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Balsolene, for Colds & Respiratory Infections, Benzoin/Eucalyptus, Levomenthol, Niaouli essential oils, Inhalation solution via steam treatment, +12 years, 100ml vial, Cooper

Supportive treatment for congestion in the upper respiratory tracts. More Info
Warning: This is a medicine




    

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Balsolène, Rhume Affections Repiratoires, Benjoin du Laos/ HE d'Eucalyptus/ Levomenthol/ Niaouli, Solution pour inhalation par fumigation, +12ans, Flacon 100ml, Cooper

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  • Balsolène, Rhume Affections Repiratoires, Benjoin du Laos/ HE d'Eucalyptus/ Levomenthol/ Niaouli, Solution pour inhalation par fumigation, +12ans, Flacon 100ml, Cooper

Buy Balsolene, for Colds & Respiratory Infections, Benzoin/Eucalyptus, Levomenthol, Niaouli essential oils, Inhalation solution via steam treatment, +12 years, 100ml vial, Cooper

Warning: This is a medicine. Please ensure you carefully read all literature provided with your product prior to use. In case of doubt, ask your Doctor or Pharmacist for advice before taking this medicine.

1. NAME OF DRUG


BALSOLENE Inhalation Solution via steam treatment

2. QUALITATIVE AND QUANTITATIVE COMPOSITION


Eucalyptus Essential Oil .........................................................................1.165 g
Niaouli Essential Oil ................................................................................0.720 g
Levomenthol ........................................................................................... 0.720 g
Benzoin ................................................................................................... 1.350 g
Per 100ml of inhalation solution.
Total alcoholic strength: 60 % (V/V).
To see a complete list of dilutants, see section 6.1.

3. PHARMACEUTICAL FORM


Inhalation Solution via steam treatment

4. CLINICAL DATA


4.1. Therapeutic Indications
Supportive treatment for congestion in the upper respiratory tracts.

4.2. Dosage and how to use
Suitable for adults and, children over the age of 12 years old.
Inhalation via steam treatment - DO NOT SWALLOW.
Pour a teaspoon of the solution in a bowl of hot water (not boiling) and breathe in the vapours.
Repeat this 3 times per day.

4.3. Contraindications
· allergy to one of its components,
· linked to the terpene content: children with history of convulsions (feverish or not).

4.4. Special warnings and side effects
Special warnings
This contains terpene derivatives (eucalyptus, niaouli, levomenthol) which with excessive doses can cause:
- convulsions for the newborn and children
- respiratory pauses or collapses for newborns.
Keep to the recommended doses and guidelines: do not exceed the recommended doses.
Precautions for use
- If symptoms persist and/or signs of a secondary infection occur, the treatment must be re-evaluated.
- DO NOT SWALLOW.
- In case of an allergic reaction, stop treatment.
- Due to the terpene derivatives in this drug, patients with a history of epilepsy need to be careful.

4.5. Interactions with other drugs
Not applicable.

4.6. Pregnancy and breast feeding
It is not advisable to take this drug during breast feeding due to:
- lack of kinetic data on the passing of the terpene derivatives into the human milk,
- the potential neurological toxicity for the baby.

4.7. Effects on the ability to drive and operate machinery
No effects on the ability to drive vehicles or use machinery have been found.

4.8. Side effects
- Possible local irritation or allergy.
- Due to the terpene derivative content and not respecting the prescribed dose:
- Risk of convulsions for children and babies,
- Possibility of agitation and confusion among elderly patients.

4.9. Overdose
Not applicable.

5. PHARMACOLOGICAL PROPERTIES


5.1. Pharmaco-dynamic properties
Pharmaco-therapeutic class: DECONGESTANT.
(R. Respiratory system)
Terpene derivatives (eucalyptus, niaouli, levomenthol) can lower the seizure threshold.

5.2. Pharmacokinetics properties
Not known.

5.3. Preclinical safety data
Not known.

6. PHARMACEUTICAL DATA


6.1. List of dilutants
96% ethanol, purified water.

6.2. Incompatibilities
Not applicable.

6.3. Shelf life
5 years.

6.4. Storage precautions
Store in a place below 25°C.

6.5. Nature and contents of outside packaging

100 ml or 125ml glass vial (type III), closed with a lid made of polyethylene.

6.6. Precautions for handling and disposal
No specific requirements.

7. THE MARKETING AUTHORISATION HOLDER


COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX

8. NUMBER OF THE MARKETING AUTHORSATION HOLDER


· 315 389-1125 ml in a vial (colourless glass).
· 389 702-5 or 34009 389 702 5 8: 100 ml bottle (colourless glass).

9. START/RENEWEL DATE OF AUTHORISATION

[To be completed by holder]

10. DATE OF UPDATE OF TEXT

[To be completed by holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION

Not applicable.


If your symptoms persist, consult your doctor.


Last updated the 15/04/2019 at 07:05
Additional Information
Brand Cooper
Symptom Respiratory disease, Cold
Pour qui A partir de 12 ans
Forme Flacon
Femme enceinte No
Pour diabétique No
Homéopathie No
acl code 3400938970258
EAN 3400938970258

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