• 100 mg procaine hydrochloride

• sodium chloride
• Citric acid monohydrate
• Sodium hydroxide for pH adjustment
• water for injections

Indication/ PASCONEURAL, procaine hydrochlorideApplication

• The preparation is a drug for local anesthetic (ester-type local anaesthetic)
• It is used within the framework of neural therapy application principles.

dosage

• Always use the medicine exactly as directed. Please ask your doctor or pharmacist if you are not sure.
• The drug is generally administered by a doctor. Please ask your doctor if you are unsure about the application.
• In principle, only the smallest dose may be administered with which the desired sufficient nerve blockade is achieved. The dosage is to be made individually according to the characteristics of the individual case.
• Unless otherwise instructed by the doctor, the usual dose for each type of administration for adolescents over 15 years of age and adults of average height is:
• skin wheals:
  • up to 10 mg per wheal corresponding to 0.5 ml injection solution
  • The maximum recommended dose for single use in tissues from which there is rapid absorption of drugs is 500 mg procaine (equivalent to 25 ml solution for injection). When used on the head, neck and genitals, the maximum recommended dose is 200 mg procaine at one time (over a 2-hour period).
  • In patients with certain previous illnesses (vascular occlusions, vascular hardening and narrowing (arteriosclerosis) or nerve damage in diabetes), the dose should also be reduced by a third. In the case of impaired liver or kidney function, increased plasma levels can occur, especially with repeated use. In these cases a lower dose range is also recommended.
  • Please talk to your doctor if you have the impression that the effect is too strong or too weak.

• Duration of application:
  • In principle, the duration of the application is not limited, but note the information under areas of application.

• If you use more than you should:
  • the doctor treating you must be informed immediately.
    • a. Symptoms of an overdose
      • The drug acts as a central nervous system stimulant in low damaging doses and has the opposite effect in high damaging dose ranges. Procaine hydrochloride poisoning occurs in 2 phases:
        • They become restless, complain of dizziness, acoustic and visual disturbances and tingling, especially in the tongue and lip area. Speech is slurred, chills and muscle spasms herald an impending whole-body seizure. As the poisoning of the central nervous system progresses, there is increasing dysfunction of the brainstem with the symptoms of restricted breathing and coma, leading to death.
    • b. Emergency measures and antidotes will be initiated immediately by the doctor treating you according to the signs of the disease.

• If you forgot the application:
  • Do not apply a double dose to make up for a forgotten application.

• If you cancel the application:
  • The treatment can be stopped at any time.

way

• The medicine is injected into the skin (intracutaneously).
• It should only be sprayed by those with the knowledge to successfully complete the application.
• Basically, with continuous use, only low-concentration solutions of procaine are used.
• Repeated use of this drug may result in reversible loss of efficacy due to tachyphylaxis (rapid development of tolerance to the drug).
• The solution for injection is intended for single use only. The application must take place immediately after opening the container. Unused residues are to be discarded.

Side PASCONEURAL, procaine hydrochloride effects

• Like all medicines, this can cause side effects, although not everyone gets them.
• Possible side effects:
  • If you are affected by any of the side effects listed below, stop using the product and contact your doctor as soon as possible.
  • Adverse effects of procaine affecting the whole body primarily affect the central nervous and cardiovascular systems.
  • At plasma concentrations such as are generally reached with regular use, the blood pressure is usually only slightly influenced by the effect that promotes heart strength and heart rate.
  • Procaine can cause changes in the heart's pacing pattern, which show up on the EKG (as a flattened T wave or shortened ST segment).
  • A drop in blood pressure can be the first sign of a relative overdose in the sense of a heart-damaging effect. Disorders of the central nervous system such as abnormal sensations around the mouth, restlessness, disturbances of consciousness or a seizure can be triggered.
  • Allergic reactions in the form of hives, swelling of the tissue due to water retention, spasms of the airways or shortness of breath, and circulatory reactions have been described.
  • Local allergies and allergy-like reactions in the form of skin inflammation with skin reddening, itching and even blistering can occur on contact with ester local anesthetics such as this medicine.
  • In addition, when used under the skin (subcutaneously) and in the muscle (intramuscularly), local reactions such as swelling, reddening of the skin and bruising can occur.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

