natgillin/translations-raw huggingface dataset:
Den orale absorption af cyclodextrin er generelt lav, og der forventes ingen effekt på ammende børn, som følge af administrationen af en enkelt dosis til ammende kvinder.
Oral absorption of cyclodextrins in general is low and no effects on the suckling child is anticipated following a single dose to the breast-feeding woman.
1. 700 patienter og 120 frivillige.
The safety of sugammadex has been evaluated based on an integrated safety database of approximately 1700 patients and 120 volunteers.
Den mest almindelig rapporterede bivirkning, dysgeusi (metallisk eller bitter smag) var mest set efter doser på 32 mg/ kg sugammadex eller højere.
The most commonly reported adverse reaction dysgeusia (metal or bitter taste) was mainly seen after doses of 32 mg/ kg sugammadex or higher.
Hos få personer blev der rapporteret allergilignende reaktioner (dvs. rødme, erytematøst udslæt) efter indgivelse af sugammadex, hvoraf en var bekræftet som mild allergisk reaktion.
In a few individuals allergic-like reactions (i. e. flushing, erythematous rash) following sugammadex were reported of which one was a confirmed mild allergic reaction.
Organklasse Immunsystemet
Body system Immune system disorders
Hyppighed Ikke almindelig (> 1/ 1. 000 til, < 1/ 100)
Subject incidence Uncommon (≥ 1/ 1000 to < 1/ 100)
4. 4)
Undesirable effect Allergic reactions (see section 4.4)
Almindelig (> 1/ 100 til, < 1/ 10) Ikke almindelig (> 1/ 1. 000 til, < 1/ 100)
Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1000 to < 1/ 100)
4. 4) Uønsket bevidsthed under anæstesi
Anaesthetic complication (see section 4.4) Unwanted awareness during anaesthesia
Meget almindelig (> 1/ 10) i frivillige
Very common (≥ 1/ 10) in volunteers
Anæstesi komplikation:
Anaesthetic complication:
Anæstesi komplikationer, antydet ved genopbygning af den neuromuskulære funktion, inkluderer bevægelse af ekstremiteter eller kroppen eller hoste under anæstesiproceduren eller under operation, grimasser, eller sutten på det trakeale rør.
Anaesthetic complications, indicative of the restoration of neuromuscular function, include movement of a limb or the body or coughing during the anaesthetic procedure or during surgery, grimacing, or suckling on the endotracheal tube.
4. 4 Let anæstesi.
See section 4.4 light anaesthesia.
Bevidsthed:
Awareness:
Der har været rapporteret få tilfælde af bevidsthed hos personer behandlet med sugammadex.
In sugammadex treated subjects a few cases of awareness were reported.
Relationen til sugammadex er ikke klar.
The relation to sugammadex is uncertain.
7 Genetablering af blokade:
Re-occurrence of blockade:
I databasen for de poolede fase I- III studier med en placebogruppe, var tilfældene af genetablering af blokade 2% efter sugammadex og 0% i placebogruppen, målt ved neuromuskulær monitorering.
7 In the data-base of pooled phase I-III studies with a placebo group, the incidence of re-occurrence of blockade as measured with neuromuscular monitoring was 2% after sugammadex and 0% in the placebo group.
4. 4).
Virtually all of these cases were from dose-finding studies in which a sub-optimal dose (less than 2 mg/ kg) was administered (see section 4.4).
Yderligere information om specielle patientgrupper
Additional information on special populations
I et klinisk forsøg hos patienter med lungekomplikationer i anamnesen, blev der rapporteret bronkospasmer, som en mulig relateret bivirkning for to patienter, årsagssammenhængen kunne ikke udelukkes.
In one clinical trial in patients with a history of pulmonary complications bronchospasm was reported as a possibly related adverse event in two patients and a causal relationship could not be fully excluded.
For alle patienter med lungekomplikationer i anamnesen, bør lægen være opmærksom på muligheden for forekomsten af bronkospasmer.
As with all patients with a history of pulmonary complications the physician should be aware of the possible occurrence of bronchospasm.
En begrænset database tyder på, at sikkerhedsprofilen for sugammadex (op til 4 mg/ kg) hos pædiatriske patienter svarede til sikkerhedsprofilen for voksne.
