattament komparatur
Local haemostatics, ATC code:
Emostatiċi lokali, kodiċi ATC:
TachoSil contains fibrinogen and thrombin as a dried coating on the surface of a collagen sponge.
TachoSil fiha l- fibrinogen u t- thrombin bħala kisja mnixxfa fuq il- wiċċ ta ’ sponża tal- collagen.
At contact with physiological fluids, e. g. blood, lymph or physiological saline solution the components of the coating dissolve and partly diffuse into the wound surface.
Malli jiġu f’ kuntatt ma ’ fluwidi fiżjoloġiċi, eż. demm, limfa jew soluzzjoni fiżjoloġika tal- melħ, il- komponenti tal- kisja jdubu u jinfirxu parzjalment fil- wiċċ tal- ferita.
This is followed by the fibrinogen- thrombin reaction which initiates the last phase of physiological blood coagulation.
Dan ikun segwit bir- reazzjoni ta ’ fibrinogen- thrombin li tagħti bidu għall- aħħar fażi ta ’ koagulazzjoni fiżjoloġika tad- demm.
Fibrinogen is converted into fibrin monomers which spontaneously polymerise to a fibrin clot, which holds the collagen sponge tightly to the wound surface.
Fibrinogen jinbidel f’ monomers tal- fibrin li jippolimerizzaw b’ mod spontanju f’ embolu tal- fibrin, li jżomm l- isponża tal- collagen sewwa mal- wiċċ tal - ferita.
The fibrin is then cross linked by endogenous factor XIII, creating a firm, mechanically stable network with good adhesive properties and provides sealing as well.
Il- fibrin imbagħad jiġi cross linked mal- fattur endoġenu XIII, u b’ hekk tinħoloq xibka mekkanikament stabbli u soda b’ karatteristiċi adeżivi tajbin u li tipprovdi wkoll siġill.
Clinical studies demonstrating haemostasis were conducted in a total of 240 patients (118 TachoSil, 122 argon beamer) undergoing partial liver resection surgery and 185 patients (95 TachoSil, 93 standard surgical treatment) undergoing surgical resection of superficial renal tumour.
Saru studji kliniċi li juru l- emostażi f’ total ta ’ 240 pazjent (118 TachoSil, 122 radjatur tal- argon) sottoposti għal kirurġija ta ’ qtugħ parzjali tal- fwied u 185 pazjent (95 TachoSil, 93 trattament kirurġiku standard) sottoposti għal qtugħ kirurġiku ta ’ tumur fis- superfiċje ta ’ kilwa.
A further controlled study in 119 patients (59 TachoSil, 60 haemostatic fleece) demonstrated sealing, haemostasis and suture support in patients undergoing cardiovascular surgery.
Studju ieħor li sar bil- kontrolli fuq 119- il pazjent (59 TachoSil, 60 suf emostatiku) urew issiġillar, emostasi u sostenn għal punti f’ pazjenti li jkunu għaddejjin minn kirurġija kardjovaskulari.
Tissue sealing in lung surgery was investigated in two controlled trials in patients undergoing lung surgery.
L- issiġillar ta ’ tessuti pulmonari kien mistħarreġ f’ żewġ provi li saru b’ kontrolli f’ pazjenti li kellhom interventi kirurġiċi pulmonari.
The first controlled clinical trial investigating tissue sealing in lung surgery failed to document superiority over standard treatment measured by air leakage due to the inclusion of a large group of patients (53%) without air leakage.
L- ewwel prova klinika kkontrollata li saret biex tinvestiga s- siġill tat- tessut fil- kirurġija tal- pulmun naqset li tiddokumenta superjorità fuq it - trattament standard imkejjel bit- telf tal- arja minħabba l- inklużjoni ta ’ għadd kbir ta ’ pazjenti (53%) mingħajr tnixxija t’ arja.
However, the second study investigating tissue sealing in 299 patients (148 TachoSil, 151 standard surgical treatment) with demonstrated intraoperative air leakage showed the superiority of TachoSil compared to standard treatment.
Madankollu, it- tieni studju li stħarreġ l- issiġillar tat- tessuti f’ 299 pazjent (148 TachoSil, 151 trattament kirurġiku standard) b’ tnixxija tal- arja murija waqt l- operazzjoni wera superjorità għal TachoSil meta mqabbel mat- trattament standard.
TachoSil is intended for local application only.
TachoSil hija maħsuba għal applikazzjoni lokali biss.
Intravascular administration is not possible.
Mhux possibbli li ssir amministrazzjoni intravaskulari.
As a consequence, intravascular pharmacokinetic studies were not performed in man.
B’ konsegwenza ta ’ hekk, ma sarux studji farmakokinetiċi intravaskulari fuq il- bniedem.
In animal studies TachoSil shows a progressive biodegradation.
5 Studji li saru fuq l- annimali wrew li TachoSil tgħaddi minn bijodegradazzjoni progressiva.
The fibrin clot is metabolised in the same way as endogenous fibrin by fibrinolysis and phagocytosis.
L- embolu tal - fibrin jiġi metabolizzat bl- istess mod bħall- fibrin endoġenu permezz ta ’ fibrinoliżi u fagoċitożi.
The collagen sponge is degraded by resorptive granulation tissue.
L- isponża tal- collagen tiġi degradata b’ tessut ta ’ granulazzjoni li jerġa ’ jiġi assorbit.
Approximately 24 weeks after application only a few remnants were present without any signs of local irritation.
Madwar 24 ġimgħa wara l - applikazzjoni, kien baqa ’ biss ftit fdalijiet mingħajr ebda sinjal ta ’ irritazzjoni lokali.
Single dose toxicity studies in different species of animals have shown no signs of acute toxic effect.
Studji ta ’ tossiċità b’ doża waħda fi speċi differenti ta ’ annimali ma taw l- ebda sinjali ta ’ effetti tossiċi akuti.
Equine collagen Human albumin Riboflavine (E 101) Sodium chloride Sodium citrate L-arginin-hydrochloride.
