Kybernin P 1000

Informazioni principali

  • Nome commerciale:
  • Kybernin P 1000 Injektionslösung
  • Forma farmaceutica:
  • Injektionslösung
  • Composizione:
  • Preparazione cryodesiccata: proteinorum plasmatis humani solutio 503-734 mg corrisp. proteina 140-240 mg corrisp. antithrombinum III humanum 1000 U. I., glycinum, natrii chloridum, natrii citras dihydricus, pro vitro. Solvens: aqua ad iniectabilia (20 ml).
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco allopatico

Documenti

  • per il pubblico:
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  • per i professionisti:
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Localizzazione

  • Disponibile in:
  • Kybernin P 1000 Injektionslösung
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Blutprodukte
  • Area terapeutica:
  • Substitutionstherapie bei kongenitalem di Antitrombina-III-Mangel

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 46928
  • Data dell'autorizzazione:
  • 24-11-1994
  • Ultimo aggiornamento:
  • 18-10-2018
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.

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  • Documenti in altre lingue sono disponibili qui

22-1-2019

SIGMA Animal Disease Data Model: A comprehensive approach for the collection of standardised data on animal diseases

SIGMA Animal Disease Data Model: A comprehensive approach for the collection of standardised data on animal diseases

Published on: Mon, 21 Jan 2019 The European Commission is routinely asking EFSA for scientific and technical support in the epidemiological analysis of animal disease outbreaks (i.e. African swine fever, lumpy skin disease and avian influenza) and to report or assess surveillance data (i.e. Echinococcus multilocularis and avian influenza). For this purpose, EFSA has over the last years carried out several data collections and gathered specific information on outbreaks, surveillance activities and concer...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Published on: Tue, 15 Jan 2019 The additive 3‐phytase FSF10000 is a solid product that contains a 3‐phytase produced by a genetically modified strain of Komagataella phaffii. A liquid formulation of the additive has been previously assessed by the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) and is currently authorised as a feed additive for poultry species. The applicant requested for the use of this new formulation of the additive in chickens for fattening or reared ...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Published on: Fri, 11 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was ini...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-12-2018

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Published on: Thu, 13 Dec 2018 Heterogeneities in the wild boar data collection frameworks across Europe were analysed using questionnaires to explore comparability of hunting data in the short term and propose a common framework for future collection. Fifty‐seven respondents representing 32 countries covering more than 95% of European territory participated to the questionnaire. The most frequently recorded information in the official statistics included the quantity of animals shot per hunting ground ...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Published on: Mon, 29 Oct 2018 00:00:00 +0100 This report presents the results from an exploratory study in 2016 on clear communication of scientific assessment results. It had a specific focus on the communication of scientific uncertainties in EFSA scientific opinions. Qualitative methods were applied to the design and communication of an opinion summary and uncertainty statements related to that opinion, and to collect evidence on how different stakeholder groups responded to them. The study tested t...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

FDA Announces FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA

FDA Announces FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA

The U.S. Food and Drug Administration announced in the Federal Register today the fiscal year 2019 rates and payment procedures for animal drugs subject to user fees under the Animal Drug User Fee Amendments of 2018 (ADUFA IV) and Animal Generic Drug User Fee Amendments of 2018 (AGDUFA III).

FDA - U.S. Food and Drug Administration

12-9-2018

Kabinet investeert in eerste 1000 dagen kind

Kabinet investeert in eerste 1000 dagen kind

Van kinderwens tot 2-jarige peuter: de ontwikkeling die we in de eerste 1000 dagen als kind meemaken is cruciaal voor zowel een gezonde groei als de ontplooiing en kansen op latere leeftijd. Verreweg de meeste kinderen in Nederland groeien veilig en gezond op. Toch heeft ongeveer 14% van de kinderen in Nederland een ‘valse’ start door vroeggeboorte, een te laag geboortegewicht of een combinatie van beide. Minister Hugo de Jonge (VWS), gemeenten, partijen uit de geboortezorg en de jeugdgezondheidszorg (JG...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

2-8-2018

Sweet Earth Foods Issues Allergy Alert for Undeclared Egg and Milk in Aloha BBQ Quesadillas Due to Mismatched Packaging

Sweet Earth Foods Issues Allergy Alert for Undeclared Egg and Milk in Aloha BBQ Quesadillas Due to Mismatched Packaging

Sweet Earth Foods is initiating a voluntary recall of a limited amount of 8-ounce packages of Sweet Earth Aloha BBQ Quesadilla due to mismatched packaging, resulting in undeclared egg and milk allergens. People who are allergic to eggs or milk could have a serious or life- threatening reaction if they consume this item. A UPC code of 016741000551 appears on the back of the package. The “best by” date of 6/28/19 and lot number of 8149 appears on the side of the package.

FDA - U.S. Food and Drug Administration

19-6-2018

Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks

Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks

Based on new information, the Endologix AFX with Strata device is at greater risk for a Type III endoleak compared to other endovascular AAA graft systems.

FDA - U.S. Food and Drug Administration

17-5-2018

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises, Inc. is voluntarily recalling 7K (Lot specific: Lot #RO) and Poseidon 4500 (Extreme 1000 mg) (Lot specific: Lot #20117BL) to the consumer level. FDA analysis found the samples of these products to contain undeclared Sildenafil and/or Tadalafil. Sildenafil and Tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED).

FDA - U.S. Food and Drug Administration

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

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Velphoro,Sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21), decision type: , therapeutic area: , PIP number: P/0196/2018

Opinion/decision on a Paediatric investigation plan (PIP): Velphoro,Sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21), decision type: , therapeutic area: , PIP number: P/0196/2018

Opinion/decision on a Paediatric investigation plan (PIP): Velphoro,Sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21), decision type: , therapeutic area: , PIP number: P/0196/2018

Europe - EMA - European Medicines Agency

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: 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) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

6-8-2018

Scientific guideline:  ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

Scientific guideline: ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

This new multidisciplinary guideline is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognized worldwide. This means that pharmaceutical companies have to follow different approaches in the different regions. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide rec...

Europe - EMA - European Medicines Agency

27-7-2018

Scientific guideline:  Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version, draft: consultation open

Scientific guideline: Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version, draft: consultation open

The guideline is an annex to the VICH parent stability guideline, stability testing of new veterinary drug substances and medicinal products (VICH GL3 (R)), and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration application submitted within the regions in the climatic zones III and IV.

Europe - EMA - European Medicines Agency

27-6-2018

EU/3/17/1874 (Sangamo Therapeutics UK LTD)

EU/3/17/1874 (Sangamo Therapeutics UK LTD)

EU/3/17/1874 (Active substance: Recombinant adeno-associated viral vector serotype 6 encoding the B-domain-deleted human factor VIII) - Transfer of orphan designation - Commission Decision (2018)4099 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/17/T/01

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2015 (Baxalta Innovations GmbH)

EU/3/18/2015 (Baxalta Innovations GmbH)

EU/3/18/2015 (Active substance: Adeno-associated viral vector serotype 8 containing a functional copy of the codon-optimised F8 cDNA encoding the B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)3382 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/18

Europe -DG Health and Food Safety

8-3-2018

Human coagulation factor VIII

Human coagulation factor VIII

Human coagulation factor VIII (Active substance: Human coagulation factor VIII) - Corrigendum - Commission Decision (2017)7630 of Thu, 08 Mar 2018

Europe -DG Health and Food Safety