Carbomix

Primær information

  • Handelsnavn:
  • Carbomix granulat til oral suspension
  • Lægemiddelform:
  • granulat til oral suspension
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.


    Anmode informationsbrochure for offentligheden.

Lokation

  • Fås i:
  • Carbomix granulat til oral suspension
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 60440
  • Sidste ændring:
  • 22-02-2018

Produktresumé

5. februar 2018

PRODUKTRESUMÉ

for

Carbomix, granulat til oral suspension (Orifarm)

0.

D.SP.NR.

9660

1.

LÆGEMIDLETS NAVN

Carbomix, granulat til oral suspension

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Hver flaske indeholder 50 g aktivt kul. Efter opløsning i vand indeholder produktet ca.

12,5 g aktivt kul pr. 100 ml homogen opløsning.

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Granulat til oral suspension (Orifarm).

4.

KLINISKE OPLYSNINGER

4.1

Terapeutiske indikationer

Ved akut oral forgiftning og overdosering af medicinske produkter

4.2

Dosering og indgivelsesmåde

Voksne og børn over 12 år:

50-100 g aktivt kul (= 1-2 flasker Carbomix) indtages så hurtigt som muligt. Ved alvorlige

forgiftninger fortsættes behandlingen i et par dage med en dosis på 20 g hver 4-6 time (20

g aktivt kul svarer ca. til 160 ml af suspensionen).

Børn under 12 år:

Anbefalet dosis: ca. 1 g aktivt kul pr. kg legemsvægt.

I tilfælde af akut forgiftning hos børn under 12 år gives halv voksendosis (= 1/2 flaske). Til

børn under 4 år startes med en dosis på 1/4 flaske, hvilket gentages flere gange i samråd

med lægen.

Ved bevidstløse patienter skal en læge, eller en sygeplejerske under lægetilsyn, give

suspensionen ved hjælp af en sonde.

60440_spc.doc

Side 1 af 5

Carbomix kan også gives efter opkastning eller maveskylning.

For at modvirke optagelse af giftstoffer i kroppen og for at fjerne de allerede absorberede

giftstoffer er det vigtigt, at Carbomix indtages hurtigt. Dog kan langsom indtagelse også

have en positiv virkning.

Ved alvorlig forgiftning anbefales det at indtage flere doser aktivt kul.

Tilberedelse af suspension:

Ryst flasken grundigt for at løsne granulatet. Tilsæt vand til flaskens røde streg. Ryst

grundigt i 1 minut. Herved fås ca. 400 ml suspension. Flasken åbnes forsigtigt og indholdet

indtages omgående. Hvis indholdet indtages ad flere gange, skal flasken rystes for hver

gang.

Flasken er udstyret med en speciel top, der kan bruges ved hurtig og direkte

sondetilslutning. Toppen løsnes forsigtigt for at frigøre evt. tryk i flasken og lukkes igen.

Derefter skæres toppen af inden sondetilslutning.

4.3

Kontraindikationer

Overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne anført i pkt. 6.

Carbomix må ikke anvendes, hvis forgiftningen helt sikkert skyldes ætsende stoffer (f.eks.

stærke syrer eller baser), da det i sådanne tilfælde kan vanskeliggøre oesofagoskopi og

gastroskopi.

4.4

Særlige advarsler og forsigtighedsregler vedrørende brugen

Ved akut oral forgiftning og overdosering af medicin skal der omgående tages kontakt til

læge eller giftcenter. Umiddelbart derefter indtages Carbomix suspensionen i henhold til

forskrifterne.

Aktivt kul adsorberer ikke organiske og uorganiske salte og opløsninger dvs. salte i jern-,

lithium-, thallium-, cyanid-, methanol-, ethanol-, ethylenglykol- og petroleumsholdige

opløsninger. I tilfælde af forgiftning med sådanne stoffer skal anden form for afgiftning

foretages (f.eks. maveskylning). De mest almindelige forgiftninger af denne type er angivet

nedenfor med den for disse stoffer relevante behandling:

Specific antidote:

Cyanid

Natriumnitrit/4-dimethylaminfenol

Jernforbindelser

Deferoxamin

Lithium

Kalciumpolystyrensulfonat

Methanol

Ethanol

Ethylenglykol

Ethanol

Ved mange typer forgiftning skal der ud over Carbomix indtages en bestemt modgift

(f.eks. ved paracetamolforgiftning: acetylcystein).

