PVP

 
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NOT AVAILABLE IN EU

LPVP-001, 1 ml
LPVP-502, 5 x 0.2 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.
     
Composition   Polyvinylpyrrilodone in an aqueous solution containing:

Sodium Chloride; Potassium Chloride; Calcium Chloride; Potassium Phosphate; Magnesium Sulfate; Sodium Bicarbonate; Glucose; Sodium Lactate; Sodium Pyruvate; Phenol Red; Gentamicin Sulfate; HEPES; Human Serum Albumin
Instructions for Use  

Link to PVP IFU

Quality Control Specifications  
Assay (performed for each batch) Specification
pH 7.2-7.9
Osmolality 280-320 mOsM
Viscosity (25°C) >170 cP
Endotoxin (LAL) < 1.0 EU/ml
Sterility Test (bacterial and fungal screen, SAL 10–3) PASS
1-cell Mouse Embryo Assay (% expanded blastocysts at 96 h of culture after 30 minute exposure) > 80%

Precautions and Warnings
 
  1. Not to be used for injection.
  2. Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
  3. PVP contains only a low concentration of sodium bicarbonate and should not be gassed with CO2.
  4. PVP contains small amounts of Human Serum Albumin (HSA). All donors used to obtain the Human Serum Albumin were individually tested and found to be non-reactive for Hepatitis B Surface Antigen (HbsAg), Hepatitis C virus (HCV) and antibodies to Human Immunodeficiency Virus (HIV) by approved testing methods. The Human Albumin used in the preparation of this product has been heated at 60°C for ten hours.
    Caution: All blood products should be treated as potentially infectious. No known test methods can offer assurances that products derived from human blood will not transmit infectious agents.
  5. Do not use the product if:
    • the product packaging appears damaged or if the seal is broken
    • the expiry date has been exceeded
    • the product becomes discolored, cloudy, or shows evidence of particulate matter
  6. To avoid problems with contamination, practice aseptic techniques and discard minimal amounts of excess medium remaining in the bottle.
  7. Once the bottle is opened, store the product tightly capped at 2-8ºC and protected from light.
  8. The user should read and understand the Instructions for Use, Precautions and Warnings, and be trained in the correct procedure before using PVP.