interactions

• Use with other medicines:
  • Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.
  • The following interactions of procaine with other medicines are known:
    • Prolongation of the effect of certain skeletal muscle relaxants (non-depolarizing muscle relaxants)
    • Enhancement of the effect of physostigmine (agent for stimulating part of the autonomic nervous system)
    • Reduction in the effectiveness of certain antibiotics (sulfonamides).
  • Procaine should not be used together with certain drugs that stimulate part of the autonomic nervous system (cholinesterase inhibitors). Among other things, the influence on procaine degradation leads to an increase in the toxicity of procaine.
  • By adding small amounts of atropine, it is possible to prolong the pain-relieving effect.
  • Physostigmine (see above) in low doses can have a preventive effect against the toxic effects of procaine.
  • Main chemical intolerances:
    • Procaine should not be mixed with other drugs because a change in pH or electrolyte concentration can cause the active ingredient to precipitate.
• Use with food and drink:
  • No mutual interference is to be expected, as this is an injection solution, ie it is used bypassing the gastrointestinal tract.

PASCONEURAL, procaine hydrochloride Contraindications

• The medicine must not be used:
  • if you are allergic (hypersensitive) to procaine, other local ester-type anaesthetics, sulphonamides (certain group of antibiotics), benzoic acid (parabens) or any of the other ingredients of this medicine
  • if there is a known deficiency of a specific endogenous substance (pseudocholinesterase) resulting in a significantly slower breakdown of procaine
  • for injection into arteries, in the vicinity of the outer covering skin of the central nervous system (epidural) or in the spinal canal (spinal).

pregnancy PASCONEURAL, procaine hydrochloride and breast feeding period

• pregnancy
  • Only allow the medicine to be used during pregnancy if your doctor considers it absolutely necessary.
• Breastfeeding:
  • Procaine hydrochloride passes into breast milk. However, with short-term use, discontinuation of breastfeeding will not be necessary. If repeated treatment or treatment with higher doses is necessary, you should stop breast-feeding.

Patient information

• Warnings and Precautions:
  • Particular caution is required when using it if you have a
    • certain form of muscle weakness (myasthenia gravis)
    • Disturbance of the cardiac conduction system
    • suffer from cardiac insufficiency or
    • the injection is to be made in an inflamed area.
  • Before use, the doctor using the drug will always ensure that the circulation is properly filled, monitor the circulation carefully and have all measures available for ventilation, therapy for seizures and resuscitation.
  • You will also need to tell the doctor if you have had an allergic reaction to other medicines that are chemically related to procaine, as you may also have an allergic reaction to procaine (paragroup allergy). This can e.g. B. be sulfonamides (a group of antibiotics), oral antidiabetics (medicines for diabetes), certain dyes, X-ray film developers or other local anesthetics.
  • If you are only able to break down procaine extremely slowly because a certain body substance is not as active (pseudocholinesterase deficiency), procaine side effects may be more likely to occur.
  • When used in the neck and head area, there is a higher degree of danger because the risk of symptoms of poisoning in the central nervous system is increased.
  • To avoid side effects, the following points should be observed:
    • In certain cases, put on an additional drip before use.
    • Choose dosage as low as possible.
    • As a rule, do not use a vasoconstrictor additive.
    • Carefully aspirate in two planes (rotate the cannula) before injecting.
    • Caution when injecting into infected areas (due to increased uptake with decreased efficacy).
    • Inject slowly.
    • Check blood pressure, pulse and pupil size.
  • It should be noted that during treatment with anticoagulants (anticoagulants such as heparin), non-steroidal anti-inflammatory drugs or plasma substitutes, not only accidental vascular injury in the context of pain treatment can lead to serious bleeding, but that an increased tendency to bleed in general must be expected . Therefore, have appropriate laboratory tests carried out before use. If necessary, the anticoagulant treatment should be discontinued in good time.
  • Use with simultaneous preventive therapy to avoid thrombosis with low molecular weight heparin should only be carried out with particular caution.
  • Children:
    • There is no application experience from which general dosage recommendations can be derived for use in children and adolescents under the age of 15.
  • Elderly people:
    • Dose adjustment is recommended in the elderly according to their general condition.

• Driving and using machines:
  • Let your doctor decide on a case-by-case basis whether you can actively participate in road traffic, operate machines or carry out work without a secure footing.