UBISTESIN 1/200 000 solution for injection & UBISTESIN FORTE 1/100 000 solution for injection are Prescription Medicnes. Contain 4% articaine and epinephrine (adrenaline- see datasheet for detailed ingredient list) Therapeutic indications: Infiltration anaesthesia and nerve block anaesthesia in dentistry. UBISTESIN FORTE is especially indicated for more complex dental procedures requiring prolonged anaesthesia. UBISTESIN and UBISTESIN FORTE must not be used in children under the age of 4 years.
Contraindications: UBISTESIN and UBISTESIN FORTE must not be used in: • children under the age of 4 years • hypersensitivity to any ingredients. In general, patients with demonstrated hypersensitivity to articaine and other amides should receive an ester-group local anaesthetic for subsequent Due to the local anaesthetic ingredient articaine, do not use in the event of: • known allergy or hypersensitivity to local anaesthetics of the amide type; • severe, uncontrolled or untreated excitation and conduction disorders of the heart (eg grade II and III AV block, pronounced bradycardia); • acutely decompensated cardiac insufficiency; • severe hypotension; • patients who are known to have a deficiency in plasma cholinesterase activity also drug induced forms; • haemorrhagic diatheses, particularly with nerve-block anaesthesia. Do not inject into inflamed or infected areas. The reduced penetration of articaine into inflamed tissue can result in failure of anaesthesia. Due to the content of adrenaline (epinephrine) as a vasoconstrictor admixture, do not use in the event of: • heart disease such as - unstable angina pectoris - recent myocardial infarction- recent coronary artery bypass surgery - refractory arrhythmias and paroxysmal tachycardia or high-frequency continuous Arrhythmia - untreated or uncontrolled hypertension -untreated or uncontrolled congestive heart failure; • concomitant treatment with monoamine oxidase (MAO) inhibitors or tricyclic antidepressants • thyrotoxicosis, untreated. Do not use in acra of extremities. UBISTESIN and UBISTESIN FORTE must not be used in persons who are allergic or hypersensitive to sulfite, as well as in persons with severe bronchial asthma. UBISTESIN and UBISTESIN FORTE can provoke acute allergic reactions with anaphylactic symptoms (eg bronchospasm).procedures.
Special warnings and precautions for use: Use with particular caution in the event of: • severe impairment to renal function; • angina pectoris • arteriosclerosis; • considerably impaired blood coagulation or concomitant treatment with anticoagulants or platelet aggregation inhibitors, the overall risk of bleeding is increased; • uncontrolled or untreated hyperthyroidism • narrow-angle glaucoma; • diabetes mellitus; • lung diseases, particularly allergic asthma; • pheochromocytoma.
Interaction with other medicines and other forms of interaction: Refer to datasheet for the extensive list.
Fertility, pregnancy and lactation Fertility: No effects on male or female fertility were observed in rats given articaine hydrochloride with adrenaline subcutaneously from prior to mating until mating (males) or early gestation (females) at doses up to 80 mg/kg/day (approximately twice the maximum recommended human dose on a mg/m² basis). Pregnancy: No clinical experience of use in pregnant and lactating women is available. Safe use of local anaesthetics during pregnancy with respect to adverse effects on foetal development has not been established. Caution should be exercised when prescribing to pregnant women. Breast-feeding: The excretion of articaine and its metabolites in human milk is unknown. It is unknown whether adrenaline (epinephrine) is excreted into the human milk. Preclinical safety data suggests that the amount of articaine in breast milk does not reach clinically relevant levels. Following anaesthesia with UBISTESIN or UBISTESIN FORTE, it is recommended that nursing mothers express and discard the first mother’s milk following anaesthesia with articaine.
Effects on ability to drive and use machines: Although trial patients have shown no impairment of their normal reactions when driving, possible impairment on the ability to drive or operate machinery should be assessed.
Undesirable effects: Summary of the safety profile: Adverse reactions following the administration of articaine / adrenaline (epinephrine)
are similar to those observed with other local amide anaesthetics / vasoconstrictors. These adverse reactions are, in general, dose-related. Serious adverse reactions are generally systemic. Early symptoms and signs of CNS toxicity include metallic taste, tinnitus, lightheadedness and confusion, followed by tremors and shivering. Seizures and cardiorespiratory arrest may ultimately occur.
DOSE: Refer to datasheet for dosing and administration details.
For full information on dosage, contraindications, precautions, interactions and adverse effects please refer to the data sheet available at www.medsafe.govt.nz or by clicking on the link provided with this product. NZ Sponsor: Clinical and Regulatory Services Limited, Hastings