Meronem

Meronem Adverse Reactions

meropenem

Manufacturer:

Sumitomo Dainippon Pharma

Distributor:

Zuellig Pharma

Marketer:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Meronem IV is generally well tolerated. Adverse reactions rarely lead to cessation of treatment. Serious adverse reactions are rare.
The following adverse reactions have been identified following clinical studies with Meronem IV. Their frequency is presented in Table 4 Frequency of Adverse Reactions (data derived from clinical trial data sources) using CIOMS III frequency classification and then listed by MedDRA SOC and at the preferred level. Frequencies of occurrence of undesirable effects are defined as: very common (≥1/10; ≥10%); common (≥1/100 to <1/10; ≥1% to <10%); uncommon (≥1/1,000 to <1/100; ≥0.1% to <1%); rare (≥1/10,000 to <1/1,000; ≥0.01% to <0.1%); very rare (<1/10,000; <0.01%). (See Table 4.)

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The following adverse reactions have been identified from post-marketing clinical trials and spontaneous reports. Their frequency is presented in Table 5: Reporting Rate of Adverse Reactions (data derived from a combination of post-marketing clinical trial and spontaneous sources) using CIOMS III frequency classification and then listed by MedDRA SOC and at the preferred level. Frequencies of occurrence of undesirable effects are defined as: very common (≥1/10; ≥10%); common (≥1/100 to <1/10; ≥1% to <10%); uncommon (≥1/1,000 to <1/100; ≥0.1% to <1%); rare (≥1/10,000 to <1/1,000; ≥0.01% to <0.1%); very rare (<1/10,000; <0.01%), not known (cannot be estimated from the available data). (See Table 5.)

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