Document: Ringer-Acetat Baxter Viaflo solution for infusion ENG SmPC change

• Ringer-Acetat Baxter Viaflo solution for infusion SmPC
• Ringer-Acetat Baxter Viaflo solution for infusion ENG SmPC

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1. Name of the Medicinal Product

Ringer-Acetat Baxter Viaflo solution for infusion.

2. Qualitative and Quantitative Composition

1000 ml contains: 5.86 g Sodium Chloride

0.30 g Potassium Chloride

0.29 g Calcium Chloride dihydrate

0.20 g Magnesium Chloride hexahydrate

4.08 g Sodium Acetate trihydrate

Na⁺ K⁺ Ca⁺⁺ Mg⁺⁺ Cl^- C₂H₃O₂^-(acetate)

mmol/l 130 4 2 1 110 30

mEq/l 130 4 4 2 110 30

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Solution for infusion.

Clear solution, free from visible particles.

277 mOsm/l (approx.)

pH: 5.0 – 6.0

4. Clinical Particulars

4.1. Therapeutic indications

4.2. Posology and Method of Administration

The dosage and rate of administration depend on the age, weight, clinical and biological (acid-base balance) conditions of the patient and concomitant therapy.

Recommendeddosage:

The amount of Ringer-Acetat Baxter Viaflo solution needed to temporary restore blood volume is 3 to 5 times the volume of lost blood.

The recommended dosage for longer treatment is:

• for adults, the erderly and adolescents (age 12 years and over): 500 ml to 3 litres/24h.

• for babies and children (from 28 days to 11 years of age): 20 ml/kg to 100 ml/kg/24h.

Administrationrate:

The infusion rate is usually 40 ml/kg/24h in adults.

In paediatric patients the infusion rate is 5 ml/kg/h in average but the value varies with age: 6-8 ml/kg/h for infants, 4-6 ml/kg/h for toddlers, and 2-4 ml/kg/h for schoolchildren.

Method of administration:

The administration is performed by intravenous route.

Due to its iso-osmolality, this solution can be administered through a peripheral vein.

Use only if the solution is clear, without visible particles and if the container is undamaged. Administer immediately following the insertion of infusion set.

Do not remove unit from overwrap until ready for use.

The inner bag maintains the sterility of the product.

Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration. Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system.

Additives may be introduced before infusion or during infusion through the injection site.

For instructions on preparing the product for administration, see section 6.6.

4.3. Contra-indications

Extracellular hyperhydration or hypervolemia.

4.4. Special warnings and precautions for use

High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure, in patients presenting oedema, ascitic cirrhosis or renal insufficiency.

The patient's clinical status and laboratory parameters (fluid balance, blood and urine electrolytes as well as acid-base balance) must be monitored during use of this solution. The plasma electrolyte levels such as natraemia, chloraemia, kalaemia, magnesaemia, calcaemiamust be closely monitored.

Solutions containing sodium chloride should be carefully administered to patients with hypertension, heart failure, peripheral or pulmonary oedema, impaired renal function, pre-eclampsia, aldosteronism, or other conditions associated with sodium retention (see also in 4.5 “Interactions with other medicinal products and other forms of interaction”).

Solutions containing potassium salts should be administered with caution to patients with cardiac diseases or conditions that can lead to hyperkalaemia such as renal or adrenocortical insufficiency, acute dehydration, or extensive tissue destruction as occurs with severe burns (see also in 4.5 “Interactions with other medicinal products and other forms of interaction”).

Although Ringer-Acetat Baxter Viaflo has a potassium concentration similar to the concentration in plasma, it is insufficient to produce a useful effect in case of severe potassium insufficiency and therefore it should not be used for this purpose.

Calcium chloride is irritant, therefore care should be taken to prevent extravasation during intravenous injection. Solutions containing calcium should be given cautiously to patients with impaired renal function, or disease associated with elevated vitamin D concentrations such as sarcoidosis or to patients receiving digitalic therapy (see also in 4.5 “Interactions with other medicinal products and other forms of interaction”). In case of concomitant blood transfusion and because of the presence of calcium, Ringer-Acetat Baxter Viaflo must not be administered via the same infusion system because of the risk of coagulation.

