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CE Marked (CE 0086)
READY-TO-USE
HGTF-050, 50 ml
HGTF-100, 100 ml |
| Indications for Use |
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Human oocyte culture and fertilization. |
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| Storage and Shelf Life |
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Store at 2-8°C and protected from light. Ten (10) weeks from the date of manufacture. |
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| Disposal Consideration |
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Treat or dispose of waste material in accordance with all local state/provincial, and national requirements. Dispose with laboratory waste. |
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| Composition |
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Sodium Chloride, Potassium Chloride, Calcium Chloride, Potassium Phosphate, Magnesium Sulfate, Sodium Bicarbonate, Glucose, Lactate Na Salt, Sodium Pyruvate, Amino Acids, EDTA, Phenol Red, Human Serum Albumin* (10 mg/ml), Gentamicin Sulfate* (10 μg/ml), *from therapeutic-grade source material
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| Instructions for Use |
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| Quality Control Specifications |
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| Assay (performed for each batch) |
Specification |
| pH (with 5% CO2) |
7.2-7.4 |
| Osmolality |
260-270 mOsM |
| Endotoxin (LAL) |
< 0.5 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% |
| Special Note on the CO2 Concentration in the Incubator: In most cases, a 5-7% concentration of CO2 in the incubator will produce a pH of 7.2 to 7.4 in global® total® for Fertilization w/ HSA. However, the exact concentration of CO2 required to produce the optimum pH of approximately 7.30 (7.27-7.33) depends on several factors, including the physical characteristics of incubator and the altitude. Consequently, we strongly recommend that each laboratory determine and use the concentration of CO2 that is required to produce a pH of 7.30 in global® total® for Fertilization w/ HSA. |
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Precautions and Warnings |
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- Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
- 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® for Fertilization w/ HSA for the culture and conventional in-vitro fertilization of human oocytes.
- Not to be used for injection.
- Do not resterilize.
- 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
- 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 global® total® for Fertilization w/ HSA 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.
- global® total® for Fertilization w/ HSA contains the antibiotic gentamicin sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
- To avoid problems with contamination, practice aseptic techniques.
- Discard unused medium within 7 days of opening. Do not use after expiry date.
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Link to global® total® for Fertilization w/ HSA IFU