qanastek/EMEA-V3 huggingface dataset:
------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only
------------------------------------------------------------------------------------------------------------------------- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku jew professjonisti fil - qasam tal- kura tas- saħħa
Prevention of Skeletal Events in Patients with Breast Cancer and Bone Metastases The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenously given every 3-4 weeks.
Prevenzjoni ta ’ Episodji Skeletriċi f’ Pazjenti b’ Kanċer tas- Sider u Metastażi fl - Għadam Id- doża rrakkomandata għall- prevenzjoni ta ’ episodji skeletriċi f’ pazjenti b’ kanċer tas- sider u metastażi fl- għadam hija ta ’ 6 mg ġol- vina li tingħata kull 3- 4 ġimgħat.
The dose should be infused over at least 15 minutes.
Id- doża għandha tingħata fuq medda ta ’ mill- anqas 15- il minuta.
Infusion Volume 2
Volum ta ’
6 mg / 15 minutes
l- Infużjoni 2
CLcr < 50 < 30
≥ 50 30 < CLcr < 50 < 30
6 mg / 1 hour / 1 hour
6mg / 15 minuta 6mg / 1 siegħa 2mg / 1 siegħa
In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥ 3 mmol/ l or ≥ 12 mg/ dl) 4 mg will be an adequate single dosage.
72 kbira tal- pazjenti b’ iperkalċemja severa (kalċju fis- serum ikkoreġut bl- albumina * ≥3 mmol/ l jew ≥12 mg/ dl) doża waħda ta '4 mg hija adegwata.
In most cases a raised serum calcium level can be reduced to the normal range within 7 days.
Fil- maġġoranza tal- każijiet livell għoli ta ’ kalċju fis- serum jista ’ jitnaqqas għal livell normali f’ 7 ijiem.
Method and route of administration Bondronat concentrate for solution for infusion should be administered as an intravenous infusion.
Il- metodu u rotta ta ’ l- amministrazzjoni Bondronat konċentrat għal soluzzjoni għall- infużjoni għandu jiġi mogħti bħala infużjoni ġol- vina.
For this purpose the contents of the vial are to be used as follows:
Għal dan il- għan il- kontenut tal- kunjett għandu jintuża kif ġej:
• Hypercalcaemia - added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over 1-2 hours. • Prevention of Skeletal Events - added to 100 ml isotonic sodium chloride solution or 100 ml 5% dextrose solution and infused over at least 15 minutes.
Prevenzjoni ta ’ Episodji Skeletriċi – miżjud ma ’ soluzzjoni ta ’ 100 ml ta ’ soluzzjoni ta ’ sodium chloride isotoniku jew ma ’ soluzzjoni ta ’ 100 ml 5% dextrose fuq medda ta ’ mill - anqas 15- il minuta.
It is recommended that the product once diluted be used immediately (see point 5 of this leaflet “ HOW TO STORE BONDRONAT”).
Huwa rrakkommandat li l- prodott la darba jkun dilwit jintuża immedjatament (ara punt 5 ta ’ dan il - fuljett “ KIF TAĦŻEN BONDRONAT ”).
Duration of treatment A limited number of patients (50 patients) have received a second infusion for hypercalcaemia.
73 Tul tat- trattament Numru limitat ta ’ pazjenti (50 pazjent) irċevew it- tieni infużjoni għal iperkalċemja.
Repeated treatment may be considered in case of recurrent hypercalcaemia or insufficient efficacy.
Trattament ripetut jista ’ jkun ikkunsidrat f’ każ ta ’ iperkalċemja rikurrenti jew effikaċja insuffiċjenti.
Since both the kidney and the liver were found to be target organs for toxicity in preclinical studies with high doses, kidney and liver function should be monitored.
Minħabba li fi studji pre- kliniċi b’ doża għoljakemm il- kliewi kif ukoll il- fwied instabu li kienu organi li setgħu kienu milquta minn tossiċittà, l- funzjoni tal- kliewi u tal- fwied għandhom jiġu mmonitorjati.
72 Clinically relevant hypocalcaemia (very low serum calcium levels) should be corrected by intravenous administration of calcium gluconate.
Ipokalċemja (livell baxx ħafna ta ’ kalċju fis- serum) li tkun klinikament relevanti għandha tkun trattata permezz ta ’ amministrazzjoni ġol- vina ta ’ calcium gluconate.
What is Bonviva?
X’ inhu Bonviva?
Bonviva is a medicine that contains the active substance ibandronic acid.
Bonviva huwa mediċina li fiha s- sustanza attiva aċidu ibandroniku (ibandronic acid).
It is available as white, oblong tablets (150 mg) or as a solution for injection (3 mg).
Jiġi bħala pilloli oblongi bojod (150 mg) jew bħala soluzzjoni għall- injezzjoni (3 mg).
What is Bonviva used for?
Għal xiex jintuża Bonviva?
Bonviva is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures (breaks).
Bonviva jintuża fit- trattament tal- osteoporożi (marda li ddgħajjef l- għadam) fin- nisa li jkunu għaddew mill- menopawża u li hemm ir- riskju li jkollhom ksur fl- għadam.
Its effect in reducing the risk of vertebral (spine) fractures has been shown in studies, but its effect on the risk of fractures of the neck of the femur (the top of the thighbone) has not been established.
L- effett tiegħu fit- tnaqqis tar- riskju ta ’ ksur vertebrali (tas- sinsla tad- dahar) intwera fi studji, iżda l- effett tiegħu fuq ir- riskju ta ’ ksur fl - għonq tal- wirk (il- parti ta ’ fuq tal- għadam tal- koxxa) kien għadu ma ġiex stabbilit.
How is Bonviva used?
Kif jintuża Bonviva?
Bonviva can be given either by mouth as a tablet or as an injection into a vein.
Bonviva jista ’ jingħata jew mill- ħalq bħala pillola jew bħala injezzjoni f’ vina.
The tablet must always be taken after an overnight fast, one hour before any food of drink except for water, and with a full glass of plain water.
Il- pillola dejjem għandha tittieħed wara sawma ta ’ lejl sħiħ, siegħa qabel l- ikel jew ix- xorb, ħlief l- ilma, u ma ’ tazza mimlija ilma naturali.
Patients taking Bonviva should also take vitamin D and calcium supplements if they do not get enough from their diet.
Il - pazjenti li jieħdu Bonviva għandhom jieħdu wkoll supplimenti ta 'kalċju u ta' vitamina D jekk ma jkunux qegħdin jieħdu biżżejjed mid- dieta tagħhom.
Bonviva is not recommended for patients who have severe kidney problems.
Bonviva mhuwiex irrakkomandat għal pazjenti bi problemi severi fil- kliewi.
How does Bonviva work?
Kif jaħdem Bonviva?
The active substance in Bonviva, ibandronic acid, is a bisphosphonate.
Is- sustanza attiva f’ Bonviva, aċidu ibandroniku huwa bisfosfonat.
