global® total® with HEPES with Human Serum Albumin (HSA)

READY-TO-USE
HGTH-050, 50 ml
HGTH-100, 100 ml
HGTH-250, 250 ml

Human oocyte and embryo washing and manipulation, fertilization by intracytoplasmic sperm injection (ICSI), embryo transfer.

Store at 2-8°C and protected from light. Ten (10) weeks from the date of manufacture. For best results, use within four (4) weeks.

A HEPES-buffered medium is required when oocytes and embryos are handled outside of a CO2 incubator.

Sodium Chloride; Sodium Pyruvate; Potassium Chloride; Calcium Chloride; Potassium Phosphate; Magnesium Sulfate; Sodium Bicarbonate; Amino Acids; EDTA; Glucose; Phenol Red; Sodium Lactate; HEPES; Human Serum Albumin (4.4 mg/ml); Human α- and β-globulins (0.6 mg/ml); Gentamicin Sulfate* (10 µg/ml)

Paramater SpecificationpH 7.2-7.4Osmolality 260-270LAL Endotoxin < 0.5 EU/mlSterility Test, membrane filtration Negative1-cell Mouse Embryo Assay (% blastocysts at 96 h of culture) > 80%

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 global® total® w/ HEPES for human oocyte and embryo washing and manipulation, ICSI or embryo transfer.
3. Not to be used for injection.
4. 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
5. 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: All blood products should be treated as potentially infectious. Source material from which this product was derived was found negative when tested for antibodies to HIV, HBc, HCV, and HTLV I/II and non-reactive for HbsAg, HCV RNA and HIV-1 RNA and syphilis. No known test methods can offer assurances that products derived from human blood will not transmit infectious agents.
6. global® total® w/ HEPES contains the antibiotic gentamicin sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
7. To avoid problems with contamination, practice aseptic techniques.
8. Discard unused medium within 7 days of opening. Do not use after expiry date.