Når oral behandling eller en bestemt, oral modgift er meget vigtig for patienten, frarådes

indtagelse af aktivt kul.

Indtagelse af aktivt kul frarådes for patienter, der tager anti-peristaltisk medicin, eller der

har indtaget et giftstof med anti-peristaltisk virkning, pga. risiko for paralytisk ileus,

hvilket kan medføre tarmperforering (se 4.3).

60440_spc.doc

Side 2 af 5

Aktivt kul giver sort afføring.

4.5

Interaktion med andre lægemidler og andre former for interaktion

Indtagelse af aktivt kul vil normalt nedsætte virkningen af andre orale præparater pga.

virkningsforløbet.

Samtidig indtagelse af furosemide og aktivt kul har vist sig at resultere i en stor reduktion

af virkningen af furosemide.

Indtagelse af aktivt kul kan også reducere virkningen af ægløsningshæmmende medicin (se

4.6)

4.6

Graviditet og amning

Kvinder med risiko for graviditet / Svangerskabsforebyggelse

Aktivt kul kan nedsætte virkningen af p-piller. Derfor anbefales det at anvende alternativ,

effektiv og sikker prævention under behandlingen.

Graviditet

Aktivt kul kan, ifølge tidligere erfaringer, anvendes som foreskrevet uden risiko for

fosteret.

Amning

Aktivt kul kan, ifølge tidligere erfaringer, anvendes som foreskrevet uden risiko for barnet.

4.7

Virkninger på evnen til at føre motorkøretøjer eller betjene maskiner

Carbomix påvirker ikke køre- eller maskinbetjeningsevnen.

4.8

Bivirkninger

De fleste rapporterede bivirkninger i forbindelse med indtagelse af aktivt kul relaterer til

mavetarmsystemet. De fleste af disse kan dog også skyldes tilgrundliggende

omstændigheder.

Hændelsesfrekvensen kendes ikke (kan ikke vurderes ud fra forhåndenværende data).

Almindeligt rapporterede bivirkninger er: opkastning, forstoppelse, mavesmerter, diarré,

kvalme, pludselig afføringstrang, anal irritation.

Der har været enkelte rapporter (alle som følge af indtagelse af gentagne høje doser af

aktivt kul) om: (pseudo)forstoppelse af tyndtarmen, der har krævet operation og om hård

afføring med perforering af tyktarmen til følge (se 4.9)

Indberetning af formodede bivirkninger

Når lægemidlet er godkendt, er indberetning af formodede bivirkninger

vigtig. Det muliggør løbende overvågning af benefttriikkforholdet for

lægemidlet. Læger og iundhediperionale anmodei om at indberette

alle formodede bivirkninger via:

Lægemiddelityrelien

Axel Heidei Gade 1

DKk2300 København S

Webited: www.meldenbivirkning.dk

Ekmail: dkma@dkma.dk

4.9

Overdosering

60440_spc.doc

Side 3 af 5

Der kan opstå forstoppelse af tyndtarmen ved gentagen overdosering af medicinsk kul.

Dette kan undgå ved at indtage afføringsmiddel (f.eks. natriumsulfat).

4.3

Udlevering

5.

FARMAKOLOGISKE EGENSKABER

5.0

Terapeutisk klassifikation

Antidot, aktivt kul: ATC-kode: A 07 BA 01

5.1

Farmakodynamiske egenskaber

Farmakodynamisk gruppe: medicinsk kul.

ATC-kode: A07BA01.

Aktivt kul er et specielt carboniseret materiale baseret på plantestoffer og med en stor

indvendig overflade, som kan adsorbere skadelige, uønskede og sygdomsfremkaldende

stoffer i mavetarmkanalen. Ved forgiftning kan aktivt kul adsorbere de aktive stoffer fra

mavetarmkanalen.

