ESPA Lipon inJ 600, 10x24 ml

Instructions for use for ESPA Lipon inJ 600, 10x24 ml

Dear patient, dear patient!
Please read the following useful information because it contains important information about what you should consider when using this medicine. For questions, please contact your doctor or pharmacist.


Insurance information


ESPA-Lipon® 600 mg i.v., Infusion solution concentrate
Active substance: alpha-lipoic acid, ethylenediamine salt (1: 1)

composition

Active pharmaceutical ingredients:

24 ml infusion solution concentrate included:
755 mg of alpha lipoic acid, ethylenediamine salt
(corresponding to 600 mg of alpha lipoic acid).

Other ingredients:
Water for injections, nitrogen, argon
Dosage form and content (pack sizes)

OP with 5 ampoules of 24 ml each (N1)
OP with 10 ampoules of 24 ml (N2) each)
OP with 20 ampoules of 24 ml each (N3)


Cloth group and mode of action

Alpha-lipoic acid is a substance formed at higher living beings in the body's own metabolism, which influences certain material changing performance of the body. In addition, alpha-lipoic acid has antioxidant properties.

Pharmaceutical entrepreneur and manufacturer:

Esparma Gmbleange Göhren 339171 Osterwedding phone: (039205) 42-0Telefax: (039205) 42-240Pharma Hameln Gmbleanges field 1331789 Hameln



application areas

Dispenses for diabetic nerve damage (Polyneuropathy).

Contraction

When may you be ESPA-Lipon® 600 mg i.v., Infusion solution concentrate, do not apply?
You may be ESPA-Lipon® 600 mg i.v., Infusion Solution Concentrate, do not use in known hypersensitivity to alpha-lipoic acid.

What do you need in pregnancy?
It corresponds to the general principles of pharmacotherapy, during pregnancy and lactation of medicines only after careful benefit risk balancing.

Pregnant and nursing ends should undergo treatment with alpha-lipoic acid only after careful recommendation and monitoring by the doctor, as so far no experiences with this patient group are available. Special studies on animals have not shown any indications of fertility disorders or fruit harmful effects.

What do you consider in the lactation?
Nothing is known about a possible transfer of alpha-lipoic acid into the breast milk. ESPA-Lipon® 600 mg i.v. Infusion solution concentrate, therefore, should not be used during lactation.

What should be considered in children?
Children and adolescents are from treatment with ESPA-Lipon® 600 mg i.v., Infusion solution concentrate, except, as there are no clinical experiences.
Precautions for the application and warnings

What precautions should be taken?
Alpha-lipoic acid reacts in vitro with metal ion complexes (eg With cisplatin), alpha-lipoic acid goes with sugar molecules (eg Lävulosolosolution) Solid complex compounds. ESPA Lipon® 600 mg i.v., infusion solution concentrate, is incompatible with glucose solution, ring solution and solutions known to react with SH groups or disulfide bridges.

As a carrier solution for an infusion application of ESPA-Lipon® 600 mg i.v., infusion solution concentrate, only physiological saline is to be used.

What do you need to consider in traffic as well as working with machinery and work without a secure stop?
There are no special precautions required.


Interactions with other means

Which other medicines affect the effect of ESPA-Lipon® 600 mg i.v., infusion solution concentrate, and what do you need to consider if you apply other medicines?

Please note that this information can also apply to recently used medicines.

It can not be ruled out that the simultaneous application of ESPA-Lipon® 600 mg i.v., infusion solution concentrate, leads to the loss of effect loss of cisplatin (a cancer agent.

The blood sugar-lowering effect of insulin or oral antidiabetics can be strengthened. Therefore, especially in the starting stage of therapy with ESPA-Lipon® 600 m isg i.v., Infusion solution concentrate, a tight blood sugar control indicated. In individual cases, it may be necessary to avoid sub-sugar phenomena to reduce the insulin dose or the dose of the oral antidiabetics according to the instructions of the attending physician.


Which semiluxury food, dishes and beverages should you avoid?

The regular enjoyment of alcohol represents a significant risk factor for the development and progression (progression) Neuropathic diseases and can thereby also the success of treatment with ESPA-Lipon® 600 mg i.v., Infusion solution concentrate, affect. Therefore, patients with diabetic polyneuropathy are generally recommended to avoid the enjoyment of alcohol as far as possible. This also applies to therapy intervals.

