Espestesin Forte 40 mg/ml + 10 microgram/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Articaine hydrochloride; Epinephrine

Available from:

3M Deutschland GmbH

ATC code:

N01BB; N01BB58

INN (International Name):

Articaine hydrochloride; Epinephrine

Dosage:

40 mg/ml +1/100000

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Amides; articaine, combinations

Authorization status:

Not marketed

Authorization date:

2003-02-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESPESTESIN FORTE
40 mg/ml + 10 microgram/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 doctor, dentist or
pharmacist.
-
If you get any side effects, talk to your doctor, dentist or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Espestesin Forte is and what it is used for
2.
What you need to know before you use Espestesin Forte
3.
How to use Espestesin Forte
4.
Possible side effects
5.
How to store Espestesin Forte
6.
Contents of the pack and other information
1.
WHAT ESPESTESIN FORTE IS AND WHAT IT IS USED FOR
Espestesin Forte 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 (epinephrine), 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 Espestesin Forte by a dentist.
Espestesin Forte is for children over 4 years of age (ca. 20 kg in
body weight), adolescents and adults.
Espestesin Forte is more adapted to procedures lasting longer or with
possible significant bleeding.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ESPESTESIN FORTE
DO NOT USE ESPESTESIN FORTE IF YOU SUFFER FROM ANY OF THE FOLLOWING
CONDITIONS:
•
allergy to articaine or epinephrine or any of the other ingredients of
these medicines (listed in
section 6);
•
allergy to other local anaesthetics;
•
epilepsy, not adequately controlled by drug treatment.
2
WARNINGS AND PRECAUTIONS
Talk to your dentist before using Espestesin Forte if you suffer from
any of the following conditions:
•
severe heart rhyth

Summary of Product characteristics

Health Products Regulatory Authority
05 September 2022
CRN00CXKG
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Espestesin Forte 40 mg/ml + 10 microgram/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains
1 cartridge with 1.7 ml solution for injection
contains
Articaine hydrochloride
40 mg
68 mg
Epinephrine (adrenaline) (as hydrochloride)
10 micrograms
17 micrograms
Excipient with known effect
Sodium sulfite (E 221)
0.6 mg
1.02 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection. Clear colourless solution with a pH value of
3.6 to 4.4.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Local and loco-regional anaesthesia in dental procedures.
Espestesin Forte is indicated in adults, adolescents and children
above 4 years of age (or from 20 kg 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, it is preferable to use
Espestesin.
For more complex procedures, such as requiring pronounced hemostasis,
it is preferable to use Espestesin Forte.
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 (see section4.5).

ADULTS AND ADOLESCENTS (12 TO 18 YEARS OFAGE)
In adults and adolescents, the maximum articaine dose is 7 mg/kg with
an absolute maximum articaine dose of 500 mg. The
maximum artic