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Aspen Germany XYLOCAIN PUMPSPRAY DENTAL

Aspen Germany

AED 279.00
+ AED 65.00 Air Shipping

Includes any applicable VAT and customs duty.
Air shipping cost to be recalculated with delivery address at checkout.
To be delivered in 6 - 9 * working days.
100% genuine and new product.
Credit card / Cash on Delivery

Summary

Important information (mandatory information):

Xylocaine pump spray dental Active ingredient: lidocaine. Areas of application: used in adults and children from the age of 3 years for anesthesia (prophylactic and therapeutic surface anesthesia) in the area of the oral cavity. Warning: Contains 28.9% alcohol by volume!

Active Ingresients:

- 10 mg Lidocain

Exceptions:

Saccharin

Bananen-Aroma, 85509/H, Givaudan

water, purified

Levomenthol

Macrogol 400

Ethanol 96% (V/V)

Description

Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor has told you.

Keep the leaflet. You might want to read it again.
Ask your pharmacist if you need more information or advice.
If your condition worsens, you definitely need to see a doctor.
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not listed in this leaflet. See section 4

What is in this leaflet:

WHAT XYLOCAIN PUMPSPRAY DENTAL IS AND WHAT IT IS USED FOR
WHAT SHOULD YOU KNOW BEFORE USING XYLOCAIN PUMPSPRAY DENTAL?
HOW TO USE XYLOCAIN PUMPSPRAY DENTAL?
WHAT SIDE EFFECTS ARE POSSIBLE?
HOW TO STORE XYLOCAIN PUMPSPRAY DENTAL?
CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT XYLOCAIN PUMPSPRAY DENTAL IS AND WHAT IT IS USED FOR

1.1 Xylocain pump spray dental is a drug for superficial anesthesia in the oral cavity.

1.2 Xylocaine pump spray dental is used in adults and children from the age of 3 years for anesthesia (prophylactic and therapeutic surface anesthesia) in the area of the oral cavity, e.g

to prevent puncture pain and prick fear during injections,
for minor surgical interventions,
when removing loose root remains or milk teeth,
during tartar removal,
in periodontosis treatment,
when fitting prostheses or orthodontic work,
with mouth rash,
with prosthesis pressure points,
to prevent nausea when taking impressions or x-rays.

2. WHAT YOU SHOULD KNOW BEFORE USING XYLOCAIN PUMPSPRAY DENTAL?

2.1 Xylocaine pump spray dental must not be used:

if you are allergic (hypersensitive) to lidocaine (the active ingredient in Xylocaine Dental Pump Spray) or other topical numbing drugs from the same class of drugs as lidocaine (amide-type local anaesthetics) or to any of the
in the case of significant disorders of the stimulus formation and conduction system of the heart,
if you have cardiac insufficiency that has not been stabilized by medical measures,
in shock caused by heart failure,
in shock caused by a reduction in the amount of blood in the body,
in patients with bronchial asthma or other respiratory diseases associated with marked hypersensitivity of the airways. Inhaling menthol can cause shortness of breath or trigger an asthma attack.

You must not use Xylocain Pump Spray dental on infants and children up to 2 years of age because of the menthol content. In this age group, menthol can lead to a spasmodic closure of the larynx with subsequent severe shortness of breath.

2.2 Warnings and Precautions:
Particular caution is required with the use of this medicine if, based on the dose or the method of administration, high concentrations of the active substance in the blood are to be expected. Your dentist or doctor will pay particular attention to

if you suffer from circulatory disorders of the heart or cardiac insufficiency (see also section 2.1 "Xylocaine pump spray dental must not be used"),
if you are in poor general condition,
if you suffer from pathological muscle weakness (myasthenia gravis),
if you suffer from advanced liver disease,
If your kidney function is severely reduced.

If you suffer from porphyria, you may only use Xylocaine Dental Pump Spray under medical supervision. Xylocaine pump spray dental may also trigger porphyria. Please ask your doctor about this. Very high doses or too short intervals between the individual doses can lead to high concentrations of the active substance in the blood. Emergency medical measures may then be necessary. That is why it is important to follow the recommended dosage exactly. Because of the risk of the body absorbing large amounts of the active ingredient, you should only use Xylocaine dental pump spray on wound surfaces after consulting your dentist or doctor. The active ingredient in xylocaine pump spray dental is particularly absorbed on wound surfaces and on injured or inflamed areas of skin or mucous membranes. You should therefore be particularly careful when using it in these areas. To prevent side effects, you should strictly follow the recommended dosage. Do not spray Xylocaine Pump Spray dental in your eyes. If you accidentally get some spray in your eyes, you should immediately rinse your eyes with running water. Swallowing can be difficult when using Xylocaine Pump Spray dental in the mouth or throat. Then there is a risk of choking. You could also bite your tongue or the lining of your cheeks if those areas are numbed. If an allergy to lidocaine is known, a cross-allergy to other local anesthetics of the acid amide type must be expected. This medicinal product contains 28.9% alcohol by volume.

