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METHOTREXATE (methotrexate) Dosage Forms, Composition And Packaging

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Pfizer reconnaît les préoccupations du grand public concernant la situation liée à la COVID-19, qui continue d'évoluer. Cliquez ici pour savoir comment nous avons réagi.

Dosage Forms, Composition And Packaging

(1) Methotrexate Injection USP is supplied in a carton containing 20 mg, 50 mg and 500 mg of methotrexate (as the sodium salt) as follows:

10 mg/mL methotrexate

20 mg/2 mL* (contains no preservative)

25 mg/mL methotrexate

50 mg/2 mL* (contains no preservative)

25 mg/mL methotrexate

50 mg/2 mL+ (contains preservative)

25 mg/mL methotrexate

500 mg/20 mL+ (contains preservative)

*
Single-use vials
+
Multidose vials

Note: The 10 mg/mL presentation is available in packs of 5 vials. The 25 mg/mL presentations are available in packs of 5 vials (2 mL) or as single vials (2 mL and 20 mL).

(2) Methotrexate Injection USP Pharmacy Bulk Vials which are packaged in a carton, are for intravenous use only and are supplied to hospitals with a recognized intravenous admixture program only, as follows:

25 mg/mL methotrexate

500 mg/20 mL (contains no preservative)

25 mg/mL methotrexate

1 g/40 mL (contains no preservative)

25 mg/mL methotrexate

2.5 g/100 mL (contains no preservative)

Composition: Methotrexate Injection USP is a sterile, isotonic solution containing:

  1. Methotrexate Sodium equivalent to 10 mg/mL Methotrexate with 7.0 mg/mL Sodium Chloride, (unpreserved), with Sodium Hydroxide and Hydrochloric Acid as pH adjusters.
  2. Methotrexate Sodium equivalent to 25 mg/mL Methotrexate with 4.9 mg/mL Sodium Chloride, (unpreserved), with Sodium Hydroxide and Hydrochloric Acid as pH adjusters.
  3. Methotrexate Sodium equivalent to 25 mg/mL Methotrexate with 2.6 mg/mL Sodium Chloride and 0.9% v/v Benzyl alcohol (preserved), with Sodium Hydroxide and Hydrochloric Acid as pH adjusters.

Note: 50 mg/2 mL and 500 mg/20 mL Methotrexate Injection USP, with benzyl alcohol (as preservative) are supplied as multidose vials. Please see STORAGE AND STABILITY for special storage conditions once the vials are punctured.

Latex-free Stoppers – Stoppers contain no dry natural rubber

 

Submission Control No.: 224776
July 08, 2019

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