|CE Marked (CE 0086)
LPVP-001, 1 ml
|Indications for Use||To restrict the motility of human sperm.|
|Storage and Shelf Life||Store at 2-8°C and protected from light. Nine (9) 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.|
|Disposal Consideration||Treat or dispose of waste material in accordance with all local state/provincial, and national requirements. Dispose with laboratory waste.|
Dialysed Ph Eur grade polyvinylpyrrolidone (PVP) in Flushing Medium. Flushing Medium is an aqueous solution containing physiologic salts, HEPES, lactate, pyruvate, glucose and human albumin solution.
|Recommendations for Use||
For a full and detailed recommended protocol of use for PVP - 1 ml please contact us at firstname.lastname@example.org.
|Quality Control Specifications||
|Precautions and Warnings||
PVP 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 PVP 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.
Only for the intended use. Do not resterilize.
The long term safety of Intracytoplasmatic Sperm Injection (ICSI), including the use of PVP, on children born following this procedure is unknown.