natgillin/translations-raw huggingface dataset:
Data fra kliniske undersøgelser indikerer, at der er en tendens til, at proportionen af behandlinger forbundet med dysfagi øges med højere doser injiceret ind i nakkemusklen.
Data from clinical studies indicate that there is a tendency for the proportion of treatments associated with dysphagia to increase with higher doses injected into the sternocleidomastoid muscle.
Smerter på injektionsstedet blev også indberettet.
Injection site pain was also reported.
De to hyppigst indberettede bivirkninger i en fase IV sammenlignende klinisk undersøgelse blandt toxin- naive patienter behandlet med NeuroBloc 10. 000 E til 15. 000 E var mundtørhed og synkebesvær, som blev indberettet med en hyppighed på henholdsvis 44% og 35%.
The two most commonly reported undesirable effects in a Phase IV comparative clinical study among toxin naïve patients treated with NeuroBloc 10,000 U to 15,000 U were dry mouth and dysphagia, which were reported at a frequency of 44% and 35%, respectively.
Bivirkninger, der forekom i alle undersøgelser, er angivet nedenfor i systemorganklasser i henhold til MedDRA- konventionen og i aftagende hyppighed, som er defineret på følgende måde:
Adverse reactions seen in all trials are listed below according to MedDRA system organ class and in decreasing frequency which is defined as follows:
Meget almindelig (> 1/ 10); almindelig (> 1/ 100 til < 1/ 10); usædvanlig (> 1/ 1000 til < 1/ 100).
Very Common (> 1/ 10); Common (> 1/ 100 to < 1/10); Uncommon (> 1/1000 to < 1/100).
Patienter med tidligere eksponering for Botulinum Toxin Type A
Patients with Prior Botulinum Toxin Type A Exposure
Systemorganklasser Nervesystemet
4 System Organ Class Nervous system disorders
Meget almindelig mundtørhed
Very Common dry mouth
Almindelig torticollis (forværring fra basislinie), smagsforvrængning
Common torticollis (worsening from baseline), taste perversion
stemmeændring
voice alteration
Mave- tarmkanalen Knogler, led, muskler og bindevæv
Gastrointestinal disorders Musculoskeletal connective tissue and bone disorders
dysfagi
dysphagia
dyspepsi myasteni
dyspepsia myasthenia
Smerter på injektionsstedet
injection site pain
nakkesmerter
neck pain
Patienter uden tidligere eksponering for Botulinum toxiner
Patients Naïve to Botulinum Toxins
Systemorganklasser Nervesystemet
Respiratory thoracic and mediastinal disorders
Meget almindelig mundtørhed, hovedpine
Very Common dry mouth, headache
Almindelig torticollis
Common torticollis blurred vision dysphonia
Mave- tarmkanalen Almene symptomer og reaktioner på administrationsstedet
Gastrointestinal disorders General disorders and administration site conditions
dyspepsi smerter på injektionsstedet
dyspepsia injection site pain
Ligesom det gælder for Botulinum Toxin Type A, kan der i fjerne muskler optræde elektrofysiologisk tremor, som ikke er forbundet med klinisk svaghed eller andre elektrofysiologiske abnormiteter.
In common with Botulinum Toxin Type A, electrophysiological jitter, which is not associated with clinical weakness or other electrophysiological abnormalities, may be experienced in some distant muscles.
Der er indberettet bivirkninger relateret til spredning af toxin fjernt fra indgivelsesstedet (forøget muskelsvaghed, dysfagi, dyspnø, aspirationspneumoni – i nogle tilfælde med fatalt udfald) (se afsnit 4. 4).
Post marketing experience Side effects related to spread of toxin distant from the site of administration have been reported (exaggerated muscle weakness, dysphagia, dyspnoea, aspiration pneumonia with fatal outcome in some cases) (see section 4.4).
Følgende virkninger er også blevet indberettet under brugen efter markedsføringen: unormal tilpasning, ptose, opkastning, obstipation, influenzalignende symptomer og asteni.
The following effects have also been reported during post marketing use: abnormal accommodation, ptosis, vomiting, constipation, flu-like symptoms, and asthenia.
Doser på indtil 15. 000 enheder har i sjældne tilfælde medført klinisk signifikant systemisk toksicitet hos voksne.
