PHENYLEPHRINE BNM phenylephrine hydrochloride 0.5 mg/5 mL (0.01%) solution for injection, ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

phenylephrine hydrochloride, Quantity: 0.1 mg/mL

Available from:

Boucher & Muir Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; hydrochloric acid; water for injections

Administration route:

Intravenous

Units in package:

Pack of 10 Ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Phenylephrine hydrochloride is intended for the maintenance of an adequate level of blood pressure during spinal and inhalation anaesthesia. It is also employed to overcome paroxysmal supraventricular tachycardia.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-10-04

Patient Information leaflet

PHENYLEPHRINE BNM
_SOLUTION FOR INJECTION 0.1 MG/ML (0.01 %)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you are given Phenylephrine
BNM.
This leaflet answers some common
questions about Phenylephrine BNM.
It does not contain all the available
information. The most up-to-date
Consumer Medicine Information can
be downloaded from
www.ebs.tga.gov.au.
Reading this leaflet does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks associated with giving you
Phenylephrine BNM against the
benefits this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR, PHARMACIST OR NURSE.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT PHENYLEPHRINE
BNM IS USED FOR
Phenylephrine BNM contains
phenylephrine hydrochloride. It
works by causing constriction
(narrowing) of your blood vessels.
It belongs to a group of medicines
called vasoconstrictors.
Phenylephrine BNM is used to help
increase your blood pressure and
slow down your heart, for example,
during surgery.
Your doctor may have prescribed this
medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Phenylephrine BNM is only available
with a doctor's prescription.
Phenylephrine BNM is not addictive.
BEFORE YOU ARE GIVEN
PHENYLEPHRINE BNM
Phenylephrine BNM is not suitable
for everyone.
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN
PHENYLEPHRINE BNM IF YOU ARE
ALLERGIC TO:
•
Phenylephrine
•
any of the ingredients listed at the
end of this leaflet.
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
Phenylephrine BNM if you have:
•
very high blood pressure
•
a very fast heart beat
(palpitations).
DO NOT USE IT AFTER THE

Summary of Product characteristics

Phenylephrine BNM
1
AUSTRALIAN PRODUCT INFORMATION
PHENYLEPHRINE BNM
PHENYLEPHRINE HYDROCHLORIDE 0.1 MG/ML (0.01 %)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
phenylephrine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL solution of phenylephrine hydrochloride injection 0.1 mg/mL
(0.01 %) contains
0.1 mg phenylephrine hydrochloride.
Each 5 mL ampoule contains 0.5 mg phenylephrine hydrochloride as well
as 45 mg sodium
chloride (equivalent to 17.7 mg sodium).
For the full list of excipients, see Section 6.1 List of excipients.
The solution is preservative free and sulfite free.
3
PHARMACEUTICAL FORM
Phenylephrine BNM is a clear, colourless, aqueous solution, free from
visible particulates,
in sterile form for parenteral injection. pH 3.0 - 5.0; Osmolarity:
270 to 300 mOsm/L.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Phenylephrine hydrochloride is intended for the maintenance of an
adequate level of blood
pressure
during
spinal
and
inhalation
anaesthesia.
It
is
also
employed
to
overcome
paroxysmal supraventricular tachycardia.
4.2 DOSE AND METHOD OF ADMINISTRATION
Phenylephrine BNM solution for injection 0.1 mg/mL (0.01 %) is for
slow intravenous
injection. Phenylephrine BNM is
NOT
for subcutaneous or intramuscular administration.
Phenylephrine BNM contains no antimicrobial preservative. It is for
use in one patient on
one occasion only. Discard any residue.
Phenylephrine BNM
2
It should only be administered by healthcare professionals with
appropriate training and
relevant experience.
The dose should be adjusted according to the pressor response.
_ _
_MILD OR MODERATE HYPOTENSION: _
_Intravenously: _
Usual dose, 0.2 mg. Range, from 0.1 mg to 0.5 mg. Initial dose should
not exceed 0.5 mg.
Injections should not be repeated more often than every 10 to 15
minutes. A 0.5 mg
intravenous dose should elevate blood pressure for about 15 minutes.
_SPINAL ANAESTHESIA - HYPOTENSION: _
Phenylephrine BNM solution for injection 0.1 mg/mL (0.01 %) is
NOT
for subcutaneous or
intramuscular administrati