natgillin/translations-raw huggingface dataset:
Den fuldstændige liste over alle de indberettede bivirkninger ved Bridion fremgår af indlægssedlen.
For the full list of all side effects reported with Bridion, see the Package Leaflet.
Bridion bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for sugammadex eller andre af indholdsstofferne.
Bridion should not be used in people who may be hypersensitive (allergic) to sugammadex or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Bridion er større end risiciene til ophævelse af neuromuskulær blokade fremkaldt af rocuronium eller vecuronium.
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.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Bridion.
The Committee recommended that Bridion be given marketing authorisation.
Andre oplysninger om Bridion:
Other information about Bridion:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Bridion til N. V.
The European Commission granted a marketing authorisation valid throughout the European Union for Bridion to N. V.
Organon den 25. juli 2008.
Organon on 25 July 2008.
2/ 3 Den fuldstændige EPAR for Bridion findes her.
The full EPAR for Bridion can be found here.
EU- nummer EU/ 1/ 08/ 466/ 001
EU/ 1/ 08/ 466/ 001
Særnavn Bridion
Bridion
Styrke 100 mg/ ml
100 mg/ ml
Emballage Hætteglas (glas), gummiprop og aftageligt låg
Vial (glass), rubber stopper and flip-off cap
Indhold 2 ml (100 mg/ ml)
2 ml (100 mg/ ml)
Paknings- størrelse 10 x 2 ml
10 x 2 ml
PRODUKTRESUME
SUMMARY OF PRODUCT CHARACTERISTICS 1.
Bridion 100 mg/ ml injektionsvæske, opløsning
Bridion 100 mg/ ml solution for injection
1 ml indeholder sugammadexnatrium svarende til 100 mg sugammadex.
1 ml contains sugammadex sodium equivalent to 100 mg sugammadex.
2 ml indeholder sugammadexnatrium svarende til 200 mg sugammadex.
2 ml contains sugammadex sodium equivalent to 200 mg sugammadex.
5 ml indeholder sugammadexnatrium svarende til 500 mg sugammadex.
5 ml contains sugammadex sodium equivalent to 500 mg sugammadex.
4. 4).
Each ml contains 9.7 mg sodium (see section 4.4).
Klar, farveløs til let gullig opløsning. pH er mellem 7 og 8, og osmolaliteten er mellem 300 og 500 mOsm/ kg.
The pH is between 7 and 8 and osmolality is between 300 and 500 mOsm/ kg.
Revertering af neuromuskulær blokade induceret af rocuronium eller vecuronium.
Reversal of neuromuscular blockade induced by rocuronium or vecuronium.
For den pædiatriske population: sugammadex anbefales kun til rutine revertering af rocuronium - induceret blokade hos børn og unge.
For the peadiatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents.
Sugammadex bør kun blive administeret af, eller under overvågning af en anæstesilæge.
Sugammadex should only be administered by, or under the supervision of an anaesthetist.
Det anbefales at monitorere ophævelsen af den neuromuskulære blokade med en passende neuromuskulær monitoreringsteknik.
The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade.
Som ved almindelig postanæstesisk praksis efter en neuromuskulær blokade, anbefales det at monitorere patienten i den intermediære post- operative periode for utilsigtede hændelser, herunder genetablering af blokade (se pkt.
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).
4. 4 og 4. 5).
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).
Der anbefales en dosis på 4 mg/ kg sugammadex, hvis genopvågningen efter en rocuronium - eller vecuroniuminduceret blokade har nået mindst 1- 2 post- tetanic counts (PTC).
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.
5. 1).
Median time to recovery of the T4/ T1 ratio to 0.9 is around 3 minutes (see section 5.1).
2 En dosis på 2 mg/ kg sugammadex anbefales, hvis der er sket en spontan genopvågning op til mindst genetablering af T2 efter en rocuronium - eller vecuroniuminduceret blokade.
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.
5. 1).
Median time to recovery of the T4/ T1 ratio to 0.9 is around 2 minutes (see section 5.1).
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).
Hvis der er klinisk behov for øjeblikkelig revertering efter indgivelse af rocuronium, anbefales en dosis på 16 mg/ kg sugammadex.
If there is a clinical need for immediate reversal following administration of rocuronium a dose of 16 mg/ kg sugammadex is recommended.
5. 1).
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).
Gen- administration af sugammadex:
Re-administration of sugammadex:
4. 4) efter en initial dosis på 2 mg/ kg eller 4 mg/ kg sugammadex, anbefales en gen- administration af sugammadex på 4 mg/ kg.
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.
Efter den anden dosis sugammadex, skal patienten monitoreres tæt for at sikre vedvarende retablering af neuromuskulær funktion.
Following a second dose of sugammadex, the patient should be closely monitored to ascertain sustained return of neuromuscular function.
