USA - engelsk - NLM (National Library of Medicine)

pacira pharmaceuticals, inc. - bupivacaine (unii: y8335394ro) (bupivacaine - unii:y8335394ro) - bupivacaine 13.3 mg in 1 ml - exparel is indicated to produce postsurgical: - local analgesia via infiltration in patients aged 6 years and older - regional analgesia via an interscalene brachial plexus nerve block in adults - regional analgesia via a sciatic nerve block in the popliteal fossa in adults - regional analgesia via an adductor canal block in adults limitations of use the safety and effectiveness of exparel have not been established to produce postsurgical regional analgesia via other nerve blocks besides an interscalene brachial plexus nerve block, a sciatic nerve block in the popliteal fossa, or an adductor canal block. exparel is contraindicated in obstetrical paracervical block anesthesia [see use in specific populations (8.1)]. while exparel has not been tested with this technique, the use of bupivacaine hcl with this technique has resulted in fetal bradycardia and death. risk summary there are no studies conducted with exparel in pregnant women. in animal reproduction studies, embryo-fetal deaths were observed with subcutaneous administration of bupivacaine to rabbits during organogenesis at a dose equivalent to 1.6 times the maximum recommended human dose (mrhd) of 266 mg. subcutaneous administration of bupivacaine to rats from implantation through weaning produced decreased pup survival at a dose equivalent to 1.5 times the mrhd [see data] . based on animal data, advise pregnant women of the potential risks to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. clinical considerations labor or delivery bupivacaine is contraindicated for obstetrical paracervical block anesthesia. while exparel has not been studied with this technique, the use of bupivacaine for obstetrical paracervical block anesthesia has resulted in fetal bradycardia and death. bupivacaine can rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity [see clinical pharmacology (12.3)] . the incidence and degree of toxicity depend upon the procedure performed, the type, and amount of drug used, and the technique of drug administration. adverse reactions in the parturient, fetus, and neonate involve alterations of the central nervous system, peripheral vascular tone, and cardiac function. data animal data bupivacaine hydrochloride was administered subcutaneously to rats and rabbits during the period of organogenesis (implantation to closure of the hard plate). rat doses were 4.4, 13.3, and 40 mg/kg/day (equivalent to 0.2, 0.5 and 1.5 times the mrhd, respectively, based on the bsa comparisons and a 60 kg human weight) and rabbit doses were 1.3, 5.8, and 22.2 mg/kg/day (equivalent to 0.1, 0.4 and 1.6 times the mrhd, respectively, based on the bsa comparisons and a 60 kg human weight). no embryo-fetal effects were observed in rats at the doses tested with the high dose causing increased maternal lethality. an increase in embryo-fetal deaths was observed in rabbits at the high dose in the absence of maternal toxicity. decreased pup survival was noted at 1.5 times the mrhd in a rat pre- and post-natal development study when pregnant animals were administered subcutaneous doses of 4.4, 13.3, and 40 mg/kg/day bupivacaine hydrochloride (equivalent to 0.2, 0.5 and 1.5 times the mrhd, respectively, based on the bsa comparisons and a 60 kg human weight) from implantation through weaning (during pregnancy and lactation). risk summary limited published literature reports that bupivacaine and its metabolite, pipecoloxylidide, are present in human milk at low levels. there is no available information on effects of the drug in the breastfed infant or effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for exparel and any potential adverse effects on the breastfed infant from exparel or from the underlying maternal condition. the safety and effectiveness of exparel to produce postsurgical local analgesia via infiltration have been established in pediatric patients aged 6 years and older. use of exparel for this indication is supported by evidence from adequate and well-controlled studies in adults, and pharmacokinetic (pk) and safety data in pediatric patients aged 6 years and older from studies peds-1 and peds-2 [see adverse reactions (6.1), clinical pharmacology (12.3)]. - study peds-1 was a multicenter, randomized, open-label, two-part study (nct03682302) to evaluate the pk and safety of exparel for local infiltration in pediatric patients aged 6 to less than 17 years who were undergoing spine or cardiac surgery (postsurgically, patients were administered opioid rescue medication according to the study site's standard of care). group 1: 61 patients aged 12 to less than 17 years, undergoing spine surgeries, were randomized 1:1 to receive either exparel 4 mg/kg (maximum 266 mg) or bupivacaine hcl 2 mg/kg (maximum 175 mg). group 2: 34 patients aged 6 to less than 12 years, undergoing either spine or cardiac surgeries, received open-label exparel 4 mg/kg (maximum up to 266 mg). - group 1: 61 patients aged 12 to less than 17 years, undergoing spine surgeries, were randomized 1:1 to receive either exparel 4 mg/kg (maximum 266 mg) or bupivacaine hcl 2 mg/kg (maximum 175 mg). - group 2: 34 patients aged 6 to less than 12 years, undergoing either spine or cardiac surgeries, received open-label exparel 4 mg/kg (maximum up to 266 mg). - study peds-2 was a phase 1, open-label study that evaluated the pk and safety of 4 mg/kg (maximum 266 mg) of exparel (administered intraoperatively prior to wound closure) in 15 pediatric patients aged 12 to less than 17 who were undergoing spinal surgery. the safety and effectiveness of exparel have not been established to produce postsurgical: - local analgesia via infiltration in pediatric patients aged less than 6 years old. - regional analgesia via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, or adductor canal block in pediatric patients. of the total number of patients in the exparel local infiltration clinical studies (n=823), 171 patients were greater than or equal to 65 years of age and 47 patients were greater than or equal to 75 years of age. of the total number of patients in the exparel nerve block clinical studies (n= 1046), 312 patients were greater than or equal to 65 years of age and 70 patients were greater than or equal to 75 years of age. no overall differences in safety or effectiveness of exparel have been observed between patients 65 years of age and older and younger adult patients. in clinical studies, differences in various pharmacokinetic parameters have been observed between patients 65 years of age and older and younger adult patients. bupivacaine is known to be substantially excreted by the kidney, and the risk of adverse reactions to bupivacaine may be greater in patients with renal impairment than in patients with normal renal function. because patients 65 years of age and older are more likely to have renal impairment, increase monitoring for exparel-associated adverse reactions [see adverse reactions (6)]. amide-type local anesthetics, such as bupivacaine, are metabolized by the liver. patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations, and potentially local anesthetic systemic toxicity [see clinical pharmacology (12.3)]. therefore, consider increased monitoring for local anesthetic systemic toxicity in patients with moderate to severe hepatic disease. bupivacaine is known to be substantially excreted by the kidney, and the risk of adverse reactions to exparel may be greater in patients with renal impairment than in patients with normal renal function. therefore, in patients with renal impairment, increase monitoring for exparel-associated adverse reactions [see adverse reactions (6)].