Doses of up to 15,000 U have infrequently resulted in clinically significant systemic toxicity in adults.
Hos børn (ikke- godkendt anvendelse) er klinisk signifikant systemisk toksicitet imidlertid indtruffet ved doser, der er godkendt til behandling af voksne patienter.
However, in children (non-approved use) clinically significant systemic toxicity has occurred at doses approved for the treatment of adult patients.
Som for andre botulinum toksiner vil spontan helbredelse indtræde i løbet af en periode.
As with other botulinum toxins spontaneous recovery will occur over a period of time.
Farmakoterapeutisk klassifikation: perifert virkende muskelrelaksantia, ATC- kode:
Pharmacotherapeutic group: muscle relaxant, peripherally acting agent, ATC code:
NeuroBlocs virkningsmekanisme, der blokerer neuromuskulær transmission, sker ved en 3- trins proces:
The mechanism of action of NeuroBloc in blocking neuromuscular conduction occurs by a three-step process:
Ekstracellulær binding af toxinet til specifikke receptorer på motoriske nerveender.
Extracellular binding of the toxin to specific acceptors on motor nerve terminals 2.
3.
Internalisation and release of the toxin into the cytosol of the nerve terminals 3.
Mekanismen, hvorved muskelparalysen i tidens løb reverseres, er stadig ukendt, men kan være forbundet med den intraneuronale omdannelse af det påvirkede protein og/ eller fremskydning af nerveenden.
The mechanism by which muscle paralysis is reversed over time remains unknown, but may be associated with the intraneuronal turnover of the affected protein and/ or sprouting of the nerve ending.
To fase III randomiserede, multicenter, dobbeltblinde, placebo- kontrollerede undersøgelser er blevet udført hos patienter med cervikal dystoni.
Two Phase III randomised, multicentre, double-blind, placebo-controlled studies were conducted in patients with cervical dystonia.
Begge undersøgelser inkluderede voksne patienter (≥ 18 år), som i anamnesen havde modtaget Botulinum Toxin Type A.
Both studies enrolled adult patients (≥ 18 years) who had a history of receiving Botulinum Toxin Type A.
Den første undersøgelse inkluderede
The first study enrolled patients who were clinically resistant to type A toxin (A-non responders), confirmed by a Frontalis Type A test.
Den anden undersøgelse inkluderede patienter, som fortsatte med at reagere på type A toxin (A- responsive).
The second study enrolled patients who continued to respond to type A toxin (A-responders).
Ved indtrædelsen i undersøgelsen havde alle patienter på Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) – et totalt score på 20 eller derover med mindst to muskler involveret, ingen halskontrakturer eller andre årsager til nedsat halsbevægelsesområde, og ingen anamnese med nogen anden neuromuskulær sygdom.
On enrolment all patients had Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total scores of 20 or greater with at least two muscles involved, no neck contractures or other causes of decreased neck range of motion, and no history of any other neuromuscular disorder.
TWSTRS består af tre underskalaer, der undersøger sværhedsgrad, smerter og invaliditet.
The TWSTRS is comprised of three sub-scales which examine severity, pain and disability.
I den første undersøgelse blev type A resistente patienter (A- ikke responsive) randomiseret til at modtage placebo eller 10. 000 E NeuroBloc, og i den anden blev type A toxin responsive patienter (A- responsive) randomiseret til at modtage placebo, 5000 E eller 10. 000 E toxin.
In the first study, type A resistant patients (A-non responders) were randomised to receive placebo or 10,000 U of NeuroBloc and in the second, type A toxin responsive patients (A-responders) were randomised to receive placebo, 5000 U or 10,000 U of toxin.
Undersøgelseslægemidlet blev injiceret ved en enkelt lejlighed i 2 - 4 af følgende muskler: splenius capitus, sternocleidomastoid, levator scapulae, trapezius, semispinalis capitus og scalene.
Study drug was injected on a single occasion into 2 to 4 of the following muscles: splenius capitus, sternocleidomastoid, levator scapulae, trapezius, semispinalis capitus and scalene.
Den primære effektresultatsvariabel for begge undersøgelser var det totale score på TWSTRS (muligt scoreområde er 0- 87) i uge 4.
The primary efficacy outcome variable for both studies was the TWSTRS-Total score (range of possible scores is 0-87) at Week 4.
