Prostin VR 500 microgram/1mL injection ampoule

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

alprostadil, Quantity: 500 microgram/mL

Доступна с:

Pfizer Australia Pty Ltd

Фармацевтическая форма:

Injection, solution

состав:

Excipient Ingredients: ethanol

Администрация маршрут:

Intravenous, Intraarterial

Штук в упаковке:

5 x 1mL

класс:

Medicine Registered

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

INDICATIONS AS AT 14 JANUARY 1994: PROSTIN VR Sterile Solution (alprostadil) is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon a patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, mitral atresia, or transposition of the great vessels with or without other defects. PROSTIN VR should be administered only by medically trained personnel in facilities in which paediatric patients can receive or have access to paediatric intensive care.

Обзор продуктов:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Статус Авторизация:

Registered

Дата Авторизация:

1994-04-11

тонкая брошюра

PROSTIN
® VR
_Alprostadil_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Prostin VR.
It does not contain all the available
information and it does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of your child being given
Prostin VR against the benefits they
expect it to provide your child.
If you have any concerns about your
child being given this medicine, ask
your doctor or pharmacist.
Keep this leaflet with you.
You may need to read it again.
WHAT PROSTIN VR IS
USED FOR
Prostin VR is used to keep a blood
vessel called the ductus arteriosis
open temporarily after your child is
born. Normally this blood vessel
closes soon after birth. In some
children who are born with heart
defects, this blood vessel needs to be
kept open for a longer time so that
enough blood can reach the rest of
the body.
Once the child's heart defect has been
fixed or treated, s/he will not usually
need to be given Prostin VR any
more, and the blood vessel should
close.
Your doctor may prescribe Prostin
VR for other reasons. Ask your
doctor if you have any questions
about why Prostin VR has been
prescribed for your child.
BEFORE YOUR CHILD IS
GIVEN PROSTIN VR
Some information is given below.
However, always talk to your doctor
if you have any concerns or questions
about your child's treatment.
_WHEN YOUR CHILD MUST NOT BE_
_GIVEN PROSTIN VR_
Children with the following medical
conditions must not be given Prostin
VR:
•
a blue appearance of the skin, lips
and nails due to poor blood flow
through the lungs
•
abnormal or unusual blood flow
between the lungs and the heart
_BEFORE YOUR CHILD IS GIVEN_
_PROSTIN VR_
Your child should only be given
Prostin VR by qualified medical
staff. Treatment will normally take
place in a hospital because of the
need for hospital facilities and skilled
personnel.
TELL YOUR DOCTOR IF YOUR CHILD IS
BEING GIVEN ANY OTHER MEDICINE,
INCLUDING MEDICINES YOU BUY
WITHOUT A P

Характеристики продукта

Version: pfpprosi11019
Supersedes: pfpprosi11106
Page 1 of 9
AUSTRALIAN
PRODUCT
INFORMATION
–
PROSTIN VR (ALPROSTADIL)
1.
NAME OF THE MEDICINE
Alprostadil (also known as prostaglandin E
1
).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL ampoule contains 500 micrograms alprostadil.
EXCIPIENT(S) WITH KNOWN EFFECT
Ethanol.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
PROSTIN VR is a clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PROSTIN VR is indicated for palliative, not definitive, therapy to
temporarily maintain the
patency of the ductus arteriosus until corrective or palliative
surgery can be performed in
neonates who have congenital heart defects and who depend upon a
patent ductus for survival.
Such congenital heart defects include pulmonary atresia, pulmonary
stenosis, tricuspid atresia,
tetralogy of Fallot, interruption of the aortic arch, coarctation of
the aorta, mitral atresia, or
transposition of the great vessels with or without other defects.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
PROSTIN VR should be administered only by medically trained personnel
in facilities in
which paediatric patients can receive or have access to paediatric
intensive care.
Infusion should begin with 0.1 micrograms alprostadil per kilogram of
body weight per minute.
Doses above 0.1 micrograms per kilogram per minute, do not appear to
offer additional
benefits. When an effect is achieved, decrease the infusion to the
lowest possible dose while
maintaining the desired effects.
Version: pfpprosi11019
Supersedes: pfpprosi11106
Page 2 of 9
METHOD OF ADMINISTRATION
The preferred route of administration for PROSTIN VR is by continuous
intravenous infusion
into a large vein. Alternatively, PROSTIN VR may be administered
through an umbilical
artery catheter placed at the ductal opening. Adverse effects have
occurred with both routes of
administration although the types of reactions are different. The
incidences of flush