Clinimix (Intravenous)

Amino acids in dextrose injection is used as a dietary supplement for patients who cannot get enough calories and protein in their diet, often due to certain illnesses or recent surgery. It may also be used to treat negative nitrogen balance in the blood.

This medicine should only be given by or under the supervision of your doctor.

It is very important that your doctor checks you or your child closely to ensure that this medicine is working properly. Blood and urine tests are needed to monitor for unwanted effects.

This medicine may increase your risk for blood clots forming in the lungs or veins. This can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a cough, chest pain, fast heartbeat, trouble breathing, dizziness, lightheadedness, or fainting, or tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area.

Serious allergic reactions may occur while you are using this medicine. Tell your doctor right away if you have the following symptoms: rapid, shallow breathing, trouble breathing, fast heartbeat, lightheadedness, dizziness, or fainting, nausea or vomiting, rash or itchy skin, or a fever or chills.

This medicine may increase your risk of developing infections. Call your doctor right away if you start to have a cough that won't go away, weight loss, night sweats, fever, chills, flu-like symptoms (such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill), painful or difficult urination, or sores, ulcers, or white spots in the mouth or on the lips.

This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, talk with your doctor.

Call your doctor if you have redness, swelling, pain, or infection at the injection site.

This medicine may cause liver problems, including parenteral nutrition associated liver disease (PNALD). This usually occurs in patients who have been receiving parenteral nutrition for a long time, especially preterm infants. Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin.

This medicine may cause electrolyte imbalance, fluid overload, and aluminum toxicity (too much aluminum in the blood). Talk to your doctor if you have concerns.

In deciding to use a medicine, you and your doctor must consider the risks of taking it against the benefits it may provide. For this medicine, please consider the following:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients closely.

Pediatric

Research has not shown any specific problems in children that would limit the usefulness of amino acids in dextrose injection in the pediatric population. However, infants and children receiving this medicine are more likely to experience serious side effects (including low or high blood sugar, aluminum toxicity, liver problems, or excess ammonia in the blood). Safety and effectiveness have not been confirmed.

Geriatric

Research has not shown any specific problems in older adults that would limit the usefulness of amino acids in dextrose injection in the elderly. However, older patients are more likely to have age-related liver, kidney, or heart issues, which may require careful monitoring and a change in dosage for those receiving this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how your medicine interacts with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

• Acidosis (too much acid in the blood) or
• Errors in amino acid metabolism, inborn or
• Pulmonary edema (fluid in the lungs)—Should not be used in patients with these conditions.

• Diabetes or
• Heart disease or
• Kidney disease—Use with caution. May worsen these conditions.

• Electrolyte imbalance or
• Severe metabolic disorders—Should be corrected before using this medicine.

• Hyperglycemia (high blood sugar) worsened by dextrose or
• Weak immune system due to poor nutrition or other medicines—May increase the risk of infections.

• Severely undernourished patients—May cause refeeding syndrome. Monitor and gradually increase nutrient intake for these patients.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

Incidence not known

• Anxiety
• bloating
• blurred vision
• chest pain
• chills
• confusion
• cough or hoarseness
• dark urine
• decrease in the amount of urine
• dizziness or lightheadedness
• dry mouth
• extreme thirst
• fainting
• fast heartbeat
• fatigue
• fever
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• light-colored stools
• lower back or side pain
• nausea
• noisy, rattling breathing
• pain or redness at the injection site
• painful or difficult urination
• pale skin at the injection site
• seizure
• stomach pain
• sugar in the urine
• sweating
• swelling of the fingers, hands, feet, or lower legs
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• troubled breathing
• troubled breathing at rest
• unexplained weight loss
• urinating large amounts or very little
• vomiting
• weakness
• weight gain
• yellow eyes or skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Clinimix

Available Dosage Forms:

• Solution

Therapeutic Class: Parenteral Amino Acids

Chemical Class: Amino Acid

A nurse or other trained health professional will give you this medicine in a hospital or clinic. It is given through a needle placed into one of your veins.