Frequently Asked Questions - Diabetes

If more than one shoot is necessary, there should be 2 prefilled ampoules available. The reset of the injector is not lavish. There are nurses, who can do this very quickly. Many dentists invest in 2 or 3 injectors, to safe time. 2 – 3 injectors prepared with prefilled ampoules are optimal for every treatment. 

Is the word „edema“the correct characterisation? A swelling can be seen in very few cases, when the injection site is producing an allergic reaction on the preservatives of the local anaesthetic agent. 

The Injectors trigger has a „press point“. This point has to be found and it’s position has to be trained. If you start pressing the trigger from this point, you will get a proper injection. The injector will not start producing uncontrolled movements, because the trigger will not perform two different movements. 

The patient should be sitting upright in a relaxed position. The time between positioning and releasing the injector should be kept as brief as possible with children and especially restless patients . 

The patient should be informed about the release noise of the injector to prevent defensive arm movement or startle reflexes 

Haematoma at the injection site are still possible even when using a needle-free system.
They might occur with patients taking anticoagulants to treat cardiovascular disease (e.g., Marcumar) or thrombocytic aggregation inhibitors (e.g., ASS100 = time-released aspirin), or patients occasionally taking aspirin for pain relief.
Small bruises can also be due to too little or too much pressure when positioning the injector on the gingiva. 

Swelling is observed in a few cases, which might also be caused by the local anaesthetic itself (preservatives).  

Bleeding usually does not occur. As with needle injections, INJEX might cause some damage to the uppermost capillaries. In rare cases, this might cause a pin-sized drop of blood to emerge at the injection site. This is especially the case if the patient has been taking medication to treat cardiovascular disease (e.g., Marcumar, ASS100 = time-released aspirin) or normal aspirin for pain relief. 

The recommended basic dosage is 0.3 ml per injection. A second injection to prolong the effect can be administered at any time. The local anaesthetic dose is still lower than with a conventional syringe in spite of the second injection. 

Less than 0.3 ml for the initial injection is not sufficient and the degree of anaesthesia is too low, just as with conventional infiltration anaesthesia.  

The local anaesthetic becomes effective more quickly than after a conventional injection. The injected area is anaesthetized after just a few seconds 

Injecting with INJEX provides a therapeutic window larger than with conventional infiltration anaesthesia due to the better distribution within the tissue. 

It is recommended to use a probe to check the anaesthesia depth before commencing treatment. An additional injection may be administered if necessary. 

Each ampoule of the INJEX system may be filled with max 0.3 ml of anaesthetic. A dose of 0.3 ml is recommended for dental applications.  

The transporter adapter is a sterile disposable product and can be used only with one cylinder cartridge to prevent contamination as well as diminishing functionality. Dispose of the adapter when the medication cartridge is empty. The local anaesthetic may crystallize within the adapter if the same adapter is used with additional medication cartridges. This can impair the transfer to the INJEX ampoule. 

Insulins with differing period of effect can be mixed and administered with one ampoule. Please ask your doctor or pharmacist, if the mixture is recommended by the manufacturer. 

In Germany, all commercially available U-40 und U-100 insulin can be used. 

When using a U-40 insulin, a minimum of 2 and a maximum of 12 units can be administered in dosage stages of half units.
When using a U-100 insulin, a minimum of 5 and a maximum of 30 units can be administered in dosage stages of one unit. 

Yes, the pen cartridges and even the pens can still be used. INJEX has developed special adapters for this purpose which can be used to transfer the insulin directly from the pen or pen cartridges in to the needle-free INJEX. 

If a wet shot occurs, not all of the medication has been administered as part of it remains on the skin. In the case of insulin, please measure your blood-sugar level one hour after the wet shot and correct this with a further dose of insulin accordingly.
A wet shot is caused by the INJEX not being placed firmly enough on the skin or not being applied vertically. Please ensure the next time that the INJEX is placed on the skin firmly and vertically. Press the injector firmly onto the injection site until the skin is clearly dented and the ampoule tip is completely enclosed by the skin. 

Yes, the injections site should be changed in the same way as with the conventional syringe. 

