Vitamin C ROTEXMEDICA injection solution, 10x5 ml

Instructions for use for Vitamin C ROTEXMEDICA injection solution, 10x5 ml

Important notes (compulsory information):

Vitamin C-Rotexmedica 100 mg / ml, injection solution. Active substance: Ascorbic acid. Areas of application: For childhood methemoginemia (especially after poisoning, threatening reducing oxygen transport in the blood) and for vitamin C supply for artificial (parenteral) diet.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


LEAFLET: INFORMATION FOR THE USER

Vitamin C-Rotexmedica 100 mg / ml, injection solution
Active substance: ascorbic acid

Read the entire leaflet carefully before starting using this medicine. This medicine is available without prescription. DM to achieve the best possible treatment success, but Vitamin C-Rotexmedica must be used properly.

• Lift the package leaflet. You might want to read it again.
• Ask your doctor or pharmacist if you need more information or advice.
• If your symptoms get worse or no improvement occurs, you must definitely look for a doctor.
• If one of the listed side effects are significantly affected or if you notice side effects that are not specified in this information information, please inform your doctor or pharmacist.

This leaflet contains:

1. What is Vitamin C-Rotexmedica and what is it used for?
2. What do you need to consider before using vitamin C-Rotexmedica?
3. How is vitamin C-Rotexmedica to apply?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep vitamin C-Rotexmedica?
6. ADDITIONAL INFORMATION

1. What is vitamin C-ROTEXMEDICA and what is it used for?

Vitamin C-Rotexmedica is a vitamin-containing medicine. Vitamin C-Rotexmedica is applied to methemoglobinemia in childhood (Especially after poisoning, threatening reducing oxygen transport in the blood) and the vitamin C supply for artificial (parenteral) diet.

2. What do you need to consider before using vitamin C-Rotexmedica?

Vitamin C-Rotexmedica must not be taken if it is hypersensitive (allergic) against ascorbic acid.

Take special care with the use of vitamin C-Rotexmedica is required, for renal stones from oxalate and certain diseases, where too much iron is stored in the body (Thalassemia, hemochromatosis, sideroblastic anemia). Intravenous injection of high doses of vitamin C-Rotexmedica can lead to acute renal failure due to precipitation of calcium oxalate crystals in the kidney to acute renal failure due to renal stones. This was already observed at doses of 1.5 - 2.5 g. Patients with already existing restriction of renal function (renal insufficiency) are particularly at risk for this purpose. In patients with recurring kidney stone formation should be the daily vitamin C-dose 100 to 200 Do not exceed MG. Patients with high-level or terminal renal insufficiency (dialysis patients) should not receive 50 to 100 mg more than daily. In patients with erythrocytic glucose-6-phosphate dehydrogenase deficiency (hereditary disruption of the metabolism of red blood cells) were observed under high doses of vitamin C (more than 4 g daily) in individual cases, for example, severe hemolyses (dissolution of red blood cells). An exceeding of the specified dosage is therefore to be avoided.

Application of vitamin C-Rotexmedica along with other medicines:
Please inform your doctor or pharmacist if you take / use other medicines or recently taken / applied, even if it is non-prescription medicines. Vitamin C-Rotexmedica can chemically change other medicines (due to high redox potential); The compatibility with other medicines must therefore be checked in individual cases with simultaneous administration. Vitamine C-Rotexmedica must not be mixed with medicaments whose effect is reduced by chemical reduction.

Pregnancy and breast feeding period:
Ask your doctor or pharmacist for advice before taking / application of all medicines. The specified application quantities should not be exceeded in pregnancy and lactation.

Important information about certain other ingredients of vitamin C-ROTEXMEDICA:
An ampoule contains 64.4 mg of sodium. If you need to meet a saline diet, you should consider this.

3. How is Vitamin C-Rotexmedica to apply?

Always use Vitamin C-Rotexmedica exactly as directed in this leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by the doctor, the usual dose is: for the prevention of a vitamin C deficiency with longer artificial (parenteral) Nutrition receive adults intravenously 100 to 500 mg ascorbic acid per day (corresponding to 1 - 5 ml of vitamin C-Rotexmedica). Children intravenously 5 to 7 mg ascorbic acid / kg kg per day. With methemoglobinemia in childhood: it will be unique 500 to 1000 mg ascorbic acid (corresponding to 1 to 2 ampoules vitamin C-Rotexmedica) injected intravenously. If necessary, the administration with the same dosage is to be repeated. A dose of 100 mg / kg kg per day should not be exceeded. Vitamin C-Rotexmedica is slowly injected by your doctor or other medical staff intravenously (into the veins). The duration of the application your doctor decides on the basis of the course of the disease and the blood levels. Please talk to your doctor or pharmacist if you have the impression that the effect of vitamin C-Rotexmedica is too strong or too weak.

When a larger amount of vitamin C-Rotexmedica has been used, as prescribed:
The use of vitamin C-Rotexmedica is interrupted. Other measures are generally, except when hemolysenic or renal stones (see section "Precautions for the application and warnings"), not necessary. For pain in kidney area or difficult urination after a high dose of vitamin C-Rotexmedica, a doctor must be communicated immediately.

If you have further questions about the application of the medicine, ask your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, vitamin C-RotexMedica may have side effects that do not have to occur each other. The assessment of side effects is based on the following frequency information:

The frequency information on side effects is based on the following categories:
Very often:	more than 1 treated from 10
Frequently:	1 to 10 treated from 100
Occasionally:	1 to 10 treated from 1 000
Rarely:	1 to 10 treated from 10 000
Very rare:	less than 1 treated from 10 000
Not known:	Frequency on the basis of the available data does not estimate.

Very rarely hypersensitivity reactions (e.g., Respiratory difficulties, allergic skin reactions) observed.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also effectively effect the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep vitamin C-Rotexmedica?

Store drug out of reach of children! You may be the medicine after the on the outer carton and on the ampoules "Usable until" specified expiry date no longer usen. The expiry date refers to the last day of the month. Storage conditions: Keep the ampoules in the carton to protect the content from light! Do not store over 25 ° C!

6. Further information

What contains vitamin C-Rotexmedica:
The active ingredient is: ascorbic acid. 1 ml injection solution contains 100 MG ascorbic acid. The other ingredients are: Sodium bicarbonate, water for injection purposes.

Like vitamin C-Rotexmedica looks and content of the pack:
Original pack with 10 ampoules to 5 ml injection solution (N2), Clinic pack with 100 (10 x 10) ampoules to 5 ml injection solution.

Pharmaceutical entrepreneur and manufacturer:
ROTEXMEDICA GmbH Arzneimittelwerk
Bunsenstraße 4
22946 Trittau
Telephone: 0 41 54 / 862-0
Fax: 0 41 54 / 862-155

This information information was last revised in June 2015.

Source: Information of the leaflet
Status: 08/2016