Solutions containing magnesium salts should be used with caution to patient with renal impairment, severe heart rate disorders and in patients with myasthenia gravis. Patients should be monitored for clinical signs of excess magnesium, particularly when being treated for eclampsia (see also in 4.5 “Interactions with other medicinal products and other forms of interaction”).

Administration in the postoperative period after neuromuscular block should be used with caution since magnesium salts can lead to a recurarisation effect.

Infusion of Ringer-Acetat Baxter Viaflo may cause metabolic alkalosis because of the presence of acetate ions however, it is not suitable to treat severe metabolic or respiratory acidosis.

During long-term parenteral treatment, a convenient nutritive supply must be given to the patient.

4.5. Interaction with other medicinal products and other forms of interaction

Suxamethonium and potassium, when administered concomitantly, may result in considerable hyperkalaemias, thereby intensifying their negative effects on cardiac rhythm. Magnesium salts may potentiate the effect of depolarising neuromuscular blocker such as suxamethonium, vecuronium or tubocurarine. Therefore, concomitant administration of Ringer-Acetat Baxter Viaflo and drugs containing the above mentioned substances, is not recommended.

The effect on potassium and/or sodium retention of certain drugs should be considered such as: Corticoids/Steroids, Potassium-sparing diuretics, Angiotensin converting enzyme inhibitors (ACEi), Tacrolimus, Cyclosporin.

Calcium increases the risk of toxic effects of digitalis glycosids.

Alkalisation of the urine by bicarbonate resulting from acetate metabolism, will increase the elimination of certain drugs (such as kinidin, salicylates, lithium) and will decrease elimination of sympathomimetics (such as amfetamin).

4.6. fertility, Pregnancy and lactation

Ringer-Acetat Baxter Viaflo can be used during pregnancy and lactation.

4.7. Effects on the ability to drive and use machines

Not applicable.

4.8. Undesirable effects

During administration of Ringer-Acetat Baxter Viaflo, the following undesirable effects have been reported as:

System Organ Class	Very Common (>1/10)	Common (>1/100, <1/10)	Uncommon (>1/1000, <1/100)	Rare (>1/10000, <1/1000)	Very rare (<1/10000)
Immune system disorders	-	-	-	Hypersensitivity reactions, allergic reactions or anaphylactic/anaphylactoid symptoms	-
Metabolism and nutrition disorders	-	Overhydration	-	-	Electrolyte disturbances
Nervous system disorders	-	-	-	-	Seizure that may be precipitated by the alkalosis induced by acetate
Cardiac disorders	-	Heart failure in patient with cardiac disorder	-	Tachycardia, bradycardia	-
Respiratory, thoracic and mediastinal disorders	-	Pulmonary oedema	-	-	-
General disorders and administration site conditions	-	Febrile reaction, infection at the site of injection, local pain or reaction, vein irritation, venous thrombosis or phlebitis extending from the site of injection, extravasation,	-	Chest tightness, chest pain.	-
Skin and subcutaneous tissues disorders	-	-	-	Localized or generalized urticaria such as, skin rash & erythema and itching/pruritis	-

Adverse reactions may be associated to the medications added to the solution.

4.9. Overdose

Overdosage can lead to hyperhydration with tightened skin, venous stasis, oedema – possibly also lung- or brain oedema, disturbed acid-base balance and electrolyte balance and serum hyperosmolarity.

Acute treatment

The infusion should be interrupted immediately. Administration of diuretics and continuous monitoring of serum electrolytes, correction of electrolyte balance and acid-base balance.

5. Pharmacological properties

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Electrolytes - ATC code: B05BB01

Ringer-Acetat Baxter Viaflo has approximately the same electrolyte composition as the extracellular fluid. The product is used for corrections of disturbances in the serum electrolyte balance and in the acid-base balance. Electrolytes are given to receive or to keep normal osmotic conditions in the extracellular as well as the intracellular compartment. Acetate is oxidized into bicarbonate, mainly in the muscles and peripheral tissues and gives a weak alkalising effect. Due to the amount of metabolisable anions, Ringer-Acetat Baxter Viaflo is suitable for patients with a tendency to acidosis.

