Active ingredients: Sodium amidotrizoate, Meglumine amidotrizoate
Gastrografin 370 mg iodine / ml gastrointestinal solution
Indications Why is Gastrografin used? What is it for?
Gastrografin belongs to the category of water-soluble, nephrotropic, high osmolar radiological contrast agents.
This medicinal product is for diagnostic use only, for oral or rectal administration.
Gastrografin is a radiographic contrast agent for visualization of the gastrointestinal tract (also in combination with barium sulfate). The use of Gastrografin is mainly indicated when the use of barium sulphate is inadequate or contraindicated, or when the results obtainable with it are unsatisfactory.
In particular, Gastrografin is used in the following cases:
- if partial or total stenosis (narrowing of the digestive system) is suspected;
- if you have acute bleeding;
- if there is a danger of perforation (peptic ulcer, diverticula);
- if you have other acute conditions which are very likely to require surgery;
- if you have problems following surgery on the stomach or intestines (danger of perforation or opening of the sutures);
- if you suffer from megacolon (dilation of the last section of the intestine);
- for the visualization of foreign bodies or tumors before endoscopy;
- for the visualization of gastrointestinal fistulas (connections between organs or parts of organs that are normally not communicating).
In addition to these cases, Gastrografin can of course be used in all indications of barium sulfate.
In association with barium sulphate, Gastrografin allows a significant improvement, from both a diagnostic and organizational point of view, of the routine examination of the gastrointestinal transit. Gastrografin is not only suitable for the diagnosis of enteritis (inflammation of the intestine).
Contraindications When Gastrografin should not be used
Do not use Gastrografin
- if you are allergic to sodium amidotrizoate or meglumine amidotrizoate, iodinated contrast media or any of the other ingredients of this medicine (listed in section 6);
- in the presence of Waldenström's paraproteinemias or multiple myeloma (diseases characterized by the presence of abnormal proteins in the blood);
- in severe states of hepatic or renal insufficiency (severe reduction in liver or kidney function).
Precautions for use What you need to know before taking Gastrografin
Talk to your doctor or nurse before using Gastrografin.
The risk of anaphylactoid / allergic reactions is higher in the following cases:
- if you have a history of allergic disorders,
- if you have a history of bronchial asthma,
- if you have ever had anaphylactoid / allergic reactions to iodinated contrast media.
In these cases, pre-treatment with antihistamines and / or glucocorticoids may be considered.
THE PRE-TREATMENT IS SUITABLE FOR ALL THREE CONDITIONS, not only for allergic predisposition.
These risks are greater in the case of intravascular administration (directly into blood vessels) of iodinated contrast media, but are equally relevant for the enteral (oral or rectal) use of Gastrografin.
Patients with cardiovascular disorders (heart disease) are more prone to severe or even fatal outcomes of severe anaphylactoid / allergic reactions.
During the administration of contrast media, including Gastrografin, you may experience anaphylactoid / allergic reactions or other idiosyncratic reactions characterized by skin, respiratory or cardiovascular manifestations, up to severe reactions including shock.
Delayed reactions (after a few hours or days) are possible (see "Undesirable effects").
If you experience reactions such as nausea, vomiting, mild angioedema, conjunctivitis, cough, itching, rhinitis, sneezing and hives, warn your doctor or nurse as these may be the first signs of an onset of shock. These reactions, which can occur regardless of the dose. and the route of administration.
If allergic reactions occur (see "Undesirable Effects"), the administration of the contrast medium should be stopped immediately and - if necessary - specific therapy instituted through a venous access. It may also be subjected to treatment with drugs designed to treat allergic reactions.
Interactions Which drugs or foods may change the effect of Gastrografin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Take special care if you are being treated with:
- Beta-blockers (medicines used for high blood pressure or rapid heartbeat), as allergic reactions can be aggravated if you are taking beta-blockers, especially if you have bronchial asthma.
