SCANDONEST 3% PLAIN Solution for injection Ref.[8853] Active ingredients: Mepivacaine

Special warnings

SCANDONEST 3% PLAIN must be used with caution in:

Patients with cardiovascular disorders:

• Peripheral vascular disease
• Arrhythmias particularly of ventricular origin
• Heart failure
• Hypotension

SCANDONEST 3% PLAIN should be administered with caution in patients with impaired cardiac function since they may be less able to compensate changes due to prolongation of atrio-ventricular conduction.

Epileptic patients:

Because of their convulsive actions, all local anaesthetics should be used very cautiously.

For poorly controlled epileptic patients, see section 4.3.

Patients with a hepatic disease:

The lowest dose leading to efficient anaesthesia should be used, see section 4.2.

Patients receiving treatment with antiplatelets / anticoagulants:

The increased risk of severe bleeding following accidental vessel puncture and during oromaxillo-facial surgery should be considered. INR monitoring should be increased in patients taking anticoagulants.

Patients with porphyria:

SCANDONEST 3% PLAIN should be used cautiously.

Patients with malignant hyperthermia:

Many drugs used during the conduct of anaesthesia are considered potential triggering agents for familial malignant hyperthermia. It has been shown that the use of amide local anaesthetics in malignant hyperthermia patients is safe. However, there is no guarantee that neural blockage will prevent the development of malignant hyperthermia during surgery. It is also difficult to predict the need for supplemental general anaesthesia. Therefore, a standard protocol for the management of malignant hyperthermia should be available.

Patients with bleeding diathesis due to needle / technique / surgery.

Elderly patients:

Dosages should be reduced in elderly patients over 70 years old (lack of clinical data).

SCANDONEST 3% PLAIN must be used safely and effectively under appropriate conditions

The local anaesthetic effects may be reduced when SCANDONEST 3% PLAIN is injected into an inflamed area or into an infected area.

Risk of biting trauma (lips, cheeks, mucosa, and tongue) exists, especially in children; the patient should be told to avoid chewing gum or eating until normal sensation is restored.

SCANDONEST 3% PLAIN contains less than 1 mmol sodium (23 mg) per cartridge, i.e. it is considered as essentially ‘sodium free’.

Sportsmen should be warned that the presence of SCANDONEST 3% PLAIN in blood may yield positive results on doping tests undergone by professional athletes.

Precautions for use

Before using SCANDONEST 3% PLAIN, it is important:

• To make inquiries into the patient’s diathesis, current therapies and history;
• To maintain verbal contact with the patient.
• To have resuscitative equipment at hand (see section 4.9).

Risk associated with an accidental intravascular injection

Accidental intravascular injection (e.g.: inadvertent intravenous injection into the systemic circulation, inadvertent intravenous or intra-arterial injection in the head area and neck area) may be associated with severe adverse reactions, such as convulsions, followed by central nervous system or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest, due to the sudden high level of mepivacaine in the systemic circulation.

Thus, to ensure that the needle does not penetrate a blood vessel during injection, aspiration should be performed before the medicinal product is injected. However, the absence of blood in the syringe does not guarantee that intravascular injection has been avoided.

Risk associated with intraneural injection

Accidental intraneural injection may lead the drug to move in retrograde manner along the nerve.

In order to avoid intraneural injection and to prevent nerve injuries in connection with nerve blockades, the needle should always be slightly withdrawn if electric shock sensation is felt by the patient during injection or if the injection is particularly painful. If needle nerve injuries occur, the neurotoxic effect could be aggravated by mepivacaine’s potential chemical neurotoxicity as it may impair the perineural blood supply and prevent mepivacaine local wash-out.

Concomitant use of other medicinal products may require thorough monitoring (see section 4.5).

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 in children.

The total dose of administered mepivacaine should not exceed the maximum recommended dose.

H₂ antihistaminics (cimetidine)

Increased serum levels of amide anaesthetics have been reported following concomitant administration of cimetidine.

Sedatives (central nervous system depressants)

Reduced doses of SCANDONEST 3% PLAIN should be used due to additive effects.

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 women and no cases of pregnant women treated with injectable solution of mepivacaine 30 mg/ml were reported in literature. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Therefore, as a precautionary measure, it is preferable to avoid the use of SCANDONEST 3% PLAIN during pregnancy.

Breastfeeding

No nursing mothers were included in clinical studies involving SCANDONEST 3% PLAIN. Only literature data concerning lidocaine passage in milk are available showing no risk. However, considering the lack of data for mepivacaine, a risk to the newborns/infants cannot be excluded. Therefore, nursing mothers are advised not to breastfeed within 10 hours following anaesthesia with SCANDONEST 3% PLAIN.

Patients should not leave the dental office within 30 minutes following administration of SCANDONEST 3% PLAIN.

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, dose-related and may result from high plasma levels caused by overdose, rapid absorption or unintended intra-vascular injection. They may also result from hypersensitivity, idiosyncrasy, or diminished tolerance by patient.

Serious adverse reactions are generally systemic.

Tabulated list of adverse reactions

The reported adverse reactions come from spontaneous reporting and literature.

The frequencies classification follows the convention: Very common (≥ 1/10), Common (≥1/100 - <1/10), Uncommon (≥1/1,000 - <1/100), Rare (≥1/10,000 - <1/1,000) and Very rare (<1/10,000). Frequency “Not known”: “Not known (cannot be estimated from the available data)”.

The seriousness of adverse reactions is classified from 1 (most serious) to 3 (less serious) in the following table:

Description of selected adverse reactions

¹ Laryngo-pharyngeal oedema may characteristically occur with hoarseness and/or dysphagia.

² Bronchospasm (bronchoconstriction) may characteristically occur with dyspnoea.

³ These neural pathologies may occur with the various symptoms of abnormal sensations (i.e., paresthesia, hypoesthesia, dysesthesia, hyperesthesia, etc) of the lips, tongue and oral tissues. These data originated in post-marketings reports, mostly following nerve blocks in mandible, involving various branches of the trigeminal nerve.

⁴ This mostly occurs in patients with underlying cardiac disease or in patients receiving certain drugs.

⁵ This occurs in predisposed patients or in patients with risk factors of ischemic heart disease.

⁶ Hypoxia and hypercapnia are secondary to respiratory depression and/or to seizures and sustained muscular exertion.

⁷ This occurs by accidental biting or chewing of the lips or tongue while the anaesthesia persists.

In the absence of compatibility studies, SCANDONEST 3% PLAIN must not be mixed with any other medicinal products.