Onabotulinumtoxina (Botox Cosmetic)

Trade Name : BOTOX Cosmetic

Allergan, Inc.

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 50 [USP'U]/1

BOTULINUM TOXIN TYPE A Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA]

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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 Onabotulinumtoxina (Botox Cosmetic) which is also known as BOTOX Cosmetic and Manufactured by Allergan, Inc.. It is available in strength of 50 [USP'U]/1 per ml. Read more

Onabotulinumtoxina (Botox Cosmetic) 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

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No data

Warnings and Precautions, Dry Eye in Patients Treated with BOTOXu00a0Cosmetic () 11/2019

WARNING: DISTANT SPREAD OF TOXIN EFFECT
See full prescribing information for complete boxed warning.
5.2

BOTOX Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
BOTOX Cosmetic is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated in adult patients for the temporary improvement in the appearance of ():

Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity n
Moderate to severe lateral canthal lines associated with orbicularis oculi activity n
Moderate to severe forehead lines associated with frontalis muscle activity

No data

Botox Cosmetic is administered by intramuscular injectionn
Glabellar Lines Administration: 0.1 mL (4 Units) into each of 5 sites, for a total dose of 20 Units ()n
Lateral Canthal Lines Administration: 0.1 mL (4u00a0Units) into each of 3 sites per side (6 total injection points), for a total of 24u00a0Units ()n
Forehead Lines Administration: 0.1 mL (4 Units) into each of 5 forehead line sites (20 Units) with 0.1 mL (4 Units) into each of 5 glabellar line sites (20 Units), for a recommended total of 40 Units ()n
Follow dosage and administration recommendations. In treating adults for more than one approved indications with BOTOX and BOTOX Cosmetic, do not exceed a total dose of 400 Units administered in a 3 month interval ()n
See Preparation and Dilution Technique for instructions on BOTOX Cosmetic reconstitution, storage, and preparation before injection ()

For Injection: 50 Units or 100 Units vacuum-dried powder in a single-dose vial for reconstitution ()

No data

Hypersensitivity to any botulinum toxin preparation or to any ofu00a0the components in the formulation (, )n
Infection at the injection site ()

No data

Potency Units of BOTOX Cosmetic are not interchangeable with other preparations of botulinum toxin products (, )n
Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur (, )n
Potential serious adverse reactions after administration of BOTOX for unapproved uses ()n
Adverse event reports have been received involving the cardiovascular system, some with fatal outcomes. Use caution when administering to patients with pre-existing cardiovascular disease. ()n
Concomitant neuromuscular disorder may exacerbate clinical effects of treatment ()n
Use with caution in patients with compromised respiratory function or dysphagia ()

The following adverse reactions to BOTOX Cosmetic (onabotulinumtoxinA) for injection are discussed in greater detail in other sections of the labeling:
nttu00a0u00a0u00a0u00a0u00a0ntThe most common adverse reactions are ():

Glabellar Lines: eyelid ptosis (3%) n
Lateral Canthal Lines: eyelid edema (1%)n
Forehead Lines: headache (9%) and brow ptosis (2%)

No formal drug interaction studies have been conducted with BOTOX Cosmetic (onabotulinumtoxinA) for injection.
Patients receiving concomitant treatment of BOTOX Cosmeticand aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of BOTOX Cosmetic may be potentiated ()

No data

Excessive doses of BOTOX Cosmetic(onabotulinumtoxinA) for injection may be expected to produce neuromuscular weakness with a variety of symptoms.
Symptoms of overdose are likely not to be present immediately following injection. Should accidental injection or oral ingestion occur or overdose be suspected, these patients should be considered for further medical evaluation and appropriate medical therapy immediately instituted, which may include hospitalization. The person should be medically supervised for several weeks for signs and symptoms of systemic muscular weakness which could be local, or distant from the site of injection n n n n n n .
If the musculature of the oropharynx and esophagus are affected, aspiration may occur which may lead to development of aspiration pneumonia. If the respiratory muscles become paralyzed or sufficiently weakened, intubation and assisted respiration may be necessary until recovery takes place. Supportive care could involve the need for a tracheostomy and/or prolonged mechanical ventilation, in addition to other general supportive care.
In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration. In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Department to process a request for antitoxin through the CDC. If you do not receive a response within 30 minutes, please contact the CDC directly at 1-770-488-7100. More information can be obtained at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5232a8.htm.