This leads to less bone loss.
Dan iwassal għal inqas telf tal- għadam.
How has Bonviva been studied?
Kif ġie studjat Bonviva?
Bonviva was studied in three main studies involving women with osteoporosis.
Bonviva ġie studjat fi tliet studji ewlenin li kienu jinvolvu nisa bl- osteoporożi.
The first study compared Bonviva 2.5 mg tablets taken once a day with placebo (a dummy treatment) in almost 3,000 women and looked at how many new spine fractures were seen in the patients over three years.
L- ewwel studju qabbel pilloli ta ’ Bonviva 2. 5 mg, li ttieħdu darba kuljum, ma ’ plaċebo (trattament finta) fi kważi 3, 000 mara u eżamina kemm seħħ ksur ġdid tas- sinsla tad- dahar f’ pazjenti fuq tul ta ’ żmien ta ’ tliet snin.
Note that the 2.5 mg once-daily tablets are no longer authorised.
Innota li l- pilloli ta ’ 2. 5 mg darba kuljum m’ għadhomx awtorizzati.
What benefit has Bonviva shown during the studies?
Liema benefiċċju wera Bonviva waqt l- istudji mwettqa?
In the first study, daily treatment with Bonviva 2.5 mg tablets reduced the risk of new spine fractures by 62% in comparison with placebo.
Fl- ewwel studju, it- trattament kuljum b’ pilloli ta ’ Bonviva 2. 5 mg naqqas ir- riskju ta ’ ksur ġdid fis - sinsla tad- dahar b’ 62% meta mqabbel mal- plaċebo.
The other two studies showed that the 150 mg monthly tablets and the injections were more effective than the 2.5 mg once-daily tablets at increasing bone density in the spine and the hip.
Iż- żewġ studji l- oħra wrew li l- pilloli 150 mg ta ’ darba fix- xahar u l- injezzjonijiet kienu iktar effikaċi mill- pilloli 2. 5 mg ta ’ kuljum fiż- żieda tad - densità tal- għadam fis- sinsla tad- dahar u l- ġenbejn.
Over two years, bone density in the spine increased by 7% with the monthly tablets and by 6% with the injections, compared with 5% with the daily tablets.
Matul sentejn, id- densità tal- għadam fis- sinsla tad - dahar żdiedet b’ 7% bil- pilloli ta ’ kull xahar u b’ 6% bl- injezzjonijiet, meta mqabbla ma ’ 5% bil- pilloli ta ’ kuljum.
In the hip, bone density increased by 4% with the monthly tablets and by 3% with the injections, compared with 2% with the daily tablets.
Fil- ġenbejn, id- densità tal- għadam żdiedet b’ 4% bil- pilloli ta ’ kull xahar u b’ 3% bl - injezzjonijiet, meta mqabbla ma ’ 2% bil- pilloli ta ’ kuljum.
What is the risk associated with Bonviva?
X’ inhu r- riskju assoċjat ma ’ Bonviva?
The most common side effects with Bonviva tablets (seen in between 1 and 10 patients in 100) are gastritis (inflammation of the stomach), diarrhoea, abdominal pain (stomach ache), dyspepsia (indigestion), nausea (feeling sick), influenza-like illness, fatigue (tiredness), musculoskeletal pain (pain in the muscles and bones), arthralgia (joint pain), myalgia (muscle pain) and musculoskeletal stiffness.
L- effetti sekondarji l- iktar komuni bil- pilloli Bonviva (li dehru f’ bejn pazjent wieħed sa għaxra minn kull 100) huma gastrite (infjammazzjoni tal- istonku), dijarrea, uġigħ addominali (uġigħ fl- istonku), dispepsija (indiġestjoni), nawżea (dardir), mard li jixbah l- influwenza, għeja, uġigħ muskoluskeletriku (uġigħ fil- muskoli u l- għadam), artralġija (uġigħ fil- ġogi), mijalġija (uġigħ fil- muskoli) u ebusija mukoluskeletriku.
For the full list of all side effects reported with Bonviva, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtati b’ Bonviva, ara l- Fuljett ta ’ Tagħrif.
Bonviva should not be used in people who may be hypersensitive (allergic) to ibandronic acid or any of the other ingredients.
Bonviva m’ għandux jintuża fuq persuni li huma ipersensittivi (allerġiċi) għall- aċidu ibandroniku jew għal xi sustanza oħra tiegħu.
Bonviva treatment may be linked to osteonecrosis of the jaw (collapse of bone tissue in the jaw).
It- trattament b’ Bonviva jista ’ jkun marbut mal- osteonekrożi tax- xedaq (meta jaqa t- tessut tal- għadam fix- xedaq).
Why has Bonviva been approved?
Għaliex ġie approvat Bonviva?
The Committee for Medicinal Products for Human Use (CHMP) decided that Bonviva’ s benefits are greater than its risks for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Bonviva għandu aktar benefiċċji milli riskji għat- trattament ta 'l- osteoporożi f' nisa wara l- menopawża f' riskju miżjud ta' ksur.
The Committee recommended that Bonviva be given marketing authorisation.
Il- Kumitat irrakkomanda li Bonviva jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Bonviva:
Informazzjoni oħra dwar Bonviva:
The European Commission granted a marketing authorisation valid throughout the European Union for Bonviva to Roche Registration Limited on 23 February 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Bonviva lil Roche Registration Limited fit- 23 ta ’ Frar 2004.
The marketing authorisation was renewed on 23 February 2009.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fit- 23 ta ’ Frar 2009.
The full EPAR for Bonviva can be found here.
L- EPAR sħiħ għal Bonviva jista ’ jiġi kkonsultat hawn.
Content
Kontenut (konċentrazzjoni)
What is Bridion?
X’ inhu Bridion?
Bridion is a solution for injection that contains the active substance sugammadex (100 mg/ ml).
Bridion huwa soluzzjoni għall- injezzjoni li fiha s- sustanza attiva sugammadex (100 mg/ ml).
What is Bridion used for?
Għalxiex jintuża Bridion?
Bridion is used to reverse the effect of the muscle relaxants rocuronium and vecuronium.
Bridion jintuża biex ireġġa ’ lura l- effetti tar- rilassanti tal- muskoli rocuronium u vecuronium.
Muscle relaxants are medicines used during some types of operation to make the muscles relax, including the muscles that help the patient to breathe.
Rilassanti muskolari huma mediċini li jintużaw waqt ċerti tipi ta ’ operazzjonijiet biex jirrilassaw il - muskoli, fosthom il- muskoli li jgħinu lill- pazjent jieħu n- nifs.
Muscle relaxants make it easier for the surgeon to do the operation.
Ir- rilassanti tal- muskoli jagħmluha iktar faċli għall- kirurgu biex jagħmel l- operazzjoni.
Bridion is used to speed up the recovery from the muscle relaxant, usually at the end of the operation.
