DO OSTENIL® INJECTIONS NEED A PRESCRIPTION?

OSTENIL® injections are classed as a Class III medical device, not a prescription only medicine (POM). Therefore, Extended Scope Physiotherapists and other clinicians who have had training in intra-articular injections don’t need to have a prescribing license in order to administer viscosupplementation injections. 

For OSTENIL® TENDON peritendinous injections, however, we recommend the use of ultrasound visualising equipment to ensure correct placement of the hyaluronan, thus ensuring the best possible treatment outcome.
 

ARe Ostenil® injections safe with patients on blood thinning medication? 

There is no evidence that the intra-articular infiltration of OSTENIL® (1% concentration of non-cross linked Sodium Hyaluronate of fermentative source) or OSTENIL® PLUS (2% concentration of non-cross linked Sodium Hyaluronate of fermentative source with Mannitol) increases the potential for intra-articular bleeding/ hemarthrosis. However, the resulting needle trauma induced by any intra-articular injection needs to be considered by the treating physician on a case by case basis, and suitable titration of blood thinning medication may be necessary prior to any IA injections being administered.  
 

Hypo- or Hypertension as an undesirable effect following injection with OSTENIL®

Regarding the inclusion on SmPC of Hypo- or Hypertension as an undesirable effect following injection with OSTENIL®, OSTENIL® Mini, or OSTENIL® Plus.

Vasovagal reactions: 

It is well elucidated medical knowledge that vasovagal (blood pressure and heart rate) reactions can occur when people experience painful or unpleasant stimuli, e.g. after watching or experiencing medical procedures such as injections. It is also basic knowledge that those conceivable adverse reactions to an injection are not related to the kind of substance applied, but to the procedure itself. The vasovagal - triggered reactions can include, for instance; reduction in heart rate and blood pressure, as well as light-headedness, dizziness, palpitations, weakness, blurred vision, nausea and epigastric distress, feeling warm or cold, facial pallor, excessive sweating, and syncope (fainting).

Hypertension:
While some published clinical data exists to demonstrate that intra-articular injections of steroid have been shown to produce a transient elevation of systolic BP (returning to baseline value approx. 3 days following injection), there are no published data to demonstrate that the same effect is associated with Sodium Hyaluronate intra-articular injection. However, due to certain EU certification requirements, every potential or reported undesirable effect of any injectate is now required to be listed on the Summary of Product Characteristics (SmPC) sheet and the pack inserts. In the case of OSTENIL®, OSTENIL® Mini, or OSTENIL® Plus, the number of reported systemic reactions is extremely rare, and none were reported as a serious adverse event. 
In the absence of any definitive data pertaining to systemic / vasovagal reaction as a consequence or direct corollary of intra-articular infiltration of OSTENIL®, OSTENIL® Mini, or OSTENIL® Plus, the only correlation that might reasonably be drawn therefore, is that the IA injection itself MAY produce transient elevation/reduction of BP.
 

Advice on Intra-Muscular or Systemic administration of Ostenil® Tendon

As Ostenil® Tendon is licensed for peri-tendinous or intra-sheath infiltration, no clinical data relating to intra-muscular or systemic administration has been generated. The mode of action of OSTENIL® TENDON is contingent on the infiltrate being directed to the locus of pathology in the sheath or paratenon of the affected tendon, the direct mechanical amelioration of adhered overlying tissue is achieved by the infiltrate’s capacity to separate the tendon from any adhered or tethered tissue, and return the tendon to a normative pattern of ‘gliding’ movement within the sheath or paratenon. 

Due to the consistency and viscosity of OSTENIL® TENDON, it will not easily infiltrate or permeate the meatus of the tendon, thus the concept of IM use is not considered generally appropriate.