Equine collagen Human albumin Riboflavine (E 101) Sodium chloride Sodium citrate L- arginin- hydrochloride
Once the foil sachet is opened, TachoSil must be used immediately.
3 snin Malli jinfetaħ il- qartas tal- fojl, TachoSil għandha tintuża minnufih.
TachoSil is packed in a double packaging:
TachoSil tiġi f’ ippakkjar doppju:
- An outer container consisting of an aluminium-bonded foil sachet
- kontenitur fuq barra magħmul minn qartas tal- fojl issiġillat bl- aluminju
- An inner container (sterile) consisting of a polystyrene blister sealed with a peel lacquer-laminate
- kontenitur minn ġewwa (sterili) magħmul minn folja tal- polistyrene ssiġillata b’ karta laminata bil- laker li
paper
tista ’ titqaxxar
- A desiccant bag is included in the outer container
- borża ta ’ dessikant hija inkluża fil- kontenitur ta ’ barra
Each sponge is packed individually.
Kull sponża hija ppakkjata b’ mod individwali.
Package with 1 sponge of 9.5 cm x 4.8 cm Package with 2 sponges of 4.8 cm x 4.8 cm Package with 1 sponge of 3.0 cm x 2.5 cm Package with 5 sponges of 3.0 cm x 2.5 cm
Pakkett bi sponża waħda ta ’ 9. 5 ċm x 4. 8 ċm Pakkett b’ 2 sponoż ta ’ 4. 8 ċm x 4. 8 ċm Pakkett bi sponża waħda ta ’ 3. 0 ċm x 2. 5 ċm Pakkett b’ 5 sponoż ta ’ 3. 0 ċm x 2. 5 ċm
Not all pack sizes may be marketed.
6 Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
TachoSil comes ready to use in sterile packages and must be handled accordingly.
TachoSil tiġi lesta sabiex tintuża f’ pakketti sterili u għandha tiġi mmaniġġjata kif jixraq.
Use only undamaged packages.
Uża biss pakketti mhux mittiefsa.
Once the package is opened post-sterilisation is not possible. The outer aluminium foil sachet may be opened in a non-sterile operating area.
Il- pakkett ta ’ barra tal - fojl ta ’ l- aluminju jista ’ jinfetaħ f’ żona ta ’ operazzjoni mhux sterili.
The inner sterile blister must be opened in a sterile operating room area.
Il- folja sterili ta ’ ġewwa għandha tinfetaħ f’ żona sterili tas- sala ta ’ l- operazzjonijiet.
TachoSil should be used immediately after opening the inner sterile cover.
TachoSil għandha tintuża minnufih wara li jinfetaħ il - pakkett sterili ta ’ ġewwa.
TachoSil is used under sterile conditions.
TachoSil tintuża taħt kundizzjonijiet sterili.
Prior to application the wound area should be cleansed, e. g. from blood, disinfectants and other fluids.
Qabel ma tiġi applikata, iż- żona tal- ferita għandha titnaddaf, eż. mid- demm, diżinfettanti u fluwidi oħra.
After removal of TachoSil from the sterile package the sponge should be pre-moistened in saline solution and then applied immediately.
Wara li TachoSil tinħareġ mill- pakkett sterili l- isponża trid tixxarrab f’ soluzzjoni tal- melħ u mbagħad għandha tiġi applikata mill- ewwel.
The yellow, active side of the sponge is applied to the bleeding/ leaking surface and held against it with a gentle pressure for 3-5 minutes.
Il- parti safra, attiva ta ’ l- isponża tiġi applikata fuq il- wiċċ tal- ferita minn fejn ikun ħiereġ id- demm jew li jkun qed inixxi u għandha tinżamm fuqu bi pressjoni ħafifa għal 3- 5 minuti.
This procedure enables an easy adhesion of TachoSil to the wound surface.
Din il- proċedura tikkawża t- twaħħil faċli ta ’ TachoSil mal- wiċċ tal- ferita.
Pressure is applied with moistened gloves or a moist pad.
Il- pressjoni tiġi applikata b’ ingwanti niedja jew b’ kuxxinett niedi.
Due to the strong affinity of collagen to blood, TachoSil may also stick to surgical instruments or gloves covered with blood.
Minħabba l- affinità qawwija tal- collagen għad- demm, TachoSil tista ’ teħel ukoll ma ’ strumenti jew ingwanti kirurġiċi li jkunu miksija bid- demm.
This can be avoided by pre-moistening surgical instruments and gloves with physiological saline solution.
Dan jista ’ jiġi evitat billi l- istrumenti u l- ingwanti kirurġiċi jiġu mxarrba ftit minn qabel b’ soluzzjoni fiżjoloġika tal- melħ.
After pressing TachoSil to the wound, the glove or the pad must be removed carefully.
Wara li TachoSil tiġi magħfusa fuq il- ferita, l- ingwanta jew il- kuxxinett għandhom jitneħħew b’ attenzjoni.
To avoid the sponge from being pulled loose it may be held in place at one end, e. g. with a pair of forceps.
Sabiex jiġi evitat li l- isponża tinġibed b’ kollox, din tista ’ tinżamm f’ postha minn tarf, eż. b’ pinzetta.
Alternatively, e. g. in case of stronger bleeding, TachoSil may be applied without pre-moistening, while also pressing gently to the wound for 3-5 minutes.
Inkella, ngħidu aħna fil- każ ta ’ fsada aktar b’ saħħitha, TachoSil tista ’ tiġi applikata mingħajr ma tixxarrab, filwaqt li tintgħafas bil- mod fuq il- ferita għal 3- 5 minuti.
The TachoSil sponge should be applied so that it extends 1-2 cm beyond the margins of the wound.
L- isponża TachoSil għandha tiġi applikata sabiex toħroġ 1- 2 ċm ’ il barra mit- truf tal- ferita.
If more than one sponge is used the sponges should overlap.
Jekk tintuża aktar minn sponża waħda, l- isponoż għandhom jitrikkbu fuq xulxin.