Analyse af TWSTRS- underskalaerne viste signifikante effekter på sværhedsgraden af cervikal dystoni samt tilknyttede smerter og invaliditet.
Analysis of the TWSTRS sub scales revealed significant effects on the severity of cervical dystonia and its associated pain and disability.
Foreløbige analyser af disse undersøgelser antyder, at de fleste patienter, som viste en gunstig respons i den 4. uge eller tidligere, var vendt tilbage til deres basislinie- status mellem 12 - 16 uger efter deres injektion.
Exploratory analyses of these studies suggested that the majority of patients who showed a beneficial response by the fourth week had returned to their baseline status between 12 to 16 weeks after their injection.
(A- Resistente Patienter)
(A-Resistant Patients)
(A- Responsive Patienter)
(A-Responsive Patients)
Vurderinger TWSTRS- Total
Assessments TWSTRS-Total
10. 000 E Placebo n = 39 n = 36
10,000 U Placebo n = 39 n = 36
5000 E n = 36
5000 U n = 36
10. 000 E n = 37
10,000 U n = 37
Middel ved Basislinie Middel ved Uge 4 Ændring fra Basislinie P- Værdi * Patient - Global
Mean At Baseline Mean at Week 4 Change from Baseline P-Value* Patient Global
51, 2 49, 2 - 2, 0
51.2 49.2 -2.0
52, 8 43, 6 41, 8 39, 3 - 11, 1 - 4, 3 0, 0001
52.8 43.6 41.8 39.3 -11.1 -4.3 0.0001
46, 4 37, 1 - 9, 3 0, 0115
46.4 37.1 -9.3 0.0115
46, 9 35, 2 - 11, 7 0, 0004
46.9 35.2 -11.7 0.0004
Middel ved Uge 4 P- Værdi * Læge - Global
Mean at Week 4 P-Value* Physician Global
39, 5
39.5
60, 2 43, 6 0, 0001
60.2 43.6 0.0001
60, 6 0, 0010
60.6 0.0010
64, 6 0, 0001
64.6 0.0001
Middel ved Uge 4 P- Værdi *
Mean at Week 4 P-Value*
47, 9
47.9
60, 6 52, 0 0, 0001
60.6 52.0 0.0001
65, 3 0, 0011
65.3 0.0011
64, 2 0, 0038
64.2 0.0038
* Analyse af kovarians, to- grenede prøver, α = 0, 05
* Analysis of covariance, two-tailed tests, α = 0.05
I en yderligere foreløbig analyse af varigheden af effekt anvendtes data fra en fase II- undersøgelse ud over de beskrevne data fra fase III.
A further exploratory analysis of duration of effect employed data from a Phase II study in addition to the Phase III data described.
Hos patienterne, som reagerede på behandling (dem, som oplevede en forbedring i TWSTRS på mere end 20% over basislinie) blev følgende varighed af effekt observeret ved doser på 5000 og 10. 000 E.
In the patients who responded to treatment (those who experienced an improvement in TWSTRS greater than 20% over baseline) the following duration of effect was observed at doses of 5000 and 10,000 U.
Varighed af effekt hos responsive
Duration of Effect in Responders
6
Dose
Dosis
4 Weeks
Varighed Af Effekt (% Responsive)
8 Weeks 12 Weeks
Uger 43
43
8 Uger 12 Uger 22 16
22
16 Uger 19
16
10. 000 E I Alt
10,000 U Overall
I undersøgelser med åben etiket blev doser på op til 15. 000 E givet til patienter med intervaller på ikke mindre end 12 uger.
In open-label studies, doses up to 15,000 U were given to patients at intervals of not less than 12 weeks.
Procentdelen af patienter, der reagerede på disse injektioner, lignede dem i de kontrollerede nøgleundersøgelser.
The proportion of patients who responded to these injections was similar to that in the key controlled studies.
Der blev udført et fase IV randomiseret, multicenter, dobbeltblindt forsøg for at sammenligne effekten af NeuroBloc (10. 000 E) med Botulinum Toxin Type A (150 E) hos patienter med cervikal dystoni, som aldrig tidligere havde været behandlet med et botulinum toxin- produkt.
A Phase IV randomised, multicentre, double-blind study was conducted to compare the efficacy of NeuroBloc (10,000 U) to Botulinum Toxin Type A (150 U) in patients with cervical dystonia who have never previously received a botulinum toxin product.
