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

teva parenteral medicines, inc. - alprostadil (unii: f5td010360) (alprostadil - unii:f5td010360) - alprostadil 500 ug in 1 ml - alprostadil injection usp is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects. in infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment po2 values; that is, patients with low po2 values respond best, and patients with po2 values of 40 torr or more usually have little response. alprostadil injection usp should be administered only by trained personnel in facilities that provide pediatric intensive care. none.

Canada - English - Health Canada

advanced dosage forms inc. - alprostadil - solution - 500mcg - alprostadil 500mcg - miscellaneous vasodilatating agents

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

pharmacia & upjohn company llc - alprostadil (unii: f5td010360) (alprostadil - unii:f5td010360) - alprostadil 20.5 ug in 1 ml - caverject is indicated for the treatment of erectile dysfunction. caverject is indicated as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction. caverject is contraindicated: caverject is not indicated for use in females. caverject is not indicated for use in females. safety and effectiveness have not been established in pediatric patients [see warnings and precautions (5.8)] . a total of 341 subjects included in clinical studies were 65 and older. no overall differences in safety and effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between elderly and younger patients. caverject [kav-er-jeckt]® (alprostadil) for injection, for intracavernosal use your healthcare provider should show you how to prepare and inject caverject the right way before you inject it for the first time. do not try to inject yourself until you have been shown the right way to give your injections by your healthcare provider. information about how to safely inject caverject: supplies you will need to give your caverject injection (figure a) these items are needed for injection and are not supplied with caverject : figure a: supplies you will need for your injection. follow the instructions below to prepare and give your injection. figure b explains the parts of the needle and syringe that are referred to in the instructions. figure b: parts of the needle and syringe caverject comes in 20 mcg or 40 mcg strengths. make sure you have the right strength vial of caverject that your healthcare provider prescribed for you. prepare the syringe step 1 . wash your hands thoroughly and dry them with a clean towel. step 2 . assemble the needle and syringe as follows: figure c: remove the syringe figure d: open the needle wrapper step 3 . keeping hold of the needle assembly, remove the plastic syringe cap from the syringe tip (figure e). do not touch the syringe tip. figure e: remove the syringe cap step 4 . hold the needle assembly (still in the paper wrapper). firmly attach the needle to the syringe tip. turn it clockwise, like tightening a screw to lock it in place (figure f). figure f: attach the needle to the syringe mixing the powder and liquid to prepare the dose step 5 . remove the plastic cap from the vial of caverject and remove any cover from the diluent (figure g). figure g: remove the vial cap step 6 . wipe the rubber stoppers on the vials of caverject and diluent with 1 alcohol swab. throw away the alcohol swab. step 7 . carefully hold the syringe by the barrel and remove the needle cover (figure h). figure h: remove the needle cover step 8 . hold the syringe with the needle attached and push the needle through the center of the diluent vial's rubber stopper (figure i). be careful not to bend the needle. figure i: push the needle into the diluent vial figure j: remove the liquid from the vial step 9 . push the syringe plunger to the 1ml mark on the syringe. this will remove air and extra liquid back into vial. grasp the side of the syringe barrel (not the plunger) and pull the needle from the diluent vial in a straight line to avoid bending the needle (figure k). figure k: adjust the amount of liquid in the syringe step 10 . holding the syringe with the needle attached in a straight line with the vial of caverject, push the needle through the center of the rubber stopper of the vial of caverject. be careful not to bend the needle . figure l: push the needle into the caverject vial step 11 . without removing the needle or touching the needle or stopper, gently swirl (do not shake) the vial until all the powder is dissolved in the liquid. then turn the vial and needle/syringe upside down and gently swirl the vial to dissolve any powder in the neck of the vial. do not use the solution if it is cloudy, colored, or contains particles. step 12 . keeping the needle in the vial, firmly hold the vial and syringe upside down in one hand. figure m: remove the liquid from the vial step 13 . if there are air bubbles, gently tap the syringe barrel until the bubbles float to the top of the liquid (see error! hyperlink reference not valid. ). figure n: tap the syringe barrel to remove air bubbles step 14 . carefully replace the needle used to mix the liquid with a new 29 to 30 gauge one half inch needle for your injection. set the syringe down on a level surface. how to give the injection step 15 . the injection will go into the part of the penis shown as the shaded area in figure o. do not inject caverject into the white areas because there may be blood vessels in the white areas. (see error! hyperlink reference not valid. ). figure o: top view of the penis showing injection sites (shaded areas). figure p: cross-section of the penis step 16 . wipe the area for injection with an alcohol swab and let it dry. step 17 . do not throw away the swab; you will need to use it again after you give your injection. (see error! hyperlink reference not valid. ). step 18 . if your penis is not circumcised, pull the foreskin back. take hold of the tip of your penis with your thumb and forefinger; stretch it lengthwise along your thigh. step 19 . gently squeeze your penis between your thumb and finger so that the injection site bulges out. step 20 . remove the cover from the needle. position your penis firmly against your thigh to keep it from moving during the injection. step 21 . keeping a firm grip on your penis, take the syringe in your other hand, and push the needle straight into the selected injection site (see error! hyperlink reference not valid. ). figure q: insert the needle into the injection site step 22 . holding the syringe barrel between two fingers, move your thumb or finger to the top of the plunger and, with a steady motion, push down on the plunger so that the entire contents of the syringe is slowly injected (figure r). figure r: inject the contents of the syringe. step 23 . after completing the injection, carefully pull the needle out of your penis. press gently on the injection site with the alcohol swab for about 5 minutes or until bleeding stops. after your injection: dispose of your used caverject syringe and needles. how should i store caverject? caverject 20 mcg vial storage information caverject 40 mcg vial storage information keep caverject and all medicines out of the reach of children. this patient information and instructions for use has been approved by the u.s food and drug administration. lab-0009-8.0 revised march 2023

