HYDRALAZINE LINK hydralazine hydrochloride 20 mg/1 mL solution for injection vial

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

hydralazine hydrochloride, Quantity: 20 mg

Предлага се от:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

INN (Международно Name):

Hydralazine hydrochloride

Лекарствена форма:

Injection, solution

Композиция:

Excipient Ingredients: hydrochloric acid; water for injections; sodium hydroxide; propylene glycol

Начин на приложение:

Intravenous

Броя в опаковка:

10 vials

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

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

Каталог на резюме:

Visual Identification: Sterile, clear, colourless to pale yellow coloured solution, practically free from visible particles.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Статус Оторизация:

Licence status A

Дата Оторизация:

2017-09-22

Листовка

HYDRALAZINE LINK
®
_hydralazine hydrochloride _
___________________________________________________________________________
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS CMI
This CMI answers some common
questions about Hydralazine Link
.
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 you having
Hydralazine Link against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS INFORMATION.
You may need to read it again.
WHAT HYDRALAZINE LINK
IS USED FOR
Hydralazine Link is an injection
that is used when your blood
pressure is very high and needs
to be brought down quickly.
Hydralazine Link is used to
reduce very high blood pressure
especially during late pregnancy.
Hydralazine Link 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.
Hydralazine Link is only available
with a doctor's prescription. It is
not addictive.
BEFORE YOU ARE GIVEN
HYDRALAZINE LINK
_WHEN YOU MUST NOT HAVE _
_IT _
YOU MUST NOT HAVE HYDRALAZINE
LINK IF YOU HAVE EVER HAD AN
ALLERGIC REACTION TO:
•
hydralazine, the active
ingredient in Hydralazine
Link.
•
dihydralazine
•
any of the ingredients listed
at the end of this CMI
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 HYDRALAZINE
LINK IF YOU HAVE ANY OF THESE
MEDICAL CONDITIONS:
•
Systemic lupus
erythematosus (SLE) or a
related d

Данни за продукта

_Page 1 of 10_
AUSTRALIAN PRODUCT INFORMATION- HYDRALAZINE LINK
®
(HYDRALAZINE HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Hydralazine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydralazine LINK is a 20mg/mL sterile solution for injection, supplied
in vials of 1mL containing
20mg hydralazine hydrochloride
For the full list of excipients, see
SECTION
6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Solution for injection. Hydralazine LINK is a sterile, clear,
colourless to pale yellow coloured solution,
practically free from visible particles.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Hypertensive crises, especially during late pregnancy (pre-eclampsia
and eclampsia).
4.2
DOSE
AND
METHOD
OF
ADMINSTRATION
Injection treatment with Hydralazine LINK should always be carried out
cautiously 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.
Hydralazine LINK may also be given by continuous intravenous infusion,
beginning with a flow rate of
200 to 300 micrograms/min. Maintenance flow rates must be determined
individually and are usually
within the range of 50 to 150 micrograms/min. Continuous infusion of
Hydralazine LINK exceeding 24
hours is not recommended.
INSTRUCTIONS FOR USE:
For the preparation of infusion solutions, the 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. I