Fenylefrin Aguettant 50 mikrogram/ml Injektionsvätska, lösning i förfylld spruta

Pays: Suède

Langue: suédois

Source: Läkemedelsverket (Medical Products Agency)

Ingrédients actifs:

fenylefrinhydroklorid

Disponible depuis:

Laboratoire Aguettant

Code ATC:

C01CA06

DCI (Dénomination commune internationale):

phenylephrine

Dosage:

50 mikrogram/ml

forme pharmaceutique:

Injektionsvätska, lösning i förfylld spruta

Composition:

fenylefrinhydroklorid 60,9 mikrog Aktiv substans

Type d'ordonnance:

Receptbelagt

Descriptif du produit:

Förpacknings: Förfylld spruta, 1 x 10 ml; Förfylld spruta, 10 x 10 ml

Statut de autorisation:

Godkänd

Date de l'autorisation:

2015-10-29

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FENYLEFRIN AGUETTANT 50 MICROGRAMS/ML, SOLUTION FOR INJECTION IN
PRE-FILLED SYRINGE
(REFERRED TO AS “PHENYLEPHRINE INJECTION” IN THIS LEAFLET)
PHENYLEPHRINE
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 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 thickeni

Résumé des caractéristiques du produit

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fenylefrin Aguettant 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_
2
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
Phenylephrine should not be used:
-
In case of hypersensitivity to the active substance or to any of the
excipients li