Composition, form of production and packaging
Lyophilizate for the preparation of a solution for IM and parabulbar injection in the form of a powder or a porous mass of white or white with a yellowish hue.
1 f.
complex of water-soluble polypeptide fractions of the retina of eyes of cattle 5 mg
[PRING] glycine - 17 mg (stabilizer).
22 g - vials with a capacity of 5 ml (5) - packings of cellular contour (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Stimulator of tissue repair. Retinalamine В® is a complex of water-soluble polypeptide fractions with a molecular mass of not more than 10 000 Da.
The drug has a stimulating effect on the photoreceptors and cellular elements of the retina, improves the functional interaction of the pigment epithelium and the outer segments of photoreceptors, glial cells in dystrophic changes, accelerates the restoration of the light sensitivity of the retina. Normalizes vascular permeability, reduces manifestations of local inflammatory reaction, stimulates reparative processes in diseases and traumas of the retina.
The mechanism of action of the drug Retinalamin В® is determined by its metabolic activity: the drug improves the metabolism of the eye tissues and normalizes the functions of cell membranes, improves intracellular protein synthesis, regulates the processes of lipid peroxidation, promotes the optimization of energy processes.
PHARMACOKINETICS
The composition of the drug Retinalamin В® , the active ingredient of which is a complex of polypeptide fractions, does not allow the usual pharmacokinetic analysis of its components.
INDICATIONS
- compensated primary open-angle glaucoma;
- diabetic retinopathy;
- central retinal dystrophy of inflammatory and traumatic genesis;
- central retinal dystrophy;
- myopic disease (as part of complex therapy);
- central and peripheral taperotorhinal abiotrophy;
- rhegmatogenous and traumatic retinal detachment (rehabilitation postoperative period as part of complex therapy).
DOSING MODE
Adults with diabetic retinopathy, central retinal dystrophy of inflammatory and traumatic genesis, central and peripheral taperotorinal abiotrophy - parabulbar or IM 5-10 mg 1 time / day. The course of treatment is 5-10 days; if necessary, repeat after 3-6 months.
With compensated primary open-angle glaucoma - parabulbar or IM in 5 mg 1 time / day.
In the rehabilitation postoperative period of rhegmatogenic and traumatic retinal detachment - parabulbarno 5 mg 1 time / day. The course of treatment is 10 days.
When myopic disease - parabulbarno 5 mg 1 time / day. The course of treatment is 10 days.
It is recommended in combination with angioprotective and group B vitamins.
The drug is dissolved in 1-2 ml of water for injection, 0.9% solution of sodium chloride or 0.5% solution of procaine (novocaine), directing the needle to the wall of the vial to avoid foaming.
Children aged 1-5 years with central dystrophy of the retina of inflammatory and traumatic genesis, central and peripheral taperotorhinal abiotrophy - parabulbarno or IM in 2.5 mg 1 time / day.
Children aged 6-18 years with central retinal dystrophy of inflammatory and traumatic genesis, central and peripheral taperotorhinal parabulbarno abiotrophy or in / m 2.5-5 mg 1 time / day.
The drug is dissolved in 1-2 ml of a 0.9% solution of sodium chloride, directing the needle to the wall of the vial to avoid foaming.
The course of treatment is 10 days; if necessary, repeat after 3-6 months.
SIDE EFFECT
There were no known side effects.
Allergic reactions are possible in case of individual hypersensitivity to the components of the drug.
CONTRAINDICATIONS
- age to 18 years - with compensated primary open-angle glaucoma, diabetic retinopathy, myopic disease, rhegmatogenous and traumatic retinal detachment (due to lack of data on efficacy and safety);
- age up to 1 year - with central retinal dystrophy of inflammatory and traumatic genesis, central and peripheral taperotorhinal abiotrophy;
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
The drug is contraindicated in pregnancy (there is no data on efficacy and safety).
If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued.
APPLICATION FOR CHILDREN
Contraindicated:
- at the age of 18 years - with compensated primary open-angle glaucoma, diabetic retinopathy (due to lack of data on efficacy and safety);
- at the age of up to 1 year - with central retinal dystrophy of inflammatory and traumatic genesis, central and peripheral taperotorhinal abiotrophy.
SPECIAL INSTRUCTIONS
Retinalamine В® should only be used as directed by a doctor.
The bottle with dissolved medicinal product can not be stored and used after storage.
Solution Retinalamin В® is not recommended to mix with other solutions.
Features of the drug at the first reception or when it is canceled are absent.
In the case of missed injections, it is not recommended to administer a double dose, but to carry out the next injection as usual on the target day.
Special precautions for the destruction of unused medications are not required.
Impact on the ability to drive vehicles and manage mechanisms
The drug does not affect the ability to drive vehicles and mechanisms.
OVERDOSE
No cases of drug overdose have been reported.
DRUG INTERACTION
Drug interaction of the drug Retinalamin В® is not described.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, protected from light at a temperature of 2 В° to 20 В° C. Shelf life - 3 years.
