» Pt lip 08, 2022 17:12
Re: Kot nerkowy dla początkujących: wydanie 2, najnowsze
Znalazlam w necie specyfikacje tego stenofundinu. Pisza, ze ze wgledu na jego pH nie powinien byc podawany podskornie.
SUMMARY OF PRODUCT CHARACTERISTICS
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Sterofundin ISO B. Braun Vet Care
Solution for infusion for cattle, horse, sheep, goat, pig, dog and cat
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 000 ml of solution for infusion contains
Sterofundin ISO B. Braun Vet Care
Infusionslösung für Rinder, Pferde, Schafe, Ziegen, Schweine, Hunde und Katzen (AT/DE)
Isofundin solución para perfusión para bovino, caballos, ovino, caprino, porcino, perros y gatos (ES)
Isofundin solução para perfusão para bovinos, equinos, ovinos, caprinos, suínos, cães e gatos (PT)
Sodium chloride
Potassium chloride
Magnesium chloride hexahydrate Calcium chloride dihydrate Sodium acetate trihydrate L-Malic acid (E296)
Electrolyte concentrations: Sodium
Potassium
Magnesium
Calcium Chloride Acetate Malate
6.80 g 0.30 g 0.20 g 0.37 g 3.27 g 0.67 g
145.0 mmol/l 4.0 mmol/l 1.0 mmol/l 2.5 mmol/l
127.0 mmol/l 24.0 mmol/l 5.0 mmol/l
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless aqueous solution Theoreticalosmolarity 309mOsm/l pH 5.1 – 5.9
4. CLINICAL PARTICULARS 4.1 Target species
Cattle, horse, sheep, goat, pig, dog, cat.
4.2 Indications for use, specifying the target species
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Dog and cat: Correction of hypotonic and isotonic dehydration, for fluid and electrolyte replacement under the conditions of undisturbed acid-base balance or mild acidosis.
Cattle, horse, sheep, goat and pig: Correction of hypotonic and isotonic dehydration and for fluid and electrolyte replacement under the conditions of undisturbed acid-base balance.
All target species: Short term intravascular volume replacement.
4.3 Contraindications
Do not use in:
Metabolic alkalosis
Oedema, associated with decompensated heart failure and renal/hepatic insufficiency Severe renal insufficiency with oliguria or anuria
Hyperkalaemia, Hypernatremia
Hypertonic dehydration
Addison’s disease
4.4 Special warnings for each target species
None
4.5 Special precautions for use
Special precautions for use in animals
Before administering this solution the clinical and biological data of the animal have to be carefully examined.
Serum electrolyte status should be monitored in case of electrolyte imbalances, such as hypertonic or hypotonic dehydration, or a single increase of one electrolyte (e.g. hyperchloremia). In addition, the water balance (hydration) and acid base balance should be monitored during the administration of the solution.
Use with caution in congestive heart failure, renal insufficiency and in animals treated with corticoids and their derivatives.
Due to the potassium content of this solution it should be used prudently in severe renal impairment. [size=150]Due to the pH of the product it should not be administered subcutaneously.[/size]
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Special precautions to be taken by the person administering the veterinary medicinal product to animals
Not applicable
4.6 Adverse reactions (frequency and seriousness)
This veterinary medicinal product contains calcium, thus an effect on the heart cannot be ruled out. The risk increases if the solution is administered too quickly.
Adverse effects such as local pain or reactions, venous irritation, venous phlebitis, thrombosis or extravasation may occur.
Occasional cases of hypersensitivity reactions in the form of urticaria have been reported in connection with intravenous administration of magnesium salts.
4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy or lactation. Use only according to the benefit-risk assessment by the responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
None known
4.9 Amounts to be administered and administration route
Intravenous use.
General guidance for fluid intake:
The volume and rate of infusion depends on the clinical condition, existing hydration deficits of the animal, maintenance needs and continuing losses and should be determined under the supervision of the responsible veterinarian for specific case.
Maintenance requirements for adult animals
Body weight (kg)
< 5 5-20 20-100 > 100
In cats:
Maintenance volume ml/kg body weight/day 120-80
80-50
50-30 30-10
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1-8 80-50 Maintenance requirements for small ruminants
Maintenance fluid requirements for small ruminants can be estimated using the following general guidelines:
- Adults: 50 ml/kg body weight/day
- Neonates: 70 to 80 ml/kg body weight/day
Estimation of dehydration grade:
Degree of dehydration (% kg body weight) Slight (4 – 6%) Moderate (6 – 8%) Severe (>8%)
Volume deficit
(ml/kg body weight/day) 40-60
60-80
>80 (-120)
The degree of dehydration can also be calculated as follows:
Degree of dehydration [%] x kg body weight x 10 = ml of volume substitution
Infusion rate:
It is generally recommended to adjust the infusion rate according to fluid deficiency.
Half of the patient's calculated fluid deficit should be replaced within 6 hours, three quarters within 24 hours. The complete deficit should be replaced within 48 hours.
