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Gastrografin®

Bayer

Oral lösning/rektallösning 370 mg I/ml
(Klar, färglös till svagt gul lösning)

Röntgenkontrastmedel

Aktiv substans:
ATC-kod: V08AA01
Läkemedel från Bayer omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan (Läs mer om miljöpåverkan)

Amidotrizoinsyra

Miljörisk: Risk för miljöpåverkan av amidotrizoinsyra kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning: Amidotrizoinsyra är potentiellt persistent.
Bioackumulering: Amidotrizoinsyra har låg potential att bioackumuleras.


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Detaljerad miljöinformation

Gastrografin consist of the sodium salt or the meglumin salt of amidotrizoic acid. The following assessment is based on the effects of amidotrizoic acid, which is independent from the type of salt. 


Environmental Risk Classification

Predicted Environmental Concentration (PEC)

PEC is calculated according to the following formula:

PEC (μg/L) = (A*109*(100-R))/(365*P*V*D*100) = 1.5*10-6*A(100-R)

Where:

A = 1197 kg (Megluminamidotrizoat: 1039.5; Natriumamidotrizoat: 157.5 kg) (total sold amount API in Sweden year 2016, data from QuintilesIMS).
R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available.

P = number of inhabitants in Sweden = 9 *106 

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default)

PEC = 0,18 μg/L


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Crustacean (waterflea Daphnia magna):

Acute toxicity

EC50 /48 h (immobilization) = >100 mg/L (guideline OECD 202) (1)

Bacteria (Pseudomonas putida)

EC50 >1000 mg/L (guideline DIN38412 L8) (2)

The tests were performed with the meglumin salt of amidotrozoate, but can be used in analogy to the sodium salt. Because there are only acute studies for two species available, it is justified to state that “risk of environmental impact of “Amidotrizoat sodium or -meglumin” cannot be excluded, since there is not sufficient data available.


Excretion (metabolism)

Natriumamidotrizoat is introduced unmetabolized as parent compound (3).


Biodegradation

The test compound (meglumin salt of amidotrizoate) was studied for ready biodegradability in a test conducted over 28 days in the modified OECD screening test (OECD 301E) (4). The observed degradation did not exceed 19% (day 3). Specific analytical measurements of the parent compound (megluminamidotrizoate) showed that the amount of the compound did not decrease over time. Therefore, it is likely that the meglumin fraction of the molecule accounted for the observed degradation.

The lack of degradation of the parent compound justifies the phrase: “Amidotrizoat sodium or meglumin salt” is potentially persistent.


Bioaccumulation

The octanol/water partition coefficient of megluminamidotrizoate was determined with -4.09, using a shake-flask method at 25 degrees C and 24h shaking (5). The sodium salt of amidotrizoate can be treated in analogy.

The low octanol/water partition coefficient justifies the statement that “Amidotrizoat sodium or meglumin salt” has a low potential for bioaccumulation.


References

  1. Acute immobilization test of ZK2336/Megl to Daphnia magna (limit test), Schering AG, Experimental Toxicology, Report no 8944, Study no TX89378 (1998)

  2. Growth inhibition test of meglumin amidotrizoate on the bacterium Pseudomonas putida. Schering AG, Experimental Toxicology, Report no. 9193, Study no. TX90151 (1990)

  3. Bourin M, Jolliet P, Ballereau F. An overview of the clinical pharmacokinetics of x-ray contrast media. Clin Pharmacokinet Mar: 32 (3):180-93 (1997)

  4. Study of biodegradability of meglumin amidotrizoate, iohexol and iopromid according to the modified OECD Screening Test. Schering AG, Experimental Toxicology, Report no 9170, Study no TX90105 (1990)

  5. Krause W1, Miklautz H, Kollenkirchen U, Heimann G. Physicochemical parameters of x-ray contrast media, 29(1):72-80 (1994)