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CAVERJECT 10 MICROGRAM POWDER FOR SOLUTION FOR INJECTION

Active substance(s): ALPROSTADIL

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Patient Information Leaflet
Caverject® 10 microgram powder for solution for
injection
(alprostadil)
Read all of this leaflet carefully before you start using this
medicine.




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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• 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.
Your medicine is called Caverject 10 micrograms powder for solution
for injection but will be referred to as Caverject throughout this
leaflet.
Caverject 10 micrograms powder for solution for injection is also
available in other strengths.
In this leaflet:
1. What Caverject is and what it is used for
2. Before you use Caverject
3. How to use Caverject
4. Possible side effects
5. How to store Caverject
6. Further information
1. What Caverject is and what it is used for
Caverject contains alprostadil which is similar to the natural
substance in your body called prostaglandin E1. It widens blood
vessels so that blood can flow in your penis more easily. This makes
it easier for you to have an erection.
Caverject is used for ‘erectile dysfunction’ including weak erections
or impotence. Your doctor may also use it to help find the exact
cause of your erectile dysfunction along with other tests.
2. Before you use Caverject
Do not use Caverject if you:


are allergic (hypersensitive) to Caverject or any other medicines
containing alprostadil or any of the other ingredients of
Caverject.
• have sickle cell anaemia (a blood disease), leukaemia (cancer of
the blood), multiple myeloma (bone cancer) or any other
problem which increases the risk of getting ‘priapism’. This is a
painful condition when your penis continues to remain erect.
• Have an implant in your penis.
• Have a condition (such as severe heart disease) in which sexual
activity should be avoided.
• Have a penis which is scarred or not straight
• Have a tight foreskin.
Do not use any Caverject until your doctor says that it is right for
you.
Take special care with Caverject
Tell your doctor before using Caverject if you:
• Have a lung, chest or heart disorder (in these cases you also
should engage in sexual activity with caution)
• Have a history of mental illness or addiction
• Have had a mini-stroke (transient ischaemic attack)
Sexually transmitted diseases
Caverject will not protect you or your partner from sexually
transmitted diseases like AIDS, herpes and gonorrhoea. Injection of
Caverject can start a small amount of bleeding where the needle
enters. This could increase the risk of transmission of such diseases.
Condoms can protect against sexually transmitted diseases. If you
need advice about contraception or ‘safe sex’ speak to your doctor
or contact your local Family Planning Clinic.
Taking other medicines
Tell your doctor if you are taking any of the following medicines
before you start using Caverject:
• Medicines used for treating high blood pressure
(antihypertensives)
• Medicines used for respiratory and heart disease
(sympathomimetics)
• Medicines that widen blood vessels (vasodilative agents)
• Other medicines for erectile dysfunction such as sildenafil or
papaverine
• Medicines to thin your blood such as warfarin or heparin, as you
might bleed more when you do the injection.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
Caverject can be used by couples wishing to conceive and with a
partner who is pregnant or breast-feeding. It will not protect your
partner from pregnancy, so you should use a reliable contraceptive if
appropriate.
Driving and using machines
Caverject should not affect your ability to drive or use machines.
Important information about some of the ingredients of
Caverject
Caverject contains benzyl alcohol which may cause allergic
reactions.
This medicine contains less than 1 mmol sodium (23 mg) per dose
and is essentially ‘sodium-free’.