BOTOX Cosmetic(onabotulinumtoxinA)for injection, is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain type A intended for intramuscular use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.
The primary release procedure for BOTOX Cosmeticuses a cell-based potency assay to determine the potency relative to a reference standard. The assay is specific to Allerganu2019s products BOTOX and BOTOX Cosmetic. One Unit of BOTOX Cosmetic corresponds to the calculated median intraperitoneal lethal dose (LD) in mice. Due to specific details of this assay such as the vehicle, dilution scheme and laboratory protocols, Units of biological activity of BOTOX Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. The specific activity of BOTOX Cosmetic is approximately 20 Units/nanogram of neurotoxin complex.
Each vial of BOTOXu00a0Cosmeticcontains either 50 Units of Clostridium botulinumtype A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride; or 100 Unitsof Clostridium botulinumtype A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.

No data

Long term studies in animals have not been performed to evaluate carcinogenic potential of BOTOX Cosmetic.
BOTOX Cosmetic was negative in a battery of (microbial reverse mutation assay, mammalian cell mutation assay, and chromosomal aberration assay) and (micronucleus assay) genetic toxicologic assays.
In fertility studies of BOTOX Cosmetic (4, 8, or 16 Units/kg) in which either male or female rats were injected intramuscularly prior to mating and on the day of mating (3 doses, 2 weeks apart for males, 2 doses, 2 weeks apart for females) to untreated animals, reduced fertility was observed in males at the intermediate and high doses and in females at the high dose. The no-effect doses for reproductive toxicity (4 Units/kg in males, 8 Units/kg in females) are approximately 4-8u00a0times the average high human dose for glabellar lines, lateral canthal lines, and forehead lines of 64 Units on a body weight basis (Units/kg).

No data

BOTOX Cosmeticn- u00a0
50 Units: NDC 0023-3919-50
100 Units: NDC 0023-9232-01
The top and bottom flaps of the BOTOX Cosmetic cartons have a tamper-evident seal that contains a translucent silver Allergan logo, and the BOTOX Cosmetic vial labels have a holographic film that contains the name u201cAllerganu201d within rainbow colored horizontal lines (rotate the vial back and forth between your fingers under a desk lamp or fluorescent light source to see the hologram). (Note: The holographic film on the label is absent in the date/lot area.) Each BOTOX Cosmetic vial label and carton labeling also contain the U.S. License number 1145 n n .
Do not use the product and contact Allergan for additional information at 1-800-890-4345 from 7:00 AM to 3:00 PM Pacific Time if the labeling is notu00a0as described above.
Storage
Unopened vials of BOTOX Cosmetic should be stored in a refrigerator 2u00b0 to 8u00b0Cu00a0(36u00ba to 46u00baF). Do not use after the expiration date on the vial. Reconstituted BOTOX Cosmetic should be stored in a refrigerator 2u00b0 to 8u00b0C (36u00ba to 46u00baF) and administered within 24 hours.u00a0

See FDA-approved patient labeling (n- Arrayn- )
Provide a copy of the Medication Guide and review the contents with the patient.
Swallowing, Speaking or Breathing Difficulties, or Other Unusual Symptoms
Patients should be advised to inform their doctor or pharmacist if they develop any unusual symptoms (including difficulty with swallowing, speaking, or breathing), or if any existing symptom worsens n n n n n n .
Ability to Operate Machinery or Vehicles
Patients should be counseled that if loss of strength, muscle weakness, blurred vision, or drooping eyelids occur, they should avoid driving a car or engaging in other potentially hazardous activities.
Ophthalmic Adverse Reactions
Inform patients that BOTOX Cosmetic injection may cause eye dryness. Advise patients to report symptoms of eye dryness (e.g., eye pain, eye irritation, photosensitivity, or changes in vision) to their doctor.
Manufactured by: Allergan Pharmaceuticals Irelanda subsidiary of: Allergan, Inc. U.S. License number 1145
Distributed by: Allergan USA, Inc.Madison, NJ 07940
u00a9u00a02020u00a0Allergan. All rights reserved.All trademarks are the property of their respective owners. Patented. See: www.allergan.com/patents
v1.0USPI3919

This Medication Guide has been approved by the U.S. Food and Drug Administration nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntn n n
v3.0MG1145

BotoxCosmeticonabotulinumtoxinAfor Injection50Units/Vial

BotoxCosmeticonabotulinumtoxinAfor Injection100Units/Vial

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Onabotulinumtoxina (Botox Cosmetic)

Trade Name : BOTOX Cosmetic

INJECTION, POWDER, LYOPHILIZED, FOR 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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Onabotulinumtoxina (Botox Cosmetic)

Trade Name : BOTOX Cosmetic

INJECTION, POWDER, LYOPHILIZED, FOR 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)

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Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

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