- Drugs normally used to treat allergic or allergic-like reactions (i.e. beta agonist drugs) may not work if you are being treated with beta blockers.Interleukin-2 (medicine that modulates the immune system), as 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 THERAPY OF THYROID ALTERATIONS WITH THYROID RADIOISOTOPES CAN BE OBSTACULATED UP TO SEVERAL WEEKS AFTER THE ADMINISTRATION OF IODATED CONTRAST AGENTS DUE TO THE REDUCED RECEPTION OF THE RADIOISOTOPES.
Warnings It is important to know that:
Thyroid dysfunction
If you have or are suspected of having hyperthyroidism (excess thyroid gland function) or goiter (enlarged thyroid gland), your doctor will particularly consider the risks and benefits of using Gastrografin, as iodinated contrast media can interfere with thyroid function and aggravate or induce hyperthyroidism and thyrotoxic crisis (severe complication of hyperthyroidism).
Gastrointestinal system
PROLONGED RETENTION OF GASTROGRAFIN IN THE GASTROINTESTINAL TRACT (FOR EXAMPLE IN THE PRESENCE OF OBSTRUCTION, STASIS) CAN CAUSE TISSUE DAMAGE, BLOODING, NECROSIS (TISSUE DEATH) AND INTESTINAL PERFORATION.
Children
Gastrografin should only be administered diluted in patients with low plasma volume, such as neonates, infants and children.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before using this medicine.
Pregnancy
Adequate and sufficiently controlled studies in pregnant women have not been conducted.
If you are pregnant, caution should be exercised when administering Gastrografin Since, where possible, radiation exposure should be avoided during pregnancy, your doctor will carefully evaluate the benefits and possible risks of an X-ray diagnostic investigation. , with or without contrast medium.
Feeding time
After intravascular use, the salts of diatrizoic acid are excreted in breast milk. However, no effects on the suckling child are expected at the recommended doses of Gastrografin. You are likely to be able to continue breastfeeding safely, particularly taking into account the low enteral absorption of Gastrografin.
Dosage and method of use How to use Gastrografin: Dosage
Always use this medicine exactly as your doctor or nurse has told you. If you are unsure, ask your doctor or nurse.
The use of the medicinal product is reserved for hospitals, clinics, nursing homes and specialist radiological studies and must be used under medical supervision.
Diet tips and hydration
To increase the diagnostic validity it may be necessary that you have to undergo a previous bowel cleansing.
If you have multiple myeloma (cancer affecting the bone marrow), diabetes mellitus with kidney complications, polyuria or oliguria (increased or decreased amount of urine), hyperuricaemia (increased uric acid in the blood), if you are elderly or if the drug is used in newborns, infants or young children, an adequate control of the hydration status is necessary, both before and after the administration of the contrast medium.
The recommended doses are:
Pure Gastrografin
- Oral use
The dose should be adjusted according to your age and the type of investigation you are undergoing.
Adults
You will be given 60 ml for the stomach investigation and up to 100 ml for the serial examination of the gastrointestinal tract.
Elderly and debilitated patients
The contrast medium will be given to you after dilution with water in a ratio of 1: 1.
- Rectal use
Adults
The contrast medium will be given to you in diluted form with 3-4 times the volume of water. In contrast to the barium sulfate enema, 500 ml of this diluted solution is sufficient.
Gastrografin associated with barium sulfate
Adults
You will be given a combination of approximately 30ml of Gastrografin with the usual amounts of barium gruel.
If you have pylorospasm or pyloric stenosis (spasm or narrowing of the valve in the lower stomach), your doctor may further increase the amount of Gastrografin in the suspension, without this interfering with the intensity of the contrast. Stomach radiographs. they can be performed with the normal methods using Gastrografin either alone or in association with barium sulphate.The stomach emptying times are identical to those of barium gruel.
The filling of the intestine is instead accelerated. When Gastrografin is administered alone, the contrast medium generally reaches the rectum within 2 hours, while in association with barium sulphate the transit can last up to three hours, or more depending on of the case.
The most favorable time to take x-rays of the colon will be the moment in which he will feel the urge to defecate, which never fails.