In contrast to the conventional subcutaneous injection method, you must not form any folds of the skin, rather the INJEX must be placed on the skin vertically and firmly  until a visible indentation of the skin appears and the ampoule tip is completely enclosed by the skin. If the INJEX is not held on the skin firmly enough, a so-called wet shot can occur. You cannot harm yourself in this way (though a small bruise can form in exceptional cases). However, in the case of a wet shot, the desired dose is not fully administered. Part of the medication remains on the surface of the skin, hence the moisture.  

No. The pressure and speed are calculated in such a way that the medication only enters into the subcutaneous adipose tissue. Accidental administration of the medication into the muscle is virtually impossible.
In contrast to insulin injections in diabetic children that frequently and unintentionally are performed intramuscular when using a needle syringe (30,5 % of performed injections). (literature review: POLAK et al., 1996)  

Yes, publications from the past two decades and our own clinical results show a comparable resorption of insulin between the injection with INJEX or with a pen.
(literature review: BREMSETH et al., 2001, MALONE et al., 1986, HALLE et al., 1986, PEHLING et al., 1984)
Clinical findings and laboratory tests demonstrate unchanged molecular structures and normal potencies of the insulin formulations.
 

A modified injection angle results in an enlarged medication injection point. This may lead to increased bleeding and risk of haematoma. 

The pressure and speed are calculated in such a way that the medicine only enters into the subcutaneous adipose tissue. The depth of penetration is depending on the applied volume, it reaches from 4 to 9 mm.
Accidental intramuscular administration of the medication is virtually impossible.
 

The basic equipment you need is the INJEX injector and the reset box.
In addition, you will need the appropriate ampoules and adapters for the medication concerned. If you use U-40 insulin, you will need the U-40 ampoules, or for U-100 insulin the U-100 ampoules. For all other medications, the 0.3 ml ampoules must be used.
The choice of the adapter depends on the vessel containing the medication. The following rule can be applied in this regard:
 

• If you use pen cartridges without a pen (e.g. first use of insulin), you should use the transporter with transporter adapter.
• If you use a (insulin) pen, you should use the pen adapter.
• If you use injection vials (e.g. U-40 or Heparin), you should use vial adapter 14.
•  If you use snap-off ampoules (e.g. Heparin, local anaesthetics, homeopathics), you should use the Luer adapter.

Children (over 7 years) can use INJEX for injection after prior consultation of a doctor. 

Tests with different types of needle-free systems have shown hat the medication chooses the path of least resistance, thus going around blood vessels and nerve fibres to penetrate the subcutaneous adipose tissue.
Changes in the skin described as lipodystrophy in diabetics in the case of prolonged administration of insulin are quite improbable. Individual publications even report receding of existent thickening in the subcutaneous adipose tissue resp. fat atrophy.
 

Medications licensed for subcutaneous use can be administered with the needle-free INJEX.
The main applications for the INJEX system at present are diabetes (subcutaneous administration of insulin), the prevention of thrombosis (by means of Heparin) and local anaesthesia (e.g. prior to venous catheterisation, prior to minor surgical procedures or for dental infiltration anaesthesia). Other applications for INJEX are the treatment of dupuytren´s disease or homeosiniatry. Please note the technical reports for these mentioned applications.

When applied correctly the injection with INJEX is virtually painless. The sensation can be described as a short slight pressure on the skin surface. As pain is felt individually one cannot state a general and obliging assertion. As fluid is pressed under the skin the patient will sense the injection with INJEX more or less, depending on the volume and the individual sensibility. Patients generally assesse the sting from a needle as more unpleasant than the injection with INJEX.
(literature review: DENNE et al., 1992, TEINTZ et al., 1991, RESMAN et al., 1985)
The micro orifice of the ampoule has a diameter of 0.18 mm. Currently, the thinnest needle has a comparatively thick diameter of 0.25 mm. 

No. In order to guarantee sterility and function, the ampoules are intended to be used once only. 

No, the utilized materials are not suitable for autoclave treatment. Adapter, ampoules, and SiliTop are sterile products for single-use only. The injector, the reset box, and the transporter are designed for multiple-use and need not be sterilized since they are not in direct contact with the patient.  

Basically it is not necessary to adjust insulin doses for the use of INJEX in comparison with needle injections. Pharmacokinetics are almost identical. Regarding injection-food-periods adjustment is not required either.
Yet a primary requirement is the extensive briefing of the patient for the administration of INJEX by a physician or diabetes consultant, similar to the briefing for the use of disposable syringes or pens.