Kinder:
In children, the dosage should be adjusted to the child's body weight.

Elderly people:
In elderly patients, it should be used with particular caution if high concentrations of the active substance in the blood are to be expected.

2.3 Use of Xylocain pump spray dental together with other medicines:
Tell your dentist, doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines, including those obtained without a prescription. Xylocaine Pump Spray dental and other topical anesthetics or structurally related substances (e.g. certain antiarrhythmic medicines such as mexiletine and tocainide) must be used with extreme care when Xylocaine Pump Spray dental is used at the same time. The undesirable effects can increase in these cases. If you receive medicines for cardiac arrhythmia with, for example, the active ingredient amiodarone, you should only use Xylocain pump spray dental under medical supervision (ECG monitoring). Lidocaine does not cause sensitization and does not interfere with treatment with antibiotics or sulfonamides. The wound healing is not delayed by the use of Xylocaine pump spray dental. If you are taking medicines containing the active ingredient cimetidine to regulate gastric acid production or if you are using beta-blockers, you must not increase the dosage of Xylocaine pump spray dental without medical advice. Repeated high doses over a longer period of time can possibly lead to an accumulation of the active ingredient in Xylocaine Pump Spray dental in the blood.

2.4 Pregnancy, breast-feeding and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your dentist, doctor or pharmacist for advice before using this medicine.

Pregnancy:
Lidocaine, the active ingredient in Xylocaine Pump Spray dental, should only be used during pregnancy if your doctor considers it absolutely necessary, as no controlled studies have been carried out on pregnant women. So far there is no evidence of congenital malformations after the use of lidocaine during pregnancy. Lidocaine is known to cross the placenta after injection into the body. Studies on transfer after application to the skin or mucous membranes are not available.

Breastfeeding:
After injection into the body, lidocaine passes into breast milk in small amounts. Studies on the transfer after application to the skin or mucous membranes are not available, but a hazard to infants is unlikely.

2.5 Ability to drive and use machines:
Ask your dentist, doctor or pharmacist whether you can drive or operate machines after using Xylocaine Pump Spray dental.

3. HOW TO USE XYLOCAIN PUMPSPRAY DENTAL?

Always use Xylocaine Dental Pump Spray exactly as directed in this leaflet. Check with your dentist, doctor or pharmacist if you are not sure.

3.1 Type of application:
For use in the oral cavity.

3.2 Dosage:
In dentistry, 1 to 2 sprays are usually sufficient, depending on the size of the area to be numbed. Basically, you should only use the smallest dose with which the desired sufficient anesthesia is achieved. You should adjust the dosage according to the specifics of each individual case.

Recommended maximum doses:
The maximum dose for adults with a normal body weight (70 kg) corresponds to 20 sprays (= approx. 200 mg lidocaine, corresponding to 3 mg/kg body weight). On this basis, in individual cases, e.g. B. for children, elderly patients and people in poor general condition, the maximum dose can be calculated. For children over 12 years of age who weigh less than 25 kg, the dose should be appropriate for body weight and physical condition. In children under 12 years of age, a maximum dose of 4 to 5 mg/kg body weight should not be exceeded. Less concentrated lidocaine solutions are recommended for children younger than 3 years.

Application Notes:
A slight burning sensation that may occur during the first application will subside as the surface numbing effect quickly sets in. The superficial anesthesia of the oral mucosa occurs after 1 to 3 minutes. The anesthetic lasts about 10 to 15 minutes. After you have removed the protective cap and attached the spray cannula to the bottle, Xylocain pump spray dental is ready to use. Each press of the valve button releases approximately 100 mg of spray, which contains 10 mg of lidocaine. Do not spray Xylocaine Pump Spray dental in your eyes. If you accidentally get some spray in your eyes, you should immediately flush your eyes with running water. The spray cannula is already bent into its final shape. Therefore, before using the spray cannula, do not make any further changes to the shape. The end of the spray cannula contains the spray nebulizer and therefore must not be cut off. The spray cannulas are intended for single use and should be disposed of immediately after use. Please talk to your doctor or dentist if you have the impression that the effect of Xylocaine Pump Spray dental is too strong or too weak.

