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Does this help.Not sure what you guys are looking for?http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm
12/03/2013 = Sep 12: Takeda and Apricus Biosciences have entered into a licence agreement to market Vitaros®, a treatment for erectile dysfunction, in the UK. A licence is anticipated in 2013 [5].
12/03/2013 16:29:29
Good repost for new people and those who do not pay attention.Package lea et: Information for the user
3 mg/g cream
Alprostadil
Read all of this lea et carefully before you start using this
medicine because it contains important information for you.
- Keep this lea et. 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 phamacist.
This includes any possible side effects not listed in this lea et.
See section 4.
What is in this lea et:
1. What VITAROS is and what it is used for
2. What you need to know before you use VITAROS
3. How to use VITAROS
4. Possible side effects
5. How to store VITAROS
6. Contents of the pack and other information
For an erection: the starting dose should be recommended by a
physician. Do not adjust your dose yourself. Talk to your doctor
who will instruct you on proper technique for administration and
accomodation of your dose.
Do not apply Vitaros more than 2-3 times a week and only once
per 24 hour period.
The onset of effect is within 5 to 30 minutes after administration.
The duration of effect is approximately 1 to 2 hours. But, the
actual duration can vary from patient to patient.
Apply Vitaros to the tip of the penis within 5 to 30 minutes prior
to attempting intercourse by following the instructions below:
1. Wash your hands before applying Vitaros. Remove the
AccuDose container from the foil pouch by tearing fully across
from the notched edge. Remove the AccuDose container from
the sachet. Save the sachet for discarding the used AccuDose
container later. Remove the cap from the tip of the container.
(Figure 1)
Plunger
1. What Vitaros is and what it is used for
Vitaros is available in two dosage strengths of 200 and 300 mcg
alprostadil in 100 mg of cream.Vitaros is used to treat erectile
dysfunction (ED) in men 18 years of age or older. ED is the
inability to attain or maintain an erection suf cient for sexual
intercourse. There are several causes of ED including medications
that you may be taking for other conditions, poor blood
circulation in the penis, nerve damage, emotional problems, too
much smoking or alcohol use, and hormonal problems. Often ED
is due to more than one cause. Treatments for ED include
switching medications, if you are taking a medication that causes
ED, prescription medications, medical devices that produce an
erection, surgical procedures to correct blood ow to the penis,
penile implants and psychological counseling. After application of
Vitaros the onset of erection is within 5 to 30 minutes. You
should not stop taking any prescription medications, unless told
to do so by your doctor.
PAGE 1 OF 2
2. What you need to know before you use Vitaros
Do not use Vitaros
- if you have underlying disorders such as drop in blood
pressure when going from a lying/sitting to a standing
position, history of a heart attack, and syncope (dizziness)
- if you are allergic to alprostadil or any of the other ingredients
of this medicine (listed in section 6).
- if you have a condition that might result in a long-lasting
erection or a condition such as sickle cell anaemia or trait,
thrombocythemia, polycythemia, multiple myeloma, or
leukaemia
- if you have an abnormally formed penis
- if you have an in ammation or infection of the penis
- if you are prone to a venous thrombosis
- if you have a hyperviscosity syndrome which could result in a
long-lasting erection
- if you have been told not to have sex for health reasons such
as heart problems or a recent stroke.
- if your partner is pregnant, breast feeding or of childbearing
potential unless you use a condom barrier.
Warnings and precautions
Talk to your doctor or pharmacist before using Vitaros if you have
a history of the following local effects that have been observed
with the use of Vitaros:
- prolonged erections lasting >4 hours (priapism)
- symptomatic hypotension (dizziness)
- hepatic and/or renal insuf ciency, a lowered dose due to
impaired metabolism may be required
- fainting
A condom should be used in the following situations:
- your partner is pregnant or breastfeeding
- your partner is of childbearing potential
- to prevent sexually transmitted diseases
- during oral sex and anal sex
Only latex condoms have been studied. It is not known if
condoms made of other materials may be damaged.
