VISTASEAL- human fibrinogen, human thrombin
GRIFOLS USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use VISTASEAL™ safely and effectively. See full prescribing information for VISTASEAL.
VISTASEAL™ [Fibrin Sealant (Human)] Frozen solutions of fibrinogen and thrombin For Topical Use Only Initial U.S. Approval: 2017 INDICATIONS AND USAGEVISTASEAL™, a fibrin sealant, is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients. (1) DOSAGE AND ADMINISTRATIONFor topical use only.
DOSAGE FORMS AND STRENGTHSVISTASEAL is supplied as a kit consisting of two separate packages:
VISTASEAL is available in the following package sizes:
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSThe most common adverse reactions (reported in >1% of patients) were procedural pain, and nausea. (6)
See 17 for PATIENT COUNSELING INFORMATION. Revised: 9/2024 |
VISTASEAL, a fibrin sealant (human), is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.
For topical use only.
The recommended dose of VISTASEAL is based on the surface area coverage.
The approximate surface area coverage for each VISTASEAL package size is provided in Table 1.
VISTASEAL package size | Surface area coverage (cm2) Application by dripping or spray (1 mm thick layer) |
2 mL | 16 - 22 |
4 mL | 32 - 44 |
6 mL | 48 - 66 |
10 mL | 80 - 110 |
Dose depends on variables including, but not limited to, the type of surgical intervention, the size of the area, the intended application method, and the number of applications.
Apply a sufficient volume of VISTASEAL to entirely cover the intended application area with a thin layer. Repeat the application if necessary.
Prepare and administer the product only according to the instructions and with the recommended devices.
An overview of thawing methods and storage after thawing is provided in Table 2.
Thawing method | Thawing time per package size | Maximum storage time after thawing | |
For 2 mL and 4 mL | For 6 mL and 10 mL | ||
Refrigerator (2 – 8 °C [36 – 46 °F]) | Minimum 7 hours | Minimum 10 hours | 7 days at 2 - 8 °C [36 – 46 °F] (refrigerator) in original package OR 24 hours at 20 - 25 °C [68 - 77 °F] (room temperature) in original package |
Room Temperature (20 - 25 °C [68 – 77 °F]) | Minimum 70 minutes | Minimum 90 minutes | 7 days at 2 - 8 °C [36 – 46 °F] (refrigerator) in original package OR 24 hours at 20 - 25 °C [68 - 77 °F] (room temperature) in original package |
Sterile water bath set at 37 °C [99 °F] inside sterile field. The water temperature must not exceed 39 °C [102 °F]. | Minimum 5 minutes. Do not exceed 10 minutes. | Minimum 5 minutes. Do not exceed 10 minutes. | Use immediately during the surgery |
Preferred thawing methods
Option 1: Refrigerator thawing
After thawing, it is not necessary to warm the product for its use.
After thawing, the solutions must be clear to slightly opalescent, colorless to pale yellow and must not be cloudy nor have deposits.
Option 2: Room Temperature Thawing
Remove carton from freezer, open it and take out the two blisters.
Place the blister containing the VISTASEAL Dual Applicator at room temperature until the VISTASEAL fibrin sealant (human) is ready to use.
Thaw blister with VISTASEAL pre-filled syringes at room temperature using the following steps:
After thawing, it is not necessary to warm the product for its use.
After thawing, the solutions must be clear to slightly opalescent, colorless to pale yellow and must not be cloudy nor have deposits.
Post-Thawing Storage:
After thawing, the kit containing the VISTASEAL syringe holder with pre-filled syringes and Dual Applicator can be stored before use for not more than 7 days in the refrigerator at 2 ‑ 8 ºC [36 - 46 ºF] or 24 hours at room temperature (20 - 25 °C [68 - 77 ºF]) if it remains sealed in the original packaging. Once the blisters are opened, use VISTASEAL immediately during the surgery and discard any unused contents.
Once thawed, do not refreeze.
Transferring instructions:
Sterile Water Bath (Quick Thawing) method
Remove carton from freezer, open it and take out the two blisters.
Place the blister containing the VISTASEAL Dual Applicator at room temperature until VISTASEAL fibrin sealant (human) is ready to use.
