PHENYLALPHA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50MCGML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Phenylephrine Hydrochloride 60.9mcg/ml eqv to Phenylephrine

Available from:

AGUETTANT ASIA PACIFIC PTE. LTD.

ATC code:

C01CA06

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Phenylephrine Hydrochloride 60.9mcg/ml eqv to Phenylephrine 50.0mcg/ml

Administration route:

INTRAVENOUS, INTRAVENOUS BOLUS

Prescription type:

Prescription Only

Manufactured by:

Laboratoire Aguettant

Authorization status:

ACTIVE

Authorization date:

2019-04-15

Summary of Product characteristics

PACKAGE LEAFLET: INFORMATION FOR THE USER
50 MICROGRAMS/ML, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
106374
1. NAME OF THE MEDICINAL PRODUCT
50 micrograms/ml, solution for injection in pre-
filled syringe
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
Phenylephrine
........................................................50.00
micrograms
In the form of phenylephrine hydrochloride ..........60.90 micrograms
For 1 ml
One 10-ml pre-filled syringe contains 500 micrograms of
phenylephrine (in the form of phenylephrine hydrochloride).
Excipients with known effect: sodium.
One ml of solution for injection contains 3.72 mg of sodium,
equivalent to 0.162 mmol.
One 10 ml pre-filled syringe contains 37.2 mg of sodium, equivalent
to 1.62 mmol.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
Clear colourless solution.
pH: 4.7 - 5.3
Osmolality: 270-300 mOsm/Kg
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of hypotension during general anaesthesia and
locoregional anaesthesia, whether spinal or epidural, and whether for
surgical or obstetric procedures.
Preventive treatment of hypotension during spinal anaesthesia for
surgical or obstetric procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Intravenous bolus injection:_
Normal dose is 50 to 100 micrograms, which can be repeated until
the desired effect is attained. The doses may be increased in the
case of severe hypotension, but must not exceed a bolus of 100
micrograms.
_Continuous infusion:_
Initial dose is 25 to 50 micrograms/min. Doses can be increased
up to 100 micrograms/min or reduced in order to maintain systolic
blood pressure close to its reference value.
Doses between 25 and 100 micrograms/min have been considered
effective in maintaining maternal blood pressure.
_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.