natgillin/translations-raw huggingface dataset:
[Udfyldes nationalt]
Keeping the syringe and needle aligned, attach the needle with an easy clockwise twisting motion to the luer connection of the syringe.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ( E)
Pull sheath away from the needle – do not twist.
Kun til intramuskulær brug.
Inject the entire contents (solvent) of the syringe into the vial.
ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
Withdraw the syringe with the reconstitution needle from the vial.
Opbevares utilgængeligt for børn.
Unscrew the needle from the syringe and discard the needle appropriately.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER
Open the cover of the second reconstitution needle.
UDLØBSDATO
Keeping the empty syringe and needle aligned, attach the second needle with an easy clockwise twisting motion to the luer connection of the syringe.
SÆRLIGE OPBEVARINGSBETINGELSER
Do not remove the sheath from the needle at this time.
[Udfyldes nationalt]
36 7.
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF
Shake the vial vigorously for at least 10 seconds until obtaining a homogeneous suspension.
62 UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
Mixing is complete when the suspension appears uniform, thick, and milky in colour, and all the powder is fully dispersed.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
DO NOT STORE THE VIAL AFTER RECONSTITUTION OR THE SUSPENSION MAY SETTLE.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
Take the syringe and pull sheath away from the reconstitution needle – do not twist.
[Udfyldes nationalt]
Insert the reconstitution needle into the upright vial.
FREMSTILLERENS BATCHNUMMER
Withdraw the syringe with the reconstitution needle from the vial.
GENEREL KLASSIFIKATION FOR UDLEVERING
Unscrew the needle from the syringe and discard the needle appropriately.
[Udfyldes nationalt]
Discard the vial appropriately.
15.
37 10.
INSTRUKTIONER VEDRØRENDE ANVENDELSEN
Peel the blister pouch of the Needle-Pro device open half way.
INFORMATION I BRAILLE- SKRIFT
Grasp sheath using the plastic peel pouch.
63 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
Attach the luer connection of the Needle-Pro device with an easy clockwise twisting motion to the syringe.
Ydre karton (pakning med 3- nåls- system)
Seat the needle firmly on the Needle-Pro device with a push and clockwise twist.
LÆGEMIDLETS NAVN
Prepare the patient for injection.
RISPERDAL CONSTA og associerede navne (se Bilag I) 37, 5 mg pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion
RESUSPENSION OF RISPERDAL CONSTA WILL BE NECESSARY PRIOR TO ADMINISTRATION AS SETTLING WILL OCCUR OVER TIME ONCE PRODUCT IS RECONSTITUTED.
[Se Bilag I – udfyldes nationalt]
RESUSPEND THE MICROSPHERES IN THE SYRINGE BY SHAKING VIGOROUSLY.
ANGIVELSE AF AKTIVT STOF/ AKTIVE STOFFER
Pull sheath away from the needle – do not twist sheath as needle may be loosened from Needle- Pro device.
[Udfyldes nationalt]
Tap the syringe gently to make any air bubbles rise to the top.
LISTE OVER HJÆLPESTOFFER
Inject the entire contents of the syringe intramuscularly into the buttock of the patient.
[Udfyldes nationalt]
DO NOT ADMINISTER INTRAVENOUSLY.
4.
WARNING:
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE)
After procedure is completed, press the needle into the needle protection device.
Pulver og solvens til depotinjektionsvæske, suspension.
As the needle protection device is pressed, the needle is firmly engaged into it.
[Udfyldes nationalt]
Immediately discard appropriately.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ( E)
Instructions for Needle-Free Vial Access Device
Kun til intramuskulær brug.
Do not substitute any components in the dose pack.
ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
To assure that the intended dose of risperidone is delivered, the full contents from the vial must be administered.
Opbevares utilgængeligt for børn.
Administration of partial contents may not deliver the intended dose of risperidone.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER
Remove the dose pack of RISPERDAL CONSTA from the refrigerator and allow it to come to room temperature prior to reconstitution.