Thaw VISTASEAL pre-filled syringes inside the sterile field in a sterile thermostatic water bath set at a temperature of 37 °C [99 °F] using the following steps:
NOTE: Prepare and maintain the sterile water bath following the instructions of the water bath manufacturer and according to hospital procedures to maintain a sterile surgical field and avoid the possibility of contamination.
NOTE: Once the VISTASEAL blisters are opened, use the product immediately during surgery. Use sterile technique to avoid the possibility of contamination due to improper handling, and follow the steps below accurately. Do not remove the syringe luer cap until thawing is complete and the Dual Applicator is ready to be attached.
Confirm that the VISTASEAL pre-filled syringes are completely thawed. After thawing, the solutions must be clear to slightly opalescent, colorless to pale yellow and must not be cloudy nor have deposits.
Use VISTASEAL immediately during the surgery and discard any unused contents.
Connection instructions
For topical use only.
Apply VISTASEAL using the syringe holder and plunger supplied.
Apply VISTASEAL using the Dual Applicator provided with the product. Applicator tips cleared by the FDA for specific use with the VISTASEAL may also be used. When using the provided Dual Applicator, follow the connection instructions in the above section for Preparation. When using other applicator tips, follow the instructions for use that are provided with the applicator tips.
Before administration of VISTASEAL:
- To prevent tissue adhesion at undesired sites, protect (cover) parts of the body outside the intended application area. [see Dosage and Administration (2.4) ]
- Use standard techniques (e.g., intermittent application of compresses, swabs, use of suction devices) to dry the surface area of the target bleeding site.
Application by spraying
Application by dripping
VISTASEAL is supplied as a kit consisting of two separate packages:
The available package sizes of VISTASEAL are shown in Table 3.
Package size (Total volume) | Human fibrinogen | Human thrombin |
2 mL | 1 mL | 1 mL |
4 mL | 2 mL | 2 mL |
6 mL | 3 mL | 3 mL |
10 mL | 5 mL | 5 mL |
Life-threatening thromboembolic complications may occur if VISTASEAL is administered intravascularly.
Allergic-type hypersensitivity reactions are possible. Signs of hypersensitivity reactions include hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. If these symptoms occur, discontinue the administration of VISTASEAL immediately. Treat the reaction accordingly.
Because VISTASEAL is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and theoretically, the Creutzfeldt-Jakob (CJD) agent. This also applies to unknown or emerging viruses and other pathogens. All suspected infections related to this product should be reported by the physician or other healthcare provider to Grifols Therapeutics LLC at 1-800-520-2807. The physician should discuss the risks and benefits of the use of VISTASEAL with the patient. [see Patient Counseling Information (17)]
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety data described in this section reflect exposure to VISTASEAL in four clinical studies. A total of 591 patients (489 adults and 102 pediatric) received VISTASEAL for vascular (Study 1), parenchymal (Study 2 and Study 4), or soft tissue (Study 3 and Study 4) surgery. [see Clinical Studies (14)]
The most frequently occurring adverse reactions are shown in Tables below.
In the VISTASEAL group in these 4 trials, 11% of trial patients experienced one or more adverse reactions, and 7% of control patients experienced one or more adverse reactions.
