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SEQUENTIAL CULTURE MEDIA SYSTEM

Contents

Gamete solutions...... 7

Fertilization solutions...... 15

Cleavage solutions...... 21

Blastocyst solutions...... 25

Complete list of order numbers...... 30

Nurture gametes and embryos with the nutrients they need.

Our culture system mimics the delicate and dynamic environment of the female reproductive tract by providing nutrients to meet the shifting metabolic requirements of gametes and embryos.

7

GAMETE SOLUTIONS Gamete collection preparation and might be the most stressful process and thein IVF, environmental disruption that occurs can significantly These gamete viability. gamete impair solutions meet the metabolic requirements of the oocyte and help to maintain oocyte homeostasis so that subsequent steps in IVF can succeed. SOLUTIONS GAMETE SOLUTIONS FERTILIZATION SOLUTIONS CLEAVAGE SOLUTIONS BLASTOCYST

8 SYDNEY IVF GAMETE BUFFER

Sydney IVF Gamete Buffer is used to physically wash and CONSTITUENTS store gametes in preparation for the fertilization step in the lactate L-proline IVF process. D-glucose L-serine • Designed to be used in atmospheric air conditions, not Gentamicin sulphate

Glutamine, stabilized chloride SOLUTIONS GAMETE an enriched CO2 environment Glycine Potassium phosphate • HEPES buffered HEPES Purified water • Designed to prepare oocytes and maintain a stable envi- Human serum albumin (HSA)* bicarbonate ronment during washing of cumulus-enclosed oocytes. L-alanine • Designed to prepare sperm for swim-up, L-asparagine Sodium pyruvate gradient, and diluent procedures L-aspartic acid L-glutamic acid • Can be used during ICSI SOLUTIONS FERTILIZATION

USAGE RELEASE SPECIFICATIONS Sydney IVF Gamete Buffer is designed for gamete washing, pH (in air): 7.3-7.5 swim-up procedures, and use as a diluent in density Osmolality: 285-295 mOsm/kg gradient and sperm-thawing procedures. It can also be used 2-cell MEA: ≥ 80% of control expanded for ICSI when a HEPES-buffered environment is required. to blastocysts at 72 hours After ovum aspiration, Sydney IVF Gamete Buffer is used to Endotoxins: < 0.4 EU/mL wash the cumulus-oocyte complex before it is transferred Shelf life: 20 weeks from date of manufacture

into Sydney IVF Fertilization Medium. The nonessential Sterile: Aseptically filtered SOLUTIONS CLEAVAGE amino acids prevent the depletion of the oocyte’s internal HSA assay: 5.00–12.50 mg/mL pool of amino acids. HSSA: ≥ 90% of control at 24 hours Order Reference Volume Number Part Number mL G46320 K-SIGB-20-AA 20 G46318 K-SIGB-50-AA 50 G46317 K-SIGB-100-AA 100 SOLUTIONS BLASTOCYST RELATED PRODUCTS Sydney IVF Follicle Flush Buffer Sydney IVF Spermient® Sydney IVF Sperm Gradient Kit Cook® Flexipet® Pipettes

We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

*We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

9 SYDNEY IVF SPERM MEDIUM

Sydney IVF Sperm Medium is intended for use during in CONSTITUENTS vitro fertilization procedures to process sperm. Calcium lactate • Used for sperm preparation and storage D-glucose Potassium phosphate Gentamicin Purified water • Recommended for swim-up and sperm washing in SOLUTIONS GAMETE Glutamine, stabilized Sodium bicarbonate 6% CO 2 Glycine Sodium chloride USAGE Human serum albumin (HSA)* Sodium pyruvate Sydney IVF Sperm Medium is designed for use with the Magnesium sulphate Taurine swim-up technique to separate motile populations of sperm. Intrauterine insemination can be performed in this medium, RELEASE SPECIFICATIONS or sperm can be resuspended in Sydney IVF Fertilization pH (in air): 7.5-7.8 Medium prior to the insemination of oocytes in vitro. The Osmolality: 285-295 mOsm/kg SOLUTIONS FERTILIZATION product should be equilibrated in 6% CO2 before use. 2-cell MEA: ≥ 80% of control expanded to blastocysts at 72 hours Order Reference Volume Number Part Number mL Endotoxins: < 0.4 EU/mL G46316 K-SISM-20-AA 20 Shelf life: 20 weeks from date of manufacture G46315 K-SISM-50-AA 50 Sterile: Aseptically filtered G46314 K-SISM-100-AA 100 HSA assay: 5.00–12.50 mg/mL

