Cerebrolysin: what it is, how it is given and what the studies actually show

In Romania you will see it written two ways: cerebrolizin, the way it is usually pronounced and spelled in Romanian, and Cerebrolysin, the brand name on the leaflet. It is the same medicine — we use both names in this article, because both are searched for just as often.

Cerebrolysin is searched for in Romania for two very different reasons: either because a neurologist prescribed it after a stroke or a head injury, or because someone read somewhere that it “helps memory and concentration”. The first situation is covered by the leaflet. The second is not.

This article explains what the substance is, what its marketing authorisation says and what independent systematic reviews have found — including where the results are disappointing. We do not sell cognitive promises.

What it is, in concrete terms

Cerebrolysin is a porcine brain protein hydrolysate: a mixture of low-molecular-weight peptides and free amino acids, obtained by controlled enzymatic breakdown. It sits under ATC code N07XX — other nervous system drugs.

The concentration is fixed at 215.2 mg of concentrate per millilitre, whatever the size of the ampoule. The rest of the solution is sodium hydroxide and water for injections. There is no “more concentrated” version — there are only larger ampoules.

The packs authorised in Romania are boxes of 10 ampoules of 1 ml, 5 ampoules of 5 ml and 5 ampoules of 10 ml.

The indications on the leaflet

This is the part worth reading before anything else. The approved indications are neurological and limited:

• organic, metabolic and neurodegenerative brain disorders — in particular senile dementia of the Alzheimer type;
• complications after a stroke;
• traumatic brain injury — post-operative, contusions or concussion.

What is not on this list: tiredness, stress, “brain fog”, reduced performance at work, ageing itself. Cerebrolysin has no indication for improving memory in a person without a neurological diagnosis, and using it for that purpose is outside its marketing authorisation.

How it is given, according to the leaflet

The doses differ by indication:

• organic and neurodegenerative brain disorders: 5–30 ml a day;
• complications after a stroke: 10–50 ml a day;
• traumatic brain injury: 10–50 ml a day;
• children: 1–2 ml a day.

The route of administration depends strictly on the volume. Up to 5 ml may be given intramuscularly, up to 10 ml intravenously. Doses of 10–50 ml are given only by infusion, diluted to a total volume of 250 ml in 0.9% saline, Ringer's solution or 5% glucose. The infusion must last between 15 and 60 minutes.

A detail that advertising almost always leaves out: the leaflet describes a course of treatment — daily administration for 10–20 days — not a one-off infusion. A single session is not a course; it is one session of a regimen set by the doctor.

What the studies show — the honest part

This is where this article parts ways with most Romanian writing on the subject.

Acute stroke

The Cochrane review updated in October 2023 analysed seven randomised trials with 1,773 participants. Its conclusions, in brief:

• Cerebrolysin probably makes no difference to all-cause mortality — moderate-certainty evidence.
• It probably increases the number of patients with non-fatal serious adverse events.
• None of the included trials reported poor functional outcome, defined as death or dependency at the end of follow-up — exactly the measure that would matter most to a patient.

The authors note explicitly that three of the trials involved the manufacturer, which may have influenced how they were designed.

Vascular dementia

The Cochrane review on vascular dementia, updated in November 2019, included six randomised trials with 597 participants. It found a modest beneficial effect on cognitive function and global function, with no difference in the rate of adverse reactions — but the authors warn that the data are not definitive and that, if the benefits exist, they may be too small to matter clinically. Their conclusion is that methodologically robust trials with adequate statistical power are needed.

Between the 2013 review and the 2019 update, no new trials appeared that could be included. For a medicine that has been in use for decades, that in itself is information.

What this means in practice

That Cerebrolysin is not a treatment with solidly demonstrated efficacy, but a medicine with approved indications and a weak, contested evidence base. Anyone who promises you certain cognitive results is not citing the literature — they are ignoring it.

Contraindications and side effects

It is not given in case of hypersensitivity to its components, epilepsy or severe kidney failure.

Side effects reported very rarely include hypersensitivity reactions, seizures, gastrointestinal disturbances and injection-site reactions. Rarely: loss of appetite, agitation or confusion, palpitations, rises or falls in blood pressure, tremor, depression.

Because it is a protein hydrolysate, the practically relevant risk is a hypersensitivity reaction. That is why it is given where there are staff and equipment to intervene, not at home.

Cerebrolysin, Neurovert or Actovegin — not the same thing

Three names that often turn up in the same search, even though they are not even in the same category. The difference matters, because it changes who decides and how the product is taken.

Neurovert Forte is not a medicine. It is a food supplement (sold over the counter in Romania) containing citicoline, taken by mouth. Comparing “Cerebrolysin or Neurovert” sets a medicine given intravenously under supervision against a supplement off the shelf — two things that do not substitute for each other and are not decided the same way. A supplement has no approved indications for the after-effects of stroke or traumatic brain injury, because it has not been assessed for that. Actovegin, like Cerebrolysin, is a prescription medicine, comes in injectable and infusion forms and has indications in cerebral circulatory disorders. It is authorised in Romania but not approved in the United States, and its evidence base is criticised for the same reasons as Cerebrolysin's: trials that do not meet current standards. We do not administer Actovegin.

Which of them — if any — makes sense in a given case is not decided from a table, but by the doctor who makes the diagnosis.

How we work at Synerva

We give it only at the clinic, only on the basis of a documented neurological diagnosis and after a medical assessment — not on request and not as a wellness protocol. The first step is always the assessment, not the infusion.

Our protocol uses one 10 ml ampoule, diluted in 250 ml saline, given over 45–60 minutes, with monitoring throughout. The number of sessions is set by the doctor, according to the indication. Details and the price are on the protocol page: Cerebrolysin infusion.

If what brought you here is tiredness, lack of energy or a wish to support cognitive function without a neurological diagnosis, Cerebrolysin is not the answer. The right conversation starts with an initial longevity consultation, where we work out whether anything makes sense, and what.

Sources

Cerebrolysin 215.2 mg/ml leaflet — 5 ampoules × 10 ml (Romanian patient leaflet): composition, indications, doses, dilution rules and infusion time, contraindications, side effects.

Cochrane — Cerebrolysin for acute ischaemic stroke: review updated in October 2023, seven trials, 1,773 participants.

Cochrane — Cerebrolysin for vascular dementia: review updated in November 2019, six trials, 597 participants.

Neurovert Forte leaflet — Sun Wave Pharma: food supplement, citicoline 500 mg and Bacopa monnieri extract, capsules.

Actovegin 200 mg leaflet — National Agency for Medicines and Medical Devices (ANM, Romania's medicines regulator): a deproteinised haemoderivative from calf blood, prescription medicine.

This article is for information only and does not replace a medical consultation. Cerebrolysin is a prescription-only medicine; the decision to give it rests with the doctor, after assessing each case individually.