CAVERJECT IMPULSE- alprostadil injection, powder, lyophilized, for solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

ALPROSTADIL (UNII: F5TD010360) (ALPROSTADIL - UNII:F5TD010360)

Tersedia dari:

Pharmacia & Upjohn Company LLC

INN (Nama Internasional):

ALPROSTADIL

Komposisi:

ALPROSTADIL 10 ug in 0.5 mL

Rute administrasi :

INTRACAVERNOUS

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

CAVERJECT IMPULSE is supplied as a disposable, single-dose, dual chamber syringe system. The system includes a glass cartridge, which contains sterile, freeze-dried alprostadil in the front chamber and sterile bacteriostatic water for reconstitution in the rear chamber. The syringes contain either 12.8 or 25.6 mcg of alprostadil to allow delivery of a maximum of 10 or 20 mcg/0.5mL. Store the unreconstituted product at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. When reconstituted and used as directed, the deliverable amount for the 10 mcg strength is 10 mcg/0.5 mL or an increment of 10 mcg/0.5 mL: 2.5 mcg/0.125 mL, 5 mcg/0.25 mL, or 7.5 mcg/0.375 mL of alprostadil. The deliverable amount for the 20 microgram strength is 20 mcg/0.5 mL or an increment of 20 mcg/0.5 mL: 5 mcg/ 0.125 mL, 10 mcg/0.250 mL, or 15 mcg/0.375 mL of alprostadil. The reconstituted solution should be used within 24 hours when stored between 36–77°F (2°C to 25°C). Do not freeze. CAVERJECT IMPULSE is supplied in a carton containing 2 blister trays. Each blister tray contains one dual chamber syringe system, one needle and 2 alcohol swabs. It is available in the following strengths: 10 mcg NDC 0009-5181-01 20 mcg NDC 0009-5182-01

Status otorisasi:

New Drug Application

Karakteristik produk

CAVERJECT IMPULSE- ALPROSTADIL INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
PHARMACIA & UPJOHN COMPANY LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CAVERJECT IMPULSE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CAVERJECT
IMPULSE.
CAVERJECT IMPULSE (ALPROSTADIL) FOR INJECTION, FOR INTRACAVERNOSAL USE
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
CAVERJECT IMPULSE is a prostaglandin E1 agonist indicated
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
For injection: 10 mcg or 20 mcg freeze-dried powder for reconstitution
in a dual-chamber syringe (3).
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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®
For the treatment of erectile dysfunction (1.1)
As an adjunct to other diagnostic tests in the diagnosis of erectile
dysfunction (1.2).
Determine the most suitable dose and presentation of CAVERJECT to use.
Use a new syringe for each
dose of CAVERJECT (2.1).
Administer first intracavernosal injections in the health care
provider’s office and titrate the dose for
each patient to the lowest effective dose (2.1).
Instruct the patient on proper use and assess that they are well
trained in the self-injection technique
prior to initiation of at-home use (2.1).
Recommended dosage for erectile dysfunction (2.2):
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Erectile dysfunction of vasculogenic, psychogenic, or mixed etiology:
Initiate dosing with 2.5 mcg
Erectile dysfunction of pure neurogenic etiology (spinal cord injury):
Initiate dosing with 1.25 mcg
Follow dose titration procedures for each type of erectile dysfunction
and determine the maintenance
dosage for patient home use in the health care provider’s office
(2.2).
The recommended frequency of injection is no more than 3 times weekly,
with at least 24 hours
between each dose (2.2).
While on self-injection treatment, the patient should visit the
prescribing health care provider’s office
every 3 months to assess the efficacy and safety of