UDLØBSDATO EXP:
Contents of the dose pack:
SÆRLIGE OPBEVARINGSBETINGELSER
• One vial containing RISPERDAL CONSTA extended release microspheres • One Alaris SmartSite needle-free vial access device for reconstitution • One prefilled syringe containing the solvent for RISPERDAL CONSTA • One Needle-Pro needle for intramuscular injection (safety 20G 2” TW needle-with needle protection device)
64 UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
Flip off the plastic coloured cap from the vial.
11.
39 2.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
Peel back the blister pouch and remove the vial access device by holding the white luer cap.
[Se Bilag I – udfyldes nationalt]
Do not touch the spike tip of the access device at any time.
[Udfyldes nationalt]
Place vial on a hard surface.
FREMSTILLERENS BATCHNUMMER
Swab the connection point of the vial access device with preferred antiseptic prior to attaching the syringe to the vial access device.
LOT:
40 5.
14.
6.
GENEREL KLASSIFIKATION FOR UDLEVERING
Press the syringe tip into the vial access device and twist in a clockwise motion to ensure that the syringe is securely attached to the white luer cap of the vial access device.
[Udfyldes nationalt]
Hold the skirt of the vial access device during attachment to prevent spinning.
INSTRUKTIONER VEDRØRENDE ANVENDELSEN
Keep the syringe and the vial access device aligned.
16.
7.
Ydre karton (pakning med Alaris og separat opbevaring til solvens)
Inject the entire contents (solvent) of the syringe into the vial.
1.
41 8.
RISPERDAL CONSTA og associerede navne (se Bilag I) 37, 5 mg pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion
Holding the plunger rod down with the thumb, shake the vial vigorously for at least 10 seconds until obtaining a homogeneous suspension.
[Se Bilag I – udfyldes nationalt]
Mixing is complete when the suspension appears uniform, thick, and milky in colour and all the powder is fully dispersed.
ANGIVELSE AF AKTIVT STOF/ AKTIVE STOFFER
DO NOT STORE THE VIAL AFTER RECONSTITUTION OR THE SUSPENSION MAY SETTLE.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE)
Invert the vial completely and slowly withdraw the entire contents of the suspension from the vial.
[Udfyldes nationalt]
For identification purposes, tear section of the vial label at the perforation and apply detached section to the syringe.
5.
10.
Læs indlægssedlen inden brug.
Unscrew the syringe from the vial access device.
Kun til intramuskulær brug.
Discard the vial and the vial access device appropriately.
6.
42 11.
ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
Peel the blister pouch of the Needle-Pro device open half way.
Opbevares utilgængeligt for børn.
Grasp sheath using the plastic peel pouch.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER
Attach the luer connection of the Needle-Pro device with an easy clockwise twisting motion to the syringe.
SÆRLIGE OPBEVARINGSBETINGELSER
Seat the needle firmly on the Needle-Pro device with a push and clockwise twist.
[Udfyldes nationalt]
Prepare the patient for injection.
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF
RESUSPENSION OF RISPERDAL CONSTA WILL BE NECESSARY PRIOR TO ADMINISTRATION AS SETTLING WILL OCCUR OVER TIME ONCE PRODUCT IS RECONSTITUTED.
66 UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
RESUSPEND THE MICROSPHERES IN THE SYRINGE BY SHAKING VIGOROUSLY.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
Pull sheath away from the needle – do not twist sheath as needle may be loosened from Needle- Pro device.
[Se Bilag I – udfyldes nationalt]
Tap the syringe gently to make any air bubbles rise to the top.
{Navn og adresse}
Remove air bubbles from the syringe barrel by moving the plunger rod forward with the needle in an upright position.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
Inject the entire contents of the syringe intramuscularly into the buttock of the patient.
FREMSTILLERENS BATCHNUMMER
DO NOT ADMINISTER INTRAVENOUSLY.
LOT:
43 WARNING:
GENEREL KLASSIFIKATION FOR UDLEVERING
As the needle protection device is pressed, the needle is firmly engaged into it.