RELATED PRODUCTS

SOLUTIONS CLEAVAGE Sydney IVF Gamete Buffer Sydney IVF Sperm Gradient Kit Sydney IVF Fertilization Medium IUI catheters SOLUTIONS BLASTOCYST

We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

*We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

10 SYDNEY IVF SPERM GRADIENT KIT

Sydney IVF Sperm Gradient is intended for use during in CONSTITUENTS vitro fertilization procedures to separate motile sperm from Calcium lactate Potassium phosphate seminal plasma. D-glucose Purified water • Sold as a convenient two-part kit for separating motile Gentamicin Silane-coated silica sperm Glutamine, stabilized particles SOLUTIONS GAMETE Glycine Sodium bicarbonate • Contains silane-coated silica HEPES Sodium chloride • Includes one vial of 40% solution and one vial of 80% Human serum albumin (HSA)* Sodium pyruvate solution Magnesium sulphate Taurine Potassium chloride USAGE Sydney IVF Sperm Gradient was designed for use in sperm RELEASE SPECIFICATIONS preparation via density-gradient separation. The gradients pH (in air): 7.3-7.5 SOLUTIONS FERTILIZATION are prepared by adding 1.5 mL of 40% solution underlaid Osmolality: 285-295 mOsm/kg with 1.5 mL of 80% solution in a conical-bottom test tube. 2-cell MEA: ≥ 80% of control expanded The liquefied semen is then overlaid onto the gradients. The to blastocysts at 72 hours test tube is centrifuged, and the resultant pellet is aspirated Endotoxins: < 0.4 EU/mL and washed in Sydney IVF Gamete Buffer. The final pellet is Shelf life: 20 weeks from date of manufacture resuspended in either Sydney IVF Sperm Medium or Sydney Sterile: Aseptically filtered IVF Fertilization Medium. HSA assay: 5.00–12.50 mg/mL Order Reference Volume Number Part Number mL SOLUTIONS CLEAVAGE G46313 K-SISG-20-AA 20 (x2) G46312 K-SISG-50-AA 50 (x2)

RELATED PRODUCTS Sydney IVF Gamete Buffer Sydney IVF Sperm Medium Sydney IVF Fertilization Medium SOLUTIONS BLASTOCYST

We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

*We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

11 SYDNEY IVF SPERMIENT®

Sydney IVF Spermient is intended for use during in vitro CONSTITUENTS fertilization procedures to separate motile sperm from Calcium lactate Potassium chloride seminal plasma. D-glucose Potassium phosphate • Sold at a 100% concentration of silane-coated-silica– Gentamicin Purified water SOLUTIONS GAMETE based stock solution to enable customization of sperm Glutamine, stabilized Silane-coated silica density separation Glycine particles HEPES Sodium bicarbonate • Can be diluted with Sydney IVF Gamete Buffer to any Human serum albumin Sodium chloride required concentration (HSA)** Sodium pyruvate USAGE Magnesium sulphate Taurine Sydney IVF Spermient is a 100% stock solution that should be diluted with Sydney IVF Gamete Buffer to the density RELEASE SPECIFICATIONS

