SCANDONEST 3% PLAIN Solution for injection (2013)
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Περιεχόμενα
Name of the medicinal product
SCANDONEST 3% PLAIN, solution for injection.
Qualitative and quantitative composition
<u>1 ml solution for injection contains:</u> mepivacaine hydrochloride 30 mg. One cartridge of 1.8 ml of solution for injection contains 54 mg of mepivacaine hydrochloride. For a full list of excipients, ...
Pharmaceutical form
Solution for injection. Clear and colourless solution. pH adjusted to 6.4 with sodium hydroxide.
Therapeutic indications
SCANDONEST 3% PLAIN is a local anaesthetic indicated for the local and loco-regional anaesthesia in dental surgery in adults, in adolescents and in children above 4 years of age (c.a. 20 kg of body weight). ...
Posology and method of administration
For professional use by dentists and stomatologists. Posology Adults As occurs with all local anaesthetics, doses vary and depend on the area to be anaesthetised, on the vascularity of tissues, on the ...
Contraindications
Hypersensitivity to mepivacaine (or to any local anaesthetics agent of the amide type) or to any of the excipients Children (age below 4 years old) Severe conduction disturbances Poorly controlled epileptic ...
Special warnings and precautions for use
Special warnings SCANDONEST 3% PLAIN must be used with caution in: <u>Patients with cardiovascular disorders:</u> Peripheral vascular disease Arrhythmias particularly of ventricular origin Heart failure ...
Interaction with other medicinal products and other forms of interaction
Interactions requiring precautions for use Other local anaesthetics Toxicity of local anaesthetics is additive. It is not relevant considering dental anaesthesia doses and blood levels, but it is a concern ...
Fertility, pregnancy and lactation
Fertility No relevant data reported any toxic effects on fertility in animals with mepivacaine. To date, no data are available regarding humans. Pregnancy No clinical studies were performed in pregnant ...
Effects on ability to drive and use machines
Patients should not leave the dental office within 30 minutes following administration of SCANDONEST 3% PLAIN.
Undesirable effects
Summary of the safety profile Adverse reactions following the administration of SCANDONEST 3% PLAIN are similar to those observed with other local amide anaesthetics. These adverse reactions are, in general, ...
Overdose
Types of overdose Local anaesthetic overdose in the largest sense is often used to describe: absolute overdose, relative overdose such as:inadvertent injection into a blood vessel, or abnormal rapid absorption ...
Pharmacodynamic properties
Pharmacotherapeutic group: Nervous System/Anaesthetics/Local anaesthetics/Amides/Mepivacaine ATC code: N01BB03 SCANDONEST 3% PLAIN contains mepivacaine, which is an amide local anaesthetic. Mepivacaine ...
Pharmacokinetic properties
Absorption The rate of systemic absorption of mepivacaine in humans depends mainly upon the total dose and concentration of administered drug, on the route of administration, on the vascularity of the ...
Preclinical safety data
General toxicity studies (single dose and repeat-dose studies) were performed with mepivacaine demonstrating a good safety margin. <em>In vitro</em> and <em>in vivo</em> testing carried out on mepivacaine ...
List of excipients
Sodium chloride Sodium hydroxide (for pH-adjustment) Water for injections
Incompatibilities
In the absence of compatibility studies, SCANDONEST 3% PLAIN must not be mixed with any other medicinal products.
Shelf life
36 months.
Special precautions for storage
Do no store above 25°C. In order to protect from light, keep the cartridge in the outer carton tightly closed. Do not freeze.
Nature and contents of container
Type I glass cartridge, sealed at its base by a mobile type I synthetic rubber and at the top by a type I synthetic rubber seal kept in place by a metal cap. Cartridges of 1.8 ml. Box containing 50 cartridges. ...
Special precautions for disposal and other handling
As for any cartridge, the diaphragm should be disinfected prior to use. It should be carefully swabbed: either with 70% ethyl alcohol or with 90% pure isopropyl alcohol for pharmaceutical use. The cartridges ...
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