Bridion jintuża biex iħaffef l- irkurpru mir- rilassanti muskolari, ġeneralment fi tmiem l- operazzjoni.
Bridion can be used in adults who have received rocuronium and vecuronium, and in children and adolescents who have received rocuronium.
Bridion jista ’ jintuża fl- adulti li jkunu ngħataw rocuronium u vecuronium, u fit- tfal u l- adolexxenti li jkunu ngħataw rocuronium.
How is Bridion used?
Kif jintuża Bridion?
Bridion can only be given by or under the supervision of an anaesthetist (a doctor specialised in anaesthesia).
Bridion jista ’ jingħata biss minn jew taħt is- superviżjoni ta ’ anestetista (tabib speċjalizzat fl - anestesija).
It is given as a single intravenous ‘ bolus’ injection (given into a vein all at once).
Jingħata b’ injezzjoni intravenuża ‘ bolus ’ (injezzjoni fil- vina mogħtija f’ daqqa).
The standard dose of Bridion is between 2 and 4 mg per kilogram body weight, depending on how much the muscle relaxant is affecting the muscles.
Id- doża standard ta ’ Bridion hija ta ’ bejn 2 u 4 mg għal kull kilogramma li jiżen il- pazjent, skond kemm ir - rilassant muskolari jkun qed jaffettwa lill- muskoli.
A dose of 16 mg/ kg can be used if rapid recovery from muscle relaxation is needed.
Jekk ikun hemm bżonn ta ’ irkupru malajr mir- rilassament muskolari tista ’ tintuża doża ta ’ 16 - il mg/ kg.
This might be necessary if patients need to be able to start to breathe on their own again during the operation.
Din tista ’ tkun meħtieġa jekk il- pazjenti jkolhom bżonn jerġgħu jibdew jieħdu n- nifs waħidhom waqt l- operazzjoni.
This dose is expected to be used in only a limited number of the treatments (less than 1%).
Din id- doża mistennija tintuża biss f’ numru limitat ta ’ trattamenti (inqas minn 1%).
In children and adolescents, the recommended dose is 2 mg/ kg body weight.
Fit- tfal u l- adolexxenti, id- doża rakkomandata hija ta ’ 2 mg/ kg piż.
Bridion is not recommended for use in children and adolescents for recovery after vecuronium, or for rapid recovery after any muscle relaxant, because its use has not been investigated in these situations.
Bridion mhuwiex rakkomandat għall- użu fi tfal u adolexxenti għall- irkupru wara l- għoti ta ’ vecuronium, jew għall- irkupru ta ’ malajr minn rilassanti muskolari oħrajn, għax l- użu tiegħu f’ dawn is- sitwazzjonijiet ma ġiex studjat.
Bridion is not recommended for use in children below two years of age because there is not enough information on its safety and effectiveness in this age group.
Bridion mhux rakkomandat għal tfal ta ’ inqas minn sentejn minħabba li m’ hemmx biżżejjed tagħrif fuq is - sigurtà u l- effikaċja f’ dan il- grupp ta ’ età.
Bridion is not recommended for patients who have severe problems with their kidneys.
Bridion m’ huwiex rakkomandat għal pazjenti li għandhom problemi severi fil- kliewi.
It should be used with great caution in patients with severe liver problems.
Għandu jintuża b’ kawtela kbira f’ pazjenti bi problemi severi fil- fwied.
Reproduction is authorised provided the source is acknowledged. the muscle relaxants and stops them having an effect.
Kif jaħdem Bridion?
As a result, the effect of blockade of the muscles due to rocuronium and vecuronium on the muscles is reversed, and the muscles begin to work normally again, including the muscles that help the patient to breathe.
Dan ifisser li jaqbad mar- rilassanti tal- muskoli rocuronium u vecuronium u jifforma ‘ kumpless ’ li jattiva r- rilassanti tal- muskoli u jwaqqafhom milli jkollhom effett.
How has Bridion been studied?
Kif ġie studjat Bridion?
The effects of Bridion were first tested in experimental models before being studied in humans.
L- effetti ta ’ Bridion għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fuq il - bnedmin.
Bridion has been studied in four main studies in a total of 579 adults undergoing surgery using muscle relaxants.
Bridion ġie studjat f’ erba ’ studji ewlenin li fihom b’ kollox ħadu sehem 579 adult li sarulhom operazzjonijiet bl- użu ta ’ rilassanti muskolari.
Two of the studies, involving a total of 282 patients, looked at the effectiveness of 2 mg/ kg Bridion in reversing moderate relaxation of the muscles due to rocuronium or vecuronium.
Tnejn mill- istudji, li fihom b’ kollox ħadu sehem 282 pazjent, ħarsu lejn l- effikaċja ta ’ 2 mg/ kg Bridion fit- treġġigħ lura tar- rilassament moderat tal- muskoli kkawżat minn rocuronium jew vecuronium.
Bridion was compared with neostigmine (another medicine used to stop the effect of muscle relaxants) given after rocuronium or vecuronium in the first study and after cis-atracurium (another muscle relaxant) in the second.
Bridion tqabbel ma ’ neostigmine (mediċina oħra użata fit- twaqqif ta ’ l- effetti tar- rilassanti tal - muskoli) mogħti wara rocuronium jew vecuronium fl- ewwel studju u wara cis- atracurium (rilassant tal- muskoli ieħor) fit- tieni wieħed.
The third study compared the effectiveness of 4 mg/ kg Bridion with that of neostigmine after deep relaxation of the muscles using rocuronium or vecuronium in 182 patients.
It- tielet studju qabbel l- effikaċja ta ’ 4 mg/ kg Bridion ma ’ dik ta ’ neostigmine wara rilassament qawwi tal- muskoli bl- użu ta ’ rocuronium jew vecuronium f’ 182 pazjent.
The fourth study, involving 115 patients, looked at the effectiveness of 16 mg/ kg Bridion in producing rapid reversal of the muscle relaxation using rocuronium.
Ir- raba ’ studju, li fih ħadu sehem 115- il pazjent, ħares lejn l- effikaċja ta ’ 16- il mg/ kg Bridion fit - treġġigħ lura malajr għan- normal wara rilassament tal- muskoli bl- użu ta ’ rocuronium.
This was compared with spontaneous recovery after muscle relaxation using succinylcholine (another muscle relaxant).
Dan tqabbel ma ’ l- irkupru spontanju wara rilassament muskolari bl- użu ta ’ succinylcholine (rilassant muskolari ieħor).
An additional study looked at the effectiveness of Bridion given after rocuronium in 90 children and adolescents.
Studju ieħor ħares lejn l- effikaċja ta ’ Bridion mogħti wara rocuronium f’ 90 parteċipant bejn adolexxenti u tfal.
In all of the studies, the main measure of effectiveness was how long it took for the muscles to recover.
Fl- istudji kollha, il- mezz ewlieni ta ’ l- effikaċja kien kemm kellu jgħaddi ħin biex jirkupraw il - muskoli.
