LifeGlobal® Protein Supplement

LG Protein Supplement  

NOT AVAILABLE IN EU


LGPS-605, 6 x 5 ml
LGPS-020, 20 ml
LGPS-050, 50 ml

Intended Use  

For use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth, and embryo cryopreservation.

     
Storage and Shelf Life  

Store at 2-8°C and protected from light. One (1) year from the date of manufacture. Do not use the product for longer than 30 days after opening the container.

     
Disposal Consideration  

Treat or dispose of waste material in accordance with all local state/provincial, and national requirements. Dispose with laboratory waste.

     
Composition   LifeGlobal® Protein Supplement contains a total protein concentration of 50 mg/ml, comprising 44 mg/ml human serum albumin and 6 mg/ml human α- and β-globulins from therapeutic-grade source material, in a sterile saline solution.
     
Recommendations for Use   For a full and detailed recommended protocol of use for LifeGlobal® Protein Supplement please contact us at customerservice@lifeglobal.com.

     
Quality Control Specifications  
Assay (performed for each batch) Specification
pH 7.2-7.4
Osmolality 250-270 mOsM
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) > 80%
     
Precautions and Warnings  
  1. Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
  2. Caution: The user should read and understand the Instructions for Use, Precautions and Warnings, and be trained in the correct procedure before using LifeGlobal® Protein Supplement for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth, and embryo cryopreservation.
  3. Not to be used for injection.
  4. Do not resterilize.
  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. This product contains human serum albumin, a derivative of human blood. 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 LifeGlobal® Protein Supplement 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.
  7. To avoid problems with contamination, practice aseptic techniques.
  8. Once the bottle is opened, store the product tightly capped at 2-8°C and protected from light. Do not use the product for longer than 30 days after opening the container.