APRESOLINE 20mg powder for injection ampoule

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

hydralazine hydrochloride, Quantity: 20 mg

Beszerezhető a:

Amdipharm Mercury Australia Pty Ltd

Gyógyszerészeti forma:

Injection, powder for

Összetétel:

Excipient Ingredients:

Az alkalmazás módja:

Intravenous

db csomag:

5 X 20mg ampoules

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

Hypertensive crises, especially during late pregnancy (pre-eclampsia and eclampsia).

Termék összefoglaló:

Visual Identification: White to yellowish lyophilisation residue (cake).; Container Type: Ampoule; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Engedélyezési státusz:

Registered

Engedély dátuma:

1993-02-15

Betegtájékoztató

APRESOLINE
®
_hydralazine hydrochloride_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS CMI
This CMI answers some common
questions about Apresoline. It does
not contain all the available
information.
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 giving you Apresoline
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS INFORMATION.
You may need to read it again.
WHAT APRESOLINE IS
USED FOR
Apresoline is an injection that is used
when your blood pressure is very
high and needs to be brought down
quickly. Apresoline is used to reduce
very high blood pressure especially
during late pregnancy.
Apresoline belongs to a group of
medicines called vasodilators. It acts
by relaxing and widening (dilating)
the walls of blood vessels. This
action helps to reduce blood pressure
and increase blood and oxygen
supply to the heart, brain, spleen and
kidneys.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
Apresoline is only available with a
doctor's prescription. It is not
addictive.
BEFORE YOU ARE GIVEN
APRESOLINE
_WHEN YOU MUST NOT HAVE IT_
YOU MUST NOT BE GIVEN APRESOLINE
IF YOU HAVE EVER HAD AN ALLERGIC
REACTION TO:
•
hydralazine, the active ingredient
in Apresoline
•
dihydralazine
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
YOU MUST NOT HAVE APRESOLINE IF
YOU HAVE ANY OF THESE MEDICAL
CONDITIONS:
•
Systemic lupus erythematosus
(SLE) or a related disease
•
recent heart attack or other severe
heart problems, e.g. due to
inflammation around the heart,
narrowing of blood vessels o

Termékjellemzők

APRESOLINE
®
1
AUSTRALIAN PRODUCT INFORMATION
APRESOLINE
®
HYDRALAZINE HYDROCHLORIDE
POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Hydralazine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 20 mg hydralazine hydrochloride.
3
PHARMACEUTICAL FORM
Hydralazine hydrochloride is a white to yellowish odourless
crystalline powder.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertensive crises, especially during late pregnancy (pre-eclampsia
and eclampsia).
4.2 DOSE AND METHOD OF ADMINISTRATION
Treatment with Apresoline for injection should always be carried out
with caution and under
strict medical surveillance (if possible in hospital).
ADULT DOSAGE
The initial dose is 5 to 10 mg, administered by slow intravenous
injection in order to avoid
precipitous decreases in mean arterial pressure with a critical
reduction in cerebral or utero-
placental perfusion. If it is necessary to repeat the injection, this
should be done after an
interval of 20 to 30 minutes, throughout which the blood pressure and
heart rate should be
monitored. A satisfactory response can be defined as a decrease in
diastolic blood pressure
to 90 to 100 mm Hg.
Apresoline may also be given by continuous intravenous infusion,
beginning with a flow
rate of 200 to 300 micograms/min. Maintenance flow rates must be
determined individually
and are usually within the range of 50 to 150 micrograms/min.
APRESOLINE
®
2
INSTRUCTIONS FOR USE
Prior to each injection, the contents of the ampoule should be
completely dissolved in 1 mL
water for injections. The freshly prepared solution should be used
immediately. For the
preparation of infusion solutions, this fresh solution should be
diluted with sodium chloride
intravenous infusion 9 mg/mL. Glucose infusion solutions are not
compatible because
contact between hydralazine and glucose causes the active substance to
be rapidly broken
down.
The product contains no antimicrobial preservative. Infusion of the
reconstituted injection
and of admixtures of the injection should be commen