Preferred Term | N = 591 n (%) |
Procedural pain | 11 (2) |
Nausea | 6 (1) |
Preferred Term | N = 168 n (%) |
Procedural pain | 4 (2) |
Nausea | 2 (1) |
Pyrexia (fever) | 2 (1) |
Vascular graft complication | 2 (1) |
Parvovirus B19 test positive | 2 (1) |
Urinary retention (Unable to empty the bladder completely) | 2 (1) |
Preferred Term | N = 163 n (%) |
Postprocedural bile leak | 2 (1) |
Procedural pain | 2 (1) |
Pulmonary embolism (Blood clot in the lungs) | 2 (1) |
Deep vein thrombosis (Blood clot that forms in a vein deep) | 2 (1) |
Preferred Term | N = 169 n (%) |
Nausea | 4 (2) |
Procedural pain | 4 (2) |
Pruritus (Itching) | 4 (2) |
Anemia (Low red blood cells) | 2 (1) |
Leukocytosis (Increased white blood cells) | 2 (1) |
Ileus (Decreased or absent movement of the stomach or intestine) | 2 (1) |
Alanine aminotransferase increased | 2 (1) |
Aspartate aminotransferase increased | 2 (1) |
Hypocalcemia (Low serum calcium) | 2 (1) |
Hypokalemia (Low serum potassium) | 2 (1) |
Hyponatremia (Low serum sodium) | 2 (1) |
Prothrombin time prolonged (Increased bleeding time) | 2 (1) |
Headache | 2 (1) |
Insomnia | 2 (1) |
Hypertension | 2 (1) |
Additionally, in the pediatric clinical study (Study 4) conducted to assess safety and efficacy of VISTASEAL compared to EVICEL (human fibrin sealant), one adverse reaction (procedural pain) occurred in one patient (1%) who received VISTASEAL. [see Pediatric Use (8.4) and Clinical Studies [14]]
The following adverse reactions have been identified during post-approval use of VISTASEAL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General disorders and administration site conditions: adhesions
Risk Summary
There are no available data with VISTASEAL use in pregnant women. Animal reproduction studies have not been performed with VISTASEAL. It is unknown whether VISTASEAL can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Risk Summary
There is no information regarding the presence of VISTASEAL in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VISTASEAL and any potential adverse effects on the breastfed infant from VISTASEAL or from the underlying maternal condition.
The safety and effectiveness of VISTASEAL have been established in pediatric patients as an adjunct to hemostasis during surgery. The use of VISTASEAL for this indication is supported by evidence from adequate and well-controlled studies for assessment of safety and efficacy in pediatric patients in the following age groups: 4 neonates (aged ≤ 27 days), 24 infants (aged ≥ 28 days to 23 months), 39 children (aged 2 years to < 12 years) and 39 adolescents aged 12 years to < 18 years of age. [see Adverse Reactions (6.1) and Clinical Studies (14)]
VISTASEAL is a two-component fibrin sealant consisting of human fibrinogen (component 1) and human thrombin with calcium chloride (component 2) sterile solutions filled in syringes which are assembled in a syringe holder.
VISTASEAL is supplied as frozen solutions. After thawing, the human fibrinogen and human thrombin solutions are clear or slightly opalescent and colorless or pale yellow. VISTASEAL does not contain any preservatives.
Fibrinogen
Component 1 is a sterile solution, pH 6.5 – 8.0, which contains concentrated human fibrinogen and excipients. Fibrinogen is a protein from human blood that forms a clot when combined with thrombin. The composition of the human fibrinogen solution is as follows:
Active ingredient: human fibrinogen (80 mg/mL)
Other ingredients: sodium citrate, sodium chloride, arginine, L-isoleucine, L-glutamic acid monosodium and water for injection.
Thrombin
Component 2 is a sterile solution, pH 6.0 – 8.0, which contains purified human thrombin and excipients. Thrombin is a specific protease that activates clotting of the final combined product and converts fibrinogen to fibrin. The composition of the human thrombin solution is as follows:
Active ingredient: human thrombin (500 IU/mL)
Other ingredients: calcium chloride, human albumin, sodium chloride, glycine and water for injection.
The starting material for the production of both fibrinogen and thrombin components of VISTASEAL is pooled human Source Plasma obtained from FDA-licensed plasma collection centers in the United States. Cohn’s plasma fractionation method is used to obtain Fraction I, which is the starting material for the production of fibrinogen, and the prothrombin complex isolated from supernatant of Fraction I, which is the starting material for the production of thrombin. The purification process of fibrinogen includes solvent/detergent treatment, three glycine precipitation steps, and double nanofiltration using 35-nm and 20-nm filters. The purification process of thrombin includes solvent/detergent treatment, ion exchange chromatography, and double nanofiltration through 15-nm filters. After nanofiltration, the fibrinogen and thrombin solutions are formulated, sterile filtered, aseptically filled in syringes, packaged, sterilized, and frozen.
