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LGHY-010, 10 ml

Indications for Use   For the removal of the cumulus complex and corona of the oocyte before ICSI.
Storage and Shelf Life   Store at 2-8°C and protected from light. Six (6) months from the date of manufacture.
Disposal Consideration   Treat or dispose of waste material in accordance with all local state/provincial, and national requirements. Dispose with laboratory waste.
Composition   Hyaluronidase (80 IU/ml) in an aqueous solution containing:

Sodium Phosphate, Sodium Bicarbonate, Phenol Red, Potassium Chloride, Glucose, Calcium Chloride, Sodium Lactate, HEPES, Potassium Phosphate, Sodium Pyruvate, Magnesium Sulfate, Human Serum Albumin* (5 mg/ml), Gentamicin Sulfate* (10 mg), *from therapeutic-grade source material
Instructions for Use  

Link to Hyaluronidse IFU

Quality Control Specifications  
Assay (performed for each batch) Specification
pH 7.2-7.6
Osmolarity 270-290 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 Hyaluronidase to remove cumulus cells from human oocytes.
  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 Hyaluronidase 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. Hyaluronidase contains only a low concentration of sodium bicarbonate and should not be gassed, or used for culture under CO2.
  8. To avoid problems with contamination, practice aseptic techniques.
  9. Discard unused medium within 7 days of opening. Do not use after expiry date.