Paricalcitol (Zemplar)

Trade Name : Zemplar

AbbVie Inc.

INJECTION, SOLUTION

Strength 5 ug/mL

PARICALCITOL Cholecalciferol [CS],Vitamin D3 Analog [EPC]

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Paricalcitol (Zemplar) which is also known as Zemplar and Manufactured by AbbVie Inc.. It is available in strength of 5 ug/mL per ml. Read more

Paricalcitol (Zemplar) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

No data

ZEMPLAR is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis.
ZEMPLAR is a vitamin D analog indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease on dialysis ().

Adult Dose:
Pediatric Dose:

Injection: clear, colorless solution available as follows:
ZEMPLAR is available as :

Injection: 2 mcg/mL single-dose vial
Injection: 5 mcg/mL single-dose vial
Injection: 10 mcg/2 mL (5 mcg/mL) multiple-dose vial

ZEMPLAR is contraindicated in patients with:

Hypercalcemia ()
Vitamin D toxicity ()
Known hypersensitivity to paricalcitol or any inactive ingredient ().

No data

Hypercalcemia:
Digitalis toxicity:
Adynamic Bone Disease:

The following serious adverse reactions are described below and elsewhere in the labeling:
The most common adverse reactions (> 5% and more frequent than placebo) are nausea, vomiting and edema ().n
To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Table 4 includes clinically significant drug interactions with ZEMPLAR.
p141200291534859127
Strong CYP3A Inhibitors
2.4
7

No data

Overdosage of ZEMPLAR may lead to hypercalcemia, hypercalciuria, and hyperphosphatemia. .
The treatment of acute overdosage should consist of supportive measures and discontinuation of drug administration. Serum calcium levels should be measured until normal.
Paricalcitol is not significantly removed by dialysis.

Paricalcitol, USP, is a synthetically manufactured active vitamin D analog. It is a white powder chemically designated as 19-nor-1u03b1,3u03b2,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula:
Molecular formula is CHO.
Molecular weight is 416.64.
ZEMPLAR (paricalcitol) injection is a sterile, clear, colorless, aqueous solution for intravenous use. Each mL contains paricalcitol, 2 mcg or 5 mcg and the following inactive ingredients: alcohol, 20% (v/v) and propylene glycol, 30% (v/v).

No data

In a 104-week carcinogenicity study in CD-1 mice, an increased incidence of uterine leiomyoma and leiomyosarcoma was observed at subcutaneous doses of 1, 3, 10 mcg/kg administered 3 times per week (2 to 15 times the AUC at a human dose of 14 mcg, equivalent to 0.24 mcg/kg based on AUC). The incidence rate of uterine leiomyoma was significantly different than the control group at the highest dose of 10mcg/kg.
In a 104-week carcinogenicity study in rats, there was an increased incidence of benign adrenal pheochromocytoma at subcutaneous doses of 0.15, 0.5, 1.5 mcg/kg administered 3 times per week (at less than clinical exposure to 7 times the exposure following a human dose of 14 mcg, equivalent to 0.24 mcg/kg based on AUC). The increased incidence of pheochromocytomas in rats may be related to the alteration of calcium homeostasis by paricalcitol.
Paricalcitol did not exhibit genetic toxicity with or without metabolic activation in the microbial mutagenesis assay (Ames Assay), mouse lymphoma mutagenesis assay (L5178Y), or a human lymphocyte cell chromosomal aberration assay. There was also no evidence of genetic toxicity in an mouse micronucleus assay.
Paricalcitol had no effect on fertility (male or female) in rats at intravenous doses up to 20 mcg/kg/dose (13 times a human dose of 14 mcg, equivalent to 0.24u00a0mcg/kg based on surface area, mg/m).