The sponge can be cut to the correct size and shaped if too large.
L- isponża tista ’ tinqata ’ għad- daqs eżatt u tingħata l- forma jekk tkun kbira wisq.
Peter Strasse 25 A-4020 Linz Austria
Peter Strasse 25 A- 4020 Linz L- Awstrija
7 ANNEX II
8 ANNESS II
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZI BIJOLOĠIĊI ATTIVI U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
8 A MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
9 A MANIFATTURI TAS- SUSTANZI BIJOLOĠIĊI ATTIVI U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Box 1230 D-35002 Marburg/ Lahn Germany
Box 1230 D- 35002 Marburg/ Lahn Il- Ġermanja
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu li jwettaq l- istudji u attivitajiet ta ’ farmakoviġilanza addizzjonali, kif miftehem fil- verżjoni 3. 0 tal- Pjan ta ’ Ġestjoni tar- Riskju (RMP) preżentata f’ Modulu 1. 8. 2 tal- Applikazzjoni tal- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti tal- RMP miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skont il- Linja Gwida ta ’ CHMP dwar Sistemi ta ’ Ġestjoni dwar ir- Riskju għal prodotti mediċinali li jintużaw mill- bniedem, RMP aġġornat għandu jiġi sottomess fl- istess ħin tar- Rapport ta ’ Aġġornament Perijodiku dwar is- Sigurtà (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, RMP aġġornat għandu jiġi sottomess • Meta jasal tagħrif ġdid li jista ’ jkollu impatt fuq l- Ispeċifikazzjoni dwar is- Sigiurtà attwali, il- Pjan ta ’ Farmakoviġilanza u attivitajiet li jnaqqsu r- riskju • Fi żmien 60 jum li jintlaħaq tragward importanti (farmakoviġilanza dwar minimizzazzjoni ta ’ riskju) • Fuq talba tal- EMEA
Official batch release: in accordance with Article 114 of Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
10 Ħruġ tal- lott uffiċjali: b’ mod konformi ma ’ Artikolu 114 tad- Direttiva 2001/ 83/ KE kif emendata, il- ħruġ tal - lott uffiċjali jsir minn laboratorju ta 'l- istat jew laboratorju ieħor li jiġi maħtur għal dak l- għan.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA U FULJETT TA ’ TAGĦRIF
CARDBOARD BOX
TIKKETTA
TachoSil, medicated sponge
TachoSil, sponża medikata
Per cm2 Human fibrinogen 5.5 mg Human thrombin 2.0 IU
Għal kull ċm2 Fibrinogen tal- bniedem 5. 5 mg Thrombin tal- bniedem 2. 0 IU
Equine collagen, human albumin, riboflavine (E101), sodium chloride, sodium citrate, L-arginin- hydrochloride
Equine collagen, human albumin, riboflavine (E101), sodium chloride, sodium citrate, L- arginin - hydrochloride
Medicated sponge 1 sponge of 9.5 cm x 4.8 cm 2 sponges of 4.8 cm x 4.8 cm 1 sponge of 3.0 cm x 2.5 cm 5 sponges of 3.0 cm x 2.5 cm
Sponża medikata Sponża waħda ta ’ 9. 5 ċm x 4. 8 ċm 2 sponoż ta ’ 4. 8 ċm x 4. 8 ċm Sponża waħda ta ’ 3. 0 ċm x 2. 5 ċm 5 sponoż ta ’ 3. 0 ċm x 2. 5 ċm
For local use Read the package leaflet before use.
Għal użu lokali Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Once the foil sachet is opened, use immediately.
Ladarba l- qartas tal- fojl jinfetaħ, użaha minnufih.
Do not resterilise.
Tisterilizzax mill- ġdid.
NYCOMED Austria GmbH St. Peter Strasse 25 A- 4020 Linz, Austria
NYCOMED Austria GmbH St. Peter Strasse 25 A - 4020 Linz, l- Awstrija
EU/ 1/ 04/ 277/ 001 1 sponge of 9.5 cm x 4.8 cm EU/ 1/ 04/ 277/ 002 2 sponges of 4.8 cm x 4.8 cm EU/ 1/ 04/ 277/ 003 1 sponge of 3.0 cm x 2.5 cm EU/ 1/ 04/ 277/ 004 5 sponges of 3.0 cm x 2.5 cm
EU/ 1/ 04/ 277/ 001 sponża waħda ta ’ 9. 5 ċm x 4. 8 ċm EU/ 1/ 04/ 277/ 002 2 sponoż ta ’ 4. 8 ċm x 4. 8 ċm EU/ 1/ 04/ 277/ 003 sponża waħda ta ’ 3. 0 ċm x 2. 5 ċm EU/ 1/ 04/ 277/ 004 5 sponoż ta ’ 3. 0 ċm x 2. 5 ċm
(primary packaging)
15 TAGĦRIF MINIMU LI GĦANDU JIDHER JEW FUQ L- ISTRIXXI JEW FUQ IL- FOLJI (pakkett ewlieni)
14 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
16 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
LABEL ON THE ALUMINIUM FOIL (secondary packaging)
TIKKETTA FUQ IL- FOJL TA ’ L- ALUMINJU (pakkett sekondarju)
TachoSil, medicated sponge For local use
TachoSil, sponża medikata Għal użu lokali
1 sponge of 9.5 cm x 4.8 cm 1 sponge of 4.8 cm x 4.8 cm 1 sponge of 3.0 cm x 2.5 cm
Sponża waħda ta ’ 9. 5 ċm x 4. 8 ċm Sponża waħda ta ’ 4. 8 ċm x 4. 8 ċm Sponża waħda ta ’ 3. 0 ċm x 2. 5 ċm
16 PACKAGE LEAFLET:
18 FULJETT TA ’ TAGĦRIF:
TachoSil, medicated sponge Human fibrinogen, human thrombin
TachoSil, sponża medikata Fibrinogen tal- bniedem, thrombin tal- bniedem
Read all of this leaflet carefully.
