Cyclosporine (Restasis)

Trade Name : RESTASIS

Allergan, Inc.

EMULSION

Strength 0.5 mg/mL

CYCLOSPORINE Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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 Cyclosporine (Restasis) which is also known as RESTASIS and Manufactured by Allergan, Inc.. It is available in strength of 0.5 mg/mL per ml. Read more

Cyclosporine (Restasis) 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

Validated Cold Chain Shipment

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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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

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.

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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  • No data
  • RESTASIS
  • 1
  • Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using. Instill one drop of n ophthalmic emulsion twice a day in each eye approximately 12 hours apart. n can be used concomitantly with lubricant eye drops, allowing a 15-minute interval between products.u00a0Discard vial immediately after use.
  • Instill one drop of n ophthalmic emulsion twice a day in each eye approximately 12 hours apart. ()
  • Ophthalmic emulsion containing cyclosporine 0.5u00a0mg/mL
  • Cyclosporine ophthalmicu00a0emulsion 0.5u00a0mg/mL ()
  • No data
  • Hypersensitivityu00a0()
  • No data
  • To avoid the potential for eye injury and contamination, be careful not to touch the vial tip to your eye or other surfaces. ()
  • The following serious adverse reactions are described elsewhere in the labeling:
  • The most common adverse reaction following the use of n was ocular burning (17%).u00a0()
  • No data
  • RESTASISn- Arrayn- En- Sn- Rn- Rn- Nn- Nn- Nn- Nn- Nn- N
  • Structural Formula
  • Formula: CHNOMol. Wt.:u00a01202.6
  • Cyclosporine is a fine white powder. n appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5-8.0. Each mL of n ophthalmic emulsion contains: cyclosporine 0.05%. glycerin; castor oil; polysorbate 80; carbomer copolymer type A; purified water; and sodium hydroxide to adjust pH.
  • No data
  • Carcinogenesis
  • Systemic carcinogenicity studies were conducted in male and female mice and rats. In the 78-week oral (diet) mouse study, at doses of 1, 4, and 16 mg/kg/day, evidence of a statistically significant trend was found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose males significantly exceeded the control value.
  • In the 24-month oral (diet) rat study, conducted at 0.5, 2, and 8 mg/kg/day, pancreatic islet cellu00a0adenomas significantly exceeded the control rate in the low dose level. The hepatocellularu00a0carcinomas and pancreatic islet cell adenomas were not dose related. The low doses in mice andu00a0rats are approximately 80 times greater (normalized to body surface area) than the daily recommended human dose ofu00a0one drop (approximately 28 mcL) of 0.05% n u00a0twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed.
  • Mutagenesis
  • Cyclosporine has not been found to be mutagenic/genotoxic in the Ames Test, the V79-HGPRT Test, the micronucleus test in mice and Chinese hamsters, the chromosome-aberration tests in Chinese hamster bone-marrow, the mouse dominant lethal assay, and the DNA-repair test in sperm fromu00a0treated mice. A study analyzing sister chromatid exchange (SCE) induction by cyclosporine using human lymphocytes gave indication of a positive effect (i.e., induction of SCE).
  • Impairment of Fertility
  • No impairment in fertility was demonstrated in studies in male and female rats receiving oral doses of cyclosporine up to 15 mg/kg/day (approximately 2,000 times the human daily dose of 0.001 mg/kg/day normalized to body surface area)u00a0for 9 weeks (male) and 2 weeks (female) prior to mating.
  • Four multicenter, randomized, adequate and well-controlled clinical studies were performed inu00a0approximately 1,200 patients with moderate to severe keratoconjunctivitis sicca.u00a0n n demonstrated statistically significant increases in Schirmer wetting of 10 mm versus vehicle atu00a0six months in patients whose tear production was presumed to be suppressed due to ocularu00a0inflammation. This effect was seen in approximately 15% of n ophthalmic emulsion-treated patients versus approximately 5% of vehicle-treated patients. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
  • No increase in bacterial or fungal ocular infections was reported following administration ofu00a0n .
  • RESTASISn- Array
  • 30 Vials 0.4 mL each - NDC 0023-9163-30
  • 60 Vials 0.4 mL each - NDC 0023-9163-60
  • Storage:
  • Handling the Container
  • Advise patients to not allow the tip of the vial to touch the eye or any surface, as this may contaminate the emulsion.u00a0Advise patients to not touch the vial tip to their eye to avoid the potential for injury to the eye [n n n n ].
  • Use with Contact Lensn- es
  • RESTASISn- Arrayn- RESTASISn- Arrayn- see Warnings and Precautions (n- Arrayn- )n- .
  • Administration
  • Advise patients that the emulsion from one individual single-use vial is to be used immediately after opening foru00a0administration to one or both eyes, and the remaining contents should be discarded immediatelyu00a0after administration.
  • u00a9 2017u00a0Allergan. All rights reserved.All trademarks are the property of their respective owners.
  • Patented.u00a0Seeu00a0www.allergan.com/patentsIrvine, CA 92612
  • Made in the U.S.A.
  • 71876US19
  • NDC 0023-9163-60n- u00a0n- Array
  • Restasisn- u00aen- u00a0n- (Cyclosporine Ophthalmic Emulsion) 0.05%
  • 60 Single-Use Vials (0.4 mL each) One Month Supply Sterile, Preservative-Free

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