natgillin/translations-raw huggingface dataset:
Supplerende oral antipsykotisk behandling bør derfor gives i de første 3 ugers behandling med RISPERDAL CONSTA (se pkt.
The effect of this dose adjustment should not be anticipated earlier than 3 weeks after the first injection with the higher dose.
4. 2).
Doses higher than 50 mg every 2 weeks are not recommended.
Terapeutiske plasmakoncentrationer vedbliver med at være til stede indtil 4- 6 uger efter sidste injektion af RISPERDAL CONSTA.
In patients with clinical factors such as hepatic or renal impairment or certain drug interactions that increase risperidone plasma concentrations (see section 4.5), dose reduction as low as 12.5 mg may be appropriate.
Der blev ikke observeret akkumulering af risperidon ved langvarig brug (12 måneder) hos patienter, der fik injiceret 25- 50 mg hver anden uge.
The efficacy of the 12.5 mg dose has not been investigated in clinical trials.
Fordeling Risperidon fordeles hurtigt.
Elderly No dose adjustment is required.
Fordelingsvolumenet er 1- 2 l/ kg.
The recommended dose is 25 mg intramuscularly every two weeks.
I plasma bindes risperidon til albumin og alfa- 1- glykoproteinsyre.
Where patients are not currently taking oral risperidone, the recommended dose is 25 mg RISPERDAL CONSTA every two weeks.
Plasmaproteinbindingen for risperidon er 90% og 77% for den aktive metabolit 9- hydroxyrisperidon.
For those patients on a fixed dose of oral risperidone for two weeks or more, the following conversion scheme should be considered.
Biotransformation og eliminering Risperidon metaboliseres af CYP 2D6 til 9- hydroxyrisperidon, som har farmakologisk aktivitet svarende til risperidon.
Sufficient antipsychotic coverage should be ensured during the three-week lag period following the first RISPERDAL CONSTA injection (see section 5.2).
Risperidon plus 9- hydroxyrisperidon udgør den aktive antipsykotiske fraktion.
RISPERDAL CONSTA clinical data in elderly are limited.
CYP 2D6 undergår genetisk polymorfisme.
RISPERDAL CONSTA should be used with caution in elderly.
32 9- hydroxyrisperidon, hvorimod personer med en langsom CYP 2D6- funktion omdanner det meget langsommere.
Hepatic and renal impairment RISPERDAL CONSTA has not been studied in hepatically and renally impaired patients.
In vitro- forsøg med humane levermikrosomer har vist, at risperidon i klinisk relevante koncentrationer ikke væsentligt inhiberer metaboliseringen af lægemidler, der metaboliseres af cytokrom P450- isozymer, bl. a.
If hepatically or renally impaired patients require treatment with RISPERDAL CONSTA, a starting dose of 0.5 mg twice daily oral risperidone is recommended during the first week.
Elimineringsfasen er afsluttet ca.
The second week 1 mg twice daily or 2 mg once daily can be given.
7- 8 uger efter sidste injektion af RISPERDAL CONSTA.
If an oral total daily dose of at least 2 mg is well tolerated, an injection of 25 mg RISPERDAL CONSTA can be administered every 2 weeks.
Linearitet Risperidons farmakokinetik efter enkeltdoser af RISPERDAL CONSTA er lineær i dosisområdet 12, 5- 75 mg.
Alternatively, a starting dose of RISPERDAL CONSTA of 12.5 mg may be appropriate.
Risperidons farmakokinetik er også lineær i dosisområdet 25- 50 mg injiceret hver anden uge.
The efficacy of the 12.5 mg dose has not been investigated in clinical trials.
35%.
Sufficient antipsychotic coverage should be ensured during the three-week lag period following the first RISPERDAL CONSTA injection (see section 5.2).
Køn, race og rygevaner En farmakokinetisk populationsanalyse viste ingen tydelig effekt af køn, race eller rygevaner på risperidons farmakokinetik eller den aktive antipsykotiske fraktion.