Der blev udført en endelig analyse af de i alt 93 rekrutterede botulinum behandlingsnaive patienter (46 i NeuroBloc gruppen) efter en enkelt injektion i 2 ud af 4 forudbestemte muskler.
Final analysis was carried out on a total of 93 enrolled botulinum naive patients (46 in the NeuroBloc group) following a single injection, into 2 of 4 predetermined muscles.
Basislinie- vurderinger, inklusive TWSTRS og VAS smerteevaluering, evalueret af patienten og investigatoren, blev gentaget 4, 8 og 12 uger efter behandlingen.
Baseline assessments, including TWSTRS and VAS pain evaluation by patient and investigator, were repeated at 4, 8 and 12 weeks after treatment.
Den primære effektanalyse påviser, at NeuroBloc ikke er ringere end Type A- toxin, som vist ved det totale TWSTRS- score ved behandlingsrunde 1, uge 4, for PP- populationen.
The primary efficacy analysis demonstrates the noninferiority of NeuroBloc to Type A toxin as shown by the TWSTRS total score at session 1, week 4, for the PP population.
Med undtagelse af forsøgssted 121 var det gennemsnitlige score for NeuroBloc og Type A- toxin henholdsvis 32, 7 (SD 11, 61) og 36, 0 (SD 11, 71) med et 95% konfidensinterval (CI) på henholdsvis 29, 3, 36, 2 og 32, 6, 39, 4.
Excluding site 121, the mean scores for NeuroBloc and Type A toxin were 32.7 (SD 11.61) and 36.0 (SD 11.71) respectively with a 95% CI of 29.3, 36.2 and 32.6, 39.4 respectively.
Dette ligger godt inden for det prædefinerede kriterium for non- inferioritet med 4 point i middelforskellen mellem grupperne, justeret for basislinie for TWSTRS.
The upper limit of the 1-sided CI in the LS mean difference (NeuroBloc - type A toxin) in the TWSTRS total score at week 4 of session 1 for the PP population (excluding site 121) was 0.6 which is well within the predefined criterion for noninferiority of 4 points in the mean difference between groups adjusted for baseline for the TWSTRS.
Disse fund førte til den samme konklusion, når forsøgssted 121 var inkluderet.
These findings led to an identical conclusion when site 121 was included.
Robustheden af denne analyse blev bekræftet af yderligere analyser, der beregnede den enkeltsidede 97, 5% CI, analyser der anvendte de ikke- justerede scores samt analyser, der anvendte ITT - og interim- CSR- PP- populationerne.
7 The robustness of this analysis was confirmed by additional analyses that calculated the 1-sided 97.5% CI, analyses using the unadjusted scores, and analyses using the ITT and interim CSR PP populations.
En lignende forbedring blev set hos forsøgspersoner, der oplevede mindst et 20% fald fra basislinie i TWSTRS- score ved uge 4 af behandlingsrunde 1 (51% NeuroBloc, 47% Botox).
In this regard the noninferiority of NeuroBloc compared to Botulinum Toxin Type A is also supported by a responder analysis using the ITT population, which showed that a similar percentages of subjects showed any improvement in the TWSTRS score at Week 4 of Session 1 (86% NeuroBloc and 85% Botox), as did subjects who experienced at least a 20% decrease from baseline in the TWSTRS score at Week 4 of Session 1 (51% NeuroBloc, 47% Botox).
Der er udført et fase IV forsøg med åben etiket med henblik på at evaluere sikkerheden, immunogeniciteten og effekten af gentagne doser NeuroBloc hos forsøgspersoner med cervikal dystoni (CD), som tidligere var behandlet med botulinum toxin type A.
A Phase IV open label study has been conducted to evaluate the safety, immunogenicity and effect of repeated doses of NeuroBloc in subjects with cervical dystonia (CD) who were previously treated with Botulinum Toxin Type A.
De primære mål for det åbne forsøg var at evaluere sikkerheden, immunogeniciteten og effekten af gentagne doser NeuroBloc hos forsøgspersoner med CD, som allerede var resistente over for botulinum toxin type A sammenlignet med forsøgspersoner, som var responsive over for botulinum toxin type A.