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - alprostadil - powder for solution for injection - alprostadil 20 mcg/vial - alprostadil - alprostadil - treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic or mixed etiology. useful adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - alprostadil - powder for solution for injection - alprostadil 10 mcg - alprostadil - alprostadil - for the treatment of erectile dysfunction in adult males, due to neurogenic, vasculogenic, psychogenic or mixed etiology. useful adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

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

pfizer australia pty ltd - alprostadil -

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

pfizer australia pty ltd - alprostadil -

Canada - English - Health Canada

novopharm limited - alprostadil - liquid - 500mcg - alprostadil 500mcg - miscellaneous vasodilatating agents

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

u.s. pharmaceuticals - alprostadil (unii: f5td010360) (alprostadil - unii:f5td010360) - alprostadil 10 ug in 0.5 ml - caverject impulse is indicated for the treatment of erectile dysfunction. caverject impulse is indicated as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction. caverject impulse should not be used: - in men who have a known hypersensitivity to the drug [see adverse reactions (6.1)] - in men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia [see warnings and precautions (5.1)] - for the treatment of erectile dysfunction in men with fibrotic conditions of the penis, such as anatomical deformation, angulation, cavernosal fibrosis, or peyronie's disease [see warnings and precautions (5.2)] - in men with penile implants. caverject impulse is not indicated for use in females. caverject impulse is not indicated for use in females. caverject impulse is not indicated for use in pediatric patients [see warnings and precautions (5.8)] . a total of 341 subjects included in clinical studies were 65 and older. no o

