SmofKabiven extra Nitrogen is an emulsion for infusion given into your blood by a drip (intravenous infusion). The product contains amino acids (components used to build proteins), glucose (carbohydrates), lipids (fat) and salts (electrolytes) in a plastic bag and can be given to adults and children aged 2 years and above.

A healthcare professional will give you SmofKabiven extra Nitrogen when other forms of feeding are not good enough or have not worked.

Do not use SmofKabiven extra Nitrogen

-        if you are allergic (hypersensitive) to active substances or any of the other ingredients of this medicine (listed in section 6)

-        if you are allergic to fish or egg

-        if you are allergic to peanuts or soya you should not use this product. SmofKabiven extra Nitrogen contains soya-bean oil

-        if you have too much lipids in the blood (hyperlipidemia)

-        if you have serious liver disorder

-        if you have blood clotting problems (coagulation disorder)

-        if your body has problems using amino acids

-        if you have serious kidney disease without access to dialysis

-        if you are in acute shock

-        if you have too much sugar in your blood (hyperglycaemia) which is uncontrolled

-        if you have high blood (serum) levels of the salts (electrolytes) included in SmofKabiven extra Nitrogen

-        if you have fluid in the lungs (acute pulmonary oedema)

-        if you have too much body fluid (hyperhydrated)

-        if you have heart failure that is not treated

-        if you have a defect in your blood clotting system (hemophagocytotic syndrome)

-        if you are in an unstable condition, such as after serious trauma, uncontrolled diabetes, acute heart attack, stroke, blood clot, metabolic acidosis (a disturbance resulting in too much acid in the blood), serious infection (severe sepsis), coma and if you don’t have enough body fluid (hypotonic dehydration)

-        in newborn babies or children under 2 years of age

Warnings and precautions

Talk to your doctor before using SmofKabiven extra Nitrogen if you have:

-            kidney problems

-            diabetes mellitus

-            pancreatitis (inflammation of the pancreas)

-            liver problems

-            hypothyrodism (thyroid problems)

-            sepsis (serious infection)

If you during the infusion get fever, rash, swelling, difficulty in breathing, chills, sweating, nausea or vomiting, tell the healthcare professional immediately because these symptoms might be caused by an allergic reaction or that you have been given too much of the medicine.

Your doctor may regularly need to check your blood for liver function tests and other values.

Children and adolescents

SmofKabiven extra Nitrogen is not meant for newborn babies or children younger than 2 years of age. SmofKabiven extra Nitrogen can be given to children and adolescents from 2 to 16/18 years old.

Other medicines and SmofKabiven extra Nitrogen

Tell your doctor if you are taking, have recently taken or might take any other medicines, even without prescription.

Pregnancy and breast-feeding

Data from using SmofKabiven extra Nitrogen during pregnancy or breast-feeding is lacking. SmofKabiven extra Nitrogen should therefore be given to pregnant or breast-feeding women only if the doctor find it necessary. The use of SmofKabiven extra Nitrogen may be considered during pregnancy and breastfeeding, as advised by your doctor.

Driving and using machines

Not relevant as the medicine is given at the hospital.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Your doctor will decide on the dose for you individually depending on your body weight and function. SmofKabiven extra Nitrogen will be given to you by a healthcare professional.

If you use more SmofKabiven extra Nitrogen than you should

It is unlikely that you will receive too much medicine as SmofKabiven extra Nitrogen is given to you by a healthcare professional.

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

Common (may affect up to 1 in 10 people): a slightly raised body temperature.

Uncommon (may affect up to 1 in 100 people): high blood (plasma) levels of compounds from the liver, lack of appetite, nausea, vomiting, chills, dizziness and headache.

Rare (may affect up to 1 in 1,000 people): low or high blood pressure, difficulty in breathing, fast heart beat (tachycardia). Hypersensitivity reactions (that can give symptoms like swelling, fever, fall in blood pressure, skin rashes, wheals (raised red areas), flushing, headache). Sensations of hot and cold. Paleness. Light blue coloured lips and skin (because of too less oxygen in the blood). Pain in the neck, back, bones, chest and loins.

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 via (see details below).
*By reporting side effects you can help provide more information on the safety of this medicine.
 

To report any side effect(s):

·        

Saudi Arabia:

• -     Pharmacovigilance & Medical Device section: ·         P.O.Box: 1853 ·         Tel: 80011111 ·         E-mail: pv@mohap.gov.ae Drug Department Ministry of Health & Prevention – Dubai- UAE

  UAE:

-     Pharmacovigilance & Medical Device section:

·         P.O.Box: 1853

·         Tel: 80011111

·         E-mail: pv@mohap.gov.ae

Drug Department

Ministry of Health & Prevention – Dubai- UAE

Other GCC states

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

Store in overpouch. Do not store above 25°C. Do not freeze.

Do not use this medicine after the expiry date which is stated on the label on the bag and box. The expiry date refers to the last day of that month.