Patient Leaflet Updated 09-Mar-2023 | Merck Sharp & Dohme (UK) Limited
PRIMAXIN IV Injection
PRIMAXIN® IV 500mg/500mg powder for solution for infusion
imipenem/cilastatin
1. What PRIMAXIN IV is and what it is used for
2. What you need to know before you use PRIMAXIN IV
3. How to use PRIMAXIN IV
4. Possible side effects
5. How to store PRIMAXIN IV
6. Contents of the pack and other information
PRIMAXIN IV belongs to a group of medicines called carbapenem antibiotics. It kills a wide range of bacteria (germs) that cause infections in various parts of the body in adults and children one year of age and above.
Your doctor has prescribed PRIMAXIN IV because you have one (or more) of the following types of infection:
PRIMAXIN IV may be used in the management of patients with low white blood cell counts, who have fever that is suspected to be due to a bacterial infection.
PRIMAXIN IV may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above.
Tell your doctor about any medical condition you have or have had including:
You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells. Your doctor will discuss this with you.
Children
PRIMAXIN IV is not recommended in children less than one year of age or children with kidney problems.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking ganciclovir which is used to treat some viral infections.
Also, tell your doctor if you are taking valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraine, or schizophrenia) or any blood thinners such as warfarin.
Your doctor will decide whether you should use PRIMAXIN IV in combination with these medicines.
It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving PRIMAXIN IV. PRIMAXIN IV has not been studied in pregnant women. PRIMAXIN IV should not be used during pregnancy unless your doctor decides the potential benefit justifies the potential risk to the developing baby.
It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving PRIMAXIN IV. Small amounts of this medicine may pass into breast milk and it may affect the baby. Therefore, your doctor will decide whether you should use PRIMAXIN IV while breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
There are some side effects associated with this product (such as seeing, hearing, or feeling something that is not there, dizziness, sleepiness, and a spinning sensation) that may affect some patients' ability to drive or operate machinery (see section 4).
This medicine contains 37.6 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 1.9% of the recommended maximum daily dietary intake of sodium for an adult.
PRIMAXIN IV will be prepared and given to you by a doctor or another health care professional. Your doctor will decide how much PRIMAXIN IV you need.
Use in adults and adolescents
The recommended dose for adults and adolescents is 500 mg/500 mg every 6 hours or 1,000 mg/1,000 mg every 6 or 8 hours. If you have kidney problems your doctor may lower your dose.
Use in children
The recommended dose for children one year of age or older is 15/15 or 25/25 mg/kg/dose every 6 hours. PRIMAXIN IV is not recommended in children under one year of age and children with kidney problems.
Method of administration
PRIMAXIN IV is given intravenously (into a vein) over 20-30 minutes for a dose of ≤500 mg/500 mg or 40-60 minutes for a dose of >500 mg/500 mg. The rate of infusion may be slowed if you feel sick.
Symptoms of overdose may include seizures (fits), confusion, tremors, nausea, vomiting, low blood pressure and slow heart rate. If you are concerned that you may have been given too much PRIMAXIN IV, contact your doctor or another healthcare professional immediately.
If you are concerned that you may have missed a dose, contact your doctor or another healthcare professional immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
The following side-effects occur rarely, however if they do occur, while receiving or after receiving PRIMAXIN IV, the medicine must be stopped and your doctor contacted immediately.
Other possible side effects:
Common
Uncommon
Rare
Very rare
Not known
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of that month.
Do not store above 25 °C.
After reconstitution:
Diluted solutions should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed two hours.
Do not freeze the reconstituted solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
PRIMAXIN IV is a white to light yellow powder for solution for infusion in a glass vial. Pack sizes of 1, 10 or 25 vials. Not all pack sizes may be marketed.
The Marketing Authorisation Holder is
The manufacturer is
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria: Zienam
Bulgaria: Tienam
Cyprus: Tienam
France: TIENAM
Germany: ZIENAM
Hungary: Tienam
Netherlands: TIENAM
Norway: Tienam
Portugal: Tienam IV
Sweden: Tienam
United Kingdom (Northern Ireland): Primaxin IV
This leaflet was last revised in January 2023
© 2023 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.
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