Ástralía - enska - Department of Health (Therapeutic Goods Administration)

mathys orthopaedics pty ltd - 33711 - reverse shoulder prosthesis - the conversion shell provides a means of revising an anatomic turon shoulder prosthesis to a reverse shoulder without the need to remove a well fixed turon humeral stem. it is an adapter between the turon and rsp shoulder systems. the turon stem has a smaller neck angle (135?) as compared to the rsp stem which has a neckangle of 150? without the shell.the conversion shell is designed to minimize the humeral lengthening and lateralization.the two types allow options for humeral positioning. the reverse humeral socket shell (turon to rsp conversion shell) is indicated for revision surgeries in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. the patient?s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. the socket shell is only indicated for use with a well fixed turon humeral stem.

Bandaríkin - enska - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - diltiazem hydrochloride (unii: olh94387te) (diltiazem - unii:ee92bbp03h) - diltiazem hydrochloride injection is indicated for the following: atrial fibrillation or atrial flutter temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. it should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in wolff-parkinson-white (wpw) syndrome or short pr syndrome. paroxysmal supraventricular tachycardia rapid conversion of paroxysmal supraventricular tachycardias (psvt) to sinus rhythm. this includes av nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the wpw syndrome or short pr syndrome. unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. the use of diltiazem hydrochloride injection should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: periphera

Bandaríkin - enska - NLM (National Library of Medicine)

northstar rx llc - dofetilide (unii: r4z9x1n2nd) (dofetilide - unii:r4z9x1n2nd) - dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [af/afl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. in general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. recurrence is expected in some patients (see clinical studies ). dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation. dofetilide capsules are contraindicated in patients with congenital or acquired long qt syndromes. dofetilide capsules should not be used i

Bandaríkin - enska - NLM (National Library of Medicine)

liberty bioscience llc - dofetilide (unii: r4z9x1n2nd) (dofetilide - unii:r4z9x1n2nd) - dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [af/afl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. in general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. recurrence is expected in some patients (see clinical studies ). dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation. dofetilide capsules are contraindicated in patients with congenital or acquired long qt syndromes. dofetilide capsules should not be used in pa

Írland - enska - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - methylphenidate hydrochloride - prolonged-release tablet - 27 milligram(s) - centrally acting sympathomimetics; methylphenidate

Írland - enska - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - methylphenidate hydrochloride - prolonged-release tablet - 36 milligram(s) - centrally acting sympathomimetics; methylphenidate

Írland - enska - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - methylphenidate hydrochloride - prolonged-release tablet - 54 milligram(s) - centrally acting sympathomimetics; methylphenidate

