OLIGOSTANDARD CONCENTRATED SOLUTION FOR INTRAVENOUS INFUSION

Introduction

Package Leaflet: Information for thepatient

OLIGOSTANDARD concentrate for solution for infusion

Read all of this leaflet carefully before you start using this medicine

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What OligoStandard is and what it is used for
2. Before using OligoStandard
3. How to use OligoStandard
4. Possible side effects
5. Storage of OligoStandard
6. Further information

1. What OligoStandard is and what it is used for

OligoStandard belongs to the group of electrolytes. It is used as part of intravenous nutrition, providing a source of oligoelements for adult patients.

2. Before using OligoStandard

Do not use OligoStandard:

• If you are allergic (hypersensitive) to the active substances or to any of the other components of OligoStandard.

• If you have Wilson's disease (a hereditary metabolic disorder that causes copper accumulation in the liver).

• If you have liver problems, such as pronounced cholestasis (decreased bile in the liver, causing bilirubin levels above 140 mmol/l and elevated levels of gamma-glutamyltransferase and alkaline phosphatase).

• OligoStandard should not be administered to newborns, infants, and children.

Be cautious when using OligoStandard:

• If artificial nutrition is prolonged, manganese levels in the blood should be monitored. If this element accumulates, the dose to be administered should be reduced or administration should be stopped.
• If you have liver failure (liver alteration) and reduced bile excretion (bile duct alteration), as the biliary elimination of manganese, copper, and zinc may be affected, leading to accumulation and overdose.

• If you have kidney failure (kidney alteration), as this may significantly affect the renal excretion of chromium and zinc.

• If you are undergoing medium- to long-term parenteral nutrition, zinc needs should be monitored. An extra supplement of this electrolyte may be necessary.

• If you have insulin-dependent diabetes mellitus (elevated blood glucose levels requiring insulin administration) and chromium deficiency, you may require a reduction in insulin dosage during OligoStandard administration, as chromium deficiency causes decreased glucose tolerance, which improves after chromium intake with OligoStandard.

Diarrhea may cause an increase in intestinal losses of zinc. In this case, serum zinc concentrations should be monitored.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Use of other medicines:

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

The addition of any medicine to OligoStandard should be specifically monitored, as there may be incompatibility with some of them (see section 6).

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, OligoStandard will only be administered if your doctor considers it necessary.

Driving and using machines:

No effects on driving ability or machine operation have been described with the use of OligoStandard.

3. How to use OligoStandard

Follow the instructions for administration of OligoStandard exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate to the healthcare staff the most suitable dose for your needs. To meet the basic requirements of oligoelements, 10 ml of OligoStandard (1 ampoule) diluted in a compatible solution are infused. This corresponds to the normal daily dose.

In cases of moderately increased oligoelement requirements, higher doses (up to 20 ml, 2 ampoules) may be necessary, monitoring the serum levels of oligoelements.

In cases of significantly increased requirements (such as extensive burns, polytraumatized patients, severe hypercatabolism, and those with intestinal fluid loss), doses higher than the recommended guideline may be necessary.

Administration can be continued during the duration of parenteral nutrition:

• Cautious use is recommended in cases of liver failure (liver alteration), cholestasis (decreased bile excretion in the liver), and/or kidney failure (kidney alteration), as dose adjustment or treatment suspension may be required (see "Be cautious when using OligoStandard").

Whenever possible, any deficiency of an individual oligoelement should be corrected through specific supplements.

If you use more OligoStandard than you should:

Your doctor will stop treatment if laboratory tests confirm an overdose.

4. Possible side effects

Like all medicines, OligoStandard can cause side effects, although not everybody gets them.

No side effects are expected if the administration instructions are followed.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of OligoStandard

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use OligoStandard if the packaging shows visible signs of deterioration.

Discard the solution if it appears turbid or sedimented.

Do not use OligoStandard after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

Validity period after reconstitution:

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user, and the time should not normally exceed 24 hours at 2-8°C, unless the dilution has been performed under validated and controlled aseptic conditions.

6. Further information

Composition of OligoStandard

Concentrate for solution for intravenous infusion

The active substances are:

Per 1 mlPer 10 ml

Zinc chloride 625.400 micrograms 6,254 mg

Copper sulfate 5H2O 196.450 micrograms 1,9645 mg

Chromium chloride 6H2O 5.100 micrograms 0.051 mg

Manganese sulfate H2O 61.550 micrograms 0.6155 mg

Electrolyte composition per ampoule:

Zinc 46 micromoles 3000 micrograms

Copper 8 micromoles 500 micrograms

Manganese 3.64 micromoles 200 micrograms

Chromium 0.2 micromoles 10 micrograms

The other components are:

Hydrochloric acid and water for injectable preparations.

Appearance and packaging of the product

OligoStandard is a concentrate for solution for intravenous infusion presented in 10 ml plastic ampoules (Mini-Plasco®), in packs of 80 units.

Marketing authorization holder and manufacturer

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

This leaflet was approved in

June 2015

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products.

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This information is intended only for healthcare professionals:

OligoStandard should be administered only by intravenous route after dilution in at least 250 ml of a suitable infusion solution. The infusion solutions that can be used are: glucose solutions (e.g., 5% or 10% glucose) or electrolyte solutions (e.g., 0.9% sodium chloride, Ringer's solution).

Before adding to other infusion solutions, compatibility should be checked. The addition to infusion solutions should be performed immediately before administration and under aseptic conditions.

This mixture can be used for 24 hours. Residual amounts should be discarded.

Concomitant administration should not be performed with:

• Alkaline solutions
• Lipid emulsions
• Intravenous infusion solutions containing vitamin C, as oligoelements may accelerate its degradation
• Solutions containing inorganic phosphate (additives).

Complete information on incompatibilities is not available. Please contact the manufacturer for further information.

MEDICINE SUBJECT TO MEDICAL PRESCRIPTION

HOSPITAL USE

B|BRAUN

• Braun Medical SA

Ctra. de Terrassa, 121

08191 Rubí (Barcelona)