Articaine hydrochloride/Epinephrine NewLine Pharma 40 mg/mL + 0.01 mg/mL, solution for injection

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Articaine hydrochloride; Adrenaline tartrate

Tilgjengelig fra:

NewLine Pharma, S.L.

ATC-kode:

N01BB58

INN (International Name):

Articaine hydrochloride; Adrenaline tartrate

Dosering :

40+0.01 milligram(s)/millilitre

Legemiddelform:

Solution for injection

Terapeutisk område:

articaine, combinations

Autorisasjon dato:

2020-06-26

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARTICAINE HYDROCHLORIDE/EPINEPHRINE NEWLINE PHARMA 40 MG/ML + 0.01
MG/ML, SOLUTION FOR INJECTION
Articaine hydrochloride / Epinephrine tartrate
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, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Articaine hydrochloride/Epinephrine NewLine Pharma is and what it
is used for
2.
What you need to know before you use Articaine
hydrochloride/Epinephrine NewLine Pharma
3.
How to use Articaine hydrochloride/Epinephrine NewLine Pharma
4.
Possible side effects
5.
How to store Articaine hydrochloride/Epinephrine NewLine Pharma
6.
Contents of the pack and other information
1.
WHAT ARTICAINE HYDROCHLORIDE/EPINEPHRINE NEWLINE PHARMA
IS AND WHAT IT IS USED FOR
Articaine hydrochloride/Epinephrine NewLine Pharma contains two
different active substances:
articaine hydrochloride and epinephrine (also known as adrenaline).
Articaine hydrochloride/Epinephrine NewLine Pharma is a local
anesthetic (agent which reduces or
abolishes sensation, affecting a particular region). This medicine is
indicated in adults and children
aged 4 years and above to numb (anaesthetize) a part of the mouth
during dental procedures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ARTICAINE
HYDROCHLORIDE/EPINEPHRINE NEWLINE
PHARMA
_ _
DO NOT USE ARTICAINE HYDROCHLORIDE/EPINEPHRINE NEWLINE PHARMA:

If you are allergic (hypersensitive) to articaine hydrochloride,
adrenaline or any of the other
ingredients of this medicine (listed in section 6)

If you are allergic to other ‘local anaest

Preparatomtale

Health Products Regulatory Authority
05 May 2023
CRN00D9YS
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Articaine hydrochloride/Epinephrine NewLine Pharma 40 mg/mL + 0.01
mg/mL, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Articaine hydrochloride……………………...40.00 mg/mL
Adrenaline tartrate
Quantity corresponding to adrenaline………..0.01 mg/mL
Excipient(s) with known effect:
Sodium metabisulphite (E223)……………….0.5 mg/mL
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection for dental use.
Sterile, clear and colourless solution for injection with a pH between
2.7 – 4.5 and osmolality of aproximately 267 mOsm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Local or local-regional anesthesia in dentistry and dental surgical
procedures in patients at least 4 years old.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The smallest possible volume of solution which will lead to an
effective anaesthesia should be used.
_Adults_
_ _
The quantity to be injected will be adjusted as a function of the
extent of the intervention.
As a general rule, one to three cartridges per session.
The dose should not exceed 7 mg of articaine hydrochloride per
kilogram of body weight.
_Paediatric population_
_ _
Articaine hydrochloride/Epinephrine NewLine Pharma should not be used
in children aged below 4 years because of safety and
efficacy concerns.
The quantity to be injected depends on the age and the weight of the
child as well as the type of intervention to be
performed.
The maximum dose is 5 mg of articaine hydrochloride (0.125 mL of
anaesthetic solution) per kilogram of body weight.
The average dose in mg of articaine hydrochloride that can be
administered in children can be calculated as follows:
Weight of the child (in kilograms) x 1.33
Health Products Regulatory Authority
05 May 2023
CRN00D9YS
Page 2 of 7
_Elderly _
Reduce to one-half the dose used for adults.
Method of administration
Local or re