Aqra dan il- fuljett kollu b’ attenzjoni.
What TachoSil is and what it is used for 2.
X’ inhu TachoSil u għalxiex jintuża 2.
Before TachoSil is used.
Qabel ma jintuża TachoSil.
How to use TachoSil 4.
Kif jintuża TachoSil 4.
How to store TachoSil 6.
Kif taħżen TachoSil 6.
WHAT TACHOSIL IS AND WHAT IT IS USED FOR
X’ INHU TACHOSIL U GĦAL XIEX JINTUŻA
How does TachoSil work?
Kif taħdem TachoSil?
The yellow side of the TachoSil sponge contains the active components: fibrinogen and thrombin.
In- naħa s- safra ta ’ l- isponża TachoSil fiha s- sustanzi attivi: fibrinogen u thrombin.
The yellow side of the sponge is therefore the active side.
In- naħa s - safra ta ’ l- isponża hija għalhekk il- parti attiva.
When the sponge comes into contact with fluids (such as blood, lymph or saline solution) the fibrinogen and the thrombin are activated and form a fibrin network.
Meta l- isponża tiġi f’ kuntatt mal- fluwidi (bħal demm, limfa jew soluzzjoni bil- melħ) il- fibrinogen u t- thrombin jiġu attivati u jiffurmaw xibka ta ’ fibrin.
This means that the sponge sticks to the tissue surface, the blood coagulates (local haemostasis) and the tissue is sealed.
Dan ifisser li l- isponża teħel mal- wiċċ tat- tessut, id- demm jagħqad (emostasi lokali) u t- tessut jiġi ssiġillat.
In the body TachoSil will dissolve and disappears completely.
Fil- ġisem, TachoSil iddub u tisparixxi għal kollox.
What is TachoSil used for?
Għalxiex tintuża TachoSil?
TachoSil is used during surgery to stop local bleeding (haemostasis) and to seal tissue surfaces on internal organs.
TachoSil tintuża matul il- kirurġija sabiex twaqqaf fsada lokali (emostasi) u biex jissiġilla wċuħ ta ’ tessuti fuq organi interni.
BEFORE TACHOSIL IS USED
QABEL MA JINTUŻA TACHOSIL
Do not use TachoSil
Tużax TachoSil
- if you are allergic (hypersensitive) to human fibrinogen, human thrombin or any of the other
- jekk int allerġiku/ a (sensittiv/ a żżejjed) għall- fibrinogen tal- bniedem, it- thrombin tal- bniedem jew xi
ingredients of TachoSil.
sustanza oħra ta ’ TachoSil.
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 tuża mediċini oħra Jekk jogħgbok għid lit- tabib tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Important information about some of the ingredients of TachoSil When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to the patients.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ TachoSil Meta l- mediċini jkunu magħmulin mid- demm jew mill- plażma tal- bniedem, għandhom jittieħdu ċerti miżuri sabiex jiġi evitat li xi infezzjonijiet jiġu mgħoddija lill- pazjenti.
These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/ infections.
Dawn jinkludu l- għażla bir- reqqa tad - donaturi tad- demm u tal- plażma sabiex jiġi aċċertat li dawk li qegħdin f’ riskju li jġorru xi infezzjonijiet ikunu esklużi, u l- ittestjar ta ’ kull donazzjoni u tal- ġabriet ta ’ plażma biex jiġi identifikat jekk hemmx sinjali ta ’ virus/ infezzjonijiet.
Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Il- manifatturi ta ’ dawn il- prodotti jinkludu wkoll proċeduri fl- ipproċessar tad- demm jew plażma li jistgħu jinattivaw jew ineħħu l- viruses.
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
19 mediċini mħejjija mid- demm jew mill- plażma tal- bniedem, il- possibbiltà li tiġi trasmessa infezzjoni ma tistax tiġi eskluża għal kollox.
This also applies to any unknown or emerging viruses or other types of infections.
Dan jgħodd ukoll għal viruses mhux magħrufa jew li jkunu għadhom kif ħarġu jew tipi oħra ta ’ infezzjonijiet.
17 The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus.
Il- miżuri meħuda jitqiesu li huma effettivi għal enveloped viruses bħall- virus ta ’ l- immunodefiċjenza umana (HIV), il- virus ta ’ l- epatite B u l- virus ta ’ l- epatite Ċ u għall- virus ta ’ l- epatite A li mhux enveloped.
Parvovirus B19 infection may be serious for pregnant woman (fetal infection) and for individuals whose immune system is depressed or who have some types of anaemia, (e. g. sickle cell disease or haemolytic anaemia).
Infezzjoni tal - parvovirus B19 tista ’ tkun serja għal nisa tqal (infezzjoni tal- fetu) u għal individwi li s- sistema ta ’ immunità tagħhom tkun dgħajfa jew li jkollhom xi tipi ta ’ anemija (eż. marda tas- sickle cell jew anemija emolitika).
It is strongly recommended that when you receive TachoSil the name and batch number of the product are recorded at the hospital in order to maintain a record of the batches used.
Huwa rrakkomandat ħafna li meta tirċievi TachoSil, l- isem u n- numru tal- lott tal- prodott jiġu rreġistrati fl - isptar sabiex jinżamm rekord tal- lottijiet użati.
HOW TO USE TACHOSIL
KIF JINTUŻA TACHOSIL
The doctor treating you will administer TachoSil during surgery.
It- tabib li jkun qiegħed jieħu ħsiebek ser juża TachoSil matul il- kirurġija.
The doctor will place the sponge on the internal organ to stop the bleeding or to seal the tissue.
It- tabib ser ipoġġi l- isponża fuq l- organu intern sabiex iwaqqaf il- fsada, jew jisiġilla t- tessut.
During the following time the sponge will dissolve and disappear completely.
Aktar tard l- isponża ddub u tisparixxi għal kollox.
Like all medicines, TachoSil can cause side effects although not everybody gets them.
