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CISPLATIN injection


  1. Patient Information
  2. Manufactured By:

Patient Information 

Nephrotoxicity

Inform patients that cisplatin injection can cause nephrotoxicity and that renal function and electrolyte monitoring during treatment is necessary. If indicated, inform patients about the use of electrolyte supplements[see Warnings and Precautions (5.1)].

Peripheral Neuropathy

Advise patients to report any new paresthesias to their healthcare provider[see Warnings and Precautions (5.2)].

Nausea and Vomiting

Advise patients concerning the use of antiemetics to prevent nausea and vomiting and to report persistent or severe symptoms to their healthcare provider[see Warnings and Precautions (5.3)].

Myelosuppression

Advise patients that cisplatin injection can reduce the absolute neutrophil count and the platelet count resulting in an increased risk of infection and bleeding and to contact their healthcare provider for new onset fever, symptoms of infection, or bleeding[see Warnings and Precautions (5.4)].

Ototoxicity

Advise patients to report any symptoms of hearing loss or vestibular dysfunction to their healthcare provider and that periodic monitoring of hearing may be performed[see Warnings and Precautions (5.6)].

Embryo-Fetal Toxicity

Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider if they are pregnant or become pregnant[see Warnings and Precautions5.9and Use in Specific Populations8.1)].
Advise females of reproductive potential to use effective contraception during treatment and for 14 months following the last dose of cisplatin injection[see Use in Specific Populations (8.3)].
Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 11 months following the last dose of cisplatin injection[see Use in Specific Populations (8.3)].

Lactation

Advise females not to breastfeed during treatment with cisplatin injection[seeUse in Specific Populations (8.2)].

Infertility

Inform patients that treatment with cisplatin injection may lead to permanent impairment of spermatogenesis, ovarian failure or premature menopause, and reduced fertility in both genders[see Use in Specific Populations (8.3)].

Alopecia

Inform patients that cisplatin injection can cause alopecia.

Manufactured By: 


Intas Pharmaceuticals Limited,
Plot No. 5 to 14 Pharmez,
Nr. Village Matoda,
Bavla Road, Ta.- Sanand,
Dist. Ahmedabad - 382213,
India

For BluePoint Laboratories

51 0369 1 721039

Issued: April 2019



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