What benefit has Bridion shown during the studies?
Liema benefiċċji wera Bridion f’ dawn l- istudji?
Bridion was more effective than neostigmine in reducing the time it took for the muscles to recover, after both moderate and deep muscle relaxation using rocuronium or vecuronium.
Bridion kien iktar effettiv minn neostigmine fit- tnaqqis tal- ħin meħud biex il- muskoli jirkupraw, wara rilassament moderat jew qawwi tal- muskoli bl- użu ta ’ rocuronium jew vecuronium.
After moderate muscle relaxation, the average time for recovery was between 1.4 and 2.1 minutes for 2 mg/ kg Bridion, compared with 17.6 to 18.9 minutes for neostigmine.
Wara rilassament moderat tal- muskoli, il- ħin medju għall- irkupru kien bejn 1. 4 u 2. 1 minuti għal 2 mg/ kg Bridion, meta mqabbel ma ’ bejn 17. 6 u 18. 9 minuti għal neostigmine.
After deep muscle relaxation, recovery took an average of around 3.0 minutes with 4 mg/ kg Bridion, compared with around 49.5 minutes for neostigmine.
Wara rilassament tal - muskoli fil- fond, l- irkupru medju seħħ f’ madwar 3. 0 minuti b’ 4 mg/ kg Bridion, imqabbel ma ’ madwar 49. 5 minuti għal neostigmine.
When used for rapid recovery, patients receiving 16 mg/ kg Bridion recovered after 4.2 minutes.
Meta jintuża għall- irkupru immedjat, il- pazjenti li jkunu ngħataw 16- il mg/ kg Bridion irkupraw wara 4. 2 minuti.
In contrast, muscle relaxation recovered spontaneously after 7.1 minutes.
Min- naħa l- oħra, ir- rilassament tal- muskoli waqaf waħdu wara 7. 1 minuti.
The effect of Bridion seen in adults was similar in adolescents and children aged over two years.
L- effetti ta ’ Bridion li dehru fl- adulti kien simili fl- adolexxenti u fit- tfal ta ’ iktar minn sentejn.
There were too few children aged below two years to determine the safety and effectiveness of Bridion in this age group.
L - għadd ta ’ tfal ta ’ inqas minn sentejn kien żgħir wisq biex ikunu stabbiliti s- sigurtà u l- effikaċja ta ’ Bridion f’ dan il- grupp ta ’ età.
What is the risk associated with Bridion?
Liema riskju huwa assoċjat ma ’ Bridion?
The most common side effect with Bridion (seen in more than 1 patient in 10) is dysgeusia (a bitter or unusual taste in the mouth).
L- iktar effett sekondarju komuni ma ’ Bridion (li deher f’ iktar minn pazjent wieħed minn kull 10) huwa togħma morra jew mhux tas- soltu fil- ħalq.
For the full list of all side effects reported with Bridion, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati ma ’ Bridion, ara l- Fuljett ta ’ Tagħrif.
Bridion should not be used in people who may be hypersensitive (allergic) to sugammadex or any of the other ingredients.
Bridion m’ għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal sugammadex jew għal xi sustanza oħra tiegħu.
Why has Bridion been approved?
Għaliex ġie approvat Bridion?
The Committee for Medicinal Products for Human Use (CHMP) decided that Bridion’ s benefits are greater than its risks for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Bridion huma ikbar mir- riskji tiegħu għat- treġġigħ lura ta ’ l- imblokk newromuskolari indott minn rocuronium jew vecuronium.
The Committee recommended that Bridion be given marketing authorisation.
Il- Kumitat irrakkomanda li Bridion jingħata l- awtorizzazzjoni għat - tqegħid fis- suq.
Other information about Bridion:
Tagħrif ieħor dwar Bridion:
The European Commission granted a marketing authorisation valid throughout the European Union for Bridion to N. V.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Bridion lil N. V.
Organon on 25 July 2008.
Organon fil- 25 ta ’ Lulju 2008.
The full EPAR for Bridion can be found here.
2/ 3 L- EPAR sħiħ għal Bridion jinstab hawn.
This summary was last updated in 07-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi 07- 2008.
EU number
Numru ta ’ Proċedura ta ’ l- EU
Invented name
Isem ivventat
Route of administration
Mnejn jingħata
Content (concentration)
Kontenut (konċentrazzjoni) 2 ml (100 mg/ ml)
Solution for injection
Soluzzjoni għall - injezzjoni
Vial (glass), rubber stopper and flip-off cap
Kunjett (ħġieġ), tapp tal- lastku u għatu flip- off
SUMMARY OF PRODUCT CHARACTERISTICS 1.
SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
Bridion 100 mg/ ml solution for injection
Bridion 100 mg/ ml soluzzjoni għall- injezzjoni.
2 ml contains sugammadex sodium equivalent to 200 mg sugammadex.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
5 ml contains sugammadex sodium equivalent to 500 mg sugammadex.
5 ml fihom sugammadex sodium ekwivalenti għal 500 mg ta ’ sugammadex.
Excipient(s):
Sustanza( i) mhux attiva( i):
Each ml contains 9.7 mg sodium (see section 4.4).
Kull ml fih 9. 7 mg ta ’ sodium (ara sezzjoni 4. 4).
Solution for injection (injection).
Soluzzjoni għall- injezzjoni (injezzjoni).
Clear and colourless to slightly yellow solution.
Soluzzjoni bejn ċara u bla kulur sa kemm kemm tagħti fl- isfar.
The pH is between 7 and 8 and osmolality is between 300 and 500 mOsm/ kg.
Il- pH hu bejn 7 u 8 u l- osmolalità hi bejn 300 u 500 mOsm/ kg.
Reversal of neuromuscular blockade induced by rocuronium or vecuronium.
It- treġġigħ lura ta ’ imblokk newromuskolari kkaġunat minn rocuronium jew vecuronium.
For the peadiatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents.
Għall- popolazzjoni pedjatrika: sugammadex hu rakkomandat biss għat- treġġigħ lura ta ’ rutina ta ’ imblokk ikkaġunat minn rocuronium fit- tfal u fl- adolexxenti.
Sugammadex should only be administered by, or under the supervision of an anaesthetist.
Sugammadex għandu jingħata biss minn, jew taħt is- superviżjoni ta ’ anestetista.
The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade.
L- użu ta ’ teknika adattata ta ’ monitoraġġ newromuskolari hi rrakkomandata biex isir monitoraġġ ta ’ l- irkuprar ta ’ l - imblokk newromuskolari.
As is normal post-anesthetic practice following neuromuscular blockade it is recommended to monitor the patient in the immediate post-operative period for untoward events including re-occurrence of blockade (see section 4.4).