E0483-1

3. How to use Caverject
A doctor or nurse will show you how to do the injection for at least
the first time. Do not try to do it yourself until you have learnt the
correct way or if you can’t remember what to do, see your trainer
again. These instructions are a reminder only. Keep the antiseptic
swab away from the eyes.
How much Caverject should you inject?
Different people need different amounts of Caverject to treat erectile
dysfunction. Your doctor will advise on the right dose for you and
monitor you regularly to check how it is working. The starting dose is
1.25 – 2.5 micrograms.
Most men find that a dose of 5 – 20 micrograms is right for them,
however, some men may require a higher dose. To minimise the risk
of prolonged painful erection, your doctor will select the lowest
effective dose. You should never use more than 60 micrograms.
If Caverject is being used to find the reason for your erectile
dysfunction, the dose will be 5 – 20 micrograms.
If the dose that has been prescribed for you does not work well
enough, tell your doctor. Do not change your dose unless your
doctor tells you to. If you forget how much to use, read the label on
the pack or speak to your doctor.
You and your partner
You may like your partner to be involved in preparing and/or giving
the injection. If so, you should speak to your doctor about training for
your partner. Wash your hands. Dry them on a clean towel. If your
partner wishes to be involved in preparing or giving the injection,
they should wash their hands too.
1. Check your pack
Make sure that the vial is the correct strength and the expiry date is
still valid. The vial, syringe and needles all have protective covers.
The flip-off cap on the vial can rotate; this is normal. Check that all
the covers are on firmly and if they are not on properly, do not use
them – take the whole pack back to your pharmacist. There are two
needles in the pack:
• The larger 22 gauge needle with the grey end is used to mix the
solution and Caverject Powder.
• The smaller and finer 30 gauge needle with the yellow end is
used to inject the mixture into your penis.
2. To prepare the vial
Flip the plastic cap off the vial. Wipe the rubbery top with one of the
wet antiseptic pads.

3. Fitting the needle to the syringe
Hold the syringe and twist the white tamper evident cap to break the
seal. Take the foil off the larger needle, (22 gauge) with the grey
end, keeping the cover on. Join the needle to the syringe by turning
the needle clockwise tightly onto the syringe, then remove the
needle cover by pushing it away from the syringe with your thumb
and forefinger.

4. Mixing the solution with the powder
Push the needle through the rubbery middle of the vial top. Press
the plunger down firmly to squirt all the solution onto the powder.
Gently swirl the vial until all the powder has dissolved. If the mixture
is cloudy or does not dissolve completely, do not use it. Never use
tap water or any liquid other than the one supplied in the syringe.

5. Filling the syringe
With the needle still inserted, turn the vial upside down. The needle
should support the vial unaided. Make sure the needle tip is
underneath the level of the liquid. Gently pull the plunger to draw all
the mixture into the syringe. Pull the needle out of the vial.

6. Changing to the injecting needle
Gently twist the larger needle anticlockwise off the syringe. Remove
the smaller injecting needle, (27 gauge) with the yellow end from its
package, keeping the cover on. Twist the needle clockwise tightly
onto the syringe, then remove the needle cover by pushing it away
from the syringe with your thumb and forefinger.

7. Setting the dose
Tap the syringe gently to send any air bubbles to the top, then push
the plunger to squeeze the air bubbles out, ensuring that at least one
drop of solution comes out of the needle. Continue pushing until the
plunger is exactly at the right mark for your dose. Your doctor will
have shown you where this is.

How do you do the injection?
• Get undressed and make yourself comfortable. Take some time
to relax yourself and your partner. If your prescriber has
recommended use of the second antiseptic pad, open it now.
• Make sure that the injection needle is not bent. If it is, do not
use it and throw it away. Do not attempt to straighten it out.
• Take hold of the penis from the front, with the first two fingers
underneath close to the testicles and the thumb on top. Gently
squeeze the penis between your thumb and finger so that the
injection site bulges out. If there is a foreskin on the penis, make
sure it is stretched. The injection will go into the part of the penis
shown as the shaded area in diagram A.

A




If recommended by your prescriber wipe the skin over this area
with the second pad and let it dry.
Keeping a firm grip on the penis and taking the syringe in your
free hand, push the needle straight through the skin all the way
into the bulgy part avoiding veins or other obvious blood vessels.
The angle is shown in diagrams B and C. Push the plunger
firmly and if the Caverject does not come out fairly easily, move
the needle slightly and try again. Do not force the Caverject
liquid from the syringe.

B

C



Pull the needle out. On the needle mark, press gently with the
pad or your thumb, as recommended by your prescriber.
Massage the penis to help the Caverject spread through it.
• Do not keep any mixture in the syringe to use for a second
injection.
How to throw away the syringe and needle safely
Ensure that the syringe, vial and needles are disposed of in a
closed, puncture-resistant container such as a sharps bin. Ask your
doctor or pharmacist for instructions on how to properly dispose of
the container after use if you are at all unsure.
How often can you use Caverject?
Do not use Caverject more than once in 24 hours or more than three
times in a week. Change the exact place and side of the penis that
you inject Caverject each time you use it.
Your erection after injecting Caverject
It will take a little while for your erection to come on after the
injection. With the right dose of Caverject, your erection should be
strong enough for you and your partner to enjoy lovemaking.
Usually, your erection should not last longer than an hour. If you
would like it to last longer, talk to your doctor. If your erection lasts
longer than four hours you should seek medical advice (see the
section on side effects below).
What if you use too much Caverject
Tell your doctor straight away as you may need treatment,
particularly if you experience an erection that lasts for longer than
four hours.
If you have any further questions on how to use this product, ask
your doctor.
4. Possible side effects
Like all medicines, Caverject can cause side effects, although not
everybody gets them.
Tell your doctor immediately if
your erection goes on for longer than 4 hours. If you cannot

