Viridal Duo Starter Pack 40microgram powder and solvent for solution for injection cartridges with device

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alprostadil

Available from:

Advanz Pharma

ATC code:

G04BE01

INN (International Name):

Alprostadil

Dosage:

40microgram

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Intracavernous

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 07040500; GTIN: 5015366088178

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VIRIDAL DUO
®
10/20/40 MICROGRAMS/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Alprostadil
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 Viridal Duo is and what it is used for
2. What you need to know before you use Viridal Duo
3. How to use Viridal Duo
4. Possible side effects
5. How to store Viridal Duo
6. Contents of the pack and other information.
1. WHAT VIRIDAL DUO IS AND WHAT IT IS USED FOR
Viridal Duo contains the active substance alprostadil which belongs to
a group of drugs used
to treat erectile dysfunction. This medicine works by widening blood
vessels and increasing
blood flow to your penis.
Viridal Duo is used in adult males:
• to help you get and maintain an erection
• by your doctor to test whether you suffer from impotence.
Viridal Duo comes in a glass cartridge with two chambers.
One chamber contains alprostadil, the other contains sodium chloride
solution. These are
mixed together to make a solution that is injected into the penis.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VIRIDAL DUO
DO NOT USE VIRIDAL DUO:

if you are allergic to alprostadil or any of the other ingredients of
this medicine (listed
in section 6).

if you have a deformity or disease of your penis

if you have sickle-cell disease (abnormal red blood cells)

if you have leukaemia (cancer of blood cells)

if you have multiple myeloma (tumour of the bone marrow)

if you have an implant in your penis

if you have been told not to hav

Summary of Product characteristics

OBJECT 1
VIRIDAL DUO 40 MICROGRAMS/ML POWDER AND
SOLVENT FOR SOLUTION FOR INJECTION.
Summary of Product Characteristics Updated 15-Feb-2017 | UCB Pharma
Limited
1. Name of the medicinal product
Viridal Duo 40 micrograms/ml, Powder and Solvent for Solution for
Injection.
2. Qualitative and quantitative composition
Alprostadil 40 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 (0.9% w/v
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_:
Dosage for diagnosis of erectile dysfunction
Injections for 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
1.25 mcg Viridal Duo In all other
patients with erectile dysfunction 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 the treatment of erectile dysfunction
Treatment initiation and dose titration
Injections for treatment initiation and