Bħal ma hi prattika normali post- anestetika wara imblokk newromuskolari, hu rrakkomandat li jsir monitoraġġ tal- pazjent fil- perjodu immedjatament wara l- operazzjoni għal avvenimenti mhux mistennija li jinkludu l- okkorrenza mill- ġdid ta ’ l- imblokk (ara sezzjoni 4. 4).
When certain medicinal products that may cause displacement interactions are administered parenterally within a period of 6 hours of sugammadex, the patient should be monitored for signs of re-occurrence of blockade (see section 4.4 and 4.5).
Meta ċerti prodotti mediċinali li jistgħu jikkawżaw interazzjonijiet ta ’ spostament jingħataw b’ mod parenterali fi żmien 6 sigħat minn x’ ħin ikun ingħata sugammadex, il- pazjent għandu jkun immonitorjat għal sinjali ta ’ okkorrenza mill- ġdid ta ’ imblokk (ara sezzjoni 4. 4 u 4. 5).
The recommended dose of sugammadex depends on the level of neuromuscular blockade to be reversed.
Id- doża rrakkomandata ta ’ sugammadex tiddependi fuq il- livell ta ’ l- imblokk newromuskolari li jrid ikun jitreġġa ’ lura.
The recommended dose does not depend on the anaesthetic regimen.
Id- doża rrakkomandata ma tiddependix fuq il- kors anestetiku.
Sugammadex can be used to reverse different levels of rocuronium or vecuronium induced neuromuscular blockade:
Sugammadex jista ’ jintuża biex ireġġa ’ lura livelli differenti ta ’ imblokk newromuskolari kkaġunat minn rocuronium jew vecuronium:
Routine reversal:
Treġġigħ lura ta ’ rutina:
A dose of 4 mg/ kg sugammadex is recommended if recovery has reached at least 1-2 post-tetanic counts (PTC) following rocuronium or vecuronium induced blockade.
Doża ta ’ 4 mg/ kg ta ’ sugammadex hi rrakkomandata jekk l- irkuprar ikun laħaq mill- inqas 1- 2 għadd post - tetaniċi (PTC) wara imblokk ikkaġunat minn rocuronium jew vecuronium.
Median time to recovery of the T4/ T1 ratio to 0.9 is around 3 minutes (see section 5.1).
Il- ħin medjan sa l- irkuprar tal - proporzjon T4/ T1 għal 0. 9 hu ta ’ madwar 3 minuti (ara sezzjoni 5. 1).
A dose of 2 mg/ kg sugammadex is recommended, if spontaneous recovery has occurred up to at least the reappearance of T2 following rocuronium or vecuronium induced blockade.
2 Doża ta ’ 2 mg/ kg ta ’ sugammadex hi rrakkomandata jekk irkuprar spontanju jkun seħħ sa mill- inqas sad- dehra mill- ġdid ta ’ T2 wara imblokk ikkaġunat minn rocuronium jew vecuronium.
Median time to recovery of the T4/ T1 ratio to 0.9 is around 2 minutes (see section 5.1).
Il- ħin medjan sa l- irkuprar tal- proporzjon T4/ T1 għal 0. 9 hu ta ’ madwar 2 minuti (ara sezzjoni 5. 1).
2 Using the recommended doses for routine reversal will result in a slightly faster median time to recovery of the T4/ T1 ratio to 0.9 of rocuronium when compared to vecuronium induced neuromuscular blockade (see section 5.1).
Li tuża d- dożi rrakkomandati għal treġġigħ lura ta ’ rutina ser jirriżulta f’ ħin medjan ftit iktar mgħaġġel sa l- irkuprar tal- proporzjon T4/ T1 għal 0. 9 ta ’ rocuronium meta mqabbel ma ’ imblokk newromuskolari kkaġunat minn vecuronium (ara sezzjoni 5. 1).
Immediate reversal of rocuronium-induced blockade:
Treġġigħ lura immedjat ta ’ imblokk ikkaġunat minn rocuronium:
If there is a clinical need for immediate reversal following administration of rocuronium a dose of 16 mg/ kg sugammadex is recommended.
Jekk ikun hemm ħtieġa klinika għal treġġigħ lura immedjat wara l- għoti ta ’ rocuronium, doża ta ’ 16 mg/ kg ta ’ sugammadex hi rrakkomandata.
When 16 mg/ kg sugammadex is administered 3 minutes after a bolus dose of 1.2 mg/ kg rocuronium bromide, a median time to recovery of the T4/ T1 ratio to 0.9 of approximately 1.5 minutes can be expected (see section 5.1).
Meta jingħataw 16 mg/ kg ta ’ sugammadex 3 minuti wara doża bolus ta ’ 1. 2 mg/ kg ta ’ rocuronium bromide, ħin medjan sa l- irkuprar tal- proporzjon T4/ T1 għal 0. 9 ta ’ madwar 1. 5 minuti jista ’ jkun mistenni (ara sezzjoni 5. 1).
There is no data to recommend the use of sugammadex for immediate reversal following vecuronium induced blockade.
M’ hemm l- ebda dejta biex tirrakkomanda l- użu ta ’ sugammadex għat- treġġigħ lura immedjat wara imblokk ikkaġunat minn vecuronium.
Re-administration of sugammadex:
L- għoti mill- ġdid ta ’ sugammadex:
In the exceptional situation of re-occurrence of blockade post-operatively (see section 4.4) after an initial dose of 2 mg/ kg or 4 mg/ kg sugammadex, a repeat dose of 4 mg/ kg sugammadex is recommended.
Fis- sitwazzjoni eċċezzjonali ta ’ l- okkorrenza mill- ġdid ta ’ imblokk wara l- operazzjoni (ara sezzjoni 4. 4) wara doża inizjali ta ’ 2 mg/ kg jew 4 mg/ kg ta ’ sugammadex, doża ripetuta ta ’ 4 mg/ kg ta ’ sugammadex hi rrakkomandata.
Following a second dose of sugammadex, the patient should be closely monitored to ascertain sustained return of neuromuscular function.
Wara t- tieni doża ta ’ sugammadex, il- pazjent għandu jkun immonitorat mill- qrib biex ikun żgurat ir- ritorn sostnut tal- funzjoni newromuskolari.
Re-administration of rocuronium or vecuronium after sugammadex:
L- għoti mill- ġdid ta ’ rocuronium jew vecuronium wara sugammadex:
A waiting time of 24 hours should be taken into account (see section 4.4).
Ħin ta ’ stennija ta ’ 24 siegħa għandu jkun ikkunsidrat (ara sezzjoni 4. 4).
Additional information on special population
Informazzjoni addizzjonali dwar popolazzjonijiet speċjali
Renal impairment:
Indeboliment renali:
For mild and moderate renal impairment (creatinine clearance ≥ 30 and < 80 ml/ min): the dose recommendations are the same as for adults.
Għal indeboliment renali ħafif u moderat (tneħħija tal- krejatinina ta ’ ≥ 30 u < 80 ml/ min): ir- rakkomandazzjonijiet tad- doża huma l- istess bħal dawk ta ’ l- adulti.
