VOL.40 S-1

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1 238 CHEMOTHERAPY APRIL 1992 Russell A.W. EFreeman S.J. ESiddall R.A. ICI Pharmaceuticals Safety of Medicines Department** **Alderley Park, Macclesfield Cheshire, SK10 4TG, England

2 VOL.40 S-1

3 240 CHEMOTHERAPY APRIL 1992 Fig. 1. Body weights of male and female rats intravenously administered meropenem for 77 days and 14 days before mating (Segment I).

4 VOL.40 S-1 Table 1. Mating and fertility (Segment I) Table 2. Uterine examination (Segment I) p = Statistical significance of difference from control mean. Significance levels -*p <0.05 **p<0.01 ***p <

5 CHEMOTHERAPY APRIL 1992 Table 3. Uterine examination (Segment I additional study) Fig. 2. Body weights of dams (F0) intravenously administered meropenem on days 7 to 17 of gestation-caesarean section group-(segment II).

6 VOL.40 S-1 Table 4. Uterine examination (Segment II) p = Statistical significance of difference Significance levels: *p< from control mean. Table 5. Fetal examination (Segment II) p = Statistical significance increase from control group incidence (one-sided test for increase in incidence due to dosing). Approximate significance levels: *p <0.05. A dash (-) indicates unsuitable data for significance test.

7 CHEMOTHERAPY APRIL 1992 Table 6. Fo litter survival(segment II) p=statistical significance of difference from control group(none were significant p>0.05)(one-sided test for decrease in survival due to dosing). A dash (-) under p indicates unsuitable data for analysis.

8 VOL.40 S- 1 Fig. 3. Body weights of male and female offspring (F1) before and after weaning (Segment II). Fig. 4. Body weights of dams (F0) intravenously administered meropenem from day 17 of gestation through day 21 of lactation (Segment III).

9 CHEMOTHERAPY APRIL 1992 Table 7. Fo litter survival (Segment III) p= Statistical significance of difference from control group (none were significant p> 0.05) (one-sided test for decrease in survival due to dosing). A dash (-) under p indicates unsuitable data for analysis.

10 Fig. 5. Body weights of male and female offspring (F1) before and after weaning (Segment III).

11 CHEMOTHERAPY APRIL 1992 Table 8. Fo neonatal development (Segment III) p= Statistical significance of difference from control group. Significance levels: *p < A dash (-) under p indicates unsuitable data for significance test. Note: For percentage relative to interval 1, a negative value indicates a relative reduction in response.

12 VOL.40 S-1 1) Pisano R G and Storer T I: Burrows and feeding of the Norway rat. J Mammal 29: 374 ` 383, ) Reiter L W: Chemical exposures and animal activity: utility of the figure-8 maze. In: Developments in the science and practice of toxicology. Edited by Hayes, A W, Schnell, R C and Miya, 1.5 New York Elsevier Press, pp73 3) Adams J, Oglesby D M, Ozemek H S, Rath J, Kimmel C A, and Buelke-Sam J: Collaborative behavioral teratology study: programmed data entry and automated test systems. Neurobehavioural Toxicology and Teratology 7 (6): 547 4) Davis M: Neurochemical modulation of sensory-motor reactivity: acoustic and tactile startle reflexes. Neurosci Biobehav Rev 4: 241 5) Groves P M and Thompson R F: Habituation: a dual process theory. Psychol Rev 77: 419 ` 450, 1970 Onodera T, Ogawa H and Akimoto T: Toxicological studies of cefoxitin I. Acute, subacute and chronic toxicity. Chemotherapy 26 (S-1): 150 7) Morimoto K, Shimizu M, Tadokoro T, Takahashi S and Miyaji T: Subacute toxicity study of cefroxadine (CGP-9000) Chemotherapy: 28 (S-3), , ) Furuhashi T, Uehara M, Nakayoshi H: Safety study on ceftazidime (VI). Fertility study in rats. Chemotherapy 31 (S-3): 928 `939, ) Furuhashi T, Kato I, Nomura A and Nakayoshi H: Safety study on ceftazidime (IX) perinatal and postnatal study in rats. Chemotherapy 31 (S-3): , ) Furuhashi T, Takei A, Honda T and Nakayoshi H: Safety study on ceftazidime (VII) teratological study in rats. Chemotherapy 31 (S-3): , ) Hasegawa Y, Takegawa Y and Yoshida T: Reproduction of rats under 6315-S (Flomoxof) (2). Intravenous administration during fetal organogenesis. Chemotherapy 35 (5-1): ) Hasegawa Y and Yoshida T: A teratology study on 6059-S in rats. Chemotherapy 28 (S-7): , ) Tanaka Y, Shimakoshi Y, Kato T and Nakatani H: Teratogenicity study on SM-1652 in rats. Kiso to Rinshou 17 (3): , ) Kobayashi F, Muranaka R: Reproduction of rats under 6315-S (Flomoxef)(1). Fertility study. Chemotherapy 35 (S-1): 351 `369, ) Hasegawa Y, Andou M: Reproduction of rats under 6315-S (Flomoxof)(3) Intravenous administration during the perinatal and lactation period. Chemotherapy 35 (5-1): 404 ` 434, ) Takayama S, Furuhama K, Kato M, Yamada A,

13 250 CHEMOTHERAPY APRIL 1992 REPRODUCTION AND DEVELOPMENTAL STUDY OF MEROPENEM IN RATS Satoshi Kawamura Environmental Health Science Laboratory, Sumitomo Chemical Co. Ltd Kasugade-naka, 3-chome, Konohana-ku, Osaka 554, Japan A.W. Russel, S.J. Freeman and R.A. Siddall Safety of Medicines Department, ICI Pharmaceuticals Meropenem was administered intravenously to rats prior to and in the early stages of pregnancy (Seg. ), during the period of fetal organogenesis (Seg. II) and during the perinatal and lactation periods I(Seg. ) to investigate the effects of the drug on reproduction. The dosages were 240, 500 and 1,000 mg/kg III in Seg. I and Seg. f and 240, 500 and 750 mg/kg in Seg. II. 1. In the parent animals, soft stool and diarrhea were found in the treatment groups, but no drug-related death occurred. Low body weight or low food consumption was found in the 500 mg/kg and higher dose groups in males and in the 240 mg/kg group and higher in females. 2. The reproductive performance of parent animals and the maintenance of pregnancy, delivery and lactation in female animals were not affected. 3. There were no effects on fetal lethality, teratogenicity or retardation of fetal growth. 4. There were no effects on growth or functional development, except that, in F1 females in the maturation phase, low body weights were found in the 240 mg/kg group and higher in Seg. II and in the 1,000 mg/kg group in Seg. III.

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