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GASTROGRAFIN GASTROENTERAL SOLUTION

Active substance(s): MEGLUMINE AMIDOTRIZOATE / SODIUM AMIDOTRIZOATE

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GASTROGRAFIN® GASTROENTERAL SOLUTION
Sodium amidotrizoate and meglumine amidotrizoate
Read all of this leaflet carefully before you are given this
medicine because it contains important information for you.
R Keep this leaflet. You may need to read it again.
R If you have any further questions, ask your doctor giving you
Gastrografin (the radiologist) or the X-ray department staff
R If you get any side effects, talk to your doctor or the X-ray
department staff/radiologist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Gastrografin is and what it is used for
2. What you need to know before you are given Gastrografin
3. How you will be given Gastrografin
4. Possible side effects
5. How to store Gastrografin
6. Content of the pack and other information

1. What Gastrografin is and what it is used for
Gastrografin is a contrast medium (a dye) which contains iodine. It
is used to clearly show on X-rays the area of your body that your
doctor wants to investigate. This will be your gullet (oesophagus),
stomach or intestines (gastrointestinal tract). It may also be used
to treat an intestinal obstruction in newborn babies (meconium
ileus).
X-rays, like radio waves, can pass through objects and can be focused
to make a picture. When you have an X-ray, the beam of rays goes
through your body where it is absorbed to differing degrees by
different tissues such as bones, muscles and organs. When the rays
come out on the other side they make a pattern of light and shade
on a film. Gastrografin helps to make this pattern clearer. The film is
then examined by a specialist who will make a diagnosis.
This medicine is for diagnostic use only.

2. What you need to know before you are given Gastrografin
Do not use Gastrografin:
R if you are allergic to sodium amidotrizoate, meglumine
amidotrizoate, iodine or iodine-containing contrast media or any
of the other ingredients of this medicine (listed in section 6)
R if you have a condition caused by too much thyroid hormone
(manifest hyperthyroidism).
Warnings and precautions
Talk to your doctor or the X-ray department staff/radiologist before
receiving Gastrografin
You must tell the X-ray department staff if you have any of the
following:
R any type of thyroid disease (e.g. hyperthyroidism)
R a history of allergy or a tendency to develop hypersensitivity
reactions (for example if you have hay fever, asthma or eczema)
R heart or blood circulation problems, because in the rare event
that you have an allergic reaction, it is more likely to be serious
or fatal.
Gastrografin may affect the way the thyroid gland works for
several weeks after being given it. If you are going to have an iodine
test for thyroid disease, tell your doctor or the laboratory staff if
you have received Gastrografin recently.
Other medicines and Gastrografin
Tell your doctor or the X-ray department staff/radiologist if you are
taking, have recently taken or might take any other medicines. This
is particularly important for:
R beta-blockers (drugs used to treat heart or blood pressure),
because they can make allergic reactions worse
R if you have been treated with a drug called interleukin, because
there is a higher chance of getting delayed reactions (e.g. fever
flu-like symptoms, joint pain and pruritus (itching)).
Ask the X-ray department staff if you are not sure.
Gastrografin with food and drink
Before the examination the X-ray department staff should make sure
that you have had enough to drink and that any imbalances in your
body water and body salts are corrected.


The following information is intended for healthcare professionals
only:
Information for Healthcare Professionals

GASTROGRAFIN® GASTROENTERAL SOLUTION
SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT
Gastrografin gastroenteral solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains: 100 mg sodium amidotrizoate (sodium
diatrizoate) and 660 mg meglumine amidotrizoate (meglumine
diatrizoate).
Excipients with known effect: disodium edetate, sodium hydroxide,
saccharin sodium
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Gastroenteral solution

