Frequently Asked Questions - General (medical)

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 Adapter is a disposeble product intended to be used only once. Sterility is not guaranteed for multiple use, so never use the same Adapter for more than one medication contained. No refurbishment allowed. 

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 injector has 2 safety - devices. One in the inner thread, deactivated by screwind in the ampoule completely. The green safety ring on the outside has to be pushed into the safe-off position.

INJEX is an innovative, needle-free system for the submucous administration of medication 

The needle-free INJEX system consists of an injector, the reset box to reset and store the injector, the sterile disposable ampoules for containing and administering the medicament, as well as adapters to transport medication from a variety of different cartridges and containers to the sterile disposable ampoules. An additional cap especially developed for dental applications (SiliTop) is available as well, which allows for gentle application on firm gingiva and prevents pressure sensations during injection.  

The INJEX system has many advantages such as the following:
 

• Without needle
• Virtually painless
• Reduces psychological inhibitions and fears
• Minimizes injection-induced stress
• Targeted anaesthetizing of specific areas possible
• Easy dosing of anaesthetic
• Economic since only small doses of anaesthetic are required
• Less time between injection and effect due to shorter dispersion times of the anaesthetic compared with conventional syringe, thus saving time
• Anaesthetic effect below limit dose for local anaesthesia - also with children
• Fewer risks of side effects or negative interactions with other medications due to lower doses
• Elimination of injury to patient and physician caused by needle
•  Safe and easy use

Yes, INJEX has been CE certified on 1 September 1999 according to the German medical product law 

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. 

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)  

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 adapters are for the transfer of liquid drugs from conventional medicine containers into the ampoule of the INJEX system.
Up to now, conventional medicine containers are designed for injection by needle (cannula), e.g. pen cartridges, piercing of injection vials or snap-off ampoules. As the INJEX has no needle, INJEX Pharma´s medical technology division has developed special adapters to transfer the drug from medicine containers into the ampoules. 

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.

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. 

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. 

Besides experiences with INJEX in the field of diabetes mellitus, further experiences in the field of thrombosis prophylaxis with Heparin have been obtained also (literature review: HOLLINGSWORTH et al., 2000, BAER et al., 1996, HARENBERG et al., 1982) and local anaesthesia (ZSIGMOND et al., 1999, FLORENTINE et al., 1997, QUERALT et al., 1995, COOKE et al., 1980).
Furthermore experience reports in the fields of Dupuytren treatment and homeosiniatry are available.
The following reports regarding these questions:
 

• Abstract Heparin; Pharmacokinetics of Low-Molecular-Weight Heparin following Needle-free and Conventional Subcutaneous Injections; Prof. Dr. Gerhard Anton Müller, University Clinic Göttingen
• Technical report Dupuytren; INJEX and Dupuytren Treatment; Dr. med. Klaus Beller, Kenzingen; July 2001
• Technical report Homeosiniatry; Using INJEX in Homeosiniatry; Dr. med. Klaus Beller, Kenzingen; July 2001
•  Technical report local anaesthesia; A preliminary study using the INJEX with local anaesthesia; Yale W., March 1999

Instead of a needle, the INJEX system utilises an ampoule with special scaling and a micro orifice of only 0.18 mm in diameter that is applied directly to the skin. Medication is administered through this opening to the underlying subcutaneous fatty tissue in a fraction of a second. 

Skin irritations are most unlikely, since only miniscule liquid droplets penetrate into the tissue during the injection. 

A minimum of 0.05 ml and a maximum of 0.30 ml of a liquid drug can be administered using the INJEX (for insulin, see the set of questions under the heading of Questions on the use of insulin"). 

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.