Bħal kull mediċina oħra, TachoSil jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
TachoSil is made on the basis of human blood.
TachoSil hija magħmula fuq il- bażi tad- demm tal- bniedem.
All medicines based on human blood may uncommonly (In more than 1 in 1,000 patients, but less than 1 in 100) cause allergic reactions.
Il- mediċini kollha li huma bbażati fuq id- demm tal- bniedem jistgħu f’ każijiet mhux komuni (f’ aktar minn 1 f’ 1, 000 pazjent, imma inqas minn 1 f’ 100) jikkawżaw reazzjonijiet ta ’ allerġija.
In isolated cases these allergic reactions may progress to anaphylactic shock.
F’ każijiet iżolati, dawn ir- reazzjonijiet allerġiċi jistgħu jwasslu għal xokk anafilattiku.
The above allergic reactions may especially occur if TachoSil is used repeatedly or if you are allergic to any of the ingredients in TachoSil.
Ir- reazzjonijiet allerġiċi msemmija hawn fuq jistgħu jseħħu b’ mod speċjali jekk TachoSil tintuża b’ mod ripetut jew jekk int allerġiku/ a għal xi sustanzi ta ’ TachoSil.
In rare cases you may produce antibodies against the active substances of TachoSil.
F’ każijiet rari, inti tista ’ tipproduċi antikorpi kontra s- sustanzi attivi ta ’ TachoSil.
You may experience fever when taking Tachosil.
Jista ’ jaqbdek id- deni meta tieħu TachoSil.
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 wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib tiegħek.
HOW TO STORE TACHOSIL
KIF TAĦŻEN TACHOSIL
You will not be required to store this product.
Mhux ser ikollok bżonn taħżen dan il- prodott.
What TachoSil contains
X’ fih TachoSil
- The active substances are human fibrinogen (5.5 mg per cm2) and human thrombin (2.0 IU per
Is- sustanzi attivi huma fibrinogen tal- bniedem (5. 5 mg għal kull ċm2) u thrombin tal- bniedem (2. 0 IU
cm2).
għal kull ċm2).
- The other ingredients are equine collagen, human albumin, riboflavin (E101), sodium chloride,
- Is- sustanzi l- oħra huma equine collagen, human albumin, riboflavin (E101), sodium chloride, sodium
sodium citrate and L-arginin-hydrochloride.
citrate u L- arginin- hydrochloride.
What TachoSil looks like and contents of the pack
Id- dehra ta ’ TachoSil u d- daqs tal- pakkett
TachoSil is a sponge made of collagen, which is coated on the yellow side with human fibrinogen and human thrombin.
TachoSil hija sponża magħmula mill- collagen, li hija miksija fuq in- naħa s- safra b’ fibrinogen tal- bniedem u thrombin tal- bniedem.
18 The product is available in different sizes and comes in packages with up to 5 sponges:
Daqsijiet tal- pakkett Il- prodott huwa disponibbli f’ daqsijiet differenti u jiġi f’ pakketti li jesgħu sa 5 sponoż:
Peter Strasse 25 A-4020 Linz, Austria
Peter Strasse 25 A- 4020 Linz, l- Awstrija
Danmark Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Tlf: + 45 46 77 11 11
21 Danmark Nycomed Danmark ApS Langebjerg 1 DK- 4000 Roskilde Tlf: + 45 46 77 11 11
Österreich Nycomed Pharma GmbH EURO PLAZA, Gebäude F Technologiestraße 5 A-1120 Vienna Tel: + 43 (0)1 815 0202-0
Eesti Österreich Nycomed Pharma GmbH Nycomed SEFA AS EURO PLAZA, Gebäude F Pirita tee 20T Technologiestraße 5 EE- 10127 Tallinn A- 1120 Vienna Tel: +372 6112 569 Tel: + 43 (0) 1 815 0202- 0
Italia Nycomed Italia S. r. l.
22 Italia Nycomed Italia S. r. l.
20 This leaflet was last approved on {MM/ YYYY}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
Read this before you open the package:
Aqra dan qabel ma tiftaħ il- pakkett:
TachoSil comes in sterile packages and therefore it is important:
TachoSil tiġi f’ pakketti sterili u għalhekk huwa importanti:
• only to use undamaged packages which have not been opened (post-sterilisation is not possible). • to have a non-sterile person open the outer aluminium cover • to have a sterile person open the inner sterile package
• li jintużaw biss pakketti mhux mittiefsa li jkunu għadhom ma nfetħux (sterilizzazzjoni wara m’ hix possibbli). • li persuna mhux sterili tiftaħ il- qoxra ta ’ l- aluminju ta ’ barra • li persuna sterili tiftaħ il- pakkett sterili ta ’ ġewwa
Use TachoSil soon after opening the outer aluminium cover.
Uża TachoSil malajr wara li tiftaħ il- pakkett ta ’ l- aluminju ta ’ barra.
Use TachoSil immediately after opening the inner sterile package.
Uża TachoSil immedjatament wara li jinfetaħ il- pakkett sterili ta ’ ġewwa.
Instructions Use the TachoSil sponge under sterile conditions only.
Struzzjonijiet Uża l- isponża TachoSil f’ kundizzjonijiet sterili biss.
Find out which sponge size is needed.
Ara liema daqs ta ’ l- isponża huwa meħtieġ.
The size of the sponge depends on the size of the wound.
Id- daqs ta ’ l- isponża jiddependi mid- daqs tal- ferita.
But please note that the sponge should cover 1-2 cm beyond the margins of the wound.
Iżda, jekk jogħġbok kun af li l- isponża għandha tgħatti 1- 2 ċm aktar mit- truf tal- ferita.
If more than one sponge is needed, the sponges should overlap.
Jekk ikun hemm bżonn ta ’ aktar minn sponża waħda, l- isponoż għandhom jitrikkbu fuq xulxin.
For smaller wounds, the sponge can be cut to the appropriate size and shaped if too large.
Għal feriti iżgħar, l- isponża tista ’ tinqata ’ għad- daqs eżatt u tingħata l- forma jekk tkun kbira wisq.