Use in children and adolescents
Infants (up to 1 month), infants (1 month-2 years) and children (2-11 years)
Infants less than one year of age, and especially newborns, may be prone to electrolyte imbalances and impaired blood circulation. It is therefore necessary to pay particular attention to the dose of contrast medium to be administered, to the technical performance of the radiological procedure and to the state of health of the patient.
Pure Gastrografin
- Oral use
Children from 10 years of age will be given a dose of Gastrografin equal to 60 ml for the stomach investigation and up to 100 ml for the serial examination of the gastrointestinal tract.
In children under 10 years of age, a maximum dose of Gastrografin will be administered, possibly diluted with water in a ratio of 1: 2; in newborns, infants and frail children, the contrast medium will be diluted with water in a ratio of 1: 3.
- Rectal use
In children over 5 years of age, the contrast medium will be diluted with a volume of water 4-5 times higher; for those up to 5 years of age, on the other hand, in a ratio of 1: 5.
Gastrografin associated with barium sulfate
The optimal association of a dose of about 30 ml of Gastrografin with the usual quantities of barium gruel has been demonstrated in children from 10 years of age.
In children aged 5 to 10 years, a dose of 10 ml of Gastrografin will be given with the normal amount of barium gruel.
For those under 5, 2-5ml of Gastrografin per 100ml of barium gruel.
Overdose What to do if you have taken too much Gastrografin
In case of accidental ingestion / intake of an overdose of Gastrografin, notify your doctor immediately or go to the nearest hospital. It is recommended to compensate for disturbances in the hydroelectrolytic balance (the maintenance of water and electrolytes in the body in a constant proportion) caused by overdose.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Side Effects What are the side effects of Gastrografin
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects you will experience in connection with the use of iodinated contrast media are usually mild to moderate and transient in nature. However, serious and life-threatening reactions, in some cases even death, have been reported.
The assessment of undesirable effects is based on the following frequency data:
Common: in 1 in 100 or more patients
Rare: in less than 1 in 1000 patients
Common side effects may affect up to 1 in 10 people
- He retched,
- nausea,
- diarrhea.
Side effects Rare (may affect up to 1 in 1000 people)
- anaphylactoid shock,
- anaphylactoid / allergic reaction,
- hyperthyroidism,
- imbalance of water and electrolyte exchange (of liquids and salts),
- changes in consciousness,
- headache,
- dizziness,
- cardiac arrest,
- tachycardia (rapid heart rate),
- shock (drop in pressure and reduction of all physical and mental faculties, caused by severe circulatory insufficiency),
- hypotension (low blood pressure),
- bronchospasm (spasm of the bronchi),
- dyspnea (breathlessness),
- aspiration of the medicine,
- pulmonary edema (water in the lungs) following aspiration,
- aspiration pneumonia,
- intestinal perforation,
- abdominal pain,
- blistering of the mouth and mucous membranes,
- toxic epidermal necrolysis (severe skin disease),
- hives (small spots on the skin and itching),
- rash,
- itch,
- erythema (redness of the skin),
- face edema (swelling of the face),
- fever,
- sweating.
Immune system disorders, anaphylactoid / allergic reaction:
Generalized allergy is rare and mostly mild and usually manifests itself in the form of skin reactions. However, the possibility of a severe hypersensitivity reaction cannot be completely excluded (see "Warnings and precautions").
Gastrointestinal disorders:
The hypertonic solution of Gastrografin can cause you diarrhea which disappears as soon as your intestines are emptied. If you suffer from colitis or enteritis at the time of administration, these may transiently worsen. In case of obstruction, prolonged contact with the intestinal mucosa can cause intestinal erosions and necrosis (the destruction and death of the intestinal tissue) (see "Warnings and precautions").
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly. .it / en / responsible By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle after "Expiry". The expiry date refers to the last day of that month. The expiry date refers to the unopened product, correctly stored.
At temperatures below 7 ° C, Gastrografin may show a tendency to crystallization, which is reversible after heating and stirring. This does not affect the efficacy and stability of the preparation.