The use of sugammadex in patients with severe renal impairment (including patients requiring dialysis (CrCl < 30 ml/ min)) is not recommended (see section 4.4).
L- użu ta ’ sugammadex f’ pazjenti b’ indeboliment renali sever (li jinkludu pazjenti li jeħtieġu d- dijalisi (CrCl < 30 ml/ min)) mhuwiex rakkomandat (ara sezzjoni 4. 4).
Elderly patients:
Pazjenti anzjani:
After administration of sugammadex at reappearance of T2 following a rocuronium induced blockade, the median time to recovery of the T4/ T1 ratio to 0.9 in adults (18-64 years) was 2.2 minutes, in elderly adults (65-74 years) it was 2.6 minutes and in very elderly adults (75 years or more) it was 3.6 minutes.
Wara l- għoti ta ’ sugammadex meta T2 deher mill- ġdid wara imblokk ikkaġunat minn rocuronium, il- ħin medjan sa l- irkuprar tal- proporzjon T4/ T1 għal 0. 9 fl- adulti (minn 18 sa 64 sena) kien 2. 2 minuti, f’ adulti anzjani (minn 65 sa 74 sena) kien ta ’ 2. 6 minuti u f’ adulti anzjani ħafna (75 sena jew iktar) kien ta ’ 3. 6 minuti.
Even though the recovery times in elderly tend to be slower, the same dose recommendation as for adults should be followed (see section 4.4).
Għalkemm il- ħinijiet ta ’ l- irkuprar fl- anzjani għandhom tendenza li jkunu aktar bil- mod, l- istess rakkomandazzjoni tad- doża bħal dik ta ’ l- adulti għandha tkun segwita (ara sezzjoni 4. 4).
Obese patients:
Pazjenti ħoxnin ħafna:
In obese patients, the dose of sugammadex should be based on actual body weight.
F’ pazjenti ħoxnin ħafna, id- doża ta ’ sugammadex għandha tkun ibbażata fuq il- piż attwali tal- ġisem.
The same dose recommendations as for adults should be followed.
L- istess rakkomandazzjonijiet dwar id- doża bħal dawk ta ’ l- adulti għandhom ikunu segwiti.
Hepatic impairment:
Indeboliment epatiku:
For mild to moderate hepatic impairment: as sugammadex is mainly excreted renally no dose adjustments are required.
Għal indeboliment epatiku minn ħafif sa moderat: minħabba li sugammadex jitneħħa primarjament mill- kliewi, l- ebda aġġustamenti fid- doża mhuma meħtieġa.
Studies in patients with hepatic impairment have not been conducted and therefore patients with severe hepatic impairment should be treated with great caution (see section 4.4).
Ma sarux studji f’ pazjenti b’ indeboliment epatiku, u għalhekk pazjenti b’ indeboliment epatiku sever għandhom ikunu ttrattati bl- attenzjoni kbira (ara sezzjoni 4. 4).
Paediatric population:
Popolazzjoni pedjatrika:
The data for the paediatric population are limited (one study only for reversal of rocuronium induced blockade at reappearance of T2).
Id- dejta għall- popolazzjoni pedjatrika hi limitata (hemm studju wieħed biss dwar imblokk ikkaġunat mit- treġġigħ lura ta ’ rocuronium fid- dehra mill- ġdid ta ’ T2.
Children and adolescents:
Tfal u adolexxenti:
For routine reversal of rocuronium induced blockade at reappearance of T2 in children and adolescents (2-17 years) 2 mg/ kg sugammadex is recommended.
3 Għat- treġġigħ lura ta ’ rutina ta ’ imblokk ikkaġunat minn rocuronium meta T2 jidher mill- ġdid fit- tfal u fl- adolexxenti (minn 2 sa 17- il sena) doża ta ’ 2 mg/ kg ta ’ sugammadex hi rakkomandata.
Other routine reversal situations have not been investigated and are therefore not recommended until further data become available.
Sitwazzjonijiet oħrajn ta ’ treġġigħ lura ta ’ rutina ma kinux investigati u għalhekk mhumiex irrakkomandati sakemm dejta addizzjonali ssir disponibbli.
Immediate reversal in children and adolescents has not been investigated and is therefore not recommended until further data become available.
It- treġġigħ lura immedjat fit- tfal u fl- adolexxenti ma kienx investigat u għalhekk mhuwiex irrakkomandat sakemm dejta addizzjonali ssir disponibbli.
3 Bridion 100 mg/ ml may be diluted to 10 mg/ ml to increase the accuracy of dosing in the paediatric population (see section 6.6).
Bridion 100 mg/ ml jista ’ jkun dilwit għal 10 mg/ ml biex tiżdied l- eżattezza tad- dożaġġ fil- popolazzjon pedjatrika (ara sezzjoni 6. 6).
Term newborn infants and infants:
Trabi tat- twelid u tfal żgħar:
There is only limited experience with the use of sugammadex in infants (30 days to 2 years), and term newborn infants (less than 30 days) have not been studied.
Hemm esperjenza limitata biss bl- użu ta ’ sugammadex fi tfal żgħar (minn 30 jum sa sentejn), u trabi tat- twelid (ta ’ inqas minn 30 jum) ma kinitx studjata.
The use of sugammadex in term newborn infants and infants is therefore not recommended until further data become available.
L- użu ta ’ sugammadex fi trabi tat- twelid u tfal żgħar għalhekk mhuwiex irrakkomandat sakemm dejta addizzjonali ssir disponibbli.
Method of administration
Kif jingħata
Sugammadex should be administered intravenously as a single bolus injection.
Sugammadex għandu jingħata ġol- vina bħala injezzjoni waħda bolus.
The bolus injection should be given rapidly, within 10 seconds directly into a vein or into an existing intravenous line (see section 6.6).
L- injezzjoni bolus għandha tingħata malajr, fi żmien 10 sekondi direttament ġo vina jew ġo linja eżistenti ġol- vini (ara sezzjoni 6. 6).
Sugammadex has only been administered as a single bolus injection in clinical trials.
Sugammadex għandu jingħata biss bħala injezzjoni waħda bolus fi provi kliniċi.
Monitoring respiratory function during recovery:
Il- monitoraġġ tal- funzjoni respiratorja matul l- irkuprar:
Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored following reversal of neuromuscular block.
Sapport ventilatorju hu obbligatorju għal pazjenti sakemm respirazzjoni spontanja adegwata terġa ’ sseħħ wara t- treġġigħ lura ta ’ imblokk newromuskolari.
Even if recovery from neuromuscular blockade is complete, other medicinal products used in the peri- and postoperative period could depress respiratory function and therefore ventilatory support might still be required.
Anki jekk l- irkuprar mill- imblokk newromuskolari jkun sħiħ, prodotti mediċinali oħrajn użati fil- perijodu ta ’ waqt u ta ’ wara l- operazzjoni jistgħu jnaqqsu l- funzjoni respiratorja u għalhekk is- sapport ventilatorju jista ’ jkun meħtieġ xorta waħda.