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

pharmacia & upjohn company llc - alprostadil (unii: f5td010360) (alprostadil - unii:f5td010360) - alprostadil 10 ug in 0.5 ml - caverject impulse is indicated for the treatment of erectile dysfunction. caverject impulse is indicated as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction. caverject impulse is contraindicated: caverject impulse is not indicated for use in females. caverject impulse is not indicated for use in females. caverject impulse is not indicated for use in pediatric patients [see warnings and precautions (5.8)] . a total of 341 subjects included in clinical studies were 65 and older. no overall differences in safety and effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between elderly and younger patients. before you use caverject, your doctor must train you in how to prepare and give the injection properly. before using caverject, talk to your doctor about what to expect when using it, possible side effects, and what to do if side effects occur. your dose has been selected for your individual needs. do not change your dose without consulting your doctor. if you are not sure of the volume or dose to be used, talk to your doctor or pharmacist. follow these instructions exactly to properly prepare the syringe for use, and to correctly inject a sterile (germ-free) dose of caverject. supplies needed the caverject impulse carton contains two (2) sealed plastic trays, with one dose of caverject in each tray. each tray contains: (a) a syringe , (b) a separate needle assembly and (c) two alcohol swabs . the syringe and the needle assembly are shown in figure a (below). please note that the needle assembly is packaged as a single piece and is sealed with a paper cover on the bottom. do not try to assemble the syringe until you have read all of the instructions. first-read through all of the instructions (step 1 through step 12) before trying to assemble the syringe. then go back to step 1 and begin to prepare the syringe for use. caverject impulse is available in two versions: the 10 mcg strength (white plunger) and the 20 mcg strength (blue plunger). each syringe is designed to be used only one time , but you can select the dose that will be delivered: if you deliver a partial dose there will be left-over solution in the syringe – this is normal. make sure you have the correct strength of caverject impulse to deliver your assigned dose instructions for preparing the syringe (step 1 through step 12) wash your hands thoroughly and dry them with a clean towel. step 1. open the sealed plastic tray. remove the syringe, the needle assembly, and the alcohol swabs from the tray. all items should be present. look at the needle assembly . the needle assembly is a sealed unit that contains the outer protective cap, the inner protective cap, and the superfine needle, as shown in figure a. it is sealed with a small round paper cover (not shown in figure a). do not open the needle assembly at this point – leave it sealed inside the outer protective cap. next, examine the syringe . find the location of the dose window . right now you will not see anything in this window, but at a later step, a number will appear in this window (the dose to be delivered). finally, look at the plunger, but do not move it at this time . during the assembly process, some steps may ask you to rotate the plunger and other steps may ask you to push the plunger. it is important to only rotate the plunger – or only push – as directed in each step, but do not do both at the same time.                  never push on the plunger – even slightly – while trying to rotate it. this can cause the plastic threads on the plunger rod to stick. step 2. open the packet containing the alcohol swab, and then pick up the syringe. use the alcohol swab to wipe the rubber membrane at the tip of the syringe (figure b). discard the alcohol swab. step 3. pick up the needle assembly . grab the paper tab and peel off the paper cover (lid) from the bottom of the needle assembly (figure c). step 4. hold the needle assembly by the cap. pick up the syringe with your other hand. press the needle assembly onto the tip of the syringe and turn it clockwise (like tightening a screw) until the needle assembly is firmly locked into place. remove (twist off - clockwise) the outer protective cap from the needle (figure d), but do not remove the inner protective cap at this time. the inner protective cap is the thin plastic tube that directly covers the needle. it will be removed later. if you are not sure which piece is the inner protective cap, see figure a (step 1) to identify the inner protective cap. step 5. the next few steps will mix the powder and the fluid to make the caverject impulse solution. hold the syringe system with the needle pointing upward. the plunger rod should still be in the fully extended position, with all of the threads visible, as shown in figure e. step 6. slowly rotate the plunger rod clockwise (like tightening a screw,) until it goes all the way in and stops (figure f). this automatically combines the drug powder and the fluid. do not turn the plunger rod counter-clockwise (do not try to "unscrew" the plunger rod). do not push on the plunger while trying to rotate it. this can cause the plastic threads on the plunger rod to stick. step 7. turn the syringe upside down several times to make sure the solution is evenly mixed. the solution should be clear. do not use it if it is cloudy or contains particles. step 8. step 9. hold the syringe with the needle upward and carefully remove the inner protective cap from the needle (figure g). do not touch the exposed needle because it is sterile. next, you need to remove any large bubbles from the solution. lightly tap the glass cartridge a few times with your finger until any large bubbles disappear up into the tip. very small bubbles may remain. step 10. with the syringe pointed upward (figure h), use your thumb to push in the plunger rod until it stops . this will push the air out. some liquid will appear at the needle point. after pressing the plunger you may still see some small bubbles on the wall of the glass cartridge. this is normal. if you can't press the plunger rod in , check that the plunger rod is rotated all the way: turn it clockwise until it stops, and then repeat step 10 . after the plunger is pushed in – do not rotate the plunger. that will be done in the next step . step 11. please read the following before going on. in step 11, you will need to set the dose by rotating the plunger until the correct dose appears in the small oval dose window on the syringe. the plunger must be rotated "clock-wise" – like tightening a screw.    do not push on the plunger while trying to rotate it. this can cause the plastic threads on the plunger rod to stick. if the plunger does stick, you can try to free it by gently turning it backward ("unscrewing it") and trying again. to set the dose: locate the dose window on the syringe. this small oval window (above the left thumb in figure i) is where the dose number will appear when the plunger is rotated. then – holding the syringe as shown in figure i, slowly turn the plunger rod clockwise (like tightening a screw – see arrow in figure i) until the correct dose number appears in the center of the window (figure j). if you pass the correct number, keep turning the plunger in the same direction until the correct number comes around again – do not try to turn it backward step 12. the syringe is now ready for use. set the syringe down on a flat level surface. the needle is sterile. make sure the needle does not touch the surface or anything else. how to give the injection some liquid will remain in the syringe if you delivered a partial dose. this is expected. do not try to inject left-over liquid from a partial dose. syringes used to inject a partial dose must be discarded since each syringe can only be used one time. discard syringes with left-over liquid. do not keep any solution in the cartridge to use for a second injection. when you have finished with the syringe, discard it carefully as recommended by your doctor, so no one will use it or stick themselves with it. after your injection: dispose of your used caverject impulse syringes and needle. how should i store caverject impulse? keep caverject impulse and all medicines out of the reach of children. this patient information and instructions for use has been approved by the u.s food and drug administration. lab-1504-2.0 revised january 2023