To Saul Medrolum time. and rast. for solution for infection. 500 mg fl. + rastvo. fl. 7.8 ml No. 1 ***

To Saul Medrolum is an injection form of Methylprednisolonum (synthetic GKS) for intramuscular and intravenous administration. This high-strong solution is suitable, in particular, for treatment of morbid conditions at which it is necessary effective and fast effect of hormone. Methylprednisolonum renders strong anti-inflammatory, immunosuppressive and antiallergic action.

Use to Saul Medrolum should be considered only as exclusively symptomatic treatment, except for separate endocrine disorders when they are applied as replacement therapy.

Anti-inflammatory treatment.

Rheumatic diseases.

As auxiliary therapy for short-term use (to help the patient to endure a sharp episode or aggravations) in the following diseases:

• posttraumatic osteoarthrosis;
• a synovitis in an osteoarthritis;
• a pseudorheumatism, in particular a juvenile pseudorheumatism (in some cases can be required maintenance therapy by a low dose)
• an acute and subacute bursitis,
• an epicondylitis;
sharp nonspecific tendosinoviit
• ;
• acute gouty arthritis
• psoriasis arthritis
• ankylosing spondylitis.
• Collagenose (system diseases of connective tissue).

during aggravation or as maintenance therapy in some cases in such diseases, as:

• system lupus erythematosus (and lupoid nephrite);
• acute rheumatic carditis;
• system dermatomyositis (polymiositis)
• nodular periarteritis;
• Gudpascher's syndrome.
• Dermatological diseases:
• pukhirchatka;
• heavy multiformny erythema (Stephens-Johnson's syndrome)
• exfoliative dermatitis
• bulyozny gerpetiformny dermatitis;
• heavy seboreyny dermatitis;
• heavy psoriasis;
• fungoid mycosis;
• small tortoiseshell.
• Allergic states.

Control of serious or disabling allergic conditions which do not respond due carried out to traditional treatment, in such diseases as:

• bronchial asthma;
• contact dermatitis
• atopic dermatitis
• a serum disease,
• seasonal or year-round allergic rhinitis
• reaction of hypersensitivity to medicines;
• a small tortoiseshell
• an acute non-infectious laryngeal edema (medicine of the first choice is epinephrine).
• Ophthalmologic diseases.

Heavy acute and chronic allergic and inflammatory processes in an eye, in particular:

• internally Herpes zoster form;
• iritis, iridocyclitis;
• chorioretinitis,
• diffusion back uveitis and horioide;
• optic neuritis
• sympathetic ophthalmia;
• inflammation of an average segment of an eye;
• allergic conjunctivitis
• allergic ulcers of edge of a cornea
• keratitis.
• Disease of digestive tract.

Critical periods in the following diseases:

• ulcer colitis (system therapy);
• regional enteritis (system therapy).
• Respiratory diseases:
• sarcoidosis of lungs;
• a berylliosis,
• fulminantny or a disseminate pulmonary tuberculosis, at simultaneous use with the corresponding antitubercular chemotherapy;
• Leffler's syndrome which is not responding to treatment by other means;
• aspiration pneumonitis;
• an average and severe form of the pneumonia caused by Pneumocystis carinii at patients with AIDS (as auxiliary therapy within the first 72 hours of a protipnevmotsistnoa of therapy)
• exacerbation of a chronic obstructive disease of lungs.
• State, followed by hypostases.

For induction of a diuresis or remission in a proteinuria at a nephrotic syndrome, a proteinuria without uraemia.

Treatment of hematologic and oncological diseases.

• Hematologic diseases:
• acquired (autoimmune) hemolytic anemia
• an idiopathic Werlhof's disease of adults (only intravenously intramusculary use is contraindicated)
• secondary thrombocytopenia of adults,
• an eritroblastopeniye (erythrocyte anemia);
• congenital (erythroidal) hypoplastic anemia;
• Oncological diseases.

Palliative treatment of such diseases, as:

• leukoses and lymphoma at adults,
• an acute leukosis at children
• for improvement of quality of life of patients with an end-stage of a cancer disease.

Endocrine disorders.

• Primary or secondary insufficiency of bark of adrenal glands.
• Acute insufficiency of bark of adrenal glands.

At these indications medicaments of the choice are the hydrocortisone or a cortisone. Under certain circumstances it is possible to apply synthetic analogs in a combination from mineralokortikoida.

• Treatment of shock states: shock owing to insufficiency of bark of adrenal glands or shock which does not answer traditional treatment in case of the confirmed or expected insufficiency of bark of adrenal glands (all medicament of the choice is the hydrocortisone). If mineralokortikoidny effects are undesirable, can be preferred Methylprednisolonum.
• Before surgical intervention and in case of a severe injury or a disease at patients from the bark of adrenal glands established by insufficiency or in the presence of doubts in a reserve of bark of adrenal glands.
• Congenital adrenal hyperplasia.
• Not purulent thyroiditis.
• Hypercalcemia connected with a malignant new growth.

Structure

Active ingredient: methylprednisolone;

1 bottle contains 125 mg of Methylprednisolonum in the form of succinate sodium Methylprednisolonum;

Excipients: sodium dihydrophosphate monohydrate, sodium phosphate anhydrous

Solvent for dosing: water for injections.

Contraindication

System fungal infections.

Hypersensitivity to Methylprednisolonum or to any of the excipients specified in the section "Structure".