Other medicines and Vitaros
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
The use of Vitaros with other drugs used to treat Erectile
Dysfunction have not been studied. Therefore, if you are taking
other drugs for ED, do not combine with Vitaros as there could be
signs including dizziness, fainting and prolonged erections.
Vitaros has not been tested for use with penile implants or
smooth muscle relaxants such as papaverine; drugs used to
induce erections such as alpha blocking drugs (e.g.
intracavernosal phentolamine, thymoxamine). There is a risk of
priapism (painful prolonged abnormal erection) when used in
combination.
Although not studied, it is possible that Vitaros may have less of
an effect when taken in combination with treatments for high
blood pressure, decongestants and appetite suppressants.
If you are taking drugs to prevent blood clots, do not take Vitaros
as there may be an increased risk for bleeding or blood found in
the urine.
In combination with high blood pressure medication, Vitaros use
may increase symptoms of dizziness and fainting, especially in the
elderly.
Pregnancy and breast-feeding and fertility
There are no data on the use of Vitaros in pregnant women.
Pregnant women should not be exposed to Vitaros.
It is not recommended to use Vitaros while breastfeeding.
It is not known whether Vitaros has an effect on human male
fertility.
Driving and using machines
Vitaros may make you feel dizzy or faint. Do not drive or operate
machinery within 1 to 2 hours after administration.
3. How to use Vitaros
Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Vitaros is available in two dosage strengths of 200 and 300 mcg
alprostadil in 100 mg of cream. Vitaros should be used as needed
to achieve an erection. Each Vitaros AccuDose container is for
single use only and should be properly discarded after use.
Barrel
Tip
Protective Cap
Figure 1
2. Grasp the tip of the penis with one hand and gently
manipulate to widen the opening of the penis. Note: if you are
not circumcised, rst retract and hold the foreskin back prior
to widening the opening of the penis. (Figure 2)
Figure 2
3. Hold the barrel of the AccuDose container between your
ngers and place the tip of the container over the opening of
the penis and slowly (over 5-10 seconds) push down the
plunger with your nger until all the cream is expelled from the
AccuDose container barrel. Note: do not insert the tip of the
AccuDose container into the opening of the penis. (Figure 3)
Figure 3
4. Hold the penis in an upright position for approximately 30
seconds to allow the cream to penetrate. There might be an
excess cream. The amount of excess cream will vary
depending on the patient and it is not unusual that half of the
dose will remain at the edge of the opening. Do not use a
second AccuDose to compensate for cream not expelled into
the opening of the penis. Any excess cream covering the
opening may be rubbed gently into the skin surrounding the
application site with the tip of a nger.
5. Remember each Vitaros dose is good for a single
administration only. Replace the cap on the AccuDose
container and place in the opened foil sachet, fold and discard
in accordance with local requirements.
6. Vitaros may be irritating to the eyes. Wash your hands after
applying Vitaros.
Children and adolescents
Vitaros is not indicated for children or men below 18 years of age.
If you use more VITAROS than you should
Overdose with Vitaros requiring treatment has not been reported.
Overdose with Vitaros may result in a drop in blood pressure,
fainting, dizziness, persistent pain in the penis, and possible
prolonged erection lasting longer than 4 hours. This can result in
permanent worsening of erectile function. Call your doctor
promptly if you suffer with any of these effects.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, VITAROS can cause side effects, although not
everybody gets them.
If you get a long-lasting erection of more than 4 hours, contact
your doctor immediately.
Your doctor may reduce your dose of Vitaros or disontinue your
treatment.
Common side effects (may affect more than 1 in 10 patients):
You:
- mild to moderate local aching, burning or pain and redness of
the penis,
- rash,
- genital pruritus,
- penile oedema
- in ammation of the glans penis (balantitis)
- penile tingling, throbbing numbness, burning
Your partner:
- mild vaginal burning or itching, vaginitis
This effect may be due to the drug or to the act of vaginal
penetration. Using a water-based lubricant can help to make
vaginal penetration easier.
