1 ml solution for injection contains 40 mg articaine hydrochloride and 0.01 mg adrenaline (epinephrine) as adrenaline tartrate.

One cartridge of 1.8 ml of solution for injection contains 72 mg articaine hydrochloride and 0.018 mg adrenaline (epinephrine) as adrenaline tartrate.

Excipients with known effect:

Contains sodium metabisulphite (E223) 0.5 mg/ml.

For the full list of excipients, see section 6.1.

See more – Orabloc 1:100,000 SPC – Orabloc 1:200,000 SPC

Therapeutic indications 

Orabloc is indicated in adults, adolescents and children of 4 years and older for local anaesthesia (infiltration and nerve-block anaesthesia) in dentistry:

• mucosal and bone surgery requiring stronger ischaemia,
• dental pulp surgery (amputation and extirpation),
• extraction of fractured teeth (osteotomy),
• protracted surgical interventions,
• percutaneous osteosynthesis,
• cystectomy,
• mucogingival interventions,
• apicoectomy

See more – Orabloc 1:100,000 SPC – Orabloc 1:200,000 SPC 

Pharmacodynamic properties 

Pharmacotherapeutic group: Anaesthetics, local; Amides. 

ATC code: N01BB58 

Orabloc is an acid amide-type local anaesthetic used for terminal and nerve-block anaesthesia in dentistry. It is fast-acting (latency time 1-3 min) with a potent analgesic effect and good tissue tolerability. 

The duration of effective anaesthesia is about 45 min for Orabloc 0.005 mg/ml and about 75 min for Orabloc 0.01 mg/ml.

The mechanism of action of articaine is assumed to be based on inhibition of conduction in nerve fibres, due to blockade of voltage-dependent Na+ channels in the cell membrane.

Its extremely low adrenaline (epinephrine) concentration and high intensity of action make Orabloc 0.005 mg/ml suitable for use in patients with cardiovascular diseases. 

Paediatric population

In children 3.5 to 16 years old, clinical studies including up to 210 patients, have shown that 4% articaine + 0.005 mg/ml adrenaline (epinephrine) at doses up to 5 mg/kg and 4% articaine + 0.010 mg/ml adrenaline (epinephrine) at doses up to 7 mg/kg provided successful local anaesthesia, if given by (mandibular) infiltration or (maxillary) nerve block. The anaesthesia duration was similar for all age groups and depended on the volume administered. 

See more – Orabloc 1:100,000 SPC – Orabloc 1:200,000 SPC

List of excipients

Sodium chloride

Sodium metabisulfite (E223)

Hydrochloric acid 2% (for pH adjustment)

Water for injection

Incompatibilities

Not applicable.

Shelf life

2 years

Special precautions for storage

Do not store above 25 °C. Store in the original package in order to protect from light.

Nature and contents of container 

Clear glass cartridges (Type I) closed at one end with a bromobutylic rubber plunger and at the other with an aluminium cap and rubber seal. 

The cartidge is available in different packages: 

The cartridges are packaged in PVC blisters (10 cartridges/blister); the blisters are packaged in a cardboard box containing 5 x 10 or 10 x 10 cartridges. 

Each cartridge is assembled in a plastic injector; each injector containing a cartridge  is placed in a sealed blister; the injectors are packaged in a cardboard box together with Instructions for use of the injector: 50 or 100 units per commercial pack. 

Not all pack sizes may be marketed. 

Special precautions for disposal 

As for any cartridge, the rubber seal (diaphragm) will be disinfected just before use with either pharmaceutical grade ethyl alcohol (70%) or pharmaceutical grade  Isopropyl alcohol (90%). 

The cartridges must not be immersed in the above solutions. 

Do not mix the injectable solution with other products in the same syringe. 

Any unused solution or waste material should be disposed of in accordance with local requirements.

See more – Orabloc 1:100,000 SPC – Orabloc 1:200,000 SPC 

Pierrel Pharma S.R.L. 

Strada Statale Appia, 46/48 – 81043 Capua (CE)

Italy 

PL 42405/0001

See more – Orabloc 1:100,000 SPC – Orabloc 1:200,000 SPC

Date of first authorisation: 11/06/2013 

Date of latest renewal: 03/05/2018 

See more – Orabloc 1:100,000 SPC – Orabloc 1:200,000 SPC

November 2021

See more – Orabloc 1:100,000 SPC – Orabloc 1:200,000 SPC