The primary objectives of the open label study were to evaluate the safety, immunogenicity and effect of repeat doses of NeuroBloc in subjects with CD who were already resistant to Botulinum Toxin Type A compared to subjects who were responsive to Botulinum Toxin Type A..
Der blev rekrutteret i alt 130 forsøgspersoner omfattende 67 type A- resistente og 63 type A - responsive.
A total of 130 subjects were enrolled, comprising 67 Type A resistant and 63 type A responsive.
Forsøgspersonerne fik en startdosis på 10. 000 E NeuroBloc ved deres første behandling og efterfølgende doser, der trinvis - med doseringsintervaller på mindst 12 uger - blev forøget med 2. 500 eller 5. 000 E indtil en maksimumdosis på 25. 000 E.
Subjects were given a starting dose of 10,000 Units of NeuroBloc at their first treatment, then subsequent doses modified at increments of 2,500 or 5,000 units to a maximum of 25,000 units with a dosage interval of at least 12 weeks.
Otte af de 67 type A- resistente forsøgspersoner (11, 9%) havde udviklet neutraliserende antistoffer over for botulinum toxin type B inden afslutningen på de 4 behandlingscykler med NeuroBloc, og 15 ud af 67 forsøgspersoner (22, 4%) havde udviklet neutraliserende antistoffer på tidspunktet for interimanalyse af forsøget.
Eight of the 67 Type A resistant subjects (11.9%) had developed neutralising antibodies to Botulinum Toxin Type B within completion of 4 treatment cycles of NeuroBloc and 15 out of 67 subjects (22.4%) had developed neutralising antibodies at the time of interim study analysis.
Den tidligste udvikling af neutraliserende antistoffer blev observeret hos 2 ud af 67 forsøgspersoner (3%) 6- 9 måneder efter starten på NeuroBloc behandlingen.
The earliest development of neutralising antibodies was seen in 2 out of 67 subjects (3%) 6-9 months after the start of NeuroBloc treatment.
7 NeuroBloc behandlingen blev associeret med en lav hyppighed af udvikling af neutraliserende antistoffer over for botulinum toxin type B i løbet af det første behandlingsår.
NeuroBloc treatment was associated with a low incidence of development of neutralising antibodies to Botulinum Toxin Type B during the first year of treatment.
Tilstedeværelsen af antistoffer betyder ikke nødvendigvis resistens over for behandlingen, da antallet af patienter, der er fuldstændig resistente sandsynligvis vil være meget lavere, end resultaterne viser.
The presence of antibodies does not necessarily mean resistance to treatment as the number of patients truly resistant is likely to be much lower than the results indicate.
Derfor kan patienter, der er resistente over for botulinum toxin type A, få og over en lang periode have gavn af behandling med NeuroBloc.
Therefore patients resistant to Botulinum Toxin Type A may benefit from treatment with NeuroBloc and continue to experience this benefit over a long time period.
Efter lokal intramuskulær injektion af NeuroBloc blev der i 12% af de tilfælde af bivirkninger, der blev indberettet efter markedsføringen, observeret alvorlige bivirkninger, der kunne skyldes systemiske virkninger af Botulinum Toxin Type B (inklusive følgende bivirkninger: tørhed i munden, dysfagi og sløret syn).
Following local intramuscular injection of NeuroBloc serious adverse events that may have been due to systemic effects of Botulinum Toxin Type B, were observed in 12% of adverse drug reaction cases reported during the post-marketing experience (including the following adverse events: dry mouth, dysphagia and blurred vision).
Der er dog ikke udført farmakokinetiske undersøgelser eller absorptions -, distributions -, stofskifte - og eliminations - (ADME -) undersøgelser.
However, no pharmacokinetic or Absorption, Distribution, Metabolism and Excretion (ADME) studies have been performed.
Enkeltdosis farmakologiske undersøgelser af cynomolgus- aber har ikke vist andre virkninger end den forventede dosisafhængige paralyse af injicerede muskler samt en vis diffusion af toxin ved høje doser, som har fremkaldt lignende virkninger i nærliggende, ikke- injicerede muskler.
Single dose pharmacology studies in cynomolgus monkeys have shown no effects other than the anticipated dose-dependent paralysis of injected muscles, together with some diffusion of toxin at high doses producing similar effects in neighbouring non-injected muscles.