Viral safety
Individual plasma donations used in the manufacture of VISTASEAL are collected in FDA-licensed plasma donation centers in the U.S. and are tested for viral markers in compliance with the U.S. regulatory requirements. In addition, mini-pools of plasma units are tested as an in-process control for hepatitis A virus (HAV) and parvovirus B19 (B19V) using validated nucleic acid testing (NAT) methods. All the tests must be non-reactive (negative) except for B19V, for which the limit in plasma manufacturing pools does not exceed a titer of 104 IU/mL. The manufacturing plasma pool is also tested with NAT for HBV, HCV, and HIV, and all the tests must be non‑reactive (negative).
The manufacturing processes for fibrinogen and thrombin include processing steps which are designed to reduce the risk of viral transmission. Both components have two discrete steps with viral clearance capacity, namely solvent/detergent treatment (with 1.0% (v/v) Tween 80/0.30% (v/v) tri-n-butyl phosphate (TNBP) for 6.0 – 6.5 hours at 27.0 ± 1.5 ºC for fibrinogen or 25 ± 1 ºC for thrombin), validated to inactivate enveloped viruses, and a nanofiltration step validated to remove non-enveloped and enveloped viruses (35-nm and 20-nm filters for fibrinogen and two 15-nm filters for thrombin). Additionally, the glycine precipitation steps contribute to the overall safety of the product in the purification process of human fibrinogen. The Fraction I precipitation and ion-exchange chromatography steps contribute to the overall safety of the product in the purification process of human thrombin.
The viral clearance capacity of these virus inactivation/removal procedures has been validated in small-scale in vitro studies using relevant and model viruses with a range of physico-chemical characteristics. The results of viral clearance validation studies are summarized in Tables 8 and 9:
Manufacturing step | Virus reduction factor (log10)* | |||||
Enveloped viruses | Non-enveloped viruses | |||||
HIV-1 | PRV | WNV | BVDV | HAV | PPV | |
S/D treatment | ≥ 5.33 | ≥ 6.80 | ≥ 5.20 | ≥ 5.60 | n.a. | n.a. |
Glycine precipitations | n.d. | n.d. | n.d. | n.d. | 5.21 | 2.09 |
Nanofiltration 35 nm and 20 nm | ≥ 5.57 | ≥ 6.09 | ≥ 4.51 | ≥ 4.53 | 5.22 | 4.37 |
Global virus reduction factor (log10) | ≥ 10.90 | ≥ 12.89 | ≥ 9.71 | ≥ 10.13 | 10.43 | 6.46 |
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Manufacturing step | Virus reduction factor (log10)* | |||||
Enveloped viruses | Non-enveloped viruses | |||||
HIV-1 | PRV | WNV | BVDV | HAV | PPV | |
Fraction I precipitation | < 1.0 | 2.13 | 2.78 | 1.34 | 1.18 | < 1.0 |
S/D treatment | ≥ 5.52 | ≥ 5.85 | ≥ 5.94 | ≥ 5.09 | n.a. | n.a. |
SP-Sepharose XL chromatography | n.d. | n.d. | n.d. | n.d. | 4.61 | 3.97 |
Double nanofiltration 15 nm | ≥ 4.03 | ≥ 5.95 | ≥ 5.42 | ≥ 4.93 | 6.56 | 6.14 |
Global virus reduction factor (log10) | ≥ 9.55 | ≥ 13.93 | ≥ 14.14 | ≥ 11.36 | 12.35 | 10.11 |
VISTASEAL contains human fibrinogen and human thrombin. When applied onto the wound site and mixed, these biological components generate a cross-linked fibrin clot in a process that recreates the last stage of the human blood coagulation system. Fibrinogen is converted into fibrin monomers and fibrinopeptides by thrombin. The fibrin monomers aggregate and form a fibrin clot which stops the bleeding. Factor XIIIa, which is activated from factor XIII by thrombin, crosslinks fibrin. Calcium ions are required for both the conversion of fibrinogen and the crosslinking of fibrin.
The effectiveness of VISTASEAL was demonstrated in four clinical studies in patients undergoing vascular (Study 1), parenchymal (Study 2 and Study 4), or soft tissue (Study 3 and Study 4) surgery. The details of the studies are described below.
Study 1 (Vascular surgery)
A prospective, randomized, controlled clinical study was performed to evaluate the safety and efficacy of VISTASEAL as adjunct to hemostasis in vascular surgery. Patients underwent vascular surgical procedures utilizing polytetrafluoroethylene graft material on proximal end-to-side arterial anastomosis or upper extremity vascular access arterial anastomosis. The clinical trial was conducted with VISTASEAL using a Fibrijet® applicator.