E0483-1

contact your doctor, go to a hospital casualty department
immediately as treatment should be started within 6 hours.
Very common side effects
(occurring in more than 1 in 10 patients)
• Pain in the penis
Common side effects
(occurring in less than 1 in 10 patients)
• Penis can become bruised, scarred, bent or kinked, particularly
after long term use. Tell your doctor if this happens as you may
need to stop Caverject
• Prolonged erections
• Other problems with your penis
• Swelling and skin discolouration or bruising at site of injection.
You may find this happening the first time you use Caverject but
should occur less often with practice
• Muscle spasms.
Uncommon side effects
(occurring in less than 1 in 100 patients)
• The area injected becomes irritated, inflamed or swollen and
may itch or bleed, or feel numb, warm, tender or painful
• The testes or scrotum could become red, swollen or painful, or
develop lumps called spermatocele, which are cysts containing
sperm. The penis could feel numb
• You may get uncomfortable, painful or prolonged erections or
none at all, your ejaculation may change or your foreskin could
feel tight or swollen, as well as the head of your penis
• The desire to pass urine more urgently or frequently than normal
or you may have pain or difficulty in urinating. Some blood may
appear in the urine or at the end of the penis especially if
Caverject is injected by mistake into the tube which carries urine
out through the penis (urethra)
• Pelvic pain, weakness, sweating, feeling sick or swollen legs or
arms, having a common cold or dry mouth. You may get a yeast
infection (thrush)
• Changes in blood pressure and heart rhythm, faintness, shallow
breathing and collapse could occur because of the injection itself
• Skin itching, redness, rash or skin growth, increased sweating,
eye sensitivity to bright light or excessive dilation of the pupil
(blown pupil), impaired or enhanced sense of touch, leg cramps,
cold hands and feet, venous problems including bleeding
(bleeding from vein(s))
• If you have a blood test you may have raised levels of creatinine
(a substance found in your muscles).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. How to store Caverject
• Do not store above 25°C
• Keep out of the sight and reach of children
• When you have mixed the Caverject Powder with the solution,
use it straight away. Do not keep it to use later on.
• For single use only. Any unused Caverject should be discarded.
• Do not use Caverject if the injection is cloudy or contains
particles.
• Do not use Caverject after the ‘expiry’ date on the pack. The
expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Further Information
What Caverject contains
After reconstitution each 1ml contains alprostadil 10 micrograms.
The other ingredients are lactose monohydrate, sodium citrate, αcyclodextrine, hydrochloric acid and sodium hydroxide
The syringe contains benzyl alcohol (8.4 mg/ml) and water for
injections. The antiseptic pads are soaked in isopropyl alcohol.
What Caverject looks like and contents of the pack
In the Caverject box you will find 5 items:
1. One glass vial containing Caverject 10 micrograms as a white to
off-white powder
2. One graduated glass syringe containing 1 ml of a clear solution
3. One larger 22 gauge needle – 11/2 inches long with a grey plastic
end
4. One small 27 gauge needle – 0.5 inch long with a grey plastic
end
5. Two antiseptic pads
Manufacturer
Pfizer Manufacturing Belgium N.V/S.A, Rijksweg 12, 2870 Puurs,
Belgium.
Product licence holder: Ecosse Pharmaceutical Limited, 3 Young
Place, East Kilbride, G75 0TD Repackaged by Munro Wholesale
Medical Supplies Limited, 3 Young Place, East Kilbride, G75 0TD
PL 19065/0483
POM
This leaflet was revised: 22/05/2015
Caverject® is a registered trademark of Pfizer Enterprises SARL

Patient Information Leaflet
Alprostadil 10 microgram powder for solution for
injection
Read all of this leaflet carefully before you start using this
medicine.