A limited database suggests that the safety profile of sugammadex (up to 4 mg/ kg) in paediatric patients was similar to that in adults.
I kliniske studier blev der rapporteret ét tilfælde af utilsigtet overdosering med 40 mg/ kg uden nogen signifikante uønskede virkninger.
In clinical studies, 1 case of an accidental overdose with 40 mg/ kg was reported without any significant undesirable effects.
I et tolerancestudie på mennesker blev sugammadex administreret i doser op til 96 mg/ kg.
In a human tolerance study sugammadex was administered in doses up to 96 mg/ kg.
Der blev ikke rapporteret om dosisrelateret bivirkninger eller alvorlige bivirkninger.
No dose related adverse events nor serious adverse events were reported.
Antidoter, ATC- kode:
Pharmacotherapeutic group: all other therapeutic products, ATC code:
Sugammadex er blevet administreret med doser fra 0, 5 mg/ kg til 16 mg/ kg i dosis- respons studier af rocuroniuminduceret blokade (0, 6; 0, 9; 1, 0 og 1, 2 mg/ kg rocuroniumbromid med og uden vedligeholdelsesdoser) og vecuroniuminduceret blokade (0, 1 mg/ kg vecuroniumbromid med og uden vedligeholdelsesdoser) på forskellige tidspunkter/ dybder af blokaden.
Sugammadex has been administered in doses ranging from 0.5 mg/ kg to 16 mg/ kg in dose response studies of rocuronium induced blockade (0.6, 0.9, 1.0 and 1.2 mg/ kg rocuronium bromide with and without maintenance doses) and vecuronium induced blockade (0.1 mg/ kg vecuronium bromide with or without maintenance doses) at different time points/ depths of blockade.
Der blev i disse studier set et tydeligt dosis- respons forhold.
In these studies a clear dose-response relationship was observed.
Klinisk effekt og sikkerhed:
Clinical efficacy and safety:
Sugammadex kan administreres på flere forskellige tidspunkter efter administration af rocuronium - eller vecuroniumbromid:
Sugammadex can be administered at several time points after administration of rocuronium or vecuronium bromide:
I et pivotalt studie fik patienter rocuronium - eller vecuroniumgruppen i randomiseret orden.
In a pivotal study patients were randomly assigned to the rocuronium or vecuronium group.
Efter den sidste dosis rocuronium eller vecuronium, ved 1- 2 PTC, blev 4 mg/ kg sugammadex eller 70 µg/ kg neostigmin administreret i randomiseret orden.
After the last dose of rocuronium or vecuronium, at 1-2 PTCs, 4 mg/ kg sugammadex or 70 mcg/ kg neostigmine was administered in a randomised order.
Tiden fra begyndelsen af administreringen af sugammadex eller neostigmin til revertering af T4 / T1 ratioen til 0, 9 var:
The time from start of administration of sugammadex or neostigmine to recovery of the T4/ T1 ratio to 0.9 was:
8 Tiden (minutter) fra administrering af sugammadex eller neostigmin ved dyb neuromuskulær blokade (1- 2 PTC) efter rocuronium eller vecuronium til revertring af T4 / T1 ratioen til 0, 9 Neuromuskulær blokker Rocuronium
Time (minutes) from administration of sugammadex or neostigmine at deep neuromuscular blockade (1-2 PTCs) after rocuronium or vecuronium to recovery of the T4/ T1 ratio to 0.9
Behandlingsregime Sugammadex (4 mg/ kg)
Treatment regimen Sugammadex (4 mg/ kg)
Neostigmin (70 µg/ kg)
Neostigmine (70 mcg/ kg)
N Median (minutter) Område Vecuronium
N Median (minutes) Range Vecuronium
N Median (minutter) Område
N Median (minutes) Range
neuromuskulær blokade:
Routine reversal – moderate neuromuscular blockade:
I et andet pivotalt studie fik patienter rocuronium - eller vecuroniumgruppen i randomiseret orden.
In another pivotal study patients were randomly assigned to the rocuronium or vecuronium group.
Efter den sidste dosis af rocuronium eller vecuronium, ved genetablering til T2, blev 2 mg/ kg sugammadex eller 50 µg/ kg neostigmin administreret i randomiseret orden.
After the last dose of rocuronium or vecuronium, at the reappearance of T2, 2 mg/ kg sugammadex or 50 mcg/ kg neostigmine was administered in a randomised order.
Tiden (minutter) fra administration af sugammadex eller neostigmin ved genetablering af T2 efter rocuronium eller vecuronium til revertering af T4/ T1 ratioen til 0, 9 Neuromuskulær blokker Rocuronium
Time (minutes) from administration of sugammadex or neostigmine at reappearance of T2 after rocuronium or vecuronium to recovery of the T4/ T1 ratio to 0.9 Neuromuscular blocking agent Rocuronium
Behandlingsregime Sugammadex (2 mg/ kg)
Treatment regimen Sugammadex (2 mg/ kg)
Neostigmin (50 µg/ kg)
Neostigmine (50 mcg/ kg)
Ved genetablering af T2 blev en dosis på 2 mg/ kg sugammadex eller 50 µg/ kg neostigmin administreret.
At the reappearance of T2 a dose of 2 mg/ kg sugammadex or 50 mcg/ kg neostigmine was administered.
Tiden (minutter) fra administration af sugammadex eller neostigmin ved genetablering af T2 efter rocuronium eller cisatracurium til revertering af T4 / T1 ratioen til 0, 9 Neuromuskulær blokker
Time (minutes) from administration of sugammadex or neostigmine at reappearance of T2 after rocuronium or cis-atracurium to recovery of the T4/ T1 ratio to 0.9 Neuromuscular blocking agent
Behandlingsregime Rocuronium og sugammadex (2 mg/ kg)
Treatment regimen Rocuronium and sugammadex (2 mg/ kg)
Cisatracurium og neostigmin (50 µg/ kg)
Cis-atracurium and neostigmine (50 mcg/ kg)
Tiden til revertering efter succinylcholininduceret neuromuskulær blokade (1 mg/ kg) blev sammenlignet med sugammadex (16 mg/ kg, 3 minutter senere) – induceret revertering fra rocuronium induceret neuromuskulær blokade (1, 2 mg/ kg).
The time to recovery from succinylcholine-induced neuromuscular blockade (1 mg/ kg) was compared with sugammadex (16 mg/ kg, 3 minutes later) – induced recovery from rocuronium-induced neuromuscular blockade (1.2 mg/ kg).
9 Tiden (minutter) fra administration af rocuronium og sugammadex eller succinylcholin ved genetablering af T1 10% Neuromuskulær blokker
Time (minutes) from administration of rocuronium and sugammadex or succinylcholine to recovery of the T1 10%
Behandlingsregime Rocuronium og sugammadex (16 mg/ kg)
Treatment regimen Rocuronium and sugammadex (16 mg/ kg)
Succinylcholin (1 mg/ kg)
Succinylcholine (1 mg/ kg)
I en samlet analyse blev følgende reverteringstider for 16 mg/ kg sugammadex efter 1, 2 mg/ kg rocuroniumbromid rapporteret:
In a pooled analysis the following recovery times for 16 mg/ kg sugammadex after 1.2 mg/ kg rocuronium bromide were reported:
Tiden (minutter) fra administration af sugammadex 3 minutter efter rocuronium til revertering af T4 / T1 ratioen til 0, 9; 0, 8 eller 0, 7
Time (minutes) from administration of sugammadex at 3 minutes after rocuronium to recovery of the T4/ T1 ratio to 0.9, 0.8 or 0.7
T4 / T1 til 0, 9
T4/ T1 to 0.9
T4 / T1 til 0, 8
T4/ T1 to 0.8
T4 / T1 til 0, 7
T4/ T1 to 0.7
N Median (minutter) Område
N Median (minutes)
65 1, 5 0, 5- 14, 3
65 1.5
65 1, 3 0, 5- 6, 2
65 1.3
65 1, 1 0, 5- 3, 3
65 1.1
Farmakokinetiske parametre som clearance og distributionsvolumen antages at være de sammen for nonkompleksbundet og kompleksbundet sugammadex i bedøvede patienter.
Pharmacokinetic parameters as clearance and volume of distribution are assumed to be the same for non-complex-bound and complex-bound sugammadex in anaesthetised subjects.
11- 14 liter.
