Eligard

Primær information

  • Handelsnavn:
  • Eligard 22,5 mg pulver og solvens til injektionsvæske, opløsning
  • Dosering:
  • 22,5 mg
  • Lægemiddelform:
  • pulver og solvens til injektionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Eligard 22,5 mg pulver og solvens til injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Ikke markedsført
  • Autorisationsnummer:
  • 46977
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Oversigt over indlægssedlen:

1. Virkning og anvendelse.

2. Det skal du vide om Eligard

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.

3. Sådan bliver du behandlet med Eligard

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.

4. Bivirkninger.

5. Opbevaring.

6. Yderligere oplysninger.

7. Information til sundhedspersonale.

1. Virkning og anvendelse

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2. Det skal du vide om Eligard

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Du må ikke få Eligard

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Lægen eller sundhedspersonalet vil være ekstra forsigtig

med at behandle dig med Eligard

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Komplikationer ved opstart af behandling

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

ELIGARD

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7,5 mg, 22,5 mg og 45 mg

Pulver og solvens til injektionsvæske, opløsning

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Hvis Eligard

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Graviditet og amning

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Trafik- og arbejdssikkerhed

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3. Sådan bliver du behandlet med Eligard

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Den sædvanlige dosis er

Voksne:

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Yderligere undersøgelser

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Administrationsvej

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Trin 5:

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OÌSEFOTUUFTQÌBemærk: Der vil være små luftbobler i opløsnin-

gen. Dette er acceptabelt.

Trin 6:

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Trin 7:

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“HFTPWFSUJEKun til engangsbrug. Ubrugt opløsning skal kasseres.

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Document: 79184-01 Version: 1 Approved by: inv, 2012-07-03 14:19:01 Activated by: inv, 2012-07-03 14:19:31

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4. Bivirkninger

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Bivirkninger ved starten af behandlingen

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Alvorlige bivirkninger

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5. Opbevaring

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)WJTQBLOJOHFOFSNSLFUNFE&91CFUZEFSEFUBUVEM“CTEBUPFOFS

EFOTJETUFEBHJEFOBOG“SUFNÌOFE

"GMFWFSBMUJENFEJDJOSFTUFSQÌBQPUFLFU"GIFOTZOUJMNJMK“FUNÌEV

JLLFTNJEFNFEJDJOSFTUFSJBGM“CFU UPJMFUUFUFMMFSTLSBMEFTQBOEFO

6. Yderligere oplysninger

Eligard

®

, 7,5 mg, 22,5 mg eller 45 mg, 1 forfyldt sprøjte med pulver

til injektionsvæske, opløsning indeholder:

-FVQSPSFMJOBDFUBU

1 forfyldt sprøjte med solvens indeholder:

1PMZ %-MBDUBUDPHMZDPMTZSF  IIW PH PH/NFUIZM

QZSSPMJEPO

Pakningsstørrelser:

&MJHBSE

GÌTJ

&MJHBSE

 NHPH NHGÌTJQBLOJOHTTU“SSFMTFSËFOQBLOJOH

CFTUÌFOEFBGUPGPSNTU“CUFCBLLFSJFOTLF%FOFOFCBLLFJOEF

IPMEFSFOGPSGZMEUTUFSJMQPMZQSPQZMFOJOKFLUJPOTTQS“KUF" FUMBOHU

TUFNQFMUJMTQS“KUF#PHFOQPTFU“SSFNJEEFM%FOBOEFOCBLLFJOEF

IPMEFSFOGPSGZMEUTUFSJMTQS“KUF# FOTUFSJMHBVHFLBOZMFPHFO

QPTFU“SSFNJEEFM

&MJHBSE

NHGÌTJFOQBLOJOHTTU“SSFMTFËFOQBLOJOHCFTUÌFOEF

BGUPGPSNTU“CUFCBLLFSJFOTLF%FOFOFCBLLFJOEFIPMEFSFO

GPSGZMEUTUFSJMQPMZQSPQZMFOJOKFLUJPOTTQS“KUF" FUMBOHUTUFNQFMUJM

TQS“KUF#PHFOQPTFU“SSFNJEEFM%FOBOEFOCBLLFJOEFIPMEFSFO

GPSGZMEUTUFSJMTQS“KUF# FOTUFSJMHBVHFLBOZMFPHFOQPTFU“SSF

NJEEFM

"MMFTUZSLFSPHQBLOJOHTTU“SSFMTFSFSJLLFO“EWFOEJHWJTNBSLFETG“SU

Indehaver af markedsføringstilladelsen og fremstiller

0SJGBSN"4 &OFSHJWFK 0EFOTF4

.BJMJOGP!PSJGBSNDPN

'PSZEFSMJHFSFPQMZTOJOHFSPNEFOOFNFEJDJOPHWFESFLMBNBUJPOFS

LBOEVIFOWFOEFEJHUJM0SJGBSN"4

7. Information til sundhedspersonale

Følgende oplysninger er kun til læger og sundhedspersonale

Lad præparatet opnå stuetemperatur før brug.

Forbered patienten til injektionen først, og bland derefter præpara-

tet som angivet i følgende vejledning.

Trin 1:

¯COEFOZESFQPTFFMMFSCBLLF USLGPMJFOBGGSBEFUIK“SOF IWPSEFS

FSFOMJMMFCPCMF PHMHJOEIPMEFUQÌFUSFOUTUFE UPQPTFSFMMFSCBL

LFSJOEFIPMEFOEFTQS“KUF" GJHVS PHTQS“KUF# GJHVS 4NJE

QPTFSOFNFEU“SSFNJEEFMVE

Bemærk: Billederne af sprøjterne og kanylen viser ikke den faktiske

størrelse.

Trin 2:

'KFSOEFUCMÌLPSUFTUFNQFM(må ikke skrues løs)PHQSPQQFOQÌ

TQS“KUF# PHTNJEEFUVE GJHVS 4LSVGPSTJHUJHUEFUMBOHFIWJEF

FLTUSBTUFNQFMQÌEFOUJMCBHFWSFOEFHSÌQSPQJTQS“KUF# GJHVS 

Trin 3:

)PMETQS“KUF"JFOlodretQPTJUJPOGPSBUTJLSF BUEFSJLLFM“CFS

WTLFVE PHTLSVEFOLMBSFLBQQFBGTQS“KUF" GJHVS 'KFSOEFO

HSÌHVNNJLBQQFQÌTQS“KUF# GJHVS 4UEFUPTQS“KUFSTBN

NFOWFEBUTLVCCFPHESFKF JOEUJMEFTJEEFSGBTU GJHVS Må ikke

strammes for hårdt,BOZMFOWJMJLLFTJEEFLPSSFLUGBTU IWJTEFSFS

M“CFUWTLFVE

Trin 4:

Injicér det flydende indhold i sprøjte AJOEJTQS“KUF# EFSJOEFIPM

EFSMFVQSPSFMJOBDFUBU#MBOEQSQBSBUFUHSVOEJHUWFEforsigtigtBU

TLVCCFJOEIPMEFUJCFHHFTQS“KUFSGSFNPHUJMCBHFNFMMFNTQS“KUFSOF

DBHBOHFJBMU EFSIPMEFTJFOWBOESFUQPTJUJPOGPSBUPQOÌFO

FOTBSUFUCMBOEJOH GJHVS 4QS“KUFTZTUFNFUNÌJLLFC“KFT/ÌSPQM“T

OJOHFOFSHSVOEJHUCMBOEFU WJMEFOWSFWJTL“TNFEFOGBSWF EFSHÌS

GSBGBSWFM“TPWFSIWJEUJMCMFHHVM IWJMLFULBOPNGBUUFIWJEFOVBODFS

UJMCMFHHVM 

Bemærk: Præparatet skal blandes som beskrevet, og omrystning vil

IKKE blande præparatet tilstrækkeligt.

791840101

Document: 79184-01 Version: 1 Approved by: inv, 2012-07-03 14:19:01 Activated by: inv, 2012-07-03 14:19:31

15-3-2018

Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal acetate), a medication used to treat fibroids

Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal acetate), a medication used to treat fibroids

OTTAWA - Health Canada is advising Canadians that it will be conducting a safety review of Fibristal (ulipristal acetate), a medication used to treat uterine fibroids in women. Health Canada's review is a result of Canadian and European reports of serious adverse events affecting the liver.