Paediatric population RISPERDAL CONSTA is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy.
5. 3 Prækliniske sikkerhedsdata
Method of administration
Svarende til (sub) kroniske toksicitetsforsøg med oral risperidon til rotter og hunde var hovedeffekten af behandling med RISPERDAL CONSTA (op til 12 måneders intramuskulær indgift) prolactinmedieret brystkirtelstimulation, ændringer i kønsorganer hos begge køn og påvirkninger af centralnervesystemet (CNS), forbundet med risperidons farmakodynamiske aktivitet.
RISPERDAL CONSTA should be administered every two weeks by deep intramuscular gluteal injection using the enclosed safety needle.
Risperidon var ikke teratogent i rotter og kaniner.
Injections should alternate between the buttocks.
I rotter blev intrauterin eksponering for risperidon forbundet med kognitive forstyrrelser (mangler) i voksne dyr.
Do not administer intravenously (see section 4.4 and section 6.6).
Der blev ikke observeret osteodystrofi i hunde, der blev behandlet i 12 måneder med op til 20 mg/ kg/ 2 uger RISPERDAL CONSTA.
22 For instructions on preparation and handling RISPERDAL CONSTA, see section 6.6.
Denne dosis gav plasmaeksponeringer på op til 14 gange den maksimalt anbefalede dosis til mennesker.
Hypersensitivity to the active substance or to any of the excipients.
33 Der var ingen evidens for potentiale for genotoksicitet.
4.4 Special warnings and precautions for use
Som det kunne forventes for en potent dopamin D2- antagonist, blev der i orale carcinogenicitetsforsøg med risperidon til rotter og mus observeret stigninger i hypofyseadenomer (mus), endokrine pankreasadenomer (rotter) og brystkirteladenomer (begge arter).
For risperidone-naive patients, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with RISPERDAL CONSTA (see section 4.2).
I et intramuskulært carcinogenicitetsforsøg med RISPERDAL CONSTA hos Wistar- rotter (Hannover) (doser på 5 og 40 mg/ kg/ 2 uger) blev der observeret øget incidens af tumorer i endokrin pankreas, hypofyse og binyremarv ved 40 mg/ kg, mens brystkirteltumorer blev observeret ved både 5 and 40 mg/ kg.
Elderly patients with dementia RISPERDAL CONSTA has not been studied in elderly patients with dementia, hence it is not indicated for use in this group of patients.
Disse tumorer, som er observeret ved oral og intramuskulær administration kan relateres til langvarig dopamin D2- antagonisme og hyperprolactinæmi.
Elderly patients with dementia treated with atypical antipsychotics have an increased mortality compared to placebo in a meta-analysis of 17 controlled trials of atypical antipsychotics, including oral RISPERDAL.
Studier i vævskulturer tyder på, at cellevækst i humane brysttumorer muligvis stimuleres af prolactin.
In placebo-controlled trials with oral RISPERDAL in this population, the incidence of mortality was 4.0% for RISPERDAL-treated patients compared to 3.1% for placebo- treated patients.
Hyperkalcæmia, som menes at bidrage til øget incidens af binyremarvtumorer hos rotter behandlet med RISPERDAL CONSTA, blev observeret i begge dosisgrupper.
The odds ratio (95% exact confidence interval) was 1.21 (0.7, 2.1).
Der er ingen evidens for, at hyperkalcæmi kan forårsage fæokromocytom hos mennesker.
The mean age (range) of patients who died was 86 years (range 67-100).
Der blev observeret adenomer i nyretubuli hos hanrotter behandlet med RISPERDAL CONSTA ved 40 mg/ kg/ 2 uger.
Concomitant use with furosemide
Mekanismen bag nyretumorerne i gruppen af Wistar- hanrotter (Hannover), som blev behandlet med RISPERDAL CONSTA, kendes ikke.
In the oral RISPERDAL placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%; mean age 89 years, range 75-97) when compared to patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96) or furosemide alone (4.1%; mean age 80 years, range 67-90).
