Active ingredients: Nedocromil (sodium nedocromil)
TILADE 10 mg / 2 ml solution to be nebulised
Tilade package inserts are available for pack sizes:- TILADE 10 mg / 2 ml solution to be nebulised
- TILADE 2 mg / actuation pressurized suspension for inhalation
Why is Tilade used? What is it for?
Anti-asthmatic, anti-allergic.
Prevention of relapses of bronchial asthma attacks.
Contraindications When Tilade should not be used
Tilade nebuliser solution is contraindicated in patients with known hypersensitivity to any of the constituents of the formulation.
Precautions for use What you need to know before taking Tilade
Tilade should not be used to resolve an acute asthmatic attack.
Interactions Which drugs or foods can change the effect of Tilade
Tell your doctor or pharmacist if you have recently taken any other medicines.
Nedocromil sodium has been used in combination with numerous other drugs in humans, including oral or inhaled beta-adrenergic agonists, oral or inhaled corticosteroids, theophylline and other derivatives of methylxanthines and ipratropium bromide. Harmful interactions have been observed in both humans and animals
Warnings It is important to know that:
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Studies in animals, during pregnancy and during lactation, did not reveal harmful effects with sodium nedocromil. However, as with all drugs, caution is advised during pregnancy (particularly in the first trimester) and during breastfeeding.
Based on animal studies and the physico-chemical characteristics of nedocromil, it is believed that only minimal amounts pass into human breast milk. There are no data to suggest that the use of nedocromil sodium by lactating women may have any effects. negative about the child.
Effects on ability to drive and use of machines
No effect.
Dose, Method and Time of Administration How to use Tilade: Posology
Adults and children: one vial sprayed with a normal aerosol device 2 times a day. In the opinion of the doctor, the dosage can be increased up to 4 ampoules per day. Tilade is not a symptomatic drug, and as such cannot be used to resolve an acute asthma attack. Only the regularity of use of the product allows to obtain an adequate therapeutic response. Tilade can be used concomitantly with common asthma medications.
Instructions for Use
- Make sure that the aerosol device is working properly before filling it.The ampoule of the device must be perfectly clean before filling with Tilade solution to be nebulised.
- Close the ampoule of the device, turn on the device and bring the mask to cover the nose and mouth. Breathe slowly and deeply until the liquid is exhausted.
Attention: the nebulization time varies according to the device. In general, the administration is considered finished when the cloud begins to come out intermittently rather than continuously. A small part of the liquid will be retained by the device; this residual volume varies according to the device used. This quantity cannot be used for subsequent administrations.
After use, thoroughly clean all parts of the appliance wetted by the solution with water, then leave them to dry in the air.
NOTE:
- The vial breaks easily, without a file. The glass is thinned at the ends so that they can be broken with the hands.
- Hold the vial at an angle as shown in the drawing; break off the lower end (the solution will not come out).
- Turn the vial so that the broken end is at the top.
- Carefully place the index finger on the open part. Keeping the finger firmly, break off the lower part.
- Place the vial over the aerosol ampoule and release the index finger. The solution will come out of the vial.
- While breaking the ends, keep the vial away from the "ampoule" of the apparatus.
Overdose What to do if you have taken too much Tilade
Animal studies have shown no evidence of significant toxic effects with nedocromil sodium even at high doses, nor have long-term studies with nedocromil sodium in humans shown any safety hazard with the drug.
Overdose is therefore unlikely to cause any problems. However, in the event of a suspected overdose, treatment should be supportive and directed at controlling the relevant symptoms.
In case of accidental ingestion / intake of an excessive dose of Tilade, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of Tilade, ask your doctor or pharmacist.
Side Effects What are the side effects of Tilade
Like all medicines, Tilade can cause side effects, although not everybody gets them.
The following frequency scale was used when applicable:
Very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1000 to <1/100), rare (≥1 / 10,000 to <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
In clinical studies in patients receiving pre-dose inhaler nedocromil sodium the following undesirable effects were reported at the corresponding frequencies:
Gastrointestinal disorders
Very common: abdominal pain, vomiting, nausea
Common: dyspepsia
Respiratory, thoracic and mediastinal disorders
Very common: cough, bronchospasm
Nervous system disorders
Very common: headache
Common: dysgeusia
Rash, itching, flushing and pharyngeal irritation have also been reported. Some patients have reported a bitter taste sensation.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
Use the product within the expiration date indicated.
Store away from direct sunlight. Do not freeze.
Keep out of the reach and sight of children.
Other Information
Composition
Each 2ml vial of 0.5% aqueous solution contains:
active ingredient: sodium nedocromil 10 mg
excipients: distilled water and sodium chloride.
PHARMACEUTICAL FORM AND CONTENT
36 vials of 2 ml of 0.5% aqueous solution for aerosol use only.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
TILADE 10 MG / 2 ML SOLUTION TO NEBULIZE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
TILADE 10 mg / 2 ml solution to be nebulised
Each 2ml aerosol vial contains:
Active ingredient: nedocromil sodium 10 mg.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Solution in ampoules to be administered topically by inhalation by means of an aerosol device.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Prevention of relapses of bronchial asthma attacks.
04.2 Posology and method of administration
Adults and children: 1 spray vial using a normal aerosol device 2 times a day. In the opinion of the physician, the dosage can be increased up to 4 times a day.
Instructions for use (see point 6.6).
TILADE must be used regularly every day. TILADE is not a symptomatic drug and as such cannot be used to resolve an acute asthma attack. Only its continued use induces the remission of symptoms.
TILADE can be used concomitantly with common asthma medications.
04.3 Contraindications
Tilade nebuliser solution is contraindicated in patients with known hypersensitivity to any of the constituents of the formulation.
