Loading…
Zynrelef is a brand name for Bupivacaine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Zynrelef is indicated for treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults (see section 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
Zynrelef should be administered in a setting where trained personnel and equipment are available to treat patients promptly who show evidence of neurological or cardiac toxicity. Posology The recommended dose depends upon the size of the surgical site and the volume required to coat the affected tissues within the surgical site that could result in pain generation.
4). The volume to be withdrawn accounts for the hold-up in the Luer lock applicator. 5 mL (300 mg/9 mg) The maximum total dose of Zynrelef to be applied must not exceed 400 mg/12 mg (about 14 mL). Use with other anaesthetics Medicinal product no longer authorised 3 When using Zynrelef with other local anaesthetics, overall local anaesthetic exposure must be considered through 72 hours.
In total, the maximum administered dose of bupivacaine must not exceed 400 mg/day. Special populations Elderly patients (≥ 65 years of age) Elderly patients should be given reduced doses commensurate with their age and physical condition.
As elderly patients may have decreased renal function, this should be considered when performing dose selection. 2). 4). Hepatic impairment No dose adjustment of Zynrelef is necessary in patients with mild to moderate hepatic impairment.
2). 3). Paediatric population The safety and efficacy of Zynrelef in children and adolescents under 18 years of age have not been established. No data are available. Method of administration Intralesional use. Zynrelef is intended for application to the surgical site.
Zynrelef is intended for single-dose administration. Zynrelef should only be prepared and administered with the sterile components provided in the procedure pack (vented vial spike, syringe, Luer lock applicator). Full instructions for use are provided in the package leaflet for use by healthcare professionals.
Zynrelef should be applied into the surgical site following final irrigation and suction and prior to suturing. If multiple tissue layers are involved, the solution should be applied after final irrigation and suction of each layer before closing.
Zynrelef is not injected, it should be applied without a needle to the tissue layers below the skin incision. The solution should not be applied to the skin. A sufficient amount of solution should be applied to coat the tissues. Wipe off excess Zynrelef from the skin prior to or during closure of the wound.
1%). Tabulated list of adverse reactions The following adverse reactions are based on experience from clinical trials and displayed by system organ class and frequency in Table 1 below. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The frequency of the adverse reactions is expressed according to the following categories: very common (≥1/10); common (≥1/100 to <1/10).
Table 1:
Adverse reactions reported for Zynrelef System Organ Class Very Common Common Nervous system disorders Dizziness Dysgeusia Cardiac disorders Bradycardia Vascular disorders Hypotension Skin and subcutaneous tissue disorders Skin odour abnormal General disorders and administration site conditions Cellulitis Impaired healing* Local site reaction Local site swelling Local site erythema Peripheral swelling * Impaired wound healing, including wound dehiscence, has been observed in patients following bunionectomy (a model of surgery with a small, confined space available to instill the product).
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Medicinal product no longer authorised 9
1). It is recommended not to use this medicine in major surgeries. Local anaesthetic systemic toxicity (LAST) As there is a potential risk of severe life-threatening adverse reactions associated with the administration of bupivacaine, any bupivacaine-containing product should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity.
Bupivacaine may cause acute toxicity effects on the central nervous and cardiovascular systems if utilised for local anaesthetic procedures resulting in high blood concentrations of the active substance. This is especially the case after unintentional intravascular administration or injection into highly vascular areas.
Ventricular arrhythmia, ventricular fibrillation, sudden cardiovascular collapse, and death have been reported in connection with high systemic concentrations of bupivacaine. 2). Patients who require special attention in order to reduce the risk of dangerous adverse reactions include the following: • The elderly and patients in poor general condition should be given reduced doses commensurate with their physical status.
• Patients with partial or complete heart block – due to the fact that local anaesthetics may depress myocardial conduction. • Patients with advanced liver disease or severe renal dysfunction. The toxic effects of local anaesthetics are additive and their administration should be used with caution, including monitoring for neurologic and cardiovascular effects related to LAST.
Cardiovascular system Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
There are insufficient data to exclude such a risk for Zynrelef. The use of Zynrelef in patients with a recent myocardial infarction should be avoided unless the benefits are expected to outweigh the risk of recurrent cardiovascular thrombotic events.
1. • Patients with a known hypersensitivity to any local amide-type anaesthetic or non-steroidal antiinflammatory drugs (NSAIDs). Meloxicam must not be given to patients who have developed signs of asthma, nasal polyps, angioneurotic oedema, or urticaria following the administration of acetyl salicylic acid or other NSAIDs.
6). 4). 4). 4). 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Bupivacaine in European Union.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
When tying knots with monofilament sutures, contact with Zynrelef may cause knots to loosen or untie due to the viscosity of Zynrelef. Minimise administration of Zynrelef near the incision line and wipe off excess Zynrelef from the skin prior to suturing.
g. a Surgeon’s knot) are recommended with monofilament sutures. Consider braided or barbed sutures, especially for closure of deeper layers. 6.
Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Zynrelef after careful consideration. Gastrointestinal system Medicinal product no longer authorised 5 Gastrointestinal (GI) bleeding, ulceration, or perforation, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
As Zynrelef contains meloxicam, an NSAID, health care professionals should remain alert for signs and symptoms of GI ulceration and bleeding. If a serious GI adverse reaction is suspected, evaluation and treatment should be promptly initiated.
The risk of GI bleeding, ulceration, or perforation is higher with increasing NSAID doses in patients with a history of ulcer and in the elderly. g. 5). Patients with a history of GI toxicity, particularly when elderly, should be advised to report any unusual abdominal symptoms (especially GI bleeding).
5). Serious skin reactions Life-threatening cutaneous reactions (Stevens-Johnson syndrome [SJS] and toxic epidermal necrolysis [TEN]) have been reported with the use of meloxicam. Patients should be advised of the signs and symptoms and monitored closely for skin reactions.
The highest risk for occurrence of SJS or TEN is within the first weeks of treatment. If the patient has developed SJS or TEN with the use of meloxicam, Zynrelef must not be administered in this patient at any time. Monitoring of liver and renal function Occasional increases in serum transaminase levels, increases in serum bilirubin or other liver function parameters, as well as increases in serum creatinine and blood urea nitrogen, as well as other laboratory disturbances, have been reported with meloxicam.
The majority of these instances involved transitory and slight abnormalities. Patients should be monitored for signs of worsening liver or renal function. Renal toxicity and renal impairment Renal toxicity has been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion.
In these patients, administration of an NSAID may cause a dose- dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, nephrotic syndrome, lupus nephropathy, dehydration, hypovolemia, heart failure, severe liver dysfunction, those taking diuretics, angiotensin converting enzyme (ACE) inhibitors or angiotensin-II antagonists, and the elderly.
Renal function should be monitored in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia after administration of Zynrelef. The renal effects of meloxicam may hasten the progression of renal dysfunction in patients with pre-existing renal disease.
No information is available from controlled clinical studies […]