IMRESTOR Injection

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Elanco Animal Health (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

Injection

Composition:

Each 2. ml Solution contains PEGBOVIGRASTIM 15.0 mg PEGBOVIGRASTIM 15.0 mg

Therapeutic area:

C 21. IMMUNE MODULATING AGENTS C 21. IMMUNE MODULATING AGENTS

Authorization status:

Canceled

Summary of Product characteristics

PROPOSED PACKAGE INSERT
VETERINARY MEDICINE
FOR VETERINARY USE ONLY
SCHEDULING STATUS
S4
PROPRIETARY NAME AND DOSAGE FORM
IMRESTOR 15 mg/2.7 ml Solution for Injection
COMPOSITION
Each 2,7 ml syringe contains 15 mg Pegbovigrastim.
PHARMACOLOGICAL CLASSIFICATION
C.21 Immune modulating agents
PHARMACOLOGICAL ACTION
MECHANISM OF ACTION
Pegbovigrastim is a modified form of the naturally occurring
immunoregulatory cytokine, bovine granulocyte colony stimulating
factor (bG-CSF). Bovine granulocyte colony stimulating factor is a
naturally occurring protein produced by mononuclear
leukocytes, endothelial cells and fibroblasts.
G-CSF is a member of the cytokine class I superfamily, and is the key
hematopoietic growth factor of the myeloid lineage, supporting
proliferation, survival and differentiation of neutrophilic
progenitor cells and providing non-redundant signals for maintenance
of steady-state neutrophil levels _in vivo. _
The Colony-stimulating factors regulate the production and functional
activities of immune cells and act specifically via the
homodimeric granulocyte colony-stimulating factor receptor (G-CSFR),
which is primarily expressed on the surface of myeloid
and hematopoietic progenitor cells. These immunoregulatory activities
of granulocyte colony-stimulating factor notably
concerns cells of the neutrophilic granulocyte lineage which bear cell
surface receptors for the protein. The product increases
the number of circulating neutrophils. It has also been proven that it
enhances myeloperoxidase hydrogen peroxide halide
mediated microbiocidal capabilities of neutrophils. bG-CSF presents
additional functions beyond its action on neutrophils and
these may be direct or indirect functions on other cells/receptors and
cytokine pathways.
_ _
INDICATIONS
For the reduction in the incidence of clinical mastitis in the first
30 days of lactation in periparturient dairy cows and
periparturient replacement dairy heifers.
CONTRA-INDICATIONS
Do not administer to animals with known hypersensitivity to the active
ingredien