GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Tenecteplase Dry Powder for Injection (Lyophilized) 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Tenecteplase Dry Powder for Injection (Lyophilized) 40mg
1 vial of Tenecteplase (TNK-tPA) Lyophilized Powder for injection 40mg Each lyophilized vial contains
Tenecteplase(IHS)……………………………40mg
L-Arginine (Ph.Eur)………………………………………………440mg
Ortho Phosphoric acid (IP)…………………………………..202mg
Polysorbate 20(IP) ……………………………………………….12.6mg
Water for Injections USP………………………………….q.s.

THERAPEUTIC INDICATIONS:

Tenecteplase is indicated for use in the reduction of mortality associated with acute myocardial infarction (AMI).

CAUTION & SCHEDULE:

CAUTION: KEEP OUT OF REACH AND SIGHT OF CHILDREN< br> discard unused portion
SCHEDULE:.
Not to be sold by retail without the prescription of registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store between 2° to 8°C. Protected from light. Do not freeze. Store between 2° to 8°C. Protected from light and shake once reconstituted with sterile WFI.
Dosage: See package insert for dosage information.
As directed by Physician

Tenecteplase Dry Powder for Injection (Lyophilized) 40mg Technical Specification:

Product Name:Tenecteplase Dry Powder for Injection (Lyophilized)
Brand Name:Generics
Strength:40mg
Dosage Form:Dry Powder Injection (Sterile)
Packing:10ml Vial
Route of Administration:For I.V. USE ONLY
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Anticoagulant
Indication:  Tenecteplase is indicated for use in the reduction of mortality associated with acute myocardial infarction (AMI).
Storage:Store between 2° to 8°C. Protected from light and shake once reconstituted with sterile WFI.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Tenecteplase Dry Powder for Injection (Lyophilized) 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Tenecteplase Dry Powder for Injection (Lyophilized) 40mg
    1 vial of  Tenecteplase (TNK-tPA) Lyophilized Powder for injection 40mg
    Each lyophilized vial contains
    Tenecteplase(IHS)……………………………40mg
    L-Arginine (Ph.Eur)………………………………………………440mg
    Ortho Phosphoric acid (IP)…………………………………..202mg
    Polysorbate 20(IP) ……………………………………………….12.6mg
    Water for Injections USP………………………………….q.s.

THERAPEUTIC INDICATION:

Tenecteplase is indicated for use in the reduction of mortality associated with acute myocardial infarction (AMI).

CAUTION & SCHEDULE:

CAUTION:KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Discard unused portion
SCHEDULE:Not to be sold by retail without the prescription of registered Medical Practitioner.

STORAGE & DOSAGE:

Storage:Store between 2° to 8°C.
Protected from light.
Do not freeze.
Store between 2° to 8°C.
Protected from light and shake once reconstituted with sterile WFI.
Dosage:See package insert for dosage information.As directed by Physician.