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Botulinum Toxin Type A For Injection

Generic Name:

Botulinum Toxin Type A For Injection Ph. Eur. (Purified Neurotoxin Complex)

Description:

Botulinum toxin is a biologically active, highly purified preparation of botulinum toxin type A. It is a highly potent neurotoxic complex that, when absorbed, causes muscle relaxation, a significant reduction in gland secretory activity, and cessation of nociceptor function. Medicine has developed ways to harness the effects of magic medicines through proprietary formulations and controlled delivery techniques. It has been used non-surgically to correct unwanted muscle activity. This action can be undone in a few months.

Composition:

Each bottle contains:

 

In 100 unit vial Freeze Dried

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In 50 unit vial Freeze Dried

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Pharmaceutical Form:

Lyophilized preparation with diluent for reconstitution.

Dosage: 

Initial dose depends upon an estimate of the amount of envenomation as mentioned below: 

1. Minimal Envenomation - local swelling develops, but no systemic symptoms. We recommend dosing 5 vials (50 ml). 

2. Moderate Envenomation - Swelling beyond the bite site, mild systemic symptoms, and/or hematologic and coagulation abnormalities are present. We recommend dosing 5-10 vials (50-100 ml).

3. Severe Envenomation - Rapidly progressive and widespread local effects, systemic symptoms, and signs of hemolysis or coagulopathy. We recommend dosing at least 10-20 vials (100-200 ml). For children and small adults (weighing less than 40 kg), we recommend increasing the snake venom antiserum dose by up to 50%.

Indication:

Botulinum toxin type A for injection is one of the most effective drugs for treatment of a variety of indications.  Strabismus, Blepharospasm, Hemifacial spasm, Tremors, Cerebral palsy, Dystonia, Spasticity  Migraine, Chronic facial pain, Neck pain, hyperhydrosis-Palmer, Axilla, Spasmodic dysphonia, Drooling Saliva, Speech & voice disorders  Achlasia  Cosmetic enhancer i.e.  Glabeller frown lines, Crow Feet & Other Facial wrinkles.

Method of Administration:

Subcutaneous / Intramuscular/ intradermal depending upon the application of use.

Presentation:

Available in 50 &100 unit vial along with appropriate diluent.

 

Contraindications:

Hypersensitivity to any ingredient in the formulation.  Infection at the proposed site of inoculation.

Possible side effect:

Side Effects include localized weakness of the injected muscle(s) that represents the expected desirable action of the drug, however weakness of adjacent muscles may also occur due to spread of toxin e.g., Dysphagia and subsequent pneumonia in patients treated for cervical dystonia.  Ptosis , Keratitis, eye dryness, diplopia in patients treated for blepharospasm and strabismus.  skin rash, pruritus, allergic reaction, localized pain, bruising may be associated with the injection which may occur rarely.

Shelf Life:

36 months from the date of manufacture.

Storage:

Store at 2 oC - 8 oC. Do not freeze. Protect from light. This product is reconstituted in aseptic conditions and can be stored at 20C to 80C for 4 hrs.

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