BioComposite SwiveLock - Fixation anchor, soft-tissue, biodegradable Australia - English - Department of Health (Therapeutic Goods Administration)

biocomposite swivelock - fixation anchor, soft-tissue, biodegradable

arthrex australia pty ltd - 45061 - fixation anchor, soft-tissue, biodegradable - biocomposite swivelock anchors are comprised of absorbable pla and tcp and are provided with a non-absorbable eyelet. it is a twist-in knotless device, consisting of an eyelet and anchor body that are pre-mounted and physically separated on a driver shaft. it is designed to provide necessary pull-out strength during the healing period. the biocomposite swivelock suture anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.

BioComposite Corkscrew Suture Anchor - Ligament anchor Australia - English - Department of Health (Therapeutic Goods Administration)

biocomposite corkscrew suture anchor - ligament anchor

arthrex australia pty ltd - 36174 - ligament anchor - the biocomposite corkscrew suture anchors are comprised of absorbable pla and tcp and provided with braided non-absorbable suture. the threaded design provides increased pull-out strength, bone purchase and prevents anchor 'pull-back'. it is designed to provide necessary pull-out strength during the healing period. the biocomposite corkscrew suture anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.

BioComposite Interference Screw - Fixation screw, bone, biodegradable Australia - English - Department of Health (Therapeutic Goods Administration)

biocomposite interference screw - fixation screw, bone, biodegradable

arthrex australia pty ltd - 45039 - fixation screw, bone, biodegradable - the biocomposite interference screw is comprised of tcp, pldla and ha. significant strength is added to the implant by virtually eliminating stress risers while creating a macro and micro porous matrix to aid in the bone remodeling and replacement process. the screw provides the necessary pull-out strength during the healing period and is absorbed. intended to provide interference fixations of bone-tendon-bone or soft tissue grafts during acl reconstruction.

BioComposite PushLock - Fixation anchor, soft-tissue, biodegradable Australia - English - Department of Health (Therapeutic Goods Administration)

biocomposite pushlock - fixation anchor, soft-tissue, biodegradable

arthrex australia pty ltd - 45061 - fixation anchor, soft-tissue, biodegradable - the biocomposite pushlock anchors are comprised of absorbable pla and tcp and are provided with a non-absorbable eyelet. the surgeon can adjust the amount of tension on the tissue intraoperatively allowing for precise tissue reduction. tissue is securely held in a knotless way allowing for soft tissue healing to bone. it is designed to provide necessary pull-out strength during the healing period. intended for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.

BioComposite Corkscrew Suture Anchor - Fixation anchor, soft-tissue, biodegradable Australia - English - Department of Health (Therapeutic Goods Administration)

biocomposite corkscrew suture anchor - fixation anchor, soft-tissue, biodegradable

arthrex australia pty ltd - 45061 - fixation anchor, soft-tissue, biodegradable - the biocomposite corkscrew suture anchors are comprised of absorbable pla and tcp and provided with braided non-absorbable suture. the threaded design provides increased pull-out strength, bone purchase and prevents anchor 'pull-back'. it is designed to provide necessary pull-out strength during the healing period. the biocomposite corkscrew suture anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.

BioComposite SutureTak Suture Anchors - Fixation anchor, soft-tissue, biodegradable Australia - English - Department of Health (Therapeutic Goods Administration)

biocomposite suturetak suture anchors - fixation anchor, soft-tissue, biodegradable

arthrex australia pty ltd - 45061 - fixation anchor, soft-tissue, biodegradable - the biocomposite suturetak suture anchors are comprised of absorbable pla and tcp and provided with braided non-absorbable suture. it is designed to provide necessary pull-out strength during the healing period. the biocomposite suturetak suture anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.

BioComposite Tenodesis Screw with Disposable Driver Pack  - Fixation screw, bone, biodegradable Australia - English - Department of Health (Therapeutic Goods Administration)

biocomposite tenodesis screw with disposable driver pack - fixation screw, bone, biodegradable

arthrex australia pty ltd - 45039 - fixation screw, bone, biodegradable - a simple 'push-in' method facilitates accurate graft tensioning into the pre-drilled bone socket. the screw is then inserted (screwed in) into the socket. the construct allows for direct graft-to-bone healing without hardware prominence. the device is provided pre-mounted on a handled inserter and passing suture. a biocomposite tenodesis screw with disposable driver pack is intended to be used for fixation of tissue, including ligament or tendon to bone in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist.