Do not store above 25 ° C. Keep the bottle in the outer carton to protect from light. Store protected from X-rays.
Unused contrast medium solution within 1 day of opening the bottle should be discarded.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Deadline "> Other information
What Gastrografin contains
- The active ingredients are sodium amidotrizoate and meglumine amidotrizoate. 100 ml of gastrointestinal solution contain 10 g of sodium amidotrizoate and 66 g of meglumine amidotrizoate.
- The other ingredients are: sodium edetate, sodium saccharin, essence of anise, polysorbate 80, purified water.
What Gastrografin looks like and contents of the pack
Gastrointestinal solution
Bottle of 100 ml.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
GASTROGRAFIN 370 MG IODINE / ML GASTROENTERIC SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
100 ml of gastrointestinal solution contain 10 g of sodium amidotrizoate and 66 g of meglumine amidotrizoate (sodium diatrizoate and meglumine diatrizoate).
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Gastrointestinal solution.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
This medicinal product is for oral or rectal diagnostic use only.
Gastrografin is a radiographic contrast agent for visualization of the gastrointestinal tract (also in combination with barium sulfate). It is suitable for both oral and rectal use.
The use of Gastrografin is mainly indicated when the use of barium sulphate is inadequate or contraindicated, or when the results obtainable with it are unsatisfactory. Gastrografin is especially used in the following cases:
• suspicion of partial or total strictures
• acute bleeding
• danger of perforation (peptic ulcer, diverticula)
• any other acute condition that may require surgery
• post-resection disorders of the stomach or intestines (danger of perforation or sutural dehiscence)
• megacolon
• visualization of foreign bodies or tumors before endoscopy
• visualization of gastrointestinal fistulas.
In addition to the cases mentioned, Gastrografin can be used in all indications of barium sulphate.
In association with barium sulphate, Gastrografin allows a significant improvement, from both a diagnostic and organizational point of view, of the routine examination of gastrointestinal transit.
Gastrografin is not only suitable for the diagnosis of enteritis.
04.2 Posology and method of administration -
General informations
Due to the presence of additives (flavoring and a wetting agent), Gastrografin must not be used intravascularly.
• Diet suggestions
Previous bowel cleansing increases diagnostic validity.
• Hydration
Adequate hydration must be ensured both before and after administration of the contrast medium. This is especially true for patients with multiple myeloma, diabetes mellitus with nephropathy, polyuria, oliguria, hyperuricemia, as well as for newborns, infants, small children and the elderly. Water and electrolyte balance disturbances must be corrected prior to diagnostic examination.
• Babies (
Infants under the age of one year and especially newborns are subject to electrolyte imbalances and haemodynamic alterations. Particular attention should be paid to the dose of contrast medium to be administered, the technical performance of the radiological procedure and the patient's state of health.
Due to its high osmotic pressure and tendency to be absorbed by the intestine, Gastrografin should not be administered to newborns, infants and young children at doses higher than those recommended. In neonates and infants, low osmolar contrast media can often be used more safely than high osmolar Gastrografin.
• Posology for oral use
The dosage should be adapted to the type of investigation and the age of the patient.
Adults and children from 10 years of age:
Stomach visualization: 60ml
Serial examination of the gastrointestinal tract: up to 100 ml
In elderly and cachectic patients it is recommended to dilute the contrast medium with an equal volume of water.
Children:
Newborns, infants and young children: 15-30 ml (diluted with a volume of water 3 times higher).
Children (under 10 years of age): 15-30 ml (possibly diluted with a double volume of water)
• Dosage for rectal use
Adults:
Up to 500 ml of diluted solution (obtained by diluting Gastrografin with a volume of water 3-4 times higher)
Children:
Children (up to 5 years): up to 500 ml of diluted solution (obtained by diluting Gastrografin with a volume of water 5 times higher)
Children (over 5 years): up to 500 ml of diluted solution (obtained by diluting Gastrografin with a volume of water 4 - 5 times higher)
• Dosage in combination with barium sulphate.
