Aminophylline 250mg/10ml solution for injection ampoules

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Aminophylline

제공처:

hameln pharma Ltd

ATC 코드:

R03DA05

INN (International Name):

Aminophylline

복용량:

25mg/1ml

약제 형태:

Solution for injection

관리 경로:

Intravenous

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 03010300; GTIN: 5016386000096

환자 정보 전단

PATIENT INFORMATION LEAFLET
AMINOPHYLLINE INJECTION 250 MG IN 10 ML
1. What Aminophylline Injection 250 mg in
10 ml is and what it is used for
Aminophylline Injection 250 mg in 10 ml belongs
to a group of medicines known as xanthines,
which can stimulate breathing. It is used to treat
BREATHING DIFFICULTIES
associated with:
•
HEART FAILURE
•
REVERSIBLE
AIRWAY
OBSTRUCTION
,
as
in
ACUTE ASTHMA
or acute spasm of the airways
(BRONCHIAL SPASM)
.
2. What you need to know before you use
Aminophylline Injection 250 mg in 10 ml
DO NOT USE AMINOPHYLLINE INJECTION 250
MG IN 10 ML:
• if you are
SENSITIVE
or ALLERGIC
to Aminophylline
Injection ethylenediamine, theophylline, caffeine
or theobromine or any of the other ingredients in
this injection.
• if
you
are
taking
similar
medicines
e.g.
THEOPHYLLINE
or AMINOPHYLLINE tablets.
• if you have
PORPHYRIA
(a condition that affects
your blood).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR, PHARMACIST OR NURSE
BEFORE USING AMINOPHYLLINE INJECTION 250
MG IN 10 ML:
• if you have a
PEPTIC ULCER
• if you have an
OVERACTIVE THYROID
• if you have pressure in the eyes (known as
GLAUCOMA
)
• if you are a
DIABETIC
• if you are
EPILEPTIC
• if you have
HIGH BLOOD PRESSURE or HEART
DISEASE
• if you have
LOW BLOOD OXYGEN
• if you suffer from
POOR CIRCULATION
• if you have
HEART
or
LUNG FAILURE
• if you have chronic
BRONCHITIS
• if
you
are
a
SMOKER
or
you
are
regularly
EXPOSED
to tobacco
SMOKE
.
Important information about your medicine
►
Your doctor or nurse will give you the injection
►
If this injection causes you any problems talk to your doctor, nurse
or pharmacist
►
Please tell your doctor or pharmacist, if you have any other medical
conditions or have an allergy to
any of the ingredients of this medicine
►
Please tell your doctor or pharmacist, if you are taking any other
medicines
•
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
In some circumstances
THIS MAY NOT BE POSSI

제품 특성 요약

OBJECT 1
AMINOPHYLLINE INJECTION BP
Summary of Product Characteristics Updated 28-Jan-2015 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Aminophylline Injection BP
2. Qualitative and quantitative composition
Each ml contains 25mg of Aminophylline Ph Eur
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Sterile Injection
4. Clinical particulars
4.1 Therapeutic indications
Disease of the cardiovascular system (e.g. an adjunct in the treatment
of pulmonary oedema or
paroxysmal nocturnal dyspnoea caused by left ventricular heart
failure), reversible airways obstruction
including status asthmaticus and acute bronchospasm.
4.2 Posology and method of administration
Aminophylline Injection BP may be given by slow intravenous injection
or intravenous infusion in
glucose injection or sodium chloride injection.
Aminophylline has a narrow therapeutic index, therefore cautious
dosage determination is essential.
Therapeutic serum concentrations of theophylline are considered to
range from 10 to 20 mcg/ml and
levels greater than 20 mcg/ml are often associated with toxic effects.
A range of 5 to 15 mcg/ml may be
effective, and associated with fewer adverse effects.
The dosage should be titrated for each individual and adjusted with
caution. Serum theophylline levels
should be monitored to ensure that they remain within the therapeutic
range. During therapy, patients
should be monitored carefully for signs of toxicity.
ELIMINATION OF THEOPHYLLINE IN CHILDREN YOUNGER THAN 6 MONTHS OF AGE,
ESPECIALLY IN NEONATES,
APPEARS TO BE REDUCED. BECAUSE OF THIS VARIATION IN METABOLISM THE USE
OF AMINOPHYLLINE INJECTION
IN CHILDREN UNDER 6 MONTHS OF AGE IS NOT RECOMMENDED.
USE IN PATIENTS NOT CURRENTLY RECEIVING THEOPHYLLINE PREPARATIONS
To minimise adverse effects, IV Aminophylline should be administered
slowly, at a rate not exceeding
25mg Aminophylline per minute, up to a dose of 250-500mg (5mg/kg). If
patients experience acute
adverse effects while loading doses are being infused, the infusion
may be