N17G35E, N9G15E infusion solution 

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or nurse.

– If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Clinimix is ​​and what it is available for 
2. What you need to know before you receive Clinimix 
3. How to get Clinimix 
4. Possible side effects 
5. How to store Clinimix 6. Contents of the pack 
and other ingredients information 

1. What Clinimix is ​​and what it is available for

Clinimix is ​​a solution for infusion . It is delivered in a bag with two sections. One section contains an amino acid solution with electrolytes and the other contains a glucose solution with calcium chloride. The sections are separated by a closure which, just before it is to be given, is broken and the contents of the sections are mixed together by rolling the upper part of the bag together to open the closures.

Clinimix is ​​administered to nourish adults and children through a tube in a vein when normal oral intake is not appropriate.

Clinimix should only be given under the supervision of a medical professional.

2. What you need to know before you receive Clinimix

You should not receive Clinimix

  • you are allergic to any of the ingredients of this medicine (listed in section 6).
  • if your body can not utilize certain amino acids .
  • if you have too much sugar in your blood (severe hyperglycaemia ).
  • if the blood is too acidic (metabolic acidosis caused by access to too much lactic acid ).
  • if you have too high sodium , potassium , magnesium , calcium and / or phosphorus levels in your blood ( hypernatremia , hyperkalaemia , hypermagnesaemia, hypercalcaemia and / or hyperphosphataemia ).
  • in children younger than 28 days of age, ceftriaxone should not be given concomitantly with intravenous calcium- containing solutions , as particles may then form.

In all cases, the doctor will base his decision on whether you should receive this medicine on factors such as age, weight and medical condition, together with the results of any tests performed.

Warnings and cautions

Talk to your doctor or nurse before receiving Clinimix.

Talk to your doctor or nurse if any abnormal signs or symptoms of an allergic reaction develop, such as fever, chills, rash or difficulty breathing, excessive sweating, nausea or headache, then the infusion should be stopped immediately.

Your doctor will monitor your condition while you are receiving the medicine and may change your dose or give you additional nutrients, e.g. lipids , vitamins , electrolytes and trace elements if he / she deems it appropriate.

Some medicines and diseases can increase the risk of developing infection or sepsis(bacteria in the blood). There is a particular risk of infection or sepsis when a tube ( intravenous catheter ) is inserted into your vein. Your doctor will monitor you closely for any signs of infection . The use of aseptic bacteria-free technology when the catheter is placed and maintained and when the nutrient solution is prepared can reduce the risk of infection.

Clinimix with electrolyte contains calcium . It should not be given with the antibiotic ceftriaxone as particles can then form.

If you are severely malnourished and need nutrition through a vein, it is recommended that parenteral nutrition be started slowly and carefully.

Your doctor will monitor your condition at the beginning of the infusion , especially if you currently have liver, kidney, adrenal – heart or circulatory problems. Your doctor should also be aware of serious conditions that affect your body’s ability to handle sugar, fats, proteins or salt (metabolic disorders).

If any abnormalities occur, including venous irritation, the infusion must be stopped .

To check the effect and continuously monitor that the medication is taking place safely, the doctor will perform clinical and laboratory tests while you are receiving this medicine. If you are taking this medicine for several weeks, your blood status will be monitored regularly. Especially in case of glucose intolerance, the glucose level in the blood and urine should be monitored routinely and if you are diabetic, the insulin dose may need to be adjusted.

Children and young people

When used to treat newborns and children under 2 years of age, the solution (in sachets and administration sets) should be protected from light exposure until administration is complete. If Clinimix is ​​exposed to ambient light, especially after the addition of trace elements and / or vitamins , peroxides and other degradation products are formed, which can be reduced if the product is protected from light exposure.

Other medicines and Clinimix

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

Clinimix with electrolyte contains calcium . It should not be given with the antibiotic ceftriaxone as particles may form.

Due to the potassium content of Clinimix, special care should be taken in patients treated with potassium-sparing diuretics , (for example, amiloride, spironolactone , triamterene) ACE (angiotensin converting enzyme ) inhibitors, angiotensin II receptor antagonists, or the immunosuppressive drugs tachycosporin given the risk of hyperkalemia .

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

3. How to get Clinimix

Before giving Clinimix, the seal between the two sections should be broken and the contents of the two sections mixed.

Clinimix can be given to adults and children.

It is a solution for infusion , which should be administered via a plastic tube in a vein in the arm or in a large vein in the chest.

When used to treat newborns and children under 2 years of age, the solution (in sachets and administration sets) should be protected from exposure to light until administration is complete (see section 2).

Dosage – adults and children

Your doctor will decide what dose you need and for how long. It depends on age, weight, height, clinical condition, daily fluid requirements and energy and nitrogen requirements.

Clinimix should always be used according to the doctor’s instructions. Consult a doctor if you are unsure.

Prescription one can continue for as long as needed, depending on your clinical condition.

Infusion one of a bag usually takes between 8 and 24 hours.

If you take more Clinimix than you should

If the dose is too high or the infusion is too fast, you may get too much fluid in the circulation and the blood may become too acidic. The glucose content can increase the glucose level in the blood and urine. Excessive volume can cause nausea, vomiting, chills and disturbances in the electrolyte balance, in which case the infusionshould be stopped immediately.

In some severe cases, the doctor may need to give temporary kidney dialysis to help the kidneys get rid of the excess product.

To prevent this from happening, your doctor should monitor your condition regularly and test your blood counts.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice any change in how you feel during or after treatment, contact your doctor or nurse immediately.

The tests that your doctor performs while you are taking this medicine should minimize the risk of side effects .