Uncommon but potentially serious side effects (may affect up to
1 in 100 patients):
You:
- light-headedness/dizziness
- prolonged erection for more than 4 hours
- fainting
-
low blood pressure or rapid pulse
pain at the application site or in extremity
urethral stenosis
increase in sensitivity
penile itching
genital rash
scrotal pain
fullness in genital
lack of sensation to penis
urinary tract in ammation
Your partner:
- vulvovaginal pruritus
*Increased sexual/physical activity in combination with Vitaros my
increase the risk of heart attack or stroke in patients with
underlying disease/risk factors (see Section 2).
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Duration of side effects:
Most effects are short acting and resolve within 1-2 hours
Reporting of side effects
If you get any side effects, talk to your doctor. This includes
any possible side effects not listed in this lea et. Also you can
help to make sure that medicines remain as safe as possible
by reporting any unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to
Fridays) or ll in a paper form available from your local pharmacy.
By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Vitaros
Keep this medicine out of the sight and reach of children.
Do not use VITAROS after the expiry date which is stated on the
carton, sachet and AccuDose container label after Exp.
The expiry date refers to the last day of the month.
Store in a refrigerator (2 C - 8 C).
Do not freeze.
Unopened sachets may be kept out of the refrigerator by the
patient, at a temperature below 25 C for up to 3 days prior to
use.
At the end of this period, the product should be discarded if not
used.
Each dispenser is for single use only.
Once opened, use immediately, discard any unused portion.
Store in the original sachet in order to protect from light.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist to throw away medicines you no
longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What VITAROS contains
The active substance is Alprostadil
Each single container contains 300 micrograms of alprostadil in
100 mg of cream (3mg/g).
Vitaros is available in unit cartons with four (4) single dose
containers.
The other ingredients are puri ed water; ethanol, anhydrous;
ethyl laurate; hydroxypropyl guar gum;
dodecyl-2-N,N-dimethylaminopropionate hydrochloride;
potassium dihydrogen phosphate; sodium hydroxide, for pH
adjustment; phosphoric acid, for pH adjustment.
PAGE 2 OF 2
What VITAROS looks like and contents of the pack
Vitaros is a white to off-white cream supplied in AccuDose, a
single dose container. AccuDose is a container consisting of a
plunger, barrel, and protective cap.
Each container is provided in a protective sachet.
The sachets are composed of aluminium foil/laminate. The
container components are composed of polypropylene and
polyethylene.
Marketing Authorisation Holder
Takeda UK Ltd.
Takeda House
Mercury Park
Wycombe Lane
Wooburn Green
High Wycombe
HP10 0HH
Manufacturer
Midas Pharma GmbH
Rheinstrasse 49
55218 Ingelheim
Germany
This medicinal product is authorised in the Member States of
the EEA under the following names:
Vitaros 3mg/g cream
Member State
Germany
UK
France
Spain
Sweden
Ireland
Belgium
Luxembourg
Proposed product name
Alprostadil HEXAL 300 g/100 mg Creme
Vitaros 3 mg/g cream
Vitaros 3 mg/g Cr me
Alprostadil PPD 3 mg/g Crema
Vitaros 3 mg/g Kr m
Vitaros 3 mg/g Cream
Alprostadil Clinical Technology Centre 3 mg/g
Cr me
Vitaros 3 mg/g Cr me
This lea et was last approved in 06/2013.
Other Sources of Information
Detailed information on this medicine is available on the
Medicines and Healthcare products Regulatory Agency (MHRA)
web site: http://www.mhra.gov.uk.
