Many stroke patients are prescribed Cerebrolysin

Cerebrolysin - parenteral solution

CEREBROLYSIN

SUMMARY OF PRODUCT CHARACTERISTICS

Cerebrolysin

- parenteral solution

February 2016

1.

NAME OF THE MEDICINAL PRODUCT

Cerebrolysin

- parenteral solution

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml contains 215.2 mg of a proteolytic peptide fraction from pig brain protein (cerebrolysin

Concentrate) in aqueous solution.

For a full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Solution for injection / concentrate for making a clear amber solution for infusion

4.

CLINICAL PARTICULARS

4.1

application areas

For the supportive treatment of cerebrovascular disorders.

Especially with the following indications:

Alzheimer's type senile dementia and vascular dementia

post-apoplectic failure symptoms

Craniocerebral trauma (commotio and contusio)

Cerebrolysin is used in adults and the elderly (> 65 years).

4.2

Dosage and method of administration

dosage

Adults and the elderly

In general, patients with:

In the case of dementia, several therapeutic applications can be made after 2 months to ensure success

be repeated until further improvement can no longer be achieved. Here, from the second

Treatment cycle from daily application to 2-3 times a week application

be passed over.

One treatment cycle corresponds to a therapy duration of 4 weeks (5 applications / week).

Children and adolescents

An application in children and adolescents under 18 years of age is due to inadequate

Data situation not recommended.

type of application

Daily dose

Duration of therapy

Senile dementia of the Alzheimer's type and

vascular dementia

10-30 ml

4 weeks

Ischemic Stroke

20 - 50 ml

10 - 21 days

Hemorrhagic stroke

30 - 50 ml

10 - 21 days

Craniocerebral trauma

20 - 50 ml

7-30 days

Cerebrolysin

- parenteral solution

February 2016

Up to 5 ml intramuscularly, up to 10 ml intravenously. An infusion is recommended from 10 ml, with

can be diluted with the standard infusion solutions listed below and administered slowly

(Infusion time approximately 15 to 60 minutes).

Compatibility with the following standard infusion solutions has been established for over 24 hours

Tested at room temperature and under the influence of light.

0.9% sodium chloride solution (9 mg NaCl / ml)

Ringer's solution (Na

153.98 mmol / l, approx

2.74 mmol / L, K.

4.02 mmol / L, Cl

163.48 mmol / l)

Glucose 5%

The simultaneous administration of vitamins and the necessary cardiovascular drugs is

possible, but not in a mixed syringe.

For instructions on how to dilute the medicinal product before use, see section 6.6.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the other substances listed in section 6.1

Components.

Status epilepticus.

Severe renal impairment.

4.4

Special warnings and precautions for use

Beware of allergic diathesis, diseases of the epileptic circle and grand mal-

Seizures, as this can increase the frequency of seizures.

4.5

Interactions with other drugs and other forms of interaction

Due to the pharmacological profile of action of Cerebrolysin, joint

Administration with antidepressants or MAO inhibitors, attention should be paid to additive effects. It

In such cases, it is advisable to dose the antidepressant lower.

At doses of 30-40 ml of Cerebrolysin in combination with high doses of MAOIs it can

come to an increase in blood pressure.

Cerebrolysin should not be infused at the same time as balanced amino acid solutions

administered.

4.6

Fertility, pregnancy and lactation

Animal studies have not produced any indications of direct or indirect harmful effects

Effects related to reproductive toxicity (see section 5.3).

pregnancy

Cerebrolysin should not be used during pregnancy unless a

Treatment with Cerebrolysin is required based on the clinical condition of the woman.

Breastfeeding

A decision must be made as to whether or not to discontinue breastfeeding

the treatment with Cerebrolysin should be waived / the treatment with Cerebrolysin too

interrupt is. This includes both the benefit of breastfeeding for the child and the benefit of the

Therapy for the woman to be considered.

4.7

Effects on ability to drive and use machines

Cerebrolysin

- parenteral solution

February 2016

The clinical trials carried out do not suggest any extension of the reaction times,

however, the ability to use machines or drive is impaired

Motor vehicles cannot be ruled out, so these activities should not be carried out.

4.8

Side effects

The following side effects were reported with the following during treatment with Cerebrolysin

Frequencies of occurrence observed and reported:

Very common (≥ 1/10)

Common (≥ 1/100 to <1/10)

Uncommon (≥ 1 / 1,000 to <1/100)

Rare (≥ 1 / 10.00 to <1 / 1,000)

Very rare (<1 / 10,000)

System organ class

frequency

side effect

Diseases of

Immune system

Very rare

Allergic or hypersensitivity reactions, such as

Tingling, skin and local vascular reactions, neck,

Headache and body aches, fever, light

Back pain, dyspnoea, and chills

shock-like condition.

Metabolic and

Nutritional disorders

Rare

Loss of appetite

Psychiatric

Diseases

Rare

The desired drive-boosting effect was achieved

also with agitation (aggressiveness, confusion,

Insomnia).

Rare

If applied too quickly, dizziness may occur.

Diseases of

Nervous system

Very rare

Single grand mal seizures and a case of

Convulsion was related to cerebrolysin

brought.

Heart disease

Very rare

If applied too quickly, it can in individual cases to

Palpitations Arrhythmia coming.

Diseases of

Gastrointestinal tract

Very rare

Dyspepsia, diarrhea, constipation, vomiting,

nausea

Skin disorders

and des

Subcutaneous tissue

Rare

If the injection is too rapid, it can cause a

moderate feeling of heat rsp. Sweat come on.

Pruritus

General

Diseases and

Complaints at

Administration site

Very rare

Local reactions at the application site were shown in

Observed isolated cases, such as reddening of the skin, and itching

Burn.

