SOMAZINA Oral solution Ref.[51153] Active ingredients: Citicoline

Source: Medicines Authority (MT)  Revision Year: 2015  Publisher: Ferrer Internacional, S.A, Gran Via de Carlos III, 94, 08028, Barcelona

4.1. Therapeutic indications

  • Treatment of cognitive and neurological disorders associated with acute and sub-acute stroke.
  • Treatment of cognitive and neurological disorders associated with traumatic brain injuries.

4.2. Posology and method of administration

Posology

Adults

The recommended dose is from 500 to 2,000 mg/day, depending on the severity of the symptoms to be treated.

Older people

Somazina does not need any specific dose adjustment for this age group.

Children

The experience in children is limited; therefore it may only be administered when the expected therapeutical benefit is higher than any possible risk.

Method of administration

See the instructions for preparation of the medicine in section 6.6.

4.9. Overdose

No case of overdose has been reported.

6.3. Shelf life

Somazina 100 mg/ml oral solution: 3 years.

6.4. Special precautions for storage

Store in the original package.

6.5. Nature and contents of container

Somazina 100 mg/ml oral solution is supplied in a pack containing a 30 ml glass bottle with sealed plastic cap and a syringe graduated in ml.

6.6. Special precautions for disposal and other handling

Handling instructions for the medicinal product are the following:

Somazina 100 mg/ml oral solution

The product is administered with the aid of the dosing syringe, according to the following scheme:

1. Introduce the dosing syringe with the piston pressing to the bottom.

2. Aspirate the indicated dose making the piston turn, taking into account that the liquid contained in the syringe coincides exactly with the prescribed level.

3. Administer the preparation directly or dissolved in half a glass of water (120 ml).

After each administration, it is recommended to wash the dosing syringe with water.

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