Patient leaflet - Anestadent 4% w/v and 1:100 000 solution for injection
1. What Anestadent™ 4% w/v and 1:100,000 is and what it is used for
Anestadent™ 4% w/v and 1:100,000 contains two different active substances: articaine hydrochloride and epinephrine (also known as adrenaline).
Anestadent™ 4% w/v and 1:100,000 is a local anaesthetic (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. To be used by healthcare professionals only.
2. What you need to know before you use Anestadent™ 4% w/v and 1:100,000
Do not use Anestadent™ 4% w/v and 1:100,000:
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 anaesthetics’ called ‘amide’ anaesthetics
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Anestadent™ 4% w/v and 1:100,000 if you are not sure or if you:
- have severe kidney or liver problems
- have chest pain (angina pectoris)
- have thickening of your blood vessels (arteriosclerosis)
- have problems with the way your blood clots
suffer from hypertension or diabetes, because you may be at
risk for local necrosis
Due to the presence of adrenaline, precautions and monitoring should be increased in the following cases:
- in cases of arrhythmias, except for bradycardia
severe cardiovascular diseases such as unstable angina,
recent heart attack or recent coronary artery bypass surgery
coronary heart disease; congestive heart failure (your heart
muscle doesn’t pump blood as well as it should)
- severe high blood pressure
uncontrolled or poorly controlled high blood pressure
(hypertension)
- overactive thyroid gland (hyperthyroidism)
- diabetes mellitus
In the case of severe hepatic impairment it may be necessary that your doctor reduces the articaine hydrochloride dose, due to the mainly hepatic metabolism of local anaesthetics of the amide type.
Your doctor may advise you not to chew gum or food for as long as the insensitivity persists, due to a risk of biting yourself under anesthesia (lips, cheeks, mucosa, tongue).
Overdose of the medicine should be avoided and two maximal doses of the drug should be administered with a minimum interval of 24 hours.
Children
This product should not be used in children under age 4, because the of safety and efficacy concerns.
Other medicines and Anestadent™ 4% w/v and 1:100,000
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Anestadent™ 4% w/v and 1:100,000 can affect the way some other medicines work. Also some other medicines can affect the way this medicine works.
Precautions for use under strict medical supervision are required with:
- all classes of antidepressant medicines: monoamine oxidase inhibitors or MAOIs (iproniazide, moclobemide, toloxatone), tricyclic antidepressants (imipramine, amoxapine, amitriptyline, desipramine, nortriptyline), serotonergics and noradrenergics (milnacipran and venlafaxine)
- halogenated volatile anesthetics (isoflurane, desflurane)
- medicines which affect the way your heart beats called ‘non-selective beta-blockers’ such as propanolol. If you are given Anestadent™ 4% w/v and 1:100,000 when taking a ‘beta-blocker’ you may get very high blood pressure or a very slow heart beat
- guanethidine and related medicines, used to treat glaucoma
If any of the above apply to you (or you are not sure), talk to your dentist or doctor before using this medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, as a precautionary measure, it is preferable to avoid the use of Anestadent™ 4% w/v and 1:100,000.
If you are breast-feeding, you can use Anestadent™ 4% w/v and 1:100,000 if necessary.
Driving and using machines
Talk to your dentist or doctor before driving or using any tools or machines. They will tell you when it is safe to do these activities again after your dental work.
Anestadent™ 4% w/v and 1:100,000 contains sodium and metabisulphite
This medicinal product contains less than 1 mmol sodium (23 mg) per cartridge, i.e. essentially ‘sodium- free’.
Due to the presence of sodium metabisulphite, it may rarely cause severe hypersensitivity reactions and bronchospasm.
3. How to use Anestadent™ 4% w/v and 1:100,000
How much Anestadent™ 4% w/v and 1:100,000 you will be given
Your dentist or doctor will give you Anestadent™ 4% w/v and 1:100,000.
- The dentist or doctor will decide how much of this medicine to give you.
- The dose will depend on what it is being used for and also on other factors, such as your health, age and weight.
- The smallest possible dose will be used.
- The maximum dose for adults is 7 mg per kilogram of body weight.
The quantity to be injected will be adjusted according to the extent of the procedure.
As a general rule, one to three cartridges per session.
Use in children (4 years and older)
The dose depends on the child’s age and weight and the type of procedure being conducted. The maximum dose is 5 mg of articaine hydrochloride per kilogram of body weight.
The mean dose in mg of articaine hydrochloride that can be administered in children may be calculated as follows:
Child’s weight (in kilograms) x 1.33.
Do not use in children younger than 4 years old.
Elderly
Reduce the adult dosage by half.
This ART is to show size, copy placement and color breaks. Actual colors will be matched on press to approved color standards and/or PMS color swatches. Logo/Brand names with Superscript/Subscript ® and ™’s are to be a minimum 1/32 circumference/bold; any deviation to this will be printed as is. Nosco Glue Flap Barcode: is for internal Quality Control Purposes Only and Die Does NOT Print.
