OMEGAPHARM ACETYLCYSTEINE 2000 mg/ 10 mL acetylcysteine solution for inhalation vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

acetylcysteine, Quantity: 2000 mg

Available from:

Omegapharm

INN (International Name):

acetylcysteine

Pharmaceutical form:

Solution

Composition:

Excipient Ingredients: disodium edetate; sodium hydroxide; water for injections; hydrochloric acid

Administration route:

Intratracheal, Nasal

Units in package:

10 x 10 mL vials, 1 x 10mL vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adjuvant therapy for patients with abnormal, viscid or inspissated mucous secretions in such conditions as: - chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung); - acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis); - pulmonary complications of cystic fibrosis; - pulmonary complications associated with surgery; - post-traumatic chest conditions; - atelectasis due to mucus obstruction; - tracheostomy care; - anaesthesia. Acetylcysteine may also be used as an adjunct to diagnostic bronchial studies (bronchograms, bronchospirometry and bronchial wedge catheterisation).

Product summary:

Visual Identification: Clear colourless solution; Container Type: Vial; Container Material: Glass; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-02-28

Patient Information leaflet

Omegapharm Acetylcysteine Solution for Inhalation
1/6
v1.1 March 2011
OMEGAPHARM ACETYLCYSTEINE SOLUTION FOR INHALATION
_(as-et-il-cist-ene)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Omegapharm
Acetylcysteine Solution for
Inhalation.
It does not contain all the available information.
It does not take the place of talking with your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of your treatment using
Omegapharm Acetylcysteine Solution for Inhalation against the benefits
they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT OMEGAPHARM ACETYLCYSTEINE SOLUTION FOR INHALATION IS USED FOR
The name of your medicine is Omegapharm Acetylcysteine Solution for
Inhalation. It contains the
active ingredient called acetylcysteine.
Omegapharm Acetylcysteine Solution for Inhalation reduces the
stickiness of fluid in your airways
and lungs, making it more liquid.
Omegapharm Acetylcysteine Solution for Inhalation is used in patients
with abnormal, sticky or
thick mucous secretions in conditions such as:
•
ongoing lung disease such as pneumonia, bronchitis, emphysema,
tuberculosis and
other conditions that affect your breathing
•
short term lung disease such as pneumonia or bronchitis
•
lung problems of cystic fibrosis
•
lung problems occurring after an accident or after surgery
•
other lung problems associated with having mucus in your airway
Omegapharm Acetylcysteine Solution for Inhalation may also be used:
•
when you are having tests carried out on your lungs
•
as part of tracheostomy care
•
when you are receiving an anaesthetic
Your doctor may have prescribed Omegapharm Acetylcysteine Solution for
Inhalation for another
reason. Ask your doctor if you have any questions about why Omegapharm
Acetylcysteine
Solution for Inhalation has been prescribed for you.
There is no

Summary of Product characteristics

Omegapharm Acetylcysteine Solution 200 mg/mL
1/5
v1.0 Feb 2011
PRODUCT INFORMATION
OMEGAPHARM ACETYLCYSTEINE SOLUTION FOR INHALATION
NAME OF THE MEDICINE
Acetylcysteine
Acetylcysteine is a white, crystalline powder with a slight acetic
odour. It is soluble in water and
alcohol and practically insoluble in chloroform, dichloromethane and
ether.
Acetylcysteine is the _N_-acetyl derivative of the naturally occurring
amino acid, L-cysteine. The
chemical name is _N_-acetyl-mercapto-alanine.
Chemical Name: (2_R_)-2-acetamino-3-sulfanylpropanoic acid
Molecular Formula: C
5
H
9
NO
3
S.
Molecular Weight: 163.2
CAS Registry Number: 616-91-1.
DESCRIPTION
Acetylcysteine solution is a sterile solution for inhalation
(mucolytic agent) containing the active
ingredient acetylcysteine 20%w/v (200 mg/mL) and the inactive
ingredients disodium edetate,
sodium hydroxide and water for injections. The product may also
contain hydrochloric acid for pH
adjustment. The pH of the product is maintained in the range of 6.0
– 7.5.
The solution is presented in clear glass vials containing 4 mL or 10
mL of solution.
This product is not for injection.
PHARMACOLOGY
Acetylcysteine, the _N_-acetyl derivative of the naturally occurring
amino acid L-cysteine, is neither
an enzyme nor a detergent. The viscosity of pulmonary mucous
secretions depends on the
concentrations of mucoprotein and to a lesser extent deoxyribonucleic
acid (DNA). The latter
increases with increasing purulence owing to cellular debris. The
mucolytic action of
acetylcysteine is related to the sulfhydryl group in the molecule.
This group probably 'opens'
disulfide linkages in mucus, thereby lowering the viscosity. The
mucolytic activity of
acetylcysteine is unaltered by the presence of DNA, and increases with
increasing pH. Significant
mucolysis occurs between pH 7 and 9.
PHARMACOKINETICS
Acetylcysteine is the acetyl derivative of the normally occurring
amino acid, L-cysteine. Any
absorbed acetylcysteine probably undergoes deacetylation and the
remaining cysteine follows
the nor