In general, 5 to 10 ml/kg body weight/h should not be exceeded for long-term intravenous infusion therapy.
Maximum infusion rate:
High infusion rates should only be used for resuscitation of animals in shock, only for a short period of time (20 to 30 minutes), and in the absence of pulmonary, renal or cardiac dysfunction.
The maximum infusion rate for the target species is provided in the following table:
Target species
Clinical response of the animal rather than equations should be used to establish fluid therapy. In some cases increasing infusion rates above these values may be required.
Rate of fluid administered over a period of 10-15 minutes
should not exceed 80 ml/kg/h 40 ml/kg/h
20 to 45 ml/kg/h
80-90 ml/kg/h
45-60 ml/kg/h
For small ruminants and pigs the maximum infusion rate should be individually calculated.
Calf Cattle Horse Dog Cat
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Animals should be monitored closely for signs of hyperhydration (mainly pulmonary oedema) and the rapid administration of fluids should be discontinued when the patient is improving.
Fluid therapy and maximum infusion rates in paediatric animals should be adapted to the individual requirements established by the treating veterinarian.
IV fluids should be warmed up to body temperature prior to administration. Maintain aseptic precautions throughout administration.
Do not use if container or closure is damaged.
For single use only.
Solutions containing visible solid particles and/or showing discoloration should not be administered.
4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary
Overdose may result in cardiovascular overload and pulmonary oedema, which can lead to following symptoms such as restlessness, coughing and polyuria.
Too large volumes or too rapid infusion rates of Sterofundin ISO may lead to electrolyte and acid-base imbalances. Fluid and sodium overload, hyperkalemia, hypermagnesemia, acidification of the blood due to overdose of chloride salts, metabolic alkalosis as a result of overdose of acetate and malate, and hypercalcemia and associated clinical signs may occur.
In case overdose has occurred the rate of infusion should be drastically reduced or the infusion should be stopped.
4.11 Withdrawal period(s)
Cattle, horse, sheep, goat, pig: Meat and offal: zero days
Cattle, horse, sheep, goat: Milk: zero hours
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: I.V. Solutions affecting the electrolyte balance/electrolytes ATC vet code: QB05BB01.
5.1 Pharmacodynamic properties
The veterinary medicinal product is administered to prevent dehydration and to correct acid-base, fluid and electrolyte abnormalities in different clinical conditions. The electrolytes Na+, K+, Ca2+, Mg2+, are indispensable for the maintenance and correction of fluid and electrolyte homeostasis while the anion pattern represents a balanced combination of chloride, acetate, and malate which counteracts metabolic acidosis. All substrates are occurring during normal physiological metabolism.
5.2 Pharmacokinetic particulars
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Absorption and distribution
Due to intravenous administration the bioavailability of the active substances is 100%.
The electrolytes are transferred to their respective electrolyte pools in the body. Sodium and chloride mainly distribute in the extracellular space, whereas the preferential distribution of potassium, magnesium and calcium is intracellular.
Biotransformation
Electrolytes are not metabolised in the strict sense. Malate and acetate are oxidised via the Krebs Cycle to carbon dioxide and water.
Elimination
The kidneys are the main route of excretion for sodium, potassium, magnesium, and chloride but small amounts are lost via the skin and intestinal tract.
Calcium is excreted in approximately equal amounts in urine and endogenous intestinal secretion. Acetate and malate excretion in urine rises during the infusion. However, their metabolism by body tissues is so rapid that only a small fraction appears in urine.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for injections
Sodium hydroxide (for pH adjustment)
6.2 Major incompatibilities
This veterinary medicinal product is incompatible with tetracycline and amphotericin B, because of the risk of forming chelate complexes with Ca2+.
Mixing this product with solutions containing phosphates, carbonates, sulphates or tartrates may lead to precipitation.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Do not administer together with blood or through infusion sets that have been used or may be used for administration of blood, since the possibility of developing agglutination and hemolysis exists.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale (polyethylene bottles): 3 years Shelf life after first opening the immediate packaging: use immediately.
Dispose of any unused product.
6.4. Special precautions for storage
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Do not refrigerate or freeze.
6.5 Nature and composition of immediate packaging
Low density polyethylene bottles of 250, 500 and 1000 ml of capacity.
The additional closure cap on top of the sealed polyethylene container is made from high density polyethylene. Between the container and the closure cap an elastomeric latex free disk is placed.
Pack sizes:
Cardboard boxes containing: 10 x 250 ml
10 x 500 ml
10 x 1000 ml
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany
<{Tel.}> <{Fax}> <{E-mail}> Postal address: 34209 Melsungen Germany
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
<Date of first authorisation:> <{DD/MM/YYYY}><{DD month YYYY}.> <Date of last renewal:> <{DD/MM/YYYY}> <{DD month YYYY}.>
10 DATE OF REVISION OF THE TEXT
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<{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
PROHIBITION OF SALE, SUPPLY AND/OR USE
<Not applicable.>
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