Caverject Dual Chamber 20microgram powder and solvent for solution for injection

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Alprostadil

可用日期:

Pfizer Ltd

ATC代码:

G04BE01

INN（国际名称）:

Alprostadil

剂量:

20microgram

药物剂型:

Powder and solvent for solution for injection

给药途径:

Intracavernous

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 07040500; GTIN: 5013457025248

资料单张

Page 1 of 9
PATIENT INFORMATION LEAFLET
Caverject® Dual Chamber 10 and 20 micrograms
Powder and solvent for solution for injection
Alprostadil
Pfizer logo
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.
Page 2 of 9

have a penis which

产品特点

OBJECT 1
CAVERJECT DUAL CHAMBER 20 MICROGRAMS
Summary of Product Characteristics Updated 29-Mar-2017 | Pfizer
Limited
1. Name of the medicinal product
Caverject
®
Dual Chamber 20 micrograms, Powder and solvent for solution for
injection
2. Qualitative and quantitative composition
Each 0.5 ml cartridge delivers a maximum dose of 20 micrograms of
alprostadil.
For the full list of excipients see section 6.1
3. Pharmaceutical form
Powder and solvent for solution for injection
Dual chamber glass cartridge containing a white lyophilised powder and
diluent for reconstitution.
4. Clinical particulars
4.1 Therapeutic indications
Caverject Dual Chamber is indicated for the symptomatic treatment of
erectile dysfunction in adult males
due to neurogenic, vasculogenic, psychogenic, or mixed aetiology.
Caverject Dual Chamber may be a useful adjunct to other diagnostic
tests in the diagnosis of erectile
dysfunction.
4.2 Posology and method of administration
No formal studies with Caverject have been performed in patients
younger than 18 years and older than
75 years.
General Information
Caverject Dual Chamber should be administered by direct
intracavernosal injection using the 1/2-inch 29
gauge needle provided. The usual site of injection is along the
dorsolateral aspect of the proximal third of
the penis. Visible veins should be avoided. Both the side of the penis
and the site of injection must be
altered between injections.
The initial injections of Caverject Dual Chamber must be administered
by medically trained personnel
and after proper training, alprostadil may be injected at home. It is
recommended that patients are
regularly monitored (e.g. every 3 months) particularly in the initial
stages of self injection therapy when
dose adjustments may be needed.
The dose of Caverject Dual Chamber should be individualized for each
patient by careful titration under a
physician's supervision. The lowest, effective dose should be used
that provides the patient with an
erection that is satisfactory for sexual intercourse. It is
recom