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1 unit (1 vial) = 150 mg/mL Single-Use Pen = $550 USD

COSENTYX®
(secukinumab) Injection, for Subcutaneous Use

DESCRIPTION
Secukinumab is a recombinant human monoclonal IgG1/κ antibody that binds specifically to IL-17A. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains.

COSENTYX Injection
COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution. COSENTYX is supplied in a single-use Sensoready pen with a 27-gauge fixed ½-inch needle, or a single-use prefilled syringe with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen or prefilled syringe contains natural rubber latex.

Each COSENTYX Sensoready pen or prefilled syringe contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8.

COSENTYX For Injection
COSENTYX for injection is supplied as a sterile, preservative free, white to slightly yellow, lyophilized powder in single-use vials. Each COSENTYX vial contains 150 mg of secukinumab formulated in L-histidine/histidine hydrochloride monohydrate (4.656 mg), polysorbate 80 (0.6 mg), and sucrose (92.43 mg). Following reconstitution with 1 mL Sterile Water for Injection, USP, the resulting pH is approximately 5.8.

INDICATIONS
Plaque Psoriasis
COSENTYX® is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Psoriatic Arthritis
COSENTYX is indicated for the treatment of adult patients with active psoriatic arthritis.

Ankylosing Spondylitis
COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis.

DOSAGE AND ADMINISTRATION
Plaque Psoriasis
The recommended dosage is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. Each 300 mg dosage is given as 2 subcutaneous injections of 150 mg.

For some patients, a dosage of 150 mg may be acceptable.

Psoriatic Arthritis
For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing and administration recommendations for plaque psoriasis [see DOSAGE AND ADMINISTRATION].

For other psoriatic arthritis patients, administer COSENTYX with or without a loading dosage by subcutaneous injection. The recommended dosage:

With a loading dosage is 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
Without a loading dosage is 150 mg every 4 weeks
If a patient continues to have active psoriatic arthritis, consider a dosage of 300 mg.
COSENTYX may be administered with or without methotrexate.

Ankylosing Spondylitis
Administer COSENTYX with or without a loading dosage by subcutaneous injection. The recommended dosage:

With a loading dosage is 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
Without a loading dosage is 150 mg every 4 weeks.
Assessment Prior To Initiation Of COSENTYX
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX [see WARNINGS AND PRECAUTIONS].

Important Administration Instructions
There are three presentations for COSENTYX (i.e., Sensoready pen, prefilled syringe, and lyophilized powder in vial for reconstitution). The COSENTYX “Instructions for Use” for each presentation contains more detailed instructions on the preparation and administration of COSENTYX [see Instructions for Use].

COSENTYX is intended for use under the guidance and supervision of a physician. Patients may self-inject after proper training in subcutaneous injection technique using the Sensoready pen or prefilled syringe and when deemed appropriate. The lyophilized powder for reconstitution is for healthcare provider use only. Administer each injection at a different anatomic location (such as upper arms, thighs, or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis. Administration of COSENTYX in the upper, outer arm may be performed by a caregiver or healthcare provider.

Preparation For Use Of COSENTYX Sensoready® Pen And Prefilled Syringe
Before injection, remove COSENTYX Sensoready pen or COSENTYX prefilled syringe from the refrigerator and allow COSENTYX to reach room temperature (15 to 30 minutes) without removing the needle cap.

The removable cap of the COSENTYX Sensoready pen and the COSENTYX prefilled syringe contains natural rubber latex and should not be handled by latex-sensitive individuals [see WARNINGS AND PRECAUTIONS].

Inspect COSENTYX visually for particulate matter and discoloration prior to administration. COSENTYX injection is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the liquid contains visible particles, is discolored or cloudy. COSENTYX does not contain preservatives; therefore, administer the Sensoready pen or prefilled syringe within 1 hour after removal from the refrigerator. Discard any unused product remaining in the Sensoready pen or prefilled syringe.

Reconstitution And Preparation Of COSENTYX Lyophilized Powder
COSENTYX lyophilized powder should be prepared and reconstituted with Sterile Water for Injection by a trained healthcare provider using aseptic technique and without interruption. The preparation time from piercing the stopper until end of reconstitution on average takes 20 minutes and should not exceed 90 minutes.

-Remove the vial of COSENTYX lyophilized powder from the refrigerator and allow to stand for 15 to 30 minutes to reach room temperature. Ensure the Sterile Water for Injection is at room temperature.
-Slowly inject 1 mL of Sterile Water for Injection into the vial containing COSENTYX lyophilized powder and direct the stream of Sterile Water for Injection onto the lyophilized powder.
-Tilt the vial at an angle of approximately 45 degrees and gently rotate between the fingertips for approximately 1 minute. Do not shake or invert the vial.
-Allow the vial to stand for about 10 minutes at room temperature to allow for dissolution. Note that foaming may occur.
-Tilt the vial at an angle of approximately 45 degrees and gently rotate between the fingertips for approximately 1 minute. Do not shake or invert the vial.
-Allow the vial to stand undisturbed at room temperature for approximately 5 minutes. The reconstituted COSENTYX solution should be essentially free of visible particles, clear to opalescent, and colorless to slightly yellow. Do not use if the lyophilized powder has not fully dissolved or if the liquid contains visible particles, is cloudy or discolored.
Prepare the required number of vials (1 vial for the 150 mg dose or 2 vials for the 300 mg dose).

The COSENTYX reconstituted solution contains 150 mg of secukinumab in 1 mL of solution. After reconstitution, use the solution immediately or store in the refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours. Do not freeze.

If stored at 2°C to 8°C (36°F to 46°F), allow the reconstituted COSENTYX solution to reach room temperature (15 to 30 minutes) before administration. COSENTYX does not contain preservatives; therefore, administer within 1 hour after removal from 2°C to 8°C (36°F to 46°F) storage.

HOW SUPPLIED
Dosage Forms And Strengths
Injection: 150 mg/mL solution in a single-use Sensoready pen
Injection: 150 mg/mL solution in a single-use prefilled syringe
For Injection: 150 mg, lyophilized powder in a single-use vial for reconstitution (for healthcare professional use only)
COSENTYX Sensoready pen:

NDC 0078-0639-41: Carton of two 150 mg/mL (300 mg dose) Sensoready pens (injection)
NDC 0078-0639-68: Carton of one 150 mg/mL single-use Sensoready pen (injection)

COSENTYX prefilled syringe:

NDC 0078-0639-98: Carton of two 150 mg/mL (300 mg dose) single-use prefilled syringes (injection)
NDC 0078-0639-97: Carton of one 150 mg/mL single-use prefilled syringe (injection)

The removable cap of the COSENTYX Sensoready pen and prefilled syringe contains natural rubber latex. Each Sensoready pen and prefilled syringe is equipped with a needle safety guard.

COSENTYX vial (for healthcare professional use only):

NDC 0078-0657-61: Carton of one 150 mg lyophilized powder in a single-use vial (for injection)

Storage And Handling
COSENTYX Sensoready pens, prefilled syringes and vials must be refrigerated at 2°C to 8°C (36°F to 46°F). Keep the product in the original carton to protect from light until the time of use. Do not freeze. To avoid foaming do not shake. COSENTYX does not contain a preservative; discard any unused portion.

Add to Cart:

  • Model: Scapho Injection (Secukinumab)
  • 9.87456e26 Units in Stock
  • Manufactured by: Novartis Pharmaceutical company


This product was added to our catalog on Sunday 21 October, 2018.

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