EFFECTS AFTER APPLICATION:
Vitaros requires between 5 to 30 minutes to begin working
before you can have sexual intercourse. After administration you
can engage in foreplay, which helps arousal and the process of
developing an erection. An effective dose of Vitaros should
produce an erection suf cient for sexual intercourse. The
duration of the effect is approximately 1 to 2 hours. However, the
actual duration will vary from patient to patient and the dose of
the drug. Vitaros may not create an erection comparable to those
you experienced when you were younger. Some patients may
experience some mild pain, a burning sensation, and aching in
the penis or groin area. Also, your erection may continue for a
time after orgasm or ejaculation. After your erection is over your
penis may feel full, warm, and somewhat sensitive to the touch.
These effects are normal and may last for a few hours.
ADDITIONAL INFORMATION AND PRACTICAL TIPS:
You and your doctor will determine the appropriate dose of
Vitaros. If your erection cannot be maintained for the time need
to have foreplay and sexual intercourse, you may need to have
your dose increased. Similarly, if an erection last longer than
desired or if the side effects are not well tolerated you may need
your dose reduced. Call your doctor if you suspect that you may
require an adjustment of your dose.
Factors that may enhance your erection:
- being well rested.
- sexual foreplay with your partner or self-stimulation while
sitting or lying after application of Vitaros.
- pelvic exercises such as tightening and releasing your pelvic
and buttock muscles. These are the muscles you use to stop
urination.
- various positions that may favour and not restrict blood ow
to the penis.
Factors which may reduce your erection:
- anxiety, fatigue, tension, and too much alcohol.
- urination immediately after application may result in loss of
medication.
Do you have a purpose or a point before they block you?
I have posted this a few times. 15 to 30 minutes as fast as six minutes. http://buyalprostadilcream.com/vitaros-cream-alprostadil-for-ed-launch-date-and-availability/
It was not Lourdes I have talked to her before.Why did you not call the # yourself if you were so concerned? Instead of a hypothetical? I posted the #. Then your claim could possibly be a fact.The reason I posted a guess with a fact is because there is a Biotech conference in York Dec 3-4. I will post when she calls back .Then again you may not believe it.I say pick up the phone and call yourself in the morning.Should I just not post when she calls tomorrow? Why the tude?
Could Lourdes from Argo Partners be here. Piper Jaffry biotech conference New York Dec 3-4 . Just a guess. http://finance.yahoo.com/news/oncolytics-biotech-inc-present-25th-113000772.html;_ylt=A2KIq_wOap5SMBQAc2nQtDMD
Still no callback. I called back asking for lourdes not spelled right I am sure, anyway lady said she is in New York at a conference and she asked if she Lourdes could call me back tomorrow.I said yes. Will post if I hear anything tomorrow.
I called the company and a lady answered.I said I had a question.She asked what it was and I said can you tell me the name of the Biotech co in the 10-k? she said let me transfer you to someone who can answer that for you and next thing was a voicemail.I left a message saying only that I had a question on Apricus please call me back.Will be out most of the day but will post later if calls back. 1-858-222-8041
Novel compound currently under investigation http://www.redorbit.com/news/health/1112979963/erectile-dysfunction-drugs-market-is-expected-to-reach-usd-34/in clinical settings.
Nice mecosmo2
Welcome to the APRI board all new people.
Good follow up ty.
ZMAN POST BELOW 11465
http://www.drugs.com/uk/vitarTranscript
Package leaflet: Information for the user
Vitaros 2mg/g cream
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 phamacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What VITAROS is and what it is used for
2.
What you need to know before you use VITAROS
3.
How to use VITAROS
4.
Possible side effects
5.
How to store VITAROS
6.
Contents of the pack and other information
1.
What Vitaros is and what it is used for
Vitaros is available in two dosage strengths of 200 and 300 mcg alprostadil in 100 mg of
cream.Vitaros is used to treat erectile dysfunction (ED) in men 18 years of age or older. ED is the
inability to attain or maintain an erection sufficient for sexual intercourse. There are several causes of
ED including medications that you may be taking for other conditions, poor blood circulation in the
penis, nerve damage, emotional problems, too much smoking or alcohol use, and hormonal problems.