The primary efficacy outcome was to demonstrate superiority of VISTASEAL compared to manual compression (control) in achieving hemostasis by 4 minutes.
The study enrolled 166 patients with a median age of 64.0 years for VISTASEAL and 61.0 years for control (overall range across groups 22 to 84 years). The population characteristics included 65% Male, 90.4% White, 8.4% Black or African American, 1.2% Asian, 3.0% Hispanic or Latino patients.
VISTASEAL was shown to be superior to the control group (manual compression) when comparing the proportion of patients in each group who achieved hemostasis by 4 minutes (Table 10). Superiority was also established at 10 minutes. The median time to hemostasis was significantly shorter (p‑value <0.001) in the VISTASEAL group (4.0 minutes) compared to the control group (≥10.0 minutes).
The efficacy results are summarized in Table-10 below.
CI = confidence interval Tabulated efficacy results are cumulative results. |
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Efficacy endpoints | VISTASEAL N=109 n (%) | Control N=57 n (%) | Ratio of -proportions†
(95% CI) | P-value |
Hemostasis by 4 minutes | 83 (76.1) | 13 (22.8) | 3.3 (2.0, 5.4) | <0.001 |
Hemostasis by 10 minutes | 96 (88.1) | 26 (45.6) | 1.9 (1.4, 2.6) | <0.001 |
Study 2 (Parenchyma surgery)
A prospective, randomized, controlled clinical study was performed to evaluate the safety and efficacy of VISTASEAL as adjunct to hemostasis in parenchyma surgery. Patients underwent liver resections. The clinical trial was conducted with VISTASEAL using a Fibrijet® applicator. The primary efficacy outcome was to demonstrate superiority of VISTASEAL compared to oxidized regenerated cellulose (control) in achieving hemostasis by 4 minutes.
The study enrolled 224 patients with a median age of 61.0 years in each arm (overall range across groups 19 to 84 years). The population characteristics included 54.5% male, 93.3% White, 1.3% Black or African American, 4.5% Asian, 0.4% American Indian or Alaskan Native, 0.4% not specified, 5.4% Hispanic or Latino.
VISTASEAL was shown to be superior to the control group (oxidized regenerated cellulose) in achieving hemostasis by 4 minutes (Table 11). The median time to hemostasis was significantly shorter (p-value <0.001) in the VISTASEAL group (2.0 minutes) compared to the control group (3.0 minutes).
CI = confidence interval Tabulated efficacy results are cumulative results. |
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Efficacy endpoints | VISTASEAL
N = 111 n (%) | Control N = 113 n (%) | Ratio of proportions†
(95% CI) | P-value |
Hemostasis by 4 minutes | 103 (92.8) | 91 (80.5) | 1.2 (1.0, 1.3) | 0.010 |
Hemostasis by 2 minutes | 62 (55.9) | 47 (41.6) | 1.3 (1.0, 1.8) | 0.045 |
Study 3 (Soft tissue surgery)
A prospective, randomized, controlled clinical study was performed to evaluate the safety and efficacy of VISTASEAL as adjunct to hemostasis in soft tissue bleeding during retroperitoneal and pelvic surgical procedures, and during mastopexies and abdominoplasties. The clinical trial was conducted with VISTASEAL using a Fibrijet® applicator.
The primary efficacy outcome was to demonstrate non-inferiority of VISTASEAL compared to oxidized regenerated cellulose (control) in achieving hemostasis by 4 minutes.
The study enrolled 224 patients with the median age of 46.0 years for VISTASEAL and 45.0 years for control (overall range across groups 15 to 85 years). The population characteristics included 22.8% male, 77.7% White, 21% Black or African American, 0.9% Asian, 0.4% American Indian or Alaskan Native, 14.3% Hispanic or Latino patients.
The efficacy outcomes are summarized in Table 12 below.
