CAVERJECT DUAL CHAMBER 20 MICROGRAMS

Active substance: ALPROSTADIL

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PRE-PRESS NO.:

02-1808

PRODUCT:

Caverject dual chamber

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/2488E

DATE OF PROOF:

27/01/14

DATE:

PROOF HISTORY:
v.1 - waymade - 27/01/14

DATE:

CUSTOMER: Waymade

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
Transtec 6464/2327 2328 2329E

TVT CHECKED
UK PIL DATED NOVEMBER 2012
REPORTING OF SIDE EFFECTS

Pg 4

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 Dual Chamber
Caverject Dual Chamber 20 micrograms/0.5ml should not be stored above 25°C.
After reconstitution it is recommended to be used immediately, if it is not possible it should be used within 24
hours provided it is not stored above 25°C.
Keep the cartridge and needles out of the sight and reach of children.
Do not use after the expiry date on the pack. The expiry date refers to the last day of the month.
Do not use Caverject Dual Chamber if the injection is cloudy or contains particles.
For single use only. Any unused contents of the syringe should be discarded.
If the medicine becomes discoloured or shows signs of deterioration, you should seek the advice of the
pharmacist.
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 Dual Chamber contains
Caverject Dual Chamber 20 micrograms/0.5ml consists of a powder and solvent (diluent) for solution for
injection.
The active ingredient in Caverject Dual Chamber 20 micrograms/0.5ml is alprostadil. Each 0.5ml cartridge
delivers a maximum dose of 20 micrograms of alprostadil.
The lyophilised powder in the front compartment also contains the following inactive ingredients:
lactose monohydrate, alphadex, sodium citrate, hydrochloric acid, and sodium hydroxide.
The diluent in the rear compartment is bacteriostatic water for injection and contains benzyl alcohol and water for
injections.
What Caverject Dual Chamber looks like and contents of the pack
The product is a dual chamber glass cartridge assembled as a single unit in a disposable delivery device. The
cartridge contains a white lyophilised powder in the front compartment and diluent in the rear compartment.
There are sufficient components in each box to enable two separate injections of Caverject Dual Chamber
20 micrograms/0.5ml.
In each sealed plastic tray there is also a 29-gauge needle and two alcohol cleaning swabs.
POM

PL No: 6464/2488 Caverject Dual Chamber 20 micrograms/0.5ml

This product is manufactured by Pfizer Health AB, Stockholm, Sweden and Pfizer Manufacturing BELGIUM NV.,
Puurs, Belgium and procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 27.01.2014
Caverject is a registered trademark of Pharmacia & Upjohn Company LLC

CAVERJECT®

Pg 1

DUAL CHAMBER
20 micrograms/0.5ml
(alprostadil)
Patient Information Leaflet

The name of your medicine is Caverject Dual Chamber 20 micrograms/0.5ml but will be referred to as Caverject
Dual Chamber throughout the following leaflet. Another strength (10 micrograms) is also available.
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.
In this leaflet:
1. What Caverject Dual Chamber is and what it is used for
2. Before you use Caverject Dual Chamber
3. How to use Caverject Dual Chamber
4. Possible side effects
5. How to store Caverject Dual Chamber
6. Further information

1. What Caverject Dual Chamber is and what it is used for
Caverject Dual Chamber contains alprostadil which is similar to the natural substance in your body called
prostaglandin E1. It widens blood vessels, increasing blood flow to your penis making it easier for you to
have an erection. Caverject Dual Chamber 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 Dual Chamber
Do not use Caverject Dual Chamber if you:
• are allergic (hypersensitive) to Caverject Dual Chamber, any other medicines containing alprostadil or
any of the other ingredients of Caverject Dual Chamber.
• have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of the blood), multiple
myeloma (bone cancer) or any other problem which increases risk of getting “priapism”. This is when
your erection lasts for longer than 6 hours.
• 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, bent or kinked, or Peyronie’s disease.
• have a tight foreskin.
Take special care with Caverject Dual Chamber
If you experience an erection that lasts for longer than 4 hours seek medical advice immediately as treatment
should be started within 6 hours. If you cannot contact your doctor go to the hospital emergency department.
Tell your doctor before using Caverject Dual Chamber 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 Dual Chamber will not protect you or your partner from sexually transmitted diseases like AIDS,
herpes or gonorrhoea. The injection of Caverject Dual Chamber 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 Dual Chamber:
• Antihypertensives (used for treating high blood pressure)
• Sympathomimetics (used for respiratory and heart disease)
• Vasodilative agents (drugs that widen blood vessels)
• Anticoagulants (blood-thinning agents)
• Other treatments for erectile dysfunction (e.g. sildenafil or papaverine)
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 Dual Chamber 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 Dual Chamber should not affect your ability to drive or use machines.
Important information about some of the ingredients of Caverject Dual Chamber
Caverject Dual Chamber 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’.

Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Caverject dual chamber

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/2488E

DATE OF PROOF:

27/01/14

DATE:

PROOF HISTORY:
v.1 - waymade - 27/01/14

DATE:

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
Transtec 6464/2327 2328 2329E

TVT CHECKED
UK PIL DATED NOVEMBER 2012
REPORTING OF SIDE EFFECTS

Pg 2

3. How to use Caverject Dual Chamber
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 doctor again. These instructions are
a reminder only.
How much Caverject Dual Chamber should you inject?
Different people need different amounts of Caverject Dual Chamber 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 in the clinic is 1.25-2.5 micrograms, although doses lower than 2.5 micrograms cannot be
delivered with Caverject Dual Chamber. In this case, Caverject Powder for Injection will be used. Most men find
that a dose of 5-20 micrograms works 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 40 micrograms.
If Caverject Dual Chamber 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.

Pg 3

How do you do the injection?
• Get undressed and make yourself comfortable. Take some time to relax yourself and your partner. If your
doctor has recommended you use an alcohol cleansing pad, open one now.
• Make sure that the 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.

Injection sites (shaded areas)

• Using the alcohol swab, wipe over the area and let it dry. Check or if
necessary adjust so that the right dose is in the dose window.
• 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.

How do you use Caverject Dual Chamber?
These instructions are intended as a reminder only; you should follow your doctor’s advice where it differs from
this leaflet. If you are using Caverject Dual Chamber for the first time and you have previously used Caverject
Powder for Injection, your doctor should have given you advice about using Caverject Dual Chamber.

Avoid
injecting
these
areas

Push the plunger firmly and if the solution does not come out fairly easily,
move the needle slightly and try again. Do not force the Caverject Dual
Chamber liquid from the syringe.

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.

Top side

90°C

Underside

Corpora
Cavernosa

• Pull the needle out. On the needlemark, press gently with the alcohol swab.
Massage the penis to help the alprostadil spread through it.

The Caverject Dual Chamber device

Outer
protective cap

Inner
superfine
protective cap needle

Clear plastic tip
Dose window
(glass cartridge inside)

• Do not keep any mixture in the cartridge to use for a second injection.
When you have finished with the needle, throw it away carefully as
recommended by your doctor, so no-one will see it, use it, or prick themselves on it.
How often can you use Caverject Dual Chamber?
Do not use Caverject Dual Chamber 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 Dual Chamber each time you use it.

plunger rod

Your erection after injecting Caverject Dual Chamber
It will take a little while for your erection to come on after the injection. With the right dose of Caverject Dual
Chamber, 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 immediately (see section on Take
special care with Caverject Dual Chamber).

Preparing the injection
Wash your hands. Dry them with a clean towel. If your partner wishes to be involved in preparing or giving
the injection, they should wash their hands too.

If you use too much Caverject Dual Chamber
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.

1. Remove one of the injection devices and needles from the box.
Peel the foil cover from the needle.

4. Possible side effects
Like all medicines, Caverject Dual Chamber can cause side effects, although not everybody gets them.

2. Attach the needle to the device by pushing the needle on to the tip of
the device. Turn clockwise until it is firmly in place. The injection
needle is enclosed in 2 protective caps. Pull off the outer protective cap
of the needle.

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

3. Hold the device with the needle pointing upwards. The plunger rod
should be in the extended position.

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 Dual Chamber
• 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 Dual Chamber but should occur less often with practice
• Muscle spasms

4. Turn the plunger rod clockwise until it stops. This mixes the powder and
diluent. Gently shake to make sure that the solution is evenly mixed and
the powder has dissolved.
Do not use if it remains cloudy or contains particles.

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 specially if Caverject Dual
Chamber 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).

5. Hold the device with the needle upwards. Carefully remove the inner protective
cap from the needle. Make sure that the needle is not bent. If it is, do not use
it and throw it away. Do not attempt to straighten it out.
6. To remove any large bubbles from the solution, flick the cartridge with your
finger until the bubbles disappear. Then, keeping the device upright, make
sure that the plunger rod is fully turned to the stop by screwing it to the right
(clockwise) then immediately press the plunger rod as far as it will go.
A few drops will appear at the needle point. It is normal for there to be small
bubbles at the side of the glass cartridge.
7. Turn the end of the plunger rod slowly clockwise to select your dose.
There are four dosage options. Each option is one of four quarterly parts of a
full dose delivered by the device. Your doctor will have told you what this
should be. The number appearing in the window indicates the dose of the
injection. If you make a mistake, continue to turn the plunger rod clockwise
until you reach the correct dose.
You can prepare your injection up to 24 hours before using it, providing it is
kept at room temperature.

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.
Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

Expand view ⇕

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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