Adsorbering i aktivt kul af et delvist optaget aktivt stof giver koncentrationsfald

mellem cirkulerende plasma og tarmindhold. Derfor kan passivt adsorberende stoffer på ny

diffundere i modsat retning mod tarmen. Herved kan gentagen indtagelse af aktivt kul også

være virksom efter indtagelse af et aktivt stof.

5.2

Farmakokinetiske egenskaber

Da aktivt kul ikke optages i mavetarmkanalen, opstår der ikke nogen distributionsfase eller

metabolisme.

Aktivt kul er et lokalt virkende middel, som efter oral indtagelse kan adsorbere opløste

aktive stoffer i mavetarmkanalen. Derfor skal det indtages så hurtigt som muligt i tilfælde

af indtagelse af giftstoffer eller medicinoverdosis.

For at modvirke desorption af adsorberende giftstoffer er det vigtigt, at det aktive kul

passerer hurtigst muligt gennem mavetarmkanalen, f.eks. ved at give et osmotisk laksantia

(natriumsulfat).

5.3

Prækliniske sikkerhedsdata

De prækliniske data viser ingen særlig fare for mennesker.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Citronsyre-monohydrat, Glycerol, Acacia gummi

6.2

Uforligeligheder

Ikke relevant.

6.3

Opbevaringstid

5 år.

Færdig suspension: 3 dage.

60440_spc.doc

Side 4 af 5

6.4

Særlige opbevaringsforhold

Inden opblanding skal granulatet opbevares tørt.

Efter opblanding skal blandingen opbevares i køleskab (2

C - 8

6.5

Emballagetyper og pakningsstørrelser

HDPE-flaske med HDPE-skruelåg.

6.6

Regler for destruktion og anden håndtering

Ingen særlige krav.

7.

INDEHAVER Af MARKEDSFØRINGSTILLADELSEN

Orifarm A/S

Energivej 15

5260 Odense S

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

60440

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

5. februar 2018

10.

DATO FOR ÆNDRING AF TEKSTEN

60440_spc.doc

Side 5 af 5

  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

    Anmode informationsbrochure for offentligheden.



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Udenyca (ERA Consulting GmbH)

Udenyca (ERA Consulting GmbH)

Udenyca (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6290 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004413/0000

Europe -DG Health and Food Safety

25-9-2018

Voriconazole Hikma (Hikma FarmacEutica (Portugal), S.A.)

Voriconazole Hikma (Hikma FarmacEutica (Portugal), S.A.)

Voriconazole Hikma (Active substance: voriconazole) - Centralised - Yearly update - Commission Decision (2018)6286 of Tue, 25 Sep 2018

Europe -DG Health and Food Safety

25-9-2018

Inovelon (Eisai GmbH)

Inovelon (Eisai GmbH)

Inovelon (Active substance: Rufinamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6283 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/660/T/48

Europe -DG Health and Food Safety

25-9-2018

Zonegran (Eisai GmbH)

Zonegran (Eisai GmbH)

Zonegran (Active substance: zonisamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6285 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/577/T/90

Europe -DG Health and Food Safety

25-9-2018

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (Active substance: melatonin) - Centralised - Authorisation - Commission Decision (2018)6223 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425

Europe -DG Health and Food Safety

25-9-2018

Brilique (AstraZeneca AB)

Brilique (AstraZeneca AB)

Brilique (Active substance: ticagrelor) - PSUSA - Modification - Commission Decision (2018)6282 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1241/PSUSA/2948/201712

Europe -DG Health and Food Safety

25-9-2018

Fycompa (Eisai GmbH)

Fycompa (Eisai GmbH)

Fycompa (Active substance: Perampanel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6280 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002434/T/0040

Europe -DG Health and Food Safety

25-9-2018

Opsumit (Janssen-Cilag International NV)

Opsumit (Janssen-Cilag International NV)

Opsumit (Active substance: macitentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6279 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002697/T/0028

Europe -DG Health and Food Safety

25-9-2018

Imfinzi (AstraZeneca AB)

Imfinzi (AstraZeneca AB)

Imfinzi (Active substance: durvalumab) - Centralised - Authorisation - Commission Decision (2018)6289 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004771/0000

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Kanuma (Alexion Europe SAS)

Kanuma (Alexion Europe SAS)

Kanuma (Active substance: sebelipase alfa) - Centralised - Yearly update - Commission Decision (2018)6245 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Active substance: Botulinum Toxin Type B) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6221 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000301/T/0101

Europe -DG Health and Food Safety

24-9-2018

Renvela (Genzyme Europe B.V.)