Adults and children from 10 years of age:
In addition to the usual amounts of barium sulfate: 30 ml of Gastrografin
Children:
In addition to the usual amounts of barium sulfate:
Children (up to 5 years): 2 - 5 ml of Gastrografin per 100 ml of barium sulphate suspension
Children (5 to 10 years): 10 ml of Gastrografin per 100 ml of barium sulphate suspension
If necessary (in case of pylorospasm or pyloric stenosis), the amount of Gastrografin in the suspension can be further increased without this interfering with the intensity of the contrast.
Stomach radiographs can be performed with normal methods either using Gastrografin alone or in combination with barium sulfate. The stomach emptying times are identical to those of barium gruel.
The bowel filling is shorter. When Gastrografin is administered alone, the contrast medium generally reaches the rectum within 2 hours, while in combination with barium sulphate the transit can last up to three hours or more in individual cases. The most favorable time to take x-rays of the colon is reported by the patient himself when he feels the urge to defecate, which never fails.
04.3 Contraindications -
- Hypersensitivity to the active substances, iodinated contrast media or to any of the excipients.
- Waldenström's paraproteinemie, Multiple Myeloma and in severe states of hepatic and renal insufficiency.
Gastrografin should not be administered undiluted in patients with low plasma volume, e.g. neonates, infants, children and dehydrated patients, as hypovolaemic complications may be particularly severe in these patients.
Gastrografin should not be administered undiluted in patients with suspected possibility of aspiration or bronchoesophageal fistula, as hyperosmolarity can cause acute pulmonary edema, chemical pneumonia, respiratory collapse and death.
04.4 Special warnings and appropriate precautions for use -
The following risks are greater in the case of intravascular administration of iodinated contrast media, but are equally relevant for the enteral use of Gastrografin.
• Hypersensitivity (see section 4.3)
The use of the drug in patients with known hypersensitivity to Gastrografin or to one of its excipients must be carefully evaluated from the risk / benefit profile, due to an increased risk of anaphylactoid / hypersensitivity reactions.
Patients with hypersensitivity or a previous reaction to iodinated contrast media have an increased risk of experiencing severe reactions. However, such reactions are erratic and unpredictable in nature.
Pretreatment with antihistamines and / or glucocorticoids should be considered in patients with allergic predisposition, known hypersensitivity to iodinated contrast media or with a history of asthma.
Patients with bronchial asthma are particularly at risk of experiencing bronchospasms or hypersensitivity reactions.
As with other contrast agents, Gastrografin can be associated with anaphylactoid / hypersensitivity reactions or other idiosyncratic reactions characterized by skin, respiratory or cardiovascular manifestations, up to severe reactions including shock.
Delayed reactions (after a few hours or days) are possible (see section 4.8 "Undesirable effects").
Nausea, vomiting, mild angioedema, conjunctivitis, cough, pruritus, rhinitis, sneezing and urticaria have been reported. These reactions, which can occur regardless of the dose and route of administration, may be the first signs of an incipient state of shock.
If hypersensitivity reactions occur (see section 4.8 "Undesirable effects"), the administration of the contrast medium should be stopped immediately and - if necessary - specific therapy instituted through a venous access.
The availability of immediate countermeasures in case of emergency, as well as drugs for the treatment of hypersensitivity reactions, is recommended.
The risk of anaphylactoid / hypersensitivity reactions is higher in the following cases:
- any previous allergic disorders
- history of bronchial asthma
- previous anaphylactoid / hypersensitivity reaction to iodinated contrast media
The use of the drug in patients with a previous anaphylactoid / hypersensitivity reaction to any other iodinated contrast medium should be carefully evaluated in terms of the risk / benefit ratio, due to the increased risk of anaphylactoid / hypersensitivity reactions in such patients.
Patients on beta-blockers who experience these reactions may be resistant to beta-agonists.
Patients with cardiovascular disorders are more prone to severe or even fatal outcomes of severe anaphylactoid / hypersensitivity reactions.