INSTRUKTIONER VEDRØRENDE ANVENDELSEN
Any unused product or waste material should be disposed of in accordance with local requirements.
INFORMATION I BRAILLE- SKRIFT
MARKETING AUTHORISATION HOLDER
[Udfyldes nationalt]
[See Annex I – To be completed nationally]
Hætteglas med pulver til suspension til injektion (alle pakninger)
{Name and address}
LÆGEMIDLETS NAVN, STYRKE OG/ ELLER ADMINISTRATIONSVEJ( E)
MARKETING AUTHORISATION NUMBER(S)
[Se Bilag I – udfyldes nationalt]
[To be completed nationally]
Læs indlægssedlen inden brug.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
BATCHNUMMER
DATE OF REVISION OF THE TEXT
ANDET
44 LABELLING
68 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Fyldt injektionssprøjte (alle pakninger)
Outer Carton (Pack with ALARIS)
Solvens til RISPERDAL CONSTA 37, 5 mg og associerede navne (se Bilag I) [Se Bilag I – udfyldes nationalt]
RISPERDAL CONSTA and associated names (see Annex I) 12.5 mg powder and solvent for prolonged-release suspension for intramuscular injection [See Annex I – To be completed nationally]
INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
RISPERDAL CONSTA and associated names (see Annex I) 25 mg powder and solvent for prolonged- release suspension for intramuscular injection
Ydre karton (pakning med Alaris)
RISPERDAL CONSTA and associated names (see Annex I) 37.5 mg powder and solvent for prolonged-release suspension for intramuscular injection
RISPERDAL CONSTA og associerede navne (se Bilag I) 50 mg pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion
RISPERDAL CONSTA and associated names (see Annex I) 50 mg powder and solvent for prolonged- release suspension for intramuscular injection
Risperidon
risperidone
[Se Bilag I – udfyldes nationalt]
[See Annex I - To be completed nationally]
LOT:
Batch
71 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ydre karton (pakning med 3- nåls- system)
Outer Carton (Pack with 3 needle system)
RISPERDAL CONSTA og associerede navne (se Bilag I) 50 mg pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion
RISPERDAL CONSTA and associated names (see Annex I) 37.5 mg powder and solvent for prolonged-release suspension for intramuscular injection
[Se Bilag I – udfyldes nationalt]
RISPERDAL CONSTA and associated names (see Annex I) 50 mg powder and solvent for prolonged- release suspension for intramuscular injection
UDLØBSDATO EXP:
EXP
73 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ydre karton (pakning med Alaris og separat opbevaring til solvens)
Outer Carton (Pack with ALARIS and separate storage for solvent)
75 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
51 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Hætteglas med pulver til suspension til injektion (alle pakninger)
Vial for powder for suspension for injection (all packs)
RISPERDAL CONSTA og associerede navne (se Bilag I) 50 mg pulver til depotinjektionsvæske, suspension til intramuskulær injektion
RISPERDAL CONSTA and associated names (see Annex I) 37.5 mg powder for prolonged-release suspension for intramuscular injection
[Se Bilag I – udfyldes nationalt]
RISPERDAL CONSTA and associated names (see Annex I) 50 mg powder for prolonged-release suspension for intramuscular injection
76 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
52 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Fyldt injektionssprøjte (alle pakninger)
Pre filled Syringe (all packs)
Solvens til RISPERDAL CONSTA 50 mg og associerede navne (se Bilag I) [Se Bilag I – udfyldes nationalt]
Solvent for RISPERDAL CONSTA 12.5 mg/ 25 mg/ 37.5 mg/ 50 mg and associated names (see Annex I) [See Annex I – To be completed nationally]
Opbevar den fyldte injektionssprøjte i yderkartonen.
