PHENYLEPHRINE AGUETTANT 50 MCGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PHENYLEPHRINE AS HYDROCHLORIDE

Available from:

MBI PHARMA LTD., ISRAEL

ATC code:

C01CA06

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

PHENYLEPHRINE AS HYDROCHLORIDE 50 MCG / 1 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

LABORATOIRE AGUETTANT, FRANCE

Therapeutic area:

PHENYLEPHRINE

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.

Authorization date:

2023-07-04

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Phenylephrine Aguettant 50 mcg/ml
Solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenylephrine…………………………………………………………………………50.00
micrograms
In the form of phenylephrine
hydrochloride…………………………………………..60.90
micrograms
For 1 ml
One 10-ml ampoule 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 ampoule 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
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.
_Older people: _
Treatment of the elderly should be carried out with care.
_Paed