DBL DIAZOXIDE 300mg/20mL Injection BP

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

diazoxide, Quantity: 15 mg/mL

Dostupné z:

Pfizer Australia Pty Ltd

Forma lieku:

Injection, solution

Zloženie:

Excipient Ingredients: sodium hydroxide; water for injections

Spôsob podávania:

Intravenous

Počet v balení:

1x300mg/20mL

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Diazoxide is a non-diuretic antihypertensive agent. It is administered by rapid IV injection for emergency reduction of blood pressure in patients with malignant hypertension when prompt and urgent decrease in diastolic pressure is required. Diazoxide Injection BP is recommended in the treatment of hypertensive crises associated with acute glomerular nephritis, acute hypertensive encephalopathy, cerebral haemorrhage or congestive heart failure. Diazoxide is usually effective in patients with refractory hypertension not responsive to other agents. It has also been used in the treatment of chronic hypertension to control elevated blood pressure before commencement of therapy with oral antihypertensive agents. In order to reduce the danger of haemorrhage due to elevated blood pressure, Diazoxide Injection BP may be used in hypertensive patients undergoing diagnostic procedures such as renal biopsy or arteriography

Prehľad produktov:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Stav Autorizácia:

Registered

Dátum Autorizácia:

1991-10-08

Príbalový leták

DBL™
Diazoxide Injection CMI
Page 1
DBL™
DIAZOXIDE INJECTION BP
Diazoxide (_dye-a-ZOX-ide)_
_ _
CONSUMER MEDICINE INFORMATION
_Date of Dispensing_
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about DBL™
Diazoxide Injection.
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 being given
diazoxide 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 LEAFLET.
You may need to read it again.
WHAT DBL™
DIAZOXIDE
INJECTION IS USED FOR
This medicines is used to :
•
quickly lower very high blood
pressure in emergency
situations
•
prevent bleeding during
diagnostic procedures if you
have high blood pressure.
This medicine belongs to a group
of medicines called vasodilators.
It works by widening blood
vessels, which causes a decrease
in blood pressure.
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 reason.
This medicine is not addictive.
It is only available with a doctor’s
prescription.
BEFORE YOU ARE GIVEN
DBL™
DIAZOXIDE
INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN DBL™
DIAZOXIDE INJECTION IF YOU HAVE
AN ALLERGY TO:
•
diazoxide
•
any of the ingredients listed at
the end of this leaflet
•
other thiazides, such as
hydrochlorthiazide.
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 BE GIVEN THIS
MEDICINE IF YOU HAVE ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
hypertension due to
mechanical abnormalities of
the heart (such as an AV
shunt).
IF YOU ARE NOT SU

Súhrn charakteristických

Version: pfpdiazi10720
Supersedes: pfpdiazi10619
Page 1 of 7
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™ DIAZOXIDE INJECTION BP (DIAZOXIDE)
1.
NAME OF THE MEDICINE
Diazoxide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Diazoxide Injection BP is a sterile solution of Diazoxide BP in
Water for Injections BP.
Each 20 mL ampoule contains 300 mg of diazoxide.
For the full list of excipients, see Section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
DBL™ Diazoxide Injection BP is a clear colourless solution for
intravenous injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Diazoxide is a non-diuretic antihypertensive agent. It is administered
by rapid IV injection for
emergency reduction of blood pressure in patients with malignant
hypertension when prompt
and urgent decrease in diastolic pressure is required. DBL Diazoxide
Injection BP is
recommended in the treatment of hypertensive crises associated with
acute glomerular
nephritis, acute hypertensive encephalopathy, cerebral haemorrhage or
congestive heart failure.
Diazoxide is usually effective in patients with refractory
hypertension not responsive to other
agents. It has also been used in the treatment of chronic hypertension
to control elevated blood
pressure before commencement of therapy with oral antihypertensive
agents.
In order to reduce the danger of haemorrhage due to elevated blood
pressure, DBLDiazoxide
Injection BP may be used in hypertensive patients undergoing
diagnostic procedures such as
renal biopsy or arteriography.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The usual adult dose of diazoxide for the treatment of hypertension is
300 mg administered
undiluted by rapid intravenous (IV) injection over a period of 30
seconds or less. Children and
unusually large or small adults may be given 5 mg/kg bodyweight.
Recent studies have shown
that minibolus IV administration of diazoxide in doses of
1 TO 3MG/KG
every 5 to 15 minutes
may be as effective as the administration of a single 300 mg
intravenous dose and may be
associated with fewer