The steady-state volume of distribution of sugammadex is approximately 11 to 14 litres.
Hverken sugammadex eller komplekset af sugammadex og rocuronium binder til plasmaproteiner eller erytrocytter, som blev vist in vitro med hankønsplasma og fuldblod.
Neither sugammadex nor the complex of sugammadex and rocuronium bind to plasma proteins or erythrocytes, as was shown in vitro using male human plasma and whole blood.
Sugammadex udviser lineær kinetik i dosisintervallet 1 til 16 mg/ kg, når det administreres som en i. v. - bolusdosis.
Sugammadex exhibits linear kinetics in the dosage range of 1 to 16 mg/ kg when administered as an IV bolus dose.
Elimineringshalveringstiden (t½) af sugammadex hos voksne er 1, 8 time og plasma clearance er estimeret til 88 ml/ min.
The elimination half-life (t½) of sugammadex in adults is 1.8 hours and plasma clearance is estimated to be 88 ml/ min.
Udskillelsen via fæces eller udåndet luft var mindre end 0, 02% af dosis.
Excretion via faeces or expired air was less than 0.02% of the dose.
Ældre og nedsat nyrefunktion:
Elderly and renal impairment:
De farmakokinetiske parametre baseret på farmakokinetiske modeller i typiske ældre og/ eller patienter med nedsat nyrefunktion er vist nedenfor:
The pharmacokinetic parameters based on pharmacokinetic modelling in typical elderly and/ or renally impaired patients are presented below:
Typiske subjekter (75 kg)
Typical subject (75 kg body weight) Adult Normal CrCL:
(40 år) 100 ml/ min
(40 years) 100 ml/ min
Voksne Mild nedsat
Adult Mild renal (40 years) impairment CrCL:
Voksne (40 år)
Adult Moderate renal (40 years) impairment CrCL:
11, 4 (23, 5%)
10
5, 2 (32, 9%)
11.4 (23.5%)
Ældre (75 år)
5.2 (32.9%)
Normal CrCL:
Elderly Normal CrCL:
Ældre (75 år)
Elderly Mild renal (75 years) impairment CrCL:
Ældre (75 år)
Elderly Moderate renal (75 years) impairment CrCL:
Pædiatrisk:
Paediatrics:
Farmakokinetik i pædiatriske patienter (n=51) i alderen fra 0 til 17 år blev evalueret ved at anvende populationsfarmakokinetisk (PK) analyse.
Pharmacokinetics in paediatric patients (n=51) with ages ranging from 0 to 17 years were evaluated using population pharmacokinetic (PK) analysis.
Hos patienter under 18 år stiger fordelingsvolumet og clearance med stigende alder.
In patients under age 18, volume of distribution and clearance increase with increasing age.
Variabiliteten af sugammadex- plasmakoncentrationen hos pædiatriske patienter er sammenlignelig med den for voksne.
Variability of plasma concentrations of sugammadex in paediatric patients is comparable to the variability in adult patients.
De farmakokinetiske (PK) parametre for to typiske pædiatriske patienter ses nedenfor:
The pharmacokinetic (PK) parameters of two typical paediatric patients are summarised below:
PK parametre af sugammadex i typiske pædiatriske patienter PK parametre Eliminationshalveringstiden (timer)
PK Parameters of sugammadex in typical paediatric patients PK Parameter Elimination Half-Life (h) Volume of Distribution at Steady State (l)
8 år) 0, 9
Child (Age:8 yr) 0.9 3.1
Unge (alder:
Adolescent (Age:
15 år) 1, 7
15 yr) 1.7 9.1
Clearance (ml/ min)
Clearance (ml/ min)
Race:
Race:
Der er ikke set nogen kliniske relevante forskelle i de farmakokinetiske parametre i et studie med raske japanere og kaukasiere.
In a study in healthy Japanese and Caucasian subjects no clinically relevant differences in pharmacokinetic parameters were observed.
Begrænsede data indikerer ikke forskelle i farmakokinetiske parametre i sorte eller afrikanske amerikanere.
Limited data does not indicate differences in pharmacokinetic parameters in Black or African Americans.
Sugammadex fjernes hurtigt fra de fleste organer; der er dog nogen retention af forbindelser i knogler og tænder hos rotter.
