powder for solution for injection / infusion 0.6 g, 1.2 g, 3 g and 6 g.
benzylpenicillin sodium
1. WHAT BENZYLPENICILLIN PANPHARMA IS AND WHAT IT IS USED FOR
Benzylpenicillin Panpharma is a medicine that works against bacterial infections ( antibiotics ).
Benzylpenicillin Panpharma is used to treat infections caused by benzylpenicillin-sensitive bacteria.
Benzylpenicillin sodium contained in Benzylpenicillin Panpharma may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
2. WHAT YOU NEED TO KNOW BEFORE USING BENZYLPENICILLIN PANPHARMA
Do not use Benzylpenicillin Panpharma
- if you are hypersensitive (allergic) to penicillin or any of the other ingredients of this medicine (listed in section 6).
- if you have previously had a severe allergic reaction to cephalosporins (another type of antibiotic ).
Warnings and cautions
Talk to your doctor or pharmacist before using benzylpenicillin Panpharma.
Take special care with Benzylpenicillin Panpharma
- if you have impaired kidney function
- if you have heart failure
- is over 60 years old
- plan to give this medicine to a newborn
Other medicines and Benzylpenicillin Panpharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might have taken any other medicines. This is especially important for your doctor to know if you are taking any of the following:
- probenecid (an anti-gout medicine that inhibits the secretion of Benzylpenicillin Panpharma)
- methotrexate ( cytostatics ). Concomitant use with benzylpenicillin may increase the efficacy and toxicity of methotrexate
Pregnancy and breastfeeding
There is a small risk of adverse effects on the pregnancy, the fetus, or the newborn baby.
This drug passes to a small extent into breast milk. The risk of harmful effects on the breast-feeding baby seems unlikely, although the baby may have an effect on the bacterial flora in the gut and mouth.
Ask your doctor or pharmacist for advice before taking any medicine
Driving and using machines
Benzylpenicillin Panpharma has little or no effect on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. HOW TO USE BENZYLPENICILLIN PANPHARMA
The nurse or doctor will give you an injection.
The doctor will determine the appropriate dose for you, and how and when the injection should be given.
Benzylpenicillin Panpharma is a dry powder that is dissolved by the doctor or nurse in sterile water or other suitable diluents. The solution is either injected into a blood vessel or muscle or given via a blood vessel as a drip infusion.
If you take more Benzylpenicillin Panpharma than you should
Because an injection is given by a doctor or nurse, it is unlikely that you will receive an excessive amount.
If you think you have been given too much, you must tell the person who gave you the injection.
Seizures have occurred in patients who received an injection of very high doses of benzylpenicillin by mistake. In such cases, treatment must be stopped and antispasmodic treatment instituted.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Benzylpenicillin Panpharma can have side effects, although not everybody gets them. Tell your doctor immediately if you think the medicine makes you feel sick, or if you experience any of the following:
Severe allergic reactions (anaphylactic reactions or angioedema ):
- rash
- difficulty breathing or tightness over the chest
- swelling of the eyelids, face, or lips
- swelling or redness of the tongue
- fever
- joint pain
- swollen lymph nodes
Common (affects 1 to 10 users in 100):
- eczema and rash
- thrombophlebitis (local inflammation of a vein at the injection site)
Uncommon (affects 1 to 10 users in 1000):
- hives
- eosinophilia (increased number of white blood cells in the blood)
Rare (affects 1 to 10 users in 10,000):
- anaphylactic reactions (severe allergic reactions)
- agranulocytosis ( white blood cells deficiency of white blood cells)
- hemolytic anemia (low levels of red blood cells in the blood, autoimmune)
- leukopenia (low levels of white blood cells in the blood)
- diarrhea.
Other side effects (it is not known how often these side effects may occur)
– AGEP – Acute generalized exanthematous pustulosis with symptoms such as severe skin reactions with or without reddening of the skin, fever, warts
– maculopapular rash (a flat and red area on the skin)
– morbilliform rash (measles-like rash)
– itching
– erythema ( inflammatory skin redness)
– thrombocytopenia (low levels of platelets in the blood)
– anemia (low levels of red blood cells in the blood)
– metabolic encephalopathy (neurological disorders with seizures and loss of consciousness).
Reporting of side effects ar
If you get any side effects, talk to your doctor or pharmacist. this also applies to any side effects not mentioned in this information. You can also report side effects directly via the Medical Products Agency
Box 26
751 03 Uppsala
Website: www.läkemedelsverket.se
By reporting side effects, you can help increase drug safety information.
5. HOW TO STORE BENZYLPENICILLIN PANPHARMA
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Prepared solutions should be used immediately.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
The medicine 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 substance is benzylpenicillin sodium
- No other ingredients
What the medicine looks like and the contents of the pack
Benzylpenicillin Panpharma is a white or almost white crystalline powder.
The powder is packed in glass vials with rubber stoppers and aluminum closures and contains 0.6 g, 1.6 g, 3 g, and 6 g of powder, respectively.
The packs contain 10 glass vials.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Panpharma SA
Z.I. du Clair
35133 Luitré,
France