Septanest 40 mg/ml + 5 micrograms/ml, solution for injection

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Articaine hydrochloride; Adrenaline tartrate

Disponible des:

Septodont

Codi ATC:

N01BB58

Designació comuna internacional (DCI):

Articaine hydrochloride; Adrenaline tartrate

formulario farmacéutico:

Solution for injection

Área terapéutica:

articaine, combinations

Estat d'Autorització:

Marketed

Data d'autorització:

2022-10-28

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
SEPTANEST 40 MG/ML + 5 MICROGRAMS/ML
SEPTANEST 40 MG/ML + 10 MICROGRAMS/ML
SOLUTION FOR INJECTION
ARTICAINE HYDROCHLORIDE / ADRENALINE (EPINEPHRINE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your dentist, doctor or
pharmacist.
−
If you get any side effects, talk to your dentist, doctor or
pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Septanest is and what it is used for
2.
What you need to know before you are given Septanest
3.
How to use Septanest
4.
Possible side effects
5.
How to store Septanest
6.
Contents of the pack and other information
1.
WHAT SEPTANEST IS AND WHAT IT IS USED FOR
Septanest is used to numb (anaesthetise) your oral cavity during
dental procedures.
This medicine contains two active substances:
•
articaine, a local anaesthetic which prevents pain, and
•
adrenaline, a vasoconstrictor which narrows the blood vessels at the
site of injection, and
thereby prolongs the effect of articaine. It also decreases bleeding
during surgery.
You will be given Septanest by a dentist.
Septanest is for children over 4 years of age (ca. 20 kg in body
weight), adolescents and adults.
Depending on the kind of dental procedure performed, the dentist will
choose between the two
medicines:
•
Septanest 40 mg/ml + 5 micrograms/ml is usually used for simple and
short dental procedures
•
Septanest 40 mg/ml + 10 micrograms/ml is more adapted to procedures
lasting longer or with
possible significant bleeding.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SEPTANEST
DO NOT USE SEPTANEST IF YOU SUFFER FROM ANY OF THE FOLLOWING
CONDITIONS:
•
allergy to articaine or adrenaline or any of the other ingredients of
these medicines (listed in
section 6);
•
allergy to other local anaesthetics;
•
epilepsy, not adequately c

Fitxa tècnica

Health Products Regulatory Authority
28 October 2022
CRN009VWY
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Septanest 40 mg/ml + 5 micrograms/ml, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains 40 mg of articaine
hydrochloride and 5 micrograms of adrenaline (epinephrine) (as
adrenaline tartrate).
Each cartridge of 2.2 ml of solution for injection contains 88 mg of
articaine hydrochloride and 11 micrograms of adrenaline
(epinephrine) (as adrenaline tartrate).
Excipient(s) with known effect: sodium metabisulfite (E223), sodium
chloride.
Septanest contains 0.804 mg sodium per 1 ml of solution i.e. 1.77
mg/2.2 ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Local and loco-regional anaesthesia in dental procedures.
Septanest is indicated in adults, adolescents and children above 4
years of age (or from 20 kg (44 lbs) of body weight).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For professional use by physicians or dentists only.
Posology
For all populations, the lowest dose leading to effective anaesthesia
should be used. The necessary dosage must be
determined on an individual basis.
For a routine procedure, the normal dose for adult patients is of 1
cartridge, but the contents of less of a cartridge may be
sufficient for effective anaesthesia. At the discretion of the
dentist, more cartridges may be required for more extensive
procedures without exceeding the maximum recommended dose.
For most routine dental procedures, Septanest 40 mg/ml + 5
micrograms/ml should be used.
For more complex procedures, such as requiring pronounced hemostasis,
it is preferable to use Septanest 40 mg/ml + 10
micrograms/ml.
_Concomitant use of sedatives to reduce patient anxiety:_
The maximum safe dose of local anaesthetics may be reduced in sedated
patients due to an additive effect on central nervous
system depression