Wipe the wound surface gently before placing the sponge on the wound.
Imsaħ il- ferita bil- mod qabel ma l- isponża titpoġġa fuq il- ferita.
Strong (pulsating) bleeding should be stopped surgically.
Fsada qawwija għandha titwaqqaf b’ mod kirurġiku.
Open the inner sterile package and remove the sponge.
Iftaħ il- pakkett sterili ta ’ ġewwa u oħroġ l- isponża.
Pre-moisten the sponge in saline solution and place it on the wound immediately (if the wound is completely wetted by blood and other fluids, there is no need to moisten the sponge before application).
Xarrab l- isponża minn qabel fis- soluzzjoni bil - melħ u poġġiha fuq il- ferita mal- ewwel (jekk il- ferita tkun imxarrba għal kollox bid- demm u bi fluwidi oħra, ma hemmx bżonn li l- isponża tixxarrab qabel l- applikazzjoni).
Pre-moisten surgical instruments or gloves with a saline solution, if necessary.
Xarrab minn qabel l- istrumenti jew l- ingwanti kirurġiċi b’ soluzzjoni bil- melħ, jekk ikun hemm bżonn.
TachoSil may stick to surgical instruments or gloves covered with blood.
TachoSil tista ’ teħel ma ’ strumenti jew ingwanti kirurġiċi miksija bid- demm.
Place the yellow, active side of the sponge against the wound.
Poġġi n- naħa attiva ta ’ kulur isfar ta ’ l- isponża fuq il- ferita.
Hold down the sponge with a gentle pressure for 3-5 minutes.
Żomm l- isponża ’ l isfel bi pressjoni ħafifa għal 3- 5 minuti.
Use a moistened glove or a moist pad to keep the sponge in place.
Uża ingwanta mxarrba jew kuxxinett imxarrab sabiex l- isponża tinżamm f’ postha.
Remove the light pressure carefully after 3-5 minutes.
Neħħi l- pressjoni ħafifa bil- mod wara 3- 5 minuti.
To make sure that the sponge does not cling to the moistened glove or swab, and loosens itself from the wound, the sponge can be held down at one end e. g. by using a pair of forceps.
Sabiex tkun ċert li l- isponża ma teħilx ma ’ l - ingwanta jew mat- tajjar mxarrab, u tinqala ’ minn mal- ferita, l- isponża tista ’ tinżamm minn tarf wieħed eż. billi tintuża pinzetta.
There is no residual product which needs to be removed, the entire sponge is dissolved (resorbed)!
Ma hemm l- ebda prodott residwu li jrid jitneħħa, l- isponża kollha ddub (tiġi risorbita)!
It is strongly recommended that every time that TachoSil is administered to a patient, the name and batch number of the product are recorded in the order to maintain a link between the patient and the batch of the product.
Huwa rakkomandat ħafna li kull darba li TachoSil tiġi amministrata lil pazjent, l- isem u n- numru tal- lott tal - prodott jiġu rreġistrati sabiex tinżamm konnessjoni bejn il- pazjent u l- lott tal- prodott.
Storage of TachoSil Do not store above 25°C.
Kif taħżen TachoSil Taħżinx f’ temperatura ’ l fuq minn 25°C.
Do not use after the expiry date stated on the label and carton.
Tużax wara d- data ta ’ skadenza li tidher fuq it- tikketta u fuq il- kartuna.
What is Tadalafil Lilly?
X’ inhu Tadalafil Lilly?
Tadalafil Lilly is a medicine containing the active substance tadalafil.
Tadalafil Lilly huwa mediċina li fiha s- sustanza attiva tadalafil.
It is available as yellow, almond-shaped tablets (20 mg).
Huwa disponibbli bħala pilloli f’ għamla ta ’ kapsuli sofor fil- forma ta ’ lewża (20 mg).
This medicine is the same as Cialis, which is already authorised in the European Union (EU).
Din il- mediċina hija l- istess bħal Cialis, li hija diġà awtorizzata fl- Unjoni Ewropea (UE).
The company that makes Cialis has agreed that its scientific data can be used for Tadalafil Lilly.
Il- kumpanija li tipproduċi Cialis qablet li l- informazzjoni xjentifika tagħha tista ’ tintuża għal Tadalafil Lilly.
What is Tadalafil Lilly used for?
Għal xiex jintuża Tadalafil Lilly?
Tadalafil Lilly is used to treat men with erectile dysfunction (sometimes called impotence) when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Tadalafil Lilly jintuża fit- trattament ta 'rġiel b' disfunzjoni erettili (imsejħa wkoll impotenza) li tikkonsisti mill- inkapaċità li tintlaħaq u tinżamm erezzjoni suffiċjenti għal attività sesswali sodisfaċenti.
For Tadalafil Lilly to be effective, sexual stimulation is required.
Biex Tadalafil Lilly ikollu effett, tinħtieġ stimulazzjoni sesswali.
How is Tadalafil Lilly used?
Kif jintuża Tadalafil Lilly?
The recommended dose of tadalafil is 10 mg, taken with or without food, ‘ on demand’ at least 30 minutes before sexual activity.
Id- doża rakkomandata ta ’ tadalafil hi 10 mg, meħuda fuq stonku vojt jew le, ‘ skont il- bżonn ’, tal- inqas 30 minuta qabel l- attività sesswali.
The maximum recommended dosing frequency is once per day, but continuous daily use of 10 or 20 mg tadalafil is not recommended.
Il- frekwenza massima rakkomandata hi darba kuljum, iżda l- użu kontinwu ta 'tadalafil, kemm b' doża ta' 10 mg kif ukoll 20 mg, kuljum mhux rakkomandat.
How does Tadalafil Lilly work?
Kif jaħdem Tadalafil Lilly?
The active substance of Tadalafil Lilly, tadalafil, belongs to a group of medicines called ‘ phosphodiesterase type 5 (PDE5) inhibitors’.