Keep prefilled syringe in the outer carton
77 INDLÆGSSEDDEL
53 PACKAGE LEAFLET
78 INDLÆGSSEDDEL:
54 PACKAGE LEAFLET:
RISPERDAL CONSTA og associerede navne (se Bilag I) 12, 5, 25, 37, 5 og 50 mg pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion [Se Bilag I – udfyldes nationalt]
RISPERDAL CONSTA and associated names (see Annex I) 12.5, 25, 37.5 and 50 mg powder and solvent for prolonged-release suspension for intramuscular injection [See Annex I – To be completed nationally] Risperidone
Du kan få brug for at læse den igen. • Spørg lægen eller på apoteket, hvis der er mere, du vil vide. • Lægen har ordineret dette lægemiddel til dig personligt.
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you.
Det kan være skadeligt for andre, selv om de har de samme symptomer, som du har. • Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
RISPERDAL CONSTAS virkning og hvad du skal bruge det til 2.
What RISPERDAL CONSTA is and what it is used for 2.
Det skal du vide, før du begynder at tage RISPERDAL CONSTA 3.
Before you use RISPERDAL CONSTA 3.
Sådan skal du tage RISPERDAL CONSTA 4.
How to use RISPERDAL CONSTA 4.
Sådan opbevarer du RISPERDAL CONSTA 6.
How to store RISPERDAL CONSTA 6.
RISPERDAL CONSTAS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
WHAT RISPERDAL CONSTA IS AND WHAT IT IS USED FOR
RISPERDAL CONSTA tilhører den gruppe medicin, der kaldes antipsykotika.
RISPERDAL CONSTA belongs to a group of medicines called ‘ anti-psychotics’.
Skizofreni er en tilstand, hvor patienten ser, hører eller føler ting, som ikke er der i virkeligheden, tror ting, der ikke er sande, eller føler sig overdrevet mistænksom eller forvirret.
RISPERDAL CONSTA is used to maintain the treatment of schizophrenia, where you may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious, or confused
RISPERDAL CONSTA er beregnet til patienter, som i forvejen er i behandling med orale antipsykotika (f. eks. tabletter eller kapsler).
RISPERDAL CONSTA is intended for patients who are currently treated with oral (e. g. tablets, capsules) antipsychotics.
6 nedenfor).
Do not take RISPERDAL CONSTA • If you are allergic (hypersensitive) to risperidone or any of the other ingredients of RISPERDAL CONSTA (listed in Section 6 below).
Vær ekstra forsigtig med at tage RISPERDAL CONSTA • Hvis du aldrig tidligere har taget nogen form for RISPERDAL®, skal du begynde med oral RISPERDAL, dvs. en behandling, som tages gennem munden, før du påbegynder behandling med RISPERDAL CONSTA.
Take special care with RISPERDAL CONSTA • If you have never taken any form of RISPERDAL, you should begin with oral RISPERDAL before beginning treatment with RISPERDAL CONSTA.
79 • Hvis du har hjerteproblemer.
• You have a heart problem.
Det gælder f. eks. uregelmæssig hjerterytme, eller hvis du har tendens til lavt blodtryk eller tager blodtryksmedicin.
Examples include an irregular heart rhythm or if you are prone to low blood pressure or if you are using medicines for your blood pressure.
RISPERDAL CONSTA kan forårsage lavt blodtryk.
RISPERDAL CONSTA may cause low blood pressure.
Dosis skal muligvis justeres. • Hvis du kender til nogle faktorer, som kan gøre dig disponeret for slagtilfælde, f. eks. forhøjet blodtryk, hjerte- karsygdomme eller problemer med tilstoppede blodkar i hjernen. • Hvis du har Parkinsons sygdom eller demens. • Hvis du har diabetes. • Hvis du har epilepsi. • Hvis du har oplevet at have en langvarig eller smertefuld rejsning.
Your dose may need to be adjusted. • You know of any factors which would favour you having a stroke, such as high blood pressure, cardiovascular disorder or circulation disorders of the brain • You have Parkinson’ s disease or dementia • You are diabetic • You have epilepsy
Hvis du oplever dette, mens du tager RISPERDAL CONSTA, skal du straks kontakte lægen. • Hvis du har vanskeligt ved at kontrollere legemstemperaturen eller får hedeture. • Hvis du har nyreproblemer. • Hvis du har leverproblemer. • Hvis tests har vist, at du har et unormalt højt indhold af hormonet prolactin i blodet, eller hvis du har en svulst, som muligvis er afhængig af prolactin.
