Patient information: uses, side effects, how to take - Zynrelef
Instructions For Use
ZYNRELEF®
(bupivacaine and meloxicam)
extended-release solution,
for instillation use
400 mg bupivacaine and 12 mg meloxicam Each mL contains 29.25 mg bupivacaine and 0.88 mg meloxicam |
Intended Use
ZYNRELEF is indicated in adults to produce postsurgical analgesia for up to 72 hours after soft tissue, foot and ankle, and other orthopedic procedures in which direct exposure to articular cartilage is avoided.
Limitations of Use
Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large 4 or more level spinal, and head and neck procedures.
Dose Information
A single-dose application of a viscous solution administered directly via a needle-free syringe to coat the affected tissue within the surgical site prior to suturing. Two syringes are provided to aid in application.
Preparing the Product
Withdraw the amount needed up to 14 mL. This product does not require mixing. During preparation, do not mix with water, saline or other local anesthetics. Preparation is typically done in the Operating Room. Follow your facility's standard operating procedures regarding aseptic and sterile preparation and disposal of unused contents in the vial.
Storing the Product
ZYNRELEF kit should be stored at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature], protected from light and moisture.
For Operating Room Preparation
It is recommended that a 2-person team prepare this product: one sterile person and one non-sterile person. If product is prepared in advance of surgery, blue syringe tip caps ➍ may be used to cap the syringe until ready for application. Before administration, remove the blue syringe tip cap and attach the Luer lock applicator ➌.
The ZYNRELEF Kit Contents
Use only the components listed below supplied for use with ZYNRELEF.
- 20 mL Vial Access Needle (VAN) (sterile)
- 12 mL Luer Lock Syringe (sterile) (2×)
- Luer Lock Applicator (sterile) (2×)
- Blue Tip Caps (sterile) (2×) (preparation in advance)
- 14 mL ZYNRELEF Vial (contents sterile, exterior not sterile)
| Preparation | ||||
|---|---|---|---|---|
 NON-STERILE
|
 STERILE
|
 NON-STERILE
|
 STERILE
| |
 STERILE
Note: Air does not need to be pushed into the vial. |
 STERILE
Note: Drug inlet is at the base of the needle, not at the tip. |
 STERILE
Note: It is normal for there to be air bubbles in the syringe. Note: Product is very thick. It may take approximately 30 seconds to withdraw per syringe. Note: Pushing or pumping the plunger rod up and down at any point may prolong the withdrawal process. |
 STERILE
Note: Vial contains overfill to account for amount that remains in the components. | |
Do not substitute any of the components.
Ensure shroud is fully connected to the base to avoid compromising sterility.Frequently Asked Questions
Can I attempt to do the entire preparation process on my own? A non-sterile person is needed to place the non-sterile vial in the VAN; all other steps are to be performed by the sterile person.
Is there any way to speed up the withdrawal time? The withdrawal time is faster when the vial is at the upper end of the recommended storage condition (25 °C or 77 °F).
Do I need to dilute this product to expand the volume? No. The product should not be diluted.
Can I pour this product in a sterile cup? No, you will be unable to pull an effective dose from the sterile cup due to the thick nature of the product.
What should I do if I drop a syringe or any of the other components? If you compromise sterility of any sterile component of the ZYNRELEF kit, use a new kit or contact HERON CONNECT at 1-844-437-6611 for a replacement.
Administration Information
Please familiarize yourself with this information before you use this product for the first time.
ZYNRELEF should only be administered with the syringe and Luer lock applicator provided in the ZYNRELEF kit.
Administration
- ADMINISTER ZYNRELEF VIA INSTILLATION ONLY.
ZYNRELEF should not be administered via the following routes:
- Epidural
- Intrathecal
- Intravascular
- Intra-articular
- Regional nerve blocks
- Pre-incisional or pre-procedural locoregional anesthetic techniques
ZYNRELEF is applied without a needle into the surgical site following final irrigation and suction and prior to suturing.
Only apply ZYNRELEF after final irrigation and suction of each layer before closing, if multiple tissue layers are involved. - Using the Luer lock applicator attached to the syringe, apply ZYNRELEF to the tissues within the surgical site that could result in pain generation.
- Use a sufficient amount to coat the tissues. For small spaces, ensure there is not an excess that could be expressed from the site during closure.
Only apply ZYNRELEF to the tissue layers below the skin incision and not directly onto the skin.
ZYNRELEF does not degrade sutures.
When tying knots with monofilament sutures, contact with ZYNRELEF may cause knots to loosen or untie due to the viscosity of ZYNRELEF. In vitro studies showed an increase in elasticity with monofilament sutures exposed to ZYNRELEF with unknown clinical significance. Minimize administration of ZYNRELEF near the incision line and wipe off excess ZYNRELEF from the skin prior to suturing. Three or more knots ending in a multi-throw knot (e.g. a Surgeon's knot) are recommended with monofilament sutures. Braided or barbed sutures are recommended, especially for closure of deeper layers.
Important Information
- The amount of ZYNRELEF required depends upon the surgical area of tissue to be treated.
- ZYNRELEF spreads easily and covers a large area.
Diluting ZYNRELEF is not needed for efficacy.
ZYNRELEF cannot be mixed with water, saline, or other local anesthetics as the product will become very viscous and difficult to administer. - When ZYNRELEF comes in contact with moisture in the tissues, it becomes more viscous, allowing it to stay in place.
Avoid additional use of local anesthetics within 96 hours following administration of ZYNRELEF.
Overall local anesthetic exposure must be considered.
