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Solupred 62.5 mg

Summary of Product Characteristics in Summary of Product Characteristics Solupred 62.5 mg

1. Name of veterinary medicinal product:

Solupred 62.5 mg / ml,

Lyophilisate and solvent for solution for injection for dogs and cats

2. Qualitative and quantitative composition:

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Description

Summary of Product Characteristics in Summary of Product Characteristics Solupred 62.5 mg

1. Name of veterinary medicinal product:

Solupred 62.5 mg / ml,

Lyophilisate and solvent for solution for injection for dogs and cats

2. Qualitative and quantitative composition:

 

Packs of 187.14 mg lyophilisate and 2.0 ml solvent:

 

1 injection vial containing 187.14 mg lyophilisate contains :

Active ingredient (s):

Methylprednisolone hydrogen succinate 158.4 mg

(corresponding to 125 mg methylprednisolone)

 

Other ingredients:

For the full list of excipients, see section 6.1

 

1 injection bottle of solvent contains :

2.0 ml of water for injections.

Solupred 62.5 mg

Solupred 62.5 mg

Summary of Product Characteristics in Summary of Product Characteristics

1. Name of veterinary medicinal product:

Solupred 62.5 mg / ml,

Lyophilisate and solvent for solution for injection for dogs and cats

2. Qualitative and quantitative composition:

Packs of 187.14 mg lyophilisate and 2.0 ml solvent:

1 injection vial containing 187.14 mg lyophilisate contains :

Active ingredient (s):

Methylprednisolone hydrogen succinate 158.4 mg

(corresponding to 125 mg methylprednisolone)

Other ingredients:

For the full list of excipients, see section 6.1

1 injection bottle of solvent contains :

2.0 ml of water for injections.

Dissolve lyophilisate in 2.0 ml of enclosed solvent.

1 ml of the ready-to-use solution contains 62.5 mg of methylprednisolone.

Packs of 748.55 mg of lyophilisate and 7.8 ml of solvent:

1 injection bottle containing 748.55 mg lyophilisate contains:

Active ingredient (s):

Methylprednisolone hydrogen succinate 633.60 mg, corresponding to 500 mg methylprednisolone

Other ingredients:

For the full list of excipients, see section 6.1

1 injection bottle of solvent contains:

7.8 ml of water for injections.

Dissolve lyophilisate in 7.8 ml of enclosed solvent.

1 ml of the ready-to-use solution contains 62.5 mg of methylprednisolone.

Almost white lyophilisate and clear, colorless solvent.

The ready-to-use solution is a clear, colorless liquid.

3. Pharmaceutical form:

Lyophilisate and solvent for solution for injection.

4. Clinical Information:

4.1 Target species:

Dog Cat

4.2 Indications indicating the target species:

Solupred 62.5 mg / ml is indicated for the treatment of non-infectious inflammation and allergies as well as adjunctive therapy in animals with life-threatening conditions such as hemorrhagic / traumatic shock.

4.3 Contraindications:

Do not use if (applies in case of prolonged systemic use beyond emergency therapy):

Hypertension, fractures, poorly healing wounds and ulcers, immune deficiency, viral infections, septic processes, systemic mycoses, parasitic infections, glaucoma, Cushing’s syndrome and uremia.

None.

4.5 Special precautions for use:

Special precautions for use in animals:

Beware of acute infections. Glucocorticoid therapy may lead to more severe infections.

In case of prolonged systemic use beyond emergency therapy:

Treatment with glucocorticosteroids may result in suppression of skin reactions as part of a diagnostic intracutaneous allergy test.

For preparation of the solution for injection, only the enclosed solvent may be used.

Special precautions for the user:

If accidental self-injection occurs, seek medical advice immediately and show the package leaflet or label.

4.6 Adverse reactions (frequency and seriousness):

Especially with prolonged treatment typical for glucocorticoids side effects may occur.

Solupred 62.5 mg  Solupred 62.5 mg Solupred 62.5 mg Solupred 62.5 mg Solupred 62.5 mg

The occurrence of side effects after administration of Solupred 62.5 mg / ml should be reported to the Federal Office of Consumer Protection and Food Safety,4.7 Use during pregnancy, lactation or lay:

A repeat injection is possible. However, after initial treatment with Solupred 62.5 mg / ml, any further treatment of dogs or cats, if possible, should be carried out with an oral preparation.

For the treatment of shock events in dogs and cats :

Depending on the severity of the condition: 15-30 mg methylprednisolone / kg body weight (BW) intravenously, corresponding to 0.24-0.48 ml per kg BW.

4.11 waiting time (s):

Not applicable.

5. Pharmacological properties of Solupred 62.5 mg

Pharmacotherapeutic group: corticosteroid

ATCvet code: QH02AB04

5.1 Pharmacodynamic properties

5.2 Pharmacokinetic particulars:

In Solupred 62.5 mg / ml, the active ingredient is available in a water-soluble form (as the sodium salt). Methylprednisolone hydrogensuccinate,

6.Solupred 62.5 mg  Special precautions for the disposal of unused veterinary medicinal products or waste resulting from the application:

7. Authorization holder for Solupred 62.5 mg  : Solupred 62.5 mg Solupred 62.5 mg  Solupred 62.5 mg Solupred 62.5 mg Solupred 62.5 mg Solupred 62.5 mg Solupred 62.5 mg  Solupred 62.5 mg 

Solupred 62.5 mg  Solupred 62.5 mg  Solupred 62.5 mg

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