LABELATOL Solution for injection (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Labetalol Synchrony 5mg/ml solution for injection.
Qualitative and quantitative composition
Labetalol hydrochloride 5mg/ml. Each 10ml ampoule contains 50mg Labetalol Hydrochloride. For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for Injection. The Solution for injection is a clear, colourless liquid, pH 4 (3.5-4.5). Osmolarity 0.03 (0.024-0.036) Osmol/kg.
Therapeutic indications
Severe hypertension, including severe hypertension of pregnancy, when rapid control of blood pressure is essential. Anaesthesia when a hypotensive technique is indicated.
Posology and method of administration
Dosage Labetalol injection is intended for intravenous use in hospitalized patients. Populations Adults Severe hypertension: Bolus injection: If it is essential to reduce blood pressure quickly, a dose ...
Contraindications
Non-selective beta blockers must not be used on patients with a history of asthma or a history of obstructive pulmonary disease. Labetalol injections are contraindicated for second or third degree heart ...
Special warnings and precautions for use
Liver Disease There have been rare reports of severe hepatocellular injury with labetalol therapy. The hepatic injury is usually reversible and has occurred after both short and long term treatment. There ...
Interaction with other medicinal products and other forms of interaction
The hypotensive effect of Labetalol may be reduced when used in combination with prostaglandin synthetase inhibiting drugs (NSAIDs, nonsteroidal anti-inflammatory drugs). Dose adjustments may be necessary. ...
Fertility, pregnancy and lactation
Fertility There is no information available on the effect labetalol has on the fertility. Pregnancy On the basis of experience during human pregnancy, it is unexpected that labetalol increases the risk ...
Effects on ability to drive and use machines
No general information.
Undesirable effects
Summary of safety profile The most frequently reported undesirable effects during the use of labetalol injection and those reported in post-marketing studies include: congestive heart failure, postural ...
Overdose
Symptoms of overdosage Acute cardiac insufficiency is to be expected, e.g. excessive hypotension and sometimes bradycardia. Oliguric renal failure has been reported after massive overdosage on labetalol ...
Pharmacodynamic properties
Pharmacotherapeutic group: Alpha and beta blocking agents ATC code: C07AG01 Mechanism of action Labetalol lowers the blood pressure primarily by blocking peripheral arteriolar alpha-adrenoceptors thus ...
Pharmacokinetic properties
Pharmacokinetic Chemically, labetalol consists of 4 stereo-isomers with different pharmacodynamic effects. Distribution About 50% of labetalol in the blood is protein bound. Only negligible amounts of ...
Preclinical safety data
Carcinogenesis, mutagenesis, teratogenesis No evidence of mutagenic potential was shown in in-vitro and in-vivo tests. Labetalol did not show any evidence of carcinogenicity in long term studies performed ...
List of excipients
Hydrochloric acid (E507) (for pH adjustment) Sodium hydroxide (E524) (for pH adjustment) Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Labetalol Injection has been shown to be incompatible with sodium bicarbonate injection 4.2% ...
Shelf life
Shelf life: 2 years. Chemical and physical in-use stability diluted in dextrose 5% (w/v); sodium chloride 0.18% (w/v) and dextrose 4.3% (w/v); potassium chloride 0.3% (w/v) and dextrose 5% (w/v) and Ringer ...
Special precautions for storage
The medicinal product does not require any special temperature storage conditions. Store in the original package to protect ampoules from light. For storage of the product once opened or diluted, refer ...
Nature and contents of container
Type I amber glass ampoules: 10 ampoules of 10ml (per pack). Ampoules have a white break ring.
Special precautions for disposal and other handling
Labetalol Synchrony 5mg/ml solution for injection is compatible with the following solutions for infusion: Dextrose 5% (w/v) Sodium Chloride 0.18% (w/v) and dextrose 4.3% (w/v) Potassium Chloride 0.3% ...
Marketing authorization holder
Synchrony Pharma Ltd., Business Technology Centre, Bessemer Drive, Stevenage, Hertfordshire, SG1 2DX, United Kingdom
Marketing authorization number(s)
PL 39280/0009
Date of first authorization / renewal of the authorization
09/05/2018
Date of revision of the text
18/02/2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
