Collagen Fleece Impregnated with antibiotic Gentamicin - Biomaterials
Drug Name:
Collagen Fleece Impregnated with antibiotic Gentamicin - Biomaterials
List Of Brands:
Indication Type Description:
Indication:
Antibiotic protection with impregnated Gentamicin Collagen fleece
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Collengen with Anti-infective 06-05-1998
Gentamicin implant
Collagenase May 1994
Adverse Reaction:
No allergic reactions
Reabsorbed in 28 days
Longer lasting and more evenly distributed gentamicin concentrations
Contra-Indications:
Septocoll E must be used in patients known hypersensitivity to collagen and/or gentamicin
Septocoll E should be used in conjunction with other methods of hemostatasis at bleeding
sites requiring longer ligation or at larger arterial and/or bleeding requiring suturing.
There is a lack of clinical experience regarding the safety of use in pregnant women, nursing
mothers and children.
Instructions for use-
Before implantation all infected and necrotic tissue must be surgically removed.
Septocoll E fleece should not be moistened before being inserted into wound cavity,
as this would reduce its hemostatic efect.
The use of an overflow drain is indicated in many cases to allow the wound seretion to drain off. Irrigation /suction drainage , however causes too rapid elimination of the gentamicin and should therefore not be used in conjunction with gentamicin crobefate content.
Dosages/ Overdosage Etc:
Indication-
Antibiotic protection with impregnated Gentamicin Collagen fleece
Used for-
potentially contaminated wounds
contaminated wounds
revision operations in septic surgery
Dosage-
As per directions given-
Septocoll E 20 - size 1 : 5 * 4 cm
1 fleece -
80mg collagen( equine )
29mg gentamicin sulfate equivalent to 17.5mg gentamicin
87mg gentamicin crobefate equivalent to 17.5 mg mg gentamicin
Septocoll E 40 - size 2 : 5 * 8 cm
1 fleece -
160mg collagen( equine )
58mg gentamicin sulfate equivalent to 35mg gentamicin
175mg gentamicin crobefate equivalent to 35mg mg gentamicin
Septocoll E 80 - size 3: 10 * 8 cm
1 fleece -
320mg collagen( equine )
116mg gentamicin sulfate equivalent to 35mg gentamicin
350mg gentamicin crobefate equivalent to 35mg mg gentamicin
Septocoll E is impregnated with Gentamicin to give antibiotic protection. It can therfore be
applied anywhere where reliable protection against infection is required
Biological absorption of Septocoll E is complete after around four weeks.
Additional surgery to to remove the haemostatic material is not necessary.
The patients mobility and sense of well-being can therefore be restored quickly and
cost- effectively
It can be applied anywhere where relaible protection against secondary infection is
required.
Reabsorption-
Complete reabsorption of the collagen fleece takes place within around 4 weeks depending
on blood circulation by way of phygocytes and enzymatic degradation.
Notable properties in this connection are high biocaompatibility and low immunogenicity,
as well as good controllability of reabsorption via cross-linking agents
The collagen used is very well tolerated and supports the patients convelescence
through significantly shorter wound healing times.
Pregnancy and lactation:
There is a lack of clinical experience regarding the safety of use in pregnant women, nursing
mothers and children.