If you experience this while taking RISPERDAL CONSTA, contact your doctor straight away • You have difficulty controlling body temperature or overheating • You have kidney problems • You have liver problems • You have an abnormally high level of the hormone prolactin in your blood or if you have a tumour, which is possibly dependent on prolactin.
Fortæl det øjeblikkeligt til din læge, hvis du oplever • Ufrivillige rytmiske bevægelser af tungen, munden eller ansigtet.
• involuntary rhythmic movements of the tongue, mouth and face.
Det kan være nødvendigt at stoppe behandlingen med risperidon. • Feber, alvorlig muskelstivhed, svedudbrud eller nedsat bevidsthed (en tilstand kaldet malignt neuroleptikasyndrom).
Withdrawal of risperidone may be needed • fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “ neuroleptic malignant syndrome).
Dette gælder også medicin, som ikke er købt på recept samt naturmedicin og kosttilskud.
Using other medicines Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription and herbal medicines.
Det er især vigtigt at tale med lægen eller apoteket, hvis du tager et eller flere af følgende: • Beroligende medicin, som virker i hjernen, f. eks. for at hjælple dig med at slappe af (benzodiazepiner), eller visse smertestillende midler (opioider), midler mod allergi (nogle antihistaminer), da risperidon kan øge den sløvende effekt af disse midler. • Medicin, som kan ændre hjertets elektriske aktivitet, f. eks. malariamidler, medicin mod forstyrrelser af hjerterytmen (f. eks. kinidin), allergimidler (antihistaminer), visse depressionsmidler (antidepressiva) eller andre lægemidler mod psykiske problemer. • Medicin, som sænker hjerterytmen • Medicin, som kan medføre lavt indhold af kalium i blodet (f. eks. bestemte vanddrivende midler) • Medicin mod Parkinsons sygdom, f. eks. levodopa. • Medicin mod forhøjet blodtryk.
It is especially important to talk to your doctor or pharmacist if you are taking any of the following: • Medicines that work on your brain to help you calm down (benzodiazepines), or some medicines for pain (opiates), medicines for allergy (some antihistamines), as Risperidone may increase the sedative effect of all of these. • Medicines that may change the electrical activity of your heart, such as medicines for malaria, heart rhythm problems (such as quinidine), allergies (anti-histamines), some antidepressants or other medicines for mental problems • Medicines that cause a slow heart beat • Medicines that cause low blood potassium (e. g. certain diuretics) • Medicines for Parkinson's disease (such as levodopa) • Medicines to treat elevated blood pressure.
RISPERDAL CONSTA kan forårsage lavt blodtryk. • Vanddrivende midler (diuretika), som anvendes mod hjerteproblemer eller hævelser i kroppen på grund af væskeansamlinger (f. eks. furosemid eller chlorthiazid).
RISPERDAL CONSTA can lower blood pressure • Water tablets (diuretics) used for heart problems or swelling of parts of your body due to a build up of too much fluid (such as furosemide or chlorothiazide).
Følgende lægemidler kan nedsætte virkningen af risperidon • Rifampicin (et middel til behandling af visse infektioner)
The following medicines may reduce the effect of risperidone • Rifampicin (a medicine for treating some infections) • Carbamazepine, phenytoin (mdicines for epilepsy) • Phenobarbital If you start or stop taking such medicines you may need a different dose of risperidone
80 • Carbamazepin, fenytoin (midler mod epilepsi) • Phenobarbital Hvis du begynder eller ophører behandling med disse midler, skal du muligvis have en anden dosis af risperidon.
