Phenylephrine Hydrochloride 10 mg/ml solution for injection/infusion

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Phenylephrine hydrochloride

Fáanlegur frá:

Athlone Pharmaceuticals Limited

ATC númer:

C01CA06

INN (Alþjóðlegt nafn):

Phenylephrine hydrochloride

Lyfjaform:

Solution for injection/infusion

Lækningarsvæði:

phenylephrine

Leyfisstaða:

Marketed

Leyfisdagur:

2022-11-04

Upplýsingar fylgiseðill

CCRF21179-1-0005
PACKAGE LEAFLET: INFORMATION FOR THE USER
PHENYLEPHRINE HYDROCHLORIDE 10 MG/ML SOLUTION FOR INJECTION/INFUSION
(phenylephrine
hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Phenylephrine Hydrochloride is and what it is used for
2.
What you need to know before you are given Phenylephrine Hydrochloride
3.
How to use Phenylephrine Hydrochloride
4.
Possible side effects
5.
How to store Phenylephrine Hydrochloride
6.
Contents of the pack and other information
1.
WHAT PHENYLEPHRINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Phenylephrine Hydrochloride 10 mg/ml solution for injection/infusion
contains the active substance
phenylephrine hydrochloride, which belongs to the group of adrenergic
and dopaminergic agents. It
raises blood pressure by constricting blood vessels.
Phenylephrine Hydrochloride is used to treat low blood pressure, which
may be caused by circulatory
failure, spinal anaesthesia or certain other medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PHENYLEPHRINE
HYDROCHLORIDE
DO NOT USE PHENYLEPHRINE HYDROCHLORIDE:
•
if you are allergic to phenylephrine hydrochloride or any of the other
ingredients of this
medicine (listed in section 6)
•
if you have severe high blood pressure
•
if you have an overactive thyroid
•
if you are taking monoamine oxidase inhibitors (MAOIs) used to treat
depression or have
taken them in the last 14 days
•
if you have poor blood circulation (peripheral vascular disease)
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before being given
Phenylephrine Hydrochloride:
•
if you have any heart disease
•
if you suffer from heart rhy

Vara einkenni

Health Products Regulatory Authority
24 November 2023
CRN00D893
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phenylephrine Hydrochloride 10 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution for injection contains 10 mg phenylephrine
hydrochloride equivalent to 8.2 mg phenylephrine.
Each 1 ml ampoule contains 10 mg phenylephrine hydrochloride
equivalent to 8.2 mg phenylephrine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless, sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of hypotensive states during spinal anaesthesia or
drug-induced hypotension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Each 1 ml ampoule contains 10 mg phenylephrine hydrochloride
equivalent to 8.2 mg phenylephrine. Dosing of this medicinal
product is given in units of phenylephrine hydrochloride rather than
in units of phenylephrine which differs from other similar
authorised products. Recommended intravenous dosing regimens also vary
between formulations. Please take special note of
the presentation and concentration of the product and adjust your
administration practices accordingly.
_Adults _
_Subcutaneous and intramuscular injection_
Phenylephrine injection may be administered subcutaneously or
intramuscularly in a dosage of 2 to 5 mg with further doses of
1 to 10 mg if necessary according to response.
_Intravenous bolus injection:_
Phenylephrine hydrochloride injection may be administered in a dose of
100 to 500 micrograms by slow intravenous injection
as a 0.1% w/v solution, repeated as necessary after at least 15
minutes. See instructions on dilution in section 6.6.
_Continuous infusion:_
10 mg in 500 ml of glucose 5% w/v injection or sodium chloride 0.9%
w/v injection may be infused intravenously, initially at a
rate of up to 180 micrograms per minute, reduced according to response
to 30-60 micrograms per minute. See instructions