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VISTASEAL is a brand name for Fibrinogen, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VISTASEAL (Fibrin Sealant [Human]) is indicated in adult and pediatric patients (< 18 years) for supportive treatment in surgery for improvement of hemostasis, and for suture support in vascular surgery, where standard techniques are insufficient. VISTASEAL is effective in heparinized patients. 1.1 Pediatrics Based on…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • VISTASEAL should only be applied by experienced health professionals who have been trained in the use of this product (see 7 WARNINGS AND PRECAUTIONS, Application Precautions). • VISTASEAL is for topical use only.
Do not apply intravascularly. • The volume of VISTASEAL to be applied and the frequency of application should always be oriented towards the underlying clinical needs for the patient. VISTASEAL™ (Fibrin Sealant [Human]) Page 5 of 32 Unclassified / Non classifié • The dose to be applied is governed by variables including, but not limited to, the type of surgical intervention, the size of the area and the mode of intended application, and the number of applications.
2 Recommended Dose and Dosage Adjustment Adults and pediatric patients: Application of the product must be individualised by the treating physician. 3 to 12 mL. In a pediatric clinical trial, the dosage ranged up to 12 mL for pediatric patients ≥ 2 years of age and 6 mL for pediatric patients < 2 years of age.
Larger volumes may be required for surgical procedures other than those included in the clinical studies. The initial volume of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area with a thin (1 mm thick) layer.
The application can be repeated, if necessary. The approximate surface area coverage for each VISTASEAL package size is provided in Table 1. Table 1. Surface Area Coverage 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 Geriatric (> 65 years of age): No dose adjustments are required for patients aged 65 years or older.
4 Administration Apply VISTASEAL with the syringe holder and plunger supplied, using the Dual Applicator provided. g. laparoscopic device) may also be used. When using the Dual Applicator provided, follow the instructions described below.
When using other VISTASEAL applicator tips, follow the instructions for use that are provided with the applicator tips. The product should only be administered according to the instructions and with the devices recommended for this product.
Preparation Instructions An overview of thawing methods and storage after thawing is provided in Table 2. VISTASEAL™ (Fibrin Sealant [Human]) Page 6 of 32 Unclassified / Non classifié Table 2. Thawing and storage after thawing Thawing method Thawing time per package size Storage after thawing For 2 mL and 4 mL For 6 mL and 10 mL Refrigerator (2 – 8 °C) Minimum 7 hours Minimum 10 hours 7 days at 2 - 8 °C (refrigerator) in original package OR 24 hours not above 25 °C in original package Thawing at 20 - 25 °C Minimum 70 minutes Minimum 90 minutes Sterile water bath (37 °C) inside sterile field Minimum 5 minutes.
1 Adverse Reaction Overview The most common adverse reactions reported during clinical trials were nausea, procedural pain and VISTASEAL™ (Fibrin Sealant [Human]) Page 15 of 32 Unclassified / Non classifié pruritus. The most serious adverse drug reactions during clinical trials were abdominal and liver abscess, abdominal wound dehiscence, cellulitis, parvovirus B19 test positive, peritonitis, postoperative wound infection, postprocedural bile leak (see 7 WARNINGS AND PRECAUTIONS, Application Precautions), pulmonary embolism and deep vein thrombosis (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
As with any protein product, allergic type hypersensitivity reactions are possible. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Three single-blind, randomized, active controlled clinical studies were conducted with VISTASEAL in patients undergoing non-laparoscopic open surgical procedures using Fibrijet® drip or gas-assisted spray applicators.
g. retroperitoneal or pelvic surgery, abdominoplasties, or mastopexies (Study IG1103). There were 500 patients treated with VISTASEAL and 377 control patients, involved in 26% vascular (graft) surgeries, 37% parenchymal tissue surgeries, and 37% soft tissue surgeries.
3 to 86 years); with 87% White patients, 49% female patients and 51% male patients. There were 11 pediatric patients aged less than 18 years old treated with VISTASEAL (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics).
In the VISTASEAL treatment group, 13% of patients experienced one or more adverse reactions, compared with 8% of control patients in the oxidized regenerated cellulose treatment group and 5% in the MC treatment group. Tables 3 to 6 summarise the adverse drug reactions that occurred in ≥1% of patients for each study.
, Cardiovascular). • VISTASEAL is made from pooled human plasma which may contain infectious agents, such as viruses, that can cause disease (see 7 WARNINGS AND PRECAUTIONS, General). 1 Dosing Considerations • VISTASEAL should only be applied by experienced health professionals who have been trained in the use of this product (see 7 WARNINGS AND PRECAUTIONS, Application Precautions).
• VISTASEAL is for topical use only. Do not apply intravascularly. • The volume of VISTASEAL to be applied and the frequency of application should always be oriented towards the underlying clinical needs for the patient. VISTASEAL™ (Fibrin Sealant [Human]) Page 5 of 32 Unclassified / Non classifié • The dose to be applied is governed by variables including, but not limited to, the type of surgical intervention, the size of the area and the mode of intended application, and the number of applications.
2 Recommended Dose and Dosage Adjustment Adults and pediatric patients: Application of the product must be individualised by the treating physician. 3 to 12 mL. In a pediatric clinical trial, the dosage ranged up to 12 mL for pediatric patients ≥ 2 years of age and 6 mL for pediatric patients < 2 years of age.
Larger volumes may be required for surgical procedures other than those included in the clinical studies. The initial volume of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area with a thin (1 mm thick) layer.
The application can be repeated, if necessary. The approximate surface area coverage for each VISTASEAL package size is provided in Table 1. Table 1. Surface Area Coverage 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 Geriatric (> 65 years of age): No dose adjustments are required for patients aged 65 years or older.
• VISTASEAL is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• VISTASEAL must not be applied intravascularly. • VISTASEAL must not be used for the treatment of severe or brisk arterial bleeding.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Do not exceed 10 minutes. Minimum 5 minutes. Do not exceed 10 minutes. Use immediately during the surgery A. Thawing Preferred thawing method Refrigerator thawing 1. Remove carton from freezer and place it in the refrigerator for thawing at 2 – 8 °C a minimum of 7 hours for the 2 mL and the 4 mL package sizes a minimum of 10 hours for the 6 mL and the 10 mL package sizes After thawing, it is not necessary to warm the product for its use.
After thawing, the solutions must be colourless or pale yellow. Do not use solutions that are cloudy or have deposits. Thawing at 20 - 25 oC Remove carton from freezer, open it and take out the two blisters. Place the blister containing the Dual Applicator on a surface at 20 - 25 oC until the fibrin sealant is ready to use.
Thaw blister with VISTASEAL pre-filled syringes 20 - 25 oC using the following steps: 1. Place the blister containing the syringe holder with pre-filled syringes on a surface at 20 - 25 °C, • a minimum of 70 minutes for the 2 mL and the 4 mL package sizes • a minimum of 90 minutes for the 6 mL and the 10 mL package sizes After thawing, it is not necessary to warm the product for its use.
After thawing the solutions must be colourless or pale yellow. Solutions that are cloudy or have deposits should not be used. VISTASEAL™ (Fibrin Sealant [Human]) Page 7 of 32 Unclassified / Non classifié 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 °C or 24 hours not above 25 °C if it remains sealed in the original packaging.
Once the blisters are opened, use VISTASEAL immediately and discard any unused contents. Once thawed, do not refreeze. Transferring instructions: 1. After thawing, remove the blister from the surface at 20 - 25 oC or from the refrigerator at 2 - 8 °C.
2. Open the blister and confirm that the VISTASEAL pre-filled syringes are completely thawed. Make the VISTASEAL syringe holder with pre-filled syringes available to a second person for transfer to the sterile field. The outside of the blister should not come in contact with the sterile field.
See Figure 1. Figure 1 Sterile Water Bath (Quick thawing) Remove carton from freezer, open it and take out the two blisters. Place the blister containing the Dual Applicator on a surface at 20 - 25 oC until the fibrin sealant is ready to use.
Thaw VISTASEAL pre-filled syringes inside the sterile field in a sterile thermostatic water bath at a temperature of 37±2 °C using the following steps: NOTE: Once the VISTASEAL blisters are opened, use the product immediately. 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. 1. Open the blister and make the VISTASEAL syringe holder with pre-filled syringes […]
VISTASEAL™ (Fibrin Sealant [Human]) Page 16 of 32 Unclassified / Non classifié Table 3. 8) Table 4. 2) 0 VISTASEAL™ (Fibrin Sealant [Human]) Page 17 of 32 Unclassified / Non classifié Table 5. 3%) patients in the Manual Compression group.