3.3 If you use more Xylocaine pump spray dental than you should:
The following symptoms may occur: agitation, restlessness, dizziness, hearing and vision disorders, tingling in the mouth (perioral), slurred speech, nausea, vomiting, tremors and muscle twitching. These so-called excitatory symptoms are signs of an impending seizure. Symptoms affecting the cardiovascular system (cardiovascular symptoms) can be: arrhythmia, rapid heartbeat, high blood pressure and reddening of the skin. As the overdose progresses, the functions of the central nervous system and the heart are suppressed (depression of central and cardiac functions) with coma, respiratory and circulatory arrest. The first symptom is often low blood pressure. If symptoms of an overdose as described above occur, the use of Xylocain Pump Spray dental must be stopped immediately. Contact your doctor immediately. He will immediately initiate the emergency measures according to the signs of illness. If you have any further questions on the use of the medicine, ask your dentist, doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of side effects is based on the following categories:

The frequency of side effects is based on the following categories:
Very often:	more than 1 in 10 treated
Frequently:	1 to 10 treated in 100
Occasionally:	1 to 10 out of 1,000 people treated
Rarely:	1 to 10 out of 10,000 people treated
Very rare:	less than 1 in 10,000 people treated
Not known:	Frequency cannot be estimated from the available data.

Possible side effects:
Certain risks cannot generally be ruled out when using a superficially anesthetic drug. In rare cases, allergic reactions, in the most severe cases an acute hypersensitivity reaction up to and including shock (anaphylactic shock) to lidocaine can occur. There have been reports of irritation at the site where xylocaine dental pump spray is applied. When using xylocaine dental pump spray in the mouth and pharynx, occasional temporary swellings in the pharynx and larynx area were observed, occasionally accompanied by hoarseness. The active ingredient is particularly well absorbed on wound surfaces and in the area of the upper respiratory tract. Although it has been proven that lidocaine is initially well tolerated even in excessive doses, side effects in the form of symptoms of poisoning cannot be ruled out if a critical amount of lidocaine in the blood is exceeded. These side effects mainly lead to symptoms in the central nervous system and in the area of the heart and vessels. The safest prevention consists in strictly adhering to the recommended dosage of lidocaine and in monitoring the effects by a doctor (visual and verbal contact with the patient). Menthol can cause laryngeal spasms in infants and children up to 2 years of age, resulting in severe breathing disorders (see section 2.1 "Xylocaine pump spray dental must not be used").

Special instructions:
Tell your dentist or doctor if you experience any side effects. He will decide what action to take. In the event of severe side effects, the use of Xylocaine Pump Spray dental should be discontinued and you should proceed as indicated in section 3.3 “If you use more Xylocaine Pump Spray dental than you should”.

Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE XYLOCAIN PUMPSPRAY DENTAL?

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton. Shelf life after opening: 3 months. The spray cannulas must not be reused and must be disposed of immediately after use (see also Section 3.2 “Dosage”).

Storage conditions:
Do not store above 25°C. If stored below 8 °C, cloudiness may occur, which disappears again at room temperature. Store upright.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

6.1 What xylocaine dental pump spray contains:
The active substance is: lidocaine. 1 spray (approx. 100 mg) contains: 10 mg lidocaine. The other ingredients are: ethanol 96%, macrogol 400, banana flavor (85509/H, Givaudan), levomenthol, saccharin, purified water. Xylocain pump spray dental contains 28.9% alcohol by volume.

6.2 What Xylocaine dental pump spray looks like and contents of the pack
The pump spray consists of a glass bottle with a dosing spray pump. The pack also contains a single-use plastic spray tip. More of these short spray cannulas are available separately. Long, sterile, single-use spray tips are also available separately. Xylocaine pump spray dental is available in packs of 50ml solution. The content of a pump spray is sufficient for approx. 500 sprays. This medicinal product also contains a medical product (spray cannula) with a CE mark.

Product Safety

For risks and side effects, read the leaflet and ask your doctor or pharmacist.
LEAFLET: INFORMATION FOR THE USER

Xylocain Pumpspray dental 10 mg/Sprühstoß
Spray for use in the oral cavity
Active ingredient: lidocaine

Product Information

product quantity : 50 ml

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Aspen Germany XYLOCAIN PUMPSPRAY DENTAL

AED 279.00
+ AED 65.00 Air Shipping

Includes any applicable VAT and customs duty.
Air shipping cost to be recalculated with delivery address at checkout.
To be delivered in 6 - 9 * working days.
100% genuine and new product.
Credit card / Cash on Delivery

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Product Return and Cancellation

In the unlikely event of receipt of a defective product, we either replace the product or refund the money paid for the product, depending on the stock availability by the Seller.

For the payment made by credit/debit card, our payment gateway company will refund the amount in full to your bank account of the card.

For Cash On Delivery orders, we will request your bank account info and wire the refund in full to your bank account, except the COD fee AED 15 for UAE.

The following are the refund timeliness associated with each payment method.

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Credit Card / Debit Card	Credit Card / Debit Card	2-3 Business working days
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