4. CLINICAL PARTICULARS
4.1 Therapeutic indications
This medicinal product is for diagnostic use by oral or rectal
administration only.
Gastrografin is a contrast medium for the radiological examination
of the gastrointestinal tract (also in combination with barium
sulphate).
Gastrografin may be of particular value in the following instances:
1. Suspected partial or complete stenosis.
2. Acute haemorrhage.
3. Threatening perforation (peptic ulcer, diverticulum).
4. Other acute conditions which are likely to require surgery.
5. After resection of the stomach or intestine (danger of
perforation or leak).
6. Megacolon.
7. Visualisation of a foreign body or tumour before endoscopy.
8. Visualisation of a gastrointestinal fistula.
9. Before Endoscopy.
Further indications:
R Early diagnosis of a radiologically undetectable perforation or
anastomotic defect in the oesophagus.
R The treatment of uncomplicated meconium ileus.
R Computerised tomography in the abdominal region.
4.2 Posology and method of administration
Dosage for oral use
The dosage is dependent on the type of examination and the age of
the patient.
Adults and children of 10 years of age or over:
Visualisation of the stomach: 60 ml
Follow-through examination of the gastrointestinal tract: a
maximum of 100 ml
Computerised tomography (CT)
0.5 - 1.5 litres of approximately 3% Gastrografin solution (30 ml
Gastrografin/1 litre of water).
Older and cachectic patients: Dilution with an equal volume of
water is recommended.
Children
Children (up to 10 years of age): 15-30 ml (can be diluted with
twice its volume of water)

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Infants and young children: 15-30 ml (diluted with 3 times its
volume of water)
Dosage for rectal use (including therapy of uncomplicated meconium
ileus)
Adults
Up to 500 ml Gastrografin dilution (diluted with 3 - 4 times its
volume of water)
Children
Children (over 5 years of age): up to 500 ml Gastrografin dilution
(diluted with 4 - 5 times its volume of water)
Children (up to 5 years of age): up to 500 ml Gastrografin dilution
(diluted with 5 times its volume of water)
Therapy of uncomplicated meconium ileus
Gastrografin can be given by enema for non-operative treatment of
uncomplicated meconium ileus. Advantage is taken of the high
osmotic pressure of the contrast medium: the surrounding tissue is
forced to release considerable amounts of fluid, which then flows
into the gut and dissolves the inspissated meconium.
The procedure must be carried out slowly and only under
fluoroscopic control. Injection should stop as soon as Gastrografin
is seen to enter the ileum. Owing to its high osmolarity,
Gastrografin may cause the loss of a large amount of fluid into the
intestines. An intravenous drip must therefore be set up before the
enema is given and fluid should be infused as required. If the
Gastrografin is not expelled during the first hour after removal of the
rectal catheter, an X-ray should be taken to ensure that
overdistension of the bowel as a result of the high osmolarity of
Gastrografin has not occurred.
Dosage for Gastrografin in combination with barium sulphate: Oral
and rectal administration.
Adults
In adult patients, addition of approximately 30 ml Gastrografin to
the usual dose of barium should be adequate.
Children
Children from 5 - 10 years of age: 10 ml Gastrografin to 100 ml
barium sulphate suspension.
Children up to 5 years of age: 2 - 5 ml Gastrografin to 100 ml barium
sulphate suspension.
If necessary (in cases of pylorospasm or pyloric stenosis), the
portion of Gastrografin in the suspension may be further increased.
This does not affect the contrast.
For the early diagnosis of a perforation or investigation of an
anastomosis in the oesophagus or gastrointestinal tract, the
patient should drink up to 100 ml Gastrografin. After 30-60
minutes (later, if the defect is suspected of being in the distal gut),
a urine specimen should be taken and 5 ml mixed with 5 drops of
concentrated hydrochloric acid. The contrast medium which has
undergone renal excretion will appear within two hours as a typical
crystal formation in the precipitate.
4.3 Contraindications
Hypersensitivity to iodine-containing contrast media. Manifest
hyperthyroidism.
Gastrografin must not be administered undiluted in patients with
low plasma volume, as for example in newborns, infants, children
and in dehydrated patients, since hypovolaemic complications can
be particularly serious in these patients.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask the doctor or X-ray department
staff /radiologist for advice before receiving this medicine.
Gastrografin contains sodium
This medicinal product contains 3.8 mg sodium per ml. To be taken
into consideration by patients on a controlled sodium diet.