Often ED is due to more than one cause. Treatments for ED include switching medications, if you are
taking a medication that causes ED, prescription medications, medical devices that produce an
erection, surgical procedures to correct blood flow to the penis, penile implants and psychological
counseling. After application of Vitaros the onset of erection is within 5 to 30 minutes. You should not
stop taking any prescription medications, unless told to do so by your doctor.
2.
What you need to know before you use Vitaros
Do not use Vitaros
if you have underlying disorders such as drop in blood pressure when going from a lying/sitting to
a standing position, history of a heart attack, and syncope (dizziness)
if you are allergic to alprostadil or any of the other ingredients of this medicine (listed in section
6).
if you have a condition that might result in a long-lasting erection or a condition such as sickle
cell anaemia or trait, thrombocythemia, polycythemia, multiple myeloma, or leukaemia
if you have an abnormally formed penis
if you have an inflammation or infection of the penis
if you are prone to a venous thrombosis
if you have a hyperviscosity syndrome which could result in a long-lasting erection
if you have been told not to have sex for health reasons such as heart problems or a recent
stroke.
if your partner is pregnant, breast feeding or of childbearing potential unless you use a
condom barrier.
Warnings and precautions
Talk to your doctor or pharmacist before using Vitaros if you have a history of the following local
effects that have been observed with the use of Vitaros:
- Prolonged erections lasting >4 hours (priapism)
- Symptomatic hypotension (dizziness)
- Hepatic and/or renal insufficiency, a lowered dose due to impaired metabolism may be required
- Fainting
A condom should be used in the following situations:
- Your partner is pregnant or breastfeeding
- Your partner is of childbearing potential
- To prevent sexually transmitted diseases
- During oral sex and anal sex
Only latex condoms have been studied. It is not known if condoms made of other materials
may be damaged.
Other medicines and Vitaros
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The use of Vitaros with other drugs used to treat Erectile Dysfunction have not been studied.
Therefore, if you are taking other drugs for ED, do not combine with Vitaros as there could be signs
including dizziness, fainting and prolonged erections. Vitaros has not been tested for use with penile
implants or smooth muscle relaxants such as papaverine; drugs used to induce erections such as alpha
blocking drugs (e.g. intracavernosal phentolamine, thymoxamine). There is a risk of priapism (painful
prolonged abnormal erection) when used in combination.
Although not studied, it is possible that Vitaros may have less of an effect when taken in combination
with treatments for high blood pressure, decongestants and appetite suppressants.
If you are taking drugs to prevent blood clots, do not take Vitaros as there may be an increased risk for
bleeding or blood found in the urine.
In combination with high blood pressure medication, Vitaros use may increase symptoms of dizziness
and fainting, especially in the elderly.
Pregnancy and breast-feeding and fertility
There are no data on the use of Vitaros in pregnant women. Pregnant women should not be exposed to
Vitaros.
It is not recommended to use Vitaros while breastfeeding.
It is not known whether Vitaros has an effect on human male fertility.
Driving and using machines
Vitaros may make you feel dizzy or faint. Do not drive or operate machinery within 1 to 2 hours after
administration.
3.
How to use Vitaros
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Vitaros is available in two dosage strengths of 200 and 300 mcg alprostadil in 100 mg of cream.
Vitaros should be used as needed to achieve an erection. Each Vitaros AccuDose container is for
single use only and should be properly discarded after use.
For an erection: the starting dose should be recommended by a physician. Do not adjust your dose
yourself. Talk to your doctor who will instruct you on proper technique for administration and
accomodation of your dose.
Do not apply Vitaros more than 2-3 times a week and only once per 24 hour period.
The onset of effect is within 5 to 30 minutes after administration. The duration of effect is
approximately 1 to 2 hours. But, the actual duration can vary from patient to patients.
