infusion solution

What Rener Acetate Fresenius Kabi is and what it is used for

Ringer’s acetate Fresenius Kabi contains electrolytes (salts) (sodium chloride, sodium acetate trihydrate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate). Ringer’s acetate Fresenius Kabi is used to treat fluid loss and electrolyte (salt) imbalance. Fluid loss and/or electrolyte imbalance can occur e.g. a surgery, injury, or burns. Ringer’s acetate Fresenius Kabi can also be used as a short-term treatment for reduced blood volume.

What you need to know before you are given Fringerius Kabi Ringer Acetate

Do not use Ringer’s acetate Fresenius Kabi

  • if you are allergic to sodium chloride, sodium acetate trihydrate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, or any of the other ingredients of this medicine (listed in section 6).
  • in premature infants and newborns (≤ 28 days of age): Your baby will not receive ceftriaxone (a type of antibiotic ) as a drip into a blood vessel at the same time as this medicine.
  • if you have too much fluid in areas around the body’s cells ( extracellular hyperhydration).
  • if you have a larger than normal amount of blood in your body ( hypervolemia ).

Warnings and cautions

Talk to your doctor or nurse before receiving Fringerius Kabi Ringer Acetate if:

  • you have pain or infection
  • you have heart and lung weight, heart disorders, high blood pressure or swelling
  • you have a liver disease 
  • you have impaired kidney function
  • you are pregnant and have had seizures associated with pregnancy poisoning
  • Your steroid hormone production is impaired
  • your fluid loss occurred suddenly or you have severe burns
  • you have a disease associated with elevated levels of vitamin D.
  • you suffer from a condition that can cause high levels of vasopressin, a hormone that regulates the fluid in your body, such as:
    • sudden and severe illness or injury
    • you have recently undergone surgery
    • brain disease
    • you are taking special medicines (see section Other medicines and Ringer’s acetate Fresenius Kabi). This can increase the risk of low sodium levels in your blood and can lead to headaches, nausea, cramps, lethargy, vomiting, and swelling of the brain. Brain swelling increases the risk of death and brain damage. People who are at higher risk of getting brain swelling are:
      • children
      • women of childbearing potential
      • people who have problems with their fluid levels in the brain, for example, due to meningitis, cerebral hemorrhage, or brain damage.
  • you have Myasthenia Gravis (MG), a disease that causes weakness in the skeletal muscles
  • you receive a blood transfusion (see section Other medicines and Ringer’s acetate Fresenius Kabi)
  • you have metabolic or respiratory acidosis (a condition in which acidic substances accumulate in the body).
  • you are treated with a special antibiotic called ceftriaxone, as it should not be mixed or given at the same time as calcium-containing solutions given to you as a drip into a vein. Your doctor will know about this and will not give them to you together, not even through different infusion tubes or at different infusion sites.
    • In patients older than 28 days, however, the doctor may give calcium and ceftriaxone consecutively if infusion tubes are used at different infusion sites, or if the infusion tubes are replaced, or rinsed thoroughly with a physiological saline solution between the infusions to avoid particle formation (precipitation). If you or your child have low blood volume, your doctor will avoid giving you calcium and ceftriaxone one after the other.

Other medicines and Ringer’s acetate Fresenius Kabi

Tell your doctor if you are taking, have recently taken, or might take any other medicines. 

  • You must tell your doctor if you are taking medicines that affect the hormone et vasopressin. These can be:
    • diabetes medicine (chloropropamide)
    • cholesterol drugs (clofibrate)
    • epilepsy drug (carbamazepine)
    • amphetamine-like drugs
    • certain cancer drugs (vincristine, ifosfamide, cyclophosphamide)
    • selective serotonin reuptake inhibitors (used to treat depression)
    • drugs for psychosis
    • opioid you for severe pain
    • medicines for pain and/or inflammation (also called NSAIDs)
    • drugs that are similar to or potentiate the effect of vasopressin such as desmopressin (used to treat increased thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to initiate labor)
    • other drugs that increase the risk of hyponatremia which also includes diuretics ( diuretics ) in general and epilepsy drugs such as. oxcarbazepine.
  • Blood should not be given through the same infusion set as Ringer’s acetate Fresenius Kabi due to the risk of possible coagulation
  • Suxamethone (muscle relaxant) and potassium are given concomitantly with Ringer’s acetate Fresenius Kabi can cause noticeably high levels of potassium in the blood.
  • The effect of muscle relaxants (such as suxamethonium and vecuron) can be enhanced by Ringer’s acetate Fresenius Kabi.
  • Drugs that can make potassium and sodium stay in the body. Examples of such drugs are:
    • corticosteroids/steroids (used to treat asthma and rheumatological diseases, for example)
    • potassium-sparing agents ( diuretics used in, for example, heart failure )
    • ACE inhibitor (used to treat high blood pressure and heart failure )
    • tacrolimus (used after organ transplants or to treat atopic eczema )
    • cyclosporine (used after organ transplants or to treat rheumatoid arthritis, psoriasis, or kidney disease).
  • Digitalis glycosides (used to treat heart failure and heart rhythm disorders, the effect may be enhanced by Ringer’s acetate Fresenius Kabi and increase the risk of side effects.
  • Drugs such as salicylates (painkillers or used to prevent blood clots) and lithium (used to treat bipolar disorder ) may be reduced as Ringer’s acetate Fresenius Kabi increases the secretion of these drugs.
  • Drugs such as ephedrine (found in cough medicines), pseudoephedrine (used for allergies ), and amphetamine, the effect may increase because Ringer’s acetate Fresenius Kabi reduces the secretion of these drugs.
  • Concomitant use with ceftriaxone (an antibiotic ) is not recommended when given intravenously (see section Warnings and precautions).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