In one study, rare cases were found in connection with a cerebrolysin application

(> 1 / 10,000; <1 / 1,000) of hyperventilation, hypertension, hypotension, fatigue, tremor, depression,

Apathy rsp. Drowsiness and flu-like symptoms (cold, cough, infection of the

Respiratory tract).

Since Cerebrolysin is used in the elderly, it is the ones listed above

Symptoms mostly around ailments that are typical for this age group and over and over again

reported even without medication.

Reporting suspected side effects

Reporting suspected side effects after approval is of great importance. you

enables continuous monitoring of the benefit-risk balance of the medicinal product.

Healthcare professionals are encouraged to report any suspected adverse reactions to the

Cerebrolysin

- parenteral solution

February 2016

Federal Office for Safety in Health Care, Traisengasse 5, 1200 Vienna, Fax: + 43 (0) 50 555

36207, website: http://www.basg.gv.at/.

4.9

Overdose

So far there have been no health problems from overdosing or intoxication

known. There is no specific antidote. If necessary, it is symptomatic too

therapy.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Cerebrolysin supports and helps regeneration after stroke and traumatic brain injury

by minimizing the consequential damage. Stroke patients particularly benefit in the

first weeks of faster regeneration. In patients with traumatic brain injuries leads

Cerebrolysin to improve the level of consciousness as well as the memory and

Attention performance. In dementia, Cerebrolysin acts the progressive neurodegenerative

Counteracts changes, thereby achieving a symptomatic increase in cognitive performance

becomes. An improvement in the overall clinical impression in the early and advanced phases

the disease is also achieved.

At the experimental level, cerebrolysin shows decreased cognitive levels in animal models

Performance, such as B. in dementia or after traumatic brain injury, influence on the

synaptic plasticity and improved learning behavior. Decreased in cerebral ischemia models

Cerebrolysin the infarct volume, reduces the formation of edema, stabilizes microcirculation

and normalizes the neurological deficits and learning deficits caused by the lesion. Next

its direct effect on neurons, cerebrolysin also increases the number of glucose

Transporter molecules in the blood-brain barrier clearly and thus resembles pathological

Energy deficiencies. Positive effects of cerebrolysin on the pathologically disturbed oxidative

Metabolism showed up in an increased resistance to hypoxic conditions as well

a decrease in cerebral lactate concentration.

5.2

Pharmacokinetic properties

The proteolytic peptide fraction from porcine brain protein consists of short-chain biological ones

Peptides similar or identical to those that are endogenous. A direct measurement of pharmacokinetics

Parameter cannot therefore be carried out. Indirect pharmacokinetic data were based on the

Based on the pharmacodynamic profile of cerebrolysin. Accordingly, up to

A neurotrophic effect of cerebrolysin in the blood plasma 24 hours after a single dose

be detected.

Furthermore, components of cerebrolysin can cross the blood-brain barrier. Preclinical in vivo

Experiments showed identical results after intra-cerebroventricular or peripheral use

pharmacodynamic effects on the central nervous system. This is considered indirect evidence,

that components of cerebrolysin cross the blood-brain barrier.

5.3

Preclinical safety data

Based on conventional studies of safety pharmacology, chronic toxicity,

Reproductive toxicity, mutagenicity and carcinogenicity were found for use in humans

no particular risk.

6.

PHARMACEUTICAL DATA

Cerebrolysin

- parenteral solution

February 2016

6.1

List of excipients

Sodium hydroxide and water for injections.

6.2

Incompatibilities

Cerebrolysin is incompatible with solutions that shift the pH value (5.0 - 8.0) and with

lipid-containing solutions.

The simultaneous administration of vitamins and the necessary cardiovascular drugs is

possible, but not in a mixed syringe.

6.3

Duration of shelf life

Ampoule (1, 2, 5, 10 and 20 ml): 48 months

Piercing ampoule (20, 30 and 50 ml): 24 months

6.4

special precautions for storage

Do not store above 25ºC.

Do not store or freeze in the fridge.

Store in the original package in order to protect from light

For storage conditions of the medicinal product, see section 6.3.

6.5

Nature and content of the container

1 ml:

10 ampoules and 50 ampoules

2 ml:

10 ampoules

5 ml:

5 ampoules and 50 ampoules

10 ml:

5 ampoules, 10 ampoules, 15 ampoules and 50 ampoules

20 ml:

5 ampoules

20 ml:

5 ampoules and 20 ampoules

30 ml:

5 ampoules and 20 ampoules

50 ml:

5 ampoules and 20 ampoules

Not all pack sizes may be marketed.

6.6

Special precautionary measures for disposal and other instructions for handling

When using venous cannulas that have been in place for a longer period of time, this should be done before and after

Cerebrolysin infusion can be flushed with physiological sodium chloride solution.

For one-time removal only.

Use only clear and amber solutions.

Any unused quantities must be disposed of immediately and in accordance with local requirements.

7.

MARKETING AUTHORIZATION HOLDER

EVER Neuro Pharma GmbH, A-4866 Unterach

Tel .: + 43-7665-20555-0

Fax: + 43-7665-20555-910

[email protected]

8.

APPROVAL NUMBER (S)

Cerebrolysin

- parenteral solution

February 2016

1-21380

9.

DATE OF FIRST AUTHORIZATION / RENEWAL OF THE AUTHORIZATION

Date of issue of approval: 25.03.1996

Date of the last renewal of the approval: 25.03.2001

10.

STATE OF INFORMATION

February 2016

11.

Prescription requirement / pharmacy requirement

Rp, subject to pharmacy