Oligostandard concentrate for intravenous infusion solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

OLIGOSTANDARD concentrate for solution for infusion

Read the entire leaflet carefully before you start using this medicine

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What OligoStandard is and what it is used for
2. Before you use OligoStandard
3. How to use OligoStandard
4. Possible side effects
5. How to store 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 trace elements for adult patients.

2. Before using OligoStandard

Do not use Oligo游戏副本Standard:

• 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 causing copper accumulation in the liver).

• If you have liver problems such as severe cholestasis (reduced bile flow in the liver leading to bilirubin levels above 140 mmol/l and elevated levels of gamma-glutamyl transferase and alkaline phosphatase).

• OligoStandard must not be administered to newborns, infants, or children.

Take special care with OligoStandard:

• If artificial nutrition is prolonged, your blood levels of manganese should be monitored. If this element accumulates, the administered dose should be reduced or administration discontinued.

• If you have hepatic insufficiency (liver dysfunction) and reduced biliary excretion (gallbladder dysfunction), since biliary elimination of manganese, copper, and zinc may be impaired, potentially leading to accumulation and overdose.

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

• If you are undergoing medium- to long-term parenteral nutrition, your zinc requirements should be monitored. Additional supplementation with this electrolyte may be necessary.

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

Diarrhea may increase intestinal losses of zinc. In such cases, serum zinc concentrations should be monitored.

Consult your doctor, even if any of the above conditions have occurred in the past.

Use with other medicines:

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

Any medication added to OligoStandard must be specifically monitored, as incompatibilities with some drugs may occur (see section 6).

Pregnancy and lactation:

Consult your doctor or pharmacist before using any medication.

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

Driving and use of machinery:

No effects on the ability to drive or operate machinery have been reported with the use of OligoStandard.

3. How to use OligoStandard

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

Your doctor will instruct healthcare personnel on the most appropriate dose for your needs. To meet basic requirements of trace elements, 10 ml of OligoStandard (1 ampoule) diluted in a compatible solution should be infused. This corresponds to the normal daily dose.

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

In cases of significantly increased requirements (such as extensive burns, polytrauma patients, severe hypercatabolic states, and those with intestinal fluid losses), doses higher than the recommended regimen may be required.

Administration may be continued throughout the duration of parenteral nutrition:

• Caution is recommended in case of hepatic insufficiency (liver impairment), cholestasis (reduced bile excretion in the liver), and/or renal insufficiency (kidney impairment), as dose adjustment or discontinuation of treatment may be necessary (see section “Special warnings and precautions for use”)

Whenever possible, any deficiency of an individual trace element should be corrected with specific supplements.

If you use more OligoStandard than you should:

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

4. Possible adverse effects

Like all medicines, OligoStandard may produce adverse effects, although not everyone will experience them.

None are expected, provided the administration instructions indicated are followed.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it involves possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 container shows visible signs of deterioration.

Discard the solution if it becomes cloudy or shows sedimentation.

Do not use OligoStandard after the expiry date stated on the container. The expiry 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 medicines and containers you no longer need. This will help protect the environment.

Stability after reconstitution:

From a microbiological standpoint, 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 should normally not exceed 24 hours at 2 - 8 °C, unless reconstitution has been carried out under validated and controlled aseptic conditions.

6. Information for Healthcare Professionals

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

Electrolytic composition per vial:

Zinc 46 micromoles 3000 micrograms

Copper 8 micromoles 500 micrograms

Manganese 3.64 micromoles 200 micrograms

Chromium 0.2 micromoles 10 micrograms

Other components are:

Hydrochloric acid and water for injections.

Appearance of the medicinal product and contents of the package

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

Marketing Authorization Holder and Manufacturer

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

This summary of product characteristics was approved in

June 2015

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

This information is intended exclusively for physicians and healthcare professionals:

OligoStandard must be administered only by intravenous route after dilution in not less than 250 ml of an appropriate infusion solution. Suitable infusion solutions include: glucose solutions (e.g. 5% or 10% glucose) or electrolyte solutions (e.g. 0.9% sodium chloride, Ringer's solution).

Compatibility must be verified before adding to other infusion solutions. The addition to infusion solutions should be performed immediately before administration and under aseptic conditions.

This mixture may be used within 24 hours. Any unused portion should be discarded.

Concomitant administration must not be performed with:

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

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

MEDICINAL PRODUCT REQUIRING MEDICAL PRESCRIPTION

HOSPITAL USE

B|BRAUN

• Braun Medical SA

Ctra. de Terrassa, 121

08191 Rubí (Barcelona)