E-Z-HD powder

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Barium sulfate

Inapatikana kutoka:

Bracco UK Ltd

INN (Jina la Kimataifa):

Barium sulfate

Dawa fomu:

Oral suspension

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF:

Taarifa za kipeperushi

E-Z-HD
®
98 % W/W POWDER FOR ORAL SUSPENSION
barium sulfate
PACKAGE LEAFLET: INFORMATION FOR THE USER
E-Z-HD
®
98 % W/W POWDER FOR
ORAL SUSPENSION
barium sulfate
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,
radiographer or nurse helping you with your X-ray
examination.
•
This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, even if their signs of illness
are the same as yours.
•
If you get any side effects, talk to your doctor, radiographer
or nurse. This includes any possible side effects not listed in
this leaflet. See section 4
IN THIS LEAFLET:
1.
What E-Z-HD is and what it is used for
2.
What you need to know before you use E-Z-HD
3.
How to use E-Z-HD
4.
Possible side effects
5.
How to store E-Z-HD
6.
Contents of the pack and other information
1. WHAT E-Z-HD IS AND WHAT IT IS USED FOR
E-Z-HD belongs to a group of medicines called ‘contrast media’.
It is used when you have an X-ray of your digestive system. It
contains a chemical that helps the X-ray show up. This gives a
clearer ‘picture’ of your digestive system on the X-ray.
E-Z-HD will be given to you as a drink.
This medicine is for diagnostic use only. It only helps to diagnose
a problem. It cannot be used to treat any diseases.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE E-Z-HD
DO NOT USE E-Z-HD IF YOU:
•
are allergic to barium sulfate or any of the other ingredients
of E-Z-HD (listed in section 6)
•
know that you have a hole in your bowel or stomach
(gastrointestinal perforation)
•
know that you have an abnormal passage connecting your
stomach with your bowel (gastrointestinal fistula)
•
suffer from bleeding in your bowel or stomach
•
suffer from insufficient blood supply (ischaemia) of the
bowel wall
•
have an enlarged bowel - a condition called megacolon or
toxic megacolon
•
have an inflamed condition

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
E-Z-HD 98 % w/w powder for oral suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active Constituent: _
_ _
_ _
_ _
_ _
_ _
Barium sulfate 98.45 % w/w
_Excipients include: _
Sorbitol (E420), 1.89 g per 340 g dose.
Approximately 310 mg sodium per 340 g dose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for oral suspension.
White powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
E-Z-HD is a high density suspension for use as a radiopaque agent
during X-ray
visualisation of the upper gastro-intestinal tract (oesophagus,
stomach and
duodenum). It is designed for optimal use in double contrast X-ray
examinations.
E-Z-HD is indicated in adults and children
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
E-Z-HD must be administered orally. The powder must be reconstituted
prior
to administration (see section 6.6).
The administered dose of E-Z-HD will depend on the patient in question
and
the section of the gastrointestinal tract to be viewed.
Method of administration
ADULTS: The contents of one prefilled bottle (340 g) are dispersed in
65 mL of water
to produce a 250 % w/v suspension which is swallowed by the patient
after a suitable
gas producing agent has been administered.
CHILDREN: The dosage will be dependent on the size, age, health state
and
anatomical region to be imaged of the child. Individual requirements
should be
determined, from experience, by the radiologist.
ELDERLY: There are no special dosage recommendations. The dosage
should be
determined, from experience, by the radiologist.
4.3
CONTRAINDICATIONS
_Immune System Disorders _
Hypersensitivity to barium sulfate or to any of the excipients listed
in section
6.1.
_Gastrointestinal Disorders _
Patients with any of the following:
–
a known or suspected, perforation of the gastrointestinal tract
–
known or suspected trachea-esophageal fistula
–
gastrointestinal haemorrhage
–
gastrointes