If abnormal signs or symptoms of an allergic reaction are detected, such as abnormally low or high blood pressure , a blue or purple discoloration of the skin, abnormally high heart rate, difficulty breathing, vomiting, nausea, skin rash, elevated body temperature, excessive sweating, chills and shaking infusion is discontinued immediately.

Other side effects have been observed, more or less frequent:

  • Anaphylaxis (a severe allergic reaction that develops rapidly and can cause death)
  • High levels of glucose and ammonia- and nitrogen-containing compounds in the blood
  • Impaired liver function, abnormal blood test results for liver function
  • Inflammation of the gallbladder, presence of gallstones in the gallbladder
  • Venous inflammation at the infusion site, venous irritation, pain, irritation, feeling hot, swelling
  • Glucose in the urine
  • Diabetic coma
  • Formation of small particles that block the blood vessels in the lungs.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Clinimix

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

When used to treat newborns and children under 2 years of age, the solution (in sachets and administration sets) should be protected from exposure to light until administration is complete (see section 2).

Do not use this medicine after the expiry date which is stated on the bag and the outer carton after EXP. The expiration date is the last day of the specified month.

Do not freeze.

Store the packaging in the outer carton.

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.

6. Contents of the packaging and other information

Content declaration

The active substances for vaje bag reconstituted solution are:

Clinimix N9G15E

Active substances r 1 l 1.5 l 2 l
L-alanine 5.70 g 8.54 g 11.39 g
L- arginine 3.17 g 4.75 g 6.33 g
Glycine 2.84 g 4.25 g 5.67 g
L-histidine 1.32 g 1.98 g 2.64 g
L-isoleucine 1.65 g 2.48 g 3.30 g
L-leucine 2.01 g 3.02 g 4.02 g
L- lysine 1.60 g 2.39 g 3.19 g
(as lysine hydrochloride) (2.00 g) (2.99 g) (3.99 g)
L-methionine 1.10 g 1.65 g 2.20 g
L-phenylalanine 1.54 g 2.31 g 3.08 g
L- proline 1.87 g 2.81 g 3.74 g
L- serine 1.38 g 2.06 g 2.75 g
L-threonine 1.16 g 1.73 g 2.31 g
L-tryptophan 0.50 g 0.74 g 0.99 g
L-tyrosine 0.11 g 0.17 g 0.22 g
L- valin 1.60 g 2.39 g 3.19 g
Sodium acetate 3H 2 O 2.16 g 3.23 g 4.31 g
Dibasic potassium phosphate 2.61 g 3.92 g 5.22 g
Sodium chloride 1.12 g 1.68 g 2.24 g
Magnesium chloride 6H 2 O 0.51 g 0.77 g 1.02 g
Anhydrous glucose 75 g 113 g 150 g
(as glucose monohydrate) (83 g) (124 g) (165 g)
Calcium chloride 2H 2 O 0.33 g 0.50 g 0.66 g

Climax N17G35E

Active substances 1 l 1.5 l 2 l
L-alanine 10.35 g 15.53 g 20.70 g
L- arginine 5.75 g 8.63 g 11.50 g
Glycine 5.15 g 7.73 g 10.30 g
L-histidine 2.40 g 3.60 g 4.80 g
L-isoleucine 3.00 g 4.50 g 6.00 g
L-leucine 3.65 g 5.48 g 7.30 g
L- lysine 2.90 g 4.35 g 5.80 g
(as lysine hydrochloride) (3.63 g) (5.44 g) (7.25 g)
L-methionine 2.00 g 3.00 g 4.00 g
L-phenylalanine 2.80 g 4.20 g 5.60 g
L- proline 3.40 g 5.10 g 6.80 g
L- serine 2.50 g 3.75 g 5.00 g
L-threonine 2.10 g 3.15 g 4.20 g
L-tryptophan 0.90 g 1.35 g 1.80 g
L-tyrosine 0.20 g 0.30 g 0.40 g
L- valin 2.90 g 4.35 g 5.80 g
Sodium acetate 3H 2 O 3.40 g 5.10 g 6.80 g
Dibasic potassium phosphate 2.61 g 3.92 g 5.22 g
Sodium chloride 0.59 g 0.88 g 1.18 g
Magnesium chloride 6H 2 O 0.51 g 0.77 g 1.02 g
Anhydrous glucose 175 g 263 g 350 g
(as glucose monohydrate) (193 g) (289 g) (385 g)
Calcium chloride 2H 2 O 0.33 g 0.50 g 0.66 g

Other ingredients are:

  • concentrated acetic acid, hydrochloric acid (to adjust the pH of the solution ),
  • water for injections.

What the medicine looks like and contents of the pack

Clinimix is ​​an infusion solution, in a bag with two sections in multilayer plastic. The inner layer of the bag material (the contact layer) is made of polymers (a mixture of polyolefin copolymers) which are compatible with the ingredients and the approved additives. The other layers are made of EVA (polyethylene-vinyl acetate) and of a copolyester.

Before reconstitution , the amino acid and glucose solutions are clear and colorless or slightly yellow. After reconstitution , the solution is also clear and colorless or slightly yellow.

To avoid contact with oxygen from the air, the bag is packed in an outer bag with an oxygen barrier. It contains a small bag with an oxygen absorber.

Pack sizes:

1000 ml in a bag: carton with 8 bags

1000 ml: 1 bag

1500 ml in a bag: carton with 6 bags

1500 ml: 1 bag

2000 ml in a bag: carton with 4 bags

2000 ml: 1 bag

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Baxter Medical AB

Box 63

164 94 Kista

Manufacturer

Baxter SA, Boulevard René Branquart, 80, 7860 Lessines, Belgium

Muhammad Nadeem

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