3. How you will be given Gastrografin
The X-ray department staff will explain how everything works and
what position you should lie in on the X-ray table.
The dose of Gastrografin and how it will be given will depend on
the type of investigation. The dose range is usually from 2 ml to
125 ml Gastrografin. This may be diluted depending on the type of
investigation.
Gastrografin is either drunk as a solution or given as an enema, a
liquid that is forced by low pressure into the anus. It must not be
given by injection into the blood vessels.
If you receive more Gastrografin than you should
Overdosing is unlikely. If it does happen the radiologist will treat any
symptoms that follow.
If you have any further questions on the use of this medicine, ask
your doctor or the X-ray department staff/radiologist for advice
before receiving this medicine.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If you notice:
R itching of the skin, rash, wheals on the skin (urticaria)
R difficulty breathing, gagging, feeling of suffocation
R swelling of the face, neck or body
R itchy or watery eyes, tickling in the throat or nose, hoarseness,
coughing or sneezing
R headache, dizziness, feeling faint
R feeling particularly hot or cold, sweating
R paleness or reddening of the skin
R chest pain, cramp, tremor
R feeling sick
Tell the radiologist or X-ray staff immediately as these may be the
first signs of allergic reaction or shock. Your investigation will need
to be stopped, and you may need further treatment.

Please turn over J

Gastrografin must not be administered undiluted in patients with
suspected possibility of aspiration or broncho-oesophageal fistula,
since hyperosmolarity may cause acute pulmonary oedema,
chemical pneumonia, respiratory collapse and death.
4.4. Special warnings and precautions for use
The following risks are higher in the case of intravascular
administration of iodinated contrast media but are also relevant
for the enteral use of Gastrografin.
Hypersensitivity
As with other contrast agents, Gastrografin can be associated with
anaphylactoid/hypersensitivity or other idiosyncratic reactions,
characterized by cardiovascular, respiratory or cutaneous
manifestations, and ranging to severe reactions including shock.
Delayed reactions may occur (hours later or up to several days) (see
section 4.8).
Medication for the treatment of hypersensitivity reactions as well
as readiness for institution of emergency measures are necessary.
The risk of anaphylactoid/hypersensitivity reactions is higher in
case of:
R any history of allergic disorders,
R history of bronchial asthma,
R a previous anaphylactoid/hypersensitivity reaction to iodinated
contrast media.
Patients with cardiovascular disorders are more susceptible to
serious or even fatal outcomes of severe anaphylactoid/
hypersensitivity reactions.
Gastrografin contains sodium
This medicinal product contains 3.8 mg sodium per ml. To be taken
into consideration by patients on a controlled sodium diet.
Barium sulphate
If Gastrografin is used together with barium sulfate preparations,
attention must be drawn to the contraindications, warnings and
possible side effects relevant to the preparation.
Gastrointestinal
In case of prolonged retention of Gastrografin in the
gastrointestinal tract (e.g. obstruction, stasis), tissue damage,
bleeding, bowel necrosis and intestinal perforation may occur.
Hydration
Adequate hydration and electrolyte balance should be established
and maintained in the patients, since the hyperosmolarity of
Gastrografin may cause dehydration and electrolyte imbalance.
Because of the additives (flavourings and a wetting agent),
Gastrografin must not be used intravascularly.
4.5 Interaction with other medicinal products and other forms
of interaction
Hypersensitivity reactions can be aggravated in patients on betablockers.
Interleukin-2: Previous treatment (up to several weeks) with
Interleukin-2 is associated with an increased risk of delayed
reactions to Gastrografin.
Interference with diagnostic tests
Radioisotopes: Diagnosis and treatment of thyroid disorders with
thyrotropic radioisotopes may be impeded for up to several weeks
after administration of iodinated contrast agents due to reduced
radioisotope uptake.
4.6 Fertility, pregnancy and lactation
Pregnancy
Adequate and well-controlled studies in pregnant women have not
been conducted.
Animal studies do not indicate direct or indirect harmful effects
with respect to embryonal/foetal development (see section 5.3).
Caution should be exercised when using Gastrografin in pregnant
women.

