Gastrografin

BP22025, REC17047

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2.What you need to know before you are given Gastrografin

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Gastrografin contains sodium

• Gastrografin contains 3.76 mg of sodium (main component of cooking/table salt) in each ml. This is equivalent of 0.19% of the recommended maximum daily dietary intake of sodium for an adult.

6.Contents of the pack and other information

What Gastrografin contains

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This medicine contains 374 mg of sodium (main component of cooking salt) in each bottle (100 ml). This is equivalent to 18.7% of the recommended maximum daily dietary intake of sodium for an adult. 

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This leaflet was last revised:

September 2022April 2024

7.Information for healthcare professionals only

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• Thyroid dysfunction

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In neonates, speciallyespecially preterm infants, who have been exposed to Gastrografin, either through the mother during pregnancy or in the neonatal period, it is recommended to monitor thyroid function, as an exposure to excess iodine may cause hypothyroidism, possibly requiring treatment. 

BP22025, REC17047

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Text in blue = added text

Text in red strikethrough = deleted text

4.4 Special warnings and precautions for use

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• Hypersensitivity

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This medicinal product contains 374 mg of sodium in each bottle (100 ml), equivalent to 18.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult. 

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In neonates, speciallyespecially preterm infants, who have been exposed to Gastrografin, either through the mother during pregnancy or in the neonatal period, it is recommended to monitor thyroid function, as an exposure to excess iodine may cause hypothyroidism, possibly requiring treatment. 

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Additional information

• Information on other excipients

Gastrografin contains sodium

This medicinal product contains 3.76 mg sodium per mL, equivalent to 0.19% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Water-soluble, nephrotropic, high osmolar X-ray contrast media, ATC code: V08AA01

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

Contrast medium solution not used within one day after opening the bottle must be discarded.

The product should be inspected visually for particles prior to administration. Only clear solution free from particles should be used.

At temperatures below 7ºC Gastrografin tends to crystallise 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.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

10. DATE OF REVISION OF THE TEXT

September 2022April 2024

BP22036, REC30610

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 6. Contents of the pack and other information

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Marketing Authorisation Holder:

Bayer Limited, 1st Floor, The Grange Offices, The Grange, Brewery Road, Stillorgan, Co. Dublin, A94 H2K7, The Atrium, Blackthorn road, Dublin 18, Ireland

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This leaflet was last revised in: October 2021September 2022

BP22036, REC30610

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7. MARKETING AUTHORISATION HOLDER

Bayer Limited

1^st Floor

The Grange Offices

The Grange

Brewery Road

Stillorgan

Co. Dublin

A94 H2K7

The Atrium

Blackthorn Road

Dublin 18

Ireland

8. MARKETING AUTHORISATION NUMBER

 PA1410/004/001

10. DATE OF REVISION OF THE TEXT

 October 2021September2022

- Removal of storage conditions - no longer required.

- Updates to QRD template

Section 4.8 - Deletion of Postal Address and Email Address. Website Address only.

Section 6.3 - Shelf Life reduction from "5 years" to "4 Years".