How to give Ringer acetate Fresenius Kabi

Dosage one is individual and depends on the patient’s age, body weight, and disease state.

Ringer’s acetate Fresenius Kabi will be given to you by a doctor or nurse. Ringer’s acetate Fresenius Kabi is given as a drip into a vein ( intravenous infusion ).

If you are given too much Ringer’s acetate Fresenius Kabi 

Ringer’s acetate Fresenius Kabi solution for infusion will be given to you by a healthcare professional, so it is unlikely that you will receive too much medicine. Talk to your doctor or nurse if you experience symptoms of overdose such as:

  • Stretched skin, edema (swelling), or various disorders in your blood values.

If you have any further questions on the use of this product, ask your doctor or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediately if you get any symptoms of severe anaphylactic/anaphylactoid reaction (allergic shock) such as. swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing. (Rare side effects can affect up to 1 in 1,000 people.)

Common (may affect up to 1 in 10 people)

  • overhydration (too much fluid in the body)
  • heart failure in patients who already have a heart disease
  • pulmonary edema (accumulation of fluid in the lungs)
  • fever, injection site infection, local pain/reaction, irritation, inflammation and/or blockage of a vein, and tissue damage (due to accidental administration of the product outside the vein).

Rare (may affect up to 1 in 1,000 people)

  • hypersensitivity reactions, allergic reactions
  • conjunctivitis ( eye infection )
  • fast or slow heartbeat
  • rhinitis
  • hives on the whole body or parts of the body which means skin rash, redness, or itching
  • the feeling of pressure in the chest, chest pain.

Very rare (may affect up to 1 in 10,000 people)

  • abnormal electrolyte (salt) levels in the blood
  • cramps.

No known frequency (can not be calculated from the available data)

  • hypervolemia (abnormally large amount of blood in the body)
  • headache, nausea, cramps, sleep-like drowsiness ( lethargy ), vomiting. This can be caused by too low levels of sodium in the blood. When the blood sodium levels become very low, fluid penetrates the brain cells, causing them to swell. This increases the pressure in the skull and causes hyponatremic encephalopathy.
  • low sodium levels in the blood ( hyponatremia )
  • swelling of the brain which can cause brain damage.

How to store Ringer’s acetate Fresenius Kabi

No special storage instructions.

For storage instructions after opening, see the section for Healthcare professionals.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label/carton. The expiration date is the last day of the specified month.

Do not use this medicine if the solution is not clear and colorless or if the infusion bag is damaged.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • The active substances are:

Show larger

1 ml contains 1,000 ml contains
Sodium chloride 5.9 mg 5,900 mg
Sodium acetate trihydrate 4.1 mg 4 100 mg
Potassium chloride 0.3 mg 300 mg
Calcium chloride dihydrate 0.295 mg 295 mg
Magnesium chloride hexahydrate 0.2 mg 200 mg

The corresponding electrolyte content is: Show larger

1,000 ml contains
Cl  about 4,000 mg 112 mmol
Na + 2,990 mg 131 mmol
CH 3 COO  (acetate) 1 770 mg 30 mmol
+ 156 mg 4 mmol
Ca 2+ 80 mg 2 mmol
Mg 2+ 24 mg 1 mmol
  • The other ingredients are: water for injections, and concentrated hydrochloric acid (for pH adjustment).

What the medicine looks like and the contents of the pack

Infusion solution.

Clear, colorless, isotonic, sterile, and pyrogen-free solution with pH of about 6 and osmolality of about 270 mOsm / kg water.

Polypropylene bag (Freeflex): 15 x 500 ml, 20 x 500 ml, 10 x 1000 ml.

Plastic container (Pharmaflex): 4 x 2000 ml, 2 x 5000 ml.

Plastic container, Excel: 9 x 1000 ml

Marketing Authorization Holder and Manufacturer

Fresenius Kabi AB, 751 74 Uppsala

Manufacturer

Fresenius Kabi Norge AS, Svinesundsveien 80, 1788 Halden, Norway

Fresenius Kabi France, Louviers, France

Muhammad Nadeem

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