Apply Vitaros to the tip of the penis within 5 to 30 minutes prior to attempting intercourse by
following the instructions below:
1. Wash your hands before applying Vitaros. Remove the AccuDose container from the foil
pouch by tearing fully across from the notched edge. Remove the AccuDose container from
the sachet. Save the sachet for discarding the used AccuDose container later. Remove the cap
from the tip of the container. (Figure 1)
Plunger
Barrel
Tip
Protective Cap
Figure 1
2. Grasp the tip of the penis with one hand and gently manipulate to widen the opening of the
penis. Note: if you are not circumcised, first retract and hold the foreskin back prior to
widening the opening of the penis.(Figure 2)
Figure 2
3. Hold the barrel of the AccuDose container between your fingers and place the tip of the
container over the opening of the penis and slowly (over 5-10 seconds) push down the plunger
with your finger until all the cream is expelled from the AccuDose container barrel. Note: do
not insert the tip of the AccuDose container into the opening of the penis. (Figure 3)
Figure 3
4.
Hold the penis in an upright position for approximately 30 seconds to allow the cream to
penetrate. There might be an excess cream. The amount of excess cream will vary depending on
the patient and it is not unusual that half of the dose will remain at the edge of the opening. Do not
use a second AccuDose to compensate for cream not expelled into the opening of the penis. Any
excess cream covering the opening may be rubbed gently into the skin surrounding the application
site with the tip of a finger.
5. Remember each Vitaros dose is good for a single administration only. Replace the cap on the
AccuDose container and place in the opened foil sachet, fold and discard in accordance with local
requirements.
6. Vitaros may be irritating to the eyes. Wash your hands after applying Vitaros.
Children and adolescents
Vitaros is not indicated for children or men below 18 years of age.
If you use more VITAROS than you should
Overdose with Vitaros requiring treatment has not been reported. Overdose with Vitaros may result in
a drop in blood pressure, fainting, dizziness, persistent pain in the penis, and possible prolonged
erection lasting longer than 4 hours. This can result in permanent worsening or erectile function. Call
your doctor promptly if you suffer with any of these effects.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, VITAROS can cause side effects, although not everybody gets them.
If you get a long-lasting erection of more than 4 hours, contact your doctor immediately.
Your doctor may reduce your dose of Vitaros and disontinue your treatment.
Common side effects (may affect more than 1 in 10 patients):
You:
Mild to moderate local aching, burning or pain and redness of the penis,
rash,
genital pruritus,
penile oedema
inflammation of the glans penis (balantitis)
penile tingling, throbbing numbness, burning
Your partner:
Mild vaginal burning or itching, vaginitis
This effect may be due to the drug or to the act of vaginal penetration. Using a water-based lubricant
can help to make vaginal penetration easier.
Uncommon but potentially serious side effects (may affect up to 1 in 100 patients):
You:
Light-headedness/dizziness
Prolonged erection for more than 4 hours
Fainting
Low blood pressure or rapid pulse
Pain at the application site or in extremity
Urethral stenosis
increase in sensitivity
penile itching
genital rash
scrotal pain
fullness in genital
lack of sensation to penis
Urinary tract inflammation
Your partner:
Vulvovaginal pruritus
*Increased sexual/physical activity in combination with Vitaros my increase the risk of heart attack or
stroke in patients with underlying disease/risk factors (see Section 2).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
Duration of side effects:
Most effects are short acting and resolve within 1-2 hours
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this
leaflet. Also you can help to make sure that medicines remain as safe as possible by reporting any
unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call
Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form
available from your local pharmacy. By reporting side effects you can help provide more information
on the safety of this medicine.
5.
How to store Vitaros
Keep this medicine out of the sight and reach of children.
Do not use VITAROS after the expiry date which is stated on the carton, sachet and AccuDose
container label after Exp.
The expiry date refers to the last day of the month.
Store in a refrigerator (2 C - 8 C).
Do not freeze.
Unopened sachets may be kept out of the refrigerator by the patient, at a temperature below 25 C for
up to 3 days prior to use.
At the end of this period, the product should be discarded if not used.
Each dispenser is for single use only.
Once opened, use immediately, discard any unused portion.
Store in the original sachet in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist to throw
away medicines you no longer use. These measures will help protect the environment.