GABAPENTIN solution United States - English - NLM (National Library of Medicine)

gabapentin solution

biocomp pharma, inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin oral solution is indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin oral solution is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin oral solution, during pregnancy. encourage women who are taking gabapentin oral solution during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of gabapentin oral solution in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses similar to or lower than those used clinically [see data ]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data when pregnant mice received oral doses of gabapentin (500, 1000, or 3000 mg/kg/day) during the period of organogenesis, embryofetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. the no-effect dose for embryofetal developmental toxicity in mice (500 mg/kg/day) is less than the maximum recommended human dose (mrhd) of 3600 mg/kg on a body surface area (mg/m 2 ) basis. in studies in which rats received oral doses of gabapentin (500 to 2000 mg/kg/day) during pregnancy, adverse effect on offspring development (increased incidences of hydroureter and/or hydronephrosis) were observed at all doses. the lowest dose tested is similar to the mrhd on a mg/m 2 basis. when pregnant rabbits were treated with gabapentin during the period of organogenesis, an increase in embryofetal mortality was observed at all doses tested (60, 300, or 1500 mg/kg). the lowest dose tested is less than the mrhd on a mg/m 2 basis. in a published study, gabapentin (400 mg/kg/day) was administered by intraperitoneal injection to neonatal mice during the first postnatal week, a period of synaptogenesis in rodents (corresponding to the last trimester of pregnancy in humans). gabapentin caused a marked decrease in neuronal synapse formation in brains of intact mice and abnormal neuronal synapse formation in a mouse model of synaptic repair. gabapentin has been shown in vitro to interfere with activity of the α2δ subunit of voltage-activated calcium channels, a receptor involved in neuronal synaptogenesis. the clinical significance of these findings is unknown. risk summary gabapentin is secreted in human milk following oral administration. the effects on the breastfed infant and on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for gabapentin oral solution and any potential adverse effects on the breastfed infant from gabapentin oral solution or from the underlying maternal condition. safety and effectiveness of gabapentin oral solution in the management of postherpetic neuralgia in pediatric patients have not been established. safety and effectiveness as adjunctive therapy in the treatment of partial seizures in pediatric patients below the age of 3 years has not been established [see clinical studies (14.2) ]. the total number of patients treated with gabapentin in controlled clinical trials in patients with postherpetic neuralgia was 336, of which 102 (30%) were 65 to 74 years of age, and 168 (50%) were 75 years of age and older. there was a larger treatment effect in patients 75 years of age and older compared with younger patients who received the same dosage. since gabapentin is almost exclusively eliminated by renal excretion, the larger treatment effect observed in patients ≥75 years may be a consequence of increased gabapentin exposure for a given dose that results from an age-related decrease in renal function. however, other factors cannot be excluded. the types and incidence of adverse reactions were similar across age groups except for peripheral edema and ataxia, which tended to increase in incidence with age. clinical studies of gabapentin in epilepsy did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients [see dosage and administration (2.4) , adverse reactions (6) , and clinical pharmacology (12.3) ]. dosage adjustment in adult patients with compromised renal function is necessary [see dosage and administration (2.3) and clinical pharmacology (12.3) ]. pediatric patients with renal insufficiency have not been studied. dosage adjustment in patients undergoing hemodialysis is necessary [see dosage and administration (2.3) and clinicalpharmacology (12.3) ]. gabapentin is not a scheduled drug. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. gabapentin does not exhibit affinity for benzodiazepine, opioid (mu, delta or kappa), or cannabinoid 1 receptor sites. gabapentin misuse and abuse have been reported in the postmarketing setting and published literature. most of the individuals described in these reports had a history of polysubstance abuse. some of these individuals were taking higher than recommended doses of gabapentin for unapproved uses. when prescribing gabapentin oral solution, carefully evaluate patients for a history of drug abuse and observe them for signs and symptoms of gabapentin misuse or abuse (e.g., self-dose escalation and drug-seeking behavior). the abuse potential of gabapentin has not been evaluated in human studies. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. there are rare postmarketing reports of individuals experiencing withdrawal symptoms shortly after discontinuing higher than recommended doses of gabapentin used to treat illnesses for which the drug is not approved. such symptoms included agitation, disorientation and confusion after suddenly discontinuing gabapentin that resolved after restarting gabapentin. the dependence potential of gabapentin has not been evaluated in human studies.

Biocompatibles TheraSphere Y-90 Glass Microsphere System Singapore - English - HSA (Health Sciences Authority)

biocompatibles therasphere y-90 glass microsphere system

boston scientific asia pacific pte. ltd. - radiology / imaging - therasphere is used in the treatment of hepatic malignancies.

Biocomposites STIMULAN Bullet Mat & Introducer Singapore - English - HSA (Health Sciences Authority)

biocomposites stimulan bullet mat & introducer

emergo singapore consulting private limited - orthopaedics - stimulan bullet mat & introducer is intended for use with stimulan rapid cure 20cc to produce either: 7mm x 20mm or 9mm x 20mm bullets. for use with stimulan rapid cure 20cc to produce either: 7mm x 20mm or 9mm x 20mm bullets to insert moulded bullet shaped beads into large and / or deep bone voids.