|CE Marked (CE 0086)
FGWG-100, 100 ml
|Indications for Use||
Sperm washing and preparation for in-vitro fertilization and for intra-uterine insemination.
|Storage and Shelf Life||Store at 2-8°C and protected from light. Eighteen (18) months from the date of production when stored unopened at 2–8°C and protected from light. Do not freeze before use. Keep away from light. Discard unused medium within 7 days after opening. Do not use after expiry date.|
AllGrad Wash® is a ready-to-use HEPES-buffered medium which also contains bicarbonate, physiologic salts, glucose, lactate and human serum albumin (4 mg/ml).
|Recommendations for Use||
For a full and detailed recommended protocol of use for AllGrad wash® please contact us at firstname.lastname@example.org.
|Quality Control Specifications||
|Precautions and Warnings||
AllGrad Wash® contains small amounts of Human Serum Albumin (HSA). The Human Serum Albumin used in the preparation of this product has been heated at 60°C for ten hours.
Caution: 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 be totally excluded. This also applies to unknown or emerging viruses and other pathogens. There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes. It is strongly recommended that every time that AllGrad Wash® is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Always wear protective clothing when handling specimens.
Always work under strict hygienic conditions (e.g. LAF-bench ISO Class 5) to avoid possible contamination. AllGrad Wash® contains the antibiotic Gentamicin Sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
AllGrad Wash® contains HEPES; no CO2 incubation is required. AllGrad Wash® should be preincubated in the incubator for 12 hours before use (with lid closed).
Only for the intended use. Do not resterilize.