6.
Contents of the pack and other information
What VITAROS contains
The active substance is Alprostadil
Each single container contains 200 micrograms of alprostadil in 100 mg of cream (2mg/g).
Vitaros is available in unit cartons with four (4) single dose containers.
The other ingredients are purified water; ethanol, anhydrous; ethyl laurate; hydroxypropyl guar gum;
dodecyl-2-N,N-dimethylaminopropionate hydrochloride; potassium dihydrogen phosphate; sodium
hydroxide, for pH adjustment; phosphoric acid, for pH adjustment.
What VITAROS looks like and contents of the pack
Vitaros is a white to off-white cream supplied in AccuDose, a single dose container. AccuDose is a
container consisting of a plunger, barrel, and protective cap.
Each container is provided in a protective sachet.
The sachets are composed of aluminium foil/laminate. The container components are composed of
polypropylene and polyethylene.
Marketing Authorisation Holder and Manufacturer
Midas Pharma GmbH
Rheinstrasse 49
55218 Ingelheim
Germany
This medicinal product is authorised in the Member States of the EEA under the following
names:
Vitaros 2mg/g cream
Member State
Proposed product name
Germany
UK
France
Spain
Sweden
Ireland
Belgium
Luxembourg
Alprostadil HEXAL 200 g/100 mg Creme
Vitaros 2mg/g cream
Vitaros 2 mg/g Cr me
Alprostadil PPD 2 mg/g Crema
Vitaros 2 mg/g Kr m
Vitaros 2 mg/g Cream
Alprostadil Clinical Technology Centre 2 mg/g Cr me
Vitaros 2 mg/g Cr me
This leaflet was last approved in 05/2013.
Other Sources of Information
Detailed information on this medicine is available on the Medicines and Healthcare products
Regulatory Agency (MHRA) web site: http://www.mhra.gov.uk.
_________________________________________________________________________________
EFFECTS AFTER APPLICATION:
Vitaros requires between 5 to 30 minutes to begin working before you can have sexual intercourse.
After administration you can engage in foreplay, which helps arousal and the process of developing an
erection. An effective dose of Vitaros should produce an erection sufficient for sexual intercourse. The
duration of the effect is approximately 1 to 2 hours. However, the actual duration will vary from
patient to patient and the dose of the drug. Vitaros may not create an erection comparable to those you
experienced when you were younger. Some patients may experience some mild pain, a burning
sensation, and aching in the penis or groin area. Also, your erection may continue for a time after
orgasm or ejaculation. After your erection is over your penis may feel full, warm, and somewhat
sensitive to the touch. These effects are normal and may last for a few hours.
ADDITIONAL INFORMATION AND PRACTICAL TIPS:
You and your doctor will determine the appropriate dose of Vitaros. If your erection cannot be
maintained for the time need to have foreplay and sexual intercourse, you may need to have your dose
increased. Similarly, if an erection last longer than desired or if the side effects are not well tolerated
you may need your dose reduced. Call your doctor if you suspect that you may require an adjustment
of your dose.
Factors that may enhance your erection:
- Being well rested.
- Sexual foreplay with your partner or self-stimulation while sitting or lying after application of
Vitaros.
- Pelvic exercises such as tightening and releasing your pelvic and buttock muscles. These are the
muscles you use to stop urination.
- Various positions that may favour and not restrict blood flow to the penis.
Factors which may reduce your erection:
- Anxiety, fatigue, tension, and too much alcohol.
- Urination immediately after application may result in loss of medication.os-2-mg-g-cream-leaflet.html
Thanks zman
Lots of Doctors commenting on Vitaros on the forum at bottom, in this one. 24 comments. http://www.medscape.com/viewarticle/805568
jsbeach23 repost. Good read. http://www.peaktestosterone.com/Alprostadil_Erectile_Dysfunction.aspx
Thank you lostcoastkid.