Gen- administration af rocuronium eller vecuronium efter sugammadex:
Re-administration of rocuronium or vecuronium after sugammadex:
4. 4).
A waiting time of 24 hours should be taken into account (see section 4.4).
Der anbefales samme dosering som til voksne.
For mild and moderate renal impairment (creatinine clearance ≥ 30 and < 80 ml/ min): the dose recommendations are the same as for adults.
4. 4).
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).
Efter indgivelse af sugammadex, ved genetablering af T2 efter en rocuroniuminduceret blokade, var mediantiden for revertering af T4/ T1 ratioen til 0, 9 hos voksne (18- 64 år) 2, 2 minutter, hos gamle patienter (65- 74 år) var den 2, 6 minutter, og hos ældre patienter (75 år eller mere) var den 3, 6 minutter.
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.
4. 4).
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).
4. 4).
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).
Pædiatriske patienter:
Paediatric population:
3 Til rutinemæssig revertering af tilbagevendelsen til T2 efter rocuroniuminduceret blokade hos børn og unge (2- 17 år) anbefales 2 mg/ kg sugammadex.
For routine reversal of rocuronium induced blockade at reappearance of T2 in children and adolescents (2-17 years) 2 mg/ kg sugammadex is recommended.
6. 6).
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).
6. 6).
The bolus injection should be given rapidly, within 10 seconds directly into a vein or into an existing intravenous line (see section 6.6).
Ventilering af patienterne er påkrævet indtil tilstrækkelig spontan respiration er reetableret efter revertering af neuromuskulær blokade.
Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored following reversal of neuromuscular block.
Selv om revertering af den neuromuskulære blokade er fuldstændig, kan andre lægemidler, som er anvendt i den peri - og postoperative periode, undertrykke den respiratoriske funktion, og derfor kan ventilering stadig være påkrævet.
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.
Tilbagevenden af blokade:
Re-occurrence of blockade:
I kliniske studier blev der hovedsageligt rapporteret om tilbagevenden af blokade, når suboptimale doser (i dose finding studier) blev administreret.
In clinical trials re-occurrence of blockade was reported mainly when sub-optimal doses (in dose finding studies) were administered.
4. 2) anvendes.
In order to prevent re-occurrence of neuromuscular blockade, the recommended doses for routine or immediate reversal (see section 4.2) should be used.
Ventetider for gen- administration af neuromuskulære blokerende stoffer efter revertering med sugammadex:
Waiting times for re-administration with neuromuscular blocking agents after reversal with sugammadex:
Hvis der kræves en gen- administration af rocuronium eller vecuronium anbefales en pause på 24 timer.
If re-administration of rocuronium or vecuronium is required a waiting time of 24 hours is recommended.
Hvis neuromuskulær blokade er påkrævet før den anbefalede ventetid er gået, bør et non- steroidt neuromuskulært blokerende stof anvendes.
If neuromuscular blockade is required before the recommended waiting time has passed, a nonsteroidal neuromuscular blocking agent should be used.
Der var dog ingen tegn på, at den neuromuskulære blokade vendte tilbage hos disse patienter.
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.
Data fra et begrænset antal patienter med dialysekrævende nedsat nyrefunktion tyder på et inkonsistent fald i plasmaniveauerne for sugammadex ved hæmodialyse.
Data from a limited number of renally impaired patients requiring dialysis indicate an inconsistent decrease of plasma levels of sugammadex by haemodialysis.
Anvendelse af sugammadex til patienter med alvorligt nyresvigt anbefales ikke.
The use of sugammadex in patients with severe renal impairment is not recommended.
Når lægemidler, der potenserer neuromuskulær blokade, anvendes postoperativt, bør man være særlig opmærksom på risikoen for tilbagevenden af blokade.
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.
I
Please refer to the package leaflet of rocuronium or vecuronium for a list of the specific medicinal products which potentiate neuromuscular blockade.
4. 2).
In case re-occurrence of blockade is observed, the patient may require mechanical ventilation and re-administration of sugammadex (see section 4.2).
Mulige interaktioner: • Bindings- interaktioner:
Potential interactions: • Capturing interactions:
4. 5, Hormonelle præventionsmidler).
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).
Hvis dette opstår, anbefales det lægen at overveje gen- administration af lægemidlet, administration af et terapeutisk lignende lægemiddel (her foretrækkes en anden kemisk klasse) og/ eller en ikke- farmakologisk intervention. • Fortrængnings- interaktioner:
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:
Som resultat heraf kan tilbagevenden af blokade opstå.
As a result re-occurrence of blockade might be observed.
15 minutter) efter parenteral administration af et andet lægemiddel, som gives i op til 6 timer efter sugammadex.
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.
4. 5).
Displacement interactions are at present only expected for a few drugs substances (toremifene, flucloxacillin and fusidic acid, see section 4.5).