En behandlingsrelateret stigning i incidensen af nyretumorer blev ikke observeret i de orale carcinogenicitetsforsøg med Wistar- rotter (Wiga) eller hos Swiss- mus, som modtog oral risperidon.
The increase in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials.
Der findes ingen data, som indikerer nyrerelaterede ændringer hos hunde, som har modtaget kronisk behandling med RISPERDAL CONSTA.
Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.
Det er uvist, hvilken relevans osteodystrofien, de prolactinmedierede tumorer og de formodede rotteunderracespecifikke nyretumorer har for risikoen hos mennesker.
No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed.
Lokal irritation på injektionsstedet blev observeret hos hunde og rotter efter indgift af høje doser af RISPERDAL CONSTA.
Nevertheless, caution should be exercised and the risks and benefits of this combination or co-treatment with other potent diuretics should be considered prior to the decision to use.
I et 24- måneders intramuskulært carcinogenicitetsforsøg med rotter blev der ikke observeret stigning i incidensen af tumorer på injektionsstedet i hverken vehikelgruppen eller de aktive grupper.
There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with risperidone.
Både in vivo og in vitro viser dyremodeller, at høje doser af risperidon kan forårsage forlængelse af QT - intervallet, hvilket er blevet forbundet med en teoretisk øget risiko for torsade de points hos patienterne.
Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be carefully avoided in elderly patients with dementia.
34 6. 5 Emballagetype og pakningsstørrelser
Cerebrovascular adverse events (CVAE)
6. 6 Regler for destruktion og anden håndtering Vejledning i anvendelse af trenålesystem
In placebo-controlled trials in elderly patients with dementia there was a significantly higher incidence (approximately 3-fold increased) of CVAEs, such as stroke (including fatalities) and transient ischaemic attack in patients treated with RISPERDAL compared with patients treated with placebo (mean age 85 years; range 73 to 97).
RISPERDAL CONSTA depotmikrosfærer i hætteglasset må kun rekonstitueres i opløsningsmidlet i den injektionssprøjte, der leveres i produktpakken, og må kun indgives med den Needle- Pro sikkerhedskanyle, der leveres i produktpakken.
The pooled data from six placebo-controlled studies in mainly elderly patients (> 65 years of age) with dementia showed that CVAEs (serious and non- serious, combined) occurred in 3.3% (33/ 1009) of patients treated with risperidone and 1.2% (8/ 712) of patients treated with placebo.
Udskift ikke delene i produktpakken.
The odds ratio (95% exact confidence interval) was 2.96 (1.34, 7.50).
For at sikre, at den ønskede risperidondosis indgives, skal hele indholdet af hætteglasset indgives.
The mechanism for this increased risk is not known.
Hvis kun noget af indholdet indgives, bliver hele den ønskede risperidondosis ikke indgivet.
An increased risk cannot be excluded for other antipsychotics or other patient populations.
Tag produktpakken med RISPERDAL CONSTA ud af køleskabet, og lad den få stuetemperatur inden rekonstitution.
RISPERDAL CONSTA should be used with caution in patients with risk factors for stroke.
Produktpakkens indhold:
23 Orthostatic hypotension
• Ét hætteglas indeholdende RISPERDAL CONSTA depotmikrosfærer • To Hypoint 20G 2 "TW- kanyler til rekonstitution • Én fyldt injektionssprøjte med opløsningsmiddel til RISPERDAL CONSTA • Én Needle- Pro- kanyle til intramuskulær injektion (20G 2" TW- sikkerhedskanyle med kanylebeskyttelseshylster)
Due to the alpha-blocking activity of risperidone, (orthostatic) hypotension can occur, especially during initiation of treatment.
Fjern det farvede plasticlåg fra hætteglasset.
Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment.
Åbn sprøjten ved at bryde lukningens forsegling, og fjern den hvide hætte sammen med gummihætten indeni.
Risperidone should be used with caution in patients with known cardiovascular disease (e. g. heart failure, myocardial infarction, conduction abnormalities, dehydration, hypovolemia, or cerebrovascular disease).
