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CE Marked (CE 0086)
GALW-100, 100 ml
GALW-500, 500 ml |
| Indications for Use |
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Sperm washing and preparation for in vitro fertilization and for intra-uterine insemination. |
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| Storage and Shelf Life |
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Store at 2-8°C and protected from light. One (1) year from the date of manufacture when stored unopened at 2-8°C and protected from light.
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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, Sodium Lactate, Sodium Pyruvate, Phenol Red, HEPES, Gentamicin Sulfate (10 μg/ml), Human Serum Albumin (5 mg/ml) |
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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 (at room temperature in air) |
7.2-7.6 |
| Osmolality |
280-300 mOsM |
| Endotoxin (LAL) |
< 1.0 EU/ml |
| Sterility Test (bacterial and fungal screen) |
PASS |
| 1-cell Mouse Embryo Assay (% expanded blastocysts at 96 h of culture after 30 minute exposure) |
> 80% |
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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 AllGrad Wash® for the removal of dead sperm, debris, and other cells from human sperm cells prior to in-vitro fertilization and ICSI.
- 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
- AllGrad Wash® contains only a low concentration of sodium bicarbonate and should not be gassed with CO2.
- AllGrad Wash® contains the antibiotic gentamicin sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
- AllGrad Wash® contains small amounts of Human Serum Albumin (HSA). 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 AllGrad Wash® 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.
- 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 AllGrad Wash® IFU