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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• 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.
Your medicine is called Alprostadil 10 micrograms powder for
solution for injection but will be referred to as Alprostadil throughout
this leaflet.
Alprostadil 10 micrograms powder for solution for injection is also
available in other strengths.
In this leaflet:
1. What Alprostadil is and what it is used for
2. Before you use Alprostadil
3. How to use Alprostadil
4. Possible side effects
5. How to store Alprostadil
6. Further information
1. What Alprostadil is and what it is used for
Alprostadil contains alprostadil which is similar to the natural
substance in your body called prostaglandin E1. It widens blood
vessels so that blood can flow in your penis more easily. This makes
it easier for you to have an erection.
Alprostadil is used for ‘erectile dysfunction’ including weak erections
or impotence. Your doctor may also use it to help find the exact
cause of your erectile dysfunction along with other tests.
2. Before you use Alprostadil
Do not use Alprostadil if you:


are allergic (hypersensitive) to Alprostadil or any other medicines
containing alprostadil or any of the other ingredients of
Alprostadil.
• have sickle cell anaemia (a blood disease), leukaemia (cancer of
the blood), multiple myeloma (bone cancer) or any other
problem which increases the risk of getting ‘priapism’. This is a
painful condition when your penis continues to remain erect.
• Have an implant in your penis.
• Have a condition (such as severe heart disease) in which sexual
activity should be avoided.
• Have a penis which is scarred or not straight
• Have a tight foreskin.
Do not use any Alprostadil until your doctor says that it is right for
you.
Take special care with Alprostadil
Tell your doctor before using Alprostadil if you:
• Have a lung, chest or heart disorder (in these cases you also
should engage in sexual activity with caution)
• Have a history of mental illness or addiction
• Have had a mini-stroke (transient ischaemic attack)
Sexually transmitted diseases
Alprostadil will not protect you or your partner from sexually
transmitted diseases like AIDS, herpes and gonorrhoea. Injection of
Alprostadil can start a small amount of bleeding where the needle
enters. This could increase the risk of transmission of such diseases.
Condoms can protect against sexually transmitted diseases. If you
need advice about contraception or ‘safe sex’ speak to your doctor
or contact your local Family Planning Clinic.
Taking other medicines
Tell your doctor if you are taking any of the following medicines
before you start using Alprostadil:
• Medicines used for treating high blood pressure
(antihypertensives)
• Medicines used for respiratory and heart disease
(sympathomimetics)
• Medicines that widen blood vessels (vasodilative agents)
• Other medicines for erectile dysfunction such as sildenafil or
papaverine
• Medicines to thin your blood such as warfarin or heparin, as you
might bleed more when you do the injection.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
Alprostadil can be used by couples wishing to conceive and with a
partner who is pregnant or breast-feeding. It will not protect your
partner from pregnancy, so you should use a reliable contraceptive if
appropriate.
Driving and using machines
Alprostadil should not affect your ability to drive or use machines.
Important information about some of the ingredients of
Alprostadil
Alprostadil contains benzyl alcohol which may cause allergic
reactions.
This medicine contains less than 1 mmol sodium (23 mg) per dose
and is essentially ‘sodium-free’.

3. How to use Alprostadil
A doctor or nurse will show you how to do the injection for at least
the first time. Do not try to do it yourself until you have learnt the
correct way or if you can’t remember what to do, see your trainer
again. These instructions are a reminder only. Keep the antiseptic
swab away from the eyes.
How much Alprostadil should you inject?
Different people need different amounts of Alprostadil to treat
erectile dysfunction. Your doctor will advise on the right dose for you
and monitor you regularly to check how it is working. The starting
dose is 1.25 – 2.5 micrograms.
Most men find that a dose of 5 – 20 micrograms is right for them,
however, some men may require a higher dose. To minimise the risk
of prolonged painful erection, your doctor will select the lowest
effective dose. You should never use more than 60 micrograms.
If Alprostadil is being used to find the reason for your erectile
dysfunction, the dose will be 5 – 20 micrograms.
If the dose that has been prescribed for you does not work well
enough, tell your doctor. Do not change your dose unless your
doctor tells you to. If you forget how much to use, read the label on
the pack or speak to your doctor.
You and your partner
You may like your partner to be involved in preparing and/or giving
the injection. If so, you should speak to your doctor about training for
your partner. Wash your hands. Dry them on a clean towel. If your
partner wishes to be involved in preparing or giving the injection,
they should wash their hands too.
1. Check your pack
Make sure that the vial is the correct strength and the expiry date is
still valid. The vial, syringe and needles all have protective covers.
The flip-off cap on the vial can rotate; this is normal. Check that all
the covers are on firmly and if they are not on properly, do not use
them – take the whole pack back to your pharmacist. There are two
needles in the pack:
• The larger 22 gauge needle with the grey end is used to mix the
solution and Alprostadil Powder.
• The smaller and finer 30 gauge needle with the yellow end is
used to inject the mixture into your penis.
2. To prepare the vial
Flip the plastic cap off the vial. Wipe the rubbery top with one of the
wet antiseptic pads.