Health Canada

20-4-2018

FLECAINIDE ACETATE Tablet [Rising Health, LLC]

FLECAINIDE ACETATE Tablet [Rising Health, LLC]

Updated Date: Apr 20, 2018 EST

US - DailyMed

17-4-2018

DDAVP (Desmopressin Acetate) Spray [Ferring Pharmaceuticals Inc.]

DDAVP (Desmopressin Acetate) Spray [Ferring Pharmaceuticals Inc.]

Updated Date: Apr 17, 2018 EST

US - DailyMed

12-4-2018

FLUDROCORTISONE ACETATE Tablet [AvPAK]

FLUDROCORTISONE ACETATE Tablet [AvPAK]

Updated Date: Apr 12, 2018 EST

US - DailyMed

4-4-2018

CLEAR ANTI-ITCH (Pramoxine Hcl, Zinc Acetate) Lotion [Walgreen CO]

CLEAR ANTI-ITCH (Pramoxine Hcl, Zinc Acetate) Lotion [Walgreen CO]

Updated Date: Apr 4, 2018 EST

US - DailyMed

4-4-2018

CORTISONE ACETICUM (Cortisone Acetate) Pellet [Boiron]

CORTISONE ACETICUM (Cortisone Acetate) Pellet [Boiron]

Updated Date: Apr 4, 2018 EST

US - DailyMed

4-4-2018

CALCIUM ACETATE Tablet [Unit Dose Services]

CALCIUM ACETATE Tablet [Unit Dose Services]

Updated Date: Apr 4, 2018 EST

US - DailyMed

30-3-2018

FLECAINIDE ACETATE Tablet [AvPAK]

FLECAINIDE ACETATE Tablet [AvPAK]

Updated Date: Mar 30, 2018 EST

US - DailyMed

29-3-2018

NORETHINDRONE ACETATE (Norethindrone) Tablet [AvPAK]

NORETHINDRONE ACETATE (Norethindrone) Tablet [AvPAK]

Updated Date: Mar 29, 2018 EST

US - DailyMed

28-3-2018

ELLA (Ulipristal Acetate) Tablet [Afaxys Pharma LLC]

ELLA (Ulipristal Acetate) Tablet [Afaxys Pharma LLC]

Updated Date: Mar 28, 2018 EST

US - DailyMed

26-3-2018

HYDROCORTISONE ACETATE PRAMOXINE HCL Cream [Perrigo New York Inc]

HYDROCORTISONE ACETATE PRAMOXINE HCL Cream [Perrigo New York Inc]

Updated Date: Mar 26, 2018 EST

US - DailyMed

23-3-2018

MEGESTROL ACETATE Suspension [TWi Pharmaceuticals, Inc.]

MEGESTROL ACETATE Suspension [TWi Pharmaceuticals, Inc.]

Updated Date: Mar 23, 2018 EST

US - DailyMed

22-3-2018

Cetrotide (Merck Serono Europe Limited)

Cetrotide (Merck Serono Europe Limited)

Cetrotide (Active substance: Cetrorelix (as acetate)) - Centralised - Yearly update - Commission Decision (2018)1751 of Thu, 22 Mar 2018

Europe -DG Health and Food Safety

19-3-2018

NEOMED PHARMACEUTICAL (Hydrocortisone Acetate) Suppository [Neomed Pharmaceutical]

NEOMED PHARMACEUTICAL (Hydrocortisone Acetate) Suppository [Neomed Pharmaceutical]

Updated Date: Mar 19, 2018 EST

US - DailyMed

19-3-2018

MEGESTROL ACETATE Suspension [Morton Grove Pharmaceuticals, Inc.]

MEGESTROL ACETATE Suspension [Morton Grove Pharmaceuticals, Inc.]

Updated Date: Mar 19, 2018 EST

US - DailyMed

16-3-2018

DESMOPRESSIN ACETATE Tablet [Ferring Pharmaceuticals Inc.]

DESMOPRESSIN ACETATE Tablet [Ferring Pharmaceuticals Inc.]