Hold sprøjten og kanylen, så de flugter, og sæt kanylen på luerspidsen af sprøjten med en let drejende bevægelse i retning med uret.
The risk/ benefit of further treatment with RISPERDAL CONSTA should be assessed if clinically relevant orthostatic hypotension persists.
Træk hylsteret af kanylen uden at vride.
Tardive dyskinesia/ extrapyramidal symptoms (TD/ EPS)
Injicer hele indholdet af sprøjten med opløsningsmiddel i hætteglasset.
Medicines with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical involuntary movements, predominantly of the tongue and/ or face.
Fjern sprøjten med kanylen fra hætteglasset.
The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia.
Skru kanylen af sprøjten, og kassér kanylen på passende måde.
If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics should be considered.
Åbn hylsteret på den anden rekonstitutionskanyle.
Neuroleptic malignant syndrome (NMS)
Hold den tomme sprøjte og kanylen, så de flugter, og sæt den anden kanyle på luerspidsen af sprøjten med en let drejende bevægelse i retning med uret.
Neuroleptic Malignant Syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels has been reported to occur with antipsychotics.
Fjern ikke hylsteret fra kanylen på nuværende tidspunkt.
Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Omryst hætteglasset omhyggeligt i mindst 10 sekunder, indtil suspensionen er ensartet.
In this event, all antipsychotics, including RISPERDAL CONSTA, should be discontinued.
36 HÆTTEGLASSET MÅ IKKE OPBEVARES EFTER REKONSTITUTION, DA SUSPENSIONEN SÅ KAN BUNDFÆLDES.
Parkinson’ s disease and dementia with Lewy bodies
Tag sprøjten, og træk hylsteret af rekonstitutionskanylen uden at vride.
Physicians should weigh the risks versus the benefits when prescribing antipsychotics, including RISPERDAL CONSTA, to patients with Parkinson’ s Disease or Dementia with Lewy Bodies (DLB).
Stik rekonstitutionskanylen i det opretstående hætteglas.
Parkinson’ s Disease may worsen with risperidone.
Træk langsomt suspensionen fra hætteglasset i opretstående position, men lidt skrå vinklet som vist på illustrationen for at sikre, at hele indholdet trækkes op i sprøjten.
Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Fjern sprøjten med kanylen fra hætteglasset.
Hyperglycemia
For at sikre identifikation skal den afrivelige del af hætteglassets etiket tages af og sættes på sprøjten.
Hyperglycemia or exacerbation of pre-existing diabetes has been reported in very rare cases during treatment with RISPERDAL CONSTA.
Kassér hætteglasset på passende måde.
Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.
Grib om hylsteret ved brug af posen.
Hyperprolactinaemia
Sæt luerstykket på Needle- Pro- udstyret på sprøjten med en let drejende bevægelse i retning med uret.
Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Sæt kanylen fast i Needle- Pro- udstyret med et tryk og et vrid i urets retning.
RISPERDAL CONSTA should be used with caution in patients with pre- existing hyperprolactinaemia and in patients with possible prolactin-dependent tumours.
Forbered patienten på injektion.
QT prolongation QT prolongation has very rarely been reported postmarketing.
RESUSPENDER MIKROSFÆRERNE I SPRØJTEN VED AT OMRYSTE KRAFTIGT.
As with other antipsychotics, caution should be exercised when risperidone is prescribed in patients with known cardiovascular disease, family history of QT prolongation, bradycardia, or electrolyte disturbances (hypokalaemia, hypomagnesaemia), as it may increase the risk of arrhythmogenic effects, and in concomitant use with medicines known to prolong the QT interval.
11.
24 Seizures
Bank let på sprøjten for at få eventuelle luftbobler til at stige op til toppen.
RISPERDAL CONSTA should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Injicer hele sprøjtens indhold intramuskulært i patientens balle.
Priapism Priapism may occur with RISPERDAL CONSTA treatment due to its alpha-adrenergic blocking effects.