• Thyroid dysfunction
Particularly careful risk / benefit assessment is required in patients with known or presumed hyperthyroidism or goiter, as iodinated contrast media can interfere with thyroid function and aggravate or induce hyperthyroidism and thyrotoxic crisis in such patients.
In patients with known or suspected hyperthyroidism, testing of thyroid function may be considered before administering Gastrografin and / or taking preventive thyroid treatment.
• State of poor health
The necessity of the examination must be very carefully considered in patients with a precarious state of health.
• Barium sulphate
If Gastrografin is used together with barium sulphate preparations, attention should be drawn to the contraindications, warnings and possible side effects related to these preparations.
• Gastrointestinal system
Prolonged retention of Gastrografin in the gastrointestinal tract (e.g. in the presence of obstruction, stasis) can cause tissue damage, bleeding, necrosis and intestinal perforation.
• Hydration
It is recommended to ensure and maintain adequate hydration and electrolyte balance in patients, as hyperosmolarity of Gastrografin can cause dehydration and electrolyte imbalance.
04.5 Interactions with other medicinal products and other forms of interaction -
Hypersensitivity reactions can be aggravated in patients taking beta-blockers, especially in people with bronchial asthma. Patients who experience such reactions while taking beta-blockers may be resistant to treatment of anaphylactoid / hypersensitivity reactions with betaagonists.
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 therapy of thyroid disorders with thyrotropic radioisotopes may be hampered for up to several weeks after administration of iodinated contrast agents due to reduced radioisotope uptake.
04.6 Pregnancy and breastfeeding -
Pregnancy
Adequate and sufficiently controlled studies in pregnant women have not been conducted.
Animal studies do not indicate direct or indirect harmful effects on embryonal / fetal development (see section 5.3 "Preclinical safety data").
Caution should be exercised when using Gastrografin in pregnant women.
Since, where possible, radiation exposure should be avoided during pregnancy, the benefits of an X-ray diagnostic investigation, with or without contrast medium, must be carefully weighed against the possible risks.
Feeding time
After intravascular use, salts of diatrizoic acid are excreted in human breast milk. However, no effects on the infant are expected at the recommended doses of Gastrografin. Breastfeeding is probably safe, particularly taking into account the low enteral absorption of Gastrografin.
04.7 Effects on ability to drive and use machines -
You don't notice.
04.8 Undesirable effects -
Frequency of adverse reactions according to spontaneous reports and literature data:
Undesirable effects related to the use of iodinated contrast media are usually mild to moderate and transient in nature, however serious and life-threatening reactions, in some cases even death, have been reported.
Vomiting, nausea and diarrhea are the most frequently reported reactions.
Undesirable effects by MedDRA System Organ Class (MedDRA SOC) are presented in the table below.
The list contains the MedDRA term most appropriate to describe a particular reaction, as well as its synonym and related conditions.
Immune system disorders, anaphylactoid reaction / hypersensitivity:
Systemic hypersensitivity is rare, mostly mild and usually manifests itself in the form of skin reactions. However, the possibility of a severe hypersensitivity reaction cannot be completely excluded (see section 4.4 "Special warnings and precautions for use"). .
Gastrointestinal disorders:
The hypertonic solution of Gastrografin can cause diarrheal manifestations which disappear however as soon as the intestine is emptied. An ongoing colitis or enteritis can transiently worsen. In case of obstruction, prolonged contact with the intestinal mucosa can cause erosions and intestinal necrosis .
04.9 Overdose -
It is recommended to compensate for disturbances in the water and electrolyte balance caused by overdose.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: water-soluble, nephrotropic, high osmolar radiological contrast media.
ATC code: V08AA.
The active ingredient contained in the formulation of Gastrografin is a salt of starch (dia-) trizoic acid in which the iodine which absorbs the X radiation is present in a stable chemical bond. The chemical-physical characteristics of Gastrografin are shown below:
05.2 "Pharmacokinetic properties -
Absorption of amidotrizoic acid, the radiopaque agent of Gastrografin, after oral administration is only 3%. Even in the absence of perforation, higher levels of absorption demonstrated by opacification of renal calyxes and ureters.
