Pulmicort 0.25 mg/ml 20 sterile single dose units x 2 ml

Pulmicort 0.25 mg/ml 20 sterile single dose units x 2 ml

Composition:

Active ingredient:
budesonide (micronized).
Excipients: disodium edetate, sodium chloride, sodium citrate, citric acid, polysorbate 80, purified water.

Product Description:

Inhaled corticosteroid used for control and prevention of asthma symptoms (wheezing, shortness of breath).
Budesonide acts locally in the lungs, reducing airway inflammation and swelling, thereby improving breathing.
It is intended for regular use and is not suitable for immediate relief of acute asthma attacks.

Indications for Use:

Maintenance therapy for asthma.
Preventive therapy in children aged 12 months to 8 years.
Not indicated for acute bronchospasm.

Method of Administration and Dosage:

• Dosage is individualized by the physician depending on severity, age, formulation, and comorbidities.
• Single‑dose vials are administered via jet nebulizer connected to an air compressor.
• Medication is inhaled through a mouthpiece or face mask.

Contraindications:

Primary treatment of status asthmaticus or other acute asthma episodes requiring intensive measures.
Hypersensitivity to budesonide or excipients.

Precautions:

• Use with caution in patients with:
  Allergy to milk proteins.
  Pulmonary tuberculosis.
  Untreated bacterial, viral, fungal, or parasitic infections.
  Ocular herpes infections.
  Lack of vaccination against measles or chickenpox.
  Reduced bone mineral density.
  Eye disorders (glaucoma, cataracts, increased intraocular pressure).
  Liver impairment.
  Pregnancy and breastfeeding.

Adverse Reactions / Side Effects:

• Common: cough, conjunctivitis, nosebleeds, rash, rhinitis, nasal congestion, respiratory infections (cold, otitis).
• Rare/serious: paradoxical bronchospasm, increased infection risk, reduced bone density, growth retardation in children.
• Other: severe allergic reactions, glaucoma, cataracts, adrenal insufficiency.

Pregnancy and Lactation:

Use only if prescribed by a physician, after benefit/risk assessment.

Storage Conditions:

Store at temperatures not exceeding 25 °C.
Single‑dose vials may be stored for 2 weeks after opening the foil envelope.

Packaging:

Carton box containing 20 vials of 2 ml.