9%) patients in the Oxidized Regenerated Cellulose group. 2%) subjects in the Oxidized Regenerated Cellulose group. Pediatric Study VISTASEAL™ (Fibrin Sealant [Human]) Page 18 of 32 Unclassified / Non classifié In the Phase 3b study performed exclusively in pediatric patients undergoing open parenchymous or soft tissue surgeries that compared VISTASEAL (n=91) with EVICEL (n=87), as an adjunct to hemostasis, one adverse reaction (procedural pain) was reported in 1 (1%) subject treated with VISTASEAL.
Table 6. 3 Less Common Clinical Trial Adverse Reactions The less common clinical trial adverse reactions are the following, classified by System Organ Class and in alphabetical order: • Blood and lymphatic system disorders: hemorrhagic anemia, leukopenia, neutropenia.
• Cardiac disorders: atrial fibrillation, tachycardia, ventricular tachycardia. • Eye disorders: conjunctival irritation. • Gastrointestinal disorders: abdominal distension, pancreatitis, procedural nausea, retroperitoneal hematoma, vomiting.
• General disorders and administration site conditions: asthenia, chills, hyperthermia, edema peripheral, […]
4 Administration Apply VISTASEAL with the syringe holder and plunger supplied, using the Dual Applicator provided. g. laparoscopic device) may also be used. When using the Dual Applicator provided, follow the instructions described below.
When using other VISTASEAL applicator tips, follow the instructions for use that are provided with the applicator tips. The product should only be administered according to the instructions and with the devices recommended for this product.
Preparation Instructions An overview of thawing methods and storage after thawing is provided in Table 2. VISTASEAL™ (Fibrin Sealant [Human]) Page 6 of 32 Unclassified / Non classifié Table 2. Thawing and storage after thawing Thawing method Thawing time per package size Storage after thawing For 2 mL and 4 mL For 6 mL and 10 mL Refrigerator (2 – 8 °C) Minimum 7 hours Minimum 10 hours 7 days at 2 - 8 °C (refrigerator) in original package OR 24 hours not above 25 °C in original package Thawing at 20 - 25 °C Minimum 70 minutes Minimum 90 minutes Sterile water bath (37 °C) inside sterile field Minimum 5 minutes.
Do not exceed 10 minutes. Minimum 5 minutes. Do not exceed 10 minutes. Use immediately during the surgery A. Thawing Preferred thawing method Refrigerator thawing 1. Remove carton from freezer and place it in the refrigerator for thawing at 2 – 8 °C a minimum of 7 hours for the 2 mL and the 4 mL package sizes a minimum of 10 hours for the 6 mL and the 10 mL package sizes After thawing, it is not necessary to warm the product for its use.
After thawing, the solutions must be colourless or pale yellow. Do not use solutions that are cloudy or have deposits. Thawing at 20 - 25 oC Remove carton from freezer, open it and take out the two blisters. Place the blister containing the Dual Applicator on a surface at 20 - 25 oC until the fibrin sealant is ready to use.
Thaw blister with VISTASEAL pre-filled syringes 20 - 25 oC using the following steps: 1. Place the blister containing the syringe holder with pre-filled syringes on a surface at 20 - 25 °C, • a minimum of 70 minutes for the 2 mL and the 4 mL package sizes • a minimum of 90 minutes for the 6 mL and the 10 mL package sizes After thawing, it is not necessary to warm the product for its use.
After thawing the solutions must be colourless or pale yellow. Solutions that are cloudy or have deposits should not be used. VISTASEAL™ (Fibrin Sealant [Human]) Page 7 of 32 Unclassified / Non classifié 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 °C or 24 hours not above 25 °C if it remains sealed in the original packaging.
Once the blisters are opened, use VISTASEAL immediately and discard any unused contents. Once thawed, do not refreeze. Transferring instructions: 1. After thawing, remove the blister from the surface at 20 - 25 oC or from the refrigerator at 2 - 8 °C.
2. Open the blister and confirm that the VISTASEAL pre-filled syringes are completely thawed. Make the VISTASEAL syringe holder with pre-filled syringes available to a second person for transfer to the sterile field. The outside of the blister should not come in contact with the sterile field.
See Figure 1. Figure 1 Sterile Water Bath (Quick thawing) Remove carton from freezer, open it and take out the two blisters. Place the blister containing the Dual Applicator on a surface at 20 - 25 oC until the fibrin sealant is ready to use.
Thaw VISTASEAL pre-filled syringes inside the sterile field in a sterile thermostatic water bath at a temperature of 37±2 °C using the following steps: NOTE: Once the VISTASEAL blisters are opened, use the product immediately. Use sterile technique to avoid the possibility of contamination due to improper handling, and follow the steps […]