If there is a perforation of the gastrointestinal tract, Gastrografin passes into the abdominal cavity and surrounding tissues, where it is absorbed and finally excreted via the kidneys.
05.3 Preclinical safety data -
The flavor correctors sodium saccharin and essence of anise, the solubilizer polysorbate 80 as well as the stabilizing additive sodium edetate contained in Gastrografin are considered harmless at the doses used. Therefore, the risk assessment was carried out only for sodium and contrast compounds. meglumine amidotrizoate.
Non-clinical data reveal no special hazard for humans based on conventional studies of systemic toxicity, genotoxicity, reproductive toxicity, local tolerability and contact sensitization potential.
• Systemic toxicity
Based on the results of preclinical acute toxicity studies, there is no risk of acute intoxication with the use of Gastrografin.
No systemic tolerability studies have been conducted following repeated oral administration and were not considered necessary. Only very small amounts of amidotrizoate are available systemically.
Systemic tolerability studies with meglumine or sodium amidotrizoate, after repeated daily intravenous administration, did not show evidence against the single diagnostic dose administered intravenously generally used in humans. This is even more true in the case of oral administration in the above mentioned circumstances.
• Genotoxic potential, carcinogenicity
In vivo and in vitro studies on genotoxic effects (gene, chromosomal and genomic mutation tests) using a mixture of sodium salts and meglumine amidotrizoate did not reveal any mutagenic potential of Gastrografin.
Carcinogenicity studies have not been conducted. Given the absence of genotoxic effects and considering the metabolic stability, pharmacokinetics and the absence of any indication of toxic effects of sodium and meglumine amidotrizoate on rapidly growing tissues, as well as the fact that Gastrografin is administered only once, not c "is no obvious risk of carcinogenic effects in humans."
• Reproductive toxicity
Reproductive toxicity studies in animals with intravenous administration of meglumine or sodium amidotrizoate did not reveal any teratogenic or embryotoxic potential. Given the low resorption from the gastrointestinal tract (see systemic tolerability studies) no risk for pregnancy or for the fetus following inadvertent administration of Gastrografin during pregnancy.
• Local tolerance and potential contact sensitization
Local tolerability studies with Gastrografin have not been conducted on mucous membranes in the gastrointestinal tract. However, local tolerance studies with meglumine amidotrizoate following intraperitoneal administration as well as in the oviduct did not indicate possible local adverse effects on the mucous membranes of the human gastrointestinal tract. This assessment is supported by many years of clinical experience with Gastrografin.
Studies on the contact sensitization effect did not reveal any potential contact sensitization of meglumine amidotrizoate. However, many years of clinical experience with Gastrografin indicate that anaphylactoid reactions which are known to occur after administration of other iodinated contrast media may occur.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Sodium edetate, sodium saccharin, anise essence, polysorbate 80, purified water.
06.2 Incompatibility "-
This medicinal product must not be mixed with other products except those mentioned in section 4.2 "Posology and method of administration".
06.3 Period of validity "-
5 years in intact packaging.
06.4 Special precautions for storage -
Store at a temperature not exceeding 25 ° C; keep away from light and X-rays.
06.5 Nature of the immediate packaging and contents of the package -
Container: Yellow glass bottle (hydrolytic class III) closed with a high density polyethylene cap with internal low density polyethylene gasket.
Packaging: bottle of 100 ml
06.6 Instructions for use and handling -
At temperatures below 7 ° C Gastrografin may show a tendency to crystallization, which is reversible after heating and stirring. This does not affect the efficacy and stability of the preparation.
Unused contrast medium solution within 1 day of opening the bottle should be discarded.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
BAYER SpA - Viale Certosa, 130 - 20156 Milan
08.0 MARKETING AUTHORIZATION NUMBER -
Bottle of 100 ml AIC n. 023085020
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
09.11.1974/01.06.2005
10.0 DATE OF REVISION OF THE TEXT -
30.01.2009