• In section 1 ( Name Of  Medicinal Product), product name is updated to include reference to active concentrations: " Gastrografin, 660mg/ml and 100mg/ml Oral and Rectal Solution"
• In section 2 ( Qualitative and Quantative  Composition),  the wording is restructured to read   "Each ml of solution contains Amidotrizoic acid (dihydrate) equivalent to 597.30mg Amidotrizoic acid (anhydrous), 159.24 mg meglumine and 6.29 mg sodium hydroxide equivalent to 100 mg of sodium amidotrizoate and 660 mg of meglumine amidotrizoate (and containing the equivalent of 370 mg of iodine in combined form per ml). The following statement is also added, Excipients: Each ml also contains 3.76mg of sodium or 0.16mmol.
• In section 4.8 ( Undesirable effects ), the text format of the table is changed to Italics. The following sub sections are underlined; Anaphylactoid reactions/hypersensitivity, Gastrointestinal, Respiratory and Skin.
• In Section 6.2 ( Incompatibilities) the following statement is removed;" None known so far " and replaced with "This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2"
• In section 6.3 ( Shelf Life) , the following statement is added; " Opened: Solution not used within one day after openinig the bottle must be discarded"
• In section 6.5 ( Nature and Contents of container), the following statement is added; " Pilferproof closure:high density polyethylene, PE-HD, coloured, with sealing disk, low density polyethylene, PE-LD, natural."
• In section 6.6 ( Special precautions for disposal and other handling), the title of this section is deleted and  replaced with " Special precautions for disposal of a used medicinal product or waste material derived from such medicinal product and other handling of the product "
• In section 9 ( Date of First Authorisation/ Renewal of the Authorisation), the following is added; " Date of last renewal: 01 April 2008"
• In section 10 ( Date of Revision of the text), August 2007 is deleted and replaced with Jan 2009.

Section 2. Qualitative and Quantitative Composition

This section was changed from:

“Each ml of solution contains 597.30 mg Amidotrizoic Acid (anhydrous), 159.24 mg Meglumine and 6.29 mg Sodium Hydroxide equivalent to 100 mg of Sodium Amidotrizoate and 660 mg of Meglumine Amidotrizoate (and containing the equivalent of 370 mg of Iodine in combined form per ml).

For excipients, see 6.1.”

to;

“Each ml of solution contains Amidotrizoic Acid (dihydrate) equivalent to Amidotrizoic acid (anhydrous) 597.30 mg, 159.24 mg Meglumine and 6.29 mg Sodium Hydroxide equivalent to 100 mg of Sodium Amidotrizoate and 660 mg of Meglumine Amidotrizoate (and containing the equivalent of 370 mg of Iodine in combined form per ml).

For excipients, see 6.1.”

Main Changes to the SPC include:

Section 4.1 Therapeutic Indications

Additional indications included:

Treatment of meconium ileus

Computerised tomography (CT) in the abdominal region

Section 4.2 Posology and method of administration

Addition of general information regarding use of the product including dietary suggestions, advice on hydration and use in children, infants and newborns.

Increased level of detail regarding the recommended dosage for oral use (in adults, children and CT).

Addition of information regarding the taking of exposures of the gastrointestinal tract.

Section 4.3 Contraindications

Deletion of the following contraindications:

Use in patients with thyrotoxicosis

Use in patients with hypersensitivity to iodine

Section 4.4 Special warnings and precautions for use

Inclusion of information regarding Hypersensitivity.

Information also supplied regarding use in the presence of Thyroid dysfunction, Severe cardiovascular disease and Very poor state of health

Section 4.5 Interaction with other medicinal products and other forms of interaction

Revised/additional text:

- use in patients taking beta-blockers

- interference with diagnostic tests

Section 4.6 Pregnancy and lactation

Use during pregnancy:

Inclusion of data from reproduction-toxicological studies.

Use during lactation:

Inclusion of additional information regarding risk to breast-feeding infant.

Section 4.8 Undesirable effects

Undesirable effects have been listed according to the frequency of occurrence and system affected.

In addition, the following undesirable effects have been included: anaphylactoid/hypersensitivity reactions,

erosions and bowel necrosis in case of prolonged contact with the bowel mucosa.

Section 4.9 Overdose

Revised text: Disorders of water- and electrolyte imbalance caused by an overdose should be corrected parenterally.

Section 5.1 Pharmacodynamic properties

Addition of table showing the physico-chemical characteristics of Gastrografin.

Section 5.2 Pharmacokinetic properties

Addition of information regarding higher absorption in some patients even in the absence of perforation.

Main changes to the SPC:

Section 6.3 Shelf Life

Extension of the shelf life of Gastrografin to 5 years.

Section 6.5 Special precautions for storage

Change of the storage conditions of Gastrografin to 'Do not store above 25°C’