MÅ IKKE INDGIVES INTRAVENØST.
Body temperature regulation
ADVARSEL:
Disruption of the body’ s ability to reduce core body temperature has been attributed to antipsychotic medicines.
Undlad følgende for at undgå kanylestikskader med kontaminerede kanyler: • At frigøre Needle- Pro- udstyret med vilje • At forsøge at rette kanylen ud eller bruge Needle- Pro- udstyret, hvis kanylen er bukket eller beskadiget • At fejlhåndtere kanylebeskyttelseshylsteret på en måde, der kunne føre til, at kanylen kommer til at stikke frem fra dette
Appropriate care is advised when prescribing RISPERDAL CONSTA to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e. g., exercising strenuously, exposure to extreme heat, receiving concomitant treatment with anticholinergic activity, or being subject to dehydration.
12.
Weight gain
Kontrollér visuelt, at kanylen er helt inde i kanylebeskyttelseshylsteret.
As with other antipsychotics, patients should be advised of the potential for weight gain.
Kassér straks på passende måde.
Weight should be measured regularly.
Vejledning i anvendelse af nålefrit hætteglasadgangsudstyr
Renal or hepatic impairment
For at sikre, at den ønskede risperidondosis indgives, skal hele indholdet af hætteglasset indgives.
Although oral risperidone has been studied, RISPERDAL CONSTA has not been studied in patients with renal or liver insufficiency.
Hvis kun noget af indholdet indgives, bliver hele den ønskede risperidondosis ikke indgivet.
RISPERDAL CONSTA should be administered with caution in this group of patients (see section 4.2).
Tag produktpakken med RISPERDAL CONSTA ud af køleskabet, og lad den få stuetemperatur inden rekonstitution.
Care must be taken to avoid inadvertent injection of RISPERDAL CONSTA into a blood vessel.
Produktpakkens indhold:
Excipients
Fjern det farvede plasticlåg fra hætteglasset.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e., essentially ‘ sodium- free’.
Åbn blisterposen, og tag hætteglasadgangsudstyret ud ved at holde på den hvide luerspids.
4.5 Interaction with other medicinal products and other forms of interaction
Spidsen af udstyret må ikke berøres på noget tidspunkt.
Interaction studies were performed with oral RISPERDAL.
3.
As with other antipsychotics, caution is advised when prescribing risperidone with medicinal products known to prolong the QT interval, e. g., class Ia antiarrhythmics (e. g., quinidine, dysopiramide, procainamide), class III antiarrhythmics (e. g., amiodarone, sotalol), tricyclic antidepressants (i. e., amitriptyline), tetracyclic antidepressant (i. e., maprotiline), some antihistaminics, other antipsychotics, some antimalarials (i. e., chinice and mefloquine), and with medicines causing electrolyte imbalance (hypokalaemia, hypomagnesiaemia), bradycardia, or those which inhibit the hepatic metabolism of risperidone.
Stil hætteglasset på en hård overflade.
This list is indicative and not exhaustive.
Åbn sprøjten ved at bryde lukningens forsegling, og fjern den hvide hætte sammen med gummihætten indeni.
Potential for RISPERDAL CONSTA to affect other medicinal products
Tryk sprøjtens spids ind i hætteglasadgangsudstyret, og drej med uret for at sikre, at sprøjten sidder godt fast på den hvide luerspids på hætteglasadgangsudstyret.
Risperidone should be used with caution in combination with other centrally-acting substances notably including alcohol, opiates, antihistamines and benzodiazepines due to the increased risk of sedation.
Hold fast i svøbet omkring adgangsudstyret, så det ikke drejer sig.
25 RISPERDAL CONSTA may antagonise the effect of levodopa and other dopamine agonists.
Hold sprøjten og hætteglasadgangsudstyret, så de flugter.
If this combination is deemed necessary, particularly in end-stage Parkinson’ s disease, the lowest effective dose of each treatment should be prescribed.
Injicer hele indholdet af sprøjten med opløsningsmiddel i hætteglasset.
Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment.
Hold stemplet nede med tommelfingeren, og omryst hætteglasset kraftigt i mindst 10 sekunder, indtil suspensionen er ensartet.
RISPERDAL does not show a clinically relevant effect on the pharmacokinetics of lithium, valproate, digoxin or topiramate.
Blandingen er fuldstændig, når suspensionen fremtræder ensartet, tyk og med en mælket farve, og alt pulver er fuldstændigt dispergeret.
Potential for other medicinal products to affect RISPERDAL CONSTA
41 HÆTTEGLASSET MÅ IKKE OPBEVARES EFTER REKONSTITUTIONEN, DA SUSPENSIONEN SÅ KAN BUNDFÆLDES.
Similar effects may be observed with e. g. rifampicin, phenytoin and phenobarbital which also induce CYP 3A4 hepatic enzyme as well as P-glycoprotein.
Vend hætteglasset helt, og træk langsomt suspensionen op fra hætteglasset.
When carbamazepine or other CYP 3A4 hepatic enzyme/ P-glycoprotein (P-gp) inducers are initiated or discontinued, the physician should re-evaluate the dosing of RISPERDAL CONSTA.
For at sikre identifikation skal den afrivelige del af hætteglassets etiket tages af og sættes på sprøjten.
Fluoxetine and paroxetine, CYP 2D6 inhibitors, increase the plasma concentration of risperidone, but less so of the active antipsychotic fraction.
Skru sprøjten af hætteglasadgangsudstyret.
It is expected that other CYP 2D6 inhibitors, such as quinidine, may affect the plasma concentrations of risperidone in a similar way.
Kassér hætteglasset og hætteglasadgangsudstyret på passende måde.
When concomitant fluoxetine or paroxetine is initiated or discontinued, the physician should re-evaluate the dosing of RISPERDAL CONSTA.
Grib om hylsteret ved brug af posen.
Verapamil, an inhibitor of CYP 3A4 and P-gp, increases the plasma concentration of risperidone.
Forbered patienten på injektion.
Galantamine and donepezil do not show a clinically relevant effect on the pharmacokinetics of risperidone and on the active antipsychotic fraction.
42 RESUSPENSION AF RISPERDAL CONSTA ER NØDVENDIG INDEN INDGIFT, DA BUNDFÆLDELSE VIL FINDE STED, EFTER AT PRODUKTET ER REKONSTITUERET.
Phenothiazines, tricyclic antidepressants, and some beta-blockers may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction.
RESUSPENDER MIKROSFÆRERNE I SPRØJTEN VED AT OMRYSTE KRAFTIGT.
Amitriptyline does not affect the pharmacokinetics of risperidone or the active antipsychotic fraction.
Fjern hylsteret fra kanylen uden at vride, da dette kan løsne kanylen fra Needle- Pro® udstyret.
Cimetidine and ranitidine increase the bioavailability of risperidone, but only marginally that of the active antipsychotic fraction.
Bank let på sprøjten for at få eventuelle luftbobler til at stige op til toppen.
Erythromycin, a CYP 3A4 inhibitor, does not change the pharmacokinetics of risperidone and the active antipsychotic fraction.
Injicer hele sprøjtens indhold intramuskulært i patientens balle.
See section 4.4 regarding increased mortality in elderly patients with dementia concomitantly receiving furosemide.
MÅ IKKE INDGIVES INTRAVENØST.
4.6 Pregnancy and lactation
ADVARSEL:
Pregnancy
Efter proceduren trykkes kanylen ind i kanylebeskyttelseshylsteret ved en enhåndsteknik.
There are no adequate data from the use of risperidone in pregnant women.
Foretag enhåndsteknikken ved at trykke hylsteret LET mod en flad overflade.
According to postmarketing data reversible extrapyramidal symptoms in the neonate were observed following the use of risperidone during the last trimester of pregnancy.
Når der trykkes på hylsteret, kommer kanylen ind i dette.
Consequently, newborns should be monitored carefully.