Should neuromuscular blockade reoccur following extubation, adequate ventilation should be provided.
Jekk l- imblokk newromuskolari jseħħ mill- ġdid wara l- estubazzjoni, ventilazzjoni adegwata għandha tkun ipprovduta.
Re-occurrence of blockade:
L- okkorrenza mill- ġdid ta ’ imblokk:
In clinical trials re-occurrence of blockade was reported mainly when sub-optimal doses (in dose finding studies) were administered.
Fi provi kliniċi, l- okkorrenza mill- ġdid ta ’ l- imblokk kienet irrappurtata primarjament meta ngħataw dożi li kienu taħt l- aħjar livell (fi studju dwar is- sejbien tad- doża).
In order to prevent re-occurrence of neuromuscular blockade, the recommended doses for routine or immediate reversal (see section 4.2) should be used.
Sabiex tkun evitata l- okkorrenza mill- ġdid ta ’ imblokk newromuskolari, id- dożi irrakkomandati għal treġġigħ lura ta ’ rutina jew immedjat (ara sezzjoni 4. 2) għandhom jintużaw.
Waiting times for re-administration with neuromuscular blocking agents after reversal with sugammadex:
Ħinijiet ta ’ stennija għall- għoti mill- ġdid b’ aġenti ta ’ l- imblokk newromuskolari wara t- treġġigħ lura b’ sugammadex:
If re-administration of rocuronium or vecuronium is required a waiting time of 24 hours is recommended.
Jekk l- għoti mill- ġdid ta ’ rocuronium jew vecuronium ikun meħtieġ, ħin ta ’ stennija ta ’ 24 siegħa hu rrakkomandat.
If neuromuscular blockade is required before the recommended waiting time has passed, a nonsteroidal neuromuscular blocking agent should be used.
Jekk l- imblokk newromuskolari jkun meħtieġ qabel ma ’ jkun għadda l- ħin ta ’ stennija rrakkomandat, għandha jintuża aġent ta ’ l- imblokk newromuskolari mhux sterojdi.
In patients with severe renal failure (creatinine clearance < 30 ml/ min) the excretion of sugammadex or the sugammadex-rocuronium complex was delayed, however in these patients there were no signs of re-occurrence of neuromuscular blockade.
F’ pazjenti b’ insuffiċjenza renali severa (tneħħija tal- krejatinina ta ’ < 30 ml/ min), it- tneħħija ta ’ sugammadex jew tal- kumpless sugammadex- rocuronium damet ma seħħet, madankollu f’ dawn il- pazjenti ma kien hemm l- ebda sinjali ta ’ l- okkorrenza mill- ġdid ta ’ imblokk newromuskolari.
Data from a limited number of renally impaired patients requiring dialysis indicate an inconsistent decrease of plasma levels of sugammadex by haemodialysis.
Dejta minn numru limitat ta ’ pazjenti b’ indeboliment renali li kienu jeħtieġu d- dijalisi, tindika tnaqqis inkonsistenti fil- livelli fil- plażma ta ’ sugammadex permezz ta ’ emodijalisi.
The use of sugammadex in patients with severe renal impairment is not recommended.
L- użu ta ’ sugammadex f’ pazjenti b’ indeboliment renali sever mhuwiex irrakkomandat.
Interactions due to the lasting effect of rocuronium or vecuronium:
4 Interazzjonijiet minħabba l- effett li jdum ta ’ rocuronium jew vecuronium:
When medicinal products which potentiate neuromuscular blockade are used in the post-operative period special attention should be paid to the possibility of re-occurrence of blockade.
Meta prodotti mediċinali li jsaħħu l- imblokk newromuskolari jintużaw fil- perijodu ta ’ wara l- operazzjoni, għandha tingħata attenzjoni speċjali għall- possibbiltà ta ’ l- okkorrenza mill- ġdid ta ’ l- imblokk.
Please refer to the package leaflet of rocuronium or vecuronium for a list of the specific medicinal products which potentiate neuromuscular blockade.
Jekk jogħġbok irreferi għall- fuljett fil- pakkett ta ’ rocuronium jew vecuronium għal lista ta ’ prodotti mediċinali speċifiċi li jsaħħu l- imblokk newromuskolari.
In case re-occurrence of blockade is observed, the patient may require mechanical ventilation and re-administration of sugammadex (see section 4.2).
F’ każ li tkun osservata l- okkorrenza mill- ġdid ta ’ l- imblokk, il- pazjent jista ’ jkollu bżonn ta ’ ventilazzjoni mekkanika u l- għoti mill- ġdid ta ’ sugammadex (ara wkoll sezzjoni 4. 2).
Potential interactions: • Capturing interactions:
Interazzjonijiet potenzjali: • Interazzjonijiet li jaqbdu:
4 Due to the administration of sugammadex, certain medicinal products could become less effective due to a lowering of the (free) plasma concentrations (see section 4.5, hormonal contraceptives).
Minħabba l- għoti ta ’ sugammadex, ċerti prodotti mediċinali jistgħu jsiru inqas effettivi minħabba t- tnaqqis tal- konċentrazzjonijiet fil- plażma (ħielsa) (ara sezzjoni 4. 5, kontraċettivi ormonali).
If such a situation is observed, the clinician is advised to consider the re-administration of the medicinal product, the administration of a therapeutically equivalent medicinal product (preferably from a different chemical class) and/ or non-pharmacological interventions as appropriate. • Displacement interactions:
Jekk tkun osservata sitwazzjoni bħal din, hu rrakkomandat li t- tabib kliniku jikkunsidra l- għoti mill- ġdid tal- prodott mediċinali, l- għoti ta ’ prodott mediċinali li jkun terapewtikament ekwivalenti (preferibbilment minn klassi differenti ta ’ kimiċi) u/ jew interventi mhux farmakoloġiċi, kif ikun xieraq. • Interazzjonijiet ta ’ spostament:
Due to the administration of certain medicinal products after sugammadex, theoretically rocuronium or vecuronium could be displaced from sugammadex.
Minħabba l- għoti ta ’ ċerti prodotti mediċinali wara sugammadex, teoretikament rocuronium jew vecuronium jistgħu jkunu spostati minn sugammadex.
As a result re-occurrence of blockade might be observed.
Bħala riżultat, l- okkorrenza mill - ġdid ta ’ l- imblokk tista ’ tkun osservata.
In this situation the patient must be ventilated.
F’ din is- sitwazzjoni, il- pazjent għandu jkun ivventilat.
Administration of the medicinal product which caused displacement should be stopped in case of an infusion.
L- għoti tal- prodott mediċinali li kkawża l- ispostament għandu jitwaqqaf f’ każ ta ’ infużjoni.