Adult Studies in CKD on Dialysis
Three 12-week, placebo-controlled studies were conducted in 78 patients with CKD on hemodialysis. In these studies, patients ranged in age from 22 to 90 years, 51% were males, 13% were Caucasian, 79% were African-American, and 8% were Hispanic. The most common causes of renal failure were hypertension and diabetes. The dose of ZEMPLAR was started at 0.04 mcg/kg 3 times per week intravenously. The dose was increased by 0.04u00a0mcg/kg every 2 weeks until intact PTH levels were decreased at least 30% from baseline or a fifth escalation brought the dose to 0.24u00a0mcg/kg, or intact PTH fell to less than 100 pg/mL, or the Ca u00d7 P product was greater than 75 within any 2 week period, or serum calcium became greater than 11.5 mg/dL at any time.
Patients treated with ZEMPLAR achieved a mean intact PTH reduction of 30% within 6 weeks. The results from these studies are as follows:
Pediatric Study in CKD on Dialysis
ZEMPLAR was evaluated in a 12-week randomized, double-blind, placebo-controlled study of 29 pediatric patients, aged 5 to 19 years, with CKD on hemodialysis; nearly all had received some form of vitamin D prior to the study. Of the 29 patients, 76% were male, 52% were Caucasian and 45% were African-American. The initial dose of ZEMPLAR was 0.04 mcg/kg 3 times per week, based on baseline intact PTH level of less than 500 pg/mL, or 0.08 mcg/kg 3 times per week, based on baseline intact PTH level of 500 pg/mL or greater. The dose of ZEMPLAR was adjusted in 0.04 mcg/kg increments based on the levels of serum intact PTH, calcium and Ca u00d7 P. The mean baseline levels of intact PTH were 841 pg/mL for the 15 ZEMPLAR-treated patients and 740 pg/mL for the 14 placebo-treated patients. The mean dose of ZEMPLAR administered was 4.6 mcg (range: 0.8 mcg to 9.6 mcg). Sixty-seven percent of the ZEMPLAR-treated patients and 14% of the placebo-treated patients completed the trial. Seventy-one percent of the placebo-treated patients discontinued due to excessive elevations in intact PTH levels, as defined by 2 consecutive intact PTH levels greater than 700 pg/mL and greater than baseline after 4 weeks of treatment.
The primary efficacy analysis demonstrated that 60% of ZEMPLAR-treated patients and 21% of placebo-treated patients achieved two consecutive greater than or equal to 30% reductions from baseline in intact PTH.

ZEMPLAR injection is a clear, colorless solution available in trays of 25 vials as follows:
Store at 25u00b0C (77u00b0F). Excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F).
Discard any unused portion of the single-dose vial after use.
The contents of the multiple-dose vial remain stable up to seven days after initial use when stored at controlled room temperature.

Hypercalcemia
Advise patients to contact a health care provider if they develop symptoms of elevated calcium (e.g. feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss) .
Monitoring
Inform patients that they will need routine monitoring of laboratory parameters such as calcium and intact PTH while receiving ZEMPLAR. Inform patients that more frequent monitoring is necessary during the initiation of therapy, following dose changes or when potentially interacting medications are started or discontinued .
Drug Interactions
Advise patients to inform their physician of all medications, including prescription and nonprescription drugs, and supplements they are taking. Advise patients to also inform their physician that they are receiving ZEMPLAR if a new medication is prescribed .
Manufactured forAbbVie Inc.North Chicago, IL 60064, U.S.A.n u00a9 AbbVie Inc.
EN-5761 November, 2018

NDC 0074u20134637u201301
1 mL Single-Dose Vial
Discard unused portion
Zemplar(paricalcitol) Injection 2 mcg/mL
For Intravenous Use
Mfd for: AbbVie Inc, N. Chgo, IL 60064 USA
Rx only
NDC 0074-4637-01
Single-Dose Vials - Discard unused portion
Zemplar 2mcg/mL Rx only
(paricalcitol) Injection
For Intravenous Use
25 x 1 mL Vials abbvie
NDC 0074u20131658u201301
1 mL Single-Dose Vial
Discard unused portion
Zemplar(paricalcitol) Injection 5 mcg/mL
For Intravenous Use
Mfd for: AbbVie Inc., N. Chgo, IL 60064 USA
Rx only
NDC 0074-1658-01
Single-Dose Vials - Discard unused portion
Zemplar 5mcg/mL Rx only
(paricalcitol) Injection
for Intravenous use
25 x 1 mL Vials abbvie
NDC 0074u20131658u201305
2 mL Multi-Dose Vial
Zemplar(paricalcitol) Injection 10 mcg/2 mL (5 mcg/mL)
For Intravenous Use
Mfd for: AbbVie Inc., N. Chgo, IL 60064 USA
Rx only
NDC 0074-1658-05
Multi-dose Vials Rx only
Zemplar 10mcg/2mL
(paricalcitol) Injection (5mcg/mL)
For Intravenous Use
25 x 2 mL Vials abbvie

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Paricalcitol (Zemplar)

Trade Name : Zemplar

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Paricalcitol (Zemplar)

Trade Name : Zemplar

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?