Sugammadex is rapidly cleared from most organs; however some retention of compound occurs in bone and teeth in the rat.
Den komponent der oftest er forbundet med den reversible binding er hydroxyapatit, den uorganiske matrix i disse væv.
The most likely component involved in the reversible binding is hydroxy apatite, the inorganic matrix in these tissues.
Hos unge rotter blev observeret hvidlig misfarvning af fortænderne og forstyrrelser i emaljedannelse ved gentagne doser.
Preclinical studies in young adult and mature rats have shown that this retention does not adversely affect tooth colour or bone quality, structure, turnover and development.
Disse exponeringsdoser var 48- 480 gange den kliniske exponering ved 4 mg/ kg.
In juvenile rats whitish discoloration was observed in the incisors and disturbance of enamel formation was observed upon repeated dosing, however at exposure levels of 48-480 times the clinical exposure at 4 mg/ kg.
Saltsyre 3, 7% og/ eller natriumhydroxid (til pH justering) Vand til injektionsvæsker
Hydrochloric acid 3.7% and or sodium hydroxide (to adjust pH) 11 Water for injections
Efter første åbning og fortynding er der vist kemisk og fysisk stabilitet i brug op til 48 timer ved 2 °C til 25 °C.
After first opening and dilution chemical and physical in-use stability has been demonstrated for 48 hours at 2 °C to 25 °C.
Hvis produktet ikke anvendes med det samme, er opbevaringstider og - forhold før brug af produktet brugerens ansvar og vil normalt ikke være længere end 24 timer ved 2 °C til 8 °C, medmindre fortyndingen er foretaget under kontrollerede og validerede aseptiske forhold.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Engangsanvendelige type I glas, hætteglas, lukket med grå chlorobutyl gummiprop med aluminium låg og aftageling forsejling.
Single use type I glass vial closed with grey chlorobutyl rubber stoppers with aluminium crimp-cap and flip-off seal.
Hætteglassets gummiprop indeholder ikke latex.
The rubber stopper of the vial does not contain latex.
10 hætteglas af 2 ml eller 10 hætteglas af 5 ml.
10 vials of 2 ml or 10 vials of 5 ml.
Hvis Bridion administreres via en infusionsslange, der også anvendes til andre lægemidler, er det vigtigt, at infusionsslangen skylles grundigt (f. eks. med 9 mg/ ml (0, 9% natriumchlorid)) mellem administreringen af Bridion og andre lægemidler, hvor der er set uforligelighed med Bridion, eller hvor forligeligheden med Bridion ikke er vist.
If Bridion is administered via the same infusion line that is also used for other medicinal products, it is important that the infusion line is adequately flushed (e. g. with sodium chloride 9 mg/ ml (0.9% solution)) between administration of Bridion and medicinal products for which incompatibility with Bridion has been demonstrated or for which compatibility with Bridion has not been established.
Sugammadex kan injiceres i intravenøse infusionsslanger med følgende intravenøse opløsninger: natriumchlorid 9 mg/ ml (0, 9%), glucose 50 mg/ ml (5%), natriumchlorid 4, 5 mg/ ml (0, 45%) og glucose 25 mg/ ml (2, 5%), Ringer- laktat opløsning, Ringers opløsning, glucose 50 mg/ ml (5%) i natriumchlorid 9 mg/ ml (0, 9%).
Sugammadex can be injected into the intravenous line of a running infusion with the following intravenous solutions: sodium chloride 9 mg/ ml (0.9%), glucose 50 mg/ ml (5%), sodium chloride 4.5 mg/ ml (0.45%) and glucose 25 mg/ ml (2.5%), Ringers lactate solution, Ringers solution, glucose 50 mg/ ml (5%) in sodium chloride 9 mg/ ml (0.9%).
6. 3).
For paediatric patients Bridion can be diluted using sodium chloride 9 mg/ ml (0.9%) to a concentration of 10 mg/ ml (see section 6.3).
Organon, Kloosterstraat 6, 5349 AB Oss, Holland
Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
12 8.
12 10.
Detaljeret information om dette produkt kan findes på hjemmeside for European Medicines Agency (EMEA) http: // www. emea. europa. eu
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Box 20 NL- 5340 BH Oss Holland
Box 20 NL-5340 BH Oss The Netherlands
Organon (Irland) Ltd Drynam Road Swords Co.