Hvis neuromuskulær blokade reverterer mens anæstesien fortsættes, skal der gives yderligere doser anæsteticum og/ eller opioid som klinisk indiceret.
If neuromuscular blockade is reversed, while anaesthesia is continued, additional doses of anaesthetic and/ or opioid should be given as clinically indicated.
Derfor er der ikke udført dedikerede studier på patienter med nedsat leverfunktion.
Sugammadex is not metabolised nor excreted by the liver; therefore dedicated studies in patients with hepatic impairment have not been conducted.
Anvendelse til revertering af andre neuromuskulært blokerende stoffer end rocuronium/ vecuronium:
Use for reversal of neuromuscular blocking agents other than rocuronium or vecuronium:
Sugammadex bør ikke anvendes til revertering af blokade induceret af non- steroide neuromuskulært blokerende stoffer såsom succinylcholin - eller benzylisoquinoliniumforbindelser.
Sugammadex should not be used to reverse block induced by nonsteroidal neuromuscular blocking agents such as succinylcholine or benzylisoquinolinium compounds.
4. 2 for opvågningstiden hos ældre) eller ødematøs tilstand, kan medføre længere opvågningstider.
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.
4. 8).
Clinicians should be prepared for the possibility of allergic reactions and take the necessary precautions (see section 4.8).
Patienter på kontrolleret natrium diæt:
Patients on a controlled sodium diet:
En ml opløsning indeholder 9, 7 mg natrium.
Each ml solution contains 9.7 mg sodium.
En dosis på 23 mg natrium anses som ’ natriumfri ’.
A dose of 23 mg sodium is considered essentially ‘ sodium- free’.
Hvis der skal administreres mere end 2, 4 ml, bør det tages med i overvejelserne hos patienter på en kontrolleret natrium diæt.
If more than 2.4 ml solution needs to be administered, this should be taken into consideration by patients on a controlled sodium diet.
5 Forlænget QTc- interval:
QTc-interval prolongation:
Den ensidet øvre 95% øvre konfidensgrænse for QTc- forskellen til placebo var i begge studier godt under 10 ms marginen for hver af de 12- 13 måletidspunkter.
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.
I det kliniske program blev få tilfælde af forlænget QTc rapporteret (QTc > 500 ms eller QTc- øgning > 60 ms) i kliniske studier hvor patienter fik sugammadex i kombination med sevofluran eller propofol.
In the clinical program, a few cases of QTc prolongation were reported (QTc > 500 msec or QTc increases > 60 msec) in clinical trials in which patients received sugammadex in combination with sevoflurane or propofol.
Under anæstesi administreres adskillige lægemidler med potentiale for at forlænge QTc (f. eks. sevofluran).
During anaesthesia several medicinal products with the potential to prolong QTc (e. g. sevoflurane) are administered.
De rutinemæssige forholdsregler for behandling af arytmi skal tages med i betragtning.
The routine precautions for treating arrhythmia should be taken into consideration.
Der er ikke udført formelle kliniske interaktionsstudier hos voksne med sugammadex og andre lægemidler.
No interaction studies have been conducted in adults with sugammadex and other medicinal products.
Informationen i dette afsnit er baseret på bindingsaffinitet mellem sugammadex og andre lægemidler, ikke- kliniske eksperimenter og simuleringer, hvor der anvendes en model, der tager højde for den farmokodynamiske effekt af neuromuskulære blokkere og den farmakokinetiske interaktion mellem neuromuskulære blokkere og sugammadex.
The information in this section is based on binding affinity between sugammadex and other medicinal products, non-clinical experiments and simulations using a model taking into account the pharmacodynamic effect of neuromuscular blocking agents and the pharmacokinetic interaction between neuromuscular blocking agents and sugammadex.
På baggrund af in- vitro data og med de farmakokinetiske og anden relevant information taget i betragtning, forventes ingen klinisk signifikante farmakodynamiske interaktioner med andre lægemidler, med undtagelse af følgende:
Based on in-vitro data and taking into consideration pharmacokinetics and other relevant information, no clinically significant pharmacodynamic interaction with other medicinal products is expected, with exception of the following:
For toremifen, flucloxacillin og fusidinsyre kan fortrængnings- interaktioner ikke udelukkes (der forventes ingen klinisk relevante bindings- interaktioner).
For toremifene, flucloxacillin and fusidic acid displacement interactions could not be excluded (no clinically relevant capturing interactions are expected).
For hormonelle præventionsmidler kan klinisk relevante bindings- interaktioner ikke udelukkes (der forventes ingen fortrængnings- interaktioner).
For hormonal contraceptives a clinically relevant capturing interaction could not be excluded (no displacement interactions are expected).
4. 4):
Interactions potentially affecting the efficacy of sugammadex (see also section 4.4):
For toremifen, som har en relativ høj affinitetskonstant og relative høje plasmakoncentrationer, kan der forekomme nogen fortrængning af vecuronium eller rocuronium fra det dannede kompleks med sugammadex.
