Aminophylline 250mg/10ml solution for injection ampoules

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Aminophylline

Dostupné s:

Advanz Pharma

ATC kód:

R03DA05

INN (Mezinárodní Name):

Aminophylline

Dávkování:

25mg/1ml

Léková forma:

Solution for injection

Podání:

Intravenous

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 03010300; GTIN: 5099602301238

Informace pro uživatele

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or
nurse.
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Aminophylline Hydrate 25mg/ml solution
for Injection. It will
be referred to as Aminophylline Injection for ease of use hereafter.
WHAT IS IN THIS LEAFLET
1.
What Aminophylline Injection is and what it is used for
2.
What you need to know before you are given Aminophylline Injection
3.
How you are given Aminophylline Injection
4.
Possible side effects
5.
How to store Aminophylline Injection
6.
Contents of the pack and other information
1. WHAT AMINOPHYLLINE INJECTION IS AND WHAT IT IS USED FOR
Aminophylline belongs to a group of medicines called xanthines. It
expands the air
passages of the lungs, which helps relieve chest tightness and
wheezing
(bronchospasm).
This medicine may be used to relieve difficulty breathing due to
asthma and long term
obstruction to the flow of air in the lungs.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN AMINOPHYLLINE INJECTION
YOU SHOULD NOT BE GIVEN AMINOPHYLLINE INJECTION IF YOU:
• are allergic to ethylenediamine, theophyllines, caffeine or
theobromine or any of the
other ingredients of this medicine (listed in section 6).
• suffer from porphyria.
• are treated with other xanthine drugs (used to treat chronic
bronchitis, asthma or
emphysema e.g caffeine, theophylline, theobromine).
Aminophylline should not be given to children under 6 months of age.
Make sure your doctor knows if this is the case.
YOUR DOCTOR WILL TAKE SPECIAL CARE IF ANY OF THE FOLLOWING SITUATIONS
APPLY TO
YOU:
• you are elderly
• you have a heart problem or liver disease
• you are a smoker
• you have ever had an ulcer
• you have chronic lung disease or renal disease
• y

Charakteristika produktu

OBJECT 1
AMINOPHYLLINE HYDRATE 25MG/ML SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 04-Jan-2016 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Aminophylline Hydrate 25mg/ml Solution for Injection
2. Qualitative and quantitative composition
Each 10ml of solution contains aminophylline hydrate B.P. 250mg.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Clear, sterile solution for injection, intended for parenteral
administration to human beings.
4. Clinical particulars
4.1 Therapeutic indications
Aminophylline is a complex of theophylline and ethylenediamine and is
given for its theophylline activity
to relax smooth muscle and to relieve bronchial spasm.
Aminophylline Injection is indicated for relief of bronchospasm
associated with asthma and in chronic
obstructive pulmonary disease.
4.2 Posology and method of administration
Posology:
Aminophylline Injection B.P. 250mg/10ml is for slow intravenous
administration. The solution may be
injected very slowly, or it may be infused in a small volume of either
5% dextrose or 0.9% sodium
chloride injection.
Maintenance therapy can be administered via larger volume infusion
solutions, rate-regulated to deliver
the required amount of drug each hour.
Therapeutic plasma concentrations of theophylline are considered to be
in the range of 5 to 20mcg/ml and
levels above 20mcg/ml are more likely to be associated with toxic
effects. There is marked interpatient
variation in the dosage required to achieve plasma levels of
theophylline that are within the desired
therapeutic range.
During therapy, patients should be monitored carefully for signs of
toxicity and, where possible, the
serum theophylline levels should also be monitored.
In the following dosage guidelines for the intravenous administration
of aminophylline, doses should be
calculated on the basis of lean (ideal) body weight; the drug is not
recommended for infants under 6
months of age due to the marked variation in theophylline metabolism
in infant