Bandaríkin - enska - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - diltiazem hydrochloride (unii: olh94387te) (diltiazem - unii:ee92bbp03h) - diltiazem hydrochloride injection or diltiazem hydrochloride for injection are indicated for the following: atrial fibrillation or atrial flutter temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. it should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in wolff-parkinson-white (wpw) syndrome or short pr syndrome. in addition, diltiazem hydrochloride injection is indicated for: paroxysmal supraventricular tachycardia rapid conversion of paroxysmal supraventricular tachycardias (psvt) to sinus rhythm. this includes av nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the wpw syndrome or short pr syndrome. unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. the use of diltiazem hydrochloride injection or diltiazem hydrochloride for injection should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium. for either indication and particularly when employing continuous intravenous infusion, the setting should include continuous monitoring of the ecg and frequent measurement of blood pressure. a defibrillator and emergency equipment should be readily available. in domestic controlled trials in patients with atrial fibrillation or atrial flutter, bolus administration of diltiazem hydrochloride injection was effective in reducing heart rate by at least 20% in 95% of patients. diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm. following administration of one or two intravenous bolus doses of diltiazem hydrochloride injection, response usually occurs within 3 minutes and maximal heart rate reduction generally occurs in 2 to 7 minutes. heart rate reduction may last from 1 to 3 hours. if hypotension occurs, it is generally short-lived, but may last from 1 to 3 hours. a 24-hour continuous infusion of diltiazem hydrochloride injection in the treatment of atrial fibrillation or atrial flutter maintained at least a 20% heart rate reduction during the infusion in 83% of patients. upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours). hypotension, if it occurs, may be similarly persistent. in the controlled clinical trials, 3.2% of patients required some form of intervention (typically, use of intravenous fluids or the trendelenburg position) for blood pressure support following diltiazem hydrochloride injection. in domestic controlled trials, bolus administration of diltiazem hydrochloride injection was effective in converting psvt to normal sinus rhythm in 88% of patients within 3 minutes of the first or second bolus dose. symptoms associated with the arrhythmia were improved in conjunction with decreased heart rate or conversion to normal sinus rhythm following administration of diltiazem hydrochloride injection. injectable forms of diltiazem are contraindicated in: patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. patients with second- or third-degree av block except in the presence of a functioning ventricular pacemaker. patients with severe hypotension or cardiogenic shock. patients who have demonstrated hypersensitivity to the drug. intravenous diltiazem and intravenous beta-blockers should not be administered together or in close proximity (within a few hours). patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in wpw syndrome or short pr syndrome. as with other agents which slow av nodal conduction and do not prolong the refractoriness of the accessory pathway (e.g., verapamil, digoxin), in rare instances patients in atrial fibrillation or atrial flutter associated with an accessory bypass tract may experience a potentially life-threatening increase in heart rate accompanied by hypotension when treated with injectable forms of diltiazem. as such, the initial use of injectable forms of diltiazem should be, if possible, in a setting where monitoring and resuscitation capabilities, including dc cardioversion/defibrillation, are present (see overdosage). once familiarity of the patient's response is established, use in an office setting may be acceptable. patients with ventricular tachycardia. administration of other calcium channel blockers to patients with wide complex tachycardia (qrs ≥ 0.12 seconds) has resulted in hemodynamic deterioration and ventricular fibrillation. it is important that an accurate pretreatment diagnosis distinguish wide complex qrs tachycardia of supraventricular origin from that of ventricular origin prior to administration of injectable forms of diltiazem. to use vial in add-vantage® flexible diluent container to open: peel overwrap at corner and remove solution container. some opacity of the plastic due to moisture absorption during the sterilization process may be observed. this is normal and does not affect the solution quality or safety. the opacity will diminish gradually. to assemble vial and flexible diluent container: (use aseptic technique) remove the protective covers from the top of the vial and the vial port on the diluent container as follows:to remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (see figure 1.), then pull straight up to remove the cap. (see figure 2.) note: do not access vial with syringe. to remove the vial port cover, grasp the tab on the pull ring, pull up to break the tie membrane, then pull back to remove the cover. (see figure 3.) screw the vial into the vial port until it will go no further. the vial must be screwed in tightly to assure a seal. this occurs approximately 1/2 turn (180°) after the first audible click. (see figure 4.) the clicking sound does not assure a seal; the vial must be turned as far as it will go. note: once vial is seated, do not attempt to remove. (see figure 4.) recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. label appropriately. to reconstitute the drug: squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. with the other hand, push the drug vial down into the container telescoping the walls of the container. grasp the inner cap of the vial through the walls of the container. (see figure 5.) pull the inner cap from the drug vial. (see figure 6.) verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix. mix container contents thoroughly and use within the specified time. preparation for administration: (use aseptic technique) confirm the activation and admixture of vial contents. check for leaks by squeezing container firmly. if leaks are found, discard unit as sterility may be impaired. close flow control clamp of administration set. remove cover from outlet port at bottom of container. insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. note: see full directions on administration set carton. lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. bend the loop outward to lock it in the upright position, then suspend container from hanger. squeeze and release drip chamber to establish proper fluid level in chamber. open flow control clamp and clear air from set. close clamp. attach set to venipuncture device. if device is not indwelling, prime and make venipuncture. regulate rate of administration with flow control clamp. warning: do not use flexible containers in series connections. compatibility: diltiazem hydrochloride injection and diltiazem hydrochloride for injection were tested for compatibility with three commonly used intravenous fluids at a maximal concentration of 1 mg diltiazem hydrochloride per milliliter. diltiazem hydrochloride injection and diltiazem hydrochloride for injection were found to be physically compatible and chemically stable in the following parenteral solutions for at least 24 hours when stored in glass (diltiazem hydrochloride injection only) or polyvinylchloride (pvc) bags at controlled room temperature 20° to 25°c (68° to 77°f) [see usp] or under refrigeration 2° to 8°c (36° to 46°f). dextrose (5%) injection usp sodium chloride (0.9%) injection usp dextrose (5%) and sodium chloride (0.45%) injection usp physical incompatibilities: because of potential physical incompatibilities, it is recommended that diltiazem hydrochloride injection or diltiazem hydrochloride for injection not be mixed with any other drugs in the same container. if possible, it is recommended that diltiazem hydrochloride injection or diltiazem hydrochloride for injection not be co-infused in the same intravenous line. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. diltiazem hydrochloride injection. physical incompatibilities (precipitate formation or cloudiness) were observed when diltiazem hydrochloride injection was infused in the same intravenous line with the following drugs: acetazolamide, acyclovir, aminophylline, ampicillin, ampicillin sodium/sulbactam sodium, cefamandole, cefoperazone, diazepam, furosemide, hydrocortisone sodium succinate, insulin, (regular: 100 units/ml), methylprednisolone sodium succinate, mezlocillin, nafcillin, phenytoin, rifampin, and sodium bicarbonate. diltiazem hydrochloride for injection. physical incompatibilities (precipitate formation or cloudiness) were observed when diltiazem hydrochloride for injection at a concentration of 1 mg/ml diluted in normal saline was infused in the same intravenous line with the following drugs: acetazolamide, acyclovir, cefoperazone sodium, diazepam, furosemide, phenytoin and rifampin. note: diltiazem hydrochloride for injection at a concentration of 1 mg/ml diluted in normal saline was infused in the same intravenous line and was found to be compatible with the following drugs: aminophylline, ampicillin sodium, ampicillin sodium/sulbactam sodium, cefamandole, hydrocortisone sodium succinate, regular insulin (100 units/ml), methylprednisolone sodium succinate, mezlocillin sodium, nafcillin sodium and sodium bicarbonate. transition to further antiarrhythmic therapy. transition to other antiarrhythmic agents following administration of diltiazem hydrochloride injection is generally safe. however, reference should be made to the respective agent manufacturer's package insert for information relative to dosage and administration. in controlled clinical trials, therapy with antiarrhythmic agents to maintain reduced heart rate in atrial fibrillation or atrial flutter or for prophylaxis of psvt was generally started within 3 hours after bolus administration of diltiazem hydrochloride injection. these antiarrhythmic agents were intravenous or oral digoxin, class 1 antiarrhythmics (e.g., quinidine, procainamide), calcium channel blockers, and oral beta-blockers. experience in the use of antiarrhythmic agents following maintenance infusion of diltiazem hydrochloride injection is limited. patients should be dosed on an individual basis and reference should be made to the respective manufacturer's package insert for information relative to dosage and administration.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

fujifilm australia pty ltd - 61109 - diagnostic x-ray digital imaging conversion system - the fdr se console is a workstation intended to associate digital (for dr) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

fujifilm australia pty ltd - 61109 - diagnostic x-ray digital imaging conversion system - the device is a workstation intended to associate digital (for cr and/or dr) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.