Enkeltdosis intramuskulære toksikologiske undersøgelser er blevet udført på cynomolgus- aber.
Single dose intramuscular toxicology studies have been performed in cynomolgus monkeys.
960 E/ kg.
The systemic No Observed Effect Level (NOEL) was shown to be approximately 960 U/ kg.
2400 E/ kg.
The dose resulting in death was 2400 U/ kg.
På grund af præparatets beskaffenhed, er der ikke blevet udført dyreforsøg for at fastslå NeuroBlocs carcinogene virkninger.
8 Because of the nature of the product, no animal studies have been carried out to establish the carcinogenic effects of NeuroBloc.
I udviklingsstudier var det dosisniveau, hvor der ikke blev observeret negative virkninger (NOAEL, No Observed Adverse Effect Dose Level) på rotter 1000 E/ kg/ dag for påvirkning af moderdyret og 3000 E/ kg/ dag for påvirkning af fosteret.
In the development studies, the No Observed Adverse Effect Dose Level (NOAEL) in rats was 1000 U/ kg/ day for maternal effects and 3000 U/ kg/ day for foetal effects.
Hos kaniner var NOAEL 0, 1 E/ kg/ dag for påvirkning af moderdyret og 0, 3 E/ kg/ dag for påvirkning af fosteret.
In rabbits, the NOAEL was 0.1 U/ kg/ day for maternal effects and 0.3 U/ kg/ day for foetal effects.
I fertilitetsstudierne var NOAEL 300 E/ kg/ dag for generel toksicitet hos både hanner og hunner og 1000 E/ kg/ dag for fertilitets - og reproduktionsresultater.
In the fertility studies the NOAEL was 300 U/ kg/ day for general toxicity in both males and females and 1000 U/ kg/ day for fertility and reproductive performance.
Dinatriumsuccinat Natriumklorid Humant serumalbumin (indeholdende natriumcaprylat og natriumacetyltryptophanat som hjælpestoffer) Saltsyre (til pH justering) Vand til injektion.
Disodium succinate Sodium chloride Human serum albumin (containing sodium caprylate andsodium acetyltryptophanate as excipients) Hydrochloric acid for pH adjustment) Water for injections
Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, må NeuroBloc ikke blandes med andre lægemidler.
In the absence of incompatibility studies, NeuroBloc must not be mixed with other medicinal products.
8 Fra et mikrobiologisk synspunkt bør produktet anvendes omgående, medmindre åbnings - / fortyndingsmetoden udelukker risiko for mikrobiel kontamination.
From a microbiological point of view, unless the method of opening/ dilution precludes the risk of microbial contamination the product should be used immediately.
Opbevares i køleskab (2°C - 8°C).
Store in a refrigerator (2oC - 8oC).
Anvendes produktet ikke herefter, skal det kasseres.
Within its shelf-life, the product may be stored below 25oC for up to 3 months, without being refrigerated again during this period, and must be withdrawn if not used after this.
NeuroBloc leveres i 3, 5 ml Type I hætteglas af glas, med silikoniserede grå butylgummipropper, som er forseglet med krympede aluminiumhætter.
NeuroBloc is supplied in 3.5 ml Type I glass vials, with siliconised grey butyl rubber stoppers oversealed by aluminium crimped caps.
Æske med 1 stk. hætteglas indeholdende 0, 5 ml, 1, 0 ml eller 2, 0 ml opløsning.
Carton containing a single vial containing 0.5 ml, 1.0 ml or 2.0 ml of solution.
NeuroBloc leveres som en klar og farveløs til lysegul steril injektionsopløsning i engangshætteglas.
9 NeuroBloc is provided as a clear and colourless to light yellow sterile injectable solution in vials for single use only.
Eventuelt ikke anvendt opløsning bør bortskaffes (se anvisningerne nedenfor).
Any unused solution should be discarded (see instructions below).
Hvis NeuroBloc opløsningen ikke er klar og farveløs/ lysegul, eller hvis hætteglasset synes beskadiget, bør produktet bortskaffes som biologisk farligt affald i overensstemmelse med lokale krav.
If the NeuroBloc solution is not clear and colourless/ light yellow or if the vial appears damaged the product should be discarded as Medical Biohazardous Waste in accordance with local requirements.
Injektionsvæsken i hætteglassene er brugsklar.
The solution in the vials is ready for use.