Renvela (Genzyme Europe B.V.)

Renvela (Active substance: sevelamer (carbonate)) - Centralised - Variation - Commission Decision (2018)6225 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/993/X/39

Europe -DG Health and Food Safety

24-9-2018

Deferiprone Lipomed (Lipomed GmbH)

Deferiprone Lipomed (Lipomed GmbH)

Deferiprone Lipomed (Active substance: Deferiprone) - Centralised - Authorisation - Commission Decision (2018)6233 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4710

Europe -DG Health and Food Safety

24-9-2018

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6228 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

24-9-2018

Sevelamer carbonate Zentiva (Genzyme Europe B.V.)

Sevelamer carbonate Zentiva (Genzyme Europe B.V.)

Sevelamer carbonate Zentiva (Active substance: Sevelamer carbonate) - Centralised - Variation - Commission Decision (2018)6214 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3971/X/11

Europe -DG Health and Food Safety

24-9-2018

Rixathon (Sandoz GmbH)

Rixathon (Sandoz GmbH)

Rixathon (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6230 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Rasilez (Noden Pharma DAC)

Rasilez (Noden Pharma DAC)

Rasilez (Active substance: aliskiren) - Centralised - Yearly update - Commission Decision (2018)6229 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Cinqaero (Teva B.V.)

Cinqaero (Teva B.V.)

Cinqaero (Active substance: reslizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6218 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3912T/18

Europe -DG Health and Food Safety

24-9-2018

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (Active substance: vigabatrin) - Centralised - Authorisation - Commission Decision (2018)6224 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4534

Europe -DG Health and Food Safety

24-9-2018

Mektovi (Pierre Fabre MEdicament)

Mektovi (Pierre Fabre MEdicament)

Mektovi (Active substance: binimetinib) - Centralised - Authorisation - Commission Decision (2018)6217 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004579/0000

Europe -DG Health and Food Safety

24-9-2018

Cyramza (Eli Lilly Nederland B.V.)

Cyramza (Eli Lilly Nederland B.V.)

Cyramza (Active substance: ramucirumab) - Centralised - Yearly update - Commission Decision (2018)6246 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Braftovi (Pierre Fabre MEdicament)

Braftovi (Pierre Fabre MEdicament)

Braftovi (Active substance: encorafenib) - Centralised - Authorisation - Commission Decision (2018)6216 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004580/0000

Europe -DG Health and Food Safety

24-9-2018

Karvezide (Sanofi-Aventis groupe)

Karvezide (Sanofi-Aventis groupe)

Karvezide (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6222 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

24-9-2018

Diacomit (Biocodex)

Diacomit (Biocodex)

Diacomit (Active substance: Stiripentol) - Centralised - Renewal - Commission Decision (2018)6254 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/664/R/21

Europe -DG Health and Food Safety

24-9-2018

Nitisinone MDK (MendeliKABS Europe Limited)

Nitisinone MDK (MendeliKABS Europe Limited)

Nitisinone MDK (Active substance: nitisinone) - Centralised - Yearly update - Commission Decision (2018)6241 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Ryzodeg (Novo Nordisk A/S)

Ryzodeg (Novo Nordisk A/S)

Ryzodeg (Active substance: Insulin degludec/insulin aspart) - Centralised - Yearly update - Commission Decision (2018)6242 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (Active substance: Lutetium (177 Lu) chloride) - PSUSA - Modification - Commission Decision (2018)6236 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3999/PSUSA/10391/201712

Europe -DG Health and Food Safety

24-9-2018

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Active substance: topotecan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6238 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1192/T/33

Europe -DG Health and Food Safety