Invicorp 25 micrograms / 2mg injection solution Aviptadil / Fentolaminmesilat
1. What Invicorp Is And What It Is Used For
The active ingredients of Invicorp (aviptadil and phentolamine mesilate) affect blood flow in and out of the penis. Broadly speaking, phentolamine mesilate increases blood flow to the penis, while aviptadil reduces blood flow from the penis.
If you suffer from erectile dysfunction, it can help you get an erection more easily.
Aviptadil and phentolamine mesilate contained in Invicorp may also be authorized for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
2. What You Need To Know Before Using Invicorp
Do Not Use Invicorp
- If you are allergic to aviptadil or phentolamine mesilate or any of the other ingredients of invicorp injection (listed in section 6).
- If you have or have had leukemia (blood cancer), multiple myeloma (skeletal cancer) or sickle cell anemia (a blood disorder), or predisposition to sickle cell anemia, you may have a painful and prolonged erection
- If you are taking blood-thinning medicines such as warfarin or heparin, including blood-thinning medicines such as dabigatran, rivaroxaban, apixaban
- If your doctor has advised you not to have sex because of your health condition
- If you have a penis that is scarred or not straight, which can sometimes be called Peyronie’s disease or if you have abnormal solid (fibrous) tissue in the corpora cavernosa of the penis
- If you have an implant in your penis.
Warnings And Cautions
If your erection is uncomfortable or painful or lasts more than 4 hours, contact your doctor or emergency department immediately, as treatment must be started within 6 hours.
Talk to your doctor, pharmacist, or nurse before using Invicorp if:
- You have heart or lung problems or have had a stroke (in these cases you should participate in sexual activities with caution)
- You have a background in mental illness or addiction.
Other Medicines And Invicorp
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take other medicine for erectile dysfunction at the same time as Invicorp.
Pregnancy, Breastfeeding, And Fertility
Not relevant. Invicorp 25 micrograms / 2mg injection is for men only.
Driving And Using Machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Invicorp Contains Sodium
Invicorp contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.
3. How To Use Invicorp
Always use invicorp injection exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Invicorp is for injection into the soft tissue one on each side of the penis shaft (intracavernous injection ). A doctor or nurse will show you how to perform at least the first injection. After that, your doctor will check you regularly (eg every three months), especially in the beginning when you self-inject.
Do not try to inject yourself with Invicorp if:
- You have not been shown how to inject yourself
- You had some problems with the first injection one
- You do not understand the instructions.
If you do not remember how to administer the injections, contact your doctor. You must not try to use injection one if you are unsure of what to do.
Invicorp Dosage
- The recommended Invicorp dosage is 25 micrograms / 2 mg.
- Do not administer more than one injection per day, and no more than 3 injections per week.
- Each ampoule contains the right amount for a single injection. You must inject the entire contents of ampoule one.
How to use Invicorp
Invicorp can be allowed to reach room temperature before use or it can be used directly from the refrigerator. Unless your doctor tells you otherwise, you should follow the dosing guidelines given in this information, otherwise, Invicorp 25 micrograms / 2mg injection may not work properly.
You should perform the first Invicorp injection under the supervision of a physician or nurse.
Preparation of Invicorp injection
- Wash your hands and dry them with a clean towel.
- Take a glass ampoule with two fingers and turn it gently to ensure that all the liquid is in the lower part of the ampoule.
- Break off the top of the ampoule one and carefully place ampoule one on a level surface.
- Open the package containing a long needle. You need the long needle to fill the syringe with injection from the ampoule one. DO NOT USE THIS NEEDLE FOR INJECTION. Place the needle on a clean surface, such as a clean paper towel.
- Remove the syringe from the package and place it on the paper towel.
- Hold the syringe in the upper part and hold the needle cap. Attach the syringe to the open end of the needle. Push and turn half a turn in one direction until it is firmly seated. Remove the protective sleeve from the needle.
7. Insert the needle into ampoule one and draw all the liquid from ampoule one into the syringe by pulling on the syringe plunger. Put the protective sleeve back on the long needle and remove the needle from the syringe.
8. Open the package containing the short needle (for injection ), and place it on a clean surface such as a clean paper towel.
9. Hold the syringe at the upper end and hold the short needle-guard sleeve. Attach the needle to the syringe. Push and turn half a turn in one direction until it is firmly seated. Then remove the protective sleeve.