Organon (Ireland) Ltd Drynam Road Swords Co.
Pharmacovigilance Indehaveren af markedsføringstilladelsen skal sikre at pharmacovigilance systemet, som beskrevet i Markedsføringsansøgningen Modul 1. 8. 1, version 1. 2, er på plads og fungerer før og så længe produktet er på markedet.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Risk Management Plan Indehaveren af markedsføringstilladelsen vil udføre studier og yderligere pharmacovigilance aktiviteter detaljeret beskrevet i Pharmacovigilance Planen, som aftalt i Risk Management Planen (RMP) angivet i Markedsføringsansøgningen Modul 1. 8. 2, version 2. 0 samt enhver efterfølgende opdateret af RMP aftalt med CHMP.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.0 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.
Som beskrevet i CHMP Guideline for Risk Management Systemer for lægemidler til human brug, bør den opdaterede RMP indsendes samtidig med næste Periodiske Safety Update Report (PSUR).
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).
Herudover skal en opdateret RMP indsendes • Når der modtages ny information som kan have indflydelse på den gældende Safety Specifcation, Pharmacovigiliance Plan eller risiko- nedsættende aktiviteter • Indenfor 60 dage fra en vigtig (pharmacovigiliance eller risiko- nedsættende) milepæl er nået • Ved opfordring fra EMEA
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
15 BILAG III
15 ANNEX III
17 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
YDRE KARTON, 10 x 5 ml hætteglas
OUTER CARTON, 10 x 5 ml vials
Bridion 100 mg/ ml, injektionsvæske, opløsning sugammadex
Bridion 100 mg/ ml solution for injection sugammadex
1 ml indeholder 100 mg sugammadex (som natriumsalt).
1 ml contains 100 mg sugammadex (as sodium salt).
Andre hjælpestoffer: saltsyre 3, 7% og/ eller natriumhydroxid (til pH justering), vand til injektionsvæsker.
Other ingredients: hydrochloric acid 3.7% and/ or sodium hydroxide (to adjust pH), water for injections.
Intravenøs anvendelse.
IV Intravenous use.
Engangsanvendelse.
For single use only.
Kassér ubrugte opløsninger.
Discard any unused solution.
18 Opbevares under 30 °C.
18 Store below 30 °C.
Efter anbrud og fortynding opbevares i køleskab (2 °C til 8 °C) og skal anvendes inden for 24 timer.
After first opening and dilution, store at 2-8 °C and use within 24 hours.
Organon Kloosterstraat 6 5349 AB Oss Holland
Organon Kloosterstraat 6 5349 AB Oss The Netherlands
19 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
ETIKET TIL HÆTTEGLAS, 10 x 5 ml
VIAL LABEL, 10 x 5 ml vials
Bridion 100 mg/ ml, injektionsvæske sugammadex i. v.
Bridion 100 mg/ ml injection sugammadex IV
20 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
YDRE KARTON, 10 x 2 ml hætteglas
OUTER CARTON, 10 x 2 ml vials
21 Opbevares under 30 °C.
21 Store below 30 °C.
22 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
22 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
ETIKET TIL HÆTTEGLAS, 10 x 2 ml
VIAL LABEL, 10 x 2 ml vials
Bridion 100 mg/ ml injektionvæske, opløsning sugammadex
Bridion 100 mg/ ml solution for injection sugammadex
Læs denne indlægsseddel grundigt inden du får medicinen. • Gem indlægssedlen.
Read all of this leaflet carefully before you are given this medicine. • Keep this leaflet.
Du kan få brug for at læse den igen. • Spørg din anæstesilæge, hvis der er mere, du vil vide. • Tal med din anæstesilæge eller anden læge, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
You may need to read it again. • If you have further questions, ask your anaesthetist. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your anaesthetist or other doctor.
Bridions virkning og hvad du skal bruge det til 2.
What Bridion is and what it is used for 2.
Det du skal vide før du får Bridion 3.
Before Bridon is given 3.
Sådan gives Bridion 4.
How Bridion is given 4.
Sådan opbevares Bridion 6.
How Bridion is stored 6.