CI = confidence interval. Tabulated efficacy results are cumulative results. |
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Efficacy endpoints | VISTASEAL
N = 116 n (%) | Control N = 108 n (%) | Ratio of proportions†
(95% CI) | P-value |
Hemostasis by 4 minutes | 96 (82.8) | 84 (77.8) | 1.1 (0.9, 1.2) | 0.401 |
Study 4 (Pediatric parenchyma surgery and soft tissue surgery)
A prospective, multicenter, randomized, active controlled, single-blind, clinical trial conducted to evaluate the safety and efficacy of VISTASEAL as an adjunct to hemostasis during open parenchyma (hepatic) surgery or soft tissue surgery. The clinical trial was conducted with fibrin sealant (human) using a Fibrijet® applicator and VistaSeal™ Dual Applicator with airless tips.
The primary efficacy outcome was to demonstrate non-inferiority of VISTASEAL compared to EVICEL in achieving hemostasis by 4 minutes.
A total of 178 pediatric patients (6 neonates, 37 infants, 63 children, and 72 adolescents) were randomized and treated with VISTASEAL(n=91) or EVICEL as active control (n=87). Of the 178 patients, 89 underwent parenchyma (hepatic) surgical procedures and 89 had soft tissue surgeries. The population characteristics included 63% male, 94% White, 4% Black or African American, <1% Asian, <1% multiple races, and <1% other race patients.
Exposure to VISTASEAL consisted of a single intraoperative administration. The mean volume of VISTASEAL used per pediatric patient was 4.6 mL ± 2.7 mL.
The efficacy outcomes are summarized in Table 13 below.
Efficacy endpoints | VISTASEAL N = 91 n (%) | Control N = 87 n (%) | Ratio of proportions†
(95% CI) | P-value |
CI = confidence interval. Tabulated efficacy results are cumulative results. |
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Hemostasis by 4 minutes | 88 (96.7) | 83 (95.4) | 1.01 (0.96, 1.07) | <0.001 |
Additional information from the pediatric surgery study is described in Adverse Reactions and Use in Specific Populations Pediatric Use. [see Adverse Reactions (6.1) and Pediatric Use (8.4)]
VISTASEAL kit is comprised of two separate packages (blisters). One package includes two pre-filled syringes containing sterile frozen solutions of human fibrinogen (component 1) and human thrombin with calcium chloride (component 2), which are assembled on a syringe holder for single use. The syringe plungers are connected by a plunger link to ensure simultaneous application of the biological components. One Dual Applicator with two additional Airless Spray Tips, in the other package, is co-packaged with the product for application by spraying or dripping. The Airless Spray Tips are radiopaque. See Figure 9.
Figure 9
The available package sizes for VISTASEAL are shown in Table 14.
VISTASEAL Package Size | NDC Numbers | |||
Total Volume | Human fibrinogen | Human thrombin | Carton | Blister label |
2 mL | 1 mL | 1 mL | 61953-0011-1 | 61953-0011-2 |
4 mL | 2 mL | 2 mL | 61953-0012-1 | 61953-0012-2 |
6 mL | 3 mL | 3 mL | 61953-0013-1 | 61953-0013-2 |
10 mL | 5 mL | 5 mL | 61953-0014-1 | 61953-0014-2 |
Storage
Store the frozen kit (VISTASEAL fibrin sealant (human) with VISTASEAL Dual Applicator) in a freezer (at -18 °C [0 ºF] or colder) for up to 2 years. The cold storage condition must not be interrupted until use. Thaw before use. Once thawed, do not refreeze.
After thawing, VISTASEAL can be stored before use for not more than 7 days at 2 - 8 °C [36 - 46 °F] or 24 hours at room temperature (20 - 25 °C [68 - 77 °F]) if it remains sealed in the original packaging (blister). Once the blister is opened, use VISTASEAL immediately during the surgery and discard any unused contents.
Keep the sterilized blister in the outer carton to protect from light.
Do not use after the expiration date printed on the outer carton and container labels. Discard if the package is damaged.
Discuss the following with patient receiving VISTASEAL.
Manufactured by:
INSTITUTO GRIFOLS, S.A.
BARCELONA - SPAIN
U.S. License No. 1181
Distributed by:
Ethicon, Inc.