For toremifene, which has a relatively high affinity constant and relatively high plasma concentrations, some displacement of vecuronium or rocuronium from the complex with sugammadex could occur.
Revertering af T4/ T1 ratioen til 0, 9 kan derfor være forsinket hos patienter, som har fået toremifen på operationsdagen.
The recovery of the T4/ T1 ratio to 0.9 could therefore be delayed in patients who have received toremifene on the same day of the operation.
Intravenøs administration af flucloxacillin og fusidinsyre:
Intravenous administration of flucloxacillin and fusidic acid:
Intravenøs administration af fusidinsyre og store doser af flucloxacillin (infusion med 500 mg eller mere) kan forårsage nogen fortrængning af rocuronium eller vecuronium fra sugammadex.
Intravenous administration of fusidic acid and high dose flucloxacillin (infusion of 500 mg or more), may cause some displacement of rocuronium or vecuronium from sugammadex.
Anvendelse af disse lægemidler i den præoperative fase kan forårsage nogen forsinkelse af revertering af T4/ T1 ratioen til 0, 9.
The use of these medicinal products in the pre-operative phase may give some delay in the recovery of the T4/ T1 ratio to 0.9.
4. 4).
The use of these medicinal products in the post-operative phase after routine reversal during the surveillance period of 6 hours (see section 4.4) should be avoided.
Hvis administration af flucloxacillin eller fusidinsyre ikke kan undgås i denne periode, bør ventilationen observeres tæt, især i de første 15 minutter efter administrationen.
If administration of flucloxacillin or fusidic acid within this time period can not be avoided, ventilation should be closely observed, in particular during the first 15 minutes after dosing.
4. 2.
For re-administration of sugammadex see section 4.2.
4. 4):
Interactions potentially affecting the efficacy of other medicinal products (see also section 4.4):
Interaktionen mellem 4 mg/ kg sugammadex og et progestogen var forventet at føre til et fald i progestogeneksponeringen (34% af AUC) svarende til det fald, som ses, når en glemt daglig dosis af et oralt præventionsmiddel tages 12 timer for sent, hvilket kan medføre reduceret effektivitet.
The interaction between 4 mg/ kg sugammadex and a progestogen was predicted to lead to a decrease in progestogen exposure (34% of AUC) similar to the decrease seen when a missed daily dose of an oral contraceptive is taken 12 hours too late, which might lead to a reduction in effectiveness.
For østrogen forventes effekten at være mindre.
For estrogens, the effect is expected to be lower.
Derfor anses administration af en bolus- dosis sugammadex for at svare til én glemt daglig dosis af et oralt præventionsmiddel (enten kombinations - eller rent progestogenpræparat).
Therefore the administration of a bolus dose of sugammadex is considered to be equivalent to one missed daily dose of oral contraceptive steroids (either combined or progestogen only).
Hvis der anvendes et ikke- oralt hormonalt præventionsmiddel skal patienten de efterfølgende 7 dage anvende et alternativt ikke- hormonelt præventionsmiddel og følge rådene i indlægssedlen.
In the case of non-oral hormonal contraceptives, the patient must use an additional non hormonal contraceptive method for the next 7 days and refer to the advice in the package leaflet of the product.
6 I almindelighed påvirker sugammadex ikke laboratorieundersøgelser, dog med mulig undtagelse af serum progesteron måling og visse koagulationsparametre (aktiveret partiel tromboplastintid, protrombintid, protrombintid (international normaliseret ratio)).
6 In general sugammadex does not interfere with laboratory tests, with the possible exception of the serum progesterone assay and some coagulation parameters (activated partial thromboplastin time prothrombin time, prothrombin time (international normalized ratio)).
Denne påvirkning blev observeret i plasmaprøver tilsat en sugammadexkoncentration i samme område, som opnås for Cmax efter en dosis på 16 mg/ kg.
This interference was observed in plasma samples spiked with a concentration of sugammadex in the same range as obtained for Cmax after a dose of 16 mg/ kg.
Den kliniske relevans af disse resultater er usikker, da det ikke har været undersøgt hos patienter.
The clinical relevance of these findings is uncertain as this has not been studied in patients.
4. 4 skal også tages i betragtning, når det drejer sig om pædiatriske patienter.
The above mentioned interactions for adults and the warnings in section 4.4 should also be taken into account for the paediatric population.
Dyreforsøg viser ikke direkte eller indirekte skadelige virkninger for graviditet, embryoets/ fostrets udvikling, fødslen eller den postnatale udvikling.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/ foetal development, parturition or postnatal development.
Det er uvist, hvorvidt sugammadex udskilles i human modermælk.
It is unknown whether sugammadex is excreted in human breast milk.