04.4 Special warnings and appropriate precautions for use
Tilade should not be used to resolve an acute asthmatic attack.
04.5 Interactions with other medicinal products and other forms of interaction
Nedocromil sodium has been used in combination with numerous other drugs in humans, including oral or inhaled beta-adrenergic agonists, oral or inhaled corticosteroids, theophylline and other derivatives of methylxanthines and ipratropium bromide. Harmful interactions have been observed in both humans and animals.
04.6 Pregnancy and breastfeeding
Studies in animals, during pregnancy and during lactation, did not reveal harmful effects with sodium nedocromil. However, as with all drugs, caution is advised during pregnancy (particularly in the first trimester) and during breastfeeding.
Based on animal studies and the physico-chemical characteristics of nedocromil, it is believed that only minimal amounts pass into human breast milk. There are no data to suggest that the use of nedocromil sodium by lactating women may have any effects. negative about the child.
04.7 Effects on ability to drive and use machines
No effect.
04.8 Undesirable effects
The following frequency scale was used when applicable:
Very common (≥1 / 10), common (≥1 / 100,
In clinical studies in patients receiving pre-dose inhaler nedocromil sodium the following undesirable effects were reported at the corresponding frequencies:
Gastrointestinal disorders
Very common: abdominal pain, vomiting, nausea
Common: dyspepsia
Respiratory, thoracic and mediastinal disorders
Very common: cough, bronchospasm
Nervous system disorders
Very common: headache
Common: dysgeusia
Rash, itching, flushing, pharyngeal irritation have also been reported.
Some patients have reported a bitter taste sensation.
04.9 Overdose
Animal studies have shown no evidence of significant toxic effects with nedocromil sodium even at high doses, nor have long-term studies with nedocromil sodium in humans shown any safety hazard with the drug.
Overdose is therefore unlikely to cause any problems. However, in the event of a suspected overdose, treatment should be supportive and directed at controlling the relevant symptoms.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
ATC code: R03BC03.
The pharmacology of sodium nedocromil has been studied in a series of animal models particularly suitable for verifying the activity of antiasthmatic substances.
Two of these models are of particular relevance: the immunological reaction and non-specific bronchial hyper-reactivity.
The immunological reaction involves two distinct types of mast cell: mucosal and connective tissue.
Pharmacological studies with sodium nedocromil have shown that the compound is highly effective in inhibiting the release of chemical mediators of both mast cell classes, unlike what happens for other compounds of this type active only on connective mast cells. It has been shown that nedocromil sodium is able to inhibit or significantly attenuate the bronchoreactive response to both specific and non-specific provocations both in the animal model and in humans. Sodium nedocromil has been shown to be particularly active in those models in which other compounds of the same class have shown poor efficacy, such as, for example, the inhibition of bronchospasm induced by adenosine and sulfur dioxide.
05.2 Pharmacokinetic properties
Sodium nedocromil administered by inhalation is rapidly absorbed from the bronchial tubes while absorption from the intestine is very modest (about 2%). The absorbed drug is rapidly eliminated in the bile and urine in an unmetabolized form. The drug does not accumulate. in the body.
05.3 Preclinical safety data
Nedocromil sodium has a very low toxicity index.
The LD 50 for both oral and subcutaneous administration in rats is greater than 4000 mg / kg. Chronic administration in various animal species and by various routes of administration revealed little or no signs of toxicity.
Furthermore, nedocromil sodium has no effect on fertility or reproduction and is devoid of teratogenic effects. Carcinogenicity studies in both rats and mice have shown that the compound is devoid of carcinogenic effects.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Each 2ml aerosol vial contains:
Excipients: sodium chloride, sterile water to taste
06.2 Incompatibility
Not described.
06.3 Period of validity
Solution to be sprayed: 24 months.
06.4 Special precautions for storage
Store away from direct sunlight. Do not freeze.
Do not use after the expiration date indicated on the package.
06.5 Nature of the immediate packaging and contents of the package
Box containing 36 yellow glass vials of 2 ml of 0.5% solution.
06.6 Instructions for use and handling
1. Make sure that the aerosol device is working properly before filling it.
The ampoule of the device must be perfectly clean before filling with Tilade solution to be nebulised.
2. Close the ampoule of the device, turn on the device and bring the mask to cover the nose and mouth. Breathe slowly and deeply until the liquid is exhausted.
Attention: the nebulization time varies according to the device. In general, the administration is considered finished when the cloud begins to come out intermittently rather than continuously. A small part of the liquid will be retained by the device; this residual volume varies according to the device used. This quantity cannot be used for subsequent administrations.
After use, thoroughly clean all parts of the appliance wetted by the solution with water, then leave them to dry in the air.
NOTE: Opening the vial
The vial breaks easily, without a file. The glass is thinned at the ends so that they can be broken with the hands.
Hold the vial at an angle; break off the lower end (the solution will not come out).
Turn the vial so that the broken end is at the top.
Carefully place the index finger on the open part. Keeping the finger firmly, break off the lower part.
Place the vial over the aerosol ampoule and release the index finger. The solution will come out of the vial.
While breaking the ends, keep the vial away from the "ampoule" of the apparatus.
07.0 MARKETING AUTHORIZATION HOLDER
Sanofi S.p.A. - Viale L. Bodio, 37 / B - Milan
08.0 MARKETING AUTHORIZATION NUMBER
Tilade 10 mg / 2 ml solution to be nebulised: AIC n ° 026632036
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Tilade 10 mg / 2 ml solution for nebulisation: 31.10.1994 / 15.11.2009
10.0 DATE OF REVISION OF THE TEXT
October 2014