Route of administration

Solution of Methylprednisolonum of sodium of succinate can be entered by means of an intravenous or intramuscular injection or by infusion. When rendering primary emergency aid preference is given to use in the form of an intravenous injection (see Table 1 for obtaining information about recommended doses). The dose for babies and children can be reduced, however more it is necessary to be guided by weight of a state and the response of the patient to treatment, but not its age or body weight. The dose has to make not less than 0.5 mg/kg of body weight each 24 hours.

At an idiopathic Werlhof's disease of adults medicament is used only intravenously (intramuscular use is contraindicated).

Dose needs to be reduced or cancelled gradually if the medicament was administered more than several days. If in a chronic disease there is a spontaneous remission, treatment needs to be stopped. During long therapy it is necessary to carry out periodically ordinary laboratory researches, in particular the analysis of urine, determination of level of sugar in blood through 2:00 after a meal and also to control indicators of arterial blood pressure and body weight, to carry out a X-ray analysis of bodies of a thorax. At patients with ulcers in the anamnesis or the profound dyspepsia it is desirable to carry out a X-ray analysis of upper parts of a GIT. In case of the sudden termination of long-term treatment it is also necessary to make medical observation. For introduction in the form of intravenous (or intramuscular) injections prepare solution according to the instruction.

Instruction for use of medicament in dvoyemnisny a bottle like Act-O-Vial.

• is Pressed the plastic activator that solvent arrived in the lower capacity.
• is Carefully shaken up to mix solution.
• Remove a plastic plate which covers the center of a stopper.
• will sterilize the released part of a rubber bung.
• Enter a needle (it is desirable 22G in size) vertically through the center of a stopper until its tip becomes visible. Overturn a bottle and gather the necessary medicament dose. If use thicker needle, it is important to avoid an inclination of a needle and to enter it perpendicularly into the center of a rubber bung.

Instruction for use of medicament in a bottle complete with solvent.

In aseptic conditions add solvent to a bottle with sterile powder. Apply only special solvent.

to gather medicament from a bottle see the Paragraph 5 "Instructions for Use of Drug in Dvoyemnisny a Bottle like Act-O-Vial" concerning the size of a needle which is desirable for using.

Preparation of perfused solutions.

restored solution according to the instruction. Therapy can be begun, having entered succinate sodium Methylprednisolonum solution for not less than 5 minutes (a dose to 250 mg inclusive) and within at least 30 minutes (the doses exceeding 250 mg). The subsequent doses can be gathered and entered similarly. If it is necessary, medicine can be entered in weak solutions by means of mixing of the restored medicament from 5% glucose solution in water, normal saline solution, 5% glucose solution into 0.45% or 0.9% of sodium of chloride. The received solutions physically and chemically stable within 48 hours.

Any unused residues of medicine or waste should be utilized according to requirements of the local legislation.

Feature of use

Pregnancy

Some researches on animals showed that corticosteroids at introduction during pregnancy in high doses can cause fruit malformations. However corticosteroids do not attract development of congenital anomalies at use by pregnant women. Despite results of researches on animals, the risk of defeat of a fruit is low in case of use of medicament during pregnancy. In the absence of adequate researches of effect of medicament on the reproductive system of the person and pre-natal development of a fruit, sodium Methylprednisolonum succinate should be applied during pregnancy only after careful estimation a ratio advantage / risk to mother and a fruit. If long-term treatment by corticosteroids has to be stopped during pregnancy (as well as other long methods of treatment), it has to occur gradually (see. Also "Route of administration and doses").

Corticosteroids easily cross a placental barrier. In some retrospective researches the increase in frequency of the birth of children with low body weight at mothers receiving corticosteroids was observed. At people the risk of low body weight of newborns depends on a medicament dose. This risk can be minimized by use of low doses of corticosteroids. In spite of the fact that insufficiency of adrenal glands meets seldom at newborns who were exposed to pre-natal influence of corticosteroids, it is necessary to make careful observation and assessment of a condition of the babies who were affected by essential doses of corticosteroids on identification of signs of insufficiency of adrenal glands. Influence of corticosteroids on pains and childbirth it is unknown.

Feeding by a breast

Corticosteroids, including Prednisolonum, get into breast milk. This medicine should be applied during feeding by a breast only after careful estimation a ratio advantage / risk to mother and the baby.

Benzyl alcohol can get through a placental barrier.

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Ability to influence speed of response at control of motor transport or other mechanisms

Though disorders of vision belongs to rare side reactions, to patients who run vehicles and/or work with other mechanisms, it is necessary to be careful.

Overdose

does not exist a clinical syndrome of acute overdose of Methylprednisolonum of sodium of succinate. Chronic the overdose causes characteristic symptoms of a syndrome of Cushing. Methylprednisolonum is removed by dialysis.

Side reactions

system side reactions. In spite of the fact that they seldom arise at very short-term therapy, it is always necessary to watch them carefully. It is a part of supervision at any of corticosteroids and concerns not only specific drug. Possible side reactions on glucocorticoids, in particular Methylprednisolonum, include:

Interaction with other medicines and other types of interactions

to avoid problems with compatibility and stability, sodium Methylprednisolonum succinate it is recommended to enter separately from other connections applied century. Belong to medicines which are characterized by physical incompatibility from sodium Methylprednisolonum succinate in solution (the list is not exhaustive): sodium Allopyrinolum, docsaprama hydrochloride, taygetsiklin, diltiazem hydrochloride, calcium gluconate, vekuroniya bromide, rokuroniya bromide, tsizatrakuriya bezilat, glycopyrolat, propofol.

to Store

out of children's reach.

to Store

at a temperature not above 25 °C.

Prepared solution can be stored at the room temperature no more than 12 hours.

Expiration date - 2 years.