15.06.2015 10:15:29

Packaging Technology Berlin sgmgj
page 1
Bayer Pharma AG
client: 138
item-no.: 84621757
PZ: 2664A-3
code-no.: 278
name: LEAFLET-GASTROGRAFIN GB
country: GB/-/BPH
colors: Black
version: 15.06.2015/03
approval:
dimension: 311 x 457 mm

Package leaflet: Information for the user

Anja
Bern
wald

Digitally signed
by Anja Bernwald
DN: o=Bayer
Group,
ou=SignCert,
0.9.2342.1920030
0.100.1.1=sgrfh,
cn=Anja
Bernwald
Date: 2015.06.15
10:18:29 +02'00'

Manufacturer:

5. How to store Gastrografin
Keep this medicine out of the sight and reach of children.
The product should be used within 72 hours once opened. Unused
product should be discarded.
Do not use this medicine after the expiry date which is stated on the
label after EXP. The expiry date refers to the last day of that month.
Protect from light and X-rays. Do not store above 25°C.

Bayer Pharma AG
Berlin
Germany
or
BerliMed S.A
Madrid
Spain.
This leaflet was last revised in 04/2015.

6. Contents of the pack and other information
What Gastrografin contains
The active substances are sodium amidotrizoate and meglumine
amidotrizoate.
1 ml of solution contains 100 mg sodium amidotrizoate and 660 mg
meglumine amidotrizoate.
The other ingredients are disodium edetate, sodium hydroxide,
saccharin sodium, anise oil, polysorbate 80, and purified water.
What Gastrografin looks like and contents of the pack
Each pack of Gastrografin contains ten 100 ml brown glass bottles.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
UK

To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge:

enteritis or colitis may be temporarily exacerbated. In case of
obstruction, the prolonged contact with bowel mucosa can lead to
erosions and to bowel necrosis. Other undesirable effects include
vomiting, nausea, diarrhoea, intestinal perforation, abdominal pain
and oral mucosal blistering.
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis, urticaria, rash, pruritus, erythema,
oedema face
General disorders and administration site conditions
Pyrexia, sweating
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued monitoring of
the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Disorders of water and electrolyte balance caused by overdose
should be corrected.

6.3 Shelf life
Shelf life (unopened): 5 years
Shelf life (opened): 72 hours
6.4 Special precautions for storage
Protect from light and X-rays. Store below 25 °C.
6.5 Nature and contents of container
Packs of 10 x 100 ml brown glass bottles with pilfer proof screw
caps.
6.6 Special precautions for disposal and other handling
At temperatures below 7 ºC Gastrografin tends to crystallize, but this
can be reversed by gently warming and shaking the bottle. This
phenomenon has no effect on the effectiveness or stability of the
preparation.
Contrast medium solution not used within 72 hours after opening
the bottle must be discarded.

0800 198 5000 (UK only)
Please be ready to give the following information:
Product name

Reference number

Gastrografin Gastroenteral Solution

00010/0537

This is a service provided by the Royal National Institute of the
Blind.