HERON
THERAPEUTICS
Instructions For Use
ZYNRELEF®
(bupivacaine and meloxicam)
extended-release solution,
for instillation use
200 mg bupivacaine and 6 mg meloxicam Each mL contains 29.25 mg bupivacaine and 0.88 mg meloxicam |
Intended Use
ZYNRELEF is indicated in adults to produce postsurgical analgesia for up to 72 hours after soft tissue, foot and ankle, and other orthopedic procedures in which direct exposure to articular cartilage is avoided.
Limitations of Use
Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large 4 or more level spinal, and head and neck procedures.
Dose Information
A single-dose application of a viscous solution administered directly via a needle-free syringe to coat the affected tissue within the surgical site prior to suturing. One syringe is provided to aid in application.
Preparing the Product
Withdraw the amount needed up to 7 mL. This product does not require mixing. During preparation, do not mix with water, saline or other local anesthetics. Preparation is typically done in the Operating Room. Follow your facility's standard operating procedures regarding aseptic and sterile preparation and disposal of unused contents in the vial.
Storing the Product
ZYNRELEF kit should be stored at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature], protected from light and moisture.
For Operating Room Preparation
It is recommended that a 2-person team prepare this product: one sterile person and one non-sterile person. If product is prepared in advance of surgery, blue syringe tip cap ➍ may be used to cap the syringe until ready for application. Before administration, remove the blue syringe tip cap and attach the Luer lock applicator ➌.
The ZYNRELEF Kit Contents
Use only the components listed below supplied for use with ZYNRELEF.
- 10 mL Vial Access Needle (VAN) (sterile)
- 12 mL Luer Lock Syringe (sterile)
- Luer Lock Applicator (sterile)
- Blue Tip Cap (sterile) (preparation in advance)
- 7 mL ZYNRELEF Vial (contents sterile, exterior not sterile)
| Preparation | ||||
|---|---|---|---|---|
 NON-STERILE
|
 STERILE
|
 NON-STERILE
|
 STERILE
| |
 STERILE
Note: Air does not need to be pushed into the vial. |
 STERILE
Note: Drug inlet is at the base of the needle, not at the tip. |
 STERILE
Note: It is normal for there to be air bubbles in the syringe. Note: Product is very thick. It may take approximately 30 seconds to withdraw per syringe. Note: Pushing or pumping the plunger rod up and down at any point may prolong the withdrawal process. |
 STERILE
Note: Vial contains overfill to account for amount that remains in the components. | |
Do not substitute any of the components.
Ensure shroud is fully connected to the base to avoid compromising sterility.Frequently Asked Questions
Can I attempt to do the entire preparation process on my own? A non-sterile person is needed to place the non-sterile vial in the VAN; all other steps are to be performed by the sterile person.
Is there any way to speed up the withdrawal time? The withdrawal time is faster when the vial is at the upper end of the recommended storage condition (25 °C or 77 °F).
Do I need to dilute this product to expand the volume? No. The product should not be diluted.
Can I pour this product in a sterile cup? No, you will be unable to pull an effective dose from the sterile cup due to the thick nature of the product.
What should I do if I drop a syringe or any of the other components? If you compromise sterility of any sterile component of the ZYNRELEF kit, use a new kit or contact HERON CONNECT at 1-844-437-6611 for a replacement.
Administration Information
Please familiarize yourself with this information before you use this product for the first time.
ZYNRELEF should only be administered with the syringe and Luer lock applicator provided in the ZYNRELEF kit.
Administration
- ADMINISTER ZYNRELEF VIA INSTILLATION ONLY.
ZYNRELEF should not be administered via the following routes:
- Epidural
- Intrathecal
- Intravascular
- Intra-articular
- Regional nerve blocks
- Pre-incisional or pre-procedural locoregional anesthetic techniques
ZYNRELEF is applied without a needle into the surgical site following final irrigation and suction and prior to suturing.
Only apply ZYNRELEF after final irrigation and suction of each layer before closing, if multiple tissue layers are involved. - Using the Luer lock applicator attached to the syringe, apply ZYNRELEF to the tissues within the surgical site that could result in pain generation.
- Use a sufficient amount to coat the tissues. For small spaces, ensure there is not an excess that could be expressed from the site during closure.
Only apply ZYNRELEF to the tissue layers below the skin incision and not directly onto the skin.
ZYNRELEF does not degrade sutures.
When tying knots with monofilament sutures, contact with ZYNRELEF may cause knots to loosen or untie due to the viscosity of ZYNRELEF. In vitro studies showed an increase in elasticity with monofilament sutures exposed to ZYNRELEF with unknown clinical significance. Minimize administration of ZYNRELEF near the incision line and wipe off excess ZYNRELEF from the skin prior to suturing. Three or more knots ending in a multi-throw knot (e.g. a Surgeon's knot) are recommended with monofilament sutures. Braided or barbed sutures are recommended, especially for closure of deeper layers.
Important Information
- The amount of ZYNRELEF required depends upon the surgical area of tissue to be treated.
- ZYNRELEF spreads easily and covers a large area.
Diluting ZYNRELEF is not needed for efficacy.
ZYNRELEF cannot be mixed with water, saline, or other local anesthetics as the product will become very viscous and difficult to administer. - When ZYNRELEF comes in contact with moisture in the tissues, it becomes more viscous, allowing it to stay in place.
Avoid additional use of local anesthetics within 96 hours following administration of ZYNRELEF.
Overall local anesthetic exposure must be considered.
HERON
THERAPEUTICS