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - bupivacaine hydrochloride monohydrate, quantity: 52.7 mg - injection, solution - excipient ingredients: water for injections; sodium chloride; sodium hydroxide; hydrochloric acid - bupivacaine injection is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows: surgical anaesthesia - epidural block for surgery - field block (minor and major nerve blocks and infiltration). analgesia - continuous epidural infusion or intermittent bolus epidural administration for analgesia in post operative pain or labour pain. - field block (minor nerve block amd infiltration). the choice of 2 strengths, 0.25% and 0.5%, makes it possible to vary the degree of motor blockade.

Canada - engelsk - Health Canada

sterimax inc - bupivacaine hydrochloride - solution - 7.5mg - bupivacaine hydrochloride 7.5mg - local anesthetics

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

0.1%) infusion bags (advanz pharma - bupivacaine hydrochloride - infusion - 1mg/1ml

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

0.1%) infusion bags (sandoz ltd - bupivacaine hydrochloride - infusion - 1mg/1ml

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

0.125%) infusion bags (sandoz ltd - bupivacaine hydrochloride - infusion - 1.25mg/1ml

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

0.25%) solution for injection ampoules (mercury pharma group ltd - bupivacaine hydrochloride - solution for injection - 2.5mg/1ml

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

0.5%) solution for injection ampoules (advanz pharma - bupivacaine hydrochloride - solution for injection - 5mg/1ml

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - levobupivacaine hydrochloride, quantity: 8.449 mg/ml (equivalent: levobupivacine, qty 7.5 mg/ml) - injection, solution - excipient ingredients: sodium hydroxide; sodium chloride; water for injections; hydrochloric acid - adults levobupivacaine is indicated in adults for: surgical anaesthesia: major: epidural (including for caesarean section), intrathecal, peripheral nerve block minor: local infiltration, oral, peribulbar block in ophthalmic surgery. pain management: continuous epidural infusion, single or multiple bolus administration for post-operative, labour or chronic pain. for continuous epidural analgesia, levobupivacaine may be administered in combination with epidural fentanyl, morphine or clonidine. children levobupivacaine is indicated in children greater than 6 months of age, for infiltration analgesia (ilioinguinal/iliohypogastric blocks). after careful consideration to alternative concentrations, the 7.5mg/ml concentration of levobupivacine may be considered for those procedures requiring a dense block with low volume. the 7.5mg/ml concentration should not be considered for paediatric use.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - levobupivacaine hydrochloride, quantity: 5.633 mg/ml (equivalent: levobupivacine, qty 5 mg/ml) - injection, solution - excipient ingredients: water for injections; sodium hydroxide; sodium chloride; hydrochloric acid - adults levobupivacaine is indicated in adults for: surgical anaesthesia: major: epidural (including for caesarean section), intrathecal, peripheral nerve block minor: local infiltration, oral, peribulbar block in ophthalmic surgery. pain management: continuous epidural infusion, single or multiple bolus administration for post-operative, labour or chronic pain. for continuous epidural analgesia, levobupivacaine may be administered in combination with epidural fentanyl, morphine or clonidine. children levobupivacaine is indicated in children greater than 6 months of age, for infiltration analgesia (ilioinguinal/iliohypogastric blocks). after careful consideration to alternative concentrations, the 7.5mg/ml concentration of levobupivacine may be considered for those procedures requiring a dense block with low volume. the 7.5mg/ml concentration should not be considered for paediatric use.