Is- sustanza attiva f’ Tadalafil Lilly, tadalafil, hi parti minn grupp ta ’ mediċini magħruf bħala ‘ inibituri ta ’ fosfodijesterażi tat- tip 5 (PDE5) ’.
It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Taħdem billi timblokka l- enzima fosfodjesterażi, li normalment tkisser sustanza magħrufa bħala gwanożin monofosfat ċikliku (cGMP).
During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the blood to flow into the corpora, producing the erection.
Waqt l- istimulazzjoni sesswali normali, il- pene jipproduċi s- cGMP u jwassal għar- rilassament tal- muskolatura tat- tessut artab tal - pene (il- corpora cavernosa) u jippermetti l- fluss tad- demm fil- corpora, u b' hekk jipproduċi l- erezzjoni.
By blocking the break down of cGMP, Tadalafil Lilly restores erectile function.
Billi jiġi mblukkat it- tkissir tas- cGMP, Tadalafil Lilly ireġġa 'l- funzjoni erettili għan- normal.
Sexual stimulation is still needed to produce an erection.
Xorta jibqa ’ l- bżonn ta ’ stimulazzjoni sesswali biex isseħħ l- erezzjoni.
How has Tadalafil Lilly been studied?
Kif ġie studjat Tadalafil Lilly?
Tadalafil, when taken ‘ on demand ’ before sexual activity, has been studied in six main studies including 1,328 patients.
Tadalafil, meħud ‘ skont il- bżonn ’ qabel l- attività sesswali, ġie studjat f’ sitt studji ewlenin li fihom ħadu sehem 1, 328 pazjent.
Once-a-day dosing of tadalafil was studied in three further studies lasting 12 to 24 weeks and involving a total of 853 patients.
L- għoti ta 'doża ta' tadalafil darba kuljum ġiet studjata fi tliet studji oħra li damu bejn 12 u 24 ġimgħa u li fihom b' kollox ħadu sehem 853 pazjent.
In all studies, the effects of tadalafil were compared with those of placebo (a dummy treatment), and the main measure of effectiveness was the ability to get and maintain an erection.
Fl- istudji kollha, l- effetti ta ’ tadalafil tqabblu ma ’ dawk ta ’ plaċebo (trattament finta), u l- mezz ewlieni tal- kejl tal- effikaċja kienet l- abilità li wieħed jipproduċi u jżomm erezzjoni.
What benefit has Tadalafil Lilly shown during the studies?
X’ benefiċċji wera Tadalafil Lilly waqt l- istudji mwettqa?
Tadalafil was significantly more effective than placebo in all studies.
Tadalafil kien ferm iktar effikaċi mill- plaċebo fl- istudji kollha.
For one of the questionnaires, where the maximum score is 30, patients who recorded scores of about 15 before treatment, recorded scores of 22.6 or 25 after receiving tadalafil 10 mg or 20 mg, respectively.
F’ wieħed mill- kwestjonarji, fejn il - punteġġ massimu kien 30, il- pazjenti li rreġistraw punteġġi ta ’ madwar 15 qabel it- trattament, irreġistraw punteġġi ta ’ 22. 6 jew 25 wara li ħadu 10 mg jew 20 mg tadalafil, rispettivament.
Overall, in the studies of general populations, 81% of patients reported that tadalafil ‘ on demand ’ improved their erections as compared with 35% of those taking placebo.
Globalment, fl- istudji fil- popolazzjonijiet ġenerali, 81% tal- pazjenti rrappurtaw li tadalafil meħud ‘ skont il- bżonn ’ tejjeb l- erezzjoni meta mqabbla ma ’ 35% ta ’ dawk ittrattati bil- plaċebo.
Patients taking tadalafil once a day at doses of 2.5 or 5 mg also reported improved erections compared with those taking placebo.
Il- pazjenti li kienu qed jieħdu tadalafil darba kuljum f’ dożi ta ’ 2. 5 jew 5 mg wkoll irrappurtaw titjib fl - erezzjonijiet meta mqabbla ma ’ dawk li kienu qed jieħdu l- plaċebo.
What is the risk associated with Tadalafil Lilly?
X' inhu r- riskju assoċjat ma 'Tadalafil Lilly?
The most common side effects with tadalafil (seen in more than 1 patient in 10) are headache and dyspepsia (indigestion).
L- effetti sekondarji l- aktar komuni b’ tadalafil (li dehru f' aktar minn pazjent 1 minn 10) kienu wġigħ ta 'ras u dispepsija (indiġestjoni).
For the full list of all side effects reported with tadalafil, see the Package Leaflet.
Għal lista sħiħa tal- effetti sekondarji kollha rrappurtati b’ tadalafil, ara l - Fuljett ta ’ Tagħrif.
Tadalafil Lilly should not be used in people who may be hypersensitive (allergic) to tadalafil or any of the other ingredients, or where sexual activity is inadvisable (e. g. in men with heart disease).
Tadalafil Lilly ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal tadalafil jew għal xi sustanza tiegħu, u fil- każijiet li fihom jingħata parir li ma ssirx attività sesswali (eż. irġiel b' mard tal- qalb).
It should also not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy or NAION).
Lanqas m’ għandu jintuża minn pazjenti li xi darba kellhom telf tal- vista minħabba xi problema fiċ- ċirkolazzjoni tad- demm lejn in- nervitura tal- għajn (NAION, jew newropatija ottika anterjuri iskemika mhux arteritika).
Tadalafil Lilly should not be taken with nitrates (medicines used to treat angina).
Tadalafil Lilly ma għandux jittieħed flimkien ma ’ nitrati (mediċini użati fit- trattament ta ’ anġina).
Because Tadalafil Lilly has not been studied in patients who have had a heart attack within the last three months or a stroke within the last six months, or those who have high blood pressure or heart disorders (irregular heart beat), these men should not use it.
