Nuelin Syrup

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Theophylline 5.33 mg/mL;  ;  

Tilgjengelig fra:

iNova Pharmaceuticals (New Zealand) Limited

INN (International Name):

Theophylline 5.33 mg/mL

Dosering :

80 mg/15mL

Legemiddelform:

Syrup

Sammensetning:

Active: Theophylline 5.33 mg/mL     Excipient: Berry citrus blend AA001115 flavour Methyl hydroxybenzoate Propyl hydroxybenzoate Purified water Sorbitol Sucrose

Enheter i pakken:

Bottle, plastic, Amber PET with PP child resistant TE cap, 500 mL

Klasse:

Restricted

Resept typen:

Restricted

Produsert av:

BASF PharmaChemikalien GmbH & Co KG

Produkt oppsummering:

Package - Contents - Shelf Life: Bottle, plastic, Amber PET with PP child resistant TE cap - 500 mL - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, Amber PVC with PP TE screw cap and wad - 500 mL - 24 months from date of manufacture stored at or below 30°C

Autorisasjon dato:

1977-11-08

Informasjon til brukeren

NEULIN™ SYRUP
1
NUELIN™ SYRUP
(new-lin)
_Theophylline syrup 133.3 mg/25 mL (thee-off-o-lin) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Nuelin Syrup. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
Throughout this leaflet we are talking
about the 'patient'. By that we mean
either you or your child, whoever is
taking Nuelin Syrup.
ALL MEDICINES HAVE RISKS AND
BENEFITS. YOUR DOCTOR OR
PHARMACIST HAS WEIGHED THE RISKS
AND BENEFITS OF THE PATIENT TAKING
NUELIN AGAINST THE BENEFITS THEY
EXPECT IT WILL HAVE FOR THE PATIENT.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE OR GIVING IT TO
YOUR CHILD, ASK YOUR DOCTOR OR
PHARMACIST.
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE TAKING THIS MEDICINE OR
GIVING IT TO YOUR CHILD.
If the information in this leaflet is not
clear, or if you have any questions
that are not covered by this leaflet,
please ask your doctor or pharmacist.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
Nuelin Syrup can be bought from a
pharmacy without a doctor's
prescription on the advice of a
pharmacist.
WHAT NUELIN SYRUP IS
USED FOR
The name of the medicine is Nuelin
Syrup. It is used to treat asthma and
other conditions where breathing is
difficult. It also helps to prevent
asthma attacks. The active ingredient
in Nuelin Syrup is theophylline,
which causes the muscle lining of the
airways to relax.
Your doctor or pharmacist may
recommend Nuelin Syrup for another
purpose.
If you are not sure why the patient is
taking this medicine, please ask your
doctor or pharmacist.
BEFORE TAKING NUELIN
SYRUP
_WHEN THE PATIENT MUST NOT _
_TAKE NUELIN SYRUP _
NUELIN SYRUP SHOULD NOT BE TAKEN
IF THE PATIENT IS ALLERGIC TO:

theophylline

aminophylline

caffeine,

any of the ingredients listed at the
end of this leaflet
SOME OF THE SYMPTOMS OF AN
ALLERGIC REACTION MAY INCLUDE:

shortness of breath

wheezing or difficulty breathing

swelling

Preparatomtale

NEW ZEALAND DATA SHEET
NUELIN
TM
SYRUP
NUELIN Syrup
Page 1 of 7
1 PRODUCT NAME
NUELIN 80 mg/15 mL Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Theophylline BP 80 mg/15 mL
Excipients with known effects:
Methy lhydroxybenzoate
Propyl hydroxybenzoate
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
A clear, almost colourless liquid with a pleasant odour. Each 25mL
unit dose contains
Theophylline BP 133.3mg in a fruit flavoured aqueous vehicle.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
NUELIN syrup is indicated for the relief and prophylaxis of reversible
bronchospasm associated
with asthma, chronic bronchitis and emphysema.
4.2
Dose and method of administration
Desirable therapeutic levels are considered to be between 10-20 µg/mL
(55-110 µmol/L). Higher
levels may produce toxic effects. Toxic effects may also occur at
therapeutic levels. When
maximum response is required, dose levels should be individually
titrated. Serum theophylline
may be monitored to confirm that levels are within the therapeutic
range.
_Adults _
25mL every six hours.
_Paediatric population_
_ _
Children (from 6 months to 16 years) have a more rapid clearance of
theophylline resulting
in the need for higher per kg doses.
Children under 2 years: Not to be given except on the advice of a
physician.
Children over 2 years: 1mL/kg bodyweight (up to a maximum of 25mL)
every six hours.
NUELIN doses should be adjusted for factors known to affect
theophylline clearance (see section
4.4_ _and section 4.5).
4.3
Contraindications
Hypersensitivity to the active ingredient or excipients listed in
section 5.1 or to xanthines.
NEW ZEALAND DATA SHEET
NUELIN
TM
SYRUP
NUELIN Syrup
Page 2 of 7
4.4
Special warnings and precautions for use
Theophylline monitoring
As there is a correlation between plasma levels of theophylline and
therapeutic effect, and as
patient response can vary considerably due to variable rates of
elimination, monitoring plasma
levels in individual patients is strongly recommended.
If side effects appear