Phenylephrine 50 micrograms/ml, solution for injection in pre-filled syringe

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Phenylephrine hydrochloride

Tillgänglig från:

Laboratoire AGUETTANT

ATC-kod:

C01CA; C01CA06

INN (International namn):

Phenylephrine hydrochloride

Dos:

50 microgram(s)/millilitre

Läkemedelsform:

Solution for injection in pre-filled syringe

Administreringssätt:

Intravenous bolus injection or intravenous infusion.

Enheter i paketet:

box of 1 and 10 syringes

Receptbelagda typ:

Product subject to prescription which may not be renewed (A)

Tillverkad av:

Laboratoire AGUETTANT

Terapeutisk grupp:

Adrenergic and dopaminergic agent

Terapiområde:

Adrenergic and dopaminergic agents; phenylephrine

Terapeutiska indikationer:

Treatment of hypotension during spinal, epidural or general anesthesia

Bemyndigande status:

Marketed

Tillstånd datum:

2015-11-27

Bipacksedel

PACKAGE LEALET: INFORMATION FOR THE PATIENT
PHENYLEPHRINE 50 MICROGRAMS/ML,
SOLUTION FOR INJECTION IN PRE-ILLED SYRINGE
(Referred to as “Phenylephrine Injection” in this lealet)
Phenylephrine
READ ALL OF THIS LEALET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
- Keep this lealet. 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
lealet. See section 4.
WHAT IS IN THIS LEALET
1. What Phenylephrine Injection is and what it is used for
2. What you need to know before you are given Phenylephrine Injection
3. How Phenylephrine Injection is given
4. Possible side effects
5. How to store Phenylephrine Injection
6. Contents of the pack and other information
1. WHAT PHENYLEPHRINE INJECTION IS AND WHAT IT IS USED FOR
This medicine belongs to a group of adrenergic and dopaminergic
agents.
It is used to treat low blood pressure during anaesthesia.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PHENYLEPHRINE INJECTION
YOU WILL NOT RECEIVE PHENYLEPHRINE INJECTION:
- if you are allergic to phenylephrine hydrochloride or any of the
other ingredients of this medicine (listed in section 6);
- if you suffer from severe high blood pressure, or peripheral
vascular disease (poor blood circulation);
- if you are taking a Monoamine Oxydase inhibitor (MAO) (or within 2
weeks of their withdrawal), that is used to treat depression (such as
iproniazide, nialamide);
- if you suffer from severe overactive thyroid gland
(hyperthyroidism).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you are given
Phenylephrine Injection:
- if you are elderly;
- if you are diabetic;
- if you suffer from arterial hypertension;
- if you have an overactive thyroid gland (uncontrolled
hyperthyroidism);
- if you have blood vessel disease, such as arteriosclerosis
(hardening and thickening of the walls

Produktens egenskaper

Health Products Regulatory Authority
14 September 2020
CRN009J3S
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phenylephrine 50 micrograms/ml, solution for injection in pre-filled
syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection contains phenylephrine hydrochloride
equivalent to 50 micrograms (0.05 mg) phenylephrine.
Each 10 ml pre-filled syringe contains phenylephrine hydrochloride
equivalent to 500 micrograms (0.5 mg) phenylephrine.
Excipients with known effect:
This medicinal product contains sodium.
Each ml of solution for injection contains 3.72 mg equivalent to 0.162
mmol of sodium.
Each 10 ml pre-filled syringe contains 37.2 mg equivalent to 1.62 mmol
of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe. (Injection)
Clear colourless solution.
pH: 4.7 – 5.3
Osmolality: 270-300 mOsm/Kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of hypotension during spinal, epidural or general
anaesthesia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Normal dose is 50 to 100 micrograms, which can be repeated until the
desired effect is obtained. One bolus dose should not
exceed 100 micrograms.
_ _
_Renal impairment_
Lower doses of phenylephrine may be needed in patients with impaired
renal function.
_Hepatic Impairment_
Higher doses of phenylephrine may be needed in patients with cirrhosis
of the liver.
_Elderly:_
Treatment of the elderly should be carried out with care.
_Paediatric population_
The safety and efficacy of phenylephrine in children have not been
established. No data are available.
Method of administration:
Intravenous bolus injection.
Phenylephrine, 50 micrograms/ml, solution for injection should only be
administered by healthcare professionals with
appropriate training and relevant experience.
The pre-filled syringe is not suitable for use in a syringe driver.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
14 September 20