Sodium chloride 10% brown infusionslsg. Concentrate, 20x100 ml

Upute za korištenje Sodium chloride 10% brown infusionslsg. Concentrate, 20x100 ml

Important notes (compulsory information):

Sodium chloride 10% brown , concentrate. Application areas: For the treatment of heavy metabolic alkaloses (alkaline surplus or Restriction) and in pediatrics (pediatricity) for lowering increased concentration of ammonia in the blood (hyperammonemia) by severe congenital metabolic disorders.

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


LEAFLET: INFORMATION FOR THE USER

Sodium chloride 10% brown, concentrate for producing an infusion solution
Active substance: sodium chloride

Read the entire leaflet carefully before starting using this medicine.

• Lift the package leaflet. You might want to read it again.
• If you have further questions, contact your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people, even if they have the same complaints as they are.
• If one of the listed side effects you significantly affect it or notice side effects that are not specified in this information information, please inform your doctor or pharmacist.

This leaflet contains:

1. What is sodium chloride 10% brown and what is it used for?
2. What do you need to consider 10% brown before using sodium chloride?
3. How is sodium chloride to apply 10% brown?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How is sodium chloride to store 10% brown?
6. ADDITIONAL INFORMATION

1.What is sodium chloride 10% brown and what is it used for?

Sodium chloride 10% brown is a concentrated solution of sodium chloride (saline) for producing or enriching infusion solutions (solutions that are supplied directly to the body via a venotentrop) with sodium chloride. It serves to feed sodium chloride. Sodium chloride 10% brown is applied to the supply of sodium chloride at:

• Reduced sodium levels in the blood (hyponatremia),
• Reduced chloride levels in the blood (hypochloremia),
• Liquid surplus with reduced concentration of salts in the blood (hypotone hyperhydration).

2.What do you have to consider 10% brown before using sodium chloride?

Sodium chloride 10% brown must not be used at:

• elevated sodium mirror in the blood (hyperremia),
• increased chloride levels in the blood (hyperchloremia).

Take special care with the use of sodium chloride 10% brown is required:

• reduced potassium levels in the blood (hypokalemia),
• Diseases that have a restrained sodium supply, such as heart failure (heart failure), fluid accumulation in the tissue (generalized edema), liquid accumulation in the lungs (Pulmonary edema), hypertension (hypertension), pregnancy-related disease states with high blood pressure, cramps and fluid accumulations in tissue (ecclipsy), heavy functional disorders of kidneys (renal insufficiency),
• Treatment with corticoids or ACTH (hormones that reduce sodium excretion), see next section,
• Surgouillation of the blood (metabolic acidosis).

Controls of electrolyte levels in the blood and the water balance as well as the acid-based status are required.

When using sodium chloride 10% brown with other medicines:
Please inform your doctor or pharmacist if you occupy or apply other medicines or recently taken or applied, even if it is not a prescriptione pharmaceuticals are particularly known to their doctor, whether they are with adrenal hormones (Corticoids) or medicines that influence the function of adrenals (so-called ACTH), be treated as these means can reduce the excretion of sodium chloride and water.

Pregnancy and breast feeding period:
Before taking or using all medicines, ask your doctor or pharmacist for advice. At Eklampsie, caution is required.

Driveion and use of machines:
Sodium chloride 10% brown has no influence on the ability to drive and the ability to operate machines.

3. What is sodium chloride to apply 10% brown?

This medicine is applied to you by a doctor or medical personnel.

Type of application:
Sodium chloride 10% brown is supplied as intravenous infusion (via a venot rotary) after being diluted in a suitable carrier solution.

Dosage:
The right dose determines your doctor. Your doctor calculates your sodium chloride requirement based on your serum sodium mirror and your body weight.

Maximum daily dose:
The maximum daily quantity depends on the correction needs. Adults applies a guideline of 3-6 mmol sodium per kg of body weight, for children from 3-5 mmol sodium per kg body weight.

