Caverject 5microgram powder and solvent for solution for injection vials

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Alprostadil

Mevcut itibaren:

Pfizer Ltd

ATC kodu:

G04BE01

INN (International Adı):

Alprostadil

Doz:

5microgram

Farmasötik formu:

Powder and solvent for solution for injection

Uygulama yolu:

Intracavernous

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 07040500; GTIN: 5012882010140

Bilgilendirme broşürü

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CAVERJECT
® 5 MICROGRAMS POWDER 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, PHARMACIST OR
NURSE.

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, PHARMACIST OR NURSE.
THIS INCLUDES ANY
POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4.
WHAT IS IN THIS LEAFLET
1. What Caverject is and what it is used for
2. What you need to know before you use Caverject
3. How to use Caverject
4. Possible side effects
5. How to store Caverject
6. Contents of the pack and other 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.
Caverject is not licenced for use in children and MUST NOT BE GIVEN TO
CHILDREN.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CAVERJECT
DO NOT USE CAVERJECT:

If you are allergic to alprostadil or any of the other ingredients of
this medicine (listed in
section 6).

If you 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.

If you have an implant in your penis.

If you have a condition (such as severe heart disease) in which

Ürün özellikleri

CAVERJECT POWDER FOR INJECTION 5 MICROGRAMS
Summary of Product Characteristics Updated 25-May-2017 | Pfizer
Limited
1. Name of the medicinal product
Caverject 5 micrograms powder for solution for injection
2. Qualitative and quantitative composition
Alprostadil 5 micrograms.
When reconstituted, each 1ml delivers a dose of 5 micrograms of
alprostadil.
Excipients with known effect:
Each 1ml of reconstituted solution contains 7.96 mg of benzyl alcohol.
Sodium
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection
A white to off-white powder.
4. Clinical particulars
4.1 Therapeutic indications
Caverject is indicated for the treatment of erectile dysfunction in
adult males due to neurogenic,
vasculogenic, psychogenic or mixed aetiology.
Caverject may be a useful adjunct to other diagnostic tests in the
diagnosis of erectile dysfunction.
Caverject is not indicated for paediatric use (see section 4.4).
4.2 Posology and method of administration
Caverject is administered by direct intracavernous injection. A half
inch, 27 to 30 gauge needle is
generally recommended. The dose of Caverject should be individualised
for each patient by careful
titration under supervision by a physician.
The intracavernosal injection must be done under sterile conditions.
The site of injection is usually along
the dorsolateral aspect of the proximal third of the penis. Visible
veins should be avoided. Both the side
of the penis that is injected and the site of injection must be
alternated; prior to the injection, the injection
site must be cleansed with an alcohol swab.
To reconstitute Caverject using the prefilled diluent syringe: flip
off the plastic cap from the vial, and use
one of the swabs to wipe the rubber cap. Fit the 22 gauge needle to
the syringe.
Inject the 1 ml of diluent into the vial, and shake to dissolve the
powder entirely. Withdraw slightly more
than the required dose of Caverject solution, remove the 22 gauge
needle, and fit the 30 gauge needle.
Adjust volume to the requir