PACKAGE LEAFLET

CARBOSEN 10 mg/ml injectable solution, 20 mg/ml injectable solution, 30 mg/ml injectable solution

Mepivacaine hydrochloride
C
Carbosen 10mg/ml 20mg/ml 30mg/ml
Each ml of solution contains:
Active substance:
Mepivacaine hydrochloride 10 mg, 20 mg, 30 mg
equivalent to Mepivacaine 8.7 mg, 17.4 mg, 26.1 mg
Excipients for vials, ampoules, pre-filled syringes: Sodium chloride, Water for injections.
Excipients for multidose vials: Sodium chloride, Methyl parahydroxybenzoate, Water for injections.
F
Injectable solution for local anaesthesia.
Vials of 1-2-5-10-20 ml, in packs of 5, 50, 100 vials.
Ampoules of 1.8 ml, in packs of 5, 50, 100 ampoules.
Single-use pre-filled syringes of 2-5-10 ml, in sterile individual packaging.
Multidose vials of 50 ml, in packs of 5 vials.
T A.I.C.:
Industria Farmaceutica Galenica Senese srl - Via Cassia Nord, 351 - 53014 Monteroni d’Arbia (SI)
P :
Vials and multidose vials: Industria Farmaceutica Galenica Senese srl – Via Cassia Nord, 351 - 53014 Monteroni d’Arbia (SI)
Ampoules: Industria Farmaceutica Galenica Senese srl – Via Cassia Nord, 351 - 53014 Monteroni d’Arbia (SI) and INIBSA Laboratorios - Barcelona (Spain)
Pre-filled syringes: Industria Farmaceutica Galenica Senese srl Via Cassia Nord, 351 - 53014 Monteroni d’Arbia (SI) and FEDERA S.C. Avenue Jean Jaurès, 71 - 1030 Brussels (Belgium)
I
CARBOSEN is indicated for all procedures in: general medicine (causalgia, neuralgia, etc.), sports medicine (muscle tears, meniscopathies, etc.), orthopaedics (fracture reduction, etc.), otorhinolaryngology (tonsillectomy, rhinoplasty, middle ear surgery, etc.), ophthalmology (retrobulbar block, etc.), dermatology (removal of warts, cysts, dermoids, etc.), obstetrics and gynaecology, general surgery (minor surgery). The ampoule formulation is exclusively intended for use by dentists and is indicated for all conservative and surgical procedures in odontostomatology.
C
Known hypersensitivity to the components or to other substances closely related chemically.
Do not use in confirmed or suspected pregnancy.
O '
CARBOSEN must be used with extreme caution in patients receiving treatment with MAO inhibitors or tricyclic antidepressants. Prior to administration, assess the patient's circulatory status. Avoid overdosage and allow at least 24 hours between maximum doses. The solution must be injected carefully in small increments, following a prior aspiration test after 10 seconds. The patient must be closely monitored and administration must be stopped immediately if necessary. Serious reactions may rarely occur even in the absence of individual hypersensitivity; therefore, appropriate equipment, drugs, and trained personnel must be available for emergency treatment. THIS PRODUCT MUST BE USED UNDER DIRECT MEDICAL SUPERVISION.
U ’
Do not use in confirmed or suspected pregnancy.
I
No interactions with other medicinal products are known. CARBOSEN should nevertheless be used with great caution in patients receiving treatment with MAO inhibitors or tricyclic antidepressants.
A
The solution must be injected carefully in small increments following a prior aspiration test after 10 seconds. The patient must be closely monitored and administration must be stopped immediately if necessary. Serious reactions may rarely occur even in the absence of individual hypersensitivity; therefore, appropriate equipment, drugs, and trained personnel must be available for emergency treatment.
P ,
The maximum dose in adults (not receiving sedatives) is 7 mg/kg, whether administered as a single dose or repeated doses within less than 90 minutes. Do not exceed 550 mg per dose. The total dose must not exceed 1000 mg within 24 hours. In paediatrics, do not exceed 5–6 mg/kg.
Recommended doses:
In dentistry and stomatology:
For infiltration and peripheral nerve block: 30–90 mg.
In surgery:
For peridural and caudal block; paravertebral block; cervical, brachial, intercostal, paracervical, pudendal and terminal nerve blocks: up to 400 mg.
For other indications: as prescribed by the physician.
In obstetrics:
For paracervical block: up to 200 mg within 90 minutes.
T
Administration must be stopped at the first sign of alarm. The patient should be placed in a horizontal position and airway patency ensured, administering oxygen in case of severe dyspnoea or performing artificial ventilation if necessary. Central respiratory stimulants (bulbar analeptics) must be avoided as they may worsen the condition by increasing oxygen consumption. Seizures, if they occur, may be controlled with intravenous diazepam (10–20 mg). Barbiturates are not recommended as they may exacerbate bulbar depression. The circulation may be supported by intravenous administration of appropriate doses of corticosteroids; diluted solutions of alpha-beta vasoconstrictor stimulants or atropine sulphate may be added. Sodium bicarbonate may be used intravenously at an appropriate concentration as an antiacidotic agent.
E
The patient may exhibit toxic and allergic reactions such as: central stimulation with excitement, tremors, disorientation, dizziness, mydriasis, increased metabolism and body temperature, and, at very high doses, seizures. If the medulla oblongata is involved, cardiovascular, respiratory and emetic centres may be affected, resulting in sweating, arrhythmias, hypertension, tachypnoea, bronchodilation, nausea and vomiting. Peripheral effects may involve the cardiovascular system, causing bradycardia and vasodilation.
Locally, skin reactions such as urticaria and pruritus may occur. Generalized manifestations may also occur, including bronchospasm, laryngeal oedema, and even cardiocirculatory collapse due to anaphylactic shock.
PATIENTS ARE ADVISED TO INFORM THEIR PHYSICIAN OF ANY ADVERSE EFFECTS NOT LISTED ABOVE.
P
See the expiry date stated on the packaging, which refers to the product if unopened and properly stored. Do not use after this date.
P
Store at a temperature not exceeding 25°C, in the original packaging. Do not freeze.
Do not dispose of the container in the environment after use.
2008.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN