Krajina: Južná Afrika
Jazyk: angličtina
Zdroj: South African Health Products Regulatory Authority (SAHPRA)
Bm_squib
ZERIT 15 mg Capsule ZERIT 20 mg Capsule ZERIT 30 mg Capsule ZERIT 40 mg Capsule ZERIT 1 mg/mL Powder for oral solution SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ZERIT 15 mg Capsule ZERIT 20 mg Capsule ZERIT 30 mg Capsule ZERIT 40 mg Capsule ZERIT 1 mg/mL Powder for oral solution WARNING Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of Zerit alone or in combination. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other anti-retroviral agents (See Contraindications, Side Effects and Special Precautions.) The combination of stavudine and didanosine should be used with caution during pregnancy and only if the potential benefit clearly outweighs the potential risk. Fatal and non-fatal pancreatitis have occurred during therapy when ZERIT was part of a combination regimen that included didanosine in both treatment-naïve and treatment-experienced patients, regardless of degree of immunosuppression. The combination of ZERIT and didanosine and any other agents that are toxic to the pancreas should be suspended in patients with suspected pancreatitis. Reinstitution of ZERIT after a confirmed diagnosis of pancreatitis should be undertaken with particular caution and close patient monitoring. The new regimen should contain neither didanosine nor hydroxyurea. COMPOSITION Capsules containing stavudine (15 mg, 20 mg, 30 mg and 40 mg). Powder for oral solution containing stavudine (1 mg/mL of constituted solution). The reconstituted powder for oral solution contains methylparaben 0,15% m/v and propylparaben 0,015% m/v, as preservatives. PHARMACOLOGICAL CLASSIFICATION A 20.2.8 Antiviral agents. PHARMACOLOGICAL ACTION ZERIT contains stavudine, a synth Prečítajte si celý dokument