Dosage instructions, type and duration of the application

The following information applies as far as your doctor ESPA-Lipon® 600 mg i.v., infusion solution concentrate, not otherwise prescribed. Please stick to the application regulations, because ESPA-Lipon® 600 mg i.v., infusion solution concentrate, otherwise not correctly act!

How much of ESPA-Lipon® 600 mg i.v., infusion solution concentrate, and how often should they be ESPA-Lipon® 600 mg i.v., Infusion solution concentrate, apply?
For highly pronounced abuses of diabetic polyneuropathy, the daily dosage is an ampoule ESPA-Lipon® 600 mg i.v., infusion solution concentrate, (accordingly 600 mg of alpha lipoic acid).

How and when should they be ESPA-Lipon® 600 mg i.v., Infusion solution concentrate, apply?
The infusion solution concentrate is over a period of 2 to 4 Weeks used in the initial phase of the treatment.

As further therapy, 300 to 600 mg of alpha-lipoic acid should be taken in the form of tablets, film-coated tablets or capsules.

The intravenous administration should, after the content of ESPA-Lipon® 600 Mg i.v., infusion solution concentrate, with 250 ml of sodium chloride solution 0.9% was mixed, over at least 30 Minutes as a short infusion. Because of the photosensitivity of the active ingredient, the short-infusion should be prepared shortly before the application. The infusion solution can be protected with aluminum foil against light. The light-protected infusion solution is stable for about 6 hours. It should be ensured that the minimum infusion period of 30 minutes is maintained.

Overdose and other application errors

What to do when ESPA-Liponò 600 mg i.v. Infusion solution concentrate, was applied to large quantities?

In overdose, nausea, vomiting and headaches may occur.

In individual cases, when taking more than 10 g of alpha-lipoic acid, especially with simultaneous high alcohol consumption, severity, z. T. Observed life-threatening poisoning phenomena (such as generalized convulsions, derailment of the acid-base household with lactic acidosis, severe blood clotting disorders).
Therefore, there is a suspicion of significant overdose with ESPA-Lipon® 600 mg IV, infusion solution concentrate, immediate clinic instruction and the initiation of measures according to the general treatment principles of poisoning cases (eg triggering vomiting, stomach irrigation, activated carbon, etc.) . The treatment of potentially occurring poisoning must be oriented to the principles of modern intensive therapy and should be symptomatic.

Side effects

Which side effects can be used in the application of ESPA-Liponò 600 mg i.v., infusion solution concentrate, occur?
Occasionally, after rapid intravenous injection, head pressure and breathing removal occur, which spontaneously decay.
In individual cases, reactions were reported on the injection site. Allergic reactions of the skin with hives (Urticaria), itching, eczema and rash as well as systemically up to shock can occur.
In individual cases, after intravenous administration of alpha-lipoic acid seizures, double-imaging, spontaneous small-spot bleeding in the skin (purpura) and functional disorders of the platelets were (Thrombopathies) observed.

Due to improved glucose utilization can fall in individual cases of blood sugar levels. Hypoglycemia-like complaints with dizziness, sweating, headache and seardestruction described.

If you are watching side effects that are not listed in this leaflet, please tell your doctor or pharmacist.

Which countermeasures are to take with side effects?

If you are observing the abovementioned side effects
ESPA-Liponò 600 mg i.v., Infusion Solution Concentrate, not applied again. Notify your doctor so that it can decide on the severity and, if applicable, further measures.

In the first signs of a hypersensitivity reaction, the medicinal product must be set up and contacted immediately with a physician.
Notes and information on the durability of the medicinal product

The expiration date of this pack is printed on the ampoule and on the carton.
Do not use this pack after this date!

The duration of durability after dilution with physiological saline solution is light protected about 6 hours.

What is ESPA-Liponò 600 mg i.v., Infusion Solution Concentrate?
ESPA-Liponò 600 mg i.v., Infusion Solution Concentrate, is protected from light and not to be kept over + 25 ° C.

When is ESPA Liponò 600 mg i.v., Infusion Solution Concentrate, even before the expiration date expiry date?
For further questions about the durability of ESPA-Liponò 600 mg i.v., Infusion solution concentrate, please contact your doctor or pharmacist or to the pharmaceutical entrepreneur.
Stand of information

August 2003

Store drug out of reach of children!