Billi Tadalafil Lilly ma ġiex studjat f' pazjenti li kellhom attakk tal- qalb fl- aħħar tliet xhur jew puplesija fl- aħħar sitt xhur, jew li jkollhom pressjoni għolja jew disturbi tal- qalb (taħbit irregolari tal- qalb), dawn l- irġiel ma għandhomx jieħdu din il- mediċina.
For the full list of restrictions, see the Package Leaflet.
Għal - lista sħiħa ta 'restrizzjonijiet, ara l- Fuljett ta' Tagħrif.
Why has Tadalafil Lilly been approved?
Għaliex ġie approvat Tadalafil Lilly?
The Committee for Medicinal Products for Human Use (CHMP) decided that Tadalafil Lilly’ s benefits are greater than its risks for the treatment of men with erectile dysfunction.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Tadalafil Lilly fit- trattament ta ’ rġiel bi problemi bl- erezzjoni huma ikbar mir- riskji tiegħu.
The Committee recommended that Tadalafil Lilly be given marketing authorisation.
Il- Kumitat irrakkomanda li Tadalafil Lilly jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Tadalafil Lilly:
Aktar tagħrif dwar Tadalafil Lilly:
The European Commission granted a marketing authorisation valid throughout the EU for Tadalafil Lilly to Eli Lilly Nederland B. V. on 1 October 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Tadalafil Lilly valida fl- UE kollha lil Eli Lilly Nederland B. V. fi 1 ta 'Ottubru 2008.
The full EPAR for Tadalafil Lilly is available here.
L- EPAR sħiħ dwar Tadalafil Lilly jista ’ jiġi kkonsultat hawn.
Oral use Blister (alu/ PVC/ PE/ PCTFE)
Folja (alu/ PVC/ PE/ PCTFE)
2 tablets
2 pilloli
4 tablets
4 pilloli
8 tablets
8 pilloli
12 tablets
12- il pillola
Tadalafil Lilly 20 mg film-coated tablets
TADALAFIL LILLY 20 mg pilloli miksijin b’ rita
Tadalafil Lilly is not indicated for use by women.
TADALAFIL LILLY mhuwiex indikat għall- użu min- nisa.
Tadalafil Lilly is available as 20 mg film-coated tablets.
TADALAFIL LILLY jiġi bħala pilloli miksija b’ rita ta ’ 20 mg
Use in adult men In general, the recommended dose of tadalafil is 10 mg taken prior to anticipated sexual activity and with or without food.
Użu f’ irġiel adulti Is- soltu, id- doża rakkmandata ta ’ tadalafil hija ta ’ 10 mg meħuda qabel attivita ’ sesswali antiċipata u ma ’ l- ikel jew fuq stonku vojt.
In those patients in whom tadalafil 10 mg does not produce an adequate effect, Tadalafil Lilly 20 mg might be tried.
F’ dawk il- pazjenti li ma jkollhomx effett adegwat b’ 10mg ta ’ tadalafil, tista ’ tiġi ppruvata doża ta ’ 20 mg.
In responder patients to on-demand regimen who anticipate a frequent use of Tadalafil Lilly (i. e., at least twice weekly) a once daily regimen with the lowest doses of tadalafil might be considered suitable, based on patient choice and the physician’ s judgement.
F’ pazjenti li qegħdin jirrispondu għat- tip ta ’ kura fejn jieħdu doża biss meta jkun hemm it- talba u li jaħsbu li se jkollhom użu frekwenti ta ’ TADALAFIL LILLY (jiġifieri, għallinqas darbtejn fil- ġimgħa) jista ’ jiġi kkunsidrat dożaġġ ta ’ darba kuljum bl- inqas dożi ta ’ tadalafil, skond l- għażla tal- pazjent u l - ġudizzju tat- tabib.
In these patients the recommended dose of tadalafil is 5 mg taken once a day at approximately the same time of day.
F’ dawn il- pazjenti, id- doża rakkomandata ta ’ tadalafil hija ta ’ 5 mg meħuda darba kuljum u bejn wieħed u ieħor għandha dejjem tittieħed fl- istess ħin tal- ġurnata.
2 Use in elderly men Dose adjustments are not required in elderly patients.
2 Użu f’ irġiel anzjani Mhux meħtieġ tibdil tad- doża f’ pazjenti anzjani.
For patients with severe renal impairment tadalafil 10 mg is the maximum recommended dose.
Għall- pazjenti b’ indeboliment renali sever tadalafil 10 mg hija d- doża massima rakkomandata.
(See sections 4.4 and 5.2)
Dożaġġ ta ’ darba kuljum ta ’ tadalafil m’ huwiex rakkomandat f’ pazjenti b’ indeboliment renali sever. (Ara sezzjonijiet 4. 4 u 5. 2).
Use in men with impaired hepatic function The recommended dose of tadalafil is 10 mg taken prior to anticipated sexual activity and with or without food.
Użu f’ irġiel b’ indeboliment fil- funzjoni tal- fwied Id- doża rakkmandata ta ’ tadalafil hija ta ’ 10 mg meħuda qabel attivita ’ sesswali prevista u mingħajr rigward għall- ikel.
There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment (Child-Pugh Class C); if prescribed, a careful individual benefit/ risk evaluation should be undertaken by the prescribing physician.
Tagħrif kliniku dwar is- sigurtà ta ’ tadalafil f’ pazjenti b’ indeboliment epatiku sever (Child Pugh Class C) huwa limitat; għalhekk jekk jiġi miktub mit- tabib, dan għandu jagħmel evalwazzjoni bir- reqqa tal- benefiċċju/ riskju għal kull pazjent.
Use in children and adolescents Tadalafil Lilly should not be used in individuals below 18 years of age.
Użu fi tfal u adolexxenti TADALAFIL LILLY m’ għandux jintuża f’ persuni li għandhom inqas minn 18- il sena.
Therefore, administration of Tadalafil Lilly to patients who are using any form of organic nitrate is contraindicated.
Għalhekk l- għoti ta ’ TADALAFIL LILLY lil pazjenti li qed jużaw kwalunkwe forma ta 'nitrat organiku huwa kontra - indikat.