SOLUTIONS FERTILIZATION required for use (for example, 80% and 40%).* A one- or pH (in air): 7.3-7.5 two-layer gradient is then prepared in a conical-bottom Osmolality: 285-295 mOsm/kg test tube. The liquefied semen is overlaid on the gradient. 2-cell MEA: ≥ 80% of control expanded The tube is centrifuged, and the resultant pellet is aspirated to blastocysts at 72 hours and washed in Sydney IVF Gamete Buffer. The final pellet is Endotoxins: < 0.4 EU/mL resuspended in either Sydney IVF Sperm Medium or Sydney Shelf life: 20 weeks from date of manufacture IVF Fertilization Medium. Sterile: Aseptically filtered HSA assay: 5.00–12.50 mg/mL Order Reference Volume

SOLUTIONS CLEAVAGE Number Part Number mL G46311 K-SISP-20-AA 20 G46310 K-SISP-100-AA 100

RELATED PRODUCTS Sydney IVF Gamete Buffer Sydney IVF Sperm Medium Sydney IVF Fertilization Medium SOLUTIONS BLASTOCYST

We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

*Use of this medium at dilutions below 40% and above 80% has not been evaluated and therefore is not recommended.

**We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

12 SYDNEY IVF FOLLICLE FLUSH BUFFER

Sydney IVF Follicle Flush Buffer is intended for use during in CONSTITUENTS vitro fertilization procedures for follicle flushing and oocyte Calcium lactate L-proline collection. D-glucose L-serine • HEPES buffered Gentamicin Magnesium sulphate

Glutamine, stabilized Potassium chloride SOLUTIONS GAMETE • Suitable for flushing needles and lines Glycine Potassium phosphate • Contains nonessential amino acids HEPES Purified water • Protein free L-alanine Sodium bicarbonate L-asparagine Sodium chloride USAGE L-aspartic acid Sodium pyruvate Sydney IVF Follicle Flush Buffer contains nonessential amino L-glutamic acid Taurine acids. This solution is HEPES buffered so that it maintains pH

at 37 °C without the use of a CO incubator. SOLUTIONS FERTILIZATION 2 RELEASE SPECIFICATIONS Order Reference Volume pH (in air): 7.3-7.5 Number Part Number mL Osmolality: 285-295 mOsm/kg G46308 K-SIFB-100-AA 100 2-cell MEA: ≥ 80% of control expanded to blastocysts at 72 hours RELATED PRODUCTS Endotoxins: < 0.4 EU/mL Sydney IVF Gamete Buffer Shelf life: 20 weeks from date of manufacture Aspiration needles Sterile: Aseptically filtered Cook® Vacuum Pump SOLUTIONS CLEAVAGE Test Tube Heater SOLUTIONS BLASTOCYST

We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

13

SOLUTIONS FERTILIZATION

Achieving a high fertilization rate increases the potential success of any treatment cycle, and successful fertilization—whether ICSI or insemination—depends in part on the fertilization media. These formulations are made with carefully selected ingredients and stringent quality-control procedures.

15 SOLUTIONS GAMETE SOLUTIONS FERTILIZATION SOLUTIONS CLEAVAGE SOLUTIONS BLASTOCYST

16 SYDNEY IVF CULTURE OIL

Sydney IVF Culture Oil is intended to be used as an oil CONSTITUENTS overlay for culture of gametes, zygotes, or embryos oil in assisted reproductive technology (ART) and micromanipulation procedures. RELEASE SPECIFICATIONS • Specifically designed for human IVF SOLUTIONS GAMETE 2-cell MEA: ≥ 80% of control expanded to • Extensively tested to ensure quality blastocysts at 72 hours Peroxide toxicity MEA: Two-cell MEA ≥ 80% of – Tested for peroxide value control expanded to blastocysts at 72 hours –T ested for peroxide toxicity with a specially designed Peroxide value assay: < 0.01 mEq/kg MEA Endotoxins: < 0.40 EU/mL • Packaged to reduce headspace and protect the product Shelf life: 20 weeks from date of manufacture from light Sterile: Aseptically filtered SOLUTIONS FERTILIZATION USAGE Sydney IVF Culture Oil protects gametes and embryos during culture and IVF procedures by creating a barrier between the embryo culture medium and the atmosphere. This barrier helps to prevent evaporation and minimizes fluctuations in pH and osmolality.