5.2. Pharmacokinetic properties

The acetates in Ringer-Acetat Baxter Viaflo are metabolised by muscles and peripheral tissues to bicarbonate.

When medication is added to Ringer-Acetat Baxter Viaflo, the overall pharmacokinetics of the solution will depend on the nature of the drug used.

5.3. Preclinical safety data

There are no preclinical data considered relevant to clinical safety beyond data included in other sections of the SPC.

6. Pharmaceutical particulars

6.1. List of excipients

Water for Injections

Hydrochloric acid

6.2. Incompatibilities

Incompatibility of the medicinal product to be added with the solution in Viaflo container must be assessed before addition.

Ringer-Acetat Baxter Viaflo should not be mixed with products containing carbonates, sulfates or phosphates.

This solution must not be mixed with other medicinal products in the absence of compatibility studies.

The instruction for use of the medicinal product to be added must be consulted.

Before adding a drug, verify it is soluble and stable in water at the pH of Ringer-Acetat Baxter Viaflo (pH 5.0 to 6.0).

6.3. Shelf life

Shelf life as packaged:

18 months for 500 and 1000 ml bags

In-use shelf-life:

Chemical and Physical stability of any additive at the pH of Ringer-Acetat solution in the Viaflo container should be established prior to use.

From a microbiological point of view, the diluted product must be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C unless reconstitution has taken place in controlled and validated aseptic conditions.

6.4. Special Precautions for Storage

No special precautions for storage.

6.5. Nature and contents of containers

The bags known as Viaflo are composed of polyolefin/polyamide co-extruded plastic (PL 2442).

Bag sizes: 500ml and 1000ml

Outer carton contents: 20 bags of 500 ml

10 bags of 1000 ml

Not all pack sizes may be marketed

6.6. Special precautions for disposal and other handling

When additive is used, verify isotonicity prior to parenteral administration. Thorough and careful aseptic mixing of any additive is mandatory. Solutions containing additives should be used immediately and not stored.

Adding other medication or using an incorrect administration technique might cause the appearance of fever reactions due to the possible introduction of pyrogens. In case of adverse reaction, infusion must be stopped immediately.

Discard after single use.

Discard any unused portion.

Do not reconnect partially used bags.

1. Opening

a. Remove the Viaflo container from the overwrap just before use.

b. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution, as sterility is broken.

c. Check that the solution is clear and does not contain foreign particles . If so, discard the solution.

2. Preparation for administration

Use sterile material for preparation and administration.

a. Suspend container from eyelet support.

b. Remove plastic protector from outlet port at bottom of container:

- Grip the small wing on the neck of the port with one hand.

- Grip the large wing on the cap with the other hand and twist.

- The cap will pop off.

c. Use an aseptic method to set up the infusion.

3. Techniques for injection of additive medications

Note that additives may be incompatible.

To add medication before administration

a. Disinfect medication site.

b. Use a syringe with 19 gauge (1,10 mm) to 22 gauge (0,70 mm) needle. Puncture resealable medication port and inject.

c. Mix solution and medication thoroughly. For high-density medication such as potassium chloride, tap the ports gently while ports are upright and mix.

Caution: Do not store bags containing added medications.

To add medication during administration

a. Close clamp on the set.

b. Disinfect medication site.

c. Use a syringe with 19 gauge (1,10 mm) to 22 gauge (0,70 mm) needle. Puncture resealable medication port and inject.

d. Remove container from IV pole and/or turn to an upright position.

7. Marketing authoriSation holder

Baxter Medical Aktiebolag

Box 63

164 94 KISTA

Sweden

8. Marketing authoriSation number

20160

9. first AUTHORISATION / RENEWAL OF THE AUTHORISATION

2005-02-17/2010-02-17

10. DATE OF REVISION OF THE TEXT

2012-12-27