Gamunex 10%

Hauptinformation

  • Handelsname:
  • Gamunex 10% solution pour injection intraveineuse
  • Darreichungsform:
  • solution pour injection intraveineuse
  • Zusammensetzung:
  • immunoglobulinum menschliche normale 0,1 g, glycinum, Wasser iniectabilia excipiens der Lösung für 1 ml.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

  • für die Allgemeinheit:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie das Informationsblatt für die Öffentlichkeit.

  • Information für medizinisches Fachpersonal:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.

Lokalisierung

  • Erhältlich in:
  • Gamunex 10% solution pour injection intraveineuse
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Blutprodukte
  • Therapiebereich:
  • Immunomodulation in die idiopathische thrombozytopenische purpura (ITP), immunomodulation in dem syndrom von Kawasaki, allogene knochenmarks-und substitutionstherapie bei krankheiten, immundefekte, primäre, substitutionstherapie bei myelom oder chronischer lymphatischer leukämie mit schwerer sekundärer hypogammaglobulinämie und rezidivierenden infektionen, immunomodulation in das Guillain-Barré-syndrom (GBS), substitutionstherapie bei kindern mit angeborenem AIDS und rezidivierenden infektionen.

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 668
  • Berechtigungsdatum:
  • 26-10-2005
  • Letzte Änderung:
  • 24-10-2018

15-2-2019

Toegang tot Wet langdurige zorg ook voor mensen met een psychische stoornis

Toegang tot Wet langdurige zorg ook voor mensen met een psychische stoornis

Mensen die hun leven lang intensieve geestelijke gezondheidszorg (GGZ) nodig hebben, kunnen vanaf 2021 toegang krijgen tot de Wet langdurige zorg (Wlz). Het gaat hierbij naar verwachting om 10.000 cliënten die permanent toezicht of 24 uur per dag zorg in de nabijheid nodig hebben en nu zorg en ondersteuning krijgen vanuit de Wet maatschappelijk ondersteuning of de Zorgverzekeringswet. De ministerraad heeft op voorstel van staatssecretaris Blokhuis van Volksgezondheid, Welzijn en Sport ingestemd met toeze...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-2-2019

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Published on: Thu, 14 Feb 2019 Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on Yarrowia lipolytica yeast biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is the dried and heat‐killed biomass of Yarrowia lipolytica, a yeast species that is widespread in nature and which can be found in the environment as well as in foods. The production process is sufficiently describ...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-2-2019

Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe EMA/CMDh/689167/2018 vom 17.10.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Ciprofloxacin (systemische Anwendung)

Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe EMA/CMDh/689167/2018 vom 17.10.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Ciprofloxacin (systemische Anwendung)

Das BfArM veröffentlicht den Umsetzungsbescheid für den Wirkstoff Ciprofloxacin (systemische Anwendung) infolge des Europäischen PSUR Single Assessment Verfahrens nach Artikel 107d) bis g) der Richtlinie 2001/83/EG.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

12-2-2019

Health Canada will be updating its safety review of breast implants

Health Canada will be updating its safety review of breast implants

OTTAWA - Health Canada will be updating its safety review of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) following an increase in reports of Canadian cases. As of January 1, 2019, Health Canada has received reports of 22 confirmed and 22 suspected Canadian cases of BIA-ALCL. In its initial safety review in 2017, Health Canada found that the rate of BIA-ALCL cases was low, with 5 confirmed Canadian cases of BIA-ALCL reported by Canadian manufacturers in the last 10 years. Increased...

Health Canada

9-2-2019

Birdseed Food Co. Issues Allergy Alert on Undeclared Cashews in Craft Granola Goldenola Turmeric & Ginger

Birdseed Food Co. Issues Allergy Alert on Undeclared Cashews in Craft Granola Goldenola Turmeric & Ginger

BIRDSEED FOOD CO. of Bend, OR is recalling Craft Granola Goldenola Turmeric & Ginger that was sold between the dates of 10/03/18 - 02/07/19, because it contains undeclared cashews. People who have an allergy or severe sensitivity to cashews run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

2-2-2019

Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe EMA/CMDh/693647/2018 vom 17.10.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Cilazapril und der Wirkstoffkombination Cilazapril/Hydrochlorothiazid

Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe EMA/CMDh/693647/2018 vom 17.10.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Cilazapril und der Wirkstoffkombination Cilazapril/Hydrochlorothiazid

Das BfArM veröffentlicht den Umsetzungsbescheid für den Wirkstoff Cilazapril und die Wirkstoffkombination Cilazapril/Hydrochlorothiazid infolge des Europäischen PSUR Single Assessment Verfahrens nach Artikel 107d) bis g) der Richtlinie 2001/83/EG.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

26-1-2019

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Published on: Fri, 25 Jan 2019 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 12 flavouring substances from subgroup 4.1 of FGE.19 in the Flavouring Group Evaluation 217 (FGE.217). Based on experimental data, in previous versions of this FGE (FGE.217 and FGE217Rev1), for 6‐methylcoumarin [FL‐no: 13.012] and 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one [FL‐no: 10.023] the concern for genotoxicity was ruled out. 6‐Methylc...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe EMA/CMDh/705293/2018 vom 17.10.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Lorazepam

Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe EMA/CMDh/705293/2018 vom 17.10.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Lorazepam

Das BfArM veröffentlicht den Umsetzungsbescheid für den Wirkstoff Lorazepam infolge des Europäischen PSUR Single Assessment Verfahrens nach Artikel 107d) bis g) der Richtlinie 2001/83/EG.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

22-1-2019

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

18-1-2019

34 nieuwe maatschappelijke diensttijdprojecten van start

34 nieuwe maatschappelijke diensttijdprojecten van start

Vandaag hebben 34 nieuwe maatschappelijke diensttijdprojecten door heel Nederland bericht gekregen dat ze financiering krijgen en van start kunnen gaan. In de maatschappelijke diensttijd krijgen jongeren de mogelijkheid om hun eigen talenten te ontdekken en ontwikkelen tijdens een periode waarin ze zich vrijwillig inzetten voor een ander of voor de samenleving. Bij de nieuwe projecten kunnen jongeren hun talenten inzetten op terreinen als media, cultuur en musea, onderwijs, techniek en ICT, zorg en klima...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-1-2019

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Published on: Wed, 16 Jan 2019 The additive under assessment is pure benzoic acid (> 99.8%), manufactured in the form of flakes. It is intended to be used as a technological feed additive (acidity regulator) in feedingstuffs for weaned piglets and pigs for fattening, with maximum contents of 5,000 and 10,000 mg/kg complete feed, respectively. Benzoic acid is safe for weaned piglets at 5,000 mg/kg complete feed, and at 10,000 mg/kg complete feed for pigs for fattening. The use of benzoic acid in feedings...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

19-2-2019


Orphan designation: Rucaparib, Treatment of ovarian cancer, 10/10/2012, Withdrawn

Orphan designation: Rucaparib, Treatment of ovarian cancer, 10/10/2012, Withdrawn

Orphan designation: Rucaparib, Treatment of ovarian cancer, 10/10/2012, Withdrawn

Europe - EMA - European Medicines Agency

15-2-2019

Aldactone® 10 ml Canrenoat

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14-2-2019

EU/3/10/798 (Diurnal Europe B.V.)

EU/3/10/798 (Diurnal Europe B.V.)

EU/3/10/798 (Active substance: Synthetic double-stranded short interfering RNA oligonucleotide directed against proopiomelanocortin) - Transfer of orphan designation - Commission Decision (2019)1360 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003061

Europe -DG Health and Food Safety

13-2-2019


Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Europe - EMA - European Medicines Agency

8-2-2019

Pankreatin 10.000 Laves® Mikro

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7-2-2019

Zinkit® 10 Brausetabletten

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31-1-2019

Isoderm 10 mg/20 mg

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29-1-2019

Oxa-CT 10 mg Tabletten

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29-1-2019

Ezehron Duo 5 mg/10 mg Tabletten

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28-1-2019


Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

28-1-2019

Twynsta® 40 mg/10 mg Tabletten

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28-1-2019

Twynsta® 80 mg/10 mg Tabletten

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25-1-2019


Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Europe - EMA - European Medicines Agency

23-1-2019

EU/3/10/777 (Voisin Consulting S.A.R.L.)

EU/3/10/777 (Voisin Consulting S.A.R.L.)

EU/3/10/777 (Active substance: Cyclic pyranopterin monophosphate) - Transfer of orphan designation - Commission Decision (2019)574 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003164

Europe -DG Health and Food Safety

22-1-2019

EU/3/10/841 (Vanda Pharmaceuticals Germany GmbH)

EU/3/10/841 (Vanda Pharmaceuticals Germany GmbH)

EU/3/10/841 (Active substance: Tasimelteon) - Transfer of orphan designation - Commission Decision (2019)573 of Tue, 22 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002557

Europe -DG Health and Food Safety

21-1-2019

ZYPREXA 10 mg Pulver

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18-1-2019

LENVIMA® 4 mg/10 mg Hartkapseln

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17-1-2019

Retrovir 10 mg/ml i.v.

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16-1-2019

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (Active substance: Doxorubicin hydrochloride (in heat-sensitive liposomes)) - Transfer of orphan designation - Commission Decision (2019)237 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003113

Europe -DG Health and Food Safety

14-1-2019

Manyper 10 mg/20 mg Tabletten

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14-1-2019

Urtimed® 10 mg Tabletten

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11-1-2019


Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment

Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment

Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment of maple syrup urine disease, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019

Strensiq (Alexion Europe SAS)

Strensiq (Alexion Europe SAS)

Strensiq (Active substance: asfotase alfa) - Centralised - Yearly update - Commission Decision (2019)69 of Thu, 10 Jan 2019

Europe -DG Health and Food Safety

10-1-2019

Diazepam-ratiopharm 10 mg Tabletten

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