Welcome all.My suspension lifted.Will try to keep it on topic.
eicoman repost= great info.
eicoman Member Level Monday, 09/16/13 12:37:42 PM
Re: None
Post # of 11452
Eicoman's Top 10 - Femprox
Why Femprox works and will be moving forward:
1. Recent Vitaros approval in a major western market, by the EMA in the EU, validates not only Vitaros but NexAct and Femprox , this is a crucial turning point.
2. Because Femprox is the same drug as Vitaros, although in different concentration, Femprox works by the same mechanism in women as in men, topical increased blood flow to the target area with no systemic effects.
Study: http://www.ncbi.nlm.nih.gov/pubmed/9138056
3. NexAct clearly makes the difference, as shown by Vivus.
Vivus ran clinical trials using a topical alprostadil product for FSAD , and the trials were unsuccessful in that they showed no improvement over placebo effect.
But Femprox has seven studies including:
• PH2 trial in the USA with 100 women which showed a positive trend towards higher doses
• PH3 trial in China with 400 women, the PH3 trial had better trial design, which showed for the higher 900-µg dose, significant and clinically relevant improvements in primary arousal success and secondary efficacy outcomes (FSFI) and Global Assessment Questionnaire (GAQ) and FSDS.
4. The new Femprox trials will have a room temp product and an improved trial design regarding endpoints and the SSE score.
5. Femprox Safety
Phase II Trial USA - “Adverse events were generally mild or moderate in intensity and mainly involved localized reactions in the genital area” http://www.ncbi.nlm.nih.gov/pubmed/14504005
Phase III Trial China- “No drug related serious adverse events were reported ,
Only 5 patients (1.2%) withdrawn from the Phase III study because of local adverse events”
http://www.ncbi.nlm.nih.gov/pubmed/18564348
6. Femprox has been expanded from FSAD to include sexual interest, FSAID, a larger market.
7. Limited Competition. There is no significant competition to Femprox right now or really for the foreseeable future, since current products in development are systemic and rely on manipulating hormones, neurotransmitters or brain chemistry, all of which can cause serious side effects. http://formularyjournal.modernmedicine.com
8. Filbenserin is a possible competitor in the area of sexual interest to Femprox. It is an anti-depressant type drug for women with no sexual interest. Femprox with it’s expanded description of FSAID, also covers sexual interest but also covers the very large patient population with desire but lack of arousal and lubrication. Filbenserin has a PDUFA date later this month and if approved it could give APRI a boost, since it will be the first drug approved in this space, showing willingness on FDA’s part.
Looking at Filbenserin, it looks like they may have a shot with new trial work having been done.
http://sproutpharma.com/wp-content/uploads/2013/06/pharmceutical-approvals-monthly.pdf
"The new filing package includes a newer pivotal trial in which the drug met two co-primary efficacy endpoints, whereas results had been mixed in other studies.”
9. FSD could now face a friendlier regulatory climate. As required by the reauthorization of the Prescription Drug User Fee Act, FDA is holding patient-focused meetings in diseases with high unmet need. Female sexual dysfunction made the first cut of conditions. A patient-focused meeting is slated for between 2013 and 2015
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm347317.htm
http://www.elsevierbi.com/publications/the-pink-sheet/75/16/fdas-patientfocused-meetings-round-one-selections-include-diseases-broad-and-rare
10. SEPT. 2013 – Femprox Product Plan revealed in Q4 2013 – it is obvious from the 9/11 conf call and corp presentation that APRI is already well under way with executing of plans for moving forward with Femprox
Key Femprox Initiatives
–Review official FDA meeting minutes with Scientific Advisory Board
–Finalize Femprox Product Plan
–Initiate any planned supportive studies
–Complete Femprox Room-Temperature device design
–Complete second round of Femprox market research
–Update market on Femprox Product Plan in Q4 2013
• FDA Feedback
• Clinical Development Plan
• Commercial Assessment
• Timelines
Long and short chart update = http://www.shortanalytics.com/getshortchart.php?tsymbol=APRI
INFO. Repost-http://vitaros.us/