Updated Date: Mar 16, 2018 EST

US - DailyMed

15-3-2018

DESMOPRESSIN ACETATE Injection, Solution [Sagent Pharmaceuticals]

DESMOPRESSIN ACETATE Injection, Solution [Sagent Pharmaceuticals]

Updated Date: Mar 15, 2018 EST

US - DailyMed

14-3-2018

SYNOVEX PLUS (Trenbolone Acetate And Estradiol Benzoate) Implant [Zoetis Inc.]

SYNOVEX PLUS (Trenbolone Acetate And Estradiol Benzoate) Implant [Zoetis Inc.]

Updated Date: Mar 14, 2018 EST

US - DailyMed

14-3-2018

SYNOVEX CHOICE (Trenbolone Acetate And Estradiol Benzoate) Implant [Zoetis Inc.]

SYNOVEX CHOICE (Trenbolone Acetate And Estradiol Benzoate) Implant [Zoetis Inc.]

Updated Date: Mar 14, 2018 EST

US - DailyMed

12-3-2018

MEDROXYPROGESTERONE ACETATE Tablet [Preferred Pharmaceuticals, Inc.]

MEDROXYPROGESTERONE ACETATE Tablet [Preferred Pharmaceuticals, Inc.]

Updated Date: Mar 12, 2018 EST

US - DailyMed

12-3-2018

HYDROCORTISONE ACETATE Suppository [SI Pharmaceuticals, LLC]

HYDROCORTISONE ACETATE Suppository [SI Pharmaceuticals, LLC]

Updated Date: Mar 12, 2018 EST

US - DailyMed

6-3-2018

ANUCORT-HC (Hydrocortisone Acetate) Suppository [Preferred Pharmaceuticals, Inc]

ANUCORT-HC (Hydrocortisone Acetate) Suppository [Preferred Pharmaceuticals, Inc]

Updated Date: Mar 6, 2018 EST

US - DailyMed

6-3-2018

MEGESTROL ACETATE Tablet [Major Pharmaceuticals]

MEGESTROL ACETATE Tablet [Major Pharmaceuticals]

Updated Date: Mar 6, 2018 EST

US - DailyMed

5-3-2018

ABIRATERONE ACETATE Tablet, Film Coated [Janssen Biotech, Inc.]

ABIRATERONE ACETATE Tablet, Film Coated [Janssen Biotech, Inc.]

Updated Date: Mar 5, 2018 EST

US - DailyMed

2-3-2018

PRED-BROM (Prednisolone Acetate-Bromfenac) Suspension/ Drops [ImprimisRx NJ]

PRED-BROM (Prednisolone Acetate-Bromfenac) Suspension/ Drops [ImprimisRx NJ]

Updated Date: Mar 2, 2018 EST

US - DailyMed

28-2-2018

GLATOPA (Glatiramer Acetate) Injection, Solution [Sandoz Inc]

GLATOPA (Glatiramer Acetate) Injection, Solution [Sandoz Inc]

Updated Date: Feb 28, 2018 EST

US - DailyMed

28-2-2018

MEDROXYPROGESTERONE ACETATE Injection, Suspension [NuCare Pharmaceuticals,Inc.]

MEDROXYPROGESTERONE ACETATE Injection, Suspension [NuCare Pharmaceuticals,Inc.]

Updated Date: Feb 28, 2018 EST

US - DailyMed

28-2-2018

MEGESTROL ACETATE Suspension [McKesson Corporation]

MEGESTROL ACETATE Suspension [McKesson Corporation]

Updated Date: Feb 28, 2018 EST

US - DailyMed

27-2-2018

MEGESTROL ACETATE Tablet [McKesson Corporation]

MEGESTROL ACETATE Tablet [McKesson Corporation]

Updated Date: Feb 27, 2018 EST

US - DailyMed

27-2-2018

ELIGARD (Leuprolide Acetate) Kit [TOLMAR PHARMACEUTICALS INC.]

ELIGARD (Leuprolide Acetate) Kit [TOLMAR PHARMACEUTICALS INC.]

