Country: Շվեդիա
language: շվեդերեն
source: Läkemedelsverket (Medical Products Agency)
fenylefrinhydroklorid
Laboratoire Aguettant
C01CA06
phenylephrine
50 mikrogram/ml
Injektionsvätska, lösning i förfylld spruta
fenylefrinhydroklorid 60,9 mikrog Aktiv substans
Receptbelagt
Förpacknings: Förfylld spruta, 1 x 10 ml; Förfylld spruta, 10 x 10 ml
Godkänd
2015-10-29
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 read_full_document
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 read_full_document