Approval must be sent to ArtFlo and Acct. Manager
APPROVED
P/N: Anestadent_PIL_PI
Eval#: X3660963
SIZE: 315 x 210mm
CR: N/A FOLD: N/A DRWG: Cust. Supplied
ART: 9 DATE: 7/29/2019 CUSTOMER: Dentsply
(Signature / Date)
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Fonts used: Arial Regular, Arial Bold Route and method of administration
The medicinal product is for dental use and will be administered to you as an injection into your oral cavity by the dentist.
Injection rate should not exceed 1 mL of solution per minute.
Method of use, handling instructions (information for the doctor)
As with any cartridge, the diaphragm should be disinfected just before use. It should be carefully swabbed:
either with 70% ethyl alcohol,
- or with 90% pure isopropyl alcohol for pharmaceutical use.
The cartridges must never be immersed in any solution whatsoever. Do not mix the solution for injection in the same syringe with other products.
Previously used anaesthetic solution cartridges must not be reused.
Duration of treatment
Single use.
If you use more Anestadent™ 4% w/v and 1:100,000 than you should
It is unlikely that you will be given too much of this medicine, as it will be given by a dentist or doctor.
If you think you have been given too much, tell your dentist or doctor immediately.
The following effects may happen:
feeling confused, fear, breathing quickly (tachypnoea), an
increase in blood pressure and face blushing, feeling or being sick, tremors, spasms (including in your jaw), having a fit (convulsion)
a feeling the room is spinning (vertigo), not being able to
speak, hearing problems, loss of consciousness, muscle contractions, problems controlling the size of blood vessels (vascular-motor complications), breathing problems including stopping breathing, death
slow heart beat (bradycardia), uneven heart beat (arrhythmia),
rapid and chaotic heart beat (fibrillation), low blood pressure (hypotension), heart stopping (cardiac arrest), blue skin colour (cyanosis)
If you have any further questions on the use of this product, ask your dentist, doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may happen. If you notice any of the following possible side effects see your dentist or doctor straight away:
Rare (affects less than 1 in 1,000 people)
- slow heartbeat (bradycardia)
- uneven heart beat (arrhythmia)
excitatory reactions, tremors, feeling disorientated, taste of
metal in mouth, a feeling the room is spinning (vertigo), a ringing or other noise in the ears (tinnitus), widening of the pupil (mydriasis), pins and needles (paraesthesia), jaw spasms and fits (convulsions)
- eye problems (such as double vision) which usually go away
rapid breathing (tachypnoea), widening of air passages
(bronchodilation)
- feeling or being sick
- increase in your metabolism
- low or high blood pressure (hypotension or hypertension)
- increase in body temperature
feeling nervous (anxiety), pain in your throat or behind your
breastbone, heat sensation, sweating, headache
Very rare (affects less than 1 in 10,000 people)
skin rash, itching (pruritus), itchy skin rash often with raised
lumps (urticaria)
allergic reactions (which can range from problems breathing
and swelling of the tube which transfers air to the lungs (larynx) up to cardiorespiratory collapse from anaphylactic shock)
As the product contains sodium metabisulphite, it may rarely cause severe allergic reaction and problems breathing (bronchospasm).
If this medicine is accidently injected into blood vessels it can cause lack of blood flow where it is injected. This can sometimes progress to death of the tissue (tissue necrosis).
Lesions to nerves, hyposensitivity and alterations of taste, may occur after an incorrect injection or in case of patient with particular conditions.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Anestadent™ 4% w/v and 1:100,000
Keep this medicine out of the sight and reach of children.
This medicine should be kept at a temperature below 30°C.
Do not freeze.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Anestadent™ 4% w/v and 1:100,000 contains
The active substances are:
Articaine hydrochloride…………………….... 40.00 mg/mL Adrenaline tartrate
Quantity corresponding to adrenaline……….. 0.01 mg/mL
The other ingredients are:
Sodium chloride
Sodium metabisulphite
Hydrochloric acid
Sodium hydroxide
Water for injection
What Anestadent™ 4% w/v and 1:100,000 looks like and contents of the pack
This medicine is in the form of a solution for injection.
Box of 50 cartridges of 1.8 mL with self-aspirating stopper Box of 50 cartridges of 1.8 mL with standard stopper Box of 50 cartridges of 2.2 mL with self-aspirating stopper Box of 50 cartridges of 2.2 mL with standard stopper
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DENTSPLY Limited
Building 3, The Heights
Weybridge, Surrey, KT13 0NY
United Kingdom
Manufacturer
Laboratorios INIBSA S.A.
Ctra. Sabadell a Granollers, Km 14,5
Lliçà de Vall (Barcelona) 08185
Spain
This leaflet was last revised in 07/2019
This ART is to show size, copy placement and color breaks. Actual colors will be matched on press to approved color standards and/or PMS color swatches. Logo/Brand names with Superscript/Subscript ® and ™’s are to be a minimum 1/32 circumference/bold; any deviation to this will be printed as is. Nosco Glue Flap Barcode: is for internal Quality Control Purposes Only and Die Does NOT Print.
Approval must be sent to ArtFlo and Acct. Manager
APPROVED
P/N: Anestadent_PIL_PI
Eval#: X3660963
SIZE: 315 x 210mm
CR: N/A FOLD: N/A DRWG: Cust. Supplied
ART: 9 DATE: 7/29/2019 CUSTOMER: Dentsply
(Signature / Date)
by
Fonts used: Arial Regular, Arial Bold