10 and 20 micrograms powder and solvent for injection , solution
alprostadil
1. What Caverject Dual is and what it is used for
Caverject Dual contains alprostadil . Alprostadil is similar to a substance found naturally in the body called prostaglandin E1. It dilates the blood vessels so that the blood flow in the penis is improved, which makes it easier to get an erection . Caverject Dual is intended for the treatment of so-called erectile dysfunction , which includes weak erections and impotence . Caverject Dual can also be used with other diagnostic tools when your doctor wants to find the exact cause of your erectile dysfunction.
2. What you need to know before using Caverject Dual
Do not use Caverject Dual
- if you are allergic to alprostadil or any of the other ingredients of this medicine (listed in section 6)
- if you have sickle cell anemia (abnormal red blood cells ), leukemia (blood cancer), multiple myeloma (bone marrow cancer) or other problems that increase the risk of so-called priapism (an erection that lasts for more than 6 hours)
- if you have an implant in your penis
- if you have a disease that causes you to avoid sexual activity (eg a serious heart disease)
- if you have a penis that has scar tissue, is curved or crooked, or if you have Peyronie’s disease
- if you have a tight foreskin.
Caverject Dual must not be given to children (see “Caverject Dual contains benzyl alcohol and sodium”).
Warnings and cautions
If you get an erection that lasts for more than 4 hours, see a doctor immediately as treatment must begin within 6 hours. If you cannot reach your doctor, go to an emergency room.
Talk to your doctor or pharmacist before using Caverject Dual:
- if you have lung or heart disease (in these cases you should also be careful with sexual activity)
- if you have had a mental illness or had an addiction
- if you have had a mini- stroke ( TIA, transient ischemic attack)
- if you have one or more risk factors related to heart and vascular (such as high blood pressure, tobacco use, high blood sugar, elevated cholesterol, overweight or obesity)
- if you have one or more risk factors for stroke (for example, high blood pressure , high cholesterol, coronary heart disease, irregular heartbeat or diabetes ).
Sexually transmitted diseases
Caverject Dual does not protect you or your partner from sexually transmitted diseases such as AIDS , herpes or gonorrhea . When injecting, a small amount of bleeding may occur at the injection site. This may involve an increased risk of transmitting such diseases. Condoms can protect against sexually transmitted diseases. If you need advice on contraception or so-called safe sex, consult your doctor or contact the nearest contraceptive clinic.
Other drugs and Caverject Dual
Tell your doctor before taking Caverject Dual if you are taking any of the following medicines:
- Antihypertensive drugs
- Sympathomimetic drugs (used in respiratory and heart diseases)
- Vasodilators
- Blood thinners
- Other treatments for erectile dysfunction (eg sildenafil or papaverine)
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
Caverject Dual can be used by couples who want to have children, and together with a partner who is pregnant or breastfeeding. Caverject Dual does not protect your partner against pregnancy. To avoid unwanted pregnancy, a safe contraceptive must be used.
Driving and using machines
Caverject Dual is not expected to have any effect on the ability to drive and use machines
Caverject Dual contains benzyl alcohol and sodium
This medicine contains benzyl alcohol 8.9 mg/ml.
Benzyl alcohol can cause allergic reactions.
Using large amounts of Caverject Dual can lead to the accumulation of benzyl alcohol in the body and increase the amount of acid in the blood (metabolic acidosis ). Patients with liver or kidney disease must be especially careful and discuss this with their doctor.
Benzyl alcohol has been associated with the risk of serious side effects such as gasping syndrome in young children. Caverject Dual is not intended for use in children.
The drug contains less than 1 mmol sodium (23 mg) per dose , ie essentially ‘ sodium-free’ . it is next to “sodium-free”.
3. How to use Caverject Dual
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
At least the first injection is given by a doctor or nurse. Do not try to inject yourself until you have learned how to do it. If you have forgotten how to do this, talk to your doctor again. The following instructions are for guidance only.
How much Caverject Dual should you inject?
Different people need different amounts of Caverject Dual to treat erectile dysfunction. The doctor recommends a suitable dose for you and regularly check the dose of a function.
The starting dose at the doctor’s surgery is 1.25–2.5 micrograms. A lower dose of more than 2.5 micrograms can not give with Caverject. At such low doses, Caverject powder and solution for injection are used. For most men, a dose of 5-20 micrograms is enough, but some men need a higher dose. To minimize the risk of prolonged and painful erections, your doctor will choose the lowest effective dose. You should never use doses above 40 micrograms.
When using Caverject Dual to find the cause of erectile dysfunction, the dose is 5-20 micrograms.
If the dose you are prescribed does not have the desired effect, talk to your doctor. You must not change the dose yourself unless your doctor tells you to. If you forget to take a dose, read the label on the package or talk to your doctor.
How to use Caverject Dual
These instructions are guidelines only, always follow your doctor’s instructions if they differ from the information in the package leaflet. If this is the first time you are using Caverject Dual and you have previously used Caverject powder and solvent for solution for injection , your doctor should have given you instructions on how to use Caverject Dual.