Order Reference Volume Number Part Number mL SOLUTIONS CLEAVAGE G46319 K-SICO-50-2-AA 50 (x2)

RELATED PRODUCTS Sydney IVF Fertilization Medium Sydney IVF Cleavage Medium Sydney IVF Blastocyst Medium Cook® Flexipet® Pipettes SOLUTIONS BLASTOCYST

We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

17 SYDNEY IVF FERTILIZATION MEDIUM

Sydney IVF Fertilization Medium is intended for use during CONSTITUENTS in vitro procedures for insemination and incubation of Calcium lactate L-proline oocytes. Calcium pantothenate L-serine • Bicarbonate buffered D-glucose

SOLUTIONS GAMETE EDTA Magnesium sulphate • Can be used for both short and long insemination Gentamicin Potassium chloride protocols Glutamine, stabilized Potassium phosphate • Provides a glucose-rich environment for efficient Glycine Purified water cumulus-oocyte complex and sperm cell metabolism Human serum albumin (HSA)* Sodium bicarbonate • Includes antioxidants and nonessential amino acids L-alanine Sodium chloride L-asparagine Sodium pyruvate USAGE L-aspartic acid Taurine

SOLUTIONS FERTILIZATION After the cumulus-oocyte complex has been washed, L-glutamic acid it is placed in Sydney IVF Fertilization Medium, where insemination occurs. The oocyte can remain in this medium RELEASE SPECIFICATIONS for 16-18 hours. The fertilized oocytes are checked for pH (in air): 7.5-7.8 pronuclei and then transferred into Sydney IVF Cleavage Osmolality: 285-295 mOsm/kg Medium. This is the first step in the Cook Medical sequential 2-cell MEA: ≥ 80% of control expanded system. to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Order Reference Volume Shelf life: 20 weeks from date of manufacture SOLUTIONS CLEAVAGE Number Part Number mL G46307 K-SIFM-20-AA 20 Sterile: Aseptically filtered G46306 K-SIFM-50-AA 50 HSA assay: 2.50–6.25 mg/mL G46305 K-SIFM-100-AA 100

RELATED PRODUCTS Sydney IVF Gamete Buffer Sydney IVF Sperm Medium Sydney IVF Cleavage Medium

SOLUTIONS BLASTOCYST Cook® Flexipet® Pipettes

We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

*We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

18 SYDNEY IVF PVP

Sydney IVF PVP is intended for use as an aid in the CONSTITUENTS immobilization and isolation of individual sperm Calcium lactate cells prior to intracytoplasmic sperm injection (ICSI) D-glucose procedures. Gentamicin

• Bicarbonate buffered Glutamine, stabilized SOLUTIONS GAMETE Glycine • Contains 10% polyvinylpyrrolidone (PVP) Human serum albumin (HSA)* USAGE Magnesium sulphate Sydney IVF PVP is used to reduce the motility of Potassium chloride sperm so that it is easier to isolate and capture with Potassium phosphate an ICSI pipette. The product should be equilibrated Purified water PVP (MW 360,000) in 6% CO2 prior to use.

Sodium bicarbonate SOLUTIONS FERTILIZATION Order Reference Volume Sodium chloride Number Part Number μL Sodium pyruvate G46303 K-SIPV-200-5-AA 200 (x5) Taurine RELATED PRODUCTS Sydney IVF Gamete Buffer RELEASE SPECIFICATIONS Sydney IVF Cleavage Medium 2-cell MEA: ≥ 80% of control expanded Cook® Flexipet® Pipettes to blastocysts at 72 hours

Micromanipulation pipettes Endotoxins: < 0.4 EU/mL SOLUTIONS CLEAVAGE Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: 5.00–12.50 mg/mL SOLUTIONS BLASTOCYST

We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

*We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

19

SOLUTIONS CLEAVAGE

The embryo's metabolic needs must be met for successful cleavage to occur and for the embryo to be viable for transfer, cryopreservation, and further culturing. These media formulations meet those needs by delivering necessary metabolites to the developing embryo.

21 SOLUTIONS GAMETE SOLUTIONS FERTILIZATION SOLUTIONS CLEAVAGE SOLUTIONS BLASTOCYST

22 SYDNEY IVF CLEAVAGE MEDIUM

Sydney IVF Cleavage Medium is intended for use CONSTITUENTS during in vitro fertilization procedures for culture Calcium lactate L-aspartic acid L-valine and transfer of cleavage-stage embryos. Calcium L-cystine Magnesium • A bicarbonate-buffered medium specifically pantothenate L-glutamic acid chloride designed for early cleavage-stage development D-glucose L-histidine Magnesium SOLUTIONS GAMETE EDTA L-isoleucine sulphate • Low in glucose and high in pyruvate to support Gentamicin L-leucine Potassium chloride early cleavage-stage development Glutamine, L-lysine Potassium • Recommended for ICSI procedures to support stabilized L-methionine phosphate oocytes when cumulus cell metabolism and Glycine L-phenylalanine Purified water sperm cell movement are no longer critical Human serum L-proline Sodium albumin (HSA)* L-serine bicarbonate USAGE

L-alanine L-threonine Sodium chloride SOLUTIONS FERTILIZATION After normally fertilized oocytes are identified, they L-arginine L-tryptophan Sodium pyruvate are transferred into Sydney IVF Cleavage Medium L-asparagine L-tyrosine Taurine for culture from day 1 to day 3 (up to the eight-cell stage). Sydney IVF Cleavage Medium is formulated to provide early embryos with the necessary RELEASE SPECIFICATIONS metabolic substrates for development. This is the pH (in air): 7.5-7.8 second step in the Cook Medical sequential system. Osmolality: 285-295 mOsm/kg 2-cell MEA: ≥ 80% of control expanded to blastocysts at 72 hours Order Reference Volume Endotoxins: < 0.4 EU/mL SOLUTIONS CLEAVAGE Number Part Number mL Shelf life: 20 weeks from date of G46302 K-SICM-20-AA 20 manufacture G46301 K-SICM-50-AA 50 Sterile: Aseptically filtered G46300 K-SICM-100-AA 100 HSA assay: 2.50–6.25 mg/mL RELATED PRODUCTS Micromanipulation pipettes SOLUTIONS BLASTOCYST

We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

*We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

23

SOLUTIONS BLASTOCYST

Cellular differentiation is crucial for successful IVF outcomes, and blastocyst formation is a key indicator for embryo transfer. These blastocyst media formulations supply the nutrients that are required to produce high-quality blastocysts and to support them through uterine transfer and cryopreservation.

The vitrification and warming kits contain trehalose, ethylene glycol, and DMSO to remove and displace water, thereby reducing embryo exposure to cryoprotectants prior to vitrification. These flexible and convenient kits can be used with any registered closed- vitrification device that has a cooling rate greater than -15,000 ºC per minute.