The following medicines may increase the effect of risperidone • Quinidine (used for certain types of heart disease)
Følgende medicin kan øge virkningen af risperidon • Kinidin (bruges til behandling af forskellige typer af hjertesygdomme) • Medicin mod depression, såsom paroxetin, fluoxetin, tricykliske antidepressiva • Medicin som benævnes beta- blokkere (bruges til behandling af højt blodtryk) • Phenothiaziner (bruges f. eks. til behandling af psykoser eller til at slappe af) • Cimetidin, ranitidin (blokerer syreproduktionen i maven) Hvis du begynder eller ophører behandling med disse midler, skal du muligvis have en anden dosis af risperidon.
56 • Antidepressants such as paroxetine, fluoxetines, tricyclic antidepressants • Medicines known as beta blockers (used to treat high blood pressure) • Phenothiazines (e. g. used to treat psychosis or to calm down) • Cimetidie, ranitidine (blockers of the acidity of stomach) If you start or stop taking such medicines you may need a different dose of risperidone
Tal med lægen eller apoteket, før du tager RISPERDAL CONSTA, hvis du ikke er sikker på, om nogle af ovenstående tilfælde er relevante for dig.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using RISPERDAL CONSTA.
Graviditet og amning • Tal med lægen, før du bruger RISPERDAL CONSTA, hvis du er gravid eller prøver at blive gravid, eller hvis du ammer.
Pregnancy and breast-feeding • Talk to your doctor before using RISPERDAL CONSTA if you are pregnant, trying to become pregnant or breast-feeding.
Alle problemer forsvandt dog igen.
Your doctor will decide if you can use it • Shaking, muscle stiffness and problems feeding, all of which are reversible, have been seen in newborn babies when RISPERDAL was used during the last trimester of pregnancy.
Trafik - og arbejdssikkerhed Behandlingen med RISPERDAL CONSTA kan medføre svimmelhed, træthed og synsproblemer.
Driving and using machines Dizziness, tiredness, and vision problems may occur during treatment with RISPERDAL CONSTA.
SÅDAN SKAL DU TAGE RISPERDAL CONSTA
HOW TO USE RISPERDAL CONSTA
Injektionen gives af en sundhedsmedarbejder.
RISPERDAL CONSTA is given as an intramuscular injection into the buttocks every two weeks, administered by a health care professional.
Voksne Startdosis Hvis din daglige dosis oral risperidon (f. eks. tabletter) har været 4 mg eller mindre de sidste to uger, bør din startdosis være 25 mg RISPERDAL CONSTA.
Adults Starting dose If your daily dose of oral (e. g. tablets) risperidone was 4 mg or less for the last two weeks, your starting dose should be 25 mg RISPERDAL CONSTA.
Hvis din daglige dosis oral risperidon (f. eks. tabletter) har været over 4 mg de sidste to uger, kan du få 37, 5 mg RISPERDAL CONSTA som startdosis.
If your daily dose of oral (e. g. tablets) risperidone was more than 4 mg for the last two weeks, you may be given 37.5 mg RISPERDAL CONSTA as a starting dose.
Din læge vil vælge RISPERDAL CONSTA 25 mg eller 37, 5 mg.
Your doctor will choose RISPERDAL CONSTA 25 mg or 37.5 mg.
Du kan muligvis få en lavere dosis på 12, 5 mg.
You may be given a lower dose of 12.5 mg.
Din læge vil vælge, hvilken dosis RISPERDAL CONSTA, du skal have.
Your doctor will decide on the dose of RISPERDAL CONSTA that is right for you.
Vedligeholdelsesdosis • Den sædvanlige dosis er 25 mg hver anden uge som en injektion.
Maintenance dose • The usual dose is 25 mg every two weeks as an injection • A lower dose of 12.5 mg or a higher dose of 37.5 or 50 mg may also be necessary.
Lægen afgør, hvilken dosis af RISPERDAL CONSTA, der er den bedste for dig. • Lægen kan ordinere RISPERDAL til indtagelse gennem munden (oral indtagelse) i de første 3 uger efter den første injektion.
Your doctor will decide on the dose of RISPERDAL CONSTA that is right for you • Your doctor may prescribe oral RISPERDAL for the first three weeks following your first injection.