VIRIDAL DUO 20 Microgram/ML Pdr+Solv for Soln for Inj
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
22-03-2017
Summary of Product characteristics
(SPC)
22-03-2017
Active ingredient:
ALPROSTADIL
Available from:
UCB (Pharma) Ireland Limited
ATC code:
G04BE01
INN (International Name):
ALPROSTADIL
Dosage:
20 Microgram/ML
Pharmaceutical form:
Pdr+Solv for Soln for Inj
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Drugs used in erectile dysfunction
Authorization status:
Authorised
Authorization date:
2010-08-13
Patient Information leaflet
CIA76833D_MU1 4020019 10/462 1485
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
VIRIDAL DUO
® 10/20/40
MICROGRAMS/ML
POWDER AND SOLVENT
FOR SOLUTION FOR
INJECTION
ALPROSTADIL
FIG 10:
The injection site must be within the area shown in
figure 10.
FIG 11:
Hold the injector in your fingers as shown. Always
HOLD IT LEVEL with the penis and insert the needle
ALMOST COMPLETELY STRAIGHT, into the penis.
The place where you inject should be within the area
shown on the picture. Use a DIFFERENT SIDE of the
penis than you used the last time.
Pushing your thumb gently on the plunger, INJECT the
solution slowly over a period of 5 TO
10 SECONDS.
FIG 12:
After injection, remove the injector and needle from
your penis and put it down. If BLEEDING
occurs, APPLY PRESSURE to the injection site with
a clean pad for 3 minutes to stop the bleeding. If it
continues to occur, carry on APPLYING PRESSURE
UNTIL IT STOPS.
It will take between 5–15 minutes for your erection
to develop. Your erection should last for about one
hour. If it lasts for between 2-4 hours, discuss this
with your doctor. If it lasts for LONGER THAN
4 HOURS, CONTACT YOUR DOCTOR IMMEDIATELY.
DISPOSING OF THE USED PACK:
•
Cut the needle with a needle cutter (available from
your doctor, pharmacist or the Marketing Authori-
sation holder)
•
Unscrew the needle base and put it into a contain-
er for needles (called a sharps bin) (also available
from your doctor or pharmacist)
•
Remove the cartridge by unscrewing the plunger
from the injector body and sliding out the car-
tridge.
•
Wash the Easy-Duo
®
injector with warm water
and a mild detergent. Once dry, store it in original
carton for your next injection.
•
DO NOT THROW THE INJECTOR AWAY. Not all packs
contain injectors so you will need to use this again
for your next injection. However, do not use a
damaged injector. Replacements are available from
the company.
•
Place the cartridge in a plastic bag and tie it careful-
ly. This can be thrown away with normal household
rubbish.
•
IT IS IMPORTANT TO DISC
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Viridal Duo 20 microgram /ml, Powder and Solvent for Solution for
Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Alprostadil 20 micrograms (used as a 1:1 clathrate complex with
alfadex).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Double chamber glass cartridge containing lyophilised powder and
solvent for reconstitution (isotonic sodium chloride
solution).
The powder is white and the isotonic sodium chloride solution is
clear, colourless liquid without a special odour. The
powder is freely soluble within 60 seconds when dissolved in isotonic
sodium chloride solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Viridal Duo is indicated in adult males:
as an adjunct to the diagnostic evaluation of erectile dysfunction.
for treatment of erectile dysfunction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_
Treatment initiation and dose titration
Injections for treatment initiation, diagnostic evaluation and dose
titration must be performed by the treating
physician. He will determine an individual dose suitable to produce an
erectile response for diagnostic purposes.
For erectile dysfunction of neurological origin, the starting dose is
1.25mcg. For all other patients, the recommended
starting dose is 2.5 mcg. Dose adjustments may be performed in
increments of about 2.5 mcg to 5 mcg Viridal Duo.
Most of the patients require between 10 and 20 mcg per injection. Some
patients may need to be titrated to higher
doses. Doses exceeding 20 mcg should be prescribed with particular
care in-patients with cardiovascular risk factors.
The dose per injection should never exceed 40 mcg.
Dosage for self-injection therapy at home
Before starting treatment at home, each patient or the patient’s
partner has to be taught by a physician how to prepare
the drug and perform the injection. In no cases should the injection
therapy be started without precise instructions by
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