Maximum infusion and drip speed:
The maximum infusion and drip speed depends on your clinical condition.

If your sodium concentration is chronic low, your doctor will administer to you sodium chloride 10% brown with a low infusion rate to prevent brain damage (see "If you have gained a larger amount of sodium chloride 10% brown than you should").

Children and adolescents:
Hypertone sodium chloride solutions are used exclusively in children and adolescents with symptomatic hyponatemia. 6 MMOL / L sodium chloride per kg body weight lead to an increase in sodium chloride by a maximum of 10 mmol / l. The sodium chloride concentration should not be increased more than 10 mmol / l / day and not exceed the maximum concentration of 125 mmol / l. Likewise, the increase in sodium chloride concentration should be done slowly to prevent hyperremia.

If you received a larger amount of sodium chloride 10% brown than you should:
To rapid supply of a higher concentrated solution can lead to acute volume load. Overdose can be for overburdening, increased sodium levels in the blood (hyperremia), increased chloride mirror in the blood (hyperchloremia), increased salt concentration in the blood (hyperosmolarity) and to disturbances of the acid base household, in particular to acidification of the blood (Acidosis), lead. In patients with chronic low sodium concentration, a too rapid increase in sodium concentration can lead to a brain damage (osmotically demyelinizing disease.

Countermeasures:
Infusion stop, administration of diuretic resources (diuretics) under constant control of electrolyte balance, correction of electrolyte disorders and the disturbances of the acid-base household.

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, sodium chloride can have 10% brown side effects, but they do not have to occur each other. The frequency information on side effects is based on the following categories:

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 not ABSchessible.

The frequency of possible side effects depends essentially on the dosage and the infusion rate.

Metabolic and nutritional disorders:
When used, increased sodium and chloride mirrors in the blood can occur. For too fast infusion, high sodium chloride solution solutions can cause acute volume load.

Diseases of the stomach and intestinal tract:
For too fast infusion, there may be diarrhea in solutions with high sodium chloride concentration.

Diseases of kidneys and urinary tract:
For too fast infusion rate, high-sodium chloride concentration solutions may result in reinforced urinary excretion.

Complaints at the administration site:
In infusion of high sodium chloride solution solutions into smaller veins (arm or leg portion), irritation and inflammation of the venous wall can occur.

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 effect side effects directly via Federal Institute for Medicines and Medical Devices. Pharmacovigilance Kurt-Georg-Kiesinger Allee 3 D-53175 Bonn Website: http://www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How is sodium chloride to store 10% brown?

Store drug out of reach of children. You may follow the medicine after the on the container and the outer carton "Usable until" or "Ver. To" or "Exp" stated expiration date no longer use. The expiry date refers to the last day of the month. Not more than 25 ° C store. They may only use sodium chloride 10% brown if the solution is clear and free of suspended particles and the container is intact. The containers are determined for a single application. After application, discard remains left!

6. Further information

What contains sodium chloride 10% brown:
The active ingredient is sodium chloride. 1 ml concentrate for producing an infusion solution contains 100 mg of sodium chloride, corresponding to 1 mmol Na + and 1 mmol CL-. 1 ampoule to 10 ml contains 1.0 g of sodium chloride. 1 vial 100 ml contains 10 g of sodium chloride. The other ingredient is: water for injection purposes.

Like sodium chloride brown 10% looks and content of the pack:
Sodium chloride brown 10% is a concentrate for producing an infusion solution (i.e., it is administered as infusion after being diluted in a carrier solution.) It is a clear, colorless aqueous solution. It is available in: polyethylenampiles, content: 10 ml, in packs of 20 ampoules each and in vials of glass, content: 100 ml, in packs of 20 Vials.

Pharmaceutical entrepreneur and manufacturer:
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 mels

Postal address:
34209 melsungen

Tel.: 05661-71-0
Fax: 05661-71-4567

This information information was last revised in July 2014.

Source: Information of the leaflet
Status: 07/2016