Breast-feeding
It is unknown whether sodium amidotrizoate or meglumine
amidotrizoate are excreted in human breast milk. Intravascular use
has shown that salts of the diatrizoic acid are excreted in breast milk.
A decision on whether to continue / discontinue breast-feeding or
continue / discontinue therapy with Gastrografin should be made
taking into account the benefit of breast-feeding to the child and the
benefit of administering Gastrografin to the woman.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Undesirable effects in association with the use of iodinated
contrast media are usually mild to moderate and transient in nature.
However, severe and life-threatening reactions as well as deaths
have been reported.
Vomiting, nausea and diarrhoea are the most frequently recorded
reactions.
The following undesirable effects have been recorded in association
with the use of Gastrografin. The most appropriate MedDRA term is
used to describe a certain reaction and its synonyms and related
conditions.
Immune system disorders, anaphylactic reaction/hypersensitivity
Anaphylactoid shock, anaphylactoid / hypersensitivity reaction.
Systemic hypersensitivity is mostly mild and occurs generally in the
form of skin reactions. However, the possibility of a severe
hypersensitivity reaction cannot be entirely excluded (see section
4.4).
Endocrine disorders
Hyperthyroidism
Metabolism and nutrition disorders
Fluid and electrolyte imbalance
Nervous system disorders
Disturbances in consciousness, headache, dizziness
Cardiac disorders
Cardiac arrest, tachycardia
Vascular disorders
Shock, Hypotension
Respiratory, thoracic and mediastinal disorders
Bronchospasm, dyspnoea, medication aspiration, pulmonary oedema
following aspiration, aspiration pneumonia
Gastrointestinal disorders:
The hypertonic Gastrografin solution may give rise to diarrhoea,
but this ceases as soon as the intestine has been emptied. Existing

5. PHARMACOLOGICAL PARTICULARS
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: X-ray contrast media, iodinated and
watersoluble, ATC code: V08AA01
Gastrografin does not exert a pharmacological effect. It is an iodine
containing contrast medium, iodine being radio-opaque.
5.2 Pharmacokinetic properties
Only 3% of amidotrizoic acid, the radio-opaque agent of
Gastrografin, is absorbed following oral administration. If a
perforation of the gastrointestinal tract is present, Gastrografin finds
its way into the abdominal cavity or the surrounding tissue, where it
is absorbed and finally excreted via the kidneys.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on
conventional studies of systemic toxicity, genotoxicity, toxicity to
reproduction, local tolerance and contact-sensitizing potential.

7. MARKETING AUTHORISATION HOLDER
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA

8. MARKETING AUTHORISATION NUMBER
PL 00010/0537

9. DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
1 May 2008

10. DATE OF REVISION OF TEXT
to be updated once the variation is approved

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
disodium edetate
sodium hydroxide
saccharin sodium
anise oil
polysorbate 80
purified water
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal
products except those mentioned in section 4.2.

84621757

GASTROGRAFIN®
GASTROENTERAL
SOLUTION
84621757

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15.06.2015 10:15:42

Packaging Technology Berlin sgmgj
page 2
Bayer Pharma AG
client: 138
item-no.: 84621757
PZ: 2664A-3
code-no.: 278
name: LEAFLET-GASTROGRAFIN GB
country: GB/-/BPH
colors: Black
version: 15.06.2015/03
approval:
dimension: 311 x 457 mm

Apart from the symptoms listed above the other side effects that you
might experience are:
R feeling sick or being sick
R diarrhoea
R anaphylactic shock (a very severe allergic reaction)
R allergic-type skin reactions including itching, redness, wheals on
the skin
R overactive thyroid gland (hyperthyroidism)
R disorder of your body water and body salts balance
R fainting, dizziness, headache
R fast heart beat, sudden stopping of the heart (cardiac arrest),
low blood pressure, shock
R difficulty breathing, swelling or fluid in the lungs. If Gastrografin gets into your lungs by accident it may cause fluid to collect
in your lungs
R abdominal pain, holes in the gut wall (intestinal perforation)
R blistering inside the nose or mouth
R severe skin disease (red, blistered, bleeding, painful skin, which
may affect the lips, eyes, mouth, nose and genitals too)
R rash, redness of the skin
R swelling of the face
R fever, sweating
If you currently have inflammation of the intestine or bowel
(enteritis or colitis), this may temporarily get worse. If you currently
have a blockage in your bowel, this can lead to Gastrografin
staying in the bowel for longer than usual, which may damage the
lining of the bowel.
Delayed reactions can occur, if you are concerned you should contact
your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, radiologist or X-ray
department staff. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly (see details
below). By reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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