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 suitable for Vegetarians or Vegans?

OSTENIL® injections are a solution containing bio-synthetic, non-animal derived sodium hyaluronate and thus suitable for vegetarians and vegans. The sodium hyaluronate in OSTENIL® is very pure and is manufactured by a fermentation process. As it contains no animal proteins it is also very unlikely to cause an allergic reaction.  
 

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.  

 

Stability of Ostenil® if stored outside the recommended temperature range

OSTENIL® confirmation of stability:

ICH conform stability studies performed on OSTENIL confirm a stability of three years when stored between 2 °C and 25 °C at a dry place in the intact original packaging.

Additionally TRB Chemedica AG performed a transport validation on OSTENIL which included among several other tests storage at -10 °C and +50 °C over 72 hours. Even after winter (-10 °c, 72h) and summer conditioning (+50 °C, 72h), stacking, vibration and drop­ tests according to ISTA 2A procedures, the sterile barrier of OSTENIL proved to be intact. Integrity was tested by visual inspection, dye-test and bubble emission test.
Studies on the content of the syringes subjected to the transport simulation proved that chain length and content of the sodium hyaluronate did not change.

A closure integrity test on several batches of OSTENIL had been performed after expiry date of the product (>36 months). All blisters passed the test and proved the integrity of the sterile barrier system at the end of the shelf-life.

Stability data for OSTENIL® PLUS:

•    At 40°C and 75% humidity (accelerated stability study): stable for 6 months
•    At 25°C and 60% humidity (zone II conditions): stable for 36 months
•    At 30°C and 75% humidity (zone IVb conditions): stable for 36 months