Ambroxol hydrochloride injection

It has been approved that 1ml can be used in Children by China FDA. Also, it can be widely used for nebulization in China.

Active ingredient: Ambroxol Hydrochloride
Description: A colorless clear liquid

Dosage form:  liquid injection
Indications

This product is indicated for acute and chronic lung diseases accompanied by abnormal secretion of sputum and poor sputum function, the expectorant treatment for chronic bronchitis exacerbation, asthmatic bronchitis and bronchial asthma for example. It can also be used for prevention of pulmonary complications after surgery and treatment of infant respiratory distress syndrome (IRDS) in preterm and neonates.
Strength: 1ml: 7.5 mg

Storage: Sealed and kept under 30℃
Packaging: Brown glass ampoules, 5 ampoules/box and 6 ampoules/box, 120 boxes/craton (Can be customized)
Shelf life: 24 months
Dosage and administration

Prevention and treatment: Children aged 2-6:3 times a day, 7.5 mg each time; children under 2 years: 2 times a day, 7.5 mg each time. All are slow intravenous infusion.
Treatment of infant respiratory distress syndrome (IRDS): The total daily dose is calculated based on infant weight and 30 mg/kg is administered in 4 divided doses.
Syringe pumps should be used for administration with at least 5 minutes of intravenous injection duration.
The injection can also be used intravenously with glucose, fructose, saline or Ringer's solution.
Contraindication: It is known that allergy to ambroxol hydrochloride or other formulation ingredients should not be used.
Precaution
1. Warning There was a report of severe anaphylactic shock on this product in the post-market safety monitoring, therefore, it should be used with caution in patients with a special population, allergies, and hypersensitivity (such as the airway hyper responsiveness of bronchial asthma).If an allergic reaction occurs after medication, the drug should be discontinued immediately and given symptomatic treatment according to the severity of the reaction. Once anaphylactic shock occurs, first aid should be given immediately.
2. Use caution The following conditions should be treated with caution:= 1*GB3 eq oac(0,1)1Liver, renal insufficiency patients;= 2*GB3 eq oac(0,2)2Gastric ulcer patients; = 3*GB3 eq oac(0,3)3Patients with impaired bronchial cilia motor function and a large amount of secretions in the respiratory tract (Patients with malignant cilia syndrome may have a risk of secretions blocking the airways); = 4*GB3 eq oac(0,4)4Glaucoma patients.
3. General precautions
(1)  It is forbidden to mix this product with other drugs in the same container. Pay attention to the compatibility of the drug. Special care should be taken to avoid compatibility with cephalosporin antibiotics and Chinese medicine injections.
(2) Do not mix this product (pH 5.0) with other alkaline solutions with a pH greater than 6.3, as the increase in pH will cause precipitation of free base.
(3) If the injection speed is too fast during intravenous administration, very few patients may experience headaches, fatigue, exhaustion, and heavy lower limbs.
(4) In rare cases, severe skin reactions have occurred, such as Stevens-Johnson syndrome and Lyell’s syndrome (toxic epidermal necrolysis; TEN), and the appearance of these symptoms is related to the state of the patient at the time of use. Most of the above cases are caused by underlying diseases or concomitant medications. If a patient develops new skin or mucosal damage after use, stop using the product and promptly report to the doctor.
Pregnant and lactating women medication
Preclinical testing and extensive clinical experience after 28 weeks of gestation show no adverse effects on pregnancy. However, drugs should be used with caution during pregnancy, especially during the first trimester of pregnancy. The drug can enter the milk, but the therapeutic dose should have no effect on the baby.
Children medication: Refer to dosage and administration
Elderly medication: No special precautions
Medicine interactions: Combination therapy of this product and antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) in can increase the concentration of antibiotics in lung tissue.
Overdose: So far there have been no reports of symptoms on overdose of this medicine.

Packaging: Brown glass ampoules, 6 ampoules/box (Can be customized)