370 mg / l / ml oral / rectal solution
sodium amidotrizoate / meglumine amidotrizoate

1. What Gastrography is and what it is used for

This medicine is for diagnostic purposes only. It is given either as a solution taken by mouth or as an enema (rectal solution).

Gastrography is an X-ray contrast agent used in X-ray examinations, including computed tomography, of the gastrointestinal tract. It is used to depict constrictions, cavities, enlargements, foreign bodies, tumors, etc.

The active, contrast-enhancing substance in Gastrography contains iodine. Iodine absorbs X-rays and thus creates a stronger contrast between the fluid and the surrounding tissue than what happens in the absence of contrast agents. This gives the doctor a better picture of the intestine and gives him a greater opportunity to make a correct diagnosis.

Gastrography can sometimes be used to treat meconium ileus, a special form of intestinal obstruction.

Sodium amidotrizoate and meglumine amidotrizoate contained in Gastrografin may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you receive Gastrography

Do not use Gastrography

  • if you are allergic to sodium amidotrizoate and meglumine amidotrizoate or any of the other ingredients of this medicine (listed in section 6).
  • Gastrography should not be given undiluted:
    • to children and dehydrated patients.
    • if you have a tendency to put food / drink in your esophagus (aspiration) or if your doctor suspects that you have an increased risk of aspiration.
    • if you have an abnormal connection ( fistula ) between the trachea and esophagus.

Warnings and cautions

Talk to your doctor or pharmacist before receiving Gastrography.

Take special care with Gastrography

  • if you are allergic (eg have hay fever or hives) or have bronchial asthma
  • if you are hypersensitive to or have previously reacted to iodinated contrast media
  • if you have suspected or known overactive thyroid gland or goiter (enlarged thyroid gland )
  • if you have a cardiovascular disease
  • if you have a very bad general condition

Hydrogenation

It is important that you get enough fluids before and after the examination, as Gastrography can cause dehydration and electrolyte imbalance.

  • Before receiving Gastrography, tell your doctor if any of the above apply to you. The doctor will assess whether you can undergo the planned examination or not.

Children

The doctor will check the thyroid function in newborns who have received Gastrografin, or if the mother has received Gastrografin during pregnancy. Gastrography can cause an underactive thyroid gland that may need treatment.

Other medicines and Gastrography

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

This is especially true for:

  • beta-blockers (medicines for high blood pressure or irregular heartbeat) Hypersensitivity reactions may be exacerbated in patients treated with beta-blockers , especially in people with bronchial asthma .
  • Interleukin -2 (used in eg cancer and transplants)

Your doctor will advise you on what to do if any of the above apply to you.

Gastrography with food, drink and alcohol

The bowel should be emptied before examination with Gastrography. Your doctor will advise you on this.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

  • Tell your doctor if you are pregnant or planning to have a baby as Gastrografin should be used with caution during pregnancy.
  • If you are breast-feeding, talk to your doctor. Children who are breastfed are unlikely to be affected.

Driving and using machines

No known effect on the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Gastrography contains sodium

This medicine contains 374 mg of sodium (the main ingredient in table salt/table salt) per 100 ml of solution. This corresponds to 18.7% of the maximum recommended daily sodium intake for adults.

3. How to use Gastrography

This medicine is always given by hospital staff.

Gastrography will be given either as a solution taken orally or as an enema (rectal solution). Your doctor will calculate the dose of Gastrography that is right for you. Dose one depends on your age and the type of X-ray examination to be performed. Gastrography is sometimes given in combination with another contrast agent (barium sulfate).

If you have received too much Gastrography

Overdose is unlikely. If it should happen, after all, the doctor will treat the symptoms that appear.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects are usually mild to moderate and transient. However, serious and life-threatening reactions, as well as fatal reactions, have been reported.

Talk to your doctor or radiologist immediately if you experience any of the following rare reactions:

  • As with other contrast agents, allergic-like reactions may occur, including severe reactions ( shock ) that require immediate medical attention. Slight swelling of the face, lips, tongue or throat, cough, itching , runny nose, sneezing and hives may be the first signs that a serious reaction is developing.
  • Delayed allergy-like reactions , which occur hours or days after receiving Gastrography have been observed in rare cases.
  • Severe skin reaction, with intense redness , skin detachment and large blisters ( toxic epidermal necrolysis ).

Other possible side effects are listed below, depending on how common they are:

Common adverse s (occurring in more than 1 in 100): nausea, vomiting, diarrhea

Rare side effects are (by less than 1 in 1000):

  • Cardiac arrest, rapid pulse ( tachycardia )
  • Shock , low blood pressure
  • Breathing difficulties ( dyspnoea , bronchospasm ), inhalation of contrast medium ( aspiration ), fluid in the lungs ( pulmonary edema after aspiration ), pneumonia ( aspiration pneumonia )
  • Hole in the intestine ( intestinal perforation ), abdominal pain, blisters in the mouth
  • Disorders of consciousness, headache, dizziness
  • Overactive thyroid gland ( hyperthyroidism )
  • Disturbed fluid / electrolyte balance
  • Hives ( urticaria ), rash, severe itching ( pruritus ), redness of the skin, swelling of the face ( edema )
  • Fever, sweating.

Has been reported (occurs in an unknown number of users) :

  • Underactive thyroid gland ( hypothyroidism )

Gastrointestinal tract:

Gastrography can cause diarrhea, but it stops as soon as the bowel is emptied. Ongoing inflammation in the intestine may be temporarily exacerbated. If there is a blockage in the intestine, it may prevent gastrography from passing and tissue damage may occur.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to Store Gastrography

Keep this medicine out of the sight and reach of children.

Do not store above 25 ° C.

Store in the outer carton in order to protect from light. Store under X-ray protection.

Do not use this medicine after the expiry date which is stated on the bottle after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are sodium amidotrizoate and meglumine amidotrizoate.1 ml contains 0.1 g sodium amidotrizoate and 0.66 g meglumine amidotrizoate (370 mg I / ml)
  • Other excipients are disodium edetate, saccharin sodium, polysorbate 80, star anise oil, purified water.

What the medicine looks like and contents of the pack

Gastrography is a clear, colorless to slightly yellow solution.

Package contents: 10 bottles with 100 ml solution.

Marketing Authorisation Holder

Bayer AB

Box 606

SE-169 26 Solna

Manufacturer

BerliMed SA

28806 Alcala de Henares, Madrid

Spain

Muhammad Nadeem

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