Invicorp 25micrograms/2mg solution for injection

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

aviptadil, phentolamine mesilate

Available from:

IWA Consulting ApS

ATC code:

G04BE30

INN (International Name):

aviptadil, phentolamine mesilate

Dosage:

25micrograms/2mg

Pharmaceutical form:

Solution for injection

Administration route:

intracavernosal injection

Units in package:

Glass ampoule 1, 2, 3, 4, 5, 10 x 0.35 ml with 1, 2, 3, 4, 5, 10 syringe, 1 30G needle and 1 21G needle

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

HB-Medical ApS

Therapeutic group:

Combined medicinal products in erectile dysfunction

Therapeutic indications:

It is indicated for the symptomatic treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic, or mixed aetiology.

Authorization status:

Authorised

Authorization date:

2015-04-21

Patient Information leaflet

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

INVICORP 25 MICROGRAMS / 2 MG SOLUTION FOR 
INJECTION 

aviptadil/phentolamine mesilate 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 
USING THIS MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 
−  Keep this leaflet. You may need to read it 
again. 
−  If you have any further questions, ask your 
doctor or pharmacist. 
−  This medicine has been prescribed for you 
only. Do not pass it on to others. It may harm 
them, even if their signs of illness are the same 
as yours. 
−  If you get any side effects, talk to your doctor 
or pharmacist. This includes any possible side 
effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET  
1.  What Invicorp is and what it is used for 
2.  What you need to know before you use 
Invicorp  
3.  How to use Invicorp  
4.  Possible side effects 
5.  How to store Invicorp  
6.  Contents of the pack and other information 

1.  WHAT INVICORP IS AND WHAT IT IS USED FOR 

The active components in Invicorp (aviptadil and 
phentolamine mesilate) affect the flow of blood in 
and out of the penis. In broad outline, 
phentolamine mesilate increases the flow of blood 
into the penis, while aviptadil reduces the flow of 
blood from the penis. 

If you suffer from an erectile dysfunction, you can 
use  Invicorp  to help you to obtain an erection 
more easily. 

2.  WHAT YOU NEED TO KNOW BEFORE YOU USE 
INVICORP 

DO NOT USE INVICORP: 
−  if you are allergic to aviptadil or phentolamine 
mesilate or any of the other ingredients of this 
medicine (listed in section 6) 
−  if you have or have had leukaemia (cancer of 
the blood), multiple myeloma (bone cancer) or 
sickle cell anaemia or trait (a blood disease), 
as 

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Invicorp 25 micrograms / 2 mg solution for injection 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Invicorp 25 micrograms / 2 mg: 1 dose (ampoule 0.35 ml)
contains 25 micrograms of 
aviptadil and 2 mg of phentolamine mesilate. 

Excipients with known effect: This medicinal
product contains less than 1 mmol 
sodium (23 mg) per dose, i.e. essentially ‘sodium- free’. 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Solution for injection. 

Appearance: Colorless to pale yellow solution.  

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Invicorp is indicated for the symptomatic treatment of erectile
dysfunction in adult 
males due to neurogenic, vasculogenic, psychogenic, or mixed
aetiology. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Posology 
Invicorp 25 micrograms / 2 mg. 

The injection should provide the patient with an erection
that is satisfactory for sexual 
intercourse. It is recommended that the duration of the erection
does not exceed one 
hour. 

Injection frequency should not exceed once daily or 3 times
weekly. 

Paediatric population: Invicorp is not recommended in children. 

Elderly: No formal studies have been performed in patients above 75
years of age. 

Impaired renal or hepatic function: No formal studies have been
performed in patients 
with impaired renal or hepatic function. 

Method of administration 
The ampoule can be brought to room temperature
before use, or it can be used 
directly from the refrigerator (see section 6.6). 

The intracavernosal injection must be done under
sterile conditions. Invicorp should 
be administered by direct intracavernous injection. The usual site
of injection is along 
the dorsolateral aspect of the proximal third of the penis.
Visible veins should be 
avo