In situations when potential displacement interactions can be anticipated, patients should be carefully monitored for signs of re-occurrence of blockade (approximately up to 15 minutes) after parenteral administration of another medicinal product occurring within a period of 6 hours after sugammadex administration.
F’ sitwazzjonijiet fejn interazzjonijiet potenzjali ta ’ spostament jistgħu jiġu antiċipati, il - pazjenti għandhom ikunu mmonitorjati bir- reqqa għal sinjali ta ’ l- okkorrenza mill- ġdid ta ’ imblokk (għal madwar 15- il minuta) wara li jingħataw b’ injezzjoni prodott mediċinali ieħor li sseħħ f’ perijodu ta ’ 6 sigħat wara l- għoti ta ’ sugammadex.
Displacement interactions are at present only expected for a few drugs substances (toremifene, flucloxacillin and fusidic acid, see section 4.5).
Interazzjonijiet ta ’ spostament bħalissa huma mistennija biss għal ftit sustanzi ta ’ mediċini (toremifene, flucloxacillin u fusidic acid (ara sezzjoni 4. 5).
Light anaesthesia:
Loppju ħafif:
When neuromuscular blockade was reversed intentionally in the middle of anaesthesia in clinical trials, signs of light anaesthesia were noted occasionally (movement, coughing, grimacing and suckling of the tracheal tube).
Meta l- imblokk newromuskolari kien imreġġa ’ lura intenzjonalment f’ nofs l- għoti tal- loppju fil- provi kliniċi, sinjali ta ’ loppju ħafif kienu osservati kultant (ċaqliq, sogħla, tkerrih tal- wiċċ u sefsif tat- tubu trakeali).
If neuromuscular blockade is reversed, while anaesthesia is continued, additional doses of anaesthetic and/ or opioid should be given as clinically indicated.
Jekk l- imblokk newromuskolari jkun imreġġa ’ lura waqt li l- loppju jkompli jingħata, dożi addizzjonali ta ’ anestetiku u/ jew opjojdi għandhom jingħataw kif indikat klinikament.
Sugammadex is not metabolised nor excreted by the liver; therefore dedicated studies in patients with hepatic impairment have not been conducted.
Sugammadex mhuwiex metabolizzat u l- anqas imneħħi mill- fwied; għalhekk, ma sarux studji ddedikati għal dan l- aspett f’ pazjenti b’ indeboliment epatiku.
Patients with severe hepatic impairment should be treated with great caution.
Pazjenti b’ indeboliment epatiku sever għandhom jiġu ttrattati b’ attenzjoni kbira.
Use in Intensive Care Unit (ICU):
L- użu fit- Taqsima tal- Kura Intensiva (ICU):
Sugammadex has not been investigated in patients receiving rocuronium or vecuronium in the ICU setting.
Sugammadex ma kienx investigat f’ pazjenti li kienu qed jirċievu rocuronium jew vecuronium fi sfond ta ’ l- ICU.
Use for reversal of neuromuscular blocking agents other than rocuronium or vecuronium:
L- użu ta ’ mediċini għat- treġġigħ lura ta ’ l- imblokk newromuskolari, minbarra rocuronium jew vecuronium:
Sugammadex should not be used to reverse block induced by nonsteroidal neuromuscular blocking agents such as succinylcholine or benzylisoquinolinium compounds.
Sugammadex m’ għandux jintuża biex ireġġa ’ lura l- imblokk ikkaġunat minn mediċini ta ’ l- imblokk newromuskolari mhux sterojdi bħal sustanzi komposti ta ’ succinylcholine jew benzylisoquinolinium.
Sugammadex should not be used for reversal of neuromuscular blockade induced by steroidal neuromuscular blocking agents other than rocuronium or vecuronium, since there are no efficacy and safety data for these situations.
Sugammadex m’ għandux jintuża għat- treġġigħ lura ta ’ imblokk newromuskolari kkaġunat minn mediċini ta ’ l- imblokk newromuskolari sterojdi minbarra rocuronium jew vecuronium, għax m’ hemm l- ebda dejta dwar l- effikaċja u s- sigurtà għal dawn is- sitwazzjonijiet.
Limited data are available for reversal of pancuronium induced blockade, but it is advised not to use sugammadex in this situation.
Dejta limitata hi disponibbli għat- treġġigħ lura ta ’ imblokk ikkaġunat minn pancuronium, iżda hu rrakkomandat li ma tużax sugammadex f’ din is- sitwazzjoni.
Delayed recovery:
Dewmien fl- irkuprar:
Conditions associated with prolonged circulation time such as cardiovascular disease, old age (see section 4.2 for the time to recovery in elderly), or oedematous state may be associated with longer recovery times.
5 Kundizzjonijiet assoċjati ma ’ titwil fil- ħin taċ- ċirkolazzjoni, bħal mard kardjovaskulari, età avvanzata (ara sezzjoni 4. 2 għal ħin ta ’ l- irkupru fl- anzjani), jew stat edematuż, jistgħu jkunu assoċjati ma ’ ħinijiet itwal ta ’ l- irkupru.
Allergic reactions:
Reazzjonijiet allerġiċi:
Clinicians should be prepared for the possibility of allergic reactions and take the necessary precautions (see section 4.8).
It- tobba kliniċi għandhom ikunu ppreparati għall- possibbiltà ta ’ reazzjonijiet allerġiċi u għandhom jieħdu l- prekawzjonijiet meħtieġa (ara sezzjoni 4. 8).
Patients on a controlled sodium diet:
Pazjenti li qegħdin fuq dieta kkontrollata tas- sodium:
Each ml solution contains 9.7 mg sodium.
Kull ml ta ’ soluzzjoni fih 9. 7 mg ta ’ sodium.
A dose of 23 mg sodium is considered essentially ‘ sodium- free’.
Doża ta ’ 23 mg ta ’ sodium hi kkunsidrata li hi essenzjalment ‘ ħielsa mis- sodium ’.
If more than 2.4 ml solution needs to be administered, this should be taken into consideration by patients on a controlled sodium diet.
Jekk soluzzjoni ta ’ iktar minn 2. 4 ml tkun trid tingħata, dan il- fatt għandu jkun ikkunsidrat minn pazjenti li qegħdin fuq dieta kkontrollata tas- sodium.
QTc-interval prolongation:
Titwil ta ’ l- intervall QTc:
5 Two thorough QTc trials (N=146), both in conscious volunteers, demonstrated that sugammadex alone or in combination with rocuronium or vecuronium is not associated with QTc interval prolongation. The one-sided 95% upper confidence limits for the QTc difference to placebo were well below the 10 ms margin for each of the 12-13 evaluated timepoints in both studies.
95% tal- limiti ogħla ta ’ konfidenza unilaterali għad- differenza tal- QTc mal- plaċebo kienu ħafna taħt il- marġni ta ’ 10 ms għal kull wieħed mit- 12- 13 il- punt tal- ħin fiż- żewġ studji.