Orabloc solution for injection

Country: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

articaine (articaine hydrochloride), adrenaline (adrenaline tartrate)

Fáanlegur frá:

Pierrel S.p.A.S. S. Appia

ATC númer:

N01BB58

INN (Alþjóðlegt nafn):

articaine (articaine hydrochloride), adrenaline (adrenaline tartrate)

Skammtar:

40mg/ml+ 10mcg/ml

Lyfjaform:

solution for injection

Einingar í pakka:

(100/10x10/) cartridges 1,8ml in blister

Gerð lyfseðils:

Prescription

Leyfisstaða:

Registered

Leyfisdagur:

2019-05-17

Vara einkenni

1.3. PRODUCT LABELLING
DRAFT FOR SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Orabloc 1:100,000
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains 40 mg articaine hydrochloride and
0.01 mg epinephrine
(adrenaline) as adrenaline tartrate.
One cartridge of 1.8 ml of solution for injection contains 72 mg
articaine hydrochloride and
0.018 mg epinephrine (adrenaline) as adrenaline tartrate
Excipients with known effect:
Contains sodium metabisulphite (E223) 0.5 mg/ml and sodium 4.5 mg/ml.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution for injection.
The pH of the solution ranges from 3.0 to 4.5.
Osmolarity: 270 mOsm/KG
4
CLINICAL PARTICULARS
4.1
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
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For uncomplicated forceps extraction of the upper teeth where no
inflammation is present, a
vestibular injection of 1.8 ml per tooth is usually sufficient. In
isolated cases, an additional
vestibular injection of 1-1.8 ml may be necessary to achieve complete
anaesthesia. Injection
via the painful palatine route is normally not necessary.
Where the palate requires incision or suture, a palatine depot of
about 0.1 ml per puncture is
sufficient. Where multiple extractions of adjacent teeth are
necessary, it is possible in most
cases to reduce the number of vestibular injections required.
In uncomplicated forceps extraction of lower premolars where no
inflammation is present,
injection of 1.8 ml per tooth is usually sufficient. However, if the
anaesthesia