1000 Route 202
Raritan, New Jersey 08869
USA • 1-877-ETHICON • +1-513-337-6928
© Ethicon, Inc. 2023
NDC 61953-0011-1
ETHICON
VistaSeal™
Fibrin Sealant (Human)
VISTASEAL™
Frozen solutions
2 mL
ETHICON
Reorder number
VST02
Fibrin Sealant (Human)
VISTASEAL™
Frozen solutions
2 mL
ETHICON
Fibrin Sealant (Human)
VISTASEAL™
Frozen solutions
2 mL
Human Fibrinogen / Human Thrombin - For topical use. Do not inject.
CONTENTS
• 2 pre-filled syringes, each with a sterile frozen solution, assembled in a syringe holder for
single use.
• 1 Dual Applicator with 2 additional Airless Spray Tips.
Component 1: 1 mL of human fibrinogen (80 mg/mL). Other ingredients: Sodium citrate,
sodium chloride, arginine, L-isoleucine, L-glutamic acid monosodium and water for injection.
Component 2: 1 mL of human thrombin (500 IU/mL). Other ingredients: Calcium chloride,
human albumin, sodium chloride, glycine and water for injection.
Contains no preservatives.
Rx only
NDC 61953-0011-1
Fibrin Sealant (Human)
VISTASEAL™
Frozen solutions
2 mL
Distributed by:
Ethicon, Inc.
1000 Route 202
Raritan, New Jersey 08869
USA • 1-877-ETHICON • +1-513-337-6928
© Ethicon, Inc. 2022
pat. www.ethicon.com/patentmarking
Manufactured by:
Instituto Grifols, S.A.
2 Can Guasch St. Polígono Levante
08150 Parets del Vallès
Barcelona - SPAIN
U.S. License No. 1181
Store in a freezer (-18 °C [0 °F] or colder). The cold storage chain must not be interrupted until use.
Keep the sterilized blister in the outer carton in order to protect from light.
Thaw for use. Do not refreeze once thawed. After thawing, the kit can be stored before use for not
more than 7 days at 2 - 8 °C [36 - 46 °F] or 24 hours at room temperature (20 - 25 °C [68 - 77 °F]) if
it remains sealed in the original packaging. Once packaging is opened, use product immediately.
For usage instructions and precautions, see enclosed package insert.
Discard any unused contents and administration devices after use.
Reorder number
VST02
Fibrin Sealant (Human)
VISTASEAL™
Frozen solutions
2 mL
ETHICON
GTIN: 00361953001118
SN: XXXXXXXXXXXXXXXX
Lot XXXXXXXXXX
EXP DD-MMM-YYYY
P-1
VistaSeal™
Fibrinogen
80 mg/mL
1 mL
Lot
EXP
3062006
VistaSeal™
Thrombin
500 IU/mL
1 mL
Lot
EXP
3062007
VistaSeal™ 2mL
Lot
EXP
Thawed Exp:
3055495
Fibrin Sealant (Human)
VistaSeal™
Frozen solutions
NDC 61953-0011-2
2 mL
Rx only
Human Fibrinogen / Human Thrombin - For topical use. Do not inject.
CONTENTS
2 pre-filled syringes, each with a sterile frozen solution, assembled in a syringe holder for single use.
Component 1: 1 mL of human fibrinogen (80 mg/mL). Other ingredients: Sodium citrate, sodium chloride,
arginine, L-isoleucine, L-glutamic acid monosodium and water for injection.
Component 2: 1 mL of human thrombin (500 IU/mL). Other ingredients: Calcium chloride,
human albumin, sodium chloride, glycine and water for injection.
Contains no preservatives. Store in a freezer (-18 °C [0 °F] or colder). Thaw for use.
Do not refreeze once thawed. For usage instructions and precautions, see enclosed package insert.
ETHICON
LOT
EXP
Manufactured by: Instituto Grifols, S.A.
Barcelona - SPAIN. U.S. License No. 1181
3063058
VISTASEAL
human fibrinogen, human thrombin kit |
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VISTASEAL
human fibrinogen, human thrombin kit |
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VISTASEAL
human fibrinogen, human thrombin kit |
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VISTASEAL
human fibrinogen, human thrombin kit |
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Labeler - GRIFOLS USA, LLC (048987452) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Instituto Grifols SA | 465562213 | manufacture(61953-0011, 61953-0012, 61953-0013, 61953-0014) |