GM501 Cult is ready-to-use bicarbonate-buffered culture media, designed for fertilisation and for human embryo culture from day 1 to blastocyst stage. It can also be used for embryo transfer.
|Product description||Product code||Unit|
|GM501 Cult||4 GM 501H-20||20 ml|
|GM501 Cult||4 GM 501H-50||50 ml|
Product facts and notices
- Product specifications and quality control
- Instructions for use
- Precautions and warnings
- Storage instructions and stability
- NaCl, KCl, KH2PO4, MgSO4.7H2O, NaHCO3, CaCl2.2H2O, D(+)-Glucose anhydrous, Na-Lactate (50% solution), Na-Pyruvate, EDTA, Alanyl-Glutamine, water, non-essential and essential Amino Acids, human serum albumin (10.00 g/liter).
Produktspezifikationen und Qualitätskontrolle:
- All raw materials are of highest available purity (European Pharmacopoeia and/or USP standard) if applicable.
- A certificate of analysis is available for each batch upon request from our website with respective lot number.
- The MSDS for the medium is available upon request and can also be downloaded from our website.
- The medium is manufactured and tested according to the following specifications
|pH (at 37°C, 6 % CO2)||7.20-7.45|
|Sterility||sterile – SAL 10-3 (Sterility Assurance Level)|
|Endotoxins (EU/ml)||< 0.25|
|MEA (Blastocysts after 96 hours culture in %)||≥ 80 (96 exposure from zygote state)|
Instructions for use:
- The intended users are IVF professionals (lab technicians, embryologists or medical doctors).
- The medium must be equilibrated over night in a humidified CO2-incubator (at 5-
- 7 % CO2, 37°C). The media are designed for embryo culture under oil as well as in open systems.
Precautions and warnings:
- GM501 Cult with Gentamicin and GM501 Cult with Gentamicin and Phenolred contains the antibiotic Gentamicin Sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
- Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot totally be excluded. This also applies to unknown or emerging viruses and other pathogens. There are no reports of proven virus transmissions with albumin, manufactured to European Parmacopoeia specifications by established processes.
- Therefore, handle all specimens as if capable of transmitting HIV or hepatitis. Always wear protective clothing when handling specimens.
- Always work under strict hygienic conditions (ISO 5 environment, e.g. LAF-bench) to avoid possible contamination, even when GM501 Cult medium contains Gentamicin.
- Only for the intended use.
- Do not use the product if bottle, seal of the container or package is opened or defect when the product is delivered.
- Do not use the product if it becomes discoloured, cloudy or shows any evidence of microbial contamination.
Aufbewahrungshinweise und Haltbarkeit:
- The shelf life is 6 month from time of manufacture.
- Store between 2-8°C.
- Do not freeze before use.
- Keep away from (sun) light.
- The product can be used safely up to 7 days after opening, when sterile conditions are maintained.
- Do not use after expiry date.
- 2013 Basile N. “Type of cuture media does not affect embryo kinetics a time lapse analysis of sibling oocytes” EN
- 2013 Paternot G. “Semi automated morphometric analysis of human embryos can reveal correlations between total embryo volume and clinical pregnancy” EN
- 2012 Nadir Ciray H. “Time lapse evaluation of human embryo development in single versus sequential culture media a sibling oocyte study” EN
- 2011 Kemeter P. “Eine prospektiv randomisierte Studie zum Vergleich zweier Embryo Kultursysteme nach IVF ICSI Sequential media in 5% O2 Atmosphäre und single medium in 21% O2 Atmosphäre” DE
- 2011 Gruber I. “Embryo culture media for human IVF which possibilities exist”EN
- 2010 Schwahn “First Clinical Experience with GM501” EN
- 2010 Schwahn “Erste klinische Erfahrungen mit GM501” DE
- 2010 Paternot G. “Early embryo development in a sequential versus single medium a randomized study” EN
- 2010 Campo R. “Critical reappraisal of embryo quality as a predicive parameter for pregnancy outcome” EN
- 2010 Carrillo “A Improved Embryo Development and Comparable Pregnancy Rates Using Single vs. Sequential Culture Media” EN
- 2010 Mizobe Y. “Enhancement of Cytoplasmic Maturation of In Vitro Matured Pig Oocytes by Mechanical Vibration” EN
- 2010 Reed M. “Challenging Traditional Embryo Culture Techniques with a Simplified Continuous Single Medium Protocol” EN
- 2006 Weiss D. “Durchgehende Kultivierung von Embryonen bis zum Tag fünf in einem einfach optimierten Kultivierungsmedium GM501 im Vergleich zu Medien verschiendener Hersteller” DE
- 2006 Weiss D. “In vitro culture of human embryos up to day five in simplex optimized medium GM501” EN
- 2005 Stecher A. “Vergleich sequentielles Medium oder einfach optimiertes Medium bis Tag 5” DE
- 2005 Biggers J. “Sequential Simplex Optimization”EN
- 2005 Biggers J. “History of KSOM a single medium for embryo culture” EN
- 2004 Rinaudo P. “Effects of embryo culture on global pattern of gene expression in preimplantation mouse embryos” EN
- 2002 Biggers J. “Development of fertilized human ova to the blastocyst stage in KSOM medium” EN
- 2000 Rieger D. “A Single medium Can Support Development of Human Embryos to the Blastocyst Stage” EN