You and your partner
You may want your partner to help prepare and/or inject Caverject Dual. In such cases, you should talk to your doctor so that your partner can also learn how to proceed.
Caverject Dual syringe
How to prepare injection one
Wash your hands. Wipe your hands on a clean towel. If your partner wants to help prepare for an injection, he should also wash his hands.
You can prepare the syringe up to 24 hours before use, provided it is stored at room temperature.
How is injection done?
– Undress and sit in a comfortable position. Wait a while until you and your partner feel relaxed. If your doctor has recommended cleaning with an alcohol swab, open it now.
– Check that the needle is not bent. A bent and straightened needle can easily fall off. Broken needles, when part of the needle has remained in the penis, have been reported and in some cases, required hospitalization and surgical removal. If the needle is bent, do not use it but discard it. Do not attempt to straighten the needle. Attach a new, unused sterile needle to the syringe.
• Pull out the needle. Massage the penis to disperse the injected amount of alprostadil into the penis.
Do not save the solution in the syringe for a second injection. After using the needle, throw it away according to the doctor’s recommendations so that no one can see it, use it or stick it on.
How often can Caverject Dual be used?
Do not use Caverject Dual more than once a day or three times a week.
Change the injection site and side of the penis each time you use Caverject Dual.
Erection after injection one with Caverject Dual
It takes a while after injection one before you get an erection. With the right dose, an erection lasts a long enough time to be able to have intercourse. An erection usually lasts no longer than an hour, talk to your doctor if you want it to last longer. If an erection lasts for more than four hours, seek medical attention immediately(see section “Warnings and precautions”).
If you use more Caverject Dual than you should
Contact a doctor as soon as possible as you may need treatment, especially if you get an erection that lasts for more than four hours.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Talk to a doctor immediately
erection one lasts longer than four hours. If you cannot reach your doctor, go to an emergency room immediately as treatment must begin within 6 hours.
Very common side effect is (can occur in more than 1 in 10)
- Pain in the penis.
Common side effects are (may affect up to 1 in 10)
- Prolonged use can lead to bruising, scarring, or crooked or crooked penis. Talk to your doctor if this happens as it may mean that you have to stop using Caverject Dual.
- Prolonged erection.
- Other problems with the penis.
- Swelling and discoloration or bruising at the injection site. This may occur the first time you use Caverject Dual but should occur less frequently when you become accustomed to injecting.
- Muscle cramps.
Less common side effects are (may affect up to 1 in 100)
- The injection site may be irritated, inflamed, or swollen. Itching, bleeding, numbness, feeling hot, soreness, and pain may occur.
- The testicles or scrotum may become red, swollen, or sore and lumps may appear. These are called spermatoceles and are cysts that contain sperm. Numbness in the penis may occur.
- You may have an unpleasant, painful, or prolonged erection or no erection at all. The ejaculation may change and the foreskin may feel tight or swollen, as may the glans.
- Urinary incontinence can come faster and more often than usual. Pain when urinating or difficulty urinating may occur. Small amounts of blood can appear in the urine or at the tip of the penis, especially if Caverject Dual is accidentally injected into the urethra.
- Pelvic pain, weakness, sweating, nausea, swelling of the legs or arms, cold symptoms and dry mouth . Fungal infection can occur.
- Changes in blood pressure and heart rate, fainting, shallow breathing and collapse may occur as a result of injection .
- Itching, redness of the skin at the injection site, rash on the skin, increased sweating, photosensitivity, enlarged pupils, decreased or increased sensitivity to touch, leg cramps, cold hands or feet, blood vessel problems including bleeding (bleeding in blood vessels).
- Blood tests may show an elevated creatinine level in the blood (a substance found in the muscles).
Has been reported (occurs in an unknown number of users)
- Insufficient blood flow to the heart muscle via the coronary arteries.
- Stroke.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Caverject Dual
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
The reconstituted solution for injection is stable for 24 hours at a maximum of 25 ºC.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance in Caverject Dual is alprostadil. Depending on the strength you receive, a maximum of 10 or 20 micrograms of alprostadil is added in 0.5 ml from the front chamber of the syringe.
The other ingredients are lactose monohydrate, alfadex, sodium citrate, hydrochloric acid, and sodium hydroxide.
The diluent in the posterior chamber is bacteriostatic water containing 0.9% benzyl alcohol and water for injection . The cleaning wipes are soaked with isopropyl alcohol.
What the medicine looks like and the contents of the pack
Caverject Dual is a two-chamber glass ampoule enclosed in a single-dose syringe. The anterior chamber contains a powder and the posterior chamber contains the diluent.
The contents of each pack are sufficient for two or ten separate injections of Caverject Dual. Not all pack sizes may be marketed.
The package with Caverject Dual contains:
1. Two or ten single-dose syringes with one ampoule of Caverject Dual each.
2. Two or ten injection needles (29G)
3. Alcohol wipes
Marketing Authorization Holder and Manufacturer
Pfizer AB
191 90 Sollentuna
Phone 08 – 550 520 00
Email: eumedinfo@pfizer.com
Manufacturer
Pfizer Manufacturing
Belgium NV
Puurs, Belgium