25 SOLUTIONS GAMETE SOLUTIONS FERTILIZATION SOLUTIONS CLEAVAGE SOLUTIONS BLASTOCYST

26 SYDNEY IVF BLASTOCYST MEDIUM

Sydney IVF Blastocyst Medium is intended for use CONSTITUENTS during in vitro fertilization procedures for extended Calcium lactate L-methionine culture and transfer of embryos. Calcium pantothenate L-phenylalanine • Designed to provide the necessary nutrients D-glucose L-proline to support blastulation, differentiation, and Gentamicin L-serine SOLUTIONS GAMETE expansion Glutamine, stabilized L-threonine Glycine L-tryptophan • Bicarbonate buffered Human serum albumin (HSA)* L-tyrosine • Has a higher glucose concentration for blastocyst L-alanine L-valine metabolism and energy production L-arginine Magnesium chloride • Includes essential and nonessential amino acids L-asparagine Magnesium sulphate to support blastocyst development L-aspartic acid Potassium chloride

L-cystine Potassium phosphate SOLUTIONS FERTILIZATION • Ideal for use in a low-oxygen environment L-glutamic acid Purified water L-histidine Sodium bicarbonate USAGE L-isoleucine Sodium chloride Once an embryo has reached day 3 (the eight-cell) L-leucine Sodium pyruvate stage, it is transferred into Sydney IVF Blastocyst L-lysine Taurine Medium, which is metabolically balanced to support blastocyst development. This is the third and final step of the Cook Medical sequential system. RELEASE SPECIFICATIONS pH (in air): 7.5-7.8 SOLUTIONS CLEAVAGE Order Reference Volume Osmolality: 280-290 mOsm/kg Number Part Number mL 2-cell MEA: ≥ 80% of control expanded to blastocysts at 72 hours G46296 K-SIBM-20-AA 20 Endotoxins: < 0.4 EU/mL G46295 K-SIBM-50-AA 50 Shelf life: 20 weeks from date of manufacture RELATED PRODUCTS Sterile: Aseptically filtered Embryo transfer catheters HSA assay: 2.50–6.25 mg/mL Sydney IVF Blastocyst Vitrification Kit Sydney IVF Blastocyst Warming Kit SOLUTIONS BLASTOCYST Cook® Flexipet® Pipettes

We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

*We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

27 SYDNEY IVF BLASTOCYST VITRIFICATION KIT

The Sydney IVF Blastocyst Vitrification Kit is intended to CONSTITUENTS be used for the vitrification of human blastocysts for ART Calcium lactate L-glutamic acid procedures. This kit is designed for use with the Sydney IVF Calcium pantothenate L-proline Blastocyst Warming Kit (K-SIBW-5000-AA). D-glucose L-serine

SOLUTIONS GAMETE • HEPES buffered DMSO Magnesium chloride EDTA Magnesium sulphate • Contains dimethyl sulfoxide (DMSO), ethylene glycol, Ethylene glycol Potassium chloride and trehalose as cryoprotectants Gentamicin Potassium phosphate • Used in a three-step vitrification process Glutamine, stabilized Purified water • Not packaged ready to use—the user must combine the Glycine Sodium bicarbonate solutions HEPES Sodium chloride Human serum albumin (HSA)* Sodium pyruvate

SOLUTIONS FERTILIZATION USAGE L-alanine Trehalose The Sydney IVF Blastocyst Vitrification Kit is used for the L-asparagine Taurine vitrification of blastocysts on day 5 or day 6. This HEPES- L-aspartic acid buffered kit contains DMSO, ethylene glycol, and trehalose as cryoprotectants and has a three-step equilibration RELEASE SPECIFICATIONS protocol. pH (in air): 7.3-7.5 Osmolality of base solution: 285-295 mOsm/kg Order Reference Volume Number Part Number mL 2-cell MEA: ≥ 80% of control expanded to blastocysts at 72 hours

SOLUTIONS CLEAVAGE G46292 K-SIBV-5000-AA 20 (x3) 10 (x1) Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture RELATED PRODUCTS Sterile: Aseptically filtered Sydney IVF Blastocyst Warming Kit HSA assay: 10.00–25.00 mg/mL Sydney IVF Blastocyst Medium Cook® Flexipet® Pipettes Embryo transfer catheters SOLUTIONS BLASTOCYST