How to give yourself an injection
1. Wash the injection site on your penis with soap and water, rinse with water and dry with a clean towel.
2. Grasp the syringe with the needle pointing upwards and tap the syringe barrel gently until all the air bubbles move to the top of the syringe. Gently push the plunger up until a few drops come out of the needle. This is done to prevent air from entering the needle.
3. Hold the syringe with the needle at a right angle to the side of the penis.
4. Make sure you do not inject into the urinary tract or into visible blood vessels. Inject into the gray shaded areas shown.
5. Push the needle into the penis until about half of the needle is inside. Gently push the plunger into the syringe and inject all the liquid.
6. Pull out the needle and replace the protective sleeve on the needle.
7. Carefully place the parts of the ampoule, the used syringe, and the needle in a container for disposing of needles.
After injection of Invicorp
After the self-injection of Invicorp, it will take some time for you to get an erection. Injection one should give a sufficient erection for you to be able to have intercourse.
Erection one will not normally last longer than an hour.
Contact your doctor or emergency room immediately if you have an erection that lasts longer than 4 hours after injection of Invicorp.
If You Use More Invicorp Than You Should
Contact your doctor, doctor’s office, or pharmacy staff if you have taken more Invicorp than indicated in this leaflet or more than your doctor has prescribed.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Bring the package so that it is clear which medicine you have taken.
4. Possible Invicorp Side Effects
Like all medicines, Invicorp can cause side effects, although not everybody gets them.
Serious Invicorp side effects are
Rare: may affect up to 1 in 1,000 people
- Prolonged and painful erection.
Contact a doctor or emergency room immediately if an erection lasts longer than 4 hours.
Very rare: may affect up to 1 in 10,000 users
- Angina pectoris
- chest pain
Contact a doctor or emergency room.
- Myocardial infarction and difficulty breathing
- Anxiety
- Possibly radiating severe pain in the left arm
- Chest pain
Stop using invicorp injection and contact a doctor immediately if you experience these Invicorp side effects.
Other Invicorp side effects are
Common: may affect up to 1 in 10 users
- Redness of the face and upper body.
- Bruises around the injection site.
To reduce the risk of bruising you should avoid visible blood vessels (veins) when injecting yourself.
Uncommon: may affect up to 1 in 100 people
- Headache
- Dizziness
- Increased heart rate ( heart rate )
- Abnormal heartbeat
Stop using invicorp injection if you experience these invicorp side effects.
Accumulation of blood under the skin around the injection site.
Rare: may affect Invicorp up to 1 in 1,000 people
Small lumps on the penis may occur with repeated injections.
• Injection site pain.
Reporting of invicorp side effects:
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How To Store Invicorp
- Keep this medicine out of the sight and reach of children.
- Do not use Invicorp injection after the expiry date which is stated on the carton.
- Store in a refrigerator (2 – 8 ° C). Do not freeze.
- Ampoules can be allowed to reach room temperature before use. You should use injection one within 24 hours after taking an ampoule one out of the refrigerator.
- Ampoule one and the needle should be disposed of in a container suitable for this purpose.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of invicorp no longer required. These measures will help to protect the environment.
6. Contents Of The Packaging And Other Information
Content Declaration
The active substances are Aviptadil and fentolaminmesilat, each vial with Invicorp 25 micrograms/mg of 2 contains 25 micrograms Aviptadil and 2 mg fentolaminmesilat,
The other ingredients are
- Sodium chloride
- Disodium edetate
- Phosphoric acid
- Sodium hydroxide (for pH adjustment)
- Hydrochloric acid (for pH adjustment)
- Water for injections
What The Medicine Looks Like And The Contents Of The Pack
Pack sizes:
- Glass ampoule 1 x 0.35 ml with 1 syringe, 1 30G needle, and 1 21G needle
- The glass ampoule is 2 x 0.35 ml with 2 syringes, 2 30G needles, and 2 21G needles
- The glass ampoule is 3 x 0.35 ml with 3 syringes, 3 30G needles, and 3 21G needles
- The glass ampoule is 4 x 0.35 ml with 4 syringes, 4 30G needles, and 4 21G needles
- The glass ampoule is 5 x 0.35 ml with 5 syringes, 5 30G needles, and 5 21G needles
- The glass ampoule is 10 x 0.35 ml with 10 syringes, 10 30G needles, and 10 21G needles
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Box 120
182 12 Danderyd
Manufacturer
HB -Medical ApS
Dr. Neergaardsvej 17
DK- 2970 Hørsholm
Denmark