Ambroxol Hydrochloride Respiratory Solution 15mg Technical Specification:

Product Name:Ambroxol Hydrochloride Respiratory Solution
Brand Name:Mucoshield
Strength:15mg/Respule
Dosage Form:Nebuliser / Respules for inhalation Only
**Preservative Free
Route of Administration:Via Inhalation Route Only
Packing:2ml Respules
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Mucolytics, Anticough
Indication: Ambroxol works to thin down and break up phlegm (sputum).
Storage:Store below 25°C. Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Ambroxol Hydrochloride Respiratory Solution 15mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ambroxol Hydrochloride Respiratory Solution 15mg/2ml
    Composition:
    Each 2ml contains:
    Ambroxol Hydrochloride USP………….15mg
    In an isotonic solution………………………….Q.S.

THERAPEUTIC INDICATIONS:

Ambroxol works by thinning down the mucus in the airway passages, thus making the mucus less sticky and it also facilitates the removal of the mucus from the airways.

Direction Of Use:

The product should be used with a nebuliser only, under the direction of a physician. It is not to be injected or administered orally. Remove a pouch of combipack respule from the carton. Use a fresh respule for each dose.

  1. Open the sealed aluminum foil envelope and remove one ampoule from the plastic strip. Record the space provided.
  2. Gently shake the ampoule using a circular motion. Before if use.
  3. Hold the ampoule upright without squeezing and open by twisting off the top.
  4. Place the open end of the ampoule into the nebulizer cup, and slowly squeeze out all of the contents. Discard the respules after use.

CAUTION & WARNING:

CAUTION: Even invisible damage to respule caused during storage or transit may result in contamination. Do not use, and return for replacement if the solution is discoloured, leak found on squeezing or contains visible black particles.
Read enclosed leaflet before use.
Keep medicine out of reach of children.
For oral administration.
shake the bottle before use.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store the respules in foil pouch at all times. Once the foil pouch is opened the respules should be used within one month.
Store below 25°C.
Protect from light.
Do not freeze.

Dosage: Adults & Children (Above 5 years of age): One respule(15mg) twice daily.
Children (Below 5 years of age): Half Respule (7.5mg) twice daily.
Mucoshield Respules are inhaled with the aid of a nebulizer. They can also be diluted with distilled water in the ratio of 1:1.
Attach dispensing label as per end country.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Ambroxol Hydrochloride Respiratory Solution 15mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Ambroxol Hydrochloride Respiratory Solution 15mg/2ml
Composition:
Each 2ml contains:
Ambroxol Hydrochloride USP………….15mg
In an isotonic solution………………………….Q.S.


THERAPEUTIC INDICATIONS:

Ambroxol works by thinning down the mucus in the airway passages, thus making the mucus less sticky and it also facilitates the removal of the mucus from the airways.

Direction Of Use:

The product should be used with a nebuliser only, under the direction of a physician. It is not to be injected or administered orally. Remove a pouch of combipack respule from the carton. Use a fresh respule for each dose.
1. Open the sealed aluminum foil envelope and remove one ampoule from the plastic strip. Record the space provided.
2. Gently shake the ampoule using a circular motion. Before if use.
3. Hold the ampoule upright without squeezing and open by twisting off the top.
4. Place the open end of the ampoule into the nebulizer cup, and slowly squeeze out all of the contents. Discard the respules after use.

CAUTION & WARNING:

CAUTION:
Even invisible damage to respule caused during storage or transit may result in contamination. Do not use, and return for replacement if the solution is discoloured, leak found on squeezing or contains visible black particles.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FOR ORAL ADMINISTRATION.
SHAKE THE BOTTLE BEFORE USE.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store the respules in foil pouch at all times. Once the foil pouch is opened the respules should be used within one month.
Store below 25°C.
Protect from light.
Do not freeze.
Dosage: Adults & Children (Above 5 years of age): One respule(15mg) twice daily.
Children (Below 5 years of age): Half Respule (7.5mg) twice daily.
Mucoshield Respules are inhaled with the aid of a nebulizer. They can also be diluted with distilled water in the ratio of 1:1.
Attach dispensing label as per end country.