Patient Information Leaflet: Information for the PatientPatient Information Leaflet

OLIGOSTANDARD Concentrate for Infusion Solution

Read this leaflet carefully before you start using this medicine

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

No use OligoStandard:

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

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

• If you have liver problems such as pronounced cholestasis (decreased bile in the liver that causes 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

Tenga especial cuidado con OligoStandard:

• If artificial nutrition is prolonged, you must control your blood levels of manganese. If this element accumulates, you should reduce the dose to be administered or stop administration
• If you have liver insufficiency (liver alteration) and reduced bile excretion (bile duct alteration) since the biliary elimination of manganese, copper, and zinc may be affected, leading to accumulation and overdose

• If you have renal insufficiency (kidney alteration) since it may significantly affect the renal excretion of chromium and zinc

• If you are undergoing parenteral nutrition for a medium/long period, your zinc needs must be controlled. You may need an extra supplement of this electrolyte

• If you have insulin-dependent diabetes mellitus (elevated blood glucose levels requiring insulin administration) and chromium deficiency, you may require a reduction in the amount of insulin during OligoStandard administration, as chromium deficiency causes a decrease in glucose tolerance, which improves after chromium supplementation with OligoStandard

Diarhea may cause an increase in intestinal zinc losses. In this case, your serum zinc concentrations must be controlled

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time

Uso de otros medicamentos:

Inform your doctor or pharmacist if you are using or have recently used other medications, even those acquired without a prescription

The addition of any medication to OligoStandard must be controlled specifically, as there may be incompatibility with some of them (see section 6)

Embarazo y lactancia:

Consult your doctor or pharmacist before using any medication

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

Conducción y uso de máquinas:

No effects on driving ability, or the operation of machinery, have been described for the use of OligoStandard

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

Your doctor will instruct healthcare personnel on the most suitable dose for your needs. To meet the basic requirements for oligoelements, 10 ml of OligoStandard (1 vial) 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 vials) may be necessary, while controlling serum oligoelement values.

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

The administration may be continued during the duration of parenteral nutrition:

• Caution is recommended in cases of hepatic insufficiency (liver alteration), cholestasis (decreased bile excretion in the liver), and/or renal insufficiency (kidney alteration), as dose adjustment or suspension of treatment may be required (see section “Be especially careful with OligoStandard”)

Whenever possible, any individual oligoelement deficiency should be corrected with specific supplements.

If you use more OligoStandard than you should:

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

Like all medications, OligoStandard may cause adverse effects, although not everyone will experience them.

None are expected, as long as the administration instructions are followed.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of 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 presents turbidity or sedimentation.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and 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, storage times and previous use conditions are the responsibility of the user, and the time should not normally exceed 24 hours at 2 - 8 °C, unless the dilution was performed in validated and controlled aseptic conditions.

Composition of OligoStandard

Concentrate for intravenous infusion solution

The active principles are:

Per 1 ml Per 10 ml

Zinc chloride 625,400 micrograms 6,254 mg

Copper sulfate 5H2O 196,450 micrograms 1,964.5 mg

Chromium chloride 6H2O 5,100 micrograms 0.051 mg

Manganese sulfate H2O 61,550 micrograms 0.6155 mg

Electrolyte composition per vial:

Zinc 46 micromoles 3,000 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 of the product and contents of the package

OligoStandard is a concentrate for intravenous infusion solution that is presented in plastic vials (Mini-Plasco