Updated Date: Feb 27, 2018 EST

US - DailyMed

26-2-2018

EU/3/18/1985 (Raremoon Consulting Ltd)

EU/3/18/1985 (Raremoon Consulting Ltd)

EU/3/18/1985 (Active substance: Rusalatide acetate) - Orphan designation - Commission Decision (2018)1252 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/221/17

Europe -DG Health and Food Safety

23-2-2018

AX PHARMACEUTICAL CORP (Seractide Acetate) Powder [AX Pharmaceutical Corp]

AX PHARMACEUTICAL CORP (Seractide Acetate) Powder [AX Pharmaceutical Corp]

Updated Date: Feb 23, 2018 EST

US - DailyMed

21-2-2018

Wilzin (Orphan Europe S.A.R.L.)

Wilzin (Orphan Europe S.A.R.L.)

Wilzin (Active substance: Zinc acetate dihydrate) - Centralised - Yearly update - Commission Decision (2018) 1132 of Wed, 21 Feb 2018

Europe -DG Health and Food Safety

21-2-2018

DESMOPRESSIN ACETATE Spray [Cadila Healthcare Limited]

DESMOPRESSIN ACETATE Spray [Cadila Healthcare Limited]

Updated Date: Feb 21, 2018 EST

US - DailyMed

20-2-2018

AX PHARMACEUTICAL CORP (Buserelin Acetate) Powder [AX Pharmaceutical Corp]

AX PHARMACEUTICAL CORP (Buserelin Acetate) Powder [AX Pharmaceutical Corp]

Updated Date: Feb 20, 2018 EST

US - DailyMed

20-2-2018

FLECAINIDE ACETATE Tablet [Amneal Pharmaceuticals Of New York LLC]

FLECAINIDE ACETATE Tablet [Amneal Pharmaceuticals Of New York LLC]

Updated Date: Feb 20, 2018 EST

US - DailyMed

16-2-2018

MACRILEN (Macimorelin Acetate) Granule, For Solution [Strongbridge U.S. Inc]

MACRILEN (Macimorelin Acetate) Granule, For Solution [Strongbridge U.S. Inc]

Updated Date: Feb 16, 2018 EST

US - DailyMed

14-2-2018

DESMOPRESSIN ACETATE Tablet [AvPAK]

DESMOPRESSIN ACETATE Tablet [AvPAK]

Updated Date: Feb 14, 2018 EST

US - DailyMed

13-2-2018

CALCIUM ACETATE Capsule [AvPAK]

CALCIUM ACETATE Capsule [AvPAK]

Updated Date: Feb 13, 2018 EST

US - DailyMed

9-2-2018

ABIRATERONE ACETATE Tablet [Janssen Biotech, Inc.]

ABIRATERONE ACETATE Tablet [Janssen Biotech, Inc.]

Updated Date: Feb 9, 2018 EST

US - DailyMed

1-2-2018

DESMOPRESSIN ACETATE Spray [Zydus Pharmaceuticals (USA) Inc.]

DESMOPRESSIN ACETATE Spray [Zydus Pharmaceuticals (USA) Inc.]

Updated Date: Feb 1, 2018 EST

US - DailyMed

31-1-2018

COPAXONE (Glatiramer Acetate) Injection, Solution [Teva Neuroscience, Inc.]

COPAXONE (Glatiramer Acetate) Injection, Solution [Teva Neuroscience, Inc.]

Updated Date: Jan 31, 2018 EST

US - DailyMed

31-1-2018

AX PHARMACEUTICAL CORP (Desmopressin Acetate) Powder [AX Pharmaceutical Corp]

AX PHARMACEUTICAL CORP (Desmopressin Acetate) Powder [AX Pharmaceutical Corp]

Updated Date: Jan 31, 2018 EST

US - DailyMed

30-1-2018

NORETHINDRONE ACETATE (Norethindrone) Tablet [AvKARE, Inc.]

NORETHINDRONE ACETATE (Norethindrone) Tablet [AvKARE, Inc.]

Updated Date: Jan 30, 2018 EST

US - DailyMed

26-1-2018

FLUDROCORTISONE ACETATE Tablet [AvKARE, Inc.]

FLUDROCORTISONE ACETATE Tablet [AvKARE, Inc.]

Updated Date: Jan 26, 2018 EST

US - DailyMed