We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

*We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

28 SYDNEY IVF BLASTOCYST WARMING KIT

The Sydney IVF Blastocyst Warming Kit is intended for CONSTITUENTS the warming of human blastocysts that have undergone Calcium lactate L-proline vitrification using the Sydney IVF Blastocyst Vitrification Kit Calcium pantothenate L-serine (K-SIBV-5000-AA) for ART procedures. D-glucose Magnesium chloride

• HEPES buffered EDTA Magnesium sulphate SOLUTIONS GAMETE Gentamicin Potassium chloride • Contains trehalose Glutamine, stabilized Potassium phosphate • Used in a three-step warming process Glycine Purified water HEPES Sodium bicarbonate USAGE Human serum albumin (HSA)* Sodium chloride The Sydney IVF Blastocyst Warming Kit is used for the L-alanine Sodium pyruvate warming of vitrified human blastocysts. This kit has a three- L-asparagine Trehalose step warming and dilution protocol.

L-aspartic acid Taurine SOLUTIONS FERTILIZATION Order Reference Volume L-glutamic acid Number Part Number mL G46291 K-SIBW-5000-AA 20 (x3) RELEASE SPECIFICATIONS pH (in air): 7.3-7.5 RELATED PRODUCTS Osmolality of base solution: 285-295 mOsm/kg Sydney IVF Blastocyst Vitrification Kit 2-cell MEA: ≥ 80% of control expanded to Sydney IVF Blastocyst Medium blastocysts at 72 hours Cook® Flexipet® Pipettes Endotoxins: < 0.4 EU/mL Embryo transfer catheters SOLUTIONS CLEAVAGE Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: 10.00–25.00 mg/mL SOLUTIONS BLASTOCYST

We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

*We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure.

29 COMPLETE LIST OF ORDER NUMBERS

GAMETE SOLUTIONS FERTILIZATION SOLUTIONS

Vial Vial Order Reference Volume Order Reference Volume Number Part Number mL Number Part Number mL

Sydney IVF Gamete Buffer Sydney IVF Culture Oil G46320 K-SIGB-20-AA 20 G46319 K-SICO-50-2-AA 50 (x2) G46318 K-SIGB-50-AA 50 Sydney IVF Fertilization Medium G46317 K-SIGB-100-AA 100 G46307 K-SIFM-20-AA 20 Sydney IVF Sperm Medium G46306 K-SIFM-50-AA 50 G46316 K-SISM-20-AA 20 G46305 K-SIFM-100-AA 100

G46315 K-SISM-50-AA 50 Vial G46314 K-SISM-100-AA 100 Order Reference Volume Number Part Number μL Sydney IVF Sperm Gradient Kit Sydney IVF PVP G46313 K-SISG-20-AA 20 (x2) G46303 K-SIPV-200-5-AA 200 (x5) G46312 K-SISG-50-AA 50 (x2) Sydney IVF Spermient® G46311 K-SISP-20-AA 20 G46310 K-SISP-100-AA 100 Sydney IVF Follicle Flush Buffer G46308 K-SIFB-100-AA 100

Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details.

30 CLEAVAGE SOLUTIONS BLASTOCYST SOLUTIONS

Vial Vial Order Reference Volume Order Reference Volume Number Part Number mL Number Part Number mL

Sydney IVF Cleavage Medium Sydney IVF Blastocyst Medium G46302 K-SICM-20-AA 20 G46296 K-SIBM-20-AA 20 G46301 K-SICM-50-AA 50 G46295 K-SIBM-50-AA 50 G46300 K-SICM-100-AA 100 Sydney IVF Blastocyst Vitrification Kit G46292 K-SIBV-5000-AA 20 (x3), 10 (x1) Sydney IVF Blastocyst Warming Kit G46291 K-SIBW-5000-AA 20 (x3)

Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details.

31 NOTES

32 NOTES

33 MEDICAL

© COOK 01/2020 RH-D52254-EN-F