3. Fitting the needle to the syringe
Hold the syringe and twist the white tamper evident cap to break the
seal. Take the foil off the larger needle, (22 gauge) with the grey
end, keeping the cover on. Join the needle to the syringe by turning
the needle clockwise tightly onto the syringe, then remove the
needle cover by pushing it away from the syringe with your thumb
and forefinger.

4. Mixing the solution with the powder
Push the needle through the rubbery middle of the vial top. Press
the plunger down firmly to squirt all the solution onto the powder.
Gently swirl the vial until all the powder has dissolved. If the mixture
is cloudy or does not dissolve completely, do not use it. Never use
tap water or any liquid other than the one supplied in the syringe.

5. Filling the syringe
With the needle still inserted, turn the vial upside down. The needle
should support the vial unaided. Make sure the needle tip is
underneath the level of the liquid. Gently pull the plunger to draw all
the mixture into the syringe. Pull the needle out of the vial.

6. Changing to the injecting needle
Gently twist the larger needle anticlockwise off the syringe. Remove
the smaller injecting needle, (27 gauge) with the yellow end from its
package, keeping the cover on. Twist the needle clockwise tightly

onto the syringe, then remove the needle cover by pushing it away
from the syringe with your thumb and forefinger.

7. Setting the dose
Tap the syringe gently to send any air bubbles to the top, then push
the plunger to squeeze the air bubbles out, ensuring that at least one
drop of solution comes out of the needle. Continue pushing until the
plunger is exactly at the right mark for your dose. Your doctor will
have shown you where this is.

How do you do the injection?
• Get undressed and make yourself comfortable. Take some time
to relax yourself and your partner. If your prescriber has
recommended use of the second antiseptic pad, open it now.
• Make sure that the injection needle is not bent. If it is, do not
use it and throw it away. Do not attempt to straighten it out.
• Take hold of the penis from the front, with the first two fingers
underneath close to the testicles and the thumb on top. Gently
squeeze the penis between your thumb and finger so that the
injection site bulges out. If there is a foreskin on the penis, make
sure it is stretched. The injection will go into the part of the penis
shown as the shaded area in diagram A.

A




If recommended by your prescriber wipe the skin over this area
with the second pad and let it dry.
Keeping a firm grip on the penis and taking the syringe in your
free hand, push the needle straight through the skin all the way
into the bulgy part avoiding veins or other obvious blood vessels.
The angle is shown in diagrams B and C. Push the plunger
firmly and if the Alprostadil does not come out fairly easily, move
the needle slightly and try again. Do not force the Alprostadil
liquid from the syringe.

B

C



Pull the needle out. On the needle mark, press gently with the
pad or your thumb, as recommended by your prescriber.
Massage the penis to help the Alprostadil spread through it.
• Do not keep any mixture in the syringe to use for a second
injection.
How to throw away the syringe and needle safely
Ensure that the syringe, vial and needles are disposed of in a
closed, puncture-resistant container such as a sharps bin. Ask your
doctor or pharmacist for instructions on how to properly dispose of
the container after use if you are at all unsure.
How often can you use Alprostadil?
Do not use Alprostadil more than once in 24 hours or more than
three times in a week. Change the exact place and side of the penis
that you inject Alprostadil each time you use it.
Your erection after injecting Alprostadil
It will take a little while for your erection to come on after the
injection. With the right dose of Alprostadil, your erection should be
strong enough for you and your partner to enjoy lovemaking.
Usually, your erection should not last longer than an hour. If you
would like it to last longer, talk to your doctor. If your erection lasts
longer than four hours you should seek medical advice (see the
section on side effects below).
What if you use too much Alprostadil
Tell your doctor straight away as you may need treatment,
particularly if you experience an erection that lasts for longer than
four hours.
If you have any further questions on how to use this product, ask
your doctor.

4. Possible side effects
Like all medicines, Alprostadil can cause side effects, although not
everybody gets them.
Tell your doctor immediately if
your erection goes on for longer than 4 hours. If you cannot
contact your doctor, go to a hospital casualty department
immediately as treatment should be started within 6 hours.
Very common side effects
(occurring in more than 1 in 10 patients)
• Pain in the penis
Common side effects
(occurring in less than 1 in 10 patients)
• Penis can become bruised, scarred, bent or kinked, particularly
after long term use. Tell your doctor if this happens as you may
need to stop Alprostadil
• Prolonged erections
• Other problems with your penis
• Swelling and skin discolouration or bruising at site of injection.
You may find this happening the first time you use Alprostadil
but should occur less often with practice
• Muscle spasms.
Uncommon side effects
(occurring in less than 1 in 100 patients)
• The area injected becomes irritated, inflamed or swollen and
may itch or bleed, or feel numb, warm, tender or painful
• The testes or scrotum could become red, swollen or painful, or
develop lumps called spermatocele, which are cysts containing
sperm. The penis could feel numb
• You may get uncomfortable, painful or prolonged erections or
none at all, your ejaculation may change or your foreskin could
feel tight or swollen, as well as the head of your penis
• The desire to pass urine more urgently or frequently than normal
or you may have pain or difficulty in urinating. Some blood may
appear in the urine or at the end of the penis especially if
Alprostadil is injected by mistake into the tube which carries
urine out through the penis (urethra)
• Pelvic pain, weakness, sweating, feeling sick or swollen legs or
arms, having a common cold or dry mouth. You may get a yeast
infection (thrush)
• Changes in blood pressure and heart rhythm, faintness, shallow
breathing and collapse could occur because of the injection itself
• Skin itching, redness, rash or skin growth, increased sweating,
eye sensitivity to bright light or excessive dilation of the pupil
(blown pupil), impaired or enhanced sense of touch, leg cramps,
cold hands and feet, venous problems including bleeding
(bleeding from vein(s))
• If you have a blood test you may have raised levels of creatinine
(a substance found in your muscles).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. How to store Alprostadil
• Do not store above 25°C
• Keep out of the sight and reach of children
• When you have mixed the Alprostadil Powder with the solution,
use it straight away. Do not keep it to use later on.
• For single use only. Any unused Alprostadil should be discarded.
• Do not use Alprostadil if the injection is cloudy or contains
particles.
• Do not use Alprostadil after the ‘expiry’ date on the pack. The
expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Further Information
What Alprostadil contains
After reconstitution each 1ml contains alprostadil 10 micrograms.
The other ingredients are lactose monohydrate, sodium citrate,
αlpha-cyclodextrine, hydrochloric acid and sodium hydroxide
The syringe contains benzyl alcohol (8.4 mg/ml) and water for
injections. The antiseptic pads are soaked in isopropyl alcohol.
What Alprostadil looks like and contents of the pack
In the Alprostadil box you will find 5 items:
1. One glass vial containing Alprostadil 10 micrograms as a white
to off-white powder
2. One graduated glass syringe containing 1 ml of a clear solution
3. One larger 22 gauge needle – 11/2 inches long with a grey plastic
end
4. One small 27 gauge needle – 0.5 inch long with a grey plastic
end
5. Two antiseptic pads
Manufacturer
Pfizer Manufacturing Belgium N.V/S.A, Rijksweg 12, 2870 Puurs,
Belgium.
Product licence holder: Ecosse Pharmaceutical Limited, 3 Young
Place, East Kilbride, G75 0TD Repackaged by Munro Wholesale
Medical Supplies